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Thompson CA, Willis TA, Farrin A, Gordon A, Daffu-O'Reilly A, Noakes C, Khaliq K, Kemp A, Hall T, Bojke C, Spilsbury K. Technology-enabled CONTACT tracing in care homes in the COVID-19 pandemic: the CONTACT non-randomised mixed-methods feasibility study. Health Technol Assess 2025:1-24. [PMID: 40350743 DOI: 10.3310/uhdn6497] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/14/2025] Open
Abstract
Background Coronavirus disease 2019 devastated lives in care homes for older people, where residents faced higher mortality risks than the general population. Infection prevention and control decisions were critical to protect these vulnerable residents. Infection prevention and control measures like 'lockdowns' had their own risks, such as social isolation, alongside assumed benefits. A key non-pharmaceutical intervention for managing infections is contact tracing. Traditional contact tracing, which relies on recalling contacts, is not feasible in care homes where approximately 70% of residents have cognitive impairments. The CONtact TrAcing in Care homes using digital Technology intervention introduces Bluetooth-enabled wearable devices for automated contact tracing. We provided structured reports (scheduled regularly and in reaction to positive COVID-19 cases) on contact patterns to homes to support better-informed infection prevention and control decisions and potentially reduce blanket restrictive measures. We also partnered with the PROTECT COVID-19 research team to examine air quality in two of our homes. Methods CONTACT was a non-randomised mixed-method feasibility study in four English care homes. Recruitment was via care home research networks, with individual consent. Data collection included routine device data, case report forms, qualitative interviews, field observations of care home activity and an adapted Normalisation Measure Development questionnaire survey to explore implementation using normalisation process theory. Quantitative data were analysed using descriptive statistical methods, and qualitative data were thematically analysed using normalisation process theory. Intervention and study delivery were evaluated against predefined progression criteria. Results Of 156 eligible residents, 105 agreed to wear a device, with 102 (97%) starting the intervention. Of 225 eligible staff, 82.4% (n = 178) participated. Over 2 months, device loss and battery failure were significant: residents lost 11% of devices, with half replaced. Staff lost fewer devices, just 6.5%, but < 10% were replaced. Fob wearables needed more battery changes than card-type devices (15% vs. 0%). Homes variably understood structured and reactive feedback but were unlikely to act on it. Researcher support for interpreting reports was valued. Homes found information useful when it confirmed rather than challenged preconceived contact patterns. Staff privacy concerns were a barrier to adoption. Study procedures added to existing work, making participation burdensome. The perceived burden of participation, amplified by the pandemic context, outweighed the benefits. CONTACT did not meet its quantitative or qualitative progression criteria. Limitations Researchers had to pragmatically adapt procedures, resulting in suboptimal implementation choices from an implementation science perspective. Future research should co-design interventions with homes, focusing on implementation and wearability as much as technical effectiveness. Conclusion A definitive trial of CONTACT was not feasible or acceptable to care homes, partly due to the shifting pandemic context and demands on homes. With more effective implementation, Bluetooth-enabled wearable systems as part of 'Internet of Things' in homes could be used to: (1) better understand airborne transmission risks, ventilation and air quality and (2) make important relational aspects of care quality and residents' quality of life more transparent. Future work We will continue to explore the possibilities of Bluetooth-enabled wearables for modelling social networks, movement, infection risks and quality in care homes with academic and care partners. Funding This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR132197.
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Affiliation(s)
| | - Thomas A Willis
- Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Amanda Farrin
- Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Adam Gordon
- Academic Centre for Healthy Ageing, Queen Mary University of London, London, UK
| | | | | | - Kishwer Khaliq
- School of Civil Engineering, University of Leeds, Leeds, UK
| | - Andrew Kemp
- School of Electronic and Electrical Engineering, University of Leeds, Leeds, UK
| | - Tom Hall
- South Tyneside Council, South Shields, UK
| | - Chris Bojke
- Academic Unit of Health Economics, School of Medicine, University of Leeds, Leeds, UK
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Hirsch S, Feneberg AC, Skoluda N, Nater UM, Mewes R. Pilot study of an ecological momentary music intervention for stress reduction in Turkish immigrant women perceiving chronic ethnic discrimination. Sci Rep 2025; 15:12274. [PMID: 40210688 PMCID: PMC11985981 DOI: 10.1038/s41598-025-96998-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/02/2024] [Accepted: 04/01/2025] [Indexed: 04/12/2025] Open
Abstract
Perceived ethnic discrimination is a stressor that negatively affects mental and physical health. To address this issue, we tested the feasibility and preliminary effectiveness of an ecological momentary music intervention for stress reduction in everyday life in Turkish immigrant women perceiving chronic ethnic discrimination. Following an intra-individual randomized design, we combined subjective assessments and biological measures (salivary cortisol and alpha-amylase). Using a smartphone-based app, twenty participants responded to stress- and discrimination-related items four times a day for 35 days, and additionally reported each stressful/discriminatory event they perceived. Participants were then randomly instructed to listen to music or not. At each measurement time point, participants provided saliva samples. The feasibility of the ecological momentary music intervention was indicated by high usage rates of the app and participants' positive self-reports. We found immediate (post 1: b = - 14.64, p = .045, post 2: b = - 14.62, p = .047) and intermediate (b = - 0.81, p < .001) effects of music listening on subjective stress levels but not on biological stress levels. Our study provides valuable insights into the potential of music listening for stress reduction in the everyday life of Turkish immigrant women perceiving chronic ethnic discrimination.
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Affiliation(s)
- Stefanie Hirsch
- Outpatient Unit for Research, Teaching and Practice, Faculty of Psychology, University of Vienna, Wächtergasse 1, 1010, Vienna, Austria.
- Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria.
- University Research Platform 'The Stress of Life (SOLE) - Processes and Mechanisms Underlying Everyday Life Stress', University of Vienna, Vienna, Austria.
| | - Anja C Feneberg
- Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria
- University Research Platform 'The Stress of Life (SOLE) - Processes and Mechanisms Underlying Everyday Life Stress', University of Vienna, Vienna, Austria
- Clinical Psychology of Childhood and Adolescence, Institute of Psychology, University of Münster, Fliednerstraße 21, 48149, Münster, Germany
| | - Nadine Skoluda
- Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria
- University Research Platform 'The Stress of Life (SOLE) - Processes and Mechanisms Underlying Everyday Life Stress', University of Vienna, Vienna, Austria
| | - Urs M Nater
- Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria
- University Research Platform 'The Stress of Life (SOLE) - Processes and Mechanisms Underlying Everyday Life Stress', University of Vienna, Vienna, Austria
| | - Ricarda Mewes
- Outpatient Unit for Research, Teaching and Practice, Faculty of Psychology, University of Vienna, Wächtergasse 1, 1010, Vienna, Austria
- University Research Platform 'The Stress of Life (SOLE) - Processes and Mechanisms Underlying Everyday Life Stress', University of Vienna, Vienna, Austria
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Ferguson JL. Adopting a Holistic Approach to Alcohol Brief Interventions for Women in a Prison Setting in the UK: A Qualitative Exploration. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2024; 21:1671. [PMID: 39767511 PMCID: PMC11675901 DOI: 10.3390/ijerph21121671] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/08/2024] [Revised: 12/03/2024] [Accepted: 12/09/2024] [Indexed: 01/11/2025]
Abstract
Currently, women make up only 5% of the prison population, with 3604 women in prison in the UK compared to 74,981 men. Risky drinking is highly prevalent in both the male and female prison population, however, significantly more females drink in a risky way prior to prison (24% compared to 18% of men). In addition to risky drinking, those entering the criminal justice system (CJS), particularly women, are more likely to suffer from inequalities in society. Such inequalities can be linked to the pains of imprisonment for women. The overall research methods discussed in this paper are qualitative interviews. The interviews were designed after two systematic reviews exploring: the gendered pains of imprisonment and the feasibility and acceptability of women and alcohol brief interventions (ABI) were conducted. Interviews were conducted in an open prison setting, with both female residents and relevant staff and stakeholders. To date there is a dearth of evidence in relation to delivering ABI's in prison, specifically with women. This research explored the feasibility and acceptability of delivering ABI to women in prison and found that when delivering ABI's in a prison setting, by underpinning the research with criminological theory, could help women capitalise on the "teachable moment" necessary to induce behaviour change. The findings of the interviews found the intervention was both feasible and acceptable and identified five themes highlighting the women's journey through prison chronologically to enable a more holistic ABI to be developed in future.
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Affiliation(s)
- Jennifer Louise Ferguson
- Law, Policing and Criminology Department, School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough TS1 3BA, UK
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4
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Thompson CA, Willis T, Farrin A, Gordon A, Dafu-O'Reilly A, Noakes C, Khaliq K, Kemp A, Hall T, Bojke C, Spilsbury K. CONTACT: a non-randomised feasibility study of bluetooth-enabled wearables for contact tracing in UK care homes during the COVID-19 pandemic. Pilot Feasibility Stud 2024; 10:125. [PMID: 39358817 PMCID: PMC11445870 DOI: 10.1186/s40814-024-01549-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/08/2023] [Accepted: 09/20/2024] [Indexed: 10/04/2024] Open
Abstract
BACKGROUND The need for effective non-pharmaceutical infection prevention measures such as contact tracing in pandemics remains in care homes, but traditional approaches to contact tracing are not feasible in care homes. The CONTACT intervention introduces Bluetooth-enabled wearable devices (BLE wearables) as a potential solution for automated contact tracing. Using structured reports and reports triggered by positive COVID-19 cases in homes, we fed contact patterns and trends back to homes to support better-informed infection prevention decisions and reduce blanket application of restrictive measures. This paper reports on the evaluation of feasibility and acceptability of the intervention prior to a planned definitive cluster randomised trial of the CONTACT BLE wearable intervention. METHODS CONTACT was a non-randomised mixed-method feasibility study over 2 months in four English care homes. Recruitment was via care home research networks, with individual consent. Data collection methods included routine data from the devices, case report forms, qualitative interviews (with staff and residents), field observation of care, and an adapted version of the NoMaD survey instrument to explore implementation using Normalisation Process Theory. Quantitative data were analysed using descriptive statistical methods. Qualitative data were thematically analysed using a framework approach and Normalisation Process Theory. Intervention and study delivery were evaluated against predefined progression criteria. RESULTS Of 156 eligible residents, 105 agreed to wear a device, with 102 (97%) starting the intervention. Of 225 eligible staff, 82% (n = 178) participated. Device loss and damage were significant: 11% of resident devices were lost or damaged, ~ 50% were replaced. Staff lost fewer devices, just 6%, but less than 10% were replaced. Fob wearables needed more battery changes than card-type devices (15% vs. 0%). Structured and reactive feedback was variably understood by homes but unlikely to be acted on. Researcher support for interpreting reports was valued. Homes found information useful when it confirmed rather than challenged preconceived contact patterns. Staff privacy concerns were a barrier to adoption. Study procedures added to existing work, making participation burdensome. Study participation benefits did not outweigh perceived burden and were amplified by the pandemic context. CONTACT did not meet its quantitative or qualitative progression criteria. CONCLUSION CONTACT found a large-scale definitive trial of BLE wearables for contact tracing and feedback-informed IPC in care homes unfeasible and unacceptable - at least in the context of shifting COVID-19 pandemic demands. Future research should co-design interventions and studies with care homes, focusing on successful intervention implementation as well as technical effectiveness. TRIAL REGISTRATION ISRCTN registration: 11204126 registered 17/02/2021.
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Affiliation(s)
- Carl A Thompson
- School of Healthcare, University of Leeds, Baines Wing, Leeds, LS2 9JT, UK.
| | - Thomas Willis
- Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK
| | - Amanda Farrin
- Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK
| | - Adam Gordon
- Academic Centre for Healthy Ageing, Queen Mary University, London, E1 2AD, UK
| | | | - Catherine Noakes
- School of Civil Engineering, University of Leeds, Leeds, LS2 9JT, UK
| | - Kishwer Khaliq
- School of Civil Engineering, University of Leeds, Leeds, LS2 9JT, UK
| | - Andrew Kemp
- School of Electronics and Electrical Engineering, University of Leeds, LS2 9JT, Leeds, UK
| | - Tom Hall
- South Tyneside Council, South Shields, NE33 2RL, UK
| | - Chris Bojke
- School of Medicine, Academic Unit of Health Economics, University of Leeds, Leeds, LS2 9JT, UK
| | - Karen Spilsbury
- School of Healthcare, University of Leeds, Baines Wing, Leeds, LS2 9JT, UK
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5
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Sun L, Booth A, Sworn K. Adaptability, Scalability and Sustainability (ASaS) of complex health interventions: a systematic review of theories, models and frameworks. Implement Sci 2024; 19:52. [PMID: 39020399 PMCID: PMC11253497 DOI: 10.1186/s13012-024-01375-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2024] [Accepted: 06/23/2024] [Indexed: 07/19/2024] Open
Abstract
BACKGROUND Complex health interventions (CHIs) are increasingly used in public health, clinical research and education to reduce the burden of disease worldwide. Numerous theories, models and frameworks (TMFs) have been developed to support implementation of CHIs. This systematic review aims to identify and critique theoretical frameworks concerned with three features of implementation; adaptability, scalability and sustainability (ASaS). By dismantling the constituent theories, analysing their component concepts and then exploring factors that influence each theory the review team hopes to offer an enhanced understanding of considerations when implementing CHIs. METHODS This review searched PubMed MEDLINE, CINAHL, Web of Science, and Google Scholar for research investigating the TMFs of complex health interventions. Narrative synthesis was employed to examine factors that may influence the adaptability, scalability and sustainability of complex health interventions. RESULTS A total of 9763 studies were retrieved from the five databases (PubMed, MEDLINE, CINAHL, Web of Science, and Google Scholar). Following removal of duplicates and application of the eligibility criteria, 35 papers were eligible for inclusion. Influencing factors can be grouped within outer context (socio-political context; leadership funding, inter-organisational networks), inner context; (client advocacy; organisational characteristics), intervention characteristics (supervision, monitoring and evaluation), and bridging factors (individual adopter or provider characteristics). CONCLUSION This review confirms that identified TMFS do not typically include the three components of adaptability, scalability, and sustainability. Current approaches focus on high income countries or generic "whole world" approaches with few frameworks specific to low- and middle-income countries. The review offers a starting point for further exploration of adaptability, scalability and sustainability, within a low- and middle-income context. TRIAL REGISTRATION Not registered.
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Affiliation(s)
- Lixin Sun
- Sheffield Centre for Health and Related Research (SCHARR), University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.
| | - Andrew Booth
- Sheffield Centre for Health and Related Research (SCHARR), University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK
| | - Katie Sworn
- Sheffield Centre for Health and Related Research (SCHARR), University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK
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Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. Int J Nurs Stud 2024; 154:104705. [PMID: 38564982 DOI: 10.1016/j.ijnurstu.2024.104705] [Citation(s) in RCA: 14] [Impact Index Per Article: 14.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/04/2024]
Abstract
The UK Medical Research Council's widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.
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Affiliation(s)
- Kathryn Skivington
- MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
| | - Lynsay Matthews
- MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
| | - Sharon Anne Simpson
- MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
| | - Peter Craig
- MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
| | - Janis Baird
- Medical Research Council Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK
| | - Jane M Blazeby
- Medical Research Council ConDuCT-II Hub for Trials Methodology Research and Bristol Biomedical Research Centre, Bristol, UK
| | - Kathleen Anne Boyd
- Health Economics and Health Technology Assessment Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
| | | | - David P French
- Manchester Centre for Health Psychology, University of Manchester, Manchester, UK
| | - Emma McIntosh
- Health Economics and Health Technology Assessment Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
| | - Mark Petticrew
- London School of Hygiene and Tropical Medicine, London, UK
| | | | - Martin White
- Medical Research Council Epidemiology Unit, University of Cambridge, Cambridge, UK
| | - Laurence Moore
- MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
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7
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Smeekens L, Verburg AC, Maas M, van Heerde R, van Kerkhof A, van der Wees PJ. Feasibility of a quality-improvement program based on routinely collected health outcomes in Dutch primary care physical therapist practice: a mixed-methods study. BMC Health Serv Res 2024; 24:509. [PMID: 38658939 PMCID: PMC11040789 DOI: 10.1186/s12913-024-10958-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/27/2023] [Accepted: 04/05/2024] [Indexed: 04/26/2024] Open
Abstract
BACKGROUND This study evaluates the feasibility of a nine-month advanced quality-improvement program aimed at enhancing the quality of care provided by primary care physical therapists in the Netherlands. The evaluation is based on routinely collected health outcomes of patients with nonspecific low back pain, assessing three feasibility domains: (1) appropriateness, feasibility, and acceptability for quality-improvement purposes; (2) impact on clinical performance; and (3) impact on learning and behavioral change. METHODS A mixed-methods quality-improvement study using a concurrent triangulation design was conducted in primary care physical therapist practice. Feedback reports on the processes and outcomes of care, peer assessment, and self-assessment were used in a Plan-Do-Study-Act cycle based on self-selected goals. The program's appropriateness, feasibility, and acceptability, as well as the impact on clinical performance, were evaluated using the Intervention Appropriate Measure, Feasibility Intervention Measure, Acceptability Intervention Measure (for these three measure, possible scores range from 4 to 20), and with a self-assessment of clinical performance (scored 0-10), respectively. The impact on learning and behavioral change was evaluated qualitatively with a directed content analysis. RESULTS Ten physical therapists from two practices participated in this study. They rated the program with a mean of 16.5 (SD 1.9) for appropriateness, 17.1 (SD 2.2) for feasibility, and 16.4 (SD 1.5) for acceptability. Participants gave their development in clinical performance a mean score of 6.7 (SD 1.8). Participants became aware of the potential value of using outcome data and gained insight into their own routines and motivations. They changed their data collection routines, implemented data in their routine practice, and explored the impact on their clinical behavior. CONCLUSIONS This explorative study demonstrated that a quality-improvement program, using health outcomes from a national registry, is judged to be feasible. IMPACT STATEMENT This study provides preliminary evidence on how physical therapists may use health outcomes to improve their quality, which can be further used in initiatives to improve outcome-based care in primary physical therapy.
