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Repanovici A, Pantea I, Roman NA. Designing and Implementing a Customized Questionnaire to Assess the Attitude of Patients with Diabetes. Healthcare (Basel) 2025; 13:815. [PMID: 40218111 PMCID: PMC11988639 DOI: 10.3390/healthcare13070815] [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: 02/26/2025] [Revised: 04/02/2025] [Accepted: 04/02/2025] [Indexed: 04/14/2025] Open
Abstract
Background/Objectives: Diabetes mellitus presents significant management challenges, requiring comprehensive glycemic control, patient education, self-management, and routine monitoring. The study aims to evaluate existing tools and develop a customized questionnaire to investigate the multifaceted impact of diabetes mellitus on patients' lives through a novel questionnaire. Methods: Utilizing Survey Monkey, we efficiently collected data from 150 diabetic patients during annual evaluations over five months (March 2024-July 2024). The sample included 88 men (58.67%) and 62 women (41.33%), with a notable representation of participants having a family history of diabetes (63.42%) and varying levels of education (20% with higher education). Statistical analyses were conducted using IBM SPSS (Version 20.0), and structural equation modeling (SEM) through Amos, including exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) to validate the instrument and assess its psychometric properties. Results: The questionnaire targets four critical domains: the role of physical activity in diabetes management, the effects of diabetes on social relationships, the emotional status of diabetic patients, and the influence of diet on metabolic control. Conclusions: The findings provide valuable insights into patient attitudes toward diabetes management, emphasizing the importance of physical activity, social dynamics, emotional well-being, and dietary practices in improving health outcomes for individuals with diabetes.
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Affiliation(s)
- Angela Repanovici
- Faculty of Product Design and Environment, Transilvania University of Brasov, 500036 Brasov, Romania
| | - Ileana Pantea
- Faculty of Medicine, Transilvania University of Brasov, 500036 Brasov, Romania
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Almeida DM, Santos-de-Araújo AD, Júnior JMCB, Cacere M, Pontes-Silva A, Costa CP, Gonçalves MC, Leite JMS, Dibai-Filho AV, Bassi-Dibai D. The best internal structure of the Diabetes Quality of Life Measure (DQOL) in Brazilian patients. BMC Public Health 2024; 24:580. [PMID: 38395813 PMCID: PMC10885374 DOI: 10.1186/s12889-024-18090-z] [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: 11/10/2023] [Accepted: 02/13/2024] [Indexed: 02/25/2024] Open
Abstract
BACKGROUND Diabetes Mellitus (DM) is considered a chronic disease with numerous secondary complications that negatively affect the quality of life of patients. However, the specific, known and validated instruments for Brazilian Portuguese are too extensive, which often makes their use infeasible. OBJECTIVE To validate the internal structure of the Brazilian version of the Diabetes Quality of Life (DQOL) measure. METHODOLOGY Patients with DM type 1 or 2, between the ages of 18 and 76, were evaluated between April 2022 and May 2022. The survey was conducted online using the Google Forms platform. The original DQOL contains 46 multiple-choice questions organized into four domains. For structural validity, confirmatory factor analysis (CFA) was performed using RStudio software (Boston, MA, USA) with the packages lavaan and semPlot. RESULTS A total of 354 subjects were evaluated. The 3-domain, 24-item version of the DQOL was the most adequate, with acceptable values for all fit indices (chi-square/GL < 3, TLI and CFI > 0.90, and RMSEA and SRMR < 0.08). CONCLUSION The structure with three domains and 24 items is the most appropriate based on factor analysis. The Brazilian version of the DQOL with a structure of 3 domains and 24 items has adequate measurement properties that support its use in the clinical and scientific context in patients with DM.
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Affiliation(s)
- Denilson Menezes Almeida
- Postgraduate Program in Management of Health Programs and Services, Universidade Ceuma, Rua Josué Montello, 1, Jardim Renascença. Zip Code, 65075-120, São Luís, Brazil
| | | | | | - Marcela Cacere
- Postgraduate Program in Physical Education, Universidade Federal do Maranhão, São Luís, Brazil
| | - André Pontes-Silva
- Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, Brazil
| | | | - Maria Cláudia Gonçalves
- Department of Physical Therapy, Universidade Ceuma, São Luís, Brazil
- Postgraduate Program in Environment, Universidade Ceuma, São Luís, Brazil
| | - José Márcio Soares Leite
- Postgraduate Program in Management of Health Programs and Services, Universidade Ceuma, Rua Josué Montello, 1, Jardim Renascença. Zip Code, 65075-120, São Luís, Brazil
- Department of Medicine, Universidade Ceuma, São Luís, Brazil
| | | | - Daniela Bassi-Dibai
- Postgraduate Program in Management of Health Programs and Services, Universidade Ceuma, Rua Josué Montello, 1, Jardim Renascença. Zip Code, 65075-120, São Luís, Brazil.
- Department of Physical Therapy, Universidade Ceuma, São Luís, Brazil.
- Postgraduate Program in Dentistry, Universidade Ceuma, São Luís, Brazil.
- Postgraduate Program in Environment, Universidade Ceuma, São Luís, Brazil.
