Forging Convictions: The Effects of Active Participation in a Clinical Trial

Pain Service, Imperial College Healthcare NHS Trust, St Mary's Hospital, Salton House, South Wharf Road, London W2 1NY, UK.
Social Science [?] Medicine (Impact Factor: 2.89). 06/2011; 72(12):2041-8. DOI: 10.1016/j.socscimed.2011.04.021
Source: PubMed


This qualitative study explored non-specific influences on participation in, and outcomes of, a randomised controlled trial. It was nested within a single-blind clinical trial of western acupuncture which compared real acupuncture with two types of placebo control administered to National Health Service (NHS) patients awaiting hip and knee replacement surgery in England. Data collection (2004-2008) was based on narrative-style interviews and participant observation. The results indicate that trial recruitment and retention depend on a set of convictions forged largely as a result of contextual factors peripheral to the intervention, including the friendliness and helpfulness of research centre staff and status of the administering practitioner. These convictions also influence the reporting of the study outcomes, particularly if participants experience uncertainties when choosing an appropriate response. The findings suggest that participants in clinical trials are actively involved in shaping the research process, rather than passive recipients of treatment. Thus the outcomes of trials, notably those involving contact interventions, should be regarded not as matters of fact, but as products of complex environmental, social, interpretive and biological processes. In this paper, we develop and present a 'theory of active research participation' which offers a framework for understanding the impact of non-specific processes in clinical trials.

