A mixed methods case study investigating how randomised controlled trials (RCTs) are reported, understood and interpreted in practice.

BACKGROUND: While randomised controlled trials (RCTs) provide high-quality evidence to guide practice, much routine care is not based upon available RCTs. This disconnect between evidence and practice is not sufficiently well understood. This case study explores this relationship using a novel approach. Better understanding may improve trial design, conduct, reporting and implementation, helping patients benefit from the best available evidence. METHODS: We employed a case-study approach, comprising mixed methods to examine the case of interest: the primary outcome paper of a surgical RCT (the TIME trial). Letters and editorials citing the TIME trial's primary report underwent qualitative thematic analysis, and the RCT was critically appraised using validated tools. These analyses were compared to provide insight into how the TIME trial findings were interpreted and appraised by the clinical community. RESULTS: 23 letters and editorials were studied. Most authorship included at least one academic (20/23) and one surgeon (21/23). Authors identified wide-ranging issues including confounding variables or outcome selection. Clear descriptions of bias or generalisability were lacking. Structured appraisal identified risks of bias. Non-RCT evidence was less critically appraised. Authors reached varying conclusions about the trial without consistent justification. Authors discussed aspects of internal and external validity covered by appraisal tools but did not use these methodological terms in their articles. CONCLUSIONS: This novel method for examining interpretation of an RCT in the clinical community showed that published responses identified limited issues with trial design. Responses did not provide coherent rationales for accepting (or not) trial results. Findings may suggest that authors lacked skills in appraisal of RCT design and conduct. Multiple case studies with cross-case analysis of other trials are needed.

Complex routes into HIV care for migrant workers: a qualitative study from north India.

Migrant workers are designated a bridge population in the spread of HIV and therefore if infected, should be diagnosed and treated early. This study examined pathways to HIV diagnosis and access to care for rural-to-urban circular migrant workers and partners of migrants in northern India, identifying structural, social and individual level factors that shaped their journeys into care. We conducted a qualitative study using in-depth interviews with HIV-positive men (n = 20) and women (n = 13) with a history of circular migration, recruited from an antiretroviral therapy centre in one district of Uttar Pradesh, north India. Migrants and partners of migrants faced a complex series of obstacles to accessing HIV testing and care. Employment insecurity, lack of entitlement to sick pay or subsidised healthcare at destination and the household's economic reliance on their migration-based livelihood led many men to continue working until they became incapacitated by HIV-related morbidity. During periods of deteriorating health they often exhausted their savings on private treatments focused on symptom management, and sought HIV testing and treatment at a public hospital only following a medical or financial emergency. Wives of migrants had generally been diagnosed following their husbands' diagnosis or death, with access to testing and treatment mediated via family members. For some, a delay in disclosure of husband's HIV status led to delays in their own testing. Diagnosing and treating HIV infection early is important in slowing down the spread of the epidemic and targeting those at greatest risk should be a priority. However, despite targeted campaigns, circumstances associated with migration may prevent migrant workers and their partners from accessing testing and treatment until they become sick. The insecurity of migrant work, the dominance of private healthcare and gender differences in health-seeking behaviour delay early diagnosis and treatment initiation.

Circular labor migration and HIV in India: exploring heterogeneity in bridge populations connecting areas of high and low HIV infection prevalence.

BACKGROUND: The emerging human immunodeficiency virus (HIV) epidemics in rural areas of India are hypothesized to be linked to circular migrants who are introducing HIV from destination areas were the prevalence of HIV infection is higher. We explore the heterogeneity in potential roles of circular migrants in driving an HIV epidemic in a rural area in north India and examine the characteristics of the "sustaining bridge population", which comprises individuals at risk of HIV acquisition at destination and of HIV transmission into networks at origin capable of sustaining an epidemic. METHODS: Results of a behavioral survey of 639 male migrants from Azamgarh district, India, were analyzed using χ(2) tests and logistic regression. RESULTS: We estimated the size of various subgroups defined by specific sexual behaviors across different locations and over time. Only 20% fit our definition of a sustaining bridge population, with the majority making no apparent contribution to geographical connectedness between high- and low-prevalence areas. However, we found evidence of sexual contacts at origin that could potentially sustain an epidemic once HIV is introduced. Variables associated with sustaining bridge population membership were self-perceived HIV risk, current migrant status, and age. CONCLUSIONS: Circular migrants represent a heterogeneous population in terms of their role as a bridge group. Self-perception of heightened risk could be exploited in designing prevention programs.

Migration as a risk and a livelihood strategy: HIV across the life course of migrant families in India.

Migrant workers are understood to be vulnerable to HIV. However, little is known about the experience of migration-based households following HIV infection. This qualitative study examined the migration-HIV relationship beyond the point of infection, looking at how it affects livelihood choices, household relationships and the economic viability of migrant families. We conducted semi-structured interviews with 33 HIV-positive migrant men and women recruited from an anti-retroviral therapy (ART) centre in north India. Following infection among the migrant men, contact with free, public-sector HIV services was often made late, after the development of debilitating symptoms, abandonment of migrant work and return to native villages. After enrolment at the ART centre participants' health eventually stabilised but they now faced serious economic debt, an inflexible treatment regimen and reduced physical strength. Insecure migrant job markets, monthly drug collection and discriminatory employment policies impeded future migration plans. HIV-positive wives of migrants occupied an insecure position in the rural marital household that depended on their husbands' health and presence of children. The migration-HIV relationship continued to shape the life course of migrant families beyond the point of infection, often exposing them again to the economic insecurity that migration had helped to overcome, threatening their long-term survival.