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Affiliation(s)
- Lsf Smeekens
- Scientific Institute for Quality of Healthcare, Radboud university medical center, Kapittelweg 54, 6525 EP, Nijmegen, The Netherlands.
| | - A C Verburg
- Scientific Institute for Quality of Healthcare, Radboud university medical center, Kapittelweg 54, 6525 EP, Nijmegen, The Netherlands
| | - Mjm Maas
- Scientific Institute for Quality of Healthcare, Radboud university medical center, Kapittelweg 54, 6525 EP, Nijmegen, The Netherlands
- HAN University of Applied Sciences, Nijmegen, The Netherlands
| | - R van Heerde
- Scientific Institute for Quality of Healthcare, Radboud university medical center, Kapittelweg 54, 6525 EP, Nijmegen, The Netherlands
| | - A van Kerkhof
- Leidsche Rijn Julius Gezondheidscentra, Utrecht, The Netherlands
| | - P J van der Wees
- Scientific Institute for Quality of Healthcare, Radboud university medical center, Kapittelweg 54, 6525 EP, Nijmegen, The Netherlands
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Volkmer A, Beeke S, Warren JD, Spector A, Walton H. Development of fidelity of delivery and enactment measures for interventions in communication disorders. Br J Health Psychol 2024; 29:112-133. [PMID: 37792862 DOI: 10.1111/bjhp.12690] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/21/2022] [Revised: 08/09/2023] [Accepted: 09/04/2023] [Indexed: 10/06/2023]
Abstract
OBJECTIVES This study was part of a process evaluation for a single-blind, randomized controlled pilot study comparing Better Conversations with Primary Progressive Aphasia (BCPPA), an approach to communication partner training, with no speech and language therapy treatment. It was necessary to explore fidelity of delivery (delivery of intervention components) and intervention enactment (participants' use of intervention skills in the form of conversation behaviours comprising facilitators, that enhance the conversational flow, and barriers, that impeded the flow of conversation). This study aimed to: (1) Outline an adapted methodological process that uses video observation, to measure both fidelity of delivery and enactment. (2) Measure the extent to which the BCPPA pilot study was delivered as planned, and enacted. DESIGN Observational methods were used alongside statistical analysis to explore the fidelity of intervention and enactment using video recordings obtained from the BCPPA pilot study. METHODS A 5-step methodology, was developed to measure fidelity of delivery and enactment for the BCPPA study using video-recorded data. To identify delivery of intervention components, a random sample of eight video recorded and transcribed BCPPA intervention sessions was coded. To examine the enactment of conversation behaviours, 108 transcribed 10 -min-video recorded conversations were coded from 18 participants across the control and intervention group. RESULTS Checklists and guidelines for measurement of fidelity of treatment delivery and coding spreadsheets and guidelines for measurement of enactment are presented. Local collaborators demonstrated 87.2% fidelity to the BCPPA protocol. Participants in the BCPPA treatment group increased their use of facilitator behaviours enacted in conversation from a mean of 13.5 pre-intervention to 14.2 post-intervention, whilst control group facilitators decreased from a mean of 15.5 to 14.4, over the same timescale. CONCLUSIONS This study proposes a novel and robust methods, using video recorded intervention sessions and conversation samples, to measure both fidelity of intervention delivery and enactment. The learnings from this intervention are transferable to other communication interventions.
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Affiliation(s)
- Anna Volkmer
- Psychology and Language Sciences, University College London, London, UK
- Dementia Research Centre, University College London, London, UK
- Department of Applied Health Research, University College London, London, UK
| | - Suzanne Beeke
- Psychology and Language Sciences, University College London, London, UK
- Dementia Research Centre, University College London, London, UK
- Department of Applied Health Research, University College London, London, UK
| | - Jason D Warren
- Psychology and Language Sciences, University College London, London, UK
- Dementia Research Centre, University College London, London, UK
- Department of Applied Health Research, University College London, London, UK
| | - Aimee Spector
- Psychology and Language Sciences, University College London, London, UK
- Dementia Research Centre, University College London, London, UK
- Department of Applied Health Research, University College London, London, UK
| | - Holly Walton
- Psychology and Language Sciences, University College London, London, UK
- Dementia Research Centre, University College London, London, UK
- Department of Applied Health Research, University College London, London, UK
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Cleeve A, Annerstedt KS, Betrán AP, Mölsted Alvesson H, Kaboré Wendyam C, Carroli G, Lumbiganon P, Nhu Hung MQ, Zamboni K, Opiyo N, Bohren MA, El Halabi S, Gialdini C, Vila Ortiz M, Escuriet R, Robson M, Dumont A, Hanson C. Implementing the QUALI-DEC project in Argentina, Burkina Faso, Thailand and Viet Nam: a process delineation and theory-driven process evaluation protocol. Glob Health Action 2023; 16:2290636. [PMID: 38133667 PMCID: PMC10763892 DOI: 10.1080/16549716.2023.2290636] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/25/2023] [Accepted: 11/29/2023] [Indexed: 12/23/2023] Open
Abstract
The project 'Quality Decision-making by women and providers' (QUALI-DEC) combines four non-clinical interventions to promote informed decision-making surrounding mode of birth, improve women's birth experiences, and reduce caesarean sections among low-risk women. QUALI-DEC is currently being implemented in 32 healthcare facilities across Argentina, Burkina Faso, Thailand, and Viet Nam. In this paper, we detail implementation processes and the planned process evaluation, which aims to assess how and for whom QUALI-DEC worked, the mechanisms of change and their interactions with context and setting; adaptations to intervention and implementation strategies, feasibility of scaling-up, and cost-effectiveness of the intervention. We developed a project theory of change illustrating how QUALI-DEC might lead to impact. The theory of change, together with on the ground observations of implementation processes, guided the process evaluation strategy including what research questions and perspectives to prioritise. Main data sources will include: 1) regular monitoring visits in healthcare facilities, 2) quantitative process and output indicators, 3) a before and after cross-sectional survey among post-partum women, 4) qualitative interviews with all opinion leaders, and 5) qualitative interviews with postpartum women and health workers in two healthcare facilities per country, as part of a case study approach. We foresee that the QUALI-DEC process evaluation will generate valuable information that will improve interpretation of the effectiveness evaluation. At the policy level, we anticipate that important lessons and methodological insights will be drawn, with application to other settings and stakeholders looking to implement complex interventions aiming to improve maternal and newborn health and wellbeing.Trial registration: ISRCTN67214403.
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Affiliation(s)
- Amanda Cleeve
- Department of Women’s and Children’s Health, Karolinska Institutet, and Karolinska University Healthcare facility, Stockholm, Sweden
- Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden
| | | | - Ana Pilar Betrán
- UNDP/UNFPA/UNICEF/World Bank Special Program of Research, Development and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland
| | | | | | | | - Pisake Lumbiganon
- Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
| | | | - Karen Zamboni
- Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden
- The Global Fund, Geneva, Switzerland
| | - Newton Opiyo
- UNDP/UNFPA/UNICEF/World Bank Special Program of Research, Development and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland
| | - Meghan A. Bohren
- Gender and Women’s Health Unit, Centre for Health Equity, School of Population and Global Health, University of Melbourne, Melbourne, Australia
| | - Soha El Halabi
- Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden
| | - Celina Gialdini
- Centro Rosarino de Estudios Perinatales, Rosario, Argentina
- Faculty of Health Sciences, Fundacio Blanquerna, Barcelona, Spain
| | - Mercedes Vila Ortiz
- Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden
- Centro Rosarino de Estudios Perinatales, Rosario, Argentina
| | - Ramón Escuriet
- Faculty of Health Sciences, Fundacio Blanquerna, Barcelona, Spain
- Department of Health, Government of Catalonia, Spain
| | - Michael Robson
- The National Maternity Hospital and University College Dublin, National University of Ireland, Dublin, Ireland
| | - Alexandre Dumont
- Université Paris Cité, Research Institute for Sustainable Development (IRD), Inserm, Paris, France
| | - Claudia Hanson
- Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden
- Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK
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Reston RE, Caskey FJ, Hole B, Udayaraj U, Weinman J. CareKnowDo-A Multichannel Digital and Telephone Support Program for People With Chronic Kidney Disease: Feasibility Randomized Controlled Trial. JMIR Form Res 2023; 7:e33147. [PMID: 37995117 DOI: 10.2196/33147] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/25/2021] [Revised: 07/05/2022] [Accepted: 01/03/2023] [Indexed: 01/04/2023] Open
Abstract
BACKGROUND Chronic kidney disease (CKD) is a common, progressive condition. Lifestyle changes and antihypertensive medication can slow the progression to end-stage kidney disease, which requires renal replacement therapy. However, adherence to these recommendations is often low. OBJECTIVE The aim of CareKnowDo was to assess the feasibility of rolling out a digital self-management support and adherence program integrated with a patient-facing electronic health record, Patient View (PV). METHODS A 2-arm, parallel, individual-level pragmatic feasibility pilot randomized controlled trial was conducted at 2 National Health Service (NHS) sites in the United Kingdom. A total of 61 patients with CKD were randomized 1:1 into 2 groups and provided with either a new, tailored digital and telephone support program (CareKnowDo: 31/61, 51%) integrated with PV or standard care (PV alone: 30/61, 49%). Quantitative measures included clinical and psychosocial measures. The primary outcomes were feasibility based: recruitment rate, dropout, and the exploration of associations. RESULTS Of the 1392 patients screened in local kidney clinics, 269 (19.32%) met the basic inclusion criteria; the first 22.7% (61/269) who met the eligibility criteria were recruited to participate in the study. Of the 69 patients, 23 (38%) patients completed the final 6-month follow-up web-based survey. Reasons for the attrition were explored. A higher belief in the ability of the treatment to control CKD was associated with lower blood pressure at baseline (r=0.52; P=.005), and a higher perceived understanding of CKD at baseline was associated with lower blood pressure at follow-up (r=0.66; P<.001). Beliefs about medicines at baseline were associated with blood pressure at baseline but not at follow-up. This was true for both concerns about medicines (r=0.58; P=.001) and perceived necessity of medicines (r=0.42; P=.03). CONCLUSIONS A tailored digital and nurse call-based program to enhance support for patients with CKD was piloted in 2 NHS sites and found to be feasible and acceptable. However, to maximize the effectiveness of the intervention (and of future trials), consideration should be given to the target audience most likely to benefit, as well as how to help them access the program as quickly and easily as possible. TRIAL REGISTRATION NHS Health Research Authority, IRAS ID 184206; https://www.hra.nhs.uk/planning-and-improving -research/application-summaries/research-summaries/careknowdo-pilot-version-1/.
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Affiliation(s)
| | - Fergus J Caskey
- University of Bristol, Bristol, United Kingdom
- North Bristol National Health Service Trust, Bristol, United Kingdom
| | - Barnaby Hole
- University of Bristol, Bristol, United Kingdom
- North Bristol National Health Service Trust, Bristol, United Kingdom
| | - Udaya Udayaraj
- Oxford University Hospitals National Health Service Foundation Trust, Oxford, United Kingdom
- Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
| | - John Weinman
- School of Cancer & Pharmaceutical Sciences, King's College London, London, United Kingdom
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Ennis S, Sandhu HK, Bruce J, Seers K, Pincus T, Underwood M, McGregor G. Development of a complex exercise rehabilitation intervention for people with pulmonary hypertension: the supervised pulmonary hypertension exercise rehabilitation (SPHERe) trial. BMJ Open 2023; 13:e066053. [PMID: 37536964 PMCID: PMC10401230 DOI: 10.1136/bmjopen-2022-066053] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/27/2023] [Accepted: 06/29/2023] [Indexed: 08/05/2023] Open
Abstract
BACKGROUND People with pulmonary hypertension (PH) are not routinely referred for exercise rehabilitation despite the potential for reducing breathlessness and improving quality of life. We describe the development of a supervised pulmonary hypertension exercise rehabilitation (SPHERe) programme for people with PH. METHODS Development was completed in three phases: (1) systematic review, (2) stakeholder engagement with consensus from patients and experts and (3) prepilot intervention acceptability testing. We completed systematic reviews to identify international cardiopulmonary rehabilitation guidance and trials of exercise-based interventions for people with PH. Evidence from systematic reviews and stakeholder consensus shaped the SPHERe intervention, including addition of individual behavioural support sessions to promote exercise adherence. The draft SPHERe intervention was ratified through discussions with multidisciplinary professionals and people living with PH. We acceptability tested the centre-based intervention with eight participants in a prepilot development phase which identified a number of condition-specific issues relating to safety and fear avoidance of activity. Comprehensive intervention practitioner training manuals were produced to ensure standardised delivery. Participant workbooks were developed and piloted. Trial recruitment began in January 2020 but was subsequently suspended in March 2020 further to COVID-19 pandemic 'lockdowns'. In response to the pandemic, we undertook further development work to redesign the intervention to be suitable for exclusively home-based online delivery. Recruitment to the revised protocol began in June 2021. DISCUSSION The final SPHERe intervention incorporated weekly home-based online group exercise and behavioural support 'coaching' sessions supervised by trained practitioners, with a personalised home exercise plan and the optional loan of a stationary exercise bike. The intervention was fully manualised with clear pathways for assessment and individualised exercise prescription. The clinical and cost-effectiveness of the SPHERe online rehabilitation intervention is currently being tested in a UK multicentre randomised controlled trial. TRIAL REGISTRATION NUMBER ISCRTN10608766.
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Affiliation(s)
- Stuart Ennis
- Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
- Cardiovascular Rehabilitation, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK
| | | | - Julie Bruce
- Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
| | - Kate Seers
- Royal College of Nursing Research Institute, Warwick Medical School, University of Warwick, Coventry, UK
| | - Tamar Pincus
- Department of Psychology, Royal Hollaway University, London, UK
| | - Martin Underwood
- Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
| | - Gordon McGregor
- Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
- Cardiovascular Rehabilitation, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK
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12
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Greenwood C, Nixon J, Nelson EA, McGinnis E, Randell R. Offloading devices for the prevention of heel pressure ulcers: A realist evaluation. Int J Nurs Stud 2023; 141:104479. [PMID: 37001188 DOI: 10.1016/j.ijnurstu.2023.104479] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/30/2022] [Revised: 03/02/2023] [Accepted: 03/06/2023] [Indexed: 03/16/2023]
Abstract
BACKGROUND Heel pressure ulcers can cause pain, reduce mobility, lead to longer hospital stays and in severe cases can lead to sepsis, amputation, and death. Offloading boots are marketed as heel pressure ulcer prevention devices, working by removing pressure to the heel, yet there is little good quality evidence about their clinical effectiveness. Given that evidence is not guiding use of these devices, this study aims to explore, how, when, and why these devices are used in hospital settings. OBJECTIVE To explore how offloading devices are used to prevent heel pressure ulcers, for whom and in what circumstances. METHODS A realist evaluation was undertaken to explore the contexts, mechanisms, and outcomes that might influence how offloading devices are implemented and used in clinical practice for the prevention of heel pressure ulcers in hospitals. Eight Tissue Viability Nurse Specialists from across the UK (England, Wales, and Northern Ireland) were interviewed. Questions sought to elicit whether, and in what ways, initial theories about the use of heel pressure ulcers fitted with interviewee's experiences. RESULTS Thirteen initial theories were refined into three programme theories about how offloading devices are used by nurses 'proactively' to prevent heel pressure ulcers, 'reactively' to treat and minimise deterioration of early-stage pressure ulcers, and patient factors that influence how these devices are used. CONCLUSIONS Offloading devices were used in clinical practice by all the interviewees. It was viewed that they were not suitable to be used by every patient, at every point in their inpatient journey, nor was it financially viable. However, the interviewees thought that identifying suitable 'at risk' patient groups that can maintain use of the devices could lead to proactive and cost-effective use of the devices. This understanding of the contexts and mechanisms that influence the effective use of offloading devices has implications for clinical practice and design of clinical trials of offloading devices. TWEETABLE ABSTRACT How, for whom, and in what circumstances do offloading devices work to prevent heel pressure ulcers? Tissue viability nurses' perspectives.
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13
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Peterson H. Cost-Benefit Analysis (CBA) or the Highway? An Alternative Road to Investigating the Value for Money of International Development Research. THE EUROPEAN JOURNAL OF DEVELOPMENT RESEARCH 2022; 35:260-280. [PMID: 36311876 PMCID: PMC9589702 DOI: 10.1057/s41287-022-00565-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Accepted: 08/04/2022] [Indexed: 06/16/2023]
Abstract
UNLABELLED Research for development (R4D) funding is increasingly expected to demonstrate value for money (VfM). However, the dominance of positivist approaches to evaluating VfM, such as cost-benefit analysis, do not fully account for the complexity of R4D funds and risk undermining efforts to contribute to transformational development. This paper posits an alternative approach to evaluating VfM, using the UK's Global Challenges Research Fund and the Newton Fund as case studies. Based on a constructivist approach to valuing outcomes, this approach applies a collaboratively developed rubric-based peer review to a sample of projects. This is more appropriate for the complexity of R4D interventions, particularly when considering uncertain and emergent outcomes over a long timeframe. This approach could be adapted to other complex interventions, demonstrating that our options are not merely "CBA or the highway" and there are indeed alternative routes to evaluating VfM. SUPPLEMENTARY INFORMATION The online version contains supplementary material available at 10.1057/s41287-022-00565-7.
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Affiliation(s)
- Heidi Peterson
- Clear Horizon, 132B Gwynne St, Cremorne, VIC 3121 Australia
- University of Bath, Claverton Down, Bath, BA2 7AY UK
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14
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Nygaard SS, Høj Jørgensen TS, Srivarathan A, Brønnum-Hansen H, Kivikoski C, Kristiansen M, Lund R. Association Between Urban Regeneration and Healthcare-Seeking Behavior of Affected Residents: A Natural Experiment in two Multi-Ethnic Deprived Housing Areas in Denmark. INTERNATIONAL JOURNAL OF HEALTH SERVICES 2022:207314221126283. [PMID: 36121903 DOI: 10.1177/00207314221126283] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
Area regeneration of deprived neighborhoods is being used to reduce health inequality, socioeconomic deprivation and ethnic segregation. This quasi-experimental study examines if long-term graded exposure to urban regeneration is associated with primary healthcare-seeking behavior among residents. We compared general practitioner (GP) contacts from 2015-2020 in two adjacent, deprived social housing areas, one exposed to area regeneration. Populations were into Western and non-Western males and females aged 15 years and older (N = 3,960). Mean annual GP contact frequency for each group were estimated and a difference-in-difference (DiD) analysis was conducted with adjustments for propensity scores based on baseline characteristics. GP contact frequency increased for all groups across time with a systematically higher level and faster increase in the control groups. In particular, the mean difference between the exposed and control area for non-Western women more than doubled from -0.61 to -1.47 annual contacts across the period. The mean differences in contact frequency increased for all groups but results of the DiD analyses were insignificant. In conclusion, an emerging gap in GP contact frequency, with the highest levels in the control area, was observed for all comparisons across time. More long-term research is needed to understand how the emerging gaps evolve.
