Appendix 1.
Summary of the articles reviewed
| Reference Author, year, city/state, area (North, East, South, West) | Study information Design; setting Recruitment | Participant characteristics (Sample size, study period median/mean age (years±SD) and sex) | Measurement of QoL | Results |
|---|---|---|---|---|
| [57] Laksita J et al., 2020 Mangalore Karnataka South India |
Cross-sectional. Tertiary teaching hospital. T2D patients diagnosed with duration of ≥1 year. |
n=190 Sample size justification: not provided Study period: 4 months mean age: 53.47±13.45 Male: 63.7% |
WHOQOL-BREFa | Mean score not provided. Only individual domain scores available. Factors associated with QoL: Increase in age has impaired QoL score Participants who had regular blood sugar and those who did daily exercise had better QoL. |
| [48] Azharuddin M et al., 2020 New Delhi North India |
Cross-sectional. Tertiary teaching hospital. Confirmed T2D patients as per medical records or having fasting plasma glucose level ≥126 mg/dL. |
n=300 Sample size justification: not provided Study period: 5 months mean age: 55.29±12.45 Male: 50.7% |
Health-related quality of life-EQ-5Db | EQ-5D index 0.79±0.22 EQ-5D VAS scores 77.50±23.42 Poor sleep quality reported among participants Poor sleeping resulted in lower HRQoL. |
| [42] Deswal J et al., 2020 Chandigarh North India |
Cross-sectional. Tertiary teaching hospital. Patients diagnosed with Diabetic Retinopathy (DR) for past 5 years. |
n=250 Sample size justification: not provided Study period-not provided mean age=57.13±9.7 Male- 54.4% |
QOLIDc- modified for DR | Diabetic Retinopathy has a significant effect of the QoL which increases with severity of the disease. Proliferative Diabetic Retinopathy (PDR) patients had poor QoL than non-proliferative diabetic retinopathy (NPDR) patients |
| [39] Kumar N et al., 2020 Sonipat Haryana North India |
Cross-sectional. Tertiary care hospital. 146 children with T1D were screened for study. Children on insulin therapy and ≥6 years of age were included. |
n=46 Sample size justification: not provided Study period-not mentioned mean age of onset of diabetes=9.9 ± (0.4) Male- 52% |
Down Quality of Life for youngd (published by the DAWN youth project) | Mean DAWN QoL score=35 |
| [28] Parashar A et al., 2019 Moradabad Uttar Pradesh North India |
Cross-sectional. Tertiary care hospital. T2D (in-patients and out-patients) |
n=196 Sample size justification: provided. Study period- 6 months (Jan-June, 2019) Mean age of the participants-not provided Male- 46.43% |
QOLID (of 8 domains only 4 were used) | Domain scores not mentioned |
| [16] John R et al., 2019 Pune Maharashtra West India |
Cross-sectional. T2D patients diagnosed for≥6 months. |
n=153 Sample size justification: provided Study period- not provided Mean age of the participants=61.23± (11.41) Male- 57.5% |
QOLID-Marati version (validated) | Mean QoL score- not mentioned. Only domain scores provided. Factors associated with QoL-Participants with positive family history had better QoL. Impaired QoL was observed among participants with higher BMI, Illiterates and primary educated participants, widowed or divorced patients, participants on treatment with insulin alone or in combination with OHA. |
| [44] Vas A et al., 2019 Udupi Karnataka South India |
Cross-sectional. Tertiary teaching hospital. Participants admitted with T2D aged ≥30 years and diagnosed with diabetes for >3 months and HbA1c ≥6%. |
n=180 Sample size justification: not provided Study period- 1 year Mean age of the participants not provided Male-67.2% |
QOLID | Mean QOLID instrument score- 86.83 ± (8.3) |
| [24] Pati S et al., 2020 Bhubaneshwar, Odisha |
Cross-sectional interview survey. 17 primary urban health centers in Bhubaneswar. Patients diagnosed with T2D by a physician for >6 months according to their personal health record. |
n=942 September 2014-February 2015 Sample size justification provided Male=63.1% Mean age of participants=55.3± (10.3) |
SF-12e | Overall Physical Component Summary=32.8±13.7 Overall Mental Component Summary=45.9±9.0 Presence of comorbid conditions associated with lower QoL values Significant reduction in HRQoL with increase in the number of comorbidities. Factors associated with QoL- duration of diabetes, use of insulin, obesity associated with poor QoL. |
| [38] Simon P et al., 2019 Mangalore Karnataka South India |