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Pemau RC, González-Palacios P, Kerr KW. How quality of life is measured in studies of nutritional intervention: a systematic review. Health Qual Life Outcomes 2024; 22:9. [PMID: 38267976 PMCID: PMC10809546 DOI: 10.1186/s12955-024-02229-y] [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: 10/10/2023] [Accepted: 01/03/2024] [Indexed: 01/26/2024] Open
Abstract
BACKGROUND Nutrition care can positively affect multiple aspects of patient's health; outcomes are commonly evaluated on the basis of their impact on a patient's (i) illness-specific conditions and (ii) health-related quality of life (HRQoL). Our systematic review examined how HRQoL was measured in studies of nutritional interventions. To help future researchers select appropriate Quality of Life Questionnaires (QoLQ), we identified commonly-used instruments and their uses across populations in different regions, of different ages, and with different diseases. METHODS We searched EMCare, EMBASE, and Medline databases for studies that had HRQoL and nutrition intervention terms in the title, the abstract, or the MeSH term classifications "quality of life" and any of "nutrition therapy", "diet therapy", or "dietary supplements" and identified 1,113 studies for possible inclusion.We then reviewed titles, abstracts, and full texts to identify studies for final inclusion. RESULTS Our review of titles, abstracts, and full texts resulted in the inclusion of 116 relevant studies in our final analysis. Our review identified 14 general and 25 disease-specific QoLQ. The most-used general QoLQ were the Short-Form 36-Item Health Survey (SF-36) in 27 studies and EuroQol 5-Dimension, (EQ-5D) in 26 studies. The European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC-QLQ), a cancer-specific QoLQ, was the most frequently used disease-specific QoLQ (28 studies). Disease-specific QoLQ were also identified for nutrition-related diseases such as diabetes, obesity, and dysphagia. Sixteen studies used multiple QoLQ, of which eight studies included both general and disease-specific measures of HRQoL. The most studied diseases were cancer (36 studies) and malnutrition (24 studies). There were few studies focused on specific age-group populations, with only 38 studies (33%) focused on adults 65 years and older and only 4 studies focused on pediatric patients. Regional variation in QoLQ use was observed, with EQ-5D used more frequently in Europe and SF-36 more commonly used in North America. CONCLUSIONS Use of QoLQ to measure HRQoL is well established in the literature; both general and disease-specific instruments are now available for use. We advise further studies to examine potential benefits of using both general and disease-specific QoLQ to better understand the impact of nutritional interventions on HRQoL.
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Affiliation(s)
| | - Patricia González-Palacios
- Department of Nutrition and Food Science, University of Granada, Granada, Spain
- Biomedical Research Institute (IBS), Granada, Spain
| | - Kirk W Kerr
- Abbott Nutrition, 2900 Easton Square Place, Columbus, OH, 43219, USA.
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Abualhamael SA, Baig M, Alghamdi W, Gazzaz ZJ, Al-Hayani M, Bazi A. Quality of life, stress, anxiety and depression and associated factors among people with type 2 diabetes mellitus in Western region Saudi Arabia. Front Psychiatry 2024; 14:1282249. [PMID: 38288058 PMCID: PMC10823007 DOI: 10.3389/fpsyt.2023.1282249] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/13/2023] [Accepted: 12/28/2023] [Indexed: 01/31/2024] Open
Abstract
Introduction The objective of this study is to evaluate the quality of life (QoL), depression, anxiety, and stress, along with associated factors among individuals with diabetes in Saudi Arabia. Methods This survey was conducted at King Abdulaziz University (KAU), Jeddah, Kingdom of Saudi Arabia (KSA). The assessment of depression, anxiety, and stress related to Type 2 Diabetes Mellitus (T2DM) was conducted using the DASS-21 questionnaire, while diabetes-related QoL was evaluated using the revised version of the diabetes QoL questionnaire (RV-DQoL13). Data were analyzed using SPSS-26. Results A total of 251 subjects were included in the study (165 [65.7%] males and 86 [34.3%] females, mean age 50.1 ± 14.5 years). The individuals with DM had a mean value of QoL of 29.16 ± 9.23, with 46.9% having poor QoL. Furthermore, in dimensions of QoL, almost half of the individuals reported high worry about the disease (49.6%), followed by a high diabetes impact (46.6%) and low life satisfaction (42.9%). The prevalence of depression, anxiety, and stress was 49.4, 71.7, and 49.8%, respectively. A significant correlation was found between depression, anxiety, and stress and DASS-21 scores with QoL (p < 0.001). The regression analysis indicated an association of distinct factors with QoL like age above 41 years (p = 0.004), being married (p < 0.001), being divorced (p = 0.04), higher education (p = 0.007), regular medicine intake (p = 0.01), regular exercise (p = 0.03), lipid profile (p = 0.01), HbA1c (p < 0.001), and DASS-21 scores (p < 0.001). Poor QoL score (TQoL score > 27) was significantly associated with depression, anxiety, and stress (p < 0.001). The participants with higher monthly income, shorter disease duration, regular medicine use, and altered lipid profile, and older subjects had a lower chance of depression, anxiety, and stress. Conclusion Approximately half of individuals with T2DM experienced poor QoL, while the prevalence rates for depression, anxiety, and stress were 49.4, 71.7, and 49.8%, respectively. Scores in the domains of impact, worry, and satisfaction were below optimal levels. Several factors were linked to QoL and depression, anxiety, and stress, and an association was observed between DASS-21 scores and QoL.
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Affiliation(s)
| | - Mukhtiar Baig
- Department of Clinical Biochemistry, Faculty of Medicine, Rabigh, King Abdulaziz University, Jeddah, Saudi Arabia
| | - Waleed Alghamdi
- Department of Psychiatry, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia
| | - Zohair Jamil Gazzaz
- Department of Internal Medicine, Faculty of Medicine, Rabigh, King Abdulaziz University, Jeddah, Saudi Arabia
| | - Majid Al-Hayani
- Department of Internal Medicine, Faculty of Medicine, Rabigh, King Abdulaziz University, Jeddah, Saudi Arabia
| | - Abdulrahman Bazi
- Department of Internal Medicine, Faculty of Medicine, Rabigh, King Abdulaziz University, Jeddah, Saudi Arabia
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Tan MHP, Ong SC, Bujang MA, Shah SA, Mustafa N. Evaluation of the health-related quality of life of patients with type 2 diabetes in relation to macrovascular and microvascular complications. Acta Diabetol 2023; 60:1735-1747. [PMID: 37542199 DOI: 10.1007/s00592-023-02164-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/17/2023] [Accepted: 07/18/2023] [Indexed: 08/06/2023]
Abstract
PURPOSE The complications of type 2 diabetes (T2DM) have a negative impact on health-related quality of life (HRQoL) and could lead to increased healthcare costs. However, there is a lack of evidence regarding how and to what extent T2DM complications, particularly macrovascular and microvascular complications, affect the patients' HRQoL. This study aimed to evaluate the HRQoL in relation to diabetes complications and identify associated factors among patients with T2DM. METHODS A cross-sectional study was conducted over six months on T2DM patients at a National University Hospital, Malaysia. Since Malaysia is a multiethnic country with majority Malay-speaking and English widely used, the Malay and English versions of the revised version Diabetes Quality of life (DQoL) questionnaire was used to measure HRQoL. Multiple Linear Regression was applied to estimate association of individual DQoL domains with T2DM-related complications, sociodemographic and clinical characteristics. RESULTS A total of 513 patients were recruited in the study. Sociodemographic (age, gender, ethnicity, employment, education) and body mass index affected satisfaction, impact and worry domains while complications affected the impact domain. Poorer HRQoL were demonstrated for severe stages heart failure (p = 0.001), nephropathy (p = 0.029), retinopathy (p < 0.001). The presence of neuropathy (p = 0.004) and foot ulcer (p = 0.039) showed poor HRQoL regardless of severity stage. Increase frequencies of hypoglycaemia (p < 0.001) showed poorer HRQoL compared to those with lesser frequencies. CONCLUSION The complications, sociodemographic and clinical characteristics of patients with T2DM affect the HRQoL domains differently. Understanding the point of which complication types and stages impact HRQoL the most can provide insights to clinicians to prioritise on effective interventions. The study findings may assist researchers and policymakers in selecting appropriate health state values when conducting cost-effectiveness studies to aid decision making.