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Affiliation(s)
- Siv Steffen Nygaard
- Faculty of Health and Medical Sciences, Department of Public Health, Section of Social Medicine, University of Copenhagen, Copenhagen, Denmark.,Faculty of Health and Medical Sciences, Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark
| | - Terese Sara Høj Jørgensen
- Faculty of Health and Medical Sciences, Department of Public Health, Section of Social Medicine, University of Copenhagen, Copenhagen, Denmark.,Faculty of Health and Medical Sciences, Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark
| | - Abirami Srivarathan
- Faculty of Health and Medical Sciences, Department of Public Health, Section of Social Medicine, University of Copenhagen, Copenhagen, Denmark.,Faculty of Health and Medical Sciences, Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark
| | - Henrik Brønnum-Hansen
- Faculty of Health and Medical Sciences, Department of Public Health, Section of Social Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Cecilie Kivikoski
- Faculty of Health and Medical Sciences, Department of Public Health, Section of Social Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Maria Kristiansen
- Faculty of Health and Medical Sciences, Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.,Faculty of Health and Medical Sciences, Department of Public Health, Section for Health Services Research, University of Copenhagen, Copenhagen, Denmark
| | - Rikke Lund
- Faculty of Health and Medical Sciences, Department of Public Health, Section of Social Medicine, University of Copenhagen, Copenhagen, Denmark.,Faculty of Health and Medical Sciences, Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark
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15
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Relph S, Coxon K, Vieira MC, Copas A, Healey A, Alagna A, Briley A, Johnson M, Lawlor DA, Lees C, Marlow N, McCowan L, McMicking J, Page L, Peebles D, Shennan A, Thilaganathan B, Khalil A, Pasupathy D, Sandall J. Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial. Implement Sci 2022; 17:60. [PMID: 36064428 PMCID: PMC9446790 DOI: 10.1186/s13012-022-01228-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2021] [Accepted: 07/27/2022] [Indexed: 11/21/2022] Open
Abstract
BACKGROUND Reducing the rate of stillbirth is an international priority. At least half of babies stillborn in high-income countries are small for gestational-age (SGA). The Growth Assessment Protocol (GAP), a complex antenatal intervention that aims to increase the rate of antenatal detection of SGA, was evaluated in the DESiGN type 2 hybrid effectiveness-implementation cluster randomised trial (n = 13 clusters). In this paper, we present the trial process evaluation. METHODS A mixed-methods process evaluation was conducted. Clinical leads and frontline healthcare professionals were interviewed to inform understanding of context (implementing and standard care sites) and GAP implementation (implementing sites). Thematic analysis of interview text used the context and implementation of complex interventions framework to understand acceptability, feasibility, and the impact of context. A review of implementing cluster clinical guidelines, training and maternity records was conducted to assess fidelity, dose and reach. RESULTS Interviews were conducted with 28 clinical leads and 27 frontline healthcare professionals across 11 sites. Staff at implementing sites generally found GAP to be acceptable but raised issues of feasibility, caused by conflicting demands on resource, and variable beliefs among clinical leaders regarding the intervention value. GAP was implemented with variable fidelity (concordance of local guidelines to GAP was high at two sites, moderate at two and low at one site), all sites achieved the target to train > 75% staff using face-to-face methods, but only one site trained > 75% staff using e-learning methods; a median of 84% (range 78-87%) of women were correctly risk stratified at the five implementing sites. Most sites achieved high scores for reach (median 94%, range 62-98% of women had a customised growth chart), but generally, low scores for dose (median 31%, range 8-53% of low-risk women and median 5%, range 0-17% of high-risk women) were monitored for SGA as recommended. CONCLUSIONS Implementation of GAP was generally acceptable to staff but with issues of feasibility that are likely to have contributed to variation in implementation strength. Leadership and resourcing are fundamental to effective implementation of clinical service changes, even when such changes are well aligned to policy mandated service-change priorities. TRIAL REGISTRATION Primary registry and trial identifying number: ISRCTN 67698474. Registered 02/11/16. https://doi.org/10.1186/ISRCTN67698474 .
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Affiliation(s)
- Sophie Relph
- Department of Women and Children's Health, Faculty of Life Sciences and Medicine, School of Life Course Sciences, Women's Health Academic Centre KHP, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
| | - Kirstie Coxon
- Department of Midwifery, Faculty of Health, Social Care and Education, Kingston and St. George's Universities, Kenry House, Kingston Hill, London, KT2 7LB, UK
| | - Matias C Vieira
- Department of Women and Children's Health, Faculty of Life Sciences and Medicine, School of Life Course Sciences, Women's Health Academic Centre KHP, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK
- Department of Obstetrics and Gynaecology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, SP, 13083-881, Brazil
| | - Andrew Copas
- Centre for Pragmatic Global Health Trials, Institute for Global Health, University College London, Gower Street, London, WC1E 6BT, UK
| | - Andrew Healey
- Centre for Implementation Science and King's Health Economics, Health Services and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience at King's College London, The David Goldberg Centre, London, SE5 8AF, UK
| | - Alessandro Alagna
- The Guy's & St Thomas' Charity, 9 King's Head Yard, London, SE1 1NA, UK
| | - Annette Briley
- Department of Women and Children's Health, Faculty of Life Sciences and Medicine, School of Life Course Sciences, Women's Health Academic Centre KHP, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK
- Caring Futures Institute Flinders University and North Adelaide Local Health Network, Adelaide, SA, 5042, Australia
| | - Mark Johnson
- Department of Surgery and Cancer, Imperial College London, Kensington, London, SW7 2AZ, UK
| | - Deborah A Lawlor
- Bristol NIHR Biomedical Research Centre, Bristol, BS8 2BL, UK
- Medical Research Council Integrative Epidemiology Unit at the University of Bristol, Bristol, BS8 2BL, UK
- Population Health Science, Bristol Medical School, University of Bristol, Bristol, BS8 2BL, UK
| | - Christoph Lees
- Department of Surgery and Cancer, Imperial College London, Kensington, London, SW7 2AZ, UK
| | - Neil Marlow
- UCL Institute for Women's Health, University College London, Gower Street, London, WC1E 6BT, UK
| | - Lesley McCowan
- Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, New Zealand
| | - Jessica McMicking
- Guy's and St Thomas' NHS Trust, Westminster Bridge Road, London, SE1 7EH, UK
| | - Louise Page
- West Middlesex University Hospital, Chelsea & Westminster Hospital NHS Foundation Trust, Twickenham Road, Isleworth, TW7 6AF, UK
| | - Donald Peebles
- UCL Institute for Women's Health, University College London, Gower Street, London, WC1E 6BT, UK
| | - Andrew Shennan
- Department of Women and Children's Health, Faculty of Life Sciences and Medicine, School of Life Course Sciences, Women's Health Academic Centre KHP, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK
| | - Baskaran Thilaganathan
- Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, Blackshaw Road, London, SW17 0QT, UK
- Molecular & Clinical Sciences Research Institute, St George's University of London, Cranmer Terrace, London, SW17 0RE, UK
| | - Asma Khalil
- Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, Blackshaw Road, London, SW17 0QT, UK
- Molecular & Clinical Sciences Research Institute, St George's University of London, Cranmer Terrace, London, SW17 0RE, UK
| | - Dharmintra Pasupathy
- Department of Women and Children's Health, Faculty of Life Sciences and Medicine, School of Life Course Sciences, Women's Health Academic Centre KHP, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK
- Reproduction and Perinatal Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, 2145, Australia
| | - Jane Sandall
- Department of Women and Children's Health, Faculty of Life Sciences and Medicine, School of Life Course Sciences, Women's Health Academic Centre KHP, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK
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16
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Patients' Perceptions and Outcome Measures after Undergoing the Enhanced Transtheoretical Model Intervention (ETMI) for Chronic Low Back Pain: A Mixed-Method Study. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2022; 19:ijerph19106106. [PMID: 35627641 PMCID: PMC9140490 DOI: 10.3390/ijerph19106106] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 04/14/2022] [Revised: 05/10/2022] [Accepted: 05/16/2022] [Indexed: 02/01/2023]
Abstract
This study aimed to evaluate the outcome measures and perceptions of patients with chronic low back pain (CLBP) after being treated with the Enhanced Transtheoretical Model Intervention (ETMI). In this process evaluation mixed-methods study, 30 patients with CLBP electronically completed self-reported measures (function, pain, and fear-avoidance beliefs) before and after ETMI treatment. Subsequently, each patient participated in one-on-one, semi-structured interviews, which were audio-recorded, transcribed, coded, and analyzed thematically. Quantitative analysis showed significant improvements in function (p < 0.001), pain (p < 0.001), and fear-avoidance beliefs (p < 0.001) after receiving ETMI treatment, with a large effect size (Cohen’s d = 1.234). Moreover, the average number of physiotherapy sessions was 2.6 ± 0.6 for the ETMI intervention, while the annual average number in Maccabi is estimated at 4.1 ± 1.5. Three main themes emerged from the thematic analysis: (1) communication between the patient and the practitioner; (2) psychosocial treatment elements, and (3) ETMI as a long-term solution for CLBP. The findings of the current study highlight patients’ perceived need for an open and sincere dialogue and for receiving reassurance and encouragement about their LBP. Notably, they had no problem with the fact that they did not receive passive treatment. Accordingly, together with the significant improvement in post-treatment outcome measures, patients perceived the ETMI method as a practical tool for self-managing their back problems in the long term.
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17
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Haworth L, May K, Janssen J, Selfe J, Chohan A. The impact of breast support garments on fit, support and posture of larger breasted women. APPLIED ERGONOMICS 2022; 101:103701. [PMID: 35151120 DOI: 10.1016/j.apergo.2022.103701] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/26/2021] [Revised: 01/24/2022] [Accepted: 01/25/2022] [Indexed: 06/14/2023]
Abstract
Due to current measurement, sizing and fitting approaches, poor bra fit is prevalent amongst larger breasted women. The impact of improving bra fit hasn't yet been explored. This pre-clinical study aimed to explore immediate and short-term biomechanical responses to changing breast support garment. Asymptomatic participants (n=24) performed a static standing task, drop jumps and seated typing whilst kinematic data from the breasts and spine were recorded. Three breast support conditions were assessed: Usual, professionally fitted bra in the immediate term (PFB), and the same professionally fitted bra after four weeks wear (PFB28). Bra fit assessments were included for both bras. All participants failed the bra fit assessment when wearing the Usual bra and 67% (n=16) failed when wearing the PFB. Less bra fit issues were present in the PFB, resulting in immediate biomechanical changes relating to breast support and spinal posture, yet nothing in the short term (PFB28). This research sets the foundations for future work to investigate whether the implementation of better fitting breast support garments can influence musculoskeletal pain amongst larger breasted women, whilst attributing potential improvement of symptoms, objective measures of breast support and spinal posture.
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Affiliation(s)
- Lauren Haworth
- University of Central Lancashire, Allied Health Professions Research Unit, Preston, UK.
| | - Karen May
- University of Central Lancashire, School of Medicine, Preston, UK.
| | - Jessie Janssen
- IMC University of Applied Science Krems, Institute of Therapeutic and Midwifery Sciences, Krems, Austria.
| | - James Selfe
- Manchester Metropolitan University, Health, Psychology and Communities, Manchester, UK.
| | - Ambreen Chohan
- University of Central Lancashire, Allied Health Professions Research Unit, Preston, UK.
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18
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Brick R, Turner R, Bender C, Douglas M, Eilers R, Ferguson R, Leland N, Lyons KD, Toto P, Skidmore E. Impact of non-pharmacological interventions on activity limitations and participation restrictions in older breast cancer survivors: A scoping review. J Geriatr Oncol 2022; 13:132-142. [PMID: 34598902 DOI: 10.1016/j.jgo.2021.09.010] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/11/2021] [Revised: 08/20/2021] [Accepted: 09/15/2021] [Indexed: 11/18/2022]
Abstract
Cancer-related disability is a complex problem for older breast cancer survivors. One aspect of cancer-related disability is a survivor's inability to complete meaningful daily activities and engage in life roles, referred to as activity limitations and participation restrictions respectively. There is a limited understanding of how interventions influence activity limitations and participation restrictions in this population. A scoping review was undertaken to identify and characterize nonpharmacological interventions developed to address activity limitations and participation restrictions. A systematic search of electronic databases (Ovid Medline, Embase, EBSCO CINAHL, and Ovid PsycINFO) was conducted in April 2020 and updated October 2020. Eleven studies met inclusion criteria. Most frequently observed delivery features were in-person and one-on-one format. Six interventions incorporated telehealth delivery components. Interventions were often complex and varied in content. Exercise and behavioral strategies were among the most frequently used active ingredients. Activity limitations and participation restrictions were often secondary outcomes, and measures of these outcomes were varied in content and assessment method. Study samples were not representative of the current population of older adult breast cancer survivors. Future intervention research should clarify intervention delivery, content, and dose, prioritize comprehensive measurement of activity limitations and participation restrictions, as well as recruit and involve representative study samples to enhance generalizability of findings.
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Affiliation(s)
- Rachelle Brick
- University of Pittsburgh, Department of Occupational Therapy, Bridgeside Point I, 100 Technology Drive, Pittsburgh, PA 15219, United States of America.
| | - Rose Turner
- University of Pittsburgh, Health Sciences Library System, Falk Library, 200 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA 15261, United States of America.
| | - Catherine Bender
- University of Pittsburgh, School of Nursing, 415 Victoria Building, 3500 Victoria Street, Pittsburgh, PA 15261, United States of America.
| | - Madilyn Douglas
- University of Pittsburgh, Department of Occupational Therapy, Bridgeside Point I, 100 Technology Drive, Pittsburgh, PA 15219, United States of America.
| | - Rachel Eilers
- University of Pittsburgh, Department of Occupational Therapy, Bridgeside Point I, 100 Technology Drive, Pittsburgh, PA 15219, United States of America.
| | - Robert Ferguson
- Center for Counseling and Cancer Support, 5220 Centre Avenue, Shadyside Medical Bldg, Suite 604, Pittsburgh, PA 15232, United States of America.
| | - Natalie Leland
- University of Pittsburgh, Department of Occupational Therapy, Bridgeside Point I, 100 Technology Drive, Pittsburgh, PA 15219, United States of America.
| | - Kathleen D Lyons
- 7750 Psychiatry Dept, Dartmouth-Hitchcock Medical Center, 1 Medical Center Dr, Lebanon, NH 03756, United States of America.
| | - Pamela Toto
- University of Pittsburgh, Department of Occupational Therapy, Bridgeside Point I, 100 Technology Drive, Pittsburgh, PA 15219, United States of America.
| | - Elizabeth Skidmore
- University of Pittsburgh, Department of Occupational Therapy, Bridgeside Point I, 100 Technology Drive, Pittsburgh, PA 15219, United States of America.
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Cunningham S, Jebara T, Stewart D, Smith J, Leslie SJ, Rushworth GF. OUP accepted manuscript. INTERNATIONAL JOURNAL OF PHARMACY PRACTICE 2022; 31:190-197. [PMID: 35639759 DOI: 10.1093/ijpp/riac039] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/24/2021] [Accepted: 04/27/2022] [Indexed: 11/14/2022]
Abstract
OBJECTIVES To investigate relationships between factors influencing medication taking and behavioural determinants in patients who have undergone percutaneous coronary intervention (PCI). METHODS A cross-sectional survey using a postal questionnaire distributed to PCI patients. The questionnaire was iteratively developed by the research team with reference to the theoretical domains framework (TDF) of behavioural determinants, reviewed for face and content validity and piloted. Data were analysed using descriptive and principal component analysis (PCA). Inferential analysis explored relationships between PCA component scores and factors influencing medicating taking behaviour. KEY FINDINGS Adjusted response rate was 62.4% (325/521). PCA gave three components: (C1) Self-perceptions of knowledge and abilities in relation to medication taking; (C2) Aspects relating to activities and support in medication taking; (C3) Emotional aspects in taking medication. Generally, respondents held very positive views. Statistically significant relationships between all three components and self-reported chest pain/discomfort indicated patients with ongoing chest pain/discomfort post-PCI are more likely to have behavioural determinants and beliefs which make medication taking challenging. Respondents who were on 10 or more medications had lower levels of agreement with the C2 and C3 statements indicating challenges associated with their activities/support and anxieties in medication taking. CONCLUSIONS PCI patients show links between TDF behavioural determinants and factors influencing medication taking for those reporting chest pain or polypharmacy. Further research needs to explore the effective design and implementation of behavioural change interventions to reduce the challenge of medication taking.
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Affiliation(s)
- Scott Cunningham
- School of Pharmacy and Life Sciences, Robert Gordon University, Aberdeen, UK
| | - Tesnime Jebara
- School of Pharmacy and Life Sciences, Robert Gordon University, Aberdeen, UK
| | - Derek Stewart
- College of Pharmacy, QU Health, Qatar University, Doha, Qatar
| | - Jamie Smith
- Cardiac Unit, Raigmore Hospital, NHS Highland, Inverness, UK
| | - Stephen J Leslie
- Cardiac Unit, Raigmore Hospital, NHS Highland, Inverness, UK
- Institute of Health Research & Innovation, University of the Highlands & Islands, Inverness, UK
| | - Gordon F Rushworth
- School of Pharmacy and Life Sciences, Robert Gordon University, Aberdeen, UK
- Highland Pharmacy Education and Research Centre, NHS Highland, Inverness, UK
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20
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Volkmer A, Spector A, Swinburn K, Warren JD, Beeke S. Using the Medical Research Council framework and public involvement in the development of a communication partner training intervention for people with primary progressive aphasia (PPA): Better Conversations with PPA. BMC Geriatr 2021; 21:642. [PMID: 34781875 PMCID: PMC8591912 DOI: 10.1186/s12877-021-02561-8] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/10/2021] [Accepted: 08/22/2021] [Indexed: 11/29/2022] Open
Abstract
Background Primary progressive aphasia is a language-led dementia resulting in a gradual dissolution of language. Primary progressive aphasia has a significant psychosocial impact on both the person and their families. Speech and language therapy is one of the only available management options, and communication partner training interventions offer a practical approach to identify strategies to support conversation. The aim of this study was to define and refine a manual and an online training resource for speech and language therapists to deliver communication partner training to people with primary progressive aphasia and their communication partners called Better Conversations with primary progressive aphasia. Methods The Better Conversations with primary progressive aphasia manual and training program were developed using the Medical Research Council framework for developing complex interventions. The six-stage development process included 1. Exploratory review of existing literature including principles of applied Conversation Analysis, behaviour change theory and frameworks for chronic disease self-management, 2. Consultation and co-production over 12 meetings with the project steering group comprising representatives from key stakeholder groups, 3. Development of an initial draft, 4. Survey feedback followed by a consensus meeting using the Nominal Group Techniques with a group of speech and language therapists, 5. Two focus groups to gather opinions from people with PPA and their families were recorded, transcribed and Thematic Analysis used to examine the data, 6. Refinement. Results Co-production of the Better Conversations with primary progressive aphasia resulted in seven online training modules, and a manual describing four communication partner training intervention sessions with accompanying handouts. Eight important components of communication partner training were identified in the aggregation process of the Nominal Group Technique undertaken with 36 speech and language therapists, including use of video feedback to focus on strengths as well as areas of conversation breakdown. Analysis of the focus groups held with six people with primary progressive aphasia and seven family members identified three themes 1) Timing of intervention, 2) Speech and language therapists’ understanding of types of dementia, and 3) Knowing what helps. These data informed refinements to the manual including additional practice activities and useful strategies for the future. Conclusions Using the Medical Research Council framework to develop an intervention that is underpinned by a theoretical rationale of how communication partner training causes change allows for the key intervention components to be strengthened. Co-production of the manual and training materials ensures the intervention will meet the needs of people with primary progressive aphasia and their communication partners. Gathering further data from speech and language therapists and people living with primary progressive aphasia and their families to refine the manual and the training materials enhances the feasibility of delivering this in preparation for a phase II NHS-based randomised controlled pilot-feasibility study, currently underway. Supplementary Information The online version contains supplementary material available at 10.1186/s12877-021-02561-8.