Cross-sectional. Tertiary care hospital. Patients aged ≥18 years and diagnosed with T1D and T2D. Other inclusion criteria mentioned. |
n=382 Sample size justification: not provided Study period- Jan-December 2012 Mean age of the participants not provided |
QOLID | Diabetic complications are associated with reduced QoL. Patients with diabetic neuropathy and nephropathy were associated with lower QoL in comparison with patients with retinopathy, foot complications and cardiac complications. |
| [27] Dayal D et al., 2019 Chandigarh North India |
Cross-sectional. Tertiary care hospital. Pediatric diabetes clinic. Children 4-15 years of age diagnosed with T1D for ≥6 months |
n=97 Sample size justification provided. Study period-January- December 2012 Mean age of participants=9.6 ± (2.6) Mean age of onset of T1D=7.2± (2.86) |
QOLID (Hindi)- validated | Total QOLID score=84.1 ± (6.8) Factors associated with QoL: Poor glycemic control and increased number of hospitalizations were related to poor QoL |
| [58] Bhattacharjee K et al., 2019 Kolkatta East India |
Cross-sectional. Tertiary care hospital. |
n=not mentioned Sample size justification: not provided Study period- June- October 2018 Mean age of the participants not provided |
WHOQOL-BREF | Physical domain, psychological, emotional, and social domain of QoL was significantly affected in diabetic persons. |
| [32] Goel M et al., 2019 New Delhi North India |
Cross-sectional. Tertiary care center. |
n=100 Convenience sampling technique mentioned. Male=36% Mean age of participants=51.95 ± (11.75) Mean age of participants=51.95 ± (11.75) |
SF-36 v2f (Hindi) | Mean scores not provided The study did not find any significant differences in HRQoL based on age, sex, and other co-existing diseases |
| [46] Parik P et al., 2019 Ahmedabad Gujarat Central India |
Cross-sectional descriptive study. Tertiary care teaching hospital. T2D patients aged ≥18 years attending tertiary care hospital for ≥1 month. |
n=358 Sample size justification: not provided Study period-not provided Male=39.7% Mean age of participants=60.71 ± (11.41) |
EQ 5D 5L (Gujarati) | Mean EQ VAS score=78.83±(15.02) Factors associated with QoL- Increased age, Male gender, uncontrolled disease, and presence of comorbidities decrease QoL score |
| [54] Chaturvedi R et al., 2018 Ahmedabad Gujarat Western India |
Cross-sectional. Tertiary care hospital at Western India. All patients diagnosed with T2D (treatment naïve or otherwise) attending clinic. Each patient evaluated at 3rd and 6th month of enrolment. |
n=200 Sample size justification: not provided Time period not mentioned Mean age of the participants=52.17 ± (8.2) |
QOLID (Gujarati version-validation not mentioned). Questionnaire administered at 0, 3, and 6 months | Better QoL was observed among patients receiving single or two-drug regimen as compared to patients receiving combination regimen of OHAs and insulin. The QoL parameters improved significantly at three and 6 months but was not statistically significant. |
| [41] Sasi Sekhar TVD et al., 2018 Chinoutpalli Krishna dt Andhra Pradesh South India |
Cross-sectional. Tertiary health care center. Pregnant women included by using OGTT (Carpenter and Coustans Criteria). |
n=150 Sample size justification: not provided Study period: June 2016 to May 2017 28 GDM (cases) and 118 GDM negative (controls) Mean age of cases=24.82 ± (3.9) Mean age of controls=23.31 ± (3.9) |
SF-36 V2 | Physical Component Score=42.6 ± (18) cases and 55.2 ± (19.1) (control) Mental Component Score=50 ± (14.7) cases and 62.2 ± (14.9) (control) Factors associated with QoL-Women with higher socioeconomic class had better QoL as compared to lower socioeconomic class. |
| [59] Gosain V et al., 2016 Mandya Karnataka South India |
Cross-sectional. Tertiary care hospital. Patients aged ≥20 years. Diagnosed with hypertension and/or T2D and on treatment for ≥1 year, attending the out-patient department. |
n=52 Sample size justification: not provided Study period-2 months Male=69% Mean duration of diabetes=7.8 |
WHOQOL-BREF | The mean QoL-BREF instrument score=Not mentioned. Factors affect QoL: Elderly people more than 60 years had a good quality of life in comparison to patients of age-group 40-49 yrs. |
| [34] PrasannaKumar HR et al., 2018 Mysore, Karnataka, South India. |
Prospective cross-sectional. Tertiary care multi-specialty hospital. Patients aged ≥18 years. |
n=200 Male=34% Convenience sampling technique mentioned. |
