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Stacey D, Lewis KB, Smith M, Carley M, Volk R, Douglas EE, Pacheco-Brousseau L, Finderup J, Gunderson J, Barry MJ, Bennett CL, Bravo P, Steffensen K, Gogovor A, Graham ID, Kelly SE, Légaré F, Sondergaard H, Thomson R, Trenaman L, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2024; 1:CD001431. [PMID: 38284415 PMCID: PMC10823577 DOI: 10.1002/14651858.cd001431.pub6] [Citation(s) in RCA: 52] [Impact Index Per Article: 52.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/30/2024]
Abstract
BACKGROUND Patient decision aids are interventions designed to support people making health decisions. At a minimum, patient decision aids make the decision explicit, provide evidence-based information about the options and associated benefits/harms, and help clarify personal values for features of options. This is an update of a Cochrane review that was first published in 2003 and last updated in 2017. OBJECTIVES To assess the effects of patient decision aids in adults considering treatment or screening decisions using an integrated knowledge translation approach. SEARCH METHODS We conducted the updated search for the period of 2015 (last search date) to March 2022 in CENTRAL, MEDLINE, Embase, PsycINFO, EBSCO, and grey literature. The cumulative search covers database origins to March 2022. SELECTION CRITERIA We included published randomized controlled trials comparing patient decision aids to usual care. Usual care was defined as general information, risk assessment, clinical practice guideline summaries for health consumers, placebo intervention (e.g. information on another topic), or no intervention. DATA COLLECTION AND ANALYSIS Two authors independently screened citations for inclusion, extracted intervention and outcome data, and assessed risk of bias using the Cochrane risk of bias tool. Primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were attributes related to the choice made (informed values-based choice congruence) and the decision-making process, such as knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision-making, and adverse events. Secondary outcomes were choice, confidence in decision-making, adherence to the chosen option, preference-linked health outcomes, and impact on the healthcare system (e.g. consultation length). We pooled results using mean differences (MDs) and risk ratios (RRs) with 95% confidence intervals (CIs), applying a random-effects model. We conducted a subgroup analysis of 105 studies that were included in the previous review version compared to those published since that update (n = 104 studies). We used Grading of Recommendations Assessment, Development, and Evaluation (GRADE) to assess the certainty of the evidence. MAIN RESULTS This update added 104 new studies for a total of 209 studies involving 107,698 participants. The patient decision aids focused on 71 different decisions. The most common decisions were about cardiovascular treatments (n = 22 studies), cancer screening (n = 17 studies colorectal, 15 prostate, 12 breast), cancer treatments (e.g. 15 breast, 11 prostate), mental health treatments (n = 10 studies), and joint replacement surgery (n = 9 studies). When assessing risk of bias in the included studies, we rated two items as mostly unclear (selective reporting: 100 studies; blinding of participants/personnel: 161 studies), due to inadequate reporting. Of the 209 included studies, 34 had at least one item rated as high risk of bias. There was moderate-certainty evidence that patient decision aids probably increase the congruence between informed values and care choices compared to usual care (RR 1.75, 95% CI 1.44 to 2.13; 21 studies, 9377 participants). Regarding attributes related to the decision-making process and compared to usual care, there was high-certainty evidence that patient decision aids result in improved participants' knowledge (MD 11.90/100, 95% CI 10.60 to 13.19; 107 studies, 25,492 participants), accuracy of risk perceptions (RR 1.94, 95% CI 1.61 to 2.34; 25 studies, 7796 participants), and decreased decisional conflict related to feeling uninformed (MD -10.02, 95% CI -12.31 to -7.74; 58 studies, 12,104 participants), indecision about personal values (MD -7.86, 95% CI -9.69 to -6.02; 55 studies, 11,880 participants), and proportion of people who were passive in decision-making (clinician-controlled) (RR 0.72, 95% CI 0.59 to 0.88; 21 studies, 4348 participants). For adverse outcomes, there was high-certainty evidence that there was no difference in decision regret between the patient decision aid and usual care groups (MD -1.23, 95% CI -3.05 to 0.59; 22 studies, 3707 participants). Of note, there was no difference in the length of consultation when patient decision aids were used in preparation for the consultation (MD -2.97 minutes, 95% CI -7.84 to 1.90; 5 studies, 420 participants). When patient decision aids were used during the consultation with the clinician, the length of consultation was 1.5 minutes longer (MD 1.50 minutes, 95% CI 0.79 to 2.20; 8 studies, 2702 participants). We found the same direction of effect when we compared results for patient decision aid studies reported in the previous update compared to studies conducted since 2015. AUTHORS' CONCLUSIONS Compared to usual care, across a wide variety of decisions, patient decision aids probably helped more adults reach informed values-congruent choices. They led to large increases in knowledge, accurate risk perceptions, and an active role in decision-making. Our updated review also found that patient decision aids increased patients' feeling informed and clear about their personal values. There was no difference in decision regret between people using decision aids versus those receiving usual care. Further studies are needed to assess the impact of patient decision aids on adherence and downstream effects on cost and resource use.
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Affiliation(s)
- Dawn Stacey
- School of Nursing, University of Ottawa, Ottawa, Canada
- Centre for Implementation Research, Ottawa Hospital Research Institute, Ottawa, Canada
| | | | | | - Meg Carley
- Centre for Implementation Research, Ottawa Hospital Research Institute, Ottawa, Canada
| | - Robert Volk
- The University of Texas MD Anderson Cancer Center, Houston, TX, USA
| | - Elisa E Douglas
- Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
| | | | - Jeanette Finderup
- Department of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark
| | | | - Michael J Barry
- Informed Medical Decisions Program, Massachusetts General Hospital, Boston, MA, USA
| | - Carol L Bennett
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada
| | - Paulina Bravo
- Education and Cancer Prevention, Fundación Arturo López Pérez, Santiago, Chile
| | - Karina Steffensen
- Center for Shared Decision Making, IRS - Lillebælt Hospital, Vejle, Denmark
| | - Amédé Gogovor
- VITAM - Centre de recherche en santé durable, Université Laval, Quebec, Canada
| | - Ian D Graham
- Centre for Implementation Research, Ottawa Hospital Research Institute, Ottawa, Canada
- School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Canada
| | - Shannon E Kelly
- Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, Canada
- School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada
| | - France Légaré
- Centre de recherche sur les soins et les services de première ligne de l'Université Laval (CERSSPL-UL), Université Laval, Quebec, Canada
| | | | - Richard Thomson
- Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK
| | - Logan Trenaman
- Department of Health Systems and Population Health, School of Public Health, University of Washington, Seattle, WA, USA
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Wonggom P, Rattanakanokchai S, Suebkinorn O. Effectiveness of bowel preparation innovative technology instructions (BPITIs) on clinical outcomes among patients undergoing colonoscopy: a systematic review and meta-analysis. Sci Rep 2023; 13:10783. [PMID: 37402823 DOI: 10.1038/s41598-023-37044-w] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/07/2022] [Accepted: 06/14/2023] [Indexed: 07/06/2023] Open
Abstract
To evaluate the effectiveness of bowel preparation innovative technology instructions (BPITIs) among patients undergoing colonoscopy. We searched PubMed, MEDLINE, CINAHL, CENTRAL, Scopus, Web of Science, LILACS, ClinicalTrials.gov, and Google Scholar for randomised controlled trials (RCTs) and cluster-RCTs from inception to February 28, 2022. The Cochrane risk of bias (RoB) tool and GRADE were used to assess RoB and certainty of evidence, respectively. Meta-analyses with random-effects model were used for analysis. This review included 47 RCTs (84 records). Seven BPITIs were found among included studies: (1) mobile apps, (2) VDO stream from personal devices, (3) VDO stream from a hospital device, (4) SMS re-education, (5) telephone re-education, (6) computer-based education, and (7) web-based education. The findings demonstrate that BPITIs have a slight impact on adherence to overall instructions (RR 1.20, 95% CI 1.13-1.28; moderate-certainty evidence), adequate bowel preparation (RR 1.10, 95% CI 1.07-1.13; low-certainty evidence), and quality of bowel preparation score (SMD 0.42, 95% CI 0.33-0.52; low-certainty evidence) compared to routine care. BPITIs may enhance the clinical outcomes. Due to the low-certainty evidence and heterogeneity of the included studies, the findings should be interpreted cautiously. Well-designed and reported RCTs are required to confirm the findings.PROSPERO registration number: CRD42021217846.