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Affiliation(s)
- Michelle Hwee Pheng Tan
- Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Science, Universiti Sains Malaysia, Penang, Malaysia
- Pharmacy Department, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Siew Chin Ong
- Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Science, Universiti Sains Malaysia, Penang, Malaysia.
| | - Mohamad Adam Bujang
- Clinical Research Centre, Sarawak General Hospital, Ministry of Health Malaysia, Kuching, Sarawak, Malaysia
| | - Shamsul Azhar Shah
- Department of Public Health Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Norlaila Mustafa
- Department of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
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Mohd Hatta FH, Samsudin EZ, Aimran N, Ismail Z. Development and Validation of Questionnaires to Assess Workplace Violence Risk Factors (QAWRF): A Tripartite Perspective of Worksite-Specific Determinants in Healthcare Settings. Risk Manag Healthc Policy 2023; 16:1229-1240. [PMID: 37431510 PMCID: PMC10329825 DOI: 10.2147/rmhp.s411335] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/06/2023] [Accepted: 06/02/2023] [Indexed: 07/12/2023] Open
Abstract
Introduction Workplace violence (WPV) incidences are prevalent in healthcare, and existing WPV interventions have only moderate evidence for effectiveness. This study aimed to develop and validate an instrument to assess worksite-specific WPV risk factors in healthcare settings based on a tripartite perspective of key stakeholders to facilitate improved interventions. Methods Three questionnaires were developed to get the responses from healthcare administrators, workers, and clients, representing the three components of Questionnaires to Assess Workplace Violence Risk Factors (QAWRF). The domains of the questionnaires were developed based on The Chappell and Di Martino's Interactive Model of Workplace Violence, and the items were generated from 28 studies identified from a systematic review of the literature. Six experts, 36 raters, and 90 respondents were recruited to assess the content validity, face validity, and usability and reliability of the QAWRF respectively. Item and Scale Level Content Validity Index, Item and Scale Level Face Validity Index, and Cronbach's alpha values were determined for QAWRF-administrator, QAWRF-worker, and QAWRF-client. Results The psychometric indices for QAWRF are satisfactory. Conclusion QAWRF holds good content validity, face validity, and reliability, and findings from QAWRF can contribute towards worksite-specific interventions that are expected to be resource efficient and more effective than general WPV interventions.
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Affiliation(s)
- Faizul Haris Mohd Hatta
- Department of Public Health Medicine, Faculty of Medicine, Universiti Teknologi MARA, Selangor, Malaysia
| | - Ely Zarina Samsudin
- Department of Public Health Medicine, Faculty of Medicine, Universiti Teknologi MARA, Selangor, Malaysia
| | - Nazim Aimran
- College of Computing, Informatics, and Media, Universiti Teknologi MARA, Shah Alam, Selangor, Malaysia
| | - Zaliha Ismail
- Department of Public Health Medicine, Faculty of Medicine, Universiti Teknologi MARA, Selangor, Malaysia
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Langendoen-Gort M, Groeneveld L, Prinsen CAC, Beulens JW, Elders PJM, Halperin I, Mukerji G, Terwee CB, Rutters F. Patient-reported outcome measures for assessing health-related quality of life in people with type 2 diabetes: A systematic review. Rev Endocr Metab Disord 2022; 23:931-977. [PMID: 35779199 PMCID: PMC9515038 DOI: 10.1007/s11154-022-09734-9] [Citation(s) in RCA: 16] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 05/07/2022] [Indexed: 11/26/2022]
Abstract
Patient-Reported Outcome Measures (PROMs) are important tools to assess outcomes relevant to patients, with Health-Related Quality Of Life (HRQOL) as an important construct to be measured. Many different HRQOL PROMs are used in the type 2 diabetes field, however a complete overview of these PROMs is currently lacking. We therefore aimed to systematically describe and classify the content of all PROMs that have specifically been developed or validated to measure (aspects of) HRQOL in people with type 2 diabetes. A literature search was performed in PubMed and EMBASE until 31 December 2021. Studies on the development or validation of a PROM measuring HRQOL, or aspects of HRQOL, in people with type 2 diabetes were included. Title and abstract and full-text screening were conducted by two independent researchers and data extraction was performed independently by one of the researchers. Data were extracted on language in which the PROM was developed, target population, construct(s) being measured, names of (sub)scales and number of items per (sub)scale. In addition, all PROMs and subscales were classified according to specific aspects of HRQOL based on the Wilson & Cleary model (symptom status, functional status, general health perceptions) to aid researchers in PROM selection. In total 220 studies were identified that developed or validated PROMs that measure (aspects of) HRQOL in people with type 2 diabetes. Of the 116 unique HRQOL PROMs, 91 (of the subscales) measured symptom status, 60 measured functional status and 26 measured general health perceptions. In addition, 16 of the PROMs (subscales) measured global quality of life. 61 of the 116 PROMs (subscales) also include characteristics of the individual (e.g. aspects of personality, coping) or environment (e.g. social or financial support) and patient-reported experience measures (PREMs, e.g. measure of a patient's perception of their personal experience of the healthcare they have received, e.g. treatment satisfaction), which are not part of the HRQOL construct. Only 9 of the 116 PROMs measure all aspects of HRQOL based on the Wilson & Cleary model. Finally, 8 of the 116 PROMs stating to measure HRQOL, measured no HRQOL construct. In conclusion, a large number of PROMs are available for people with type 2 diabetes, which intend to measure (aspects of) HRQOL. These PROMs measure a large variety of (sub)constructs, which are not all HRQOL constructs, with a small amount of PROMs not measuring HRQOL at all. There is a need for consensus on which aspects of HRQOL should be measured in people with type 2 diabetes and which PROMs to use in research and daily practice. PROSPERO: CRD42017071012. COMET database: http://www.comet-initiative.org/studies/details/956 .