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Affiliation(s)
- Anna Volkmer
- Division of Psychology and Language Sciences, University College London, London, UK. .,Dementia Research Centre, Department of Neurodegenerative Disease, UCL Institute of Neurology, University College London, London, UK.
| | - Aimee Spector
- Division of Psychology and Language Sciences, University College London, London, UK
| | - Kate Swinburn
- Division of Psychology and Language Sciences, University College London, London, UK
| | - Jason D Warren
- Dementia Research Centre, Department of Neurodegenerative Disease, UCL Institute of Neurology, University College London, London, UK
| | - Suzanne Beeke
- Division of Psychology and Language Sciences, University College London, London, UK
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21
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Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ 2021; 374:n2061. [PMID: 34593508 PMCID: PMC8482308 DOI: 10.1136/bmj.n2061] [Citation(s) in RCA: 2297] [Impact Index Per Article: 574.3] [Reference Citation Analysis] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 08/09/2021] [Indexed: 11/25/2022]
Affiliation(s)
- Kathryn Skivington
- MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
| | - Lynsay Matthews
- MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
| | - Sharon Anne Simpson
- MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
| | - Peter Craig
- MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
| | - Janis Baird
- Medical Research Council Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK
| | - Jane M Blazeby
- Medical Research Council ConDuCT-II Hub for Trials Methodology Research and Bristol Biomedical Research Centre, Bristol, UK
| | - Kathleen Anne Boyd
- Health Economics and Health Technology Assessment Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
| | | | - David P French
- Manchester Centre for Health Psychology, University of Manchester, Manchester, UK
| | - Emma McIntosh
- Health Economics and Health Technology Assessment Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
| | - Mark Petticrew
- London School of Hygiene and Tropical Medicine, London, UK
| | | | - Martin White
- Medical Research Council Epidemiology Unit, University of Cambridge, Cambridge, UK
| | - Laurence Moore
- MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
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22
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Rauschenberg C, Boecking B, Paetzold I, Schruers K, Schick A, van Amelsvoort T, Reininghaus U. A Compassion-Focused Ecological Momentary Intervention for Enhancing Resilience in Help-Seeking Youth: Uncontrolled Pilot Study. JMIR Ment Health 2021; 8:e25650. [PMID: 34383687 PMCID: PMC8380580 DOI: 10.2196/25650] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/10/2020] [Revised: 04/27/2021] [Accepted: 05/25/2021] [Indexed: 01/02/2023] Open
Abstract
BACKGROUND Digital interventions offer new avenues for low-threshold prevention and treatment in young people. Ecological momentary interventions (EMIs) represent a powerful approach that allows for adaptive, real-time, and real-world delivery of intervention components in daily life by real-time processing of ecological momentary assessment (EMA) data. Compassion-focused interventions (CFIs) may be particularly amenable to translation into an EMI to strengthen emotional resilience and modify putative risk mechanisms, such as stress sensitivity, in the daily lives of young help-seeking individuals. OBJECTIVE This study aims to investigate the feasibility, safety, and initial therapeutic effects of a novel, accessible, transdiagnostic, ecological momentary CFI for improving emotional resilience to stress (EMIcompass). METHODS In this uncontrolled pilot study, help-seeking youth with psychotic, depressive, or anxiety symptoms were offered the EMIcompass intervention in addition to treatment as usual. The EMIcompass intervention consisted of a 3-week EMI (including enhancing, consolidating, and EMA-informed interactive tasks) administered through a mobile health app and three face-to-face sessions with a trained psychologist intended to provide guidance and training on the CFI exercises presented in the app (ie, training session, follow-up booster session, and review session). RESULTS In total, 10 individuals (mean age 20.3 years, SD 3.8; range 14-25) were included in the study. Most (8/10, 80%) participants were satisfied and reported a low burden of app usage. No adverse events were observed. In approximately one-third of all EMAs, individuals scored high on stress, negative affect, or threat anticipation during the intervention period, resulting in real-time, interactive delivery of the CFI intervention components in addition to weekly enhancing and daily consolidating tasks. Although the findings should be interpreted with caution because of the small sample size, reduced stress sensitivity, momentary negative affect, and psychotic experiences, along with increased positive affect, were found at postintervention and the 4-week follow-up. Furthermore, reductions in psychotic, anxiety, and depressive symptoms were found (r=0.30-0.65). CONCLUSIONS Our findings provide evidence on the feasibility and safety of the EMIcompass intervention for help-seeking youth and lend initial support to beneficial effects on stress sensitivity and mental health outcomes. An exploratory randomized controlled trial is warranted to establish the feasibility and preliminary evidence of its efficacy.
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Affiliation(s)
- Christian Rauschenberg
- Department of Public Mental Health, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.,Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, Netherlands
| | | | - Isabell Paetzold
- Department of Public Mental Health, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany
| | - Koen Schruers
- Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, Netherlands.,Mondriaan Mental Health Center, Maastricht, Netherlands
| | - Anita Schick
- Department of Public Mental Health, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany
| | - Thérèse van Amelsvoort
- Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, Netherlands.,Mondriaan Mental Health Center, Maastricht, Netherlands
| | - Ulrich Reininghaus
- Department of Public Mental Health, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.,ESRC Centre for Society and Mental Health, King's College London, London, United Kingdom.,Centre for Epidemiology and Public Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom
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23
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Marchal B, Abejirinde IOO, Sulaberidze L, Chikovani I, Uchaneishvili M, Shengelia N, Diaconu K, Vassall A, Zoidze A, Giralt AN, Witter S. How do participatory methods shape policy? Applying a realist approach to the formulation of a new tuberculosis policy in Georgia. BMJ Open 2021; 11:e047948. [PMID: 34187826 PMCID: PMC8245474 DOI: 10.1136/bmjopen-2020-047948] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/15/2020] [Accepted: 06/10/2021] [Indexed: 11/16/2022] Open
Abstract
OBJECTIVES This paper presents the iterative process of participatory multistakeholder engagement that informed the development of a new national tuberculosis (TB) policy in Georgia, and the lessons learnt. METHODS Guided by realist evaluation methods, a multistakeholder dialogue was organised to elicit stakeholders' assumptions on challenges and possible solutions for better TB control. Two participatory workshops were conducted with key actors, interspersed by reflection meetings within the research team and discussions with policymakers. Using concept mapping and causal mapping techniques, and drawing causal loop diagrams, we visualised how actors understood TB service provision challenges and the potential means by which a results-based financing (RBF) policy could address these. SETTING The study was conducted in Tbilisi, Georgia. PARTICIPANTS A total of 64 key actors from the Ministry of Labour, Health and Social Affairs, staff of the Global Fund to Fight AIDS, TB and Malaria Georgia Project, the National Centre for Disease Control and Public Health, the National TB programme, TB service providers and members of the research team were involved in the workshops. RESULTS Findings showed that beyond provider incentives, additional policy components were necessary. These included broadening the incentive package to include institutional and organisational incentives, retraining service providers, clear redistribution of roles to support an integrated care model, and refinement of monitoring tools. Health system elements, such as effective referral systems and health information systems were highlighted as necessary for service improvement. CONCLUSIONS Developing policies that address complex issues requires methods that facilitate linkages between multiple stakeholders and between theory and practice. Such participatory approaches can be informed by realist evaluation principles and visually facilitated by causal loop diagrams. This approach allowed us leverage stakeholders' knowledge and expertise on TB service delivery and RBF to codesign a new policy.
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Affiliation(s)
- Bruno Marchal
- Health Systems and Health Policy Research Group, Department of Public Health, Institute of Tropical Medicine, Antwerpen, Belgium
| | - Ibukun-Oluwa Omolade Abejirinde
- Health Systems and Health Policy Research Group, Department of Public Health, Institute of Tropical Medicine, Antwerpen, Belgium
| | - Lela Sulaberidze
- Research Unit, Curatio International Foundation, Tbilisi, Georgia
| | - Ivdity Chikovani
- Research Unit, Curatio International Foundation, Tbilisi, Georgia
| | | | - Natia Shengelia
- Research Unit, Curatio International Foundation, Tbilisi, Georgia
| | - Karin Diaconu
- Institute for Global Health and Development, Queen Margaret University Edinburgh, Musselburgh, UK
| | - Anna Vassall
- Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK
| | - Akaki Zoidze
- Research Unit, Curatio International Foundation, Tbilisi, Georgia
| | - Ariadna Nebot Giralt
- Health Systems and Health Policy Research Group, Department of Public Health, Institute of Tropical Medicine, Antwerpen, Belgium
| | - Sophie Witter
- Institute for Global Health and Development, Queen Margaret University Edinburgh, Musselburgh, UK
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24
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Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health. J 2021. [DOI: 10.3390/j4020017] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/21/2022] Open
Abstract
Within the healthcare environment, mobile health (mHealth) applications (apps) are becoming more and more important. The number of new mHealth apps has risen steadily in the last years. Especially the COVID-19 pandemic has led to an enormous amount of app releases. In most countries, mHealth applications have to be compliant with several regulatory aspects to be declared a “medical app”. However, the latest applicable medical device regulation (MDR) does not provide more details on the requirements for mHealth applications. When developing a medical app, it is essential that all contributors in an interdisciplinary team—especially software engineers—are aware of the specific regulatory requirements beforehand. The development process, however, should not be stalled due to integration of the MDR. Therefore, a developing framework that includes these aspects is required to facilitate a reliable and quick development process. The paper at hand introduces the creation of such a framework on the basis of the Corona Health and Corona Check apps. The relevant regulatory guidelines are listed and summarized as a guidance for medical app developments during the pandemic and beyond. In particular, the important stages and challenges faced that emerged during the entire development process are highlighted.
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25
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Gram L, Granados R, Krockow EM, Daruwalla N, Osrin D. Modelling collective action to change social norms around domestic violence: social dilemmas and the role of altruism. HUMANITIES & SOCIAL SCIENCES COMMUNICATIONS 2021; 8:53. [PMID: 34553143 PMCID: PMC7611687 DOI: 10.1057/s41599-021-00730-z] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/23/2019] [Accepted: 02/05/2021] [Indexed: 06/03/2023]
Abstract
Interventions promoting collective action have been used to prevent domestic violence in a range of settings, but their mechanisms of operation remain unclear. We formalise and combine feminist theoretical approaches to domestic violence into a game-theoretic model of women's collective action to change gendered social norms and outcomes. We show that social norms create a social dilemma in which it is individually rational for women to abstain from action to prevent domestic violence among neighbours, but all women suffer negative consequences if none take action. Promoting altruism among women can overcome the social dilemma. Discouraging women from tolerating domestic violence, imposing additional external punishment on men for perpetrating violence, or lowering costs to women of taking action against violence may not work or even backfire. We invite researchers on community mobilisation to use our framework to frame their understandings of collective action to prevent domestic violence.
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Affiliation(s)
- Lu Gram
- Institute for Global Health, University College London, London, UK
| | - Rolando Granados
- Institute for Global Health, University College London, London, UK
| | - Eva M Krockow
- Department of Neuroscience, Psychology and Behaviour, University of Leicester, Leicester, UK
| | - Nayreen Daruwalla
- Prevention of Violence against Women and Children, Society for Nutrition, Education and Health Action (SNEHA), Mumbai, India
| | - David Osrin
- Institute for Global Health, University College London, London, UK
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26
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Catanzano M, Bennett SD, Kerry E, Liang H, Heyman I, Coughtrey AE, Fifield K, Taylor C, Dalgleish T, Xu L, Shafran R. Evaluation of a mental health drop-in centre offering brief transdiagnostic psychological assessment and treatment for children and adolescents with long-term physical conditions and their families: a single-arm, open, non-randomised trial. EVIDENCE-BASED MENTAL HEALTH 2021; 24:25-32. [PMID: 33243761 PMCID: PMC7958088 DOI: 10.1136/ebmental-2020-300197] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 09/02/2020] [Revised: 10/24/2020] [Accepted: 10/27/2020] [Indexed: 11/04/2022]
Abstract
BACKGROUND Children and young people with long-term physical conditions have significantly elevated mental health needs. Transdiagnostic, brief psychological interventions have the potential to increase access to evidence-based psychological treatments for patients who attend health services primarily for physical health needs. OBJECTIVE A non-randomised study was conducted to assess the impact of brief, transdiagnostic psychological interventions in children and young people presenting at a drop-in mental health centre in the reception area of a paediatric hospital. METHODS 186 participants attending a transdiagnostic mental health drop-in centre were allocated to assessment and psychological intervention based on a clinical decision-making algorithm. Interventions included signposting, guided self-help based on a modular psychological treatment and referral to the hospital's paediatric psychology service. The primary transdiagnostic mental health outcome measure was the parent-reported Strengths and Difficulties Questionnaire (SDQ), which was given at baseline and 6 months post-baseline. FINDINGS There was a significant positive impact of attending the drop-in mental health centre on the SDQ (Cohen's d=0.22) and on the secondary outcome measure of Paediatric Quality of life (Cohen's d=0.55). CONCLUSIONS A mental health drop-in centre offering brief, transdiagnostic assessment and treatment may reduce emotional and behavioural symptoms and improve quality of life in children and young people with mental health needs in the context of long-term physical conditions. A randomised controlled trial to investigate the specificity of any effects is warranted. CLINICAL IMPLICATIONS Drop-in centres for mental health needs may increase access and have beneficial effects for children and young people with physical conditions.
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Affiliation(s)
- Matteo Catanzano
- UCL Great Ormond Street Institute of Child Health, University College London, London, UK
- Psychological and Mental Health Services, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
| | - Sophie D Bennett
- UCL Great Ormond Street Institute of Child Health, University College London, London, UK
- Psychological and Mental Health Services, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
| | - Ellie Kerry
- UCL Great Ormond Street Institute of Child Health, University College London, London, UK
- Psychological and Mental Health Services, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
| | - Holan Liang
- UCL Great Ormond Street Institute of Child Health, University College London, London, UK
- Psychological and Mental Health Services, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
| | - Isobel Heyman
- UCL Great Ormond Street Institute of Child Health, University College London, London, UK
- Psychological and Mental Health Services, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
| | - Anna E Coughtrey
- UCL Great Ormond Street Institute of Child Health, University College London, London, UK
- Psychological and Mental Health Services, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
| | - Kate Fifield
- UCL Great Ormond Street Institute of Child Health, University College London, London, UK
- Psychological and Mental Health Services, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
| | - Chloe Taylor
- UCL Great Ormond Street Institute of Child Health, University College London, London, UK
- Psychological and Mental Health Services, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
| | - Tim Dalgleish
- MRC Cognition and Brain Sciences Unit, Cambridge, Cambridgeshire, UK
| | - Laila Xu
- UCL Great Ormond Street Institute of Child Health, University College London, London, UK
| | - Roz Shafran
- UCL Great Ormond Street Institute of Child Health, University College London, London, UK
- Psychological and Mental Health Services, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
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27
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Bell L, Garnett C, Qian T, Perski O, Williamson E, Potts HW. Engagement With a Behavior Change App for Alcohol Reduction: Data Visualization for Longitudinal Observational Study. J Med Internet Res 2020; 22:e23369. [PMID: 33306026 PMCID: PMC7762688 DOI: 10.2196/23369] [Citation(s) in RCA: 16] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/10/2020] [Revised: 10/08/2020] [Accepted: 10/28/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Behavior change apps can develop iteratively, where the app evolves into a complex, dynamic, or personalized intervention through cycles of research, development, and implementation. Understanding how existing users engage with an app (eg, frequency, amount, depth, and duration of use) can help guide further incremental improvements. We aim to explore how simple visualizations can provide a good understanding of temporal patterns of engagement, as usage data are often longitudinal and rich. OBJECTIVE This study aims to visualize behavioral engagement with Drink Less, a behavior change app to help reduce hazardous and harmful alcohol consumption in the general adult population of the United Kingdom. METHODS We explored behavioral engagement among 19,233 existing users of Drink Less. Users were included in the sample if they were from the United Kingdom; were 18 years or older; were interested in reducing their alcohol consumption; had a baseline Alcohol Use Disorders Identification Test score of 8 or above, indicative of excessive drinking; and had downloaded the app between May 17, 2017, and January 22, 2019 (615 days). Measures of when sessions begin, length of sessions, time to disengagement, and patterns of use were visualized with heat maps, timeline plots, k-modes clustering analyses, and Kaplan-Meier plots. RESULTS The daily 11 AM notification is strongly associated with a change in engagement in the following hour; reduction in behavioral engagement over time, with 50.00% (9617/19,233) of users disengaging (defined as no use for 7 or more consecutive days) 22 days after download; identification of 3 distinct trajectories of use, namely engagers (4651/19,233, 24.18% of users), slow disengagers (3679/19,233, 19.13% of users), and fast disengagers (10,903/19,233, 56.68% of users); and limited depth of engagement with 85.076% (7,095,348/8,340,005) of screen views occurring within the Self-monitoring and Feedback module. In addition, a peak of both frequency and amount of time spent per session was observed in the evenings. CONCLUSIONS Visualizations play an important role in understanding engagement with behavior change apps. Here, we discuss how simple visualizations helped identify important patterns of engagement with Drink Less. Our visualizations of behavioral engagement suggest that the daily notification substantially impacts engagement. Furthermore, the visualizations suggest that a fixed notification policy can be effective for maintaining engagement for some users but ineffective for others. We conclude that optimizing the notification policy to target both effectiveness and engagement is a worthwhile investment. Our future goal is to both understand the causal effect of the notification on engagement and further optimize the notification policy within Drink Less by tailoring to contextual circumstances of individuals over time. Such tailoring will be informed from the findings of our micro-randomized trial (MRT), and these visualizations were useful in both gaining a better understanding of engagement and designing the MRT.
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Affiliation(s)
- Lauren Bell
- Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom
| | - Claire Garnett
- Research Department of Behavioural Science and Health, University College London, London, United Kingdom
| | - Tianchen Qian
- Department of Statistics, University of California Irvine, Irvine, CA, United States
| | - Olga Perski
- Research Department of Behavioural Science and Health, University College London, London, United Kingdom
| | - Elizabeth Williamson
- Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom
- Health Data Research UK, London, United Kingdom
| | - Henry Ww Potts
- Health Data Research UK, London, United Kingdom
- Institute of Health Informatics, University College London, London, United Kingdom
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28
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Abstract
OBJECTIVES To understand how individuals with tinnitus perceive their sound generating devices help them in managing their tinnitus. DESIGN A qualitative interview based study employing grounded theory methodology to establish a theory as to the mechanisms that sound therapies contribute to coping with tinnitus. Ten National Health Service patient participants (who had been issued with sound generating devices from an Audiology department in England) participated in in depth interviews. RESULTS This study identified that sound therapies helped create a sense of escapism and control. In addition, the process of obtaining devices created a sense of validation of the patient and their tinnitus. These mechanisms restore the previously disrupted harmony between the self and body. CONCLUSION Sound generating devices can assist coping through a number of mechanisms. There is no evidence that they ablate or remove perception of tinnitus. This study contributes novel theory based on patient accounts as to the potential benefits of sound generating device use.
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Affiliation(s)
- Shameela Munir
- Audiology department, School of Life and Health Sciences, Aston University, Birmingham, UK.,Centre of Hearing and Balance Disorders, University Hospital, Coventry, UK
| | - Helen Pryce
- Audiology department, School of Life and Health Sciences, Aston University, Birmingham, UK
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29
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Hepgul N, Wilson R, Yi D, Evans C, Bajwah S, Crosby V, Wilcock A, Lindsay F, Byrne A, Young C, Groves K, Smith C, Burman R, Chaudhuri KR, Silber E, Higginson IJ, Gao W. Immediate versus delayed short-term integrated palliative care for advanced long-term neurological conditions: the OPTCARE Neuro RCT. HEALTH SERVICES AND DELIVERY RESEARCH 2020. [DOI: 10.3310/hsdr08360] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/25/2022] Open
Abstract
Background
Palliative care is recommended to help meet the needs of patients with progressive non-cancer conditions, such as long-term neurological conditions. However, few trials have tested palliative care in this population.
Objectives
To determine the effectiveness and cost-effectiveness of short-term integrated palliative care in improving symptoms, improving patient- and caregiver-reported outcomes and reducing hospital use for people severely affected by long-term neurological conditions.
