Table 1 Overall studies characteristics
Article characteristics | Measurement characteristics | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
S.N | Authors | Year | Study location | Study design | Target population | Questionnaires and main objectives | Mode of questionnaire administration | Validity | Reproducibility | Responsiveness of the participants | Type of bias | Languages support |
1 | Wadden et al | 2014 | United States | Randomized clinical trial | 5,145 overweight or obese adults with Type 2 Diabetes Mellitus (T2DM) | Questionnaires: The Medical Outcomes Study Short Form 36 (SF-36) and the Beck Depression Inventory (BDI) Main objectives: To assess the effects of long-term intensive lifestyle intervention on depression symptoms and Quality of Life (QoL) in patients with T2DM | Self-administered | Yes | Yes | 40% for QoL at the last year of the study | Self-report and non-response bias | Yes |
2 | Hajos, T.R.S. et al | 2013 | Netherlands | Randomized clinical trial | 2,055 adult patients with Type 1 Diabetes Mellitus (T1DM) or T2DM | Questionnaires: The Problem Areas in Diabetes scale (PAID), Medical Outcomes Short Form 12 (SF-12), the World Health Organization—Five Well-Being Index (WHO-5) and the 9-item Patient Health Questionnaire (PHQ-9) Main objectives: To evaluate the psychometric properties of the WHO-5 index in a large sample of Dutch outpatients with T1DM or T2DM | Self-administered | Yes | Yes | 47% returned the first questionnaire and 38% of the initial population returned the second | Self-report and non-response bias | Yes except the PAID questionnaire |
3 | Green, A.J. et al | 2012 | United States | Cross-sectional | 2,718 US adult households with T2DM | Questionnaires: The SF-12 and the PHQ-9 Main objectives: To examine the association of hypoglycemia with QoL and depression among adults with T2DM | Self-administered | Yes | Yes | 71% from the 2008 annual follow-up Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD) survey | Self-report and non-response bias | Yes |
4 | Schunk, M. et al | 2012 | German | Cross-sectional | 846 adults between 45 and 74 years old with T2DM | Questionnaires: The SF-36 and SF-12 Main objectives: To compare the population values of QoL among patients with and without T2DM, across several large population-based survey studies from different regions in Germany and a nationwide survey | Self-administered | Yes | Yes | Overall response rates ranged between 61 and 69% from national and four regional population-based surveys (KORA, CARLA, SHIP and DHS) and the primary data which is the Diabetes Collaborative Research of Epidemiologic Studies (DIAB-CORE) | Self-report and non-response bias | Yes |
5 | Mazhar, K. et al | 2011 | United States | Cohort | 1,064 above 40 years old adults with T2DM | Questionnaires: The SF-12 and the National Eye Institute Vision- Specific Questionnaire (NEI-VFQ-25) Main objectives: To evaluate the relationship between diabetic retinopathy and its severity on QoL in a population-based sample of Latinos with T2DM | Interviewer- administered | Yes | Yes | 84% among the diabetic participants from the Los Angeles Latino Eye Study (LALES) | None | Yes |
6 | Siersma V. et al | 2013 | Denmark | Cross-sectional | 1,232 adult patients with T2DM | Questionnaires: The EuroQoL EQ-5D Main objectives: To investigate factors determining clinical outcome, healthcare consumption and QoL in patients with new foot ulcers | Self-administered | Yes | Yes | 88.30% | Self-report | Yes |
7 | Nicolucci, A. et al | 2012 | Italy | Randomized clinical trial | 606 sedentary adult patients with T2DM. From the Italian Diabetes and Exercise Study (IDES) | Questionnaires: The SF-36 Main objectives: To assess the relationship between changes in QoL and volume of physical activity/exercise, in T2DM patients | Self-administered | Yes | Yes | 87.6% from the 691 assessed for eligibility in this study | Self-report and non-response bias | Yes |
8 | Williams, E.D. et al | 2012 | Australia | Randomized clinical trial | 120 adult participants with T2DM | Questionnaires: The SF-36 Main objectives: To evaluate the Telephone-Linked Care (TLC) Australian program designed to improve the T2DM management and QoL among the participants compared with a large Australian population study | Self-administered | Yes | Yes | 92.5% of the total sample completed the six-month assessment | Self-report and selection bias | Yes |