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Affiliation(s)
- Marlous Langendoen-Gort
- General Practice, Amsterdam UMC, Location Vrije Universiteit Amsterdam, de Boelelaan 1117, Amsterdam, Netherlands
- Amsterdam Public Health, Health Behaviors & Chronic Diseases, Amsterdam, The Netherlands
| | - Lenka Groeneveld
- Epidemiology and Data Science, Amsterdam UMC, Location Vrije Universiteit Amsterdam, de Boelelaan 1117, Amsterdam, Netherlands
- Amsterdam Public Health, Health Behaviors & Chronic Diseases, Amsterdam, The Netherlands
| | - Cecilia A C Prinsen
- Epidemiology and Data Science, Amsterdam UMC, Location Vrije Universiteit Amsterdam, de Boelelaan 1117, Amsterdam, Netherlands
- Amsterdam Public Health, Methodology, Amsterdam, The Netherlands
| | - Joline W Beulens
- Epidemiology and Data Science, Amsterdam UMC, Location Vrije Universiteit Amsterdam, de Boelelaan 1117, Amsterdam, Netherlands
- Amsterdam Public Health, Health Behaviors & Chronic Diseases, Amsterdam, The Netherlands
- Amsterdam Cardiovascular Sciences, Diabetes & Metabolism, Amsterdam, The Netherlands
| | - Petra J M Elders
- General Practice, Amsterdam UMC, Location Vrije Universiteit Amsterdam, de Boelelaan 1117, Amsterdam, Netherlands
- Amsterdam Public Health, Health Behaviors & Chronic Diseases, Amsterdam, The Netherlands
- Amsterdam Cardiovascular Sciences, Diabetes & Metabolism, Amsterdam, The Netherlands
| | - Ilana Halperin
- Department of Medicine, Temerty Faculty of Medicine, Sunnybrook Health Sciences Center, King's College Circle, University of Toronto, Toronto, ON, Canada
| | - Geetha Mukerji
- Department of Medicine, Temerty Faculty of Medicine, Sunnybrook Health Sciences Center, King's College Circle, University of Toronto, Toronto, ON, Canada
- Women's College Hospital Institute for Health System Solutions and Virtual Care, 76 Grenville Street, Toronto, ON, Canada
| | - Caroline B Terwee
- Epidemiology and Data Science, Amsterdam UMC, Location Vrije Universiteit Amsterdam, de Boelelaan 1117, Amsterdam, Netherlands
- Amsterdam Public Health, Methodology, Amsterdam, The Netherlands
| | - Femke Rutters
- Epidemiology and Data Science, Amsterdam UMC, Location Vrije Universiteit Amsterdam, de Boelelaan 1117, Amsterdam, Netherlands.
- Amsterdam Public Health, Health Behaviors & Chronic Diseases, Amsterdam, The Netherlands.
- Amsterdam Cardiovascular Sciences, Diabetes & Metabolism, Amsterdam, The Netherlands.
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Terwee CB, Elders PJM, Langendoen-Gort M, Elsman EBM, Prinsen CAC, van der Heijden AA, de Wit M, Beulens JWJ, Mokkink LB, Rutters F. Content Validity of Patient-Reported Outcome Measures Developed for Assessing Health-Related Quality of Life in People with Type 2 Diabetes Mellitus: a Systematic Review. Curr Diab Rep 2022; 22:405-421. [PMID: 35819705 PMCID: PMC9355936 DOI: 10.1007/s11892-022-01482-z] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 03/18/2022] [Indexed: 12/12/2022]
Abstract
PURPOSE OF REVIEW We aimed to systematically evaluate the content validity of patient-reported outcome measures (PROMs) specifically developed to measure (aspects of) health-related quality of life (HRQOL) in people with type 2 diabetes. A systematic review was performed in PubMed and Embase of PROMs measuring perceived symptoms, physical function, mental function, social function/participation, and general health perceptions, and that were validated to at least some extent. Content validity (relevance, comprehensiveness, and comprehensibility) was evaluated using COSMIN methodology. RECENT FINDINGS We identified 54 (different versions of) PROMs, containing 150 subscales. We found evidence for sufficient content validity for only 41/150 (27%) (subscales of) PROMs. The quality of evidence was generally very low. We found 66 out of 150 (44%) (subscales of) PROMs with evidence for either insufficient relevance, insufficient comprehensiveness, or insufficient comprehensibility. For measuring diabetes-specific symptoms, physical function, mental function, social function/participation, and general health perceptions, we identified one to 11 (subscales of) PROMs with sufficient content validity, although quality of the evidence was generally low. For measuring depressive symptoms, no PROM with sufficient content validity was identified. For each aspect of HRQL, we found at least one PROM with sufficient content validity, except for depressive symptoms. The quality of the evidence was mostly very low.