Design
Pragmatic, randomised controlled, multicentre, fast-track trial, with an embedded qualitative component and surveys.
Setting
Seven UK centres (South London, Nottingham, Liverpool, Cardiff, Brighton, Ashford and Sheffield) with multiprofessional palliative care teams and neurology services.
Participants
People living with multiple sclerosis, idiopathic Parkinson’s disease, motor neurone disease, multiple system atrophy or progressive supranuclear palsy, with unresolved symptoms and/or complex psychosocial needs. The qualitative study involved patients, caregivers and health-care staff.
Interventions
Participants were randomised to receive short-term integrated palliative care, delivered by multiprofessional teams, immediately or after a 12-week wait (standard care group).
Main outcome measures
The primary outcome was a combined score of eight symptoms measured by the Integrated Palliative care Outcome Scale for Neurological conditions 8 symptom subscale (IPOS Neuro-S8) at 12 weeks. Secondary outcomes included patients’ other physical and psychological symptoms, quality of life (EuroQol-5 Dimensions, five-level version), care satisfaction, caregiver burden, service use and cost, and harms. Data were analysed using multiple imputation, generalised linear mixed models, incremental cost-effectiveness ratios (threshold was the National Institute for Health and Care Excellence £20,000 per quality-adjusted life-year) and cost-effectiveness planes. Qualitative data were analysed thematically.
Results
We recruited 350 patients and 229 caregivers. There were no significant between-group differences for primary or secondary outcomes. Patients receiving short-term integrated palliative care had a significant improvement, from baseline to 12 weeks, on the primary outcome IPOS Neuro-S8 (–0.78, 95% confidence interval –1.29 to –0.26) and the secondary outcome of 24 physical symptoms (–1.95, 99.55% confidence interval –3.60 to –0.30). This was not seen in the control group, in which conversely, care satisfaction significantly reduced from baseline to 12 weeks (–2.89, 99.55% confidence interval –5.19 to –0.59). Incremental cost-effectiveness ratios were smaller than the set threshold (EuroQol-5 Dimensions index score –£23,545; IPOS Neuro-S8 –£1519), indicating that the intervention provided cost savings plus better outcomes. Deaths, survival and hospitalisations were similar between the two groups. Qualitative data suggested that the impact of the intervention encompassed three themes: (1) adapting to losses and building resilience, (2) attending to function, deficits and maintaining stability, and (3) enabling caregivers to care.
Conclusions
Our results indicate that short-term integrated palliative care provides improvements in patient-reported physical symptoms at a lower cost and without harmful effects when compared with standard care.
Limitations
Outcome measures may not have been sensitive enough to capture the multidimensional changes from the intervention. Our surveys found that the control/standard and intervention services were heterogeneous.
Future work
Refining short-term integrated palliative care and similar approaches for long-term neurological conditions, focusing on better integration of existing services, criteria for referral and research to improve symptom management.
Trial registration
Current Controlled Trials ISRCTN18337380.
Funding
This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 36. See the NIHR Journals Library website for further project information.
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Affiliation(s)
- Nilay Hepgul
- Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, King’s College London, London, UK
| | - Rebecca Wilson
- Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, King’s College London, London, UK
| | - Deokhee Yi
- Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, King’s College London, London, UK
| | - Catherine Evans
- Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, King’s College London, London, UK
- Sussex Community NHS Foundation Trust, Brighton, UK
| | - Sabrina Bajwah
- Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, King’s College London, London, UK
| | - Vincent Crosby
- Department of Palliative Medicine, Nottingham University Hospitals NHS Trust, Nottingham, UK
| | - Andrew Wilcock
- Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK
| | | | - Anthony Byrne
- Marie Curie Palliative Care Research Centre, Cardiff University, Cardiff, UK
| | - Carolyn Young
- Department of Neurology, The Walton Centre NHS Foundation Trust, Liverpool, UK
| | | | - Clare Smith
- Department of Palliative Care, Ashford and St. Peter’s Hospitals NHS Foundation Trust, Surrey, UK
| | - Rachel Burman
- Department of Palliative Care, King’s College Hospital, London, UK
| | - K Ray Chaudhuri
- National Parkinson Foundation Centre of Excellence, King’s College Hospital and King’s College London, London, UK
| | - Eli Silber
- Department of Neurology, King’s College Hospital, London, UK
| | - Irene J Higginson
- Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, King’s College London, London, UK
| | - Wei Gao
- Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, King’s College London, London, UK
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Rocks S, Fazel M, Tsiachristas A. Impact of transforming mental health services for young people in England on patient access, resource use and health: a quasi-experimental study. BMJ Open 2020; 10:e034067. [PMID: 31948991 PMCID: PMC7044818 DOI: 10.1136/bmjopen-2019-034067] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2019] [Revised: 11/21/2019] [Accepted: 12/17/2019] [Indexed: 02/01/2023] Open
Abstract
OBJECTIVE To evaluate the impact of child and adolescent mental health services (CAMHS) transformation in South East England on patient access, resource utilisation and health outcomes. DESIGN In an observational study, we use difference-in-differences analysis with propensity score matching to analyse routinely collected patient level data. SETTING Three CAMHS services in South East England. PARTICIPANTS All patients attending CAMHS between April 2012 and December 2018, with more than 57 000 spells of care included. MAIN OUTCOME MEASURES The rate and volume of people accessing CAMHS; waiting times to the first contact and waiting times between the first and second contact; and health outcomes, including the Strengths and Difficulties Questionnaire (SDQ) and the Revised Child Anxiety and Depression Scale (RCADS). RESULTS The intervention led to 20% (incidence rate ratio: 1.20; 95% CI: 1.15 to 1.24) more new patients starting per month. There was mixed evidence on waiting times for the first contact. The intervention led to 10% (incidence rate ratio: 1.10; 95% CI: 1.02 to 1.18) higher waiting time for the second contact. The number of contacts per spell (OR: 1.08; 95% CI: 0.94 to 1.25) and the rereferral rate (OR: 1.06; 95% CI: 0.96 to 1.17) were not significantly different. During the post intervention period, patients in the intervention group scored on average 3.3 (95% CI: -5.0 to -1.6) points lower on the RCADS and 1.0 (95% CI: -1.8 to -0.3) points lower on the SDQ compared with the control group after adjusting for the baseline score. CONCLUSIONS Overall, there are signs that transformation can help CAMHS achieve the objectives of greater access and improved health outcomes, but trade-offs exist among different performance metrics, particularly between access and waiting times. Commissioners and providers should be conscious of any trade-offs when undertaking service redesign and transformation.
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Affiliation(s)
- Stephen Rocks
- Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK
| | - Mina Fazel
- Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK
| | - Apostolos Tsiachristas
- Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK
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McClurg D, Harris F, Goodman K, Doran S, Hagen S, Treweek S, Norton C, Coggrave M, Norrie J, Rauchhaus P, Donnan P, Emmanuel A, Manoukian S, Mason H. Abdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCT. Health Technol Assess 2019; 22:1-134. [PMID: 30375324 DOI: 10.3310/hta22580] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022] Open
Abstract
BACKGROUND Between 50% and 80% of people with multiple sclerosis (PwMS) experience neurogenic bowel dysfunction (NBD) (i.e. constipation and faecal incontinence) that affects quality of life and can lead to hospitalisation. OBJECTIVES To determine the clinical effectiveness and cost-effectiveness of abdominal massage plus advice on bowel symptoms on PwMS compared with advice only. A process evaluation investigated the factors that affected the clinical effectiveness and possible implementation of the different treatments. DESIGN A randomised controlled trial with process evaluation and health economic components. Outcome analysis was undertaken blind. SETTING The trial took place in 12 UK hospitals. PARTICIPANTS PwMS who had 'bothersome' NBD. INTERVENTION Following individualised training, abdominal massage was undertaken daily for 6 weeks (intervention group). Advice on good bowel management as per the Multiple Sclerosis Society advice booklet was provided to both groups. All participants received weekly telephone calls from the research nurse. MAIN OUTCOME MEASURES The primary outcome was the difference between the intervention and control groups in change in the NBD score from baseline to week 24. Secondary outcomes were measured via a bowel diary, adherence diary, the Constipation Scoring System, patient resource questionnaire and the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). RESULTS A total of 191 participants were finalised, 189 of whom were randomised (two participants were finalised in error) (control group, n = 99; intervention group, n = 90) and an intention-to-treat analysis was performed. The mean age was 52 years (standard deviation 10.83 years), 81% (n = 154) were female and 11% (n = 21) were wheelchair dependent. Fifteen participants from the intervention group and five from the control group were lost to follow-up. The change in NBD score by week 24 demonstrated no significant difference between groups [mean difference total score -1.64, 95% confidence interval (CI) -3.32 to 0.04; p = 0.0558]; there was a significant difference between groups in the change in the frequency of stool evacuation per week (mean difference 0.62, 95% CI 0.03 to 1.21; p = 0.039) and in the number of times per week that participants felt that they emptied their bowels completely (mean difference 1.08, 95% CI 0.41 to 1.76; p = 0.002), in favour of the intervention group. Of participant interviewees, 75% reported benefits, for example less difficulty passing stool, more complete evacuations, less bloated, improved appetite, and 85% continued with the massage. A cost-utility analysis conducted from a NHS and patient cost perspective found in the imputed sample with bootstrapping a mean incremental outcome effect of the intervention relative to usual care of -0.002 quality-adjusted life-years (QALYs) (95% CI -0.029 to 0.027 QALYs). In the same imputed sample with bootstrapping, the mean incremental cost effect of the intervention relative to usual care was £56.50 (95% CI -£372.62 to £415.68). No adverse events were reported. Limitations include unequal randomisation, dropout and the possibility of ineffective massage technique. CONCLUSION The increment in the primary outcome favoured the intervention group, but it was small and not statistically significant. The economic analysis identified that the intervention was dominated by the control group. Given the small improvement in the primary outcome, but not in terms of QALYs, a low-cost version of the intervention might be considered worthwhile by some patients. FUTURE WORK Research is required to establish possible mechanisms of action and modes of massage delivery. TRIAL REGISTRATION Current Controlled Trials ISRCTN85007023 and NCT03166007. FUNDING This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 58. See the NIHR Journals Library website for further project information.
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Affiliation(s)
- Doreen McClurg
- Nursing, Midwifery and Allied Health Professionals Research Unit, Glasgow Caledonian University, Glasgow, UK
| | - Fiona Harris
- Nursing, Midwifery and Allied Health Professionals Research Unit, University of Stirling, Stirling, UK
| | - Kirsteen Goodman
- Nursing, Midwifery and Allied Health Professionals Research Unit, Glasgow Caledonian University, Glasgow, UK
| | - Selina Doran
- Nursing, Midwifery and Allied Health Professionals Research Unit, Glasgow Caledonian University, Glasgow, UK
| | - Suzanne Hagen
- Nursing, Midwifery and Allied Health Professionals Research Unit, Glasgow Caledonian University, Glasgow, UK
| | - Shaun Treweek
- Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | | | | | - John Norrie
- Edinburgh Clinical Trials Unit, The University of Edinburgh, Edinburgh, UK
| | - Petra Rauchhaus
- Tayside Clinical Trials Unit, University of Dundee, Dundee, UK
| | - Peter Donnan
- Tayside Clinical Trials Unit, University of Dundee, Dundee, UK
| | - Anton Emmanuel
- National Hospital for Neurology and Neurosurgery, University College London, London, UK
| | - Sarkis Manoukian
- Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK
| | - Helen Mason
- Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK
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Vieira MC, Relph S, Copas A, Healey A, Coxon K, Alagna A, Briley A, Johnson M, Lawlor DA, Lees C, Marlow N, McCowan L, Page L, Peebles D, Shennan A, Thilaganathan B, Khalil A, Sandall J, Pasupathy D. The DESiGN trial (DEtection of Small for Gestational age Neonate), evaluating the effect of the Growth Assessment Protocol (GAP): study protocol for a randomised controlled trial. Trials 2019; 20:154. [PMID: 30832739 PMCID: PMC6398257 DOI: 10.1186/s13063-019-3242-6] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/08/2018] [Accepted: 02/06/2019] [Indexed: 11/29/2022] Open
Abstract
Background Stillbirth rates in the United Kingdom (UK) are amongst the highest of all developed nations. The association between small-for-gestational-age (SGA) foetuses and stillbirth is well established, and observational studies suggest that improved antenatal detection of SGA babies may halve the stillbirth rate. The Growth Assessment Protocol (GAP) describes a complex intervention that includes risk assessment for SGA and screening using customised fundal-height growth charts. Increased detection of SGA from the use of GAP has been implicated in the reduction of stillbirth rates by 22%, in observational studies of UK regions where GAP uptake was high. This study will be the first randomised controlled trial examining the clinical efficacy, health economics and implementation of the GAP programme in the antenatal detection of SGA. Methods/design In this randomised controlled trial, clusters comprising a maternity unit (or National Health Service Trust) were randomised to either implementation of the GAP programme, or standard care. The primary outcome is the rate of antenatal ultrasound detection of SGA in infants found to be SGA at birth by both population and customised standards, as this is recognised as being the group with highest risk for perinatal morbidity and mortality. Secondary outcomes include antenatal detection of SGA by population centiles, antenatal detection of SGA by customised centiles, short-term maternal and neonatal outcomes, resource use and economic consequences, and a process evaluation of GAP implementation. Qualitative interviews will be performed to assess facilitators and barriers to implementation of GAP. Discussion This study will be the first to provide data and outcomes from a randomised controlled trial investigating the potential difference between the GAP programme compared to standard care for antenatal ultrasound detection of SGA infants. Accurate information on the performance and service provision requirements of the GAP protocol has the potential to inform national policy decisions on methods to reduce the rate of stillbirth. Trial registration Primary registry and trial identifying number: ISRCTN 67698474. Registered on 2 November 2016. Electronic supplementary material The online version of this article (10.1186/s13063-019-3242-6) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Matias C Vieira
- Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK
| | - Sophie Relph
- Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK
| | - Andrew Copas
- Centre for Pragmatic Global Health Trials, Institute for Global Health, University College London, Gower Street, London, WC1E 6BT, UK
| | - Andrew Healey
- Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK
| | - Kirstie Coxon
- Faculty of Health, Social Care and Education, Kingston and St. George's University, 6th Floor, Hunter Wing, Cranmer Terrace, London, SW17 0RE, UK
| | - Alessandro Alagna
- The Guy's and St Thomas' Charity, 9 King's Head Yard, London, SE1 1NA, UK
| | - Annette Briley
- Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK
| | - Mark Johnson
- Department of Surgery and Cancer, Imperial College London, Kensington, London, SW7 2AZ, UK
| | - Deborah A Lawlor
- Population Health Science, Bristol Medical School, University of Bristol, Bristol, BS8 2BL, UK.,Bristol NIHR Biomedical Research Centre, Bristol, BS8 2BL, UK
| | - Christoph Lees
- Department of Surgery and Cancer, Imperial College London, Kensington, London, SW7 2AZ, UK
| | - Neil Marlow
- UCL Institute for Women's Health, University College London, Gower Street, London, WC1E 6BT, UK
| | - Lesley McCowan
- Faculty of Medical and Health Sciences, University of Auckland, Victoria Street West, Auckland, 1142, New Zealand
| | - Louise Page
- West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, Twickenham Road, Isleworth, TW7 6AF, UK
| | - Donald Peebles
- UCL Institute for Women's Health, University College London, Gower Street, London, WC1E 6BT, UK
| | - Andrew Shennan
- Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK
| | - Baskaran Thilaganathan
- Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, Blackshaw Road, London, SW17 0QT, UK.,Molecular and Clinical Sciences Research Institute, St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK
| | - Asma Khalil
- Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, Blackshaw Road, London, SW17 0QT, UK.,Molecular and Clinical Sciences Research Institute, St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK
| | - Jane Sandall
- Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK
| | - Dharmintra Pasupathy
- Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
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Booth V, Hood-Moore V, Hancox JE, Logan P, Robinson KR. Systematic scoping review of frameworks used to develop rehabilitation interventions for older adults. BMJ Open 2019; 9:e024185. [PMID: 30798309 PMCID: PMC6398678 DOI: 10.1136/bmjopen-2018-024185] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/01/2018] [Revised: 12/18/2018] [Accepted: 12/21/2018] [Indexed: 12/31/2022] Open
Abstract
OBJECTIVES Rehabilitation interventions for older adults are complex as they involve a number of interacting components, have multiple outcomes of interest and are influenced by a number of contextual factors. The importance of rigorous intervention development prior to formal evaluation has been acknowledged and a number of frameworks have been developed. This review explored which frameworks have been used to guide the development of rehabilitation interventions for older adults. DESIGN Systematic scoping review. SETTING Studies were not limited for inclusion based on setting. PARTICIPANTS Studies were included that featured older adults (>65 years of age). INTERVENTIONS Studies were included that reported the development of a rehabilitation intervention. PRIMARY AND SECONDARY OUTCOME MEASURES Data were extracted on study population, setting, type of intervention developed and frameworks used. The primary outcome of interest was the type of intervention development framework. RESULTS Thirty-five studies were included. There was a range of underlying medical conditions including mild cognitive impairment and dementia (n=5), cardiac (n=4), stroke (n=3), falls (n=3), hip fracture (n=2), diabetes (n=2), breast cancer (n=1), Parkinson's disease (n=1), depression (n=1), chronic health problems (n=1), osteoarthritis (n=1), leg ulcer (n=1), neck pain (n=1) and foot problems (n=1). The intervention types being developed included multicomponent, support based, cognitive, physical activities, nursing led, falls prevention and occupational therapy led. Twelve studies (34%) did not report using a framework. Five frameworks were reported with the Medical Research Council (MRC) framework for developing and evaluating complex interventions being the most frequently cited (77%, n=17). CONCLUSION At present, the MRC framework is the most popular for developing rehabilitation interventions for older adults. Many studies do not report using a framework. Further, specific guidance to assist this complex field of rehabilitation research is required.
