1) estimate the prevalence of physical health conditions and health risk behaviours, 2) assess access to physical healthcare and health-risk modification advice, and 3) compare findings with those of the general population. for people with SMI in Bangladesh, and Pakistan.
Design and settings
We conducted a cross-sectional survey of patients with a clinical diagnosis of SMI recruited at two national specialist mental health institutions in South Asia, the National Institute of Mental Health (NIMH) in Dhaka, Bangladesh; and Institute of Psychiatry (IOP) Rawalpindi, Pakistan. We originally planned to include a third site- the National Institute of Mental Health and Neurosciences, Bangalore, India, However, due to a delay in obtaining all requisite approvals, data collection could not be initiated before COVID-19 pandemic. Further details of the methods are reported in the published protocol, and summarised below.
We aimed to build as large a sample as possible within the resources available over the study period, with an initial target of 1,500 participants at each site. As an indicative example of precision to address some of the key research questions, we used the example of diabetes. For investigating the prevalence of type-2 diabetes, assuming a prevalence estimate of 10%, 857 participants per country would provide a precision of ± 2% (95% confidence interval).
Consenting adults (18 years and over) with a clinical diagnosis of SMI defined by the International Classification of Disease 10th revision (ICD-10) as schizophrenia, schizotypal and delusional disorders (F20-F29); bipolar affective disorder (F30, F31); and severe depression with psychotic symptoms (F32.3, F33.3), and able to provide informed consent, as assessed by the treating clinician, were eligible.
Confirmation of SMI diagnosis
To increase standardisation across sites and alignment with other studies, each SMI diagnosis was confirmed by trained researchers using the Mini-international neuropsychiatric interview (MINI) version 6.0. The MINI is a short diagnostic structured interview for mental disorders, designed to allow administration by non-specialists.
Recruitment of participants
We used stratified random sampling to recruit a sample comprising 80% outpatients and 20% inpatients, reflecting the service case mix.
Patient and public involvement
A community panel comprising patients, caregivers and advocacy group members ensured community, patient, and public involvement. The panel reviewed and piloted the planned survey questionnaire and advised on its feasibility.
We conducted a face-to-face survey using tablets (Qualtrics, Provo, UT) to collect information about physical disorders, mental health, health risk behaviours, health-related quality of life, health-risk behaviour advice and healthcare utilisation using, wherever available, validated instruments as described below. The survey was translated into Urdu and Bangla. Interviewers (including males and females to accommodate participant preference) used regional dialects where required, consistent with usual clinical practice in these settings. Data were collected between July 2019 and March 2020, when recruitment was halted due to the COVID-19 outbreak.
STEPwise approach to surveillance (STEPS)
We used the WHO STEPwise approach to Surveillance of NCDs (STEPS) instrument Version 3.2 to collect information about NCDs, associated risk factors and behaviours, access to physical healthcare and health-risk modification advice. STEPS is an international standardised tool that has already been translated, used and validated in the general population in Bangladesh and Pakistan, and therefore allows comparisons with the general population within and between countries.[14, 15] The STEPS survey includes the use of show-cards with culturally relevant examples used to aid respondents in classifying health-risk behaviours. Categorisation of health conditions and risk behaviours followed the WHO guidelines.
The STEPS module for NCDs was used to ask participants about medically-diagnosed type-2 diabetes, raised blood pressure, heart disease, and hypercholesterolemia, and treatments advised by a health worker for these conditions (such as medication and dietary, weight management, smoking cessation, or physical activity advice). Questions about lung disease, hepatitis B, C, syphilis, tuberculosis (TB) and human immunodeficiency virus (HIV) (which are not part of the STEPS survey) were asked in the same format as for the other chronic physical conditions.
Current or past use of smoked or smokeless tobacco was recorded. The alcohol module was used to categorise participants into lifetime abstainers, abstainers in the past 12 months and current users of alcohol; and the diet module was used to record the number of days that respondents consumed fruit and vegetables in a typical week, the number of servings consumed on average per day, and adherence to the WHO recommendations of at least 5 fruits and vegetables per day. The physical activity module was used to record activity for transport purposes (e.g. walking, cycling), vigorous and moderate activity at work, and vigorous, moderate activity in leisure time, time spent sitting and adherence to the WHO recommendations of < 600 metabolic equivalents minutes/week. In addition, risk behaviours related to sexually transmitted diseases, including multiple sexual partners, unprotected sexual contact, and use of injectable drugs, were assessed using three questions adapted from the 10-item HIV risk Screening Instrument.[19, 20]
Blood pressure (BP) was taken using an automated blood pressure measuring instrument (OMRON®) following instructions in the WHO STEPs surveillance manual); the average of the second and third readings was used for analysis. High blood pressure was defined as a measurement of >140/90 mmHg.
Height, weight, and waist circumference were measured for all participants except pregnant women. All measurements were taken in duplicate and the average of the two values was calculated, following the protocols set out in the WHO STEPS surveillance manual. We calculated the Body Mass Index (BMI) and classified participants using the WHO classification, namely underweight (BMI<18.49), normal weight (BMI= 18.5-24.9), overweight (BMI= 25-29.9), obesity (BMI≥30). Abdominal obesity was defined as a waist circumference of (≥ 94 cm) for males and (≥ 80 cm) for females.
In addition to administering the MINI, we collected information relevant to the SMI diagnosis, including duration of illness and type and duration of treatments. The Patient Health Questionnaire (PHQ-9) was used to measure the severity of depressive symptoms, and the Generalized Anxiety Disorder-7 (GAD-7) for severity of anxiety symptoms.
Health-Related Quality of life
The EQ-5D-5L was used to measure health-related quality of life. We used the Urdu and Bangla validated versions, provided by EuroQol.
A blood sample was taken from consenting participants for: haemoglobin, glycated haemoglobin (HbA1c), lipid profile, thyroid function tests, liver function tests and creatinine. The cut off for high HbA1c was according to the WHO definition ≥6.5%. The prevalence of high total triglycerides was defined as ≥ 180 mg/dl, high serum cholesterol was defined as LDL≥100 mg/dl. Anaemia was defined according as haemoglobin ≤13 g/dl for males and ≤12 g/dl for females.
Quantitative data were summarised using descriptive statistics with means, standard deviation and 95% confidence interval for continuous data and counts, percentages and 95% confidence interval for categorical data. Overall, and by site we described the:
1) prevalence of chronic physical conditions.
2) prevalence of risk factors (obesity, hypertension, hypercholesterolemia) and risk behaviours (poor diet, physical inactivity, tobacco and alcohol use).
3) severity of common mental disorder symptoms (anxiety, depression) and health-related quality of life.
4) access to treatment for physical conditions and health risk modification advice
To compare our findings with those in the latest STEPS reports from Bangladesh and Pakistan, we calculated weights by comparing the sex and age distribution reported in these STEPS surveys with the distribution in our data. Weights were applied using the complex sample module in SPSS 26.0 and we calculated the odds of people with SMI of having a NCD, related risk factors, engaging in health risk behaviours and being screened, treated and receiving risk modification advice compared with the STEPS survey participants in Bangladesh and Pakistan.[14, 15] Results were presented as odds ratios from cross-tabulations of STEPS and weighted survey data. Significance levels were adjusted via Bonferroni correction for multiple hypothesis testing (adjusted level p < 0.006).