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Affiliation(s)
- Caroline B Terwee
- Amsterdam UMC, Department of Epidemiology and Data Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, Netherlands.
| | - Petra J M Elders
- Amsterdam UMC, Department of General Practice, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, Netherlands
| | - Marlous Langendoen-Gort
- Amsterdam UMC, Department of General Practice, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, Netherlands
| | - Ellen B M Elsman
- Amsterdam UMC, Department of Epidemiology and Data Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, Netherlands
| | - Cecilia A C Prinsen
- Amsterdam UMC, Department of Epidemiology and Data Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, Netherlands
| | - Amber A van der Heijden
- Amsterdam UMC, Department of General Practice, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, Netherlands
| | - Maartje de Wit
- Amsterdam UMC, Department of Medical Psychology, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, Netherlands
| | - Joline W J Beulens
- Amsterdam UMC, Department of Epidemiology and Data Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, Netherlands
| | - Lidwine B Mokkink
- Amsterdam UMC, Department of Epidemiology and Data Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, Netherlands
| | - Femke Rutters
- Amsterdam UMC, Department of Epidemiology and Data Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, Netherlands
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Oluchi SE, Manaf RA, Ismail S, Kadir Shahar H, Mahmud A, Udeani TK. Health Related Quality of Life Measurements for Diabetes: A Systematic Review. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2021; 18:ijerph18179245. [PMID: 34501838 PMCID: PMC8431362 DOI: 10.3390/ijerph18179245] [Citation(s) in RCA: 46] [Impact Index Per Article: 11.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 07/19/2021] [Revised: 08/23/2021] [Accepted: 08/27/2021] [Indexed: 11/29/2022]
Abstract
Health-related quality of life (HRQOL) is an essential measure that is used to assess the effect of chronic disease management on the health status of an individual. Previous studies have identified various instruments used in the measuring of diabetes-specific health-related quality of life (HRQOL). The aim of this paper is to provide a systematic review of the various instruments used for the diabetes-specific measure of HRQOL, and place emphasis on its content and measurement properties. Methods Preferred Reporting Items for Systematic Reviews and Meta analyses (PRISMA) guidelines was used. A systematic search strategy was used to identify publications reporting diabetes HRQOL measures. The search terms used were: “diabetes quality of life”, “measurements”, and “instruments”. The database that was searched includes PubMed, Science Direct, CINAHL, and Medline. Articles written in the English language and published from January 1990 to December 2020 were included. Those articles that did not measure HRQOL for diabetic patients were excluded. Results: A total of seventeen instruments met the inclusion criteria and included in the review. The appraisal of diabetes scale (ADS), Audit of Diabetes-Dependent QOL measure (ADDQOL), Diabetes Health Profile (DHP), and Problem Areas in Diabetes (PAID) are more suitable for single-scale questionnaires when investigating one or more specific aspects of diabetes-specific quality of life (QOL). The ADDQOL, ADS, Diabetes Impact Measurement Scales (DIMS), Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R), Malay Version of Diabetes Quality of Life (DQOL), Iranian Diabetes Quality of Life (IRDQOL), Brief Clinical Inventory, and PAID are relevant measures of HRQOL for insulin dependent diabetes mellitus (IDDM) and non-insulin dependent diabetes mellitus (NIDDM) patients. The Asian Diabetes Quality of Life AsianDQOL, The Chinese Short Version of DQOL, Elderly Diabetes Burden Scale (EDBS), Malay Version of Diabetes Quality of Life (DQOL), are relevant measures of HRQOL for NIDDM patients. Only two instruments assess for responsiveness, namely PAID and DQLCTQ-R. In PAID, the effect sizes ranged from 0.32 to 0.65 for interventions. The DQLCTQ-R four domains were responsive to clinical change in metabolic control. Based on this review ADDQOL, DSQOLS, and EDBS psychometric properties are sufficient. Conclusion: Most studies did not check for responsiveness, and future studies should prioritize responsiveness to change, which was not included in the psychometric finding of the reviewed instruments.
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Affiliation(s)
- Sampson Emilia Oluchi
- Department of Community Health, Faculty of Medicine and Health Sciences Universiti Putra Malaysia, Serdang 43400, Selangor Darul Ehsan, Malaysia; (S.E.O.); (S.I.); (H.K.S.); (A.M.)
| | - Rosliza Abdul Manaf
- Department of Community Health, Faculty of Medicine and Health Sciences Universiti Putra Malaysia, Serdang 43400, Selangor Darul Ehsan, Malaysia; (S.E.O.); (S.I.); (H.K.S.); (A.M.)
- Correspondence:
| | - Suriani Ismail
- Department of Community Health, Faculty of Medicine and Health Sciences Universiti Putra Malaysia, Serdang 43400, Selangor Darul Ehsan, Malaysia; (S.E.O.); (S.I.); (H.K.S.); (A.M.)
| | - Hayati Kadir Shahar
- Department of Community Health, Faculty of Medicine and Health Sciences Universiti Putra Malaysia, Serdang 43400, Selangor Darul Ehsan, Malaysia; (S.E.O.); (S.I.); (H.K.S.); (A.M.)
| | - Aidalina Mahmud
- Department of Community Health, Faculty of Medicine and Health Sciences Universiti Putra Malaysia, Serdang 43400, Selangor Darul Ehsan, Malaysia; (S.E.O.); (S.I.); (H.K.S.); (A.M.)