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Affiliation(s)
- Vicky Booth
- Division of Rehabilitation and Ageing, University of Nottingham School of Medicine, Nottingham, UK
| | - Victoria Hood-Moore
- Division of Rehabilitation and Ageing, University of Nottingham School of Medicine, Nottingham, UK
| | - Jennie E Hancox
- Division of Rehabilitation and Ageing, University of Nottingham School of Medicine, Nottingham, UK
| | - Phillipa Logan
- Division of Rehabilitation and Ageing, University of Nottingham School of Medicine, Nottingham, UK
| | - Katie R Robinson
- Division of Rehabilitation and Ageing, University of Nottingham School of Medicine, Nottingham, UK
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Radomski AD, Wozney L, McGrath P, Huguet A, Hartling L, Dyson MP, Bennett K, Newton AS. Design and Delivery Features That May Improve the Use of Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Anxiety: A Realist Literature Synthesis With a Persuasive Systems Design Perspective. J Med Internet Res 2019; 21:e11128. [PMID: 30720436 PMCID: PMC6379818 DOI: 10.2196/11128] [Citation(s) in RCA: 25] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/25/2018] [Revised: 09/26/2018] [Accepted: 10/20/2018] [Indexed: 12/15/2022] Open
Abstract
Background Internet-based cognitive behavioral therapy (iCBT) is a persuasive system as its design combines therapeutic content, technological features, and interactions between the user and the program to reduce anxiety for children and adolescents. How iCBT is designed and delivered differs across programs. Although iCBT is considered an effective approach for treating child and adolescent anxiety, rates of program use (eg, module completion) are highly variable for reasons that are not clear. As the extent to which users complete a program can impact anxiety outcomes, understanding what iCBT design and delivery features improve program use is critical for optimizing treatment effects. Objective The objectives of this study were to use a realist synthesis approach to explore the design and delivery features of iCBT for children and adolescents with anxiety as described in the literature and to examine their relationship to program use outcomes. Methods A search of published and gray literature was conducted up to November 2017. Prespecified inclusion criteria identified research studies, study protocols, and program websites on iCBT for child and adolescent anxiety. Literature was critically appraised for relevance and methodological rigor. The persuasive systems design (PSD) model, a comprehensive framework for designing and evaluating persuasive systems, was used to guide data extraction. iCBT program features were grouped under 4 PSD categories—Primary task support, Dialogue support, System credibility support, and Social support. iCBT design (PSD Mechanisms) and delivery features (Context of use) were linked to program use (Outcomes) using meta-ethnographic methods; these relationships were described as Context-Mechanism-Outcome configurations. For our configurations, we identified key PSD features and delivery contexts that generated moderate-to-high program use based on moderate-to-high quality evidence found across multiple iCBT programs. Results A total of 44 documents detailing 10 iCBT programs were included. Seven iCBT programs had at least one document that scored high for relevance; most studies were of moderate-to-high methodological rigor. We developed 5 configurations that highlighted 8 PSD features (Tailoring, Personalization [Primary task supports]; Rewards, Reminders, Social role [Dialogue supports]; and Trustworthiness, Expertise, Authority [System credibility supports]) associated with moderate-to-high program use. Important features of delivery Context were adjunct support (a face-to-face, Web- or email-based communications component) and whether programs targeted the prevention or treatment of anxiety. Incorporating multiple PSD features may have additive or synergistic effects on program use. Conclusions The Context-Mechanism-Outcome configurations we developed suggest that, when delivered with adjunct support, certain PSD features contribute to moderate-to-high use of iCBT prevention and treatment programs for children and adolescents with anxiety. Standardization of the definition and measurement of program use, formal testing of individual and combined PSD features, and use of real-world design and testing methods are important next steps to improving how we develop and deliver increasingly useful treatments to target users.
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Affiliation(s)
- Ashley D Radomski
- Department of Pediatrics, University of Alberta, Edmonton, AB, Canada
| | - Lori Wozney
- Centre for Research in Family Health, IWK Health Centre, Halifax, NS, Canada
| | - Patrick McGrath
- Department of Psychology, Dalhousie University, Halifax, NS, Canada.,Department of Pediatrics, Dalhousie University, Halifax, NS, Canada.,Deparment of Psychiatry, Dalhousie University, Halifax, NS, Canada
| | - Anna Huguet
- Department of Community of Health and Epidemiology, Dalhousie University, Halifax, NS, Canada
| | - Lisa Hartling
- Department of Pediatrics, University of Alberta, Edmonton, AB, Canada
| | - Michele P Dyson
- Department of Pediatrics, University of Alberta, Edmonton, AB, Canada
| | - Kathryn Bennett
- Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada
| | - Amanda S Newton
- Department of Pediatrics, University of Alberta, Edmonton, AB, Canada
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35
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Steven A, Wilson G, Young-Murphy L. The Implementation of an Innovative Hydration Monitoring App in Care Home Settings: A Qualitative Study. JMIR Mhealth Uhealth 2019; 7:e9892. [PMID: 30694207 PMCID: PMC6371068 DOI: 10.2196/mhealth.9892] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/14/2018] [Revised: 09/26/2018] [Accepted: 10/07/2018] [Indexed: 11/25/2022] Open
Abstract
Background In response to marked concern regarding inadequate fluid intake recording in care homes, an innovative mobile hydration app was collaboratively developed. “Hydr8” aimed to facilitate accurate recording and communication of residents’ fluid intake and ultimately increase care quality and patient safety. Objective The aim of this study was to examine the implementation of Hydr8 in a sample of care homes in one area in England. Methods The principles of Realist Evaluation and Action research were drawn upon throughout the study. Overall, 5 care homes participated in this study, 3 interview-only sites and 2 case-study sites, where interviews and observations were conducted at 3 time-points. Furthermore, 28 staff members participated, including care staff, management, a registered nurse, and administrative staff. Results Findings suggest that Hydr8 benefits practice, enhancing the understanding of hydration and person-centered care and improving staff communication. However, technical glitches hindered the seamless embedding of Hydr8 into everyday practice, and enthusiasm for long-term use was dependent on the resolution of issues. In addition, Hydr8 heightened perceptions of personal accountability, and while managers viewed this as positive, some staff members were apprehensive. However, individuals were enthusiastic about the long-term use and potential of Hydr8. Conclusions Utilizing the findings of this study to further develop and adapt Hydr8 indicates the long-term use of Hydr8 as promising. Although perceptions of Hydr8 were primarily positive, setbacks in its implementation and use created difficulties in normalizing the solution into everyday practice. This study highlights the need for education related to hydration practice and a change of infrastructure in care home settings to implement technical solutions and changes to care.
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Affiliation(s)
- Alison Steven
- Department of Nursing, Midwifery and Health, Faculty of Health and Life Sciences, Northumbria University Newcastle, Newcastle upon Tyne, United Kingdom
| | - Gemma Wilson
- Department of Nursing, Midwifery and Health, Faculty of Health and Life Sciences, Northumbria University Newcastle, Newcastle upon Tyne, United Kingdom
| | - Lesley Young-Murphy
- NHS North Tyneside Clinical Commissioning Group, North Shields, United Kingdom
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36
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Grunfeld EA, Schumacher L, Armaou M, Woods PL, Rolf P, Sutton AJ, Zarkar A, Sadhra SS. Feasibility randomised controlled trial of a guided workbook intervention to support work-related goals among cancer survivors in the UK. BMJ Open 2019; 9:e022746. [PMID: 30670507 PMCID: PMC6347862 DOI: 10.1136/bmjopen-2018-022746] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/04/2023] Open
Abstract
OBJECTIVES Employment following illness is associated with better physical and psychological functioning. This study aimed to assess the feasibility and acceptability of a theoretically led workbook intervention designed to support patients with cancer returning to work. DESIGN Parallel-group randomised controlled trial with embedded qualitative interviews. SETTING Oncology clinics within four English National Health Service Trusts. PARTICIPANTS Patients who had received a diagnosis of breast, gynaecological, prostate or colorectal cancer and who had been receiving treatment for a minimum of two weeks. INTERVENTION A self-guided WorkPlan workbook designed to support patients with cancer to return to work with fortnightly telephone support calls to discuss progress. The control group received treatment as usual and was offered the workbook at the end of their 12-month follow-up. OUTCOME MEASURES We assessed aspects of feasibility including eligibility, recruitment, data collection, attrition, feasibility of the methodology, acceptability of the intervention and potential to calculate cost-effectiveness. RESULTS The recruitment rate of eligible patients was 44%; 68 participants consented and 58 (85%) completed baseline measures. Randomisation procedures were acceptable, data collection methods (including cost-effectiveness data) were feasible and the intervention was acceptable to participants. Retention rates at 6-month and 12-month follow-up were 72% and 69%, respectively. At 6-month follow-up, 30% of the usual care group had returned to full-time or part-time work (including phased return to work) compared with 43% of the intervention group. At 12 months, the percentages were 47% (usual care) and 68% (intervention). CONCLUSIONS The findings confirm the feasibility of a definitive trial, although further consideration needs to be given to increasing the participation rates among men and black and ethnic minority patients diagnosed with cancer. TRIAL REGISTRATION NUMBER ISRCTN56342476; Pre-results.
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Affiliation(s)
| | - Lauren Schumacher
- Faculty of Health and Life Sciences, Coventry University, Coventry, UK
| | - Maria Armaou
- Faculty of Health and Life Sciences, Coventry University, Coventry, UK
| | - Pernille L Woods
- Department of Psychological Sciences, Birkbeck University of London, London, UK
| | - Pauline Rolf
- Faculty of Health and Life Sciences, Coventry University, Coventry, UK
| | | | - Anjali Zarkar
- Oncology Department, Queen Elizabeth Hospital, University Hospitals Birmingham National Health Service Foundation Trust, Birmingham, UK
| | - Steven S Sadhra
- Occupational and Environmental Medicine, Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
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Leask CF, Sandlund M, Skelton DA, Altenburg TM, Cardon G, Chinapaw MJM, De Bourdeaudhuij I, Verloigne M, Chastin SFM, on behalf of the GrandStand, Safe Step and Teenage Girls on the Move Research Groups. Framework, principles and recommendations for utilising participatory methodologies in the co-creation and evaluation of public health interventions. RESEARCH INVOLVEMENT AND ENGAGEMENT 2019; 5:2. [PMID: 30652027 PMCID: PMC6327557 DOI: 10.1186/s40900-018-0136-9] [Citation(s) in RCA: 264] [Impact Index Per Article: 44.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/04/2018] [Accepted: 12/10/2018] [Indexed: 05/23/2023]
Abstract
PLAIN ENGLISH SUMMARY Background: Society has to cope with a large burden of health issues. There is need to find solutions to prevent diseases and help individuals live healthier lifestyles. Individual needs and circumstances vary greatly and one size fit all solutions do not tend to work well. More tailored solutions centred on individuals' needs and circumstances can be developed in collaboration with these individuals. This process, known as co-creation, has shown promise but it requires guiding principles to improve its effectiveness. The aim of this study was to identify a key set of principles and recommendations for co-creating public health interventions.Methods: These principles were collaboratively developed through analysing a set of case studies targeting different health behaviours (such as reducing sitting and improving strength and balance) in different groups of people (such as adolescent schoolgirls and older adults living in the community).Results: The key principles of co-creation are presented in four stages: Planning (what is the purpose of the co-creation; and who should be involved?); Conducting (what activities can be used during co-creation; and how to ensure buy-in and commitment?); Evaluating (how do we know the process and the outcome are valid and effective?) and Reporting (how to report the findings?). Three models are proposed to show how co-created solutions can be scaled up to a population level.Conclusions: These recommendations aim to help the co-creation of public health interventions by providing a framework and governance to guide the process. ABSTRACT Background: Due to the chronic disease burden on society, there is a need for preventive public health interventions to stimulate society towards a healthier lifestyle. To deal with the complex variability between individual lifestyles and settings, collaborating with end-users to develop interventions tailored to their unique circumstances has been suggested as a potential way to improve effectiveness and adherence. Co-creation of public health interventions using participatory methodologies has shown promise but lacks a framework to make this process systematic. The aim of this paper was to identify and set key principles and recommendations for systematically applying participatory methodologies to co-create and evaluate public health interventions. Methods: These principles and recommendations were derived using an iterative reflection process, combining key learning from published literature in addition to critical reflection on three case studies conducted by research groups in three European institutions, all of whom have expertise in co-creating public health interventions using different participatory methodologies. Results: Key principles and recommendations for using participatory methodologies in public health intervention co-creation are presented for the stages of: Planning (framing the aim of the study and identifying the appropriate sampling strategy); Conducting (defining the procedure, in addition to manifesting ownership); Evaluating (the process and the effectiveness) and Reporting (providing guidelines to report the findings). Three scaling models are proposed to demonstrate how to scale locally developed interventions to a population level. Conclusions: These recommendations aim to facilitate public health intervention co-creation and evaluation utilising participatory methodologies by ensuring the process is systematic and reproducible.
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Affiliation(s)
- Calum F. Leask
- Glasgow Caledonian University, School of Health and Life Sciences, Institute of Applied Health Research, Glasgow, UK
- NHS Grampian, Health Intelligence Department, Aberdeen, UK
| | - Marlene Sandlund
- Department of Community Medicine and Rehabilitation, Umea University, Umea, Sweden
| | - Dawn A. Skelton
- Glasgow Caledonian University, School of Health and Life Sciences, Institute of Applied Health Research, Glasgow, UK
| | - Teatske M. Altenburg
- Department of Public and Occupational Health, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands
| | - Greet Cardon
- Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
| | - Mai J. M. Chinapaw
- Department of Public and Occupational Health, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands
| | - Ilse De Bourdeaudhuij
- Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
| | - Maite Verloigne
- Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
| | - Sebastien F. M. Chastin
- Glasgow Caledonian University, School of Health and Life Sciences, Institute of Applied Health Research, Glasgow, UK
- Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
| | - on behalf of the GrandStand, Safe Step and Teenage Girls on the Move Research Groups
- Glasgow Caledonian University, School of Health and Life Sciences, Institute of Applied Health Research, Glasgow, UK
- NHS Grampian, Health Intelligence Department, Aberdeen, UK
- Department of Community Medicine and Rehabilitation, Umea University, Umea, Sweden
- Department of Public and Occupational Health, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands
- Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
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Gram L, Daruwalla N, Osrin D. Understanding participation dilemmas in community mobilisation: can collective action theory help? J Epidemiol Community Health 2018; 73:90-96. [PMID: 30377247 PMCID: PMC6839791 DOI: 10.1136/jech-2018-211045] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2018] [Revised: 08/28/2018] [Accepted: 10/12/2018] [Indexed: 11/24/2022]
Abstract
Community mobilisation interventions have been used to promote health in many low-income and middle-income settings. They frequently involve collective action to address shared determinants of ill-health, which often requires high levels of participation to be effective. However, the non-excludable nature of benefits produced often generates participation dilemmas: community members have an individual interest in abstaining from collective action and free riding on others’ contributions, but no benefit is produced if nobody participates. For example, marches, rallies or other awareness-raising activities to change entrenched social norms affect the social environment shared by community members whether they participate or not. This creates a temptation to let other community members invest time and effort. Collective action theory provides a rich, principled framework for analysing such participation dilemmas. Over the past 50 years, political scientists, economists, sociologists and psychologists have proposed a plethora of incentive mechanisms to solve participation dilemmas: selective incentives, intrinsic benefits, social incentives, outsize stakes, intermediate goals, interdependency and critical mass theory. We discuss how such incentive mechanisms might be used by global health researchers to produce new questions about how community mobilisation works and conclude with theoretical predictions to be explored in future quantitative or qualitative research.
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Affiliation(s)
- Lu Gram
- Institute for Global Health, University College London, London, UK
| | - Nayreen Daruwalla
- SNEHA (Society for Nutrition, Education and Health Action), Mumbai, India
| | - David Osrin
- Institute for Global Health, University College London, London, UK
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Jackson BD, Con D, De Cruz P. Design considerations for an eHealth decision support tool in inflammatory bowel disease self-management. Intern Med J 2018; 48:674-681. [PMID: 29136332 DOI: 10.1111/imj.13677] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/28/2017] [Accepted: 11/07/2017] [Indexed: 12/19/2022]
Abstract
BACKGROUND Electronic health (eHealth) decision support tools have the potential to: facilitate inflammatory bowel disease (IBD) self-management, reduce health care utilisation and alleviate the pressure on overburdened outpatient clinics. The purpose of this study was to explore the perspectives of key stakeholders on the potential use of a decision support tool for IBD patients. METHODS A qualitative study using focus group methodology was conducted at a tertiary IBD centre in Melbourne, Australia in February 2015. Key stakeholders, including physicians, nurses and patients, were included in the study. Two independent reviewers undertook inductive coding and generated themes. RESULTS In total, 31 participants were included in the study (including 16 males; 11 physicians; 6 nurses). An eHealth decision support tool was thought to be beneficial to facilitate IBD self-management. Four themes emerged: (i) Framework for the decision support tool - the tool should be an adjunct to current models of care and facilitate shared decision-making and patient engagement; (ii) Target population - stable patients with mild to moderate disease; (iii) Functionalities of the intervention - a web-based platform encompassing patient-reported outcomes, objective markers of disease and clinical algorithms based on international guidelines; and (iv) Design and Implementation - patients should be involved in the design. CONCLUSIONS eHealth interventions are thought to be an important strategy to facilitate self-management for patients with IBD. A multi-stage iterative approach should be adopted in the design and implementation process of eHealth interventions. Patient perspectives need to be sought prior to and throughout the development of an eHealth decision support tools for IBD.
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Affiliation(s)
- Belinda D Jackson
- Department of Gastroenterology, The Austin Hospital, Melbourne, Victoria, Australia.,Department of Medicine, Austin Academic Centre, The University of Melbourne, Melbourne, Victoria, Australia
| | - Danny Con
- Department of Gastroenterology, The Austin Hospital, Melbourne, Victoria, Australia
| | - Peter De Cruz
- Department of Gastroenterology, The Austin Hospital, Melbourne, Victoria, Australia.,Department of Medicine, Austin Academic Centre, The University of Melbourne, Melbourne, Victoria, Australia
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Nathan HL, Duhig K, Vousden N, Lawley E, Seed PT, Sandall J, Bellad MB, Brown AC, Chappell LC, Goudar SS, Gidiri MF, Shennan AH. Evaluation of a novel device for the management of high blood pressure and shock in pregnancy in low-resource settings: study protocol for a stepped-wedge cluster-randomised controlled trial (CRADLE-3 trial). Trials 2018; 19:206. [PMID: 29587875 PMCID: PMC5870727 DOI: 10.1186/s13063-018-2581-z] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/02/2017] [Accepted: 03/13/2018] [Indexed: 11/10/2022] Open
Abstract
Background Obstetric haemorrhage, sepsis and pregnancy hypertension account for more than 50% of maternal deaths worldwide. Early detection and effective management of these conditions relies on vital signs. The Microlife® CRADLE Vital Sign Alert (VSA) is an easy-to-use, accurate device that measures blood pressure and pulse. It incorporates a traffic-light early warning system that alerts all levels of healthcare provider to the need for escalation of care in women with obstetric haemorrhage, sepsis or pregnancy hypertension, thereby aiding early recognition of haemodynamic instability and preventing maternal mortality and morbidity. The aim of the trial was to determine whether implementation of the CRADLE intervention (the Microlife® CRADLE VSA device and CRADLE training package) into routine maternity care in place of existing equipment will reduce a composite outcome of maternal mortality and morbidity in low- and middle-income country populations. Methods The CRADLE-3 trial was a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care. Each cluster crossed from routine maternity care to the intervention at 2-monthly intervals over the course of 20 months (April 2016 to November 2017). All women identified as pregnant or within 6 weeks postpartum, presenting for maternity care in cluster catchment areas were eligible to participate. Primary outcome data (composite of maternal death, eclampsia and emergency hysterectomy per 10,000 deliveries) were collected at 10 clusters (Gokak, Belgaum, India; Harare, Zimbabwe; Ndola, Zambia; Lusaka, Zambia; Free Town, Sierra Leone; Mbale, Uganda; Kampala, Uganda; Cap Haitien, Haiti; South West, Malawi; Addis Ababa, Ethiopia). This trial was informed by the Medical Research Council guidance for complex interventions. A process evaluation was undertaken to evaluate implementation in each site and a cost-effectiveness evaluation will be undertaken. Discussion All aspects of this protocol have been evaluated in a feasibility study, with subsequent optimisation of the intervention. This trial will demonstrate the potential impact of the CRADLE intervention on reducing maternal mortality and morbidity in low-resource settings. It is anticipated that the relatively low cost of the intervention and ease of integration into existing health systems will be of significant interest to local, national and international health policy-makers. Trial registration ISCRTN41244132. Registered on 2 February 2016. Prospective protocol modifications have been recorded and were communicated to the Ethics Committees and Trials Committees. The adapted Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist and the SPIRIT Checklist are attached as Additional file 1. Electronic supplementary material The online version of this article (10.1186/s13063-018-2581-z) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Hannah L Nathan
- Department of Women and Children's Health, King's College London, London, UK
| | - Kate Duhig
- Department of Women and Children's Health, King's College London, London, UK
| | - Nicola Vousden
- Department of Women and Children's Health, King's College London, London, UK
| | - Elodie Lawley
- Department of Women and Children's Health, King's College London, London, UK
| | - Paul T Seed
- Department of Women and Children's Health, King's College London, London, UK
| | - Jane Sandall
- Department of Women and Children's Health, King's College London, London, UK
| | - Mrutyunjaya B Bellad
- Department of Obstetrics and Gynaecology, KLE University's JN Medical College, Belgaum, Karnataka, India
| | - Adrian C Brown
- Maternity Worldwide, Community Base, 113 Queens Rd, Brighton, UK
| | - Lucy C Chappell
- Department of Women and Children's Health, King's College London, London, UK
| | - Shivaprasad S Goudar
- Department of Obstetrics and Gynaecology, KLE University's JN Medical College, Belgaum, Karnataka, India
| | - Muchabayiwa F Gidiri
- Department of Obstetrics and Gynaecology, University of Zimbabwe, Harare, Zimbabwe
| | - Andrew H Shennan
- Department of Women and Children's Health, King's College London, London, UK.