ADDQoLg | The mean QoL score=0.07 Diabetes-dependent QoL = -1.33 (0.58) 38% associated with poor health related QoL Factors associated with QoL Gender, age, domicile, education status, occupation, family structure, duration of T2D, HbA1c, insulin treatment and presence of comorbidities are positively correlated with QoL |
| [53] Radhakrishnan C et al., 2018 Kozhikode Kerala South India |
Prospective, observational study. Tertiary care referral hospital. Patients aged 33-76 years, suffering from T2D either with or without proliferative diabetic retinopathy or diabetic macular edema. |
n=189, Sample size justification: not provided Study period: not mentioned 94 were with Proliferative diabetic retinopathy or diabetic macular edema and remaining 95 were without PDR or DME. |
EQ 5D 5L | Severity of retinopathy significantly reduces health-related QoL. Presence of PDR or DME reduces vision related QoL significantly |
| [56] Rani M et al., 2018 Patiala Punjab North India |
Descriptive, observational study. Tertiary teaching hospital. T2D patients (screened as per American Diabetes Association) ≥ 18 years of age fulfilling NCEP-ATP III criteria (diagnosed with at least 3 components out of 5 components) |
n=100 (without metabolic syndrome) and 100 (with metabolic syndrome) Sample size justification: not provided Study period- October- March, 2017) |
SF-36 v2 | Patients with T2D with metabolic syndrome have overall poor HRQoL as compared with T2D without metabolic syndrome. |
| [26] Bahety P et al., 2017 New Delhi North India. |
Case-control study. Tertiary care hospital. Patients aged 30-80 years diagnosed with T2D for ≥1 year with absence of anxiety/depression before the diagnosis of diabetes based on history or previous records. |
n=100 cases and 100 control Sample size justification provided Male=48% Mean age of participants=56.0 ± (5.69) cases 56.1 ± (7.8) yrs controls |
WHOQOL-BREF | The mean QoL-BREF instrument score=not mentioned for cases and control The mean WHO-QOL for all domains was lower among cases when compared to controls. Depression was common cases as compared to controls. The mean WHO-QOL for all domains was lower among patients with nephropathy. |
| [37] Jain A et al., 2017 Jaipur Rajasthan West India |
Case-control study. Psychiatry department Secondary care referral hospital. Patients aged 18-70 yrs. Healthy controls were enrolled. Diabetes is defined as either requiring oral or injectable antidiabetic medication or having random blood glucose level >200 mg/dL |
n=50 cases and 50 control Sample size justification: not provided Study period not mentioned men=54% Mean age of participants=48.25 ± (19.06) Mean duration of diabetes=5.6 ± (2.3) |
WHO QOL-BREF (Hindi) | The QoL scores of all four domains were significantly lower among diabetic patients as compared to their controls. 62% of the patients with diabetes had insomnia Factors that affected QoL- women, poor glycemic control, insomnia, duration of illness for longer than 1-year and increased BMI had impaired QoL |
| [43] Kokiwar PR et al., 2017 Kokiwar PR et al., 2017 Hyderabad Telengana South India |
Cross-sectional study. Known case of diabetes >25 years of age. |
n=64 Sample size justification: not provided Study period-3 months Demographic details of the participants not available |
4 domains of QOLID questionnaire were used- a. Role limitation due to physical health b. Physical endurance c. General Health d. Symptom barrier |
Role limitation among participants was not much affected. |
| [52] Pereira DM et al., 2017 Mangalore Karnataka South India |
Case-control study. Tertiary teaching hospital. Patients>18 years of age with T1D and T2D. The cases and controls were selected using a fixed criterion. |
n=123 (97 cases with diabetic retinopathy (DR) and 26 control without DR) Sample size justification: not provided Study period- Jan- Dec, 2012 Male=57.1% Mean age of participants=55.09 ± (9.56) (cases) 54.12 ± (13.01) (cases) Mean duration of diabetes=10.98 ± (5.62) (cases) 6.69 ± (2.29) (cases) |
National Eye Institute 25- Item Visual Function Questionnaire (NEI-VFQ-25)h | Composite score (cases)= 73.93±25.55 Composite score (control)= 99.26±1.01 Quality of life was significantly lower in diabetics with DR as compared with those without DR. Maximum effect was seen on general health, general vision, and mental health Factors associated with QoL- Duration of retinopathy and severity of retinopathy decreased QoL |