| | - Theophilus Kachidelu Udeani
- Department of Medical Laboratory Sciences, Faculty of Health Sciences & Technology College of Medicine, University of Nigeria Enugu Campus, Enugu 410001, Nigeria;
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Wee PJL, Kwan YH, Loh DHF, Phang JK, Puar TH, Østbye T, Thumboo J, Yoon S, Low LL. Measurement Properties of Patient-Reported Outcome Measures for Diabetes: Systematic Review. J Med Internet Res 2021; 23:e25002. [PMID: 34397387 PMCID: PMC8398743 DOI: 10.2196/25002] [Citation(s) in RCA: 24] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/14/2020] [Revised: 12/18/2020] [Accepted: 06/14/2021] [Indexed: 01/20/2023] Open
Abstract
BACKGROUND The management of diabetes is complex. There is growing recognition of the use of patient-reported outcome measures (PROMs) as a standardized method of obtaining an outlook on patients' functional status and well-being. However, no systematic reviews have summarized the studies that investigate the measurement properties of diabetes PROMs. OBJECTIVE Our aims were to conduct a systematic review of studies investigating the measurement properties of diabetes PROMs by evaluating the methodological quality and overall level of evidence of these PROMs and to categorize them based on the outcome measures assessed. METHODS This study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the Embase, PubMed, and PsychINFO databases. The PROMs were evaluated with the COSMIN (COnsensus-based Standards for the selection of health Measurement Instruments) guidelines. RESULTS A total of 363 articles evaluating the measurement properties of PROMs for diabetes in the adult population were identified, of which 238 unique PROMs from 248 studies reported in 209 articles were validated in the type 2 diabetes population. PROMs with at least a moderate level of evidence for ≥5 of 9 measurement properties include the Chinese version of the Personal Diabetes Questionnaire (C-PDQ), Diabetes Self-Management Instrument Short Form (DSMI-20), and Insulin Treatment Appraisal Scale in Hong Kong primary care patients (C-ITAS-HK), of which the C-PDQ has a "sufficient (+)" rating for >4 measurement properties. A total of 43 PROMs meet the COSMIN guidelines for recommendation for use. CONCLUSIONS This study identified and synthesized evidence for the measurement properties of 238 unique PROMs for patients with type 2 diabetes and categorized the PROMs according to their outcome measures. These findings may assist clinicians and researchers in selecting appropriate high-quality PROMs for clinical practice and research. TRIAL REGISTRATION PROSPERO International Prospective Register of Systematic Reviews CRD42020180978; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020180978.
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Affiliation(s)
| | - Yu Heng Kwan
- Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore
- Department of Pharmacy, National University of Singapore, Singapore, Singapore
| | | | - Jie Kie Phang
- Department of Rheumatology and Immunology, Singapore General Hospital, Singapore, Singapore
| | - Troy H Puar
- Department of Endocrinology, Changi General Hospital, Singapore, Singapore
| | - Truls Østbye
- Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore
| | - Julian Thumboo
- Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore
- Department of Rheumatology and Immunology, Singapore General Hospital, Singapore, Singapore
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Sungwon Yoon
- Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore
| | - Lian Leng Low
- SingHealth Office of Regional Health, Singapore, Singapore
- Department of Family Medicine and Continuing Care, Singapore General Hospital, Singapore, Singapore
- Post Acute and Continuing Care, Outram Community Hospital, SingHealth Community Hospitals, Singapore, Singapore
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11
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Patel KH, Logan K, Krkovic M. Strategies and outcomes in severe open tibial shaft fractures at a major trauma center: A large retrospective case-series. World J Orthop 2021; 12:495-504. [PMID: 34354937 PMCID: PMC8316841 DOI: 10.5312/wjo.v12.i7.495] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/09/2021] [Revised: 05/16/2021] [Accepted: 06/03/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Severe open tibia fractures are challenging to treat with a lack of published clear management strategies. Our aim was to provide an overview of the largest single-center experience in the literature, with minimum 1-year follow-up, of adult type 3 open tibial shaft fractures at Cambridge University Hospitals (a United Kingdom major trauma center). We sought to define patient characteristics and our main outcome measures were infection, union and re-fracture. AIM To retrospectively define patient and injury characteristics, present our surgical methods and analyze our outcomes-namely infection, union and re-fracture rates. METHODS Consecutive series of 74 patients with 75 open tibial fractures treated between 2014 and 2020 (26 classified as Gustilo-Anderson 3A, 47 were 3B and two were 3C). Nine patients underwent intramedullary nailing (IMN), 61 underwent Taylor spatial frame (TSF) fixation and 5 were treated with Masquelet technique (IMN and subsequent bone grafting). RESULTS Mean follow-up was 16 mo (IMN) and 25 mo (TSF). We had an infection rate of 6.7% (5), non-union rate of 4% (3) and re-fracture rate of 2.7% (2). Average time to union was 22 wk for IMN and 38.6 wk for TSF. Thirty-three cases had a bone defect with a mean of 5.4 cm (2-11). Patient age, sex, diabetes, smoking status or injury severity did not have a significant effect on union time with either fixation method. Our limb salvage rate was 98.7%. CONCLUSION Grade 1 to 3A injuries can effectively be treated with reamed or unreamed IMN. Grade 3B/C injuries are best treated by circular external fixators as they provide good, reproducible outcomes and allow large bone defects to be addressed via distraction osteogenesis.
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Affiliation(s)
- Kavi H Patel
- Department of Trauma & Orthopaedics, Cambridge University Hospitals NHS Trust, Cambridge CB2 0QQ, United Kingdom
| | - Karl Logan
- Department of Trauma & Orthopaedics, Cambridge University Hospitals NHS Trust, Cambridge CB2 0QQ, United Kingdom
| | - Matija Krkovic
- Department of Trauma & Orthopaedics, Cambridge University Hospitals NHS Trust, Cambridge CB2 0QQ, United Kingdom
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12
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Cultural Adaptation and Psychometric Properties of the Diabetes Quality of Life Scale in Afaan Oromoo among People Living with Type 2 Diabetes in Ethiopia. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2021; 18:ijerph18147435. [PMID: 34299884 PMCID: PMC8305769 DOI: 10.3390/ijerph18147435] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 06/15/2021] [Revised: 07/08/2021] [Accepted: 07/09/2021] [Indexed: 01/08/2023]
Abstract
BACKGROUND The original 46-item diabetes quality of life (DQOL) scale has been translated into different languages, and the translated DQOL has shown good reliability and validity after deleting some items. The aim of this study was to translate the diabetes quality of life (DQOL) scale into Afaan Oromoo and to culturally adapt and evaluate the psychometric properties of the DQOL-Afaan Oromoo (DQOL-AO) among people living with T2D in Ethiopia. METHODS A cross-sectional study with a convenience sampling technique was conducted in 2020. The DQOL was translated and adapted to Afaan Oromoo. Item-total correlations and exploratory factor analysis (EFA) assessed factor structure; the Cronbach's alpha assessed internal consistency and relationships with gender, educational status, marital status, age, and employment status; and status of diabetes-related disease assessed the construct validity of the DQOL-AO. RESULTS 417 participants responded to all items of the DQOL. Item-total correlation analysis and EFA produced a 34-item DQOL-AO with four subscales, which demonstrated that the internal consistency of the overall DQOL-AO was 0.867, and scores were 0.827, 0.846, 0.654, and 0.727 for the impact, satisfaction, social/vocational worry, and diabetes-related worry subscales, respectively. Statistically significant differences between QOL were obtained in educational status (F = 7.164, p < 0.001) and employment status (F = 4.21, p = 0.002). Individuals who attended college and above and government employees had better QOL. CONCLUSION The 34-item DQOL-AO provided preliminary evidence as a reliable and valid tool to measure diabetic-related QOL before it can be widely used among adults living with T2D who speak Afaan Oromoo.