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Lamontagne-Godwin F, Burgess C, Clement S, Gasston-Hales M, Greene C, Manyande A, Taylor D, Walters P, Barley E. Interventions to increase access to or uptake of physical health screening in people with severe mental illness: a realist review. BMJ Open 2018; 8:e019412. [PMID: 29440160 PMCID: PMC5829934 DOI: 10.1136/bmjopen-2017-019412] [Citation(s) in RCA: 21] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/31/2017] [Revised: 11/15/2017] [Accepted: 12/07/2017] [Indexed: 11/04/2022] Open
Abstract
OBJECTIVES To identify and evaluate interventions aimed at increasing uptake of, or access to, physical health screening by adults with severe mental illness; to examine why interventions might work. DESIGN Realist review. SETTING Primary, secondary and tertiary care. RESULTS A systematic search identified 1448 studies, of which 22 met the inclusion criteria. Studies were from Australia (n=3), Canada (n=1), Hong Kong (n=1), UK (n=11) and USA (n=6). The studies focused on breast cancer screening, infection preventive services and metabolic syndrome (MS) screening by targeting MS-related risk factors. The interventions could be divided into those focusing on (1) health service delivery changes (12 studies), using quality improvement, randomised controlled trial, cluster randomised feasibility trial, retrospective audit, cross-sectional study and satisfaction survey designs and (2) tests of tools designed to facilitate screening (10 studies) using consecutive case series, quality improvement, retrospective evaluation and pre-post audit study designs. All studies reported improved uptake of screening, or that patients had received screening they would not have had without the intervention. No estimation of overall effect size was possible due to heterogeneity in study design and quality. The following factors may contribute to intervention success: staff and stakeholder involvement in screening, staff flexibility when taking physical measurements (eg, using adapted equipment), strong links with primary care and having a pharmacist on the ward. CONCLUSIONS A range of interventions may be effective, but better quality research is needed to determine any effect size. Researchers should consider how interventions may work when designing and testing them in order to target better the specific needs of this population in the most appropriate setting. Behaviour-change interventions to reduce identified barriers of patient and health professional resistance to screening this population are required. Resource constraints, clarity over professional roles and better coordination with primary care need to be addressed.
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Affiliation(s)
| | - Caroline Burgess
- Primary Care and Public Health Sciences, King's College London, London, UK
| | | | | | - Carolynn Greene
- College of Nursing, Midwifery and Healthcare, University of West London, London, UK
| | - Anne Manyande
- School of Human and Social Sciences, University of West London, London, UK
| | - Deborah Taylor
- College of Nursing, Midwifery and Healthcare, University of West London, London, UK
| | - Paul Walters
- Department of Research and Development, Dorset HealthCare University NHS Foundation Trust, Bournemouth, UK
| | - Elizabeth Barley
- School of Human and Social Sciences, University of West London, London, UK
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Davis MM, Freeman M, Shannon J, Coronado GD, Stange KC, Guise JM, Wheeler SB, Buckley DI. A systematic review of clinic and community intervention to increase fecal testing for colorectal cancer in rural and low-income populations in the United States - How, what and when? BMC Cancer 2018; 18:40. [PMID: 29304835 PMCID: PMC5756384 DOI: 10.1186/s12885-017-3813-4] [Citation(s) in RCA: 82] [Impact Index Per Article: 11.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/26/2017] [Accepted: 11/21/2017] [Indexed: 12/26/2022] Open
Abstract
BACKGROUND Interventions to improve fecal testing for colorectal cancer (CRC) exist, but are not yet routine practice. We conducted this systematic review to determine how implementation strategies and contextual factors influenced the uptake of interventions to increase Fecal Immunochemical Tests (FIT) and Fecal Occult Blood Testing (FOBT) for CRC in rural and low-income populations in the United States. METHODS We searched Medline and the Cochrane Library from January 1998 through July 2016, and Scopus and clinicaltrials.gov through March 2015, for original articles of interventions to increase fecal testing for CRC. Two reviewers independently screened abstracts, reviewed full-text articles, extracted data and performed quality assessments. A qualitative synthesis described the relationship between changes in fecal testing rates for CRC, intervention components, implementation strategies, and contextual factors. A technical expert panel of primary care professionals, health system leaders, and academicians guided this work. RESULTS Of 4218 citations initially identified, 27 unique studies reported in 29 publications met inclusion criteria. Studies were conducted in primary care (n = 20, 74.1%), community (n = 5, 18.5%), or both (n = 2, 7.4%) settings. All studies (n = 27, 100.0%) described multicomponent interventions. In clinic based studies, components that occurred most frequently among the highly effective/effective study arms were provision of kits by direct mail, use of a pre-addressed stamped envelope, client reminders, and provider ordered in-clinic distribution. Interventions were delivered by clinic staff/community members (n = 10, 37.0%), research staff (n = 6, 22.2%), both (n = 10, 37.0%), or it was unclear (n = 1, 3.7%). Over half of the studies lacked information on training or monitoring intervention fidelity (n = 15, 55.6%). CONCLUSIONS Studies to improve FIT/FOBT in rural and low-income populations utilized multicomponent interventions. The provision of kits through the mail, use of pre-addressed stamped envelopes, client reminders and in-clinic distribution appeared most frequently in the highly effective/effective clinic-based study arms. Few studies described contextual factors or implementation strategies. More robust application of guidelines to support reporting on methods to select, adapt and implement interventions can help end users determine not just which interventions work to improve CRC screening, but which interventions would work best in their setting given specific patient populations, clinical settings, and community characteristics. TRIAL REGISTRATION In accordance with PRISMA guidelines, our systematic review protocol was registered with PROSPERO, the international prospective register of systematic reviews, on April 16, 2015 (registration number CRD42015019557 ).
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Affiliation(s)
- Melinda M. Davis
- Oregon Rural Practice-based Research Network (ORPRN), Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Mail Code: L222, Portland, 97239 OR USA
- Department of Family Medicine & OHSU-PSU School of Public Health, Oregon Health & Science University, Portland, OR USA
| | - Michele Freeman
- VA Evidence-based Synthesis Program, Portland VA Medical Center, Portland, OR USA
| | - Jackilen Shannon
- OHSU-PSU School of Public Health and Oregon Clinical and Translational Research Institute, Oregon Health & Science University, Portland, OR USA
| | | | - Kurt C. Stange
- Center for Community Health Integration, Departments of Family Medicine & Community Health, Population & Quantitative Health Sciences, Sociology, and the Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH USA
| | - Jeanne-Marie Guise
- Departments of Obstetrics & Gynecology, Medical Informatics and Clinical Epidemiology, and Emergency Medicine and the OHSU-PSU School of Public Health, Oregon Health & Science University, Portland, OR USA
| | - Stephanie B. Wheeler
- Department of Health Policy & Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC USA
| | - David I. Buckley
- Departments of Family Medicine, Medical Informatics and Clinical Epidemiology, Public Health & Preventive Medicine, Oregon Health & Science University, Portland, OR USA
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Mitchell C, Bowen A, Tyson S, Conroy P. A feasibility randomized controlled trial of ReaDySpeech for people with dysarthria after stroke. Clin Rehabil 2017; 32:1037-1046. [PMID: 29278019 PMCID: PMC6088453 DOI: 10.1177/0269215517748453] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
Objective: To evaluate the feasibility of a multicentre randomized controlled trial of ReaDySpeech, an online speech therapy programme for people with dysarthria. Design: Feasibility randomized controlled trial, 2:1 minimization procedure. Setting: Four UK NHS services across hospital and community. Participants: Forty participants with dysarthria at least one week post-stroke. Interventions/comparator: ReaDySpeech with usual care (n = 26) versus usual care only (n = 14). Main outcomes: Feasibility measures included the following: recruitment and retention rate, time taken to carry out assessments, success of outcome assessor blinding, fidelity and adherence. Participant baseline and outcome measures collected before and after 8–10 weeks of intervention were the Frenchay Dysarthria Assessment II, Therapy Outcome Measure, Communication Outcomes After Stroke Scale, EQ-5D-5L and Dysarthria Impact Profile. Results: Recruited 40 participants out of 74 eligible people, 1–13 weeks post stroke and mean age 69 years (37–99). Retention was very high (92%). Assessor blinding was not achieved with intervention allocation correctly guessed for 70% of participants (26/37). Time to carry out assessments was acceptable to participants. ReaDySpeech was delivered to 16 of 26 allocated participants, who completed 55% of prescribed activities, but both interventions were delivered at low intensity (mean 6.6 face-to-face sessions of 40-minute duration). Conclusion: Recruitment and retention in this randomized controlled trial of computerized therapy for dysarthria is feasible for acute stroke. However, further feasibility work is needed to evaluate whether it is possible to recruit chronic stroke; increase intervention delivery, intensity and adherence; achieve outcome assessor blinding by video-recording and to determine sample size for a larger trial of effectiveness.
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Affiliation(s)
- Claire Mitchell
- 1 Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.,2 Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK
| | - Audrey Bowen
- 1 Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
| | - Sarah Tyson
- 3 Division of Nursing, Midwifery and Social Work, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
| | - Paul Conroy
- 1 Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
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Cai RA, Beste D, Chaplin H, Varakliotis S, Suffield L, Josephs F, Sen D, Wedderburn LR, Ioannou Y, Hailes S, Eleftheriou D. Developing and Evaluating JIApp: Acceptability and Usability of a Smartphone App System to Improve Self-Management in Young People With Juvenile Idiopathic Arthritis. JMIR Mhealth Uhealth 2017; 5:e121. [PMID: 28811270 PMCID: PMC5575419 DOI: 10.2196/mhealth.7229] [Citation(s) in RCA: 49] [Impact Index Per Article: 6.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/02/2017] [Revised: 03/13/2017] [Accepted: 04/14/2017] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND Flare-ups in juvenile idiopathic arthritis (JIA) are characterized by joint pain and swelling and often accompanied with fatigue, negative emotions, and reduced participation in activities. To minimize the impact of JIA on the physical and psychosocial development and well-being of young people (YP), it is essential to regularly monitor disease activity and side effects, as well as to support self-management such as adherence to treatment plans and engagement in general health-promoting behaviors. Smartphone technology has the potential to engage YP with their health care through convenient self-monitoring and easy access to information. In addition, having a more accurate summary of self-reported fluctuations in symptoms, behaviors, and psychosocial problems can help both YP and health care professionals (HCPs) better understand the patient's condition, identify barriers to self-management, and assess treatment effectiveness and additional health care needs. No comprehensive smartphone app has yet been developed in collaboration with YP with JIA, their parents, and HCPs involved in their care. OBJECTIVES The objective of this study was to design, develop, and evaluate the acceptability and usability of JIApp, a self-management smartphone app system for YP with JIA and HCPs. METHODS We used a qualitative, user-centered design approach involving YP, parents, and HCPs from the rheumatology team. The study was conducted in three phases: (1) phase I focused on developing consensus on the features, content, and design of the app; (2) phase II was used for further refining and evaluating the app prototype; and (3) phase III focused on usability testing of the app. The interview transcripts were analyzed using qualitative content analysis. RESULTS A total of 29 YP (aged 10-23, median age 17) with JIA, 7 parents, and 21 HCPs were interviewed. Major themes identified as the ones that helped inform app development in phase I were: (1) remote monitoring of symptoms, well-being, and activities; (2) treatment adherence; and (3) education and support. During phase II, three more themes emerged that informed further refinement of the app prototype. These included (4) adapting a reward system to motivate end users for using the app; (5) design of the app interface; and (6) clinical practice integration. The usability testing during phase III demonstrated high rates of overall satisfaction and further affirmed the content validity of the app. CONCLUSIONS We present the development and evaluation of a smartphone app to encourage self-management and engagement with health care for YP with JIA. The app was found to have high levels of acceptability and usability among YP and HCPs and has the potential to improve health care and outcomes for this age group. Future feasibility testing in a prospective study will firmly establish the reliability, efficacy, and cost-effectiveness of such an app intervention for patients with arthritis.
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Affiliation(s)
- Ran A Cai
- Arthritis Research UK Centre for Adolescent Rheumatology, University College London, London, United Kingdom
| | - Dominik Beste
- Department of Computer Science, University College London, London, United Kingdom
| | - Hema Chaplin
- Arthritis Research UK Centre for Adolescent Rheumatology, University College London, London, United Kingdom
| | - Socrates Varakliotis
- Department of Computer Science, University College London, London, United Kingdom
| | - Linda Suffield
- Arthritis Research UK Centre for Adolescent Rheumatology, University College London, London, United Kingdom
| | - Francesca Josephs
- Arthritis Research UK Centre for Adolescent Rheumatology, University College London, London, United Kingdom
| | - Debajit Sen
- Arthritis Research UK Centre for Adolescent Rheumatology, University College London, London, United Kingdom.,University College London Hospitals NHS Foundation Trust, Adolescent Rheumatology, London, United Kingdom
| | - Lucy R Wedderburn
- Arthritis Research UK Centre for Adolescent Rheumatology, University College London, London, United Kingdom.,UCL Great Ormond Street Institute of Child Health, Infection, Immunity, Inflammation, and Physiological Medicine, London, United Kingdom
| | - Yiannakis Ioannou
- Arthritis Research UK Centre for Adolescent Rheumatology, University College London, London, United Kingdom.,University College London Hospitals NHS Foundation Trust, Adolescent Rheumatology, London, United Kingdom
| | - Stephen Hailes
- Department of Computer Science, University College London, London, United Kingdom
| | - Despina Eleftheriou
- Arthritis Research UK Centre for Adolescent Rheumatology, University College London, London, United Kingdom.,UCL Great Ormond Street Institute of Child Health, Infection, Immunity, Inflammation, and Physiological Medicine, London, United Kingdom
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Nanton V, Appleton R, Dale J, Roscoe J, Hamborg T, Ahmedzai SH, Arvanitis TN, Badger D, James N, Mendelsohn R, Khan O, Parashar D, Patel P. Integrated Care in Prostate Cancer (ICARE-P): Nonrandomized Controlled Feasibility Study of Online Holistic Needs Assessment, Linking the Patient and the Health Care Team. JMIR Res Protoc 2017; 6:e147. [PMID: 28754653 PMCID: PMC5554351 DOI: 10.2196/resprot.7667] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/10/2017] [Revised: 05/07/2017] [Accepted: 05/08/2017] [Indexed: 12/30/2022] Open
Abstract
Background The potential of technology to aid integration of care delivery systems is being explored in a range of contexts across a variety of conditions in the United Kingdom. Prostate cancer is the most common cancer in UK men. With a 10-year survival rate of 84%, there is a need to explore innovative methods of care that are integrated between primary health care providers and specialist teams in order to address long-term consequences of the disease and its treatment as well as to provide continued monitoring for recurrence. Objective Our aim was to test the feasibility of a randomized controlled trial to compare a model of prostate cancer continuing and follow-up care integration, underpinned by digital technology, with usual care in terms of clinical and cost-effectiveness, patient-reported outcomes, and experience. Methods A first phase of the study has included development of an online adaptive prostate specific Holistic Needs Assessment system (HNA), training for primary care-based nurses, training of an IT peer supporter, and interviews with health care professionals and men with prostate cancer to explore views of their care, experience of technology, and views of the proposed intervention. In Phase 2, men in the intervention arm will complete the HNA at home to help identify and articulate concerns and share them with their health care professionals, in both primary and specialist care. Participants in the control arm will receive usual care. Outcomes including quality of life and well-being, prostate-specific concerns, and patient enablement will be measured 3 times over a 9-month period. Results Findings from phase 1 indicated strong support for the intervention among men, including those who had had little experience of digital technology. Men expressed a range of views on ways that the online system might be used within a clinical pathway. Health care professionals gave valuable feedback on how the output of the assessment might be presented to encourage engagement and uptake by clinical teams. Recruitment to the second phase of the study, the feasibility trial, commenced March 2017. Conclusions To our knowledge, this study is the first in the United Kingdom to trial an online holistic needs assessment for men with prostate cancer, with data shared between patients and primary and secondary care providers. This study addresses recommendations in recent policy documents promoting the importance of data sharing and enhanced communication between care providers as a basis for care integration. We anticipate that this model of care will ultimately provide important benefits for both patients and the National Health Service. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 31380482; http://www.isrctn.com/ISRCTN31380482 (Archived by WebCite at http://www.webcitation.org/6s8I42u5N)
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Affiliation(s)
- Veronica Nanton
- Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Rebecca Appleton
- Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Jeremy Dale
- Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Julia Roscoe
- Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Thomas Hamborg
- Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Sam H Ahmedzai
- Medical School, University of Sheffield, Sheffield, United Kingdom
| | - Theodoros N Arvanitis
- Institute of Digital Healthcare, WMG, University of Warwick, Coventry, United Kingdom
| | - Douglas Badger
- South Warwickshire Prostate Support Association, Stratford, United Kingdom
| | - Nicholas James
- The Cancer Centre, University Hospital Birmingham NHS Foundation Trust, Birmingham, United Kingdom
| | | | - Omar Khan
- Institute of Digital Healthcare, WMG, University of Warwick, Coventry, United Kingdom
| | - Deepak Parashar
- Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Prashant Patel
- Department of Urology, University Hospital Birmingham NHS Foundation Trust, Birmingham, United Kingdom
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Mitchell C, Bowen A, Tyson S, Conroy P. ReaDySpeech for people with dysarthria after stroke: protocol for a feasibility randomised controlled trial. Pilot Feasibility Stud 2017; 4:25. [PMID: 28748108 PMCID: PMC5520339 DOI: 10.1186/s40814-017-0169-0] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/22/2017] [Accepted: 07/04/2017] [Indexed: 11/16/2022] Open
Abstract
BACKGROUND Dysarthria, a disordered speech production resulting from neuro-muscular impairment, is a common symptom after stroke. It causes significant problems for patients' speech intelligibility, communication, psychological well-being, social engagement and stroke recovery. Rehabilitation for dysarthria is variable in quality, intensity and duration, which may be, in part, due to the lack of good quality evidence. An online therapy programme, ReaDySpeech, has the potential to improve quality, intensity and duration of speech rehabilitation and was considered in a proof-of-concept study to be acceptable to speech and language therapists and patients which warranted further evaluation. The present study aims to examine the feasibility of running a trial using the ReaDySpeech intervention. METHODS/DESIGN A feasibility, randomised controlled trial, will recruit a minimum of 36 people with post-stroke dysarthria who are more than 1 week post stroke. Participants will be externally randomised in a 2:1 ratio to receive either ReaDySpeech and usual care (24 participants) or usual care only (12 participants). This study is single blind with the researcher carrying out the baseline and outcome measures while blinded to treatment allocation. The primary objective is to assess the feasibility of conducting a larger Phase III trial. The specific objectives are to determine the following: recruitment rate and reasons for non-recruitment; loss of participants to follow-up; acceptability of randomisation; adherence to the intervention; delivery of ReaDySpeech and content; acceptability of outcome measures; success of blinding strategies; defining 'usual' care; and the implications of the intervention for the patient/family/carer. DISCUSSION This study will involve a regional, multi-centre, randomised controlled feasibility trial of a complex intervention in order to evaluate whether a Phase III randomised controlled trial is feasible. TRIAL REGISTRATION Current Controlled Trials, ISRCTN84996500.