9 | Pintaudi, B. et al | 2015 | Italy | Cross-sectional | 2,374 adults with T2DM from the benchmarking network for clinical and humanistic outcomes in diabetes (BENCH-D) study | Questionnaires: The SF12, the WHO-5, Diabetes Empowerment Scale-Short Form (DES-SF), Patient Assessment of Chronic Illness Care-Short Form (PACIC-SF), Health Care Climate-Short Form (HCC-SF), Global Satisfaction with Diabetes Treatment (GSDT), Summary of Diabetes Self-Care Activities measure (SDSCA-6), Barriers to Medications (BM) and Perceived Social Support (PSS) Main objectives: To evaluate correlates of diabetes related distress in the context of the large sample of people with T2DM participating in the BENCH-D study | Self-administered | Yes | Yes | Not mentioned | Self-report bias | Yes all the instruments, with the only exceptions of the WHO-5 and SF- 12, already available in Italian language |
10 | Löndahl, M. et al | 2011 | Sweden | Randomized clinical trial | 75 adults with T2DM | Questionnaires: The SF-36 Main objectives: To evaluate whether hyperbaric oxygen therapy improves QoL in these patients or not | Self-administered | Yes | Yes | 98% the article mentioned that there was only two patients did not fill out the SF-36 at 12 month follow-up due to their deteriorated medical condition | Self-report bias | Yes |
11 | Adriaanse, M.C. et al | 2016 | Netherlands | Cross-sectional | 1,676 with T2DM adult patients, aged between 31 and 96 years old | Questionnaires: The SF-12 Main objectives: To study the prevalence, impact and the dose–response relationship of comorbid chronic conditions on QoL in T2DM patients | Self-administered | Yes | Yes | 44% from the original data derived from two data sources | Self-report bias | Yes |
12 | Myers, V.H. et al | 2013 | United States | Randomized clinical trial | 212 sedentary adults with T2DM aged between 30 and 75 years old | Questionnaires: The SF-36 Main objectives: To compare the effects of aerobic, resistance, or a combination of both on QoL in sedentary individuals with T2DM | Self-administered | Yes | Yes | 70% who met a minimum criteria of attendance to their exercise prescription for at least 6 months and had SF-36 data at baseline and follow-up | Self-report and non-response bias | Yes |
13 | Chew, B.-H. et al | 2015 | Malaysia | Cross-sectional | 752 adults with T2DM above 30 years old | Questionnaires: The World Health Organization Quality of Life-Brief (WHOQOL-BREF), the 17-items Diabetes Distress Scale (DDS-17), and the PHQ-9 Main objectives: To examine the effects of diabetes-related distress on QoL among patients with T2DM who received regular primary medical care in three public health clinics | Self-administered | Yes | Yes | 93.10% | Self-report bias | Yes |
14 | Shi, L. et al | 2014 | United States | Cross-sectional | 3,999 adult patients with T2DM | Questionnaires: The EuroQoL EQ-5D and the SF-12 Main objectives: To test whether fear of hypoglycemia is independently associated with poorer QoL among patients with T2DM or not | Self-administered | Yes | Yes | 20.30% | Self-report and non-response bias | Yes |
15 | Kuznetsov, L. et al | 2014 | United Kingdom | Cross-sectional | 1,876 adults with T2DM aged between 40 and 69 years old | Questionnaires: The SF-36 and the Audit of Diabetes Dependent Quality of Life (ADDQoL19) Main objectives: To examine the association between health status, diabetes-specific QoL and glycemic control among individuals with T2DM | Self-administered | Yes | Yes | 66% of the 2859 patients still alive at 5 years from the ADDITION-Europe trial cohort | Self-report, recall and social desirability bias | Yes |
16 | Bourdel-Marchasson, I. et al | 2013 | France | Cross-sectional | 2,832 patients with T2DM adults (18 years and older) | Questionnaires: The SF-12 Main objectives: To assess QoL in people with T2DM and to estimate the relative contributions of socio-demographic factors, diabetes characteristics, complications and treatment, social support and functional impairment in daily living, in mental and physical components of QoL | Self-administered | Yes | Yes | 59% | Self-report and non-response bias | Yes |
17 | Freemantle, N. et al | 2013 | United Kingdom | Randomized clinical trial | 1,922 adults with T2DM from three randomized clinical trials | Questionnaires: The SF-36 Main objectives: To compare the effect of insulin degludec and insulin glargine on QoL in patients with T2DM starting on basal insulin, in combination with oral antidiabetic drugs | Self-administered | Yes | Yes | Not mentioned | Self-report bias | Yes |
18 | Kempf, K. et al | 2012 | Germany | Cohort | 327 adults with T2DM not older than 75 years old | Questionnaires: The SF-36 and the Center for Epidemiologic Studies Depression Scale questionnaires (CES-D) Main objectives: To evaluate the impact of lifestyle intervention program on glucometabolic and QoL, with weight and HbA1c reduction as main outcome variables | Self-administered | Yes | Yes | 70% from the participants who are completed the study | Self-report and non-response bias | Yes |