| [50] Prajapati V et al. Manipal, 2017 Karnataka, South India. |
A prospective descriptive study. Tertiary care hospital. |
n=250 Sample size justification: not provided Study period Male=64% Mean age of participants=60.34 ± (12.04) |
Modified Diabetes Quality of Life (MDQoL)-17i | The average QoL score=65.47±15.07 Patients with complications had a decreased QoL The presence of comorbidity also decreased the QoL Factors associated with QoL-age, duration of diabetes history, HbA1c, number of complications, type of complication |
| [60] Swathi G KP et al., 2017 Warangal, Telangana, South India. |
Descriptive, observational study. Patients diagnosed with T2D and on anti-diabetic therapy for ≥6 months and aged ≥18 years. |
n=300 Sample size justification: not provided. Study period: not provided. Male=37% Mean age of participants=51.1± (9) |
WHOQOL-BREF | The mean QoL-BREF instrument score=not mentioned |
| [51] Mathew G et al., 2016 Thiruvalla Kerala South India |
Cross-sectional. Patients aged 35-65 years outpatient department patients with T2D of duration for more than a year. |
n=60 Sample size justification: not provided Mean age of the participants=54.85 Male=33.3% |
QOLID (Malayalam version) | Mean QOLID instrument score- 63.7 Factors associated with QoL- Increased body weight and females gender had impaired QoL scores |
| [23] Singh RK et al., 2015 Udupi Karnataka South India |
Cross-sectional. Diabetes patients of Udupi Taluk, Karnataka. Ten primary health centers (PHCs) were randomly selected. T2D patients registered in PHCs for treatment were included. |
n=138 Sample size justification provided Study period: not provided Male=46.4% Mean age of participants=57.40± (11.1) Mean duration of diabetes=9.29± (6.3) |
SF-36 v2 (Kannada version) | The total SF-36 score=43.12±(7.0) Factors associated with QoL- Men had better QoL scores than women |
| [31] Vaibhav et al. Jaipur, 2016 North India. |
Cross-sectional. Tertiary care center. T2D patients >25 years and on treatment for diabetes for <1 year attending the diabetic clinic were included. |
n=140 Sample size justification provided Study period: not provided Male=50% Mean age of participants=56.0 ± (11.6) Mean duration of diabetes=10.9± (8.3) |
SF-36 v2 | The total SF-36 score=38.40 ± (9.5) Factors associated with QoL- Men had better QoL as compared to women |
| [45] Santosh Kumar A et al., 2016 Shimoga, Karnataka, South India. |
Cross-sectional. Tertiary teaching hospital. Diabetes patients aged >20 years and on treatment for <6 months. |
n=100 Sample size justification: not provided. Study period: June- July, 2013 Male=55% Mean age of participants=54.45 ± (9.7) Mean duration of diabetes=5.78 ± (4.9) |
SF-36 v2 | Total score=57.15 ± (18.33) Factors associated with QoL- treatment for diabetes (patients who took only OHA), compliance to treatment (regular medications), physical activity, follow-up with doctor were significantly associated. |
| [49] Kumar P et al. Shivamogga, 2015 Karnataka, South India |
Cross-sectional. T2D patients at tertiary medical. Study participants >30 years of age. |
n=200 Sample size justification: not provided. Study period-December, 2014 (1 month) Male=52.5% Mean age of the participants: not provided |
QOLID | Mean QOLID instrument score for Male=108 Mean QOLID instrument score for Females=105 Factors affect QoL- Increase in age, years of diabetes, and lower-income class decreased the QoL |
| [36] Kumar P et al. Patna, 2015 Bihar, North India. |
Case-control. Diabetic camps conducted by tertiary teaching hospitals. |
n=85 (diabetes) and 85 (nondiabetes) age and sex matched. Sample size justification: not provided. Study period- March- April, 2013 Male=83.5% Mean age of the participants=49.5 |
WHOQOL-BREF (Hindi) | The mean QoL-BREF instrument score=57.80. |
| [47] Sindhu L et al., 2015 Thiruvananthapuram Kerala South India |
Cross-sectional study. Tertiary teaching hospital. T2D patients >25 years and on treatment for diabetes for <1 year attending the diabetic clinic. |
n=140 Sample size justification: not provided. Study period: not provided. Male=50% Mean age of the participants=56+11.6 |
SF-36 V2 | The mean QoL score=38.40+9.55. Factors identified with QoL -Males had higher QoL scores as compared to females. |
| [33] Mathew A et al. Mangalore, 2014 Karnataka South India |
Cross-sectional. Tertiary teaching hospital. T2D patients. |
