Public Sector

The study was conducted in Mysore city of Mysore district during March 2014 to August 2014. The district is located in the southern part of Karnataka state, South India with a population of nearly four million. The health care services in the district are delivered by private and public sector.

The local community of approximately 200 000 people is of low socio-economic status, live in informal housing or crowded conditions and have high levels of unemployment. Infectious diseases including pneumonia, HIV (antenatal prevalence approximately 30%) and tuberculosis (annual reported incidence 293/100 000) are common. There is a high prevalence of tobacco smoke exposure, alcohol misuse, malnutrition and other poverty-related exposures. Pneumonia is the predominant cause of childhood hospitalisation and death, with the estimated incidence similar to the reported LMIC incidence of 0.22 per child-year in early life.2 (link) The population is stable, with little immigration or emigration. More than 90% of the population access healthcare in the public sector including antenatal and child health services. The public health system comprises 23 primary health clinics and one hospital, Paarl Hospital, where all births and hospital care occur. The well-established, free primary healthcare system provides childhood immunisations including 13-valent pneumococcal and H influenzae b vaccines as part of the national immunisation schedule.
Consenting pregnant women are enrolled from two primary health clinics serving different populations—TC Newman (serving a mixed race population) and Mbekweni (serving a black African population). Pregnant women who are not enrolled are included in a control cohort; these mother–infant pairs are followed annually to compare outcomes with the active cohort.

The study protocol and informed consent documents were reviewed by the local ethics committees of the University of KwaZulu-Natal, the University of Cape Town, the University of the Witwatersrand in Johannesburg, and by the Prevention Sciences Review Committee (PSRC) of the Division of AIDS (DAIDS, National Institutes of Health, U.S.A.). The consent forms were translated into isiZulu and written informed consent is obtained at each stage of the study (screening, enrolment into HIV-negative cohort, enrolment into acute infection phase, and for sample storage). All women screened for participation, whether ultimately enrolled into the study cohort or not, receive HIV pre- and post-test counselling, risk reduction counselling, male and female condoms, access to clinical care, and treatment for sexually transmitted infections (STIs). HIV/STI risk reduction counselling, condom provision, and prevention education supplies are administered at each subsequent study visit. One-on-one counselling was provided by a non-governmental organization which offered the same service in the public sector in the region, to be consistent with the services in the region. Overcoming one of the key challenges to doing HIV-related work in this context [11] (link), participants who were HIV infected during the study were referred to the CAPRISA Antiretroviral Treatment (CAT) programme where they were offered ongoing care, and treatment for HIV when clinically eligible.

A convenience sample of 500 employees was recruited online through posts on various professional (e.g., LinkedIn) and non-professional (e.g., Facebook) social media platforms. The study was carried out following the American Psychological Association (2017) ethical principles guidelines. Before being asked to fill our survey, participants were made aware of the two retained inclusion criteria: (1) being an office employee (i.e., administrative work, desk-job) and (2) having been working in the same organization for at least 1 year. If so, participants were then informed about the aims of the study–that is, to study the relationship between workplace bullying and work engagement. They were all asked to confirm their informed consent to participate and reminded that they could abandon the survey at any time. The survey was completely anonymous and involved no monetary compensation.
After eliminating 28 participants, as they did not fully respond to the survey, our sample was comprised of 472 office workers, 31.1% men and 68.9% women, aged between 20 and 65 (M = 41.05, SD = 11.94) and with a length of service between 1 and 42 years (M = 16.02, SD = 11.39). Of these, 89.4% reported working in the public sector. We conducted an a posteriori power analysis to test the power our sample via G*Power 3.1 software (Faul et al., 2007 (link)). Assuming conservative criteria of an average effect size (f² = 0.15) and an acceptable probability of error (α = 0.05), we obtained a β of 0.95.

This prospective observational study was carried out in the Department of Pharmacology in a tertiary care institute over a period of one year after approval from the Institutional Ethics Committee (All India Institute of Medical Sciences (AIIMS), Rishikesh) (approval number AIIMS/IEC/18/160). Our study followed the principles of the Declaration of Helsinki. Subjects were recruited from patients presenting to the Rheumatology Outpatient Department (OPD) with a primary diagnosis of RA after obtaining written informed consent. Inclusion criteria were all new and previously diagnosed patients with rheumatoid arthritis based on the American College of Rheumatology (ACR) 2010 diagnostic criteria of either sex. Patients excluded from this study included those affected with arthritis due to reasons other than RA, such as vasculitis, polymyalgia rheumatica, spondyloarthropathies (reactive arthritis, ankylosing spondylitis, and psoriatic arthritis), bacterial arthritis, and fibromyalgia.
On the basis of DMARD therapy being received by the patients, they were divided into different groups: Regimen 1, monotherapy with one DMARD (methotrexate (MTX)); Regimen 2, double DMARD therapy or two DMARD therapy (methotrexate + hydroxychloroquine (MTX + HCQ)); Regimen 3, triple DMARD therapy or three DMARD therapy (methotrexate + hydroxychloroquine + leflunomide (MTX + HCQ + Lef)); and Regimen 4, >3 DMARD therapy (MTX + HCQ + Lef + bDMARD adalimumab). Patients were assessed at baseline and after the follow-up visit as per the clinician’s discretion (varying from 7 to 12 weeks). Treatment response was recorded at the baseline and follow-up visit based on the Disease Activity Score (DAS28) criteria, which comprises a number of tender joints, swollen joints, erythrocyte sedimentation rate (ESR), and “patient global health” score [10 (link)].
The medication cost of DMARD therapy was analyzed by calculating the cost of therapy per month for each patient by taking the prices from the Bureau of Pharma Public Sector Undertakings of India (BPPI), Department of Pharmaceuticals, Government of India, for all the DMARDs, except the biological drug for which the price from Cadila Healthcare Ltd. (Zydus Cadila, Ahmedabad, India) was taken. Cost-effectiveness was calculated by dividing the cost of therapy by the change in DAS in a month. Adherence was assessed using the Morisky-Green-Levine Scale (MGLS) [11 (link)]. Patients were interviewed and asked to answer four questions listed in the questionnaire on their second visit. High adherence was denoted by a score of 0, medium adherence was denoted by a score of 1 or 2, and low adherence was denoted by a score of 3 or 4. The p value was taken to be 0.05. For the cost-effective analysis, the mean was applied to the DAS28 values and the cost of treatment. Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) software (IBM SPSS Statistics, Armonk, NY, USA).