19 | Wermeling, P.R. et al | 2012 | Netherlands | Cross-sectional | 2,086 adults with T2DM aged between 40 and 80 years old | Questionnaires: The SF-36 and EuroQoL EQ-5D Main objectives: To assess the association between the number and type of comorbidities and health status in a large sample of well-controlled T2DM in general practice | Self-administered | Yes | Yes | 95% from the invited participants | Self-report and selection bias | Yes |
20 | Reach, G. et al | 2013 | France | Cross-sectional | 1,933 adults above 18 with T2DM | Questionnaires: The SF-12 Main objectives: To evaluate the impact of insulin therapy on mental and physical quality QoL and patient adherence | Self-administered (Internet-based or online) | Yes | Yes | Not mentioned | Self-report bias | Yes |
21 | Donald, M. et al | 2013 | Australia | Cross-sectional | 3,609 patients with T2DM aged between 18 years or older | Questionnaires: The Audit of Diabetes-Dependent Quality of Life (ADDQoL) Main objectives: To assess the diabetes-specific QoL of a large sample of patients with T2DM | Self-administered | Yes | Yes | 27.3% from the invited sample of 14,439 registrants to participate | Self-report and non-response bias | Yes |
22 | Zurita-Cruz, J.N. et al | 2018 | Mexico | Cross-sectional | 1,394 patients over 18 years of age with T2DM | Questionnaires: The SF-36 and the BDI Main objectives: To understand the relationship between glycemic control and patient-centered care to better determine its legitimacy as a means of improving care for patients with T2DM | Self-administered | Yes | Yes | Questionnaires that lacked an answer were returned to the patients to complete them | Self-report bias | Yes |
23 | Williams, J.S. et al | 2016 | United States | Cross-sectional | 615 adults with T2DM above 18 years old | Questionnaires: The SF-12 Main objectives: To evaluate the relationship between patient-centered care, diabetes self-care, glycemic control, and QoL in a sample of adults with T2DM | Self-administered | Yes | Yes | Not mentioned | Self-report bias | Yes |
24 | Al Sayah, F. et al | 2015 | Canada | Controlled clinical trial | 157 adults with T2DM above 18 years old | Questionnaires: The SF-12, the PHQ-9 and the EuroQoL EQ-5D Main objectives: To examine the longitudinal associations of inadequate health literacy with depression related and other health outcomes in patients with T2DM who had recently screened positive for depression in a clinical trial | Self-administered | Yes | Yes | 71% | Self-report and non-response bias | Yes |
25 | Jayasinghe, U.W. et al | 2013 | Australian | Cross-sectional | 2,181 adults with T2DM and/or hypertension/ischemic heart disease patients aged 18 years or more | Questionnaires: The SF-12 and the Chronic Illness Care (PACIC). Main objectives: To investigate the relationship between patient or general practitioners’ characteristics and QoL in a large sample of chronically-ill Australian adults from two states and the Australian Capital Territory | Self-administered | Yes | Yes | 70% | Self-report and non-response bias | Yes |
26 | Hunger, M. et al | 2014 | German | Cohort | 1,046 participants with T2DM aged between 55 and 74 years old | Questionnaires: The SF-12 Main objectives: To examine how changes between NGT, prediabetes and diabetes over a 7-year period are associated with change in QoL | Face-to-face interview at baseline and self-administered at follow-up | Yes | Yes | 67% from the population-based German KORA (Cooperative Health Research in the region of Augsburg) study | Self-report and non-response bias | Yes |
27 | Sayah, F.A. et al | 2016 | Canada | Cohort | 1,948 adults above 18 years old with T2DM | Questionnaires: The SF-12, the EuroQoL EQ-5D, and the PHQ8 Main objectives: To examine the association of health literacy (HL) with changes in QoL among patients with T2DM | Self-administered | Yes | Yes | Not mentioned | Self-report bias | Yes |
28 | Pawaskar, M. et al | 2018 | United States | Cross-sectional | 3,630 participants above 18 years old with T2DM | Questionnaires: The SF-36 Main objectives: To explore the association between hypoglycemia severity and QoL | Self-administered (Internet-based or online) | Yes | Yes | Not mentioned | Self-report bias | Yes |
29 | Wan, E.Y.F. et al | 2016 | Hong Kong | Cross-sectional | 1,826 adults with T2DM above 18 years old | Questionnaires: The SF-12 Main objectives: To identify the predictors for poorer QoL in Chinese patients with T2DM over time and provide a 2-year estimate of preference-based measure for cost-effectiveness analysis of primary care interventions for patients with diabetes | Interviewer-administered (By phone) | Yes | Yes | Between 75.5% and 59.7% | Non-response bias | Yes |