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Affiliation(s)
- Parichat Wonggom
- Department of Adult Nursing, Faculty of Nursing, Khon Kaen University, Khon Kaen, 40002, Thailand
| | - Siwanon Rattanakanokchai
- Department of Epidemiology and Biostatistics, Faculty of Public Health, Khon Kaen University, Khon Kaen, 40002, Thailand
| | - Orathai Suebkinorn
- Department of Adult Nursing, Faculty of Nursing, Khon Kaen University, Khon Kaen, 40002, Thailand.
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Isabel Rodrigues Monteiro Grilo A, Catarina Inácio Ferreira A, Sofia Pedro Ramos M, Teresa Mata Almeida Carolino E, Filipa Pires A, da Conceição Capela de Oliveira Vieira L. Effectiveness of educational videos on patient's preparation for diagnostic procedures: Systematic Review and Meta-Analysis. Prev Med Rep 2022; 28:101895. [PMID: 35855928 PMCID: PMC9287602 DOI: 10.1016/j.pmedr.2022.101895] [Citation(s) in RCA: 14] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/21/2022] [Revised: 05/27/2022] [Accepted: 07/01/2022] [Indexed: 11/06/2022] Open
Abstract
Patients’ anxiety and unfamiliarity are barriers to undergoing diagnostic procedures. Studies found educational videos more effective than other forms of information. Educational videos minimise anxiety and improve patient satisfaction. Educational videos enable medical procedures best practices. Although diagnostic procedures are crucial for secondary prevention and patient disease control, they often trigger fear and anxiety. These reactions highlight the need to adopt effective interventions to improve patients’ experience and satisfaction. Recently, educational videos have been employed in preparing diagnostic procedures; however, there is no integrated understanding of their effects. This systematic review and meta-analysis aimed to assess the effectiveness of educational videos on patients’ anxiety and satisfaction regarding preparation for diagnostic procedures. Three scientific databases (PubMed; Web of Science, Scopus), were used in this systematic review. Studies about educational videos as a form of preparation for patients undergoing diagnostic procedures published between 2000 and 2021 were included. A meta-analysis was also conducted. Sixteen studies met the inclusion criteria for systematic review, and seven were included in the meta-analysis. Nine studies of the total sample were about vascular procedures and seven studies about other medical image procedures. Of the fourteen studies that evaluated the use of educational videos on patients’ anxiety, nine proved to reduce it significantly. Of the thirteen studies that evaluated satisfaction, seven showed a significant increase in the experimental group. Studies included in the meta-analysis show that educational video patient groups had lower anxiety levels than the control groups after the procedure. Although future studies are required, the results suggest that educational videos effectively prepare patients for diagnostic procedures, improving care quality.
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Carlisle S, Ayling K, Jia R, Buchanan H, Vedhara K. The effect of choice interventions on retention-related, behavioural and mood outcomes: a systematic review with meta-analysis. Health Psychol Rev 2021; 16:220-256. [PMID: 34423744 DOI: 10.1080/17437199.2021.1962386] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
Abstract
The provision of choice within interventions has been associated with increased motivation, engagement and interest, as well as improved clinical outcomes. Existing reviews are limited by their wide inclusion criteria or by not assessing behaviour change and mood outcomes. This review examines whether participant-driven choice-based interventions specifically are more likely to be enjoyed and accepted by participants compared to no-choice interventions, and whether this impacts on intervention outcomes in terms of behaviour change or mood. Forty-four randomised controlled trials were identified for inclusion. Random effects meta-analyses were performed for retention-related outcomes (drop-out, adherence and satisfaction), and aggregate behaviour change and mood outcomes. Choice-based interventions resulted in significantly less participant drop-out and increased adherence compared to interventions not offering choice. Results for the behaviour change and mood analyses were mixed. This meta-analytic review demonstrates that choice-based interventions may enhance participant retention and adherence, thus researchers and clinicians alike should consider the provision of choice when designing research and interventions. The evidence for the role of choice in behaviour change and mood is less convincing, and there is a need for more, higher quality research in this area.
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Affiliation(s)
- Sophie Carlisle
- Division of Primary Care, School of Medicine, University of Nottingham, Nottingham, UK
| | - Kieran Ayling
- Division of Primary Care, School of Medicine, University of Nottingham, Nottingham, UK
| | - Ru Jia
- Division of Primary Care, School of Medicine, University of Nottingham, Nottingham, UK
| | | | - Kavita Vedhara
- Division of Primary Care, School of Medicine, University of Nottingham, Nottingham, UK
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Weisfeld CC, Turner JA, Bowen JI, Eissa R, Roelk B, Ko A, Dunleavy K, Robertson K, Benfield E. Dealing with Anxious Patients: An Integrative Review of the Literature on Nonpharmaceutical Interventions to Reduce Anxiety in Patients Undergoing Medical or Dental Procedures. J Altern Complement Med 2021; 27:727-737. [PMID: 34076496 DOI: 10.1089/acm.2020.0505] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open
Abstract
Objectives: A previous systematic literature review (SLR) evaluated 501 experiments on reducing patient anxiety across medical and dental environments. This integrative review examines those interventions and explores possible mechanisms leading to relative success or failure within those environments, in the interest of interprofessional education and communication. Methods: Reviewers evaluated 501 experiments testing interventions for reducing patient anxiety in a variety of medical and dental health care settings. Methodology for the SLR, largely following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, is briefly reviewed. Results: A total of 501 experiments (from 408 articles) met review criteria. One hundred and forty-three Music experiments were included, and Music interventions were largely effective, except in the case of colonoscopy. Education is the only intervention that occasionally (5 times of 130 experiments) raised patient anxiety in the face of a procedure; the discussion focuses on the wisdom of assessing patient need for information. Thirty-seven Cognitive Behavioral Therapy (CBT) experiments of various types are included, with a success rate of 89%, with a particularly high rate of success (12 of 12 experiments) in dentistry. Massage has a success rate that is similar to that of CBT, but Massage has been tested in far fewer specialty areas. Relaxation has been tested in every specialty area, except mechanical ventilation, with promising results. Acupuncture and Acupressure have not been widely tested, but their effectiveness rate is 100% when it comes to reducing patient anxiety in various procedural settings. Similarly, experiments show Hypnosis to be successful in 90% of trials. In contrast, Distraction was successful in only 40% of the experiments summarized, although it was more effective in dentistry. A variety of Nature-based Interventions (Aromatherapy, Nature Sounds, and Visual Stimuli) were highly successful across a variety of settings. Discussion: Possible mechanisms are discussed, along with commentary on feasibility. Limitations include publication bias, small sample sizes, and the lack of placebo controls. Future areas of research are pointed out.