n=100 Non-probability purposive sampling technique used. Time period not mentioned Mean age of the participants- not provided. Male- 53% |
QOLID | Mean QoL score=54.8 |
| [35] Jain V Wardha, 2014 Maharastra, Central India. |
Case-control. Rural medical college. Cases- T2D patients with diabetes. Controls- hospitals and community. |
n=70 cases 70 control Sample size justification- not provided. Study Period-not provided. Mean age of the participants=48.63± (10.6)-cases 49.21± (10.4)-control |
WHOQOL-BREF (Marati) | Mean score not provided. Only domain scores are given separately The overall QoL was poor among the study population. Factors associated with QoL- increased age, females, complications negatively affected QoL scores. |
| [25] Manjunath K et al. Vellore, 2014 Tamil Nadu, South India. |
Cross-sectional. Secondary care facility of rural tertiary medical college. Known T2D patients aged >30 and <60 years |
n=100 Convenience sampling justification was provided. Study period- June- September 2008 Male=36% Mean age of the participants=56 |
WHOQOL-BREF (Tamil) | The mean QoL-BREF instrument score=58.03±18.29 Factors associated with better QoL- married men and those with BMI more than 25. |
| [29] Patel B et al., Ahmedabad, Gujarat, 2014 Western India. |
Cross-sectional. Tertiary medical care center. T2D patients attending medicine clinics. |
n=140 Sample size justification provided. Study period: not mentioned. Male=42.1% Mean age of the participants=56.8± (10.5) Mean duration of diabetes=8.3± (9.4) |
1. WHOQOL-BREF 2. Appraisal of Diabetes Scale (ADS)j (Gujarati) |
1. Mean WHO BREF score=76.65± (8.29) 2. Mean ADS score=19.9± (3.4) Factors associated with QoL Age, duration of diabetes, number of symptoms, number of comorbidities, blood glucose level, and number of nonpharmacological measures were |
| [30] Somappa HK et al. Kolar, 2014 Karnataka, South India. |
Cross-sectional. T2D patients at rural tertiary care center. |
n=180 Sample size justification provided Study period-2 months Male=50% Mean age of the participants=59.56± (9.64) (male) 60.9± (7.51) (female) |
WHOQOL-BREF | Mean WHO BREF score=not mentioned. Females had higher mean scores of physical, psychological, social, and environmental domains of QoL compared to males. Quality of life decreased with an increase in age and irregular control of glucose (HbA1c). |
| [40] Puri K et al., 2013 New Delhi North Delhi |
Cross-sectional. Tertiary teaching hospital. T1D children/adolescents aged 6-18 yrs. |
n=49 Sample size justification- not provided. Study Period-not provided. Male=55% Mean age of the participants=11.7±3.1 |
DAWN Youth QoL questionnaire | DAWN QoL Score=29.3±15.8 |
| [55] Das R et al., 2013 Kolkata West Bengal Eastern India |
Cross-sectional. Tertiary teaching hospital. T2D patients. |
n=195 Sample size justification- not provided. Study Period-January 2011 to January 2012 Male=41.5% Mean age of the participants=44.21±6.39 (depressed) 45.68±6.2 (non-depressed) |
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES)k SF-to evaluate the impact of depression on QoL | Depression has a negative impact on the QoL of the patient. Factors associated with QoL- Patients with poor blood control levels (HbA1c%) have worse QoL |
| [15] Gautam Y et al., 2009 New Delhi, North India. |
Cross-sectional. Tertiary teaching hospital. T1D and T2D patients included. |
n=260 Convenience sampling justification was provided. Study period- January- December 2006 Male=35% Mean age of the participants=49.7 Mean duration of diabetes=6.96± (6.08) |
MOS SF-36 v2 (Hindi version) | Total SF36 score=59.47±(18.70) Factors associated with QoL Females had lower QoL scores as compared with men. Patients with complications reported lower QoL scores as compared with patients without any complications. |
| [14] RT Varghese et al., 2007 Trivandrum, South India. |
Cross-sectional. Tertiary teaching hospital. T1D patients. |
n=200 Sample size justification: not provided Study period-February to March 2006. Male-72.5% Mean age of the participants- not mentioned. |
Diabetes Control and Complications Trial (DCCT)l questionnaire-questions deleted to fit Indian context and pertaining to T1D. | Total score not mentioned 62% of respondents were found to have a good quality of life. Factors associated with better QoL- Male gender, mixed diet, occupation with moderate physical activity, better education, family history of diabetes, having diabetic friends, better sex life, and absence of urinary incontinence. |