30 | Saffari, M. et al | 2019 | Iran | Cross-sectional | 793 adults 65 years or older with T2DM | Questionnaires: The World health organization quality of life scale brief version (WHOQOL-BREF) and Diabetes-specific quality of life questionnaire module (DMQoL) Main objectives: To investigate how religiosity may affect disease-specific QoL | Self-administered | Yes | Yes | Not mentioned | Self-report bias | Yes |
31 | Alenzi, E.O. et al | 2016 | United States | Cross-sectional | 1,033 adults aged over 21 years or older with DM and depression | Questionnaires: The SF-12 Main objectives: To examine the association between depression treatment and QoL measures of adults with DM and depression, comparing them to those who did not report any depression treatment | Interviewer-administered | Yes | Yes | Not mentioned | Self-report and recall bias | Yes |
32 | Abbatecola, A.M. et al | 2015 | Italy | Cross-sectional | 558 older people with T2DM | Questionnaires: The SF-12 and ADDQoL Main objectives: To investigate the validity and reliability of the ADDQoL in older outpatients with T2DM and to investigate the association between the overall impact of diabetes assessed using the average weighted impact score from the ADDQoL, on improvement in glycemic control over time | Self-administered | Yes | Yes | Not mentioned | Self-report and selection bias | Yes |
33 | Thiel, D.M. et al | 2017 | Canada | Cohort | 1,948 adults above 18 years old with T2DM | Questionnaires: The SF-12 and the EuroQoL EQ-5D Main objectives: To investigate the longitudinal relationship between physical activity and QoL in adults with T2DM | Self-administered | Yes | Yes | Not mentioned | Self-report bias | Yes |
34 | Janssen, L.M.M. et al | 2020 | United States | Cross-sectional | 2,915 individuals aged between 40 and 75 years old with T2DM | Questionnaires: The SF-36 and the EuroQoL EQ-5D Main objectives: To investigate the associations of diabetes related complications and other social determinants with the costs related to T2DM and with the QoL of people with the disease | Self-administered | Yes | Yes | 85% from the first participants in the Maastricht Study | Self-report and recall bias | Yes |
35 | Cai, J. et al | 2018 | United States | Randomized clinical trial | 2,536 adults with T2DM | Questionnaires: The SF-36, the Impact of Weight on Quality of Life-Lite (IWQoLLite) and Current Health Satisfaction Questionnaire (CHES-Q) Main objectives: To evaluate the effect of treatment with canagliflozin, a sodium glucose cotransporter 2 inhibitor, compared with placebo or sitagliptin on QoL outcomes in participants with T2DM from the clinical development program | Self-administered | Yes | Yes | Ranged between 81 and 93% | Self-report bias | Yes |
36 | Zhao, H. et al | 2020 | Canada | Cohort | 969 adults above 18 years old with T2DM | Questionnaires: The SF-12 and the EuroQoL EQ-5D Main objectives: To evaluate the relationship between diabetic foot disease and QoL over a 2-year period | Self-administered | Yes | Yes | 82% | Self-report bias | Yes |
37 | Lloyd, C.E. et al | 2020 | Switzerland | Cohort | 1,616 adults with T2DM aged between 18 and 65 years old | Questionnaires: The PHQ-9, the WHO-5 and the PAID Main objectives: To identify specific risk factors for the onset of diagnosed depression as well as depressive symptoms in this cohort of individuals with T2DM | Self-administered | Yes | Yes | Not mentioned | Self-report bias | Yes |
38 | Sacre, J.W. et al | 2021 | Australia | Cross-sectional | 470 adults with T2DM aged between 18 and 80 years old | Questionnaires: The Generalised Anxiety Disorder (GAD-7), the PHQ-8, the PAID, and the Confidence in Diabetes Self-Care (CIDS) scale and 12-item Diabetes Support Scale (DSS) Main objectives: To investigate worry about COVID-19 and its perceived impact on QoL and healthcare access among adults with T2DM | Self-administered (phone and online) | Yes | Yes | 96% | Self-report and selection bias | Yes |
39 | Selenius, J.S. et al | 2020 | Finland | Cross-sectional | 1,930 adults with T2DM | Questionnaires: The SF-36 and the BDI Main objectives: To investigate whether the association between the different degrees of impairment in glucose regulation and QoL is modified by the severity and type of depressive symptoms | Self-administered | Yes | Yes | Not mentioned | Self-report bias | Yes |
40 | Nicolucci, A. et al | 2021 | Italy | Cross-sectional | 12,028 adults with T2DM | Questionnaires: The SF-36-Item and the Hypoglycemia Fear Survey-II (HFS-II) Main objectives: To investigate factors associated with QoL in patients with T2DM at initiation of second-line glucose-lowering therapy | Self-administered | Yes | Yes | Between 69.1% and 72.6% | Self-report and non-response bias | Yes |