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Affiliation(s)
| | - Jill A Turner
- Libraries/IDS, University of Detroit Mercy, Detroit, MI, USA
| | | | - Reem Eissa
- Department of Psychology and University of Detroit Mercy, Detroit, MI, USA
| | - Brandi Roelk
- Department of Psychology and University of Detroit Mercy, Detroit, MI, USA
| | - Arthur Ko
- McAuley School of Nursing, College of Health Professions, University of Detroit Mercy, Detroit, MI, USA
| | - Kim Dunleavy
- Department of Physical Therapy, University of Florida, Gainesville, FL, USA
| | - Kristen Robertson
- Orthopedic Physical Therapy Program, Walk the Line Recovery Therapy, Southfield, MI, USA
| | - Erica Benfield
- Department of Psychology and University of Detroit Mercy, Detroit, MI, USA
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Sue-Chue-Lam C, Castelo M, Tinmouth J, Llovet D, Kishibe T, Baxter NN. Non-pharmacological interventions to improve the patient experience of colonoscopy under moderate or no sedation: a systematic review protocol. BMJ Open 2020; 10:e038621. [PMID: 32928862 PMCID: PMC7488806 DOI: 10.1136/bmjopen-2020-038621] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
Abstract
INTRODUCTION The patient experience is a critical dimension of colonoscopy quality. Sedative and analgesic drugs are commonly used to improve the patient experience of colonoscopy, with predominant regimens being deep sedation, typically achieved with propofol, and moderate sedation, typically achieved with an opioid and a benzodiazepine. However, non-pharmacological interventions exist that may be used to improve patient experience. Furthermore, by identifying non-pharmacological interventions to increase the quality of patient experience under moderate sedation, jurisdictions facing rising use of deep sedation for colonoscopy and its significant associated costs may be better able to encourage patients and clinicians to adopt moderate sedation. Advancing either of these aims requires synthesising the evidence and raising awareness around these non-pharmacological interventions to improve the patient experience of colonoscopy. METHODS AND ANALYSIS A systematic review will be conducted that searches multiple electronic databases from inception until 2020 to identify randomised controlled trials evaluating what, if any, non-pharmacological interventions are effective compared with placebo or usual care for improving the patient experience of routine colonoscopy under moderate or no sedation. Two reviewers will independently perform a three-stage screening process and extract all study data using piloted forms. Study quality will be assessed using the Cochrane Risk of Bias Tool V.2.0. Where multiple studies evaluate a single intervention, evidence will be quantitatively synthesised using pairwise meta-analysis, otherwise narrative syntheses will be undertaken. ETHICS AND DISSEMINATION This is a review of existing literature not requiring ethics approval. The review findings will be included in future efforts to develop an implementation strategy to reduce the use of deep sedation for routine colonoscopy. They will also be published in a peer-reviewed journal, presented at conferences and contribute to a doctoral thesis. PROSPERO REGISTRATION NUMBER CRD42020173906.
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Affiliation(s)
- Colin Sue-Chue-Lam
- Department of Surgery, Unity Health Toronto, Toronto, Ontario, Canada
- Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
| | - Matthew Castelo
- Department of Surgery, Unity Health Toronto, Toronto, Ontario, Canada
- Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
| | - Jill Tinmouth
- Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
| | - Diego Llovet
- Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
- Cancer Care Ontario, Toronto, Ontario, Canada
| | - Teruko Kishibe
- Scotiabank Health Sciences Library, Li Ka Shing Knowledge Institute, Toronto, Ontario, Canada
| | - Nancy N Baxter
- Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
- Melbourne School of Population and Global Health, Melbourne, Victoria, Australia
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Kim MJ, Oh HK, Lee KC, Yang HH, Koo BW, Lee J, Kim MH, Kang SI, Kim DW, Kang SB. Effects of an Internet-based informational video on preoperative anxiety in patients with colorectal cancer. Ann Surg Treat Res 2019; 96:290-295. [PMID: 31183333 PMCID: PMC6543051 DOI: 10.4174/astr.2019.96.6.290] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2018] [Revised: 03/11/2019] [Accepted: 03/28/2019] [Indexed: 01/11/2023] Open
Abstract
PURPOSE Surgery is the primary curative treatment for colorectal cancer; however, it remains a frightening procedure that can cause stress and pain in affected patients. Therefore, patients typically experience significant anxiety during the preoperative period, which has been associated with poorer outcome after surgery. This study aimed to evaluate the effect of an Internet-based informational video on preoperative anxiety level in patients with colorectal cancer. METHODS This prospective, single-arm, observational study included patients scheduled to undergo elective colorectal cancer surgery, who did not have a history of previous surgery or major cognitive impairment. The primary outcome measure was the change in Amsterdam Preoperative Anxiety and Information Scale - Anxiety (APAIS-A) before and after watching a 5-min informational video (https://youtu.be/VzhtOMPUe4Q) during the preoperative period. Secondary outcome measures were the change in Hospital Anxiety and Depression Scale (HADS), length of postoperative hospital day, and postoperative morbidity. RESULTS Thirty-two patients were enrolled. Anxiety was significantly decreased after watching the video (APAIS-A score: from 10.8 ± 3.7 to 8.2 ± 3.2, P < 0.001, mean reduction: 22.2%). HADS score was also significantly decreased (from 5.8 ± 4.4 to 4.0 ± 3.3, P = 0.001, mean reduction: 26.5%). All preoperative anxiety level did not significantly differ between patients who developed postoperative complication and those who did not. CONCLUSION The informational video was an effective tool to reduce preoperative anxiety. Viewing this video may confer a higher level of confidence and realistic expectations, as well as reducing patients' preoperative anxiety.
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Affiliation(s)
- Myung Jo Kim
- Department of Surgery, Chungbuk National University Hospital, Cheongju, Korea
| | - Heung-Kwon Oh
- Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Keun Chul Lee
- Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Hyun Hui Yang
- Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Bon-Wook Koo
- Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Jebong Lee
- Division of Statistics, Medical Research Collaborating Center, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Min-Hyun Kim
- Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Sung Il Kang
- Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Duck-Woo Kim
- Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Sung-Bum Kang
- Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea
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Yang C, Sriranjan V, Abou‐Setta AM, Poluha W, Walker JR, Singh H. Anxiety Associated with Colonoscopy and Flexible Sigmoidoscopy: A Systematic Review. Am J Gastroenterol 2018; 113:1810-1818. [PMID: 30385831 PMCID: PMC6768596 DOI: 10.1038/s41395-018-0398-8] [Citation(s) in RCA: 65] [Impact Index Per Article: 9.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/09/2018] [Accepted: 10/06/2018] [Indexed: 12/11/2022]
Abstract
OBJECTIVES Addressing procedure-related anxiety should improve adherence to colorectal cancer screening programs and diagnostic colonoscopy. We performed a systematic review to assess anxiety among individuals undergoing colonoscopy or flexible sigmoidoscopy (FS). METHODS We searched multiple electronic databases for studies evaluating anxiety associated with colonoscopy or FS published from 2005 to 2017. Two reviewers independently identified studies, extracted data, and assessed study quality. The main outcomes were the magnitude of pre-procedure anxiety, types of concerns, predictors of anxiety, and effectiveness of anxiety-lowering interventions in individuals undergoing lower endoscopy. The protocol was prospectively registered in PROSPERO. RESULTS Fifty-eight studies (24,490 patients) met the inclusion criteria. Patients undergoing colonoscopy had a higher mean level of anxiety than that previously reported in the general population, with some studies reporting more than 50% of patients having moderate-to-severe anxiety. Areas of anxiety-related concern included bowel preparation, difficulties with the procedure (embarrassment, pain, possible complications, and sedation), and concerns about diagnosis; including fear of being diagnosed with cancer. Female gender, higher baseline anxiety, functional abdominal pain, lower education, and lower income were associated with greater anxiety prior to colonoscopy. Providing higher-quality information before colonoscopy, particularly with a video, shows promise as a way of reducing pre-procedure anxiety but the studies to date are of low quality. CONCLUSIONS A large proportion of patients undergoing colonoscopy report anxiety before the procedure. Improvement in pre-procedure information delivery and evaluation of approaches to reduce anxiety is required, especially for those with predictors of pre-procedure anxiety.