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13
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Mikhael EM, Hassali MA, Hussain SA, Shawky N. The Development and Validation of Quality of Life Scale for Iraqi Patients with Type 2 Diabetes Mellitus. J Pharm Bioallied Sci 2020; 12:262-268. [PMID: 33100785 PMCID: PMC7574754 DOI: 10.4103/jpbs.jpbs_190_19] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/21/2019] [Revised: 01/24/2020] [Accepted: 03/08/2020] [Indexed: 11/30/2022] Open
Abstract
Background and Aim: The current trend for determining the effectiveness of new treatment or services provided for diabetes mellitus (DM) patients is based on assessing the improvement in both glycemic control and the patient quality of life. Many scales have been developed to assess quality of life among DM patients, but unfortunately, no one can be considered as gold standard. Therefore, this study aimed to develop and validate a brief and specific scale to assess quality of life among Iraqi type 2 DM patients. Methods: An extensive literature review was done using Google-Scholar and PubMed to find out scales that utilized to assess quality of life among DM patients. Four relevant scales, three diabetes specific and one general, were selected. The selected scales were carefully evaluated to find out domains that are commonly used to assess quality of life and then the items within the selected domains were reviewed to choose relevant and comprehensive items for Iraqi type 2 DM patients. Ten items were selected to formulate the quality of life scale for Iraqi DM patients (QOLSID). The content validity of QOLSID was established via an expert panel. For concurrent validity QOLSID was compared to glycosylated hemoglobin (HbA1C). For psychometric evaluation, a cross sectional study for 103 type 2 DM patients was conducted at the National Diabetes Center, Iraq. Test-retest reliability was measured by re-administering QOLSID to 20 patients 2-4 weeks later. Results: The internal consistency of the QOLSID was 0.727. All items had a corrected total-item correlation above 0.2. There was a negative significant correlation between QOLSID score and the HbA1C level (-0.518, P = 0.000). A significant positive correlation was obtained after re-testing (0.967, P = 0.000). Conclusion: The QOLSID is a reliable and valid instrument that can be used for assessing quality of life among Iraqi type 2 DM patients.
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Affiliation(s)
- Ehab M Mikhael
- Department of social and administrative Pharmacy, College of Pharmacy, Universiti Sains Malaysia, Penang, Malaysia.,Department of clinical pharmacy, College of Pharmacy, University of Baghdad, Baghdad-Iraq
| | - Mohamed A Hassali
- Department of clinical pharmacy, College of Pharmacy, University of Baghdad, Baghdad-Iraq
| | - Saad A Hussain
- Faculty of Pharmacy, Al-Rafidain University College, Baghdad, Iraq
| | - Nizar Shawky
- The National Diabetes Center, Al-Mustansiriyah University, Baghdad, Iraq
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Mohd Yusof BN, Wan Zukiman WZHH, Abu Zaid Z, Omar N, Mukhtar F, Yahya NF, Mohd Shahar AS, Hasbullah FY, Liu Xin Yi R, Marczewska A, Hamdy O. Comparison of Structured Nutrition Therapy for Ramadan with Standard Care in Type 2 Diabetes Patients. Nutrients 2020; 12:813. [PMID: 32204476 PMCID: PMC7146585 DOI: 10.3390/nu12030813] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/11/2020] [Revised: 03/14/2020] [Accepted: 03/17/2020] [Indexed: 01/20/2023] Open
Abstract
(1) Background: Structured nutrition therapy (NT) is essential for the management of type 2 diabetes (T2D), but the optimal delivery during Ramadan fasting remains unclear. The present study aimed to evaluate the effect of structured NT program versus standard care in patients with T2D during Ramadan. (2) Methods: The present study was an 8-week, parallel, non-randomized study with patients' preference design involving 64 patients with T2D. The participants were asked to choose their preferred group, i.e., structured NT (Structured Ramadan NT, sRNT) or standard care (SC). The participants in the sRNT group received a Ramadan-focused nutrition plan, including a diabetes-specific formula throughout the study, whereas the patients in the SC group received standard nutrition care. Study outcomes included clinical outcomes and quality of life (QoL). Data was analyzed using two-way repeated-measures ANOVA and linear mixed-effects model. (3) Results: More than half of the participants (n = 38, 63%) chose sRNT as their preferred group. Both groups had comparable baseline characteristics. After 8-weeks of the respective intervention, participants in the sRNT group had lower levels of fasting plasma glucose (-0.9 ± 0.3 mmol/L vs. 0.2 ± 0.3 mmol/L, p < 0.05), triglycerides (-0.21 ± 0.08 mmol/L vs. 0.20 ± 0.17 mmol/L, p < 0.05), and self-monitoring glucose at pre-dawn (6.9 mmol/L vs. 7.8 mmol/L, p < 0.05) and pre-bedtime (7.6 mmol/L vs. 8.6 mmol/L, p < 0.05) than participants in the SC group. Although not different between groups, HbA1c levels decreased significantly in the sRNT (-0.72 ± 0.16%, p < 0.001) but not in the SC group (-0.35 ± 0.24%, p = 0.155). QoL and satisfaction scores improved significantly in sRNT group, but not in SC group. (4) Conclusions: The structured NT regimen for Ramadan is a feasible and beneficial program for T2D patients observing Ramadan fasting as it showed an improvement in clinical outcomes and QoL.