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Affiliation(s)
- Claire Mitchell
- Division of Neuroscience and Experimental Psychology, Faculty of Biology, Medicine and Health, University of Manchester MAHSC, Manchester, UK
- Central Manchester University Hospitals NHS Foundation Trust, MAHSC, Manchester, UK
| | - Audrey Bowen
- Division of Neuroscience and Experimental Psychology, Faculty of Biology, Medicine and Health, University of Manchester MAHSC, Manchester, UK
| | - Sarah Tyson
- Division of Nursing, Midwifery & Social Work, University of Manchester, MAHSC, Manchester, UK
| | - Paul Conroy
- Division of Neuroscience and Experimental Psychology, Faculty of Biology, Medicine and Health, University of Manchester MAHSC, Manchester, UK
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Maidment I, Booth A, Mullan J, McKeown J, Bailey S, Wong G. Developing a framework for a novel multi-disciplinary, multi-agency intervention(s), to improve medication management in community-dwelling older people on complex medication regimens (MEMORABLE)--a realist synthesis. Syst Rev 2017; 6:125. [PMID: 28673335 PMCID: PMC5496371 DOI: 10.1186/s13643-017-0528-1] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/09/2016] [Accepted: 06/16/2017] [Indexed: 12/02/2022] Open
Abstract
BACKGROUND Medication-related adverse events have been estimated to be responsible for 5700 deaths and cost the UK £750 million annually. This burden falls disproportionately on older people. Outcomes from interventions to optimise medication management are caused by multiple context-sensitive mechanisms. The MEdication Management in Older people: REalist Approaches BAsed on Literature and Evaluation (MEMORABLE) project uses realist synthesis to understand how, why, for whom and in what context interventions, to improve medication management in older people on complex medication regimes residing in the community, work. METHOD This realist synthesis uses secondary data and primary data from interviews to develop the programme theory. A realist logic of analysis will synthesise data both within and across the two data sources to inform the design of a complex intervention(s) to help improve medication management in older people. 1. Literature review The review (using realist synthesis) contains five stages to develop an initial programme theory to understand why processes are more or less successful and under which situations: focussing of the research question; developing the initial programme theory; developing the search strategy; selection and appraisal based on relevance and rigour; and data analysis/synthesis to develop and refine the programme theory and context, intervention and mechanism configurations. 2. Realist interviews Realist interviews will explore and refine our understanding of the programme theory developed from the realist synthesis. Up to 30 older people and their informal carers (15 older people with multi-morbidity, 10 informal carers and 5 older people with dementia), and 20 care staff will be interviewed. 3. Developing framework for the intervention(s) Data from the realist synthesis and interviews will be used to refine the programme theory for the intervention(s) to identify: the mechanisms that need to be 'triggered', and the contexts related to these mechanisms. Intervention strategies that change the contexts so the mechanisms are triggered to produce desired outcomes will be developed. Feedback on these strategies will be obtained. DISCUSSION This realist synthesis aims to develop a framework (underpinned by our programme theory) for a novel multi-disciplinary, multi-agency intervention(s), to improve medication management in community-dwelling older people on complex medication regimens. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42016043506.
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Affiliation(s)
- Ian Maidment
- School of Life and Health Sciences, Aston University, Aston Triangle, Birmingham, B4 7ET UK
| | - Andrew Booth
- School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK
| | - Judy Mullan
- University of Wollongong, Northfields Ave, Wollongong, New South Wales 2522 Australia
| | - Jane McKeown
- School of Nursing and Midwifery, University of Sheffield, Barber House Annexe, 3a Clarkehouse Road, Sheffield, S10 2LA UK
| | - Sylvia Bailey
- Kingshayes Road, Aldridge, Walsall, West Midlands WS9 8RU UK
| | - Geoffrey Wong
- Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, University of Oxford, Woodstock Road, Oxford, OX2 6GG UK
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Maguire R, Fox PA, McCann L, Miaskowski C, Kotronoulas G, Miller M, Furlong E, Ream E, Armes J, Patiraki E, Gaiger A, Berg GV, Flowerday A, Donnan P, McCrone P, Apostolidis K, Harris J, Katsaragakis S, Buick AR, Kearney N. The eSMART study protocol: a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer. BMJ Open 2017; 7:e015016. [PMID: 28592577 PMCID: PMC5734219 DOI: 10.1136/bmjopen-2016-015016] [Citation(s) in RCA: 70] [Impact Index Per Article: 8.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/01/2023] Open
Abstract
INTRODUCTION While some evidence exists that real-time remote symptom monitoring devices can decrease morbidity and prevent unplanned admissions in oncology patients, overall, these studies have significant methodological weaknesses. The electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology (eSMART) study is designed to specifically address these weaknesses with an appropriately powered, repeated-measures, parallel-group stratified randomised controlled trial of oncology patients. METHODS AND ANALYSIS A total of 1108 patients scheduled to commence first-line chemotherapy (CTX) for breast, colorectal or haematological cancer will be recruited from multiple sites across five European countries.Patients will be randomised (1:1) to the ASyMS intervention (intervention group) or to standard care currently available at each site (control group). Patients in the control and intervention groups will complete a demographic and clinical questionnaire, as well as a set of valid and reliable electronic patient-reported outcome measures at enrolment, after each of their CTX cycles (up to a maximum of six cycles) and at 3, 6, 9 and 12 months after completion of their sixth cycle of CTX. Outcomes that will be assessed include symptom burden (primary outcome), quality of life, supportive care needs, anxiety, self-care self-efficacy, work limitations and cost effectiveness and, from a health professional perspective, changes in clinical practice (secondary outcomes). ETHICS AND DISSEMINATION Ethical approval will be obtained prior to the implementation of all major study amendments. Applications will be submitted to all of the ethics committees that granted initial approval.eSMART received approval from the relevant ethics committees at all of the clinical sites across the five participating countries. In collaboration with the European Cancer Patient Coalition (ECPC), the trial results will be disseminated through publications in scientific journals, presentations at international conferences, and postings on the eSMART website and other relevant clinician and consumer websites; establishment of an eSMART website (www.esmartproject.eu) with publicly accessible general information; creation of an eSMART Twitter Handle, and production of a toolkit for implementing/utilising the ASyMS technology in a variety of clinical practices and other transferable health care contexts. TRIAL REGISTRATION NUMBER NCT02356081.
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Affiliation(s)
- Roma Maguire
- University of Surrey, Faculty of Health and Medical Sciences, Duke of Kent Building, Surrey, Guildford, UK
| | - Patricia A Fox
- UCD School of Nursing, Midwifery and Health Systems, Health Sciences Centre, Belfield, Dublin, Ireland
| | - Lisa McCann
- University of Surrey, Faculty of Health and Medical Sciences, Duke of Kent Building, Surrey, Guildford, UK
| | - Christine Miaskowski
- Department of Physiological Nursing, University of California, San Francisco, California, USA
| | - Grigorios Kotronoulas
- University of Surrey, Faculty of Health and Medical Sciences, Duke of Kent Building, Surrey, Guildford, UK
| | - Morven Miller
- University of Surrey, Faculty of Health and Medical Sciences, Duke of Kent Building, Surrey, Guildford, UK
| | - Eileen Furlong
- UCD School of Nursing, Midwifery and Health Systems, Health Sciences Centre, Belfield, Dublin, Ireland
| | - Emma Ream
- University of Surrey, Faculty of Health and Medical Sciences, Duke of Kent Building, Surrey, Guildford, UK
| | - Jo Armes
- Florence Nightingale Faculty of Nursing & Midwifery, King’s College London, James Clerk Maxwell Building, England, UK
| | - Elisabeth Patiraki
- National and Kapodistrian University of Athens, Papadiamantopoulou, Goudi, Athens, Greece
| | - Alexander Gaiger
- Medical University Vienna Comprehensive Cancer Center, Spitalgasse, Austria
| | - Geir V Berg
- Innlandet Hospital Trust Lillehammer and Norwegian University of Science and Technology (NTNU), Gjøvik, Norway
| | | | - Peter Donnan
- Division of Population Health Sciences, Medical Research Institute, University of Dundee, Dundee, Scotland
| | - Paul McCrone
- King’s College London, David Goldberg Centre, Denmark Hill, London, UK
| | | | - Jenny Harris
- Florence Nightingale Faculty of Nursing & Midwifery, King’s College London, James Clerk Maxwell Building, England, UK
| | - Stylianos Katsaragakis
- National and Kapodistrian University of Athens, Papadiamantopoulou, Goudi, Athens, Greece
| | - Alison R Buick
- UCD School of Nursing, Midwifery and Health Systems, Health Sciences Centre, Belfield, Dublin, Ireland
| | - Nora Kearney
- University of Surrey, Faculty of Health and Medical Sciences, Duke of Kent Building, Surrey, Guildford, UK
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Palmer SC, Maggo JK, Campbell KL, Craig JC, Johnson DW, Sutanto B, Ruospo M, Tong A, Strippoli GFM, Cochrane Kidney and Transplant Group. Dietary interventions for adults with chronic kidney disease. Cochrane Database Syst Rev 2017; 4:CD011998. [PMID: 28434208 PMCID: PMC6478277 DOI: 10.1002/14651858.cd011998.pub2] [Citation(s) in RCA: 62] [Impact Index Per Article: 7.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
BACKGROUND Dietary changes are routinely recommended in people with chronic kidney disease (CKD) on the basis of randomised evidence in the general population and non-randomised studies in CKD that suggest certain healthy eating patterns may prevent cardiovascular events and lower mortality. People who have kidney disease have prioritised dietary modifications as an important treatment uncertainty. OBJECTIVES This review evaluated the benefits and harms of dietary interventions among adults with CKD including people with end-stage kidney disease (ESKD) treated with dialysis or kidney transplantation. SEARCH METHODS We searched the Cochrane Kidney and Transplant Specialised Register (up to 31 January 2017) through contact with the Information Specialist using search terms relevant to this review. Studies contained in the Specialised Register are identified through search strategies specifically designed for CENTRAL, MEDLINE, and EMBASE; handsearching conference proceedings; and searching the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA Randomised controlled trials (RCTs) or quasi-randomised RCTs of dietary interventions versus other dietary interventions, lifestyle advice, or standard care assessing mortality, cardiovascular events, health-related quality of life, and biochemical, anthropomorphic, and nutritional outcomes among people with CKD. DATA COLLECTION AND ANALYSIS Two authors independently screened studies for inclusion and extracted data. Results were summarised as risk ratios (RR) for dichotomous outcomes or mean differences (MD) or standardised MD (SMD) for continuous outcomes, with 95% confidence intervals (CI) or in descriptive format when meta-analysis was not possible. Confidence in the evidence was assessed using GRADE. MAIN RESULTS We included 17 studies involving 1639 people with CKD. Three studies enrolled 341 people treated with dialysis, four studies enrolled 168 kidney transplant recipients, and 10 studies enrolled 1130 people with CKD stages 1 to 5. Eleven studies (900 people) evaluated dietary counselling with or without lifestyle advice and six evaluated dietary patterns (739 people), including one study (191 people) of a carbohydrate-restricted low-iron, polyphenol enriched diet, two studies (181 people) of increased fruit and vegetable intake, two studies (355 people) of a Mediterranean diet and one study (12 people) of a high protein/low carbohydrate diet. Risks of bias in the included studies were generally high or unclear, lowering confidence in the results. Participants were followed up for a median of 12 months (range 1 to 46.8 months).Studies were not designed to examine all-cause mortality or cardiovascular events. In very-low quality evidence, dietary interventions had uncertain effects on all-cause mortality or ESKD. In absolute terms, dietary interventions may prevent one person in every 3000 treated for one year avoiding ESKD, although the certainty in this effect was very low. Across all 17 studies, outcome data for cardiovascular events were sparse. Dietary interventions in low quality evidence were associated with a higher health-related quality of life (2 studies, 119 people: MD in SF-36 score 11.46, 95% CI 7.73 to 15.18; I2 = 0%). Adverse events were generally not reported.Dietary interventions lowered systolic blood pressure (3 studies, 167 people: MD -9.26 mm Hg, 95% CI -13.48 to -5.04; I2 = 80%) and diastolic blood pressure (2 studies, 95 people: MD -8.95, 95% CI -10.69 to -7.21; I2 = 0%) compared to a control diet. Dietary interventions were associated with a higher estimated glomerular filtration rate (eGFR) (5 studies, 219 people: SMD 1.08; 95% CI 0.26 to 1.97; I2 = 88%) and serum albumin levels (6 studies, 541 people: MD 0.16 g/dL, 95% CI 0.07 to 0.24; I2 = 26%). A Mediterranean diet lowered serum LDL cholesterol levels (1 study, 40 people: MD -1.00 mmol/L, 95% CI -1.56 to -0.44). AUTHORS' CONCLUSIONS Dietary interventions have uncertain effects on mortality, cardiovascular events and ESKD among people with CKD as these outcomes were rarely measured or reported. Dietary interventions may increase health-related quality of life, eGFR, and serum albumin, and lower blood pressure and serum cholesterol levels.Based on stakeholder prioritisation of dietary research in the setting of CKD and preliminary evidence of beneficial effects on risks factors for clinical outcomes, large-scale pragmatic RCTs to test the effects of dietary interventions on patient outcomes are required.
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Affiliation(s)
- Suetonia C Palmer
- University of Otago ChristchurchDepartment of Medicine2 Riccarton AvePO Box 4345ChristchurchNew Zealand8140
| | - Jasjot K Maggo
- University of Otago ChristchurchDepartment of Medicine2 Riccarton AvePO Box 4345ChristchurchNew Zealand8140
| | - Katrina L Campbell
- Bond UniversityFaculty of Health Science and Medicine2 Promenthean WayRobinaQueenslandAustralia4226
| | - Jonathan C Craig
- The University of SydneySydney School of Public HealthEdward Ford Building A27SydneyNSWAustralia2006
- The Children's Hospital at WestmeadCochrane Kidney and Transplant, Centre for Kidney ResearchWestmeadNSWAustralia2145
| | - David W Johnson
- Princess Alexandra HospitalDepartment of Nephrology199 Ipswich RdWoolloongabbaQueenslandAustralia4102
| | - Bernadet Sutanto
- The Children's Hospital at WestmeadCentre for Kidney ResearchWestmeadNSWAustralia2145
| | - Marinella Ruospo
- DiaverumMedical Scientific OfficeLundSweden
- Amedeo Avogadro University of Eastern PiedmontDivision of Nephrology and Transplantation, Department of Translational MedicineVia Solaroli 17NovaraItaly28100
| | - Allison Tong
- The University of SydneySydney School of Public HealthEdward Ford Building A27SydneyNSWAustralia2006
- The Children's Hospital at WestmeadCentre for Kidney ResearchWestmeadNSWAustralia2145
| | - Giovanni FM Strippoli
- The University of SydneySydney School of Public HealthEdward Ford Building A27SydneyNSWAustralia2006
- The Children's Hospital at WestmeadCochrane Kidney and Transplant, Centre for Kidney ResearchWestmeadNSWAustralia2145
- DiaverumMedical Scientific OfficeLundSweden
- University of BariDepartment of Emergency and Organ TransplantationBariItaly
- Diaverum AcademyBariItaly
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McClurg D, Goodman K, Hagen S, Harris F, Treweek S, Emmanuel A, Norton C, Coggrave M, Doran S, Norrie J, Donnan P, Mason H, Manoukian S. Abdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis (AMBER - Abdominal Massage for Bowel Dysfunction Effectiveness Research): study protocol for a randomised controlled trial. Trials 2017; 18:150. [PMID: 28356133 PMCID: PMC5372315 DOI: 10.1186/s13063-017-1890-y] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/03/2016] [Accepted: 03/10/2017] [Indexed: 12/19/2022] Open
Abstract
BACKGROUND Multiple sclerosis (MS) is a life-long condition primarily affecting younger adults. Neurogenic bowel dysfunction (NBD) occurs in 50-80% of these patients and is the term used to describe constipation and faecal incontinence, which often co-exist. Data from a pilot study suggested feasibility of using abdominal massage for the relief of constipation, but the effectiveness remains uncertain. METHODS/DESIGN This is a multi-centred patient randomised superiority trial comparing an experimental strategy of once daily abdominal massage for 6 weeks against a control strategy of no massage in people with MS who have stated that their constipation is bothersome. The primary outcome is the Neurogenic Bowel Dysfunction Score at 24 weeks. Both groups will receive optimised advice plus the MS Society booklet on bowel management in MS, and will continue to receive usual care. Participants and their clinicians will not be blinded to the allocated intervention. Outcome measures are primarily self-reported and submitted anonymously. Central trial staff who will manage and analyse the trial data will be unaware of participant allocations. Analysis will follow intention-to-treat principles. DISCUSSION This pragmatic randomised controlled trial will demonstrate if abdominal massage is an effective, cost-effective and viable addition to the treatment of NBD in people with MS. TRIAL REGISTRATION ClinicalTrials.gov, ISRCTN85007023 . Registered on 10 June 2014.
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Affiliation(s)
- Doreen McClurg
- NMAHP RU, Glasgow Caledonian University, A603 Govan Mbeki Building, Glasgow, G4 0BA UK
| | - Kirsteen Goodman
- NMAHP RU, Glasgow Caledonian University, A603 Govan Mbeki Building, Glasgow, G4 0BA UK
| | - Suzanne Hagen
- NMAHP RU, Glasgow Caledonian University, A603 Govan Mbeki Building, Glasgow, G4 0BA UK
| | | | - Sean Treweek
- Centre for Healthcare Randomised Trials (CHaRT) Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Anton Emmanuel
- University College Hospital, University College London, London, UK
- National Hospital for Neurology and Neurosurgery, University College London, London, UK
| | | | | | - Selina Doran
- NMAHP RU, Glasgow Caledonian University, A603 Govan Mbeki Building, Glasgow, G4 0BA UK
| | - John Norrie
- Centre for Healthcare Randomised Trials (CHaRT) Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Peter Donnan
- Tayside Clinical Trials Unit, University of Dundee, Dundee, UK
| | - Helen Mason
- Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK
| | - Sarkis Manoukian
- Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK
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