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Affiliation(s)
- Chengyue Yang
- 1Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
| | - Vaelan Sriranjan
- 2Faculty of Science, University of Manitoba, Winnipeg, Manitoba, Canada
| | - Ahmed M. Abou‐Setta
- 3George and Fay Yee Centre for Healthcare Innovation, University of Manitoba, Winnipeg, Manitoba, Canada
| | - William Poluha
- 4Sciences and Technology Library, University of Manitoba, Winnipeg, Manitoba, Canada
| | - John R. Walker
- 5Department of Clinical Health Psychology, University of Manitoba, Winnipeg, Manitoba, Canada
| | - Harminder Singh
- 1Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
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Stacey D, Légaré F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes‐Rovner M, Llewellyn‐Thomas H, Lyddiatt A, Thomson R, Trevena L, Cochrane Consumers and Communication Group. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2017; 4:CD001431. [PMID: 28402085 PMCID: PMC6478132 DOI: 10.1002/14651858.cd001431.pub5] [Citation(s) in RCA: 1333] [Impact Index Per Article: 166.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
BACKGROUND Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping clarify congruence between decisions and personal values. OBJECTIVES To assess the effects of decision aids in people facing treatment or screening decisions. SEARCH METHODS Updated search (2012 to April 2015) in CENTRAL; MEDLINE; Embase; PsycINFO; and grey literature; includes CINAHL to September 2008. SELECTION CRITERIA We included published randomized controlled trials comparing decision aids to usual care and/or alternative interventions. For this update, we excluded studies comparing detailed versus simple decision aids. DATA COLLECTION AND ANALYSIS Two reviewers independently screened citations for inclusion, extracted data, and assessed risk of bias. Primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were attributes related to the choice made and the decision-making process.Secondary outcomes were behavioural, health, and health system effects.We pooled results using mean differences (MDs) and risk ratios (RRs), applying a random-effects model. We conducted a subgroup analysis of studies that used the patient decision aid to prepare for the consultation and of those that used it in the consultation. We used GRADE to assess the strength of the evidence. MAIN RESULTS We included 105 studies involving 31,043 participants. This update added 18 studies and removed 28 previously included studies comparing detailed versus simple decision aids. During the 'Risk of bias' assessment, we rated two items (selective reporting and blinding of participants/personnel) as mostly unclear due to inadequate reporting. Twelve of 105 studies were at high risk of bias.With regard to the attributes of the choice made, decision aids increased participants' knowledge (MD 13.27/100; 95% confidence interval (CI) 11.32 to 15.23; 52 studies; N = 13,316; high-quality evidence), accuracy of risk perceptions (RR 2.10; 95% CI 1.66 to 2.66; 17 studies; N = 5096; moderate-quality evidence), and congruency between informed values and care choices (RR 2.06; 95% CI 1.46 to 2.91; 10 studies; N = 4626; low-quality evidence) compared to usual care.Regarding attributes related to the decision-making process and compared to usual care, decision aids decreased decisional conflict related to feeling uninformed (MD -9.28/100; 95% CI -12.20 to -6.36; 27 studies; N = 5707; high-quality evidence), indecision about personal values (MD -8.81/100; 95% CI -11.99 to -5.63; 23 studies; N = 5068; high-quality evidence), and the proportion of people who were passive in decision making (RR 0.68; 95% CI 0.55 to 0.83; 16 studies; N = 3180; moderate-quality evidence).Decision aids reduced the proportion of undecided participants and appeared to have a positive effect on patient-clinician communication. Moreover, those exposed to a decision aid were either equally or more satisfied with their decision, the decision-making process, and/or the preparation for decision making compared to usual care.Decision aids also reduced the number of people choosing major elective invasive surgery in favour of more conservative options (RR 0.86; 95% CI 0.75 to 1.00; 18 studies; N = 3844), but this reduction reached statistical significance only after removing the study on prophylactic mastectomy for breast cancer gene carriers (RR 0.84; 95% CI 0.73 to 0.97; 17 studies; N = 3108). Compared to usual care, decision aids reduced the number of people choosing prostate-specific antigen screening (RR 0.88; 95% CI 0.80 to 0.98; 10 studies; N = 3996) and increased those choosing to start new medications for diabetes (RR 1.65; 95% CI 1.06 to 2.56; 4 studies; N = 447). For other testing and screening choices, mostly there were no differences between decision aids and usual care.The median effect of decision aids on length of consultation was 2.6 minutes longer (24 versus 21; 7.5% increase). The costs of the decision aid group were lower in two studies and similar to usual care in four studies. People receiving decision aids do not appear to differ from those receiving usual care in terms of anxiety, general health outcomes, and condition-specific health outcomes. Studies did not report adverse events associated with the use of decision aids.In subgroup analysis, we compared results for decision aids used in preparation for the consultation versus during the consultation, finding similar improvements in pooled analysis for knowledge and accurate risk perception. For other outcomes, we could not conduct formal subgroup analyses because there were too few studies in each subgroup. AUTHORS' CONCLUSIONS Compared to usual care across a wide variety of decision contexts, people exposed to decision aids feel more knowledgeable, better informed, and clearer about their values, and they probably have a more active role in decision making and more accurate risk perceptions. There is growing evidence that decision aids may improve values-congruent choices. There are no adverse effects on health outcomes or satisfaction. New for this updated is evidence indicating improved knowledge and accurate risk perceptions when decision aids are used either within or in preparation for the consultation. Further research is needed on the effects on adherence with the chosen option, cost-effectiveness, and use with lower literacy populations.
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Affiliation(s)
- Dawn Stacey
- University of OttawaSchool of Nursing451 Smyth RoadOttawaONCanada
- Ottawa Hospital Research InstituteCentre for Practice Changing Research501 Smyth RdOttawaONCanadaK1H 8L6
| | - France Légaré
- CHU de Québec Research Center, Université LavalPopulation Health and Optimal Health Practices Research Axis10 Rue de l'Espinay, D6‐727Québec CityQCCanadaG1L 3L5
| | - Krystina Lewis
- University of OttawaSchool of Nursing451 Smyth RoadOttawaONCanada
| | | | - Carol L Bennett
- Ottawa Hospital Research InstituteClinical Epidemiology ProgramAdministrative Services Building, Room 2‐0131053 Carling AvenueOttawaONCanadaK1Y 4E9
| | - Karen B Eden
- Oregon Health Sciences UniversityDepartment of Medical Informatics and Clinical EpidemiologyBICC 5353181 S.W. Sam Jackson Park RoadPortlandOregonUSA97239‐3098
| | - Margaret Holmes‐Rovner
- Michigan State University College of Human MedicineCenter for Ethics and Humanities in the Life SciencesEast Fee Road956 Fee Road Rm C203East LansingMichiganUSA48824‐1316
| | - Hilary Llewellyn‐Thomas
- Dartmouth CollegeThe Dartmouth Center for Health Policy & Clinical Practice, The Geisel School of Medicine at DartmouthHanoverNew HampshireUSA03755
| | - Anne Lyddiatt
- No affiliation28 Greenwood RoadIngersollONCanadaN5C 3N1
| | - Richard Thomson
- Newcastle UniversityInstitute of Health and SocietyBaddiley‐Clark BuildingRichardson RoadNewcastle upon TyneUKNE2 4AX
| | - Lyndal Trevena
- The University of SydneyRoom 322Edward Ford Building (A27)SydneyNSWAustralia2006
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Silvester JA, Kalkat H, Graff LA, Walker JR, Singh H, Duerksen DR. Information seeking and anxiety among colonoscopy-naïve adults: Direct-to-colonoscopy vs traditional consult-first pathways. World J Gastrointest Endosc 2016; 8:701-708. [PMID: 27909550 PMCID: PMC5114459 DOI: 10.4253/wjge.v8.i19.701] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/29/2016] [Revised: 05/28/2016] [Accepted: 07/22/2016] [Indexed: 02/05/2023] Open
Abstract
AIM To investigate the effects of direct to colonoscopy pathways on information seeking behaviors and anxiety among colonoscopy-naïve patients.
METHODS Colonoscopy-naïve patients at two tertiary care hospitals completed a survey immediately prior to their scheduled outpatient procedure and before receiving sedation. Survey items included clinical pathway (direct or consult), procedure indication (cancer screening or symptom investigation), telephone and written contact from the physician endoscopist office, information sources, and pre-procedure anxiety. Participants reported pre-procedure anxiety using a 10 point scale anchored by “very relaxed” (1) and “very nervous” (10). At least three months following the procedure, patient medical records were reviewed to determine sedative dose, procedure indications and any adverse events. The primary comparison was between the direct and consult pathways. Given the very different implications, a secondary analysis considering the patient-reported indication for the procedure (symptoms or screening). Effects of pathway (direct vs consult) were compared both within and between the screening and symptom subgroups.
RESULTS Of 409 patients who completed the survey, 34% followed a direct pathway. Indications for colonoscopy were similar in each group. The majority of the participants were women (58%), married (61%), and internet users (81%). The most important information source was family physicians (Direct) and specialist physicians (Consult). Use of other information sources, including the internet (20% vs 18%) and Direct family and friends (64% vs 53%), was similar in the Direct and Consult groups, respectively. Only 31% of the 81% who were internet users accessed internet health information. Most sought fundamental information such as what a colonoscopy is or why it is done. Pre-procedure anxiety did not differ between care pathways. Those undergoing colonoscopy for symptoms reported greater anxiety [mean 5.3, 95%CI: 5.0-5.7 (10 point Likert scale)] than those for screening colonoscopy (4.3, 95%CI: 3.9-4.7).