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Affiliation(s)
- Barakatun-Nisak Mohd Yusof
- Department of Nutrition & Dietetics, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia; (Z.A.Z.); (N.O.); (N.F.Y.); (A.S.M.S.); (F.Y.H.)
- Institute for Social Science Studies, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia;
| | | | - Zalina Abu Zaid
- Department of Nutrition & Dietetics, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia; (Z.A.Z.); (N.O.); (N.F.Y.); (A.S.M.S.); (F.Y.H.)
| | - Noraida Omar
- Department of Nutrition & Dietetics, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia; (Z.A.Z.); (N.O.); (N.F.Y.); (A.S.M.S.); (F.Y.H.)
| | - Firdaus Mukhtar
- Institute for Social Science Studies, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia;
- Department of Psychiatry, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia
| | - Nor Farahain Yahya
- Department of Nutrition & Dietetics, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia; (Z.A.Z.); (N.O.); (N.F.Y.); (A.S.M.S.); (F.Y.H.)
| | - Aainaa Syarfa Mohd Shahar
- Department of Nutrition & Dietetics, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia; (Z.A.Z.); (N.O.); (N.F.Y.); (A.S.M.S.); (F.Y.H.)
| | - Farah Yasmin Hasbullah
- Department of Nutrition & Dietetics, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia; (Z.A.Z.); (N.O.); (N.F.Y.); (A.S.M.S.); (F.Y.H.)
| | | | | | - Osama Hamdy
- Joslin Diabetes Centre, Harvard Medical School, MA 02215, USA;
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Bujang MA, Omar ED, Baharum NA. A Review on Sample Size Determination for Cronbach's Alpha Test: A Simple Guide for Researchers. Malays J Med Sci 2018; 25:85-99. [PMID: 30914882 PMCID: PMC6422571 DOI: 10.21315/mjms2018.25.6.9] [Citation(s) in RCA: 213] [Impact Index Per Article: 30.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/26/2018] [Accepted: 11/11/2018] [Indexed: 11/27/2022] Open
Abstract
Background Reliability studies are commonly used in questionnaire development studies and questionnaire validation studies. This study reviews the sample size guideline for Cronbach’s alpha test. Methods Manual sample size calculation using Microsoft Excel software and sample size tables were tabulated based on a single coefficient alpha and the comparison of two coefficients alpha. Results For a single coefficient alpha test, the approach by assuming the Cronbach’s alpha coefficient equals to zero in the null hypothesis will yield a smaller sample size of less than 30 to achieve a minimum desired effect size of 0.7. However, setting the coefficient of Cronbach’s alpha larger than zero in the null hypothesis could be necessary and this will yield larger sample size. For comparison of two coefficients of Cronbach’s alpha, a larger sample size is needed when testing for smaller effect sizes. Conclusions In the assessment of the internal consistency of an instrument, the present study proposed the Cronbach’s alpha’s coefficient to be set at 0.5 in the null hypothesis and hence larger sample size is needed. For comparison of two coefficients’ of Cronbach’s alpha, justification is needed whether testing for extremely low and extremely large effect sizes are scientifically necessary.
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Affiliation(s)
- Mohamad Adam Bujang
- Clinical Research Centre, Sarawak General Hospital, Ministry of Health, Sarawak, Malaysia
| | - Evi Diana Omar
- Clinical Research Centre, Serdang Hospital, Ministry of Health, Selangor, Malaysia
| | - Nur Akmal Baharum
- National Clinical Research Centre, Ministry of Health, Kuala Lumpur, Malaysia
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Bujang MA, Adnan TH, Mohd Hatta NKB, Ismail M, Lim CJ. A Revised Version of Diabetes Quality of Life Instrument Maintaining Domains for Satisfaction, Impact, and Worry. J Diabetes Res 2018; 2018:5804687. [PMID: 30327784 PMCID: PMC6169225 DOI: 10.1155/2018/5804687] [Citation(s) in RCA: 22] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/10/2018] [Accepted: 06/12/2018] [Indexed: 11/21/2022] Open
Abstract
BACKGROUND Diabetes quality of life (DQoL) instrument has been widely used to measure quality of life among diabetes patients. This study aimed to develop a revised version of DQoL instrument that incorporated issues of redundancies in the items and strengthen the basis of validity of the instrument. METHODS This was a cross-sectional study where diabetes patients were recruited from December 1, 2014, until end of March 2015 at a public health clinic in Peninsular Malaysia. A questionnaire that included patients' information and DQoL instrument was distributed to patients. Item selection of DQoL instrument was conducted to screen and finalize the items based on issues of missing values and redundancy. Validity testing was conducted for the revised DQoL instrument based on exploratory factor analysis, confirmatory factor analysis, and Rasch analysis. RESULTS The pattern structure matrix yielded three domains similar to the original version with 18 items. The minimum factor loading from the structure matrix was 0.358. The item's and person's reliability was excellent with 0.92 and 0.84 for "satisfaction" domain, 0.98 and 0.60 for "impact" domain, and 0.99 and 0.57 for "worry" domain, respectively. Confirmatory factor analysis has dropped 5 items and the revised version of DQoL contained 13 items. Composite reliability of the revised version was computed for "satisfaction" domain (0.922; 95% CI: 0.909-0.936), "impact" domain (0.781; 95% CI: 0.745-0.818), and "worry" domain (0.794; 95% CI: 0.755-0.832). CONCLUSION A revised version of DQoL that maintains the conceptualization of "satisfaction," "impact," and "worry" with 13 items was successfully developed.
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Affiliation(s)
- Mohamad Adam Bujang
- Clinical Research Centre, Sarawak General Hospital, Ministry of Health Malaysia, Kuching, Malaysia
| | - Tassha Hilda Adnan
- National Clinical Research Centre, Ministry of Health Malaysia, Kuala Lumpur, Malaysia
| | | | - Mastura Ismail
- Health Clinic Seremban 2, Ministry of Health Malaysia, Seremban Negeri Sembilan, Malaysia
| | - Chien Joo Lim
- Clinical Research Centre, Sarawak General Hospital, Ministry of Health Malaysia, Kuching, Malaysia
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