CONCLUSION Procedure indication (cancer screening or symptom investigation) was more closely associated with information seeking behaviors and pre-procedure anxiety than care pathway.
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Jung AR, Lee IS. Effects of the Provision of Information on Anxiety in Patients during Outpatient Surgery: A Systematic Review. ACTA ACUST UNITED AC 2016. [DOI: 10.16952/pns.2016.13.1.48] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/01/2022]
Affiliation(s)
- Ae-Ri Jung
- RN, Samsung Medical Center, Seoul, Korea
| | - In-Sook Lee
- Professor, College of Nursing, Seoul National University, Seoul, Korea
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Impact of a Video Intervention for Rural Peruvian Women With Cervical Neoplasia Before Loop Excisional Procedures. J Low Genit Tract Dis 2015; 19:224-8. [PMID: 25856124 DOI: 10.1097/lgt.0000000000000107] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
OBJECTIVE Indigenous Peruvian women have very high rates of cervical cancer. This study assessed the impact of an educational video on impoverished rural Peruvian women seeking loop excision surgery. MATERIALS AND METHODS Women completed baseline, postvideo and postsurgery questionnaires that assessed knowledge and attitudes about the procedure. Differences between groups were examined using repeated measures analysis of variance. RESULTS Women who watched the video were significantly more calm (2.6, 2.6, and 2.3, respectively; P = 0.04), relaxed (2.5, 2.5, and 2.1, respectively; P = 0.02), and content (3.4, 3.4, and 2.4, respectively, P < 0.01) at postvideo and postsurgery assessments compared with mean results at the baseline assessment. The same women were also significantly more tense (2.5, 2.0, and 2.0, respectively; P = 0.01), upset (1.6, 1.1, and 1.1, respectively; P = 0.01), and worried (3.0, 2.0, and 2.0, respectively; P = 0.01) at baseline compared with postvideo and postsurgery results. Approximately 93% of women believed that other women scheduled to have loop excision surgery should also watch the video. CONCLUSIONS Dissemination of culturally sensitive video information minimizes adverse emotional responses associated with loop excision procedures before surgery. Such an intervention quickly improves the psychological well-being of women eventually subjected to surgical management of cervical neoplasia.
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Toomey DP, Hackett-Brennan M, Corrigan G, Singh C, Nessim G, Balfe P. Effective communication enhances the patients' endoscopy experience. Ir J Med Sci 2015; 185:203-14. [PMID: 25690478 DOI: 10.1007/s11845-015-1270-0] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/17/2014] [Accepted: 02/07/2015] [Indexed: 01/26/2023]
Abstract
BACKGROUND Undergoing an endoscopy is a stressful experience for patients. AIMS To audit the endoscopy pathway to improve patient satisfaction. METHODS A prospective survey of endoscopy patients to identify system improvements that were then implemented. RESULTS The survey was performed before (N = 71) and after (N = 60) process improvements identified by the initial survey. Information provision and staff communication skills were identified for optimisation. Patient anxiety at home was significantly reduced (median 2 vs. 1, p < 0.01). Education of endoscopy staff significantly improved the quality of information provided before and after the procedure with regard to sedation (median 4 vs. 5, p < 0.01), discomfort (median 4 vs. 5, p < 0.01), complications (28 vs. 82 %, p < 0.01), findings (89 vs. 100 %, p < 0.01) and follow-up (73 vs. 90 %, p = 0.015). Gloucester Comfort Scores during endoscopy improved (median 1 vs. 0, p < 0.01) without increasing sedation levels. Patient feelings of invasion/trauma significantly decreased. Overall 95 % of patients were satisfied. CONCLUSION Structured information leaflets and improved staff communication skills reduce anxiety and enhance patients' experiences. They are now standard operating procedures.
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Affiliation(s)
- D P Toomey
- Endoscopy Suite, Department of Surgery, St. Luke's Hospital, Kilkenny, Co. Kilkenny, Ireland.
| | - M Hackett-Brennan
- Endoscopy Suite, Department of Surgery, St. Luke's Hospital, Kilkenny, Co. Kilkenny, Ireland
| | - G Corrigan
- Endoscopy Suite, Department of Surgery, St. Luke's Hospital, Kilkenny, Co. Kilkenny, Ireland
| | - C Singh
- Endoscopy Suite, Department of Surgery, St. Luke's Hospital, Kilkenny, Co. Kilkenny, Ireland
| | - G Nessim
- Endoscopy Suite, Department of Surgery, St. Luke's Hospital, Kilkenny, Co. Kilkenny, Ireland
| | - P Balfe
- Endoscopy Suite, Department of Surgery, St. Luke's Hospital, Kilkenny, Co. Kilkenny, Ireland
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Stacey D, Légaré F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JHC. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2014:CD001431. [PMID: 24470076 DOI: 10.1002/14651858.cd001431.pub4] [Citation(s) in RCA: 855] [Impact Index Per Article: 77.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
BACKGROUND Decision aids are intended to help people participate in decisions that involve weighing the benefits and harms of treatment options often with scientific uncertainty. OBJECTIVES To assess the effects of decision aids for people facing treatment or screening decisions. SEARCH METHODS For this update, we searched from 2009 to June 2012 in MEDLINE; CENTRAL; EMBASE; PsycINFO; and grey literature. Cumulatively, we have searched each database since its start date including CINAHL (to September 2008). SELECTION CRITERIA We included published randomized controlled trials of decision aids, which are interventions designed to support patients' decision making by making explicit the decision, providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies of participants making hypothetical decisions. DATA COLLECTION AND ANALYSIS Two review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were:A) 'choice made' attributes;B) 'decision-making process' attributes.Secondary outcomes were behavioral, health, and health-system effects. We pooled results using mean differences (MD) and relative risks (RR), applying a random-effects model. MAIN RESULTS This update includes 33 new studies for a total of 115 studies involving 34,444 participants. For risk of bias, selective outcome reporting and blinding of participants and personnel were mostly rated as unclear due to inadequate reporting. Based on 7 items, 8 of 115 studies had high risk of bias for 1 or 2 items each.Of 115 included studies, 88 (76.5%) used at least one of the IPDAS effectiveness criteria: A) 'choice made' attributes criteria: knowledge scores (76 studies); accurate risk perceptions (25 studies); and informed value-based choice (20 studies); and B) 'decision-making process' attributes criteria: feeling informed (34 studies) and feeling clear about values (29 studies).A) Criteria involving 'choice made' attributes:Compared to usual care, decision aids increased knowledge (MD 13.34 out of 100; 95% confidence interval (CI) 11.17 to 15.51; n = 42). When more detailed decision aids were compared to simple decision aids, the relative improvement in knowledge was significant (MD 5.52 out of 100; 95% CI 3.90 to 7.15; n = 19). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.82; 95% CI 1.52 to 2.16; n = 19). Exposure to a decision aid with explicit values clarification resulted in a higher proportion of patients choosing an option congruent with their values (RR 1.51; 95% CI 1.17 to 1.96; n = 13).B) Criteria involving 'decision-making process' attributes:Decision aids compared to usual care interventions resulted in:a) lower decisional conflict related to feeling uninformed (MD -7.26 of 100; 95% CI -9.73 to -4.78; n = 22) and feeling unclear about personal values (MD -6.09; 95% CI -8.50 to -3.67; n = 18);b) reduced proportions of people who were passive in decision making (RR 0.66; 95% CI 0.53 to 0.81; n = 14); andc) reduced proportions of people who remained undecided post-intervention (RR 0.59; 95% CI 0.47 to 0.72; n = 18).Decision aids appeared to have a positive effect on patient-practitioner communication in all nine studies that measured this outcome. For satisfaction with the decision (n = 20), decision-making process (n = 17), and/or preparation for decision making (n = 3), those exposed to a decision aid were either more satisfied, or there was no difference between the decision aid versus comparison interventions. No studies evaluated decision-making process attributes for helping patients to recognize that a decision needs to be made, or understanding that values affect the choice.C) Secondary outcomes Exposure to decision aids compared to usual care reduced the number of people of choosing major elective invasive surgery in favour of more conservative options (RR 0.79; 95% CI 0.68 to 0.93; n = 15). Exposure to decision aids compared to usual care reduced the number of people choosing to have prostate-specific antigen screening (RR 0.87; 95% CI 0.77 to 0.98; n = 9). When detailed compared to simple decision aids were used, fewer people chose menopausal hormone therapy (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable.The effect of decision aids on length of consultation varied from 8 minutes shorter to 23 minutes longer (median 2.55 minutes longer) with 2 studies indicating statistically-significantly longer, 1 study shorter, and 6 studies reporting no difference in consultation length. Groups of patients receiving decision aids do not appear to differ from comparison groups in terms of anxiety (n = 30), general health outcomes (n = 11), and condition-specific health outcomes (n = 11). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive. AUTHORS' CONCLUSIONS There is high-quality evidence that decision aids compared to usual care improve people's knowledge regarding options, and reduce their decisional conflict related to feeling uninformed and unclear about their personal values. There is moderate-quality evidence that decision aids compared to usual care stimulate people to take a more active role in decision making, and improve accurate risk perceptions when probabilities are included in decision aids, compared to not being included. There is low-quality evidence that decision aids improve congruence between the chosen option and the patient's values.New for this updated review is further evidence indicating more informed, values-based choices, and improved patient-practitioner communication. There is a variable effect of decision aids on length of consultation. Consistent with findings from the previous review, decision aids have a variable effect on choices. They reduce the number of people choosing discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, cost-effectiveness, use with lower literacy populations, and level of detail needed in decision aids need further evaluation. Little is known about the degree of detail that decision aids need in order to have a positive effect on attributes of the choice made, or the decision-making process.
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Affiliation(s)
- Dawn Stacey
- School of Nursing, University of Ottawa, 451 Smyth Road, Ottawa, Ontario, Canada
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Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Légaré F, Thomson R. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2011:CD001431. [PMID: 21975733 DOI: 10.1002/14651858.cd001431.pub3] [Citation(s) in RCA: 559] [Impact Index Per Article: 39.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/12/2023]
Abstract
BACKGROUND Decision aids prepare people to participate in decisions that involve weighing benefits, harms, and scientific uncertainty. OBJECTIVES To evaluate the effectiveness of decision aids for people facing treatment or screening decisions. SEARCH STRATEGY For this update, we searched from January 2006 to December 2009 in MEDLINE (Ovid); Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, issue 4 2009); CINAHL (Ovid) (to September 2008 only); EMBASE (Ovid); PsycINFO (Ovid); and grey literature. Cumulatively, we have searched each database since its start date. SELECTION CRITERIA We included published randomised controlled trials (RCTs) of decision aids, which are interventions designed to support patients' decision making by providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies in which participants were not making an active treatment or screening decision. DATA COLLECTION AND ANALYSIS Two review authors independently screened abstracts for inclusion, extracted data, and assessed potential risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards, were:A) decision attributes;B) decision making process attributes.Secondary outcomes were behavioral, health, and health system effects. We pooled results of RCTs using mean differences (MD) and relative risks (RR), applying a random effects model. MAIN RESULTS Of 34,316 unique citations, 86 studies involving 20,209 participants met the eligibility criteria and were included. Thirty-one of these studies are new in this update. Twenty-nine trials are ongoing. There was variability in potential risk of bias across studies. The two criteria that were most problematic were lack of blinding and the potential for selective outcome reporting, given that most of the earlier trials were not registered.Of 86 included studies, 63 (73%) used at least one measure that mapped onto an IPDAS effectiveness criterion: A) criteria involving decision attributes: knowledge scores (51 studies); accurate risk perceptions (16 studies); and informed value-based choice (12 studies); and B) criteria involving decision process attributes: feeling informed (30 studies) and feeling clear about values (18 studies).A) Criteria involving decision attributes:Decision aids performed better than usual care interventions by increasing knowledge (MD 13.77 out of 100; 95% confidence interval (CI) 11.40 to 16.15; n = 26). When more detailed decision aids were compared to simpler decision aids, the relative improvement in knowledge was significant (MD 4.97 out of 100; 95% CI 3.22 to 6.72; n = 15). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.74; 95% CI 1.46 to 2.08; n = 14). The effect was stronger when probabilities were expressed in numbers (RR 1.93; 95% CI 1.58 to 2.37; n = 11) rather than words (RR 1.27; 95% CI 1.09 to 1.48; n = 3). Exposure to a decision aid with explicit values clarification compared to those without explicit values clarification resulted in a higher proportion of patients achieving decisions that were informed and consistent with their values (RR 1.25; 95% CI 1.03 to 1.52; n = 8).B) Criteria involving decision process attributes:Decision aids compared to usual care interventions resulted in: a) lower decisional conflict related to feeling uninformed (MD -6.43 of 100; 95% CI -9.16 to -3.70; n = 17); b) lower decisional conflict related to feeling unclear about personal values (MD -4.81; 95% CI -7.23 to -2.40; n = 14); c) reduced the proportions of people who were passive in decision making (RR 0.61; 95% CI 0.49 to 0.77; n = 11); and d) reduced proportions of people who remained undecided post-intervention (RR 0.57; 95% CI 0.44 to 0.74; n = 9). Decision aids appear to have a positive effect on patient-practitioner communication in the four studies that measured this outcome. For satisfaction with the decision (n = 12) and/or the decision making process (n = 12), those exposed to a decision aid were either more satisfied or there was no difference between the decision aid versus comparison interventions. There were no studies evaluating the decision process attributes relating to helping patients to recognize that a decision needs to be made or understand that values affect the choice.C) Secondary outcomesExposure to decision aids compared to usual care continued to demonstrate reduced choice of: major elective invasive surgery in favour of conservative options (RR 0.80; 95% CI 0.64 to 1.00; n = 11). Exposure to decision aids compared to usual care also resulted in reduced choice of PSA screening (RR 0.85; 95% CI 0.74 to 0.98; n = 7). When detailed compared to simple decision aids were used, there was reduced choice of menopausal hormones (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable. The effect of decision aids on length of consultation varied from -8 minutes to +23 minutes (median 2.5 minutes). Decision aids do not appear to be different from comparisons in terms of anxiety (n = 20), and general health outcomes (n = 7), and condition specific health outcomes (n = 9). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive. AUTHORS' CONCLUSIONS New for this updated review is evidence that: decision aids with explicit values clarification exercises improve informed values-based choices; decision aids appear to have a positive effect on patient-practitioner communication; and decision aids have a variable effect on length of consultation.Consistent with findings from the previous review, which had included studies up to 2006: decision aids increase people's involvement, and improve knowledge and realistic perception of outcomes; however, the size of the effect varies across studies. Decision aids have a variable effect on choices. They reduce the choice of discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, patient-practitioner communication, cost-effectiveness, and use with developing and/or lower literacy populations need further evaluation. Little is known about the degree of detail that decision aids need in order to have positive effects on attributes of the decision or decision-making process.
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Affiliation(s)
- Dawn Stacey
- School of Nursing, University of Ottawa, 451 Smyth Road, Ottawa, Ontario, Canada
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Panic Attack during Elective Gastrointestinal Endoscopy. Gastroenterol Res Pract 2011; 2011:162574. [PMID: 22007196 PMCID: PMC3189558 DOI: 10.1155/2011/162574] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/31/2011] [Accepted: 07/14/2011] [Indexed: 01/04/2023] Open
Abstract
Background. Esophagogastroduodenoscopy (EGD) and colonoscopy (CS) can evoke anxiety, embarrassment, and discomfort. These concerns can culminate in panic attacks, which may traumatize patients and significantly decrease their compliance to the procedure. The objective of this study was to evaluate the relationship between preendoscopic anxiety and the possibility of a panic attack during an elective gastrointestinal endoscopy (EGE). Methods. The study population comprised of 79 Greek outpatients. The examination was carried out without the use of conscious sedation. Patients' anxiety levels were assessed before the procedure using the Greek version of the Spielberger State-Trait Anxiety Inventory (STAI-Y). Results. Seventy-nine patients were enrolled: 45 EGD and 34 CS. Females had higher state and trait anxiety levels than males (48.14 ± 7.94 versus 44.17 ± 7.43, P < 0.05; and 43.68 ± 6.95 versus 39.86 ± 7.46, P < 0.05). Patients who experienced panic attack had significantly higher levels of both trait and state anxiety, compared to those who were panic-free. There was no significant relationship between panic attacks and sex or type of procedure. Conclusions. Patients who experience panic attacks during endoscopic procedures appear to have significantly higher anxiety levels before the procedure. Administering the STAI questionnaire prior to the endoscopy seems to be a useful screening method for vulnerable patients.
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Assessment of the Impact of Cervical Cancer Prevention Educational Videos for Quechua- and Spanish-Speaking Peruvian Women. J Low Genit Tract Dis 2009. [DOI: 10.1097/lgt.0b013e318196785f] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
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O'Connor AM, Bennett CL, Stacey D, Barry M, Col NF, Eden KB, Entwistle VA, Fiset V, Holmes-Rovner M, Khangura S, Llewellyn-Thomas H, Rovner D. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2009:CD001431. [PMID: 19588325 DOI: 10.1002/14651858.cd001431.pub2] [Citation(s) in RCA: 414] [Impact Index Per Article: 25.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
BACKGROUND Decision aids prepare people to participate in 'close call' decisions that involve weighing benefits, harms, and scientific uncertainty. OBJECTIVES To conduct a systematic review of randomised controlled trials (RCTs) evaluating the efficacy of decision aids for people facing difficult treatment or screening decisions. SEARCH STRATEGY We searched MEDLINE (Ovid) (1966 to July 2006); Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library; 2006, Issue 2); CINAHL (Ovid) (1982 to July 2006); EMBASE (Ovid) (1980 to July 2006); and PsycINFO (Ovid) (1806 to July 2006). We contacted researchers active in the field up to December 2006. There were no language restrictions. SELECTION CRITERIA We included published RCTs of interventions designed to aid patients' decision making by providing information about treatment or screening options and their associated outcomes, compared to no intervention, usual care, and alternate interventions. We excluded studies in which participants were not making an active treatment or screening decision, or if the study's intervention was not available to determine that it met the minimum criteria to qualify as a patient decision aid. DATA COLLECTION AND ANALYSIS Two review authors independently screened abstracts for inclusion, and extracted data from included studies using standardized forms. The primary outcomes focused on the effectiveness criteria of the International Patient Decision Aid Standards (IPDAS) Collaboration: attributes of the decision and attributes of the decision process. We considered other behavioural, health, and health system effects as secondary outcomes. We pooled results of RCTs using mean differences (MD) and relative risks (RR) using a random effects model. MAIN RESULTS This update added 25 new RCTs, bringing the total to 55. Thirty-eight (69%) used at least one measure that mapped onto an IPDAS effectiveness criterion: decision attributes: knowledge scores (27 trials); accurate risk perceptions (11 trials); and value congruence with chosen option (4 trials); and decision process attributes: feeling informed (15 trials) and feeling clear about values (13 trials).This review confirmed the following findings from the previous (2003) review. Decision aids performed better than usual care interventions in terms of: a) greater knowledge (MD 15.2 out of 100; 95% CI 11.7 to 18.7); b) lower decisional conflict related to feeling uninformed (MD -8.3 of 100; 95% CI -11.9 to -4.8); c) lower decisional conflict related to feeling unclear about personal values (MD -6.4; 95% CI -10.0 to -2.7); d) reduced the proportion of people who were passive in decision making (RR 0.6; 95% CI 0.5 to 0.8); and e) reduced proportion of people who remained undecided post-intervention (RR 0.5; 95% CI 0.3 to 0.8). When simpler decision aids were compared to more detailed decision aids, the relative improvement was significant in knowledge (MD 4.6 out of 100; 95% CI 3.0 to 6.2) and there was some evidence of greater agreement between values and choice.In this review, we were able to explore the use of probabilities in decision aids. Exposure to a decision aid with probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.6; 95% CI 1.4 to 1.9). The effect was stronger when probabilities were measured quantitatively (RR 1.8; 95% CI 1.4 to 2.3) versus qualitatively (RR 1.3; 95% CI 1.1 to 1.5).As in the previous review, exposure to decision aids continued to demonstrate reduced rates of: elective invasive surgery in favour of conservative options, decision aid versus usual care (RR 0.8; 95% CI 0.6 to 0.9); and use of menopausal hormones, detailed versus simple aid (RR 0.7; 95% CI 0.6 to 1.0). There is now evidence that exposure to decision aids results in reduced PSA screening, decision aid versus usual care (RR 0.8; 95% CI 0.7 to 1.0) . For other decisions, the effect on decisions remains variable.As in the previous review, decision aids are no better than comparisons in affecting satisfaction with decision making, anxiety, and health outcomes. The effects of decision aids on other outcomes (patient-practitioner communication, consultation length, continuance, resource use) were inconclusive.There were no trials evaluating the IPDAS decision process criteria relating to helping patients to recognize a decision needs to be made, understand that values affect the decision, or discuss values with the practitioner. AUTHORS' CONCLUSIONS Patient decision aids increase people's involvement and are more likely to lead to informed values-based decisions; however, the size of the effect varies across studies. Decision aids have a variable effect on decisions. They reduce the use of discretionary surgery without apparent adverse effects on health outcomes or satisfaction. The degree of detail patient decision aids require for positive effects on decision quality should be explored. The effects on continuance with chosen option, patient-practitioner communication, consultation length, and cost-effectiveness need further evaluation.
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Affiliation(s)
- Annette M O'Connor
- Professor, School of Nursing, Department of Epidemiology, University of Ottawa, Senior Scientist, Clinical Epidemiology Program, Ottawa Health Research Institute, 1053 Carling Avenue, (ASB 2-008), Ottawa, Ontario, Canada, K1Y 4E9
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Coombes JM, Steiner JF, Bekelman DB, Prochazka AV, Denberg TD. Clinical outcomes associated with attempts to educate patients about lower endoscopy: a narrative review. J Community Health 2008; 33:149-57. [PMID: 18165928 DOI: 10.1007/s10900-007-9081-5] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/09/2023]
Abstract
Patient knowledge about lower endoscopy might have beneficial effects on satisfaction outcomes, pre-procedure anxiety, and adherence, although this is poorly understood. Methods Searching the national and international literature, we reviewed 20 years of observational studies and randomized trials that examine possible relationships between educating patients about lower endoscopy and clinical outcomes. Twenty-three publications were included but their heterogeneity precluded meta-analyses. Standard and modified informed consent procedures and enhanced educational interventions were associated most often with levels of patient knowledge, satisfaction, anxiety, and adherence. Regardless of the approach, a large proportion of patients have poor comprehension of lower endoscopy's risks, benefits, and alternatives; patient satisfaction with information and procedures manifests ceiling effects; only a subset of patients have clinically significant pre-procedure anxiety; and providing written information and reminders may improve procedure adherence. Future work should focus on strategies for improving patient knowledge in the setting of initial screening colonoscopy within open access systems. Patient knowledge of lower endoscopy is often inadequate even though greater knowledge might be associated with better clinical outcomes for certain patient subgroups. Professional societies have an important role to play in endorsing educational strategies and in clarifying and assessing the adequacy of patient knowledge.
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Affiliation(s)
- John M Coombes
- Five Irongate Center, Gastroenterology Associates of Northern New York, P.C., Glens Falls, NY 12801, USA
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Vist GE, Bryant D, Somerville L, Birminghem T, Oxman AD. Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate. Cochrane Database Syst Rev 2008; 2008:MR000009. [PMID: 18677782 PMCID: PMC8276557 DOI: 10.1002/14651858.mr000009.pub4] [Citation(s) in RCA: 73] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Abstract
BACKGROUND Some people believe that patients who take part in randomised controlled trials (RCTs) face risks that they would not face if they opted for non-trial treatment. Others think that trial participation is beneficial and the best way to ensure access to the most up-to-date physicians and treatments. This is an updated version of the original Cochrane review published in Issue 1, 2005. OBJECTIVES To assess the effects of patient participation in RCTs ('trial effects') independent both of the effects of the clinical treatments being compared ('treatment effects') and any differences between patients who participated in RCTs and those who did not. We aimed to compare similar patients receiving similar treatment inside and outside of RCTs. SEARCH STRATEGY In March 2007, we searched The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, The Cochrane Methodology Register, SciSearch and PsycINFO for potentially relevant studies. Our search yielded 7586 new references. In addition, we reviewed the reference lists of relevant articles. SELECTION CRITERIA Randomized studies and cohort studies with data on clinical outcomes of RCT participants and similar patients who received similar treatment outside of RCTs. DATA COLLECTION AND ANALYSIS At least two review authors independently assessed studies for inclusion, assessed study quality and extracted data. MAIN RESULTS We identified 30 new non-randomized cohort studies (45 comparisons): no new RCTs were found. This update now includes five RCTs (yielding 6 comparisons) and 80 non-randomized cohort studies (130 comparisons), with 86,640 patients treated in RCTs and 57,205 patients treated outside RCTs. In the randomised studies, patients were invited to participate in an RCT or not; these comparisons provided limited information because of small sample sizes (a total of 412 patients) and the nature of the questions they addressed. When the results of RCTs and non-randomized cohorts that reported dichotomous outcomes were combined, there were 98 comparisons; there was also heterogeneity (P < 0.00001, I(2) = 42.2%) between studies. No statistical significant differences were found for 85 of the 98 comparisons. Eight comparisons reported statistically significant better outcomes for patients treated within RCTs, and five comparisons reported statistically significant worse outcomes for patients treated within RCTs. There was significant heterogeneity (P < 0.00001, I(2) = 58.2%) among the 38 continuous outcome comparisons. No statistically significant differences were found for 30 of the 38 comparisons. Three comparisons reported statistically significant better outcomes for patients treated within RCTs, and five comparisons reported statistically significant worse outcomes for patients treated within RCTs. AUTHORS' CONCLUSIONS This review indicates that participation in RCTs is associated with similar outcomes to receiving the same treatment outside RCTs. These results challenge the assertion that the results of RCTs are not applicable to usual practice.
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Affiliation(s)
- Gunn Elisabeth Vist
- Department of Evidence-Based Health Services, Norwegian Knowledge Centre for Health Services, PO Box 7004, St Olavs Plass, Oslo, Norway, 0130.
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Chapple A, Ziebland S, Hewitson P, McPherson A. What affects the uptake of screening for bowel cancer using a faecal occult blood test (FOBt): A qualitative study. Soc Sci Med 2008; 66:2425-35. [PMID: 18358581 DOI: 10.1016/j.socscimed.2008.02.009] [Citation(s) in RCA: 111] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2007] [Indexed: 11/15/2022]
Affiliation(s)
- Alison Chapple
- Department of Primary Health Care, University of Oxford, Oxford, UK.
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Kimberger O, Illievich U, Lenhardt R. The effect of skin surface warming on pre-operative anxiety in neurosurgery patients. Anaesthesia 2007; 62:140-5. [PMID: 17223806 DOI: 10.1111/j.1365-2044.2007.04934.x] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Abstract
Skin surface warming of patients not only improves thermal comfort, but has been shown to reduce anxiety in a pre-hospital setting. We tested the hypothesis that pre-operative warming can reduce pre-operative anxiety as effectively as a conventional dose of intravenous midazolam in patients undergoing neurosurgery. We randomly allocated 80 patients to four groups in the pre-operative holding area. Treatment was applied for 30-45 min with (1) passive insulation and placebo; (2) passive insulation and intravenous midazolam (30 microg.kg-1); (3) warming with forced-air and placebo; and (4) warming with forced-air and intravenous midazolam (30 microg.kg-1). Thermal comfort levels (VAS 0-100 mm) and anxiety levels (VAS 0-100 mm, Spielberger State-Trait Anxiety Inventory) were assessed twice: before the designated treatment was started and before induction of anaesthesia. In the midazolam and the midazolam/warming groups, anxiety VAS and Spielberger state anxiety scores decreased by -19 (95% CI: -29 to -9, p<0.01) and -10 (95% CI: -14 to -6, p<0.01), respectively. In the warming and the combined groups, thermal VAS increased by +26 (95% CI: 17-34, p<0.01). Pre-operative warming did not reduce anxiety VAS (p=0.11) or Spielberger state anxiety (p=0.19). The results of our study indicate that pre-operative warming can be recommended solely to improve thermal comfort, not to replace anxiolytic premedication regimens.
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Affiliation(s)
- O Kimberger
- Department of Anaesthesia and Intensive Care, Medical University of Vienna, Vienna, Austria.
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O'Connor AM, Stacey D, Entwistle V, Llewellyn-Thomas H, Rovner D, Holmes-Rovner M, Tait V, Tetroe J, Fiset V, Barry M, Jones J. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2003:CD001431. [PMID: 12804407 DOI: 10.1002/14651858.cd001431] [Citation(s) in RCA: 397] [Impact Index Per Article: 18.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/28/2023]
Abstract
BACKGROUND Decision aids prepare people to participate in preference-sensitive decisions. OBJECTIVES 1. Create a comprehensive inventory of patient decision aids focused on healthcare options. 2. Review randomized controlled trials (RCT) of decision aids, for people facing healthcare decisions. SEARCH STRATEGY Studies were identified through databases and contact with researchers active in the field. SELECTION CRITERIA Two independent reviewers screened abstracts for interventions designed to aid patients' decision making by providing information about treatment or screening options and their associated outcomes. Information about the decision aids was compiled in an inventory; those that had been evaluated in a RCT were reviewed in detail. DATA COLLECTION AND ANALYSIS Two reviewers independently extracted data using standardized forms. Results of RCTs were pooled using weighted mean differences (WMD) and relative risks (RR) using a random effects model. MAIN RESULTS Over 200 decision aids were identified. Of the 131 available decision aids, most are intended for use before counselling. Using the CREDIBLE criteria to evaluate the quality of the decision aids: a) most included potential harms and benefits, credentials of the developers, description of their development process, update policy, and were free of perceived conflict of interest; b) many included reference to relevant literature; c) few included a description of the level of uncertainty regarding the evidence; and d) few were evaluated. Thirty of these decision aids were evaluated in 34 RCTs and another trial evaluated a suite of eight decision aids. An additional 30 trials are yet to be published. Among the trials comparing decision aids to usual care, decision aids performed better in terms of: a) greater knowledge (WMD 19 out of 100, 95% CI: 13 to 24; b) more realistic expectations (RR 1.4, 95%CI: 1.1 to 1.9); c) lower decisional conflict related to feeling informed (WMD -9.1 of 100, 95%CI: -12 to -6); d) increased proportion of people active in decision making (RR 1.4, 95% CI: 1.0 to 2.3); and e) reduced proportion of people who remained undecided post intervention (RR 0.43, 95% CI: 0.3 to 0.7). When simpler were compared to more detailed decision aids, the relative improvement was significant in: a) knowledge (WMD 4 out of 100, 95% CI: 3 to 6); b) more realistic expectations (RR 1.5, 95% CI: 1.3 to 1.7); and c) greater agreement between values and choice. Decision aids appeared to do no better than comparisons in affecting satisfaction with decision making, anxiety, and health outcomes. Decision aids had a variable effect on which healthcare options were selected. REVIEWER'S CONCLUSIONS The availability of decision aids is expanding with many on the Internet; however few have been evaluated. Trials indicate that decision aids improve knowledge and realistic expectations; enhance active participation in decision making; lower decisional conflict; decrease the proportion of people remaining undecided, and improve agreement between values and choice. The effects on persistence with chosen therapies and cost-effectiveness require further evaluation. Finally, optimal strategies for dissemination need to be explored.
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Affiliation(s)
- A M O'Connor
- School of Nursing and Faculty of Medicine, University of Ottawa, C4 Ottawa Hospital, 1053 Carling Avenue, Ottawa, Ontario, Canada, K1Y 4E9.
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