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Available from: Jan Walker, May 13, 2014
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    • "This may also foster the creation of a new identity of being a study participant. Moreover, capitalizing on the gratitude expressed by participants for the provision of quality health services, and creating a culture of ‘active participation’ and engagement may increase participants’ sense of being valued and their commitment to the trial [21]. "
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    ABSTRACT: Background Although significant progress has been made in clinical trials of women-controlled methods of HIV prevention such as microbicides and Pre-exposure Prophylaxis (PrEP), low adherence to experimental study products remains a major obstacle to being able to establish their efficacy in preventing HIV infection. One factor that influences adherence is the ability of trial participants to attend regular clinic visits at which trial products are dispensed, adherence counseling is administered, and participant safety is monitored. We conducted a qualitative study of the social contextual factors that influenced adherence in the VOICE (MTN-003) trial in Johannesburg, South Africa, focusing on study participation in general, and study visits in particular. Methods The research used qualitative methodologies, including in-depth interviews (IDI), serial ethnographic interviews (EI), and focus group discussions (FGD) among a random sub-sample of 102 female trial participants, 18 to 40 years of age. A socio-ecological framework that explored those factors that shaped trial participation and adherence to study products, guided the analysis. Key codes were developed to standardize subsequent coding and a node search was used to identify texts relating to obstacles to visit adherence. Our analysis includes coded transcripts from seven FGD (N = 40), 41 IDI, and 64 serial EI (N = 21 women). Results Women’s kinship, social, and economic roles shaped their ability to participate in the clinical trial. Although participants expressed strong commitments to attend study visits, clinic visit schedules and lengthy waiting times interfered with their multiple obligations as care givers, wage earners, housekeepers, and students. Conclusions The research findings highlight the importance of the social context in shaping participation in HIV prevention trials, beyond focusing solely on individual characteristics. This points to the need to focus interventions to improve visit attendance by promoting a culture of active and engaged participation.
    BMC Women's Health 07/2014; 14(1):88. DOI:10.1186/1472-6874-14-88 · 1.50 Impact Factor
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    • "Perceptions about relevance to report and fears of reporting appeared most likely to be influenced by differences between the trial sites. Others have explored how trial participants understand their identity, as being somewhere on a continuum from patient to active volunteer, and how this may shape outcomes [31-33]. This study describes how the South African participants appeared to take on a form of “trial citizenship”. "
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    ABSTRACT: Accurately characterizing a drug's safety profile is essential. Trial harm and tolerability assessments rely, in part, on participants' reports of medical histories, adverse events (AEs), and concomitant medications. Optimal methods for questioning participants are unclear, but different methods giving different results can undermine meta-analyses. This study compared methods for eliciting such data and explored reasons for dissimilar participant responses. Participants from open-label antimalarial and antiretroviral interaction trials in two distinct sites (South Africa, n = 18 [all HIV positive]; Tanzania, n = 80 [86% HIV positive]) were asked about ill health and treatment use by sequential use of (1) general enquiries without reference to particular conditions, body systems or treatments, (2) checklists of potential health issues and treatments, (3) in-depth interviews. Participants' experiences of illness and treatment and their reporting behaviour were explored qualitatively, as were trial clinicians' experiences with obtaining participant reports. Outcomes were the number and nature of data by questioning method, themes from qualitative analyses and a theoretical interpretation of participants' experiences. There was an overall cumulative increase in the number of reports from general enquiry through checklists to in-depth interview; in South Africa, an additional 12 medical histories, 21 AEs and 27 medications; in Tanzania an additional 260 medical histories, 1 AE and 11 medications. Checklists and interviews facilitated recognition of health issues and treatments, and consideration of what to report. Information was sometimes not reported because participants forgot, it was considered irrelevant or insignificant, or they feared reporting. Some medicine names were not known and answers to questions were considered inferior to blood tests for detecting ill health. South African inpatient volunteers exhibited a "trial citizenship", working to achieve researchers' goals, while Tanzanian outpatients sometimes deferred responsibility for identifying items to report to trial clinicians. Questioning methods and trial contexts influence the detection of adverse events, medical histories and concomitant medications. There should be further methodological work to investigate these influences and find appropriate questioning methods.
    BMC Medical Research Methodology 11/2013; 13(1):140. DOI:10.1186/1471-2288-13-140 · 2.27 Impact Factor
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    • "These studies have been nested within clinical trials of acupuncture for medically unexplained symptoms, osteoarthritis, migraine, irritable bowel syndrome and stress [12-16]. All explored patients’ experiences of receiving treatment within the context of a clinical trial, however two additionally explored patients’ experiences of taking part in the trial itself [14,16]. Paterson et al. conducted a study within a randomised sham controlled trial of traditional Chinese acupuncture for patients with migraine [16]. "
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    ABSTRACT: Nested qualitative studies within clinical trials provide data on patients' experiences of receiving trial interventions and can inform and improve trial designs. The present study explored patients' experiences of participating in a randomised controlled trial of acupressure wristbands for chemotherapy related nausea. A randomised three-group sham-controlled trial was carried out to evaluate the effectiveness of acupressure wristbands in the management of chemotherapy-related nausea. A convenience sample of 26 patients volunteered to participate in a qualitative study to explore their experiences of using acupressure wristbands, and taking part in the clinical trial. Participants were recruited from each of the three UK geographical sites from which the trial was conducted: Manchester, Liverpool and Plymouth. In-depth semi-structured interviews were conducted with the participants in their own homes or other location convenient for participating patients. Interviews were audio-taped, transcribed verbatim and analysed using Framework methodology. The main motivational factors influencing participants to take part in the trial were a desire to 'give something back' and limit their own experience of nausea. Participants were largely satisfied with the organisation and running of the acupressure wristband trial. Many participants experienced positive outcomes as a result of taking part in the trial. Lapses in memory, or poor health as a result of their chemotherapy treatment, led to some participants failing to complete trial paperwork on designated days. Two sham wristband participants reported wearing the bands inappropriately resulting in pressure being applied to the acupoint. Almost all of the participants interviewed had only experienced mild nausea or vomiting during the trial. Participants were pragmatic on the extent to which the wristbands were responsible for this lack of nausea and vomiting during the trial. However, many participants, including some patients receiving sham acupressure, believed the wristbands to have had a positive impact on their nausea and vomiting; there was a perception that the wristbands were, at least in part, responsible for the lack of nausea and vomiting they had experienced. Participants perceive acupressure wristbands as reducing the level of nausea and vomiting experienced during chemotherapy treatment. Reports that some participants wore wristbands inappropriately, and/or delayed completion of trial paperwork could represent confounding variables and have implications for the trial results, and the design of clinical trials within the field of cancer.
    BMC Complementary and Alternative Medicine 10/2013; 13(1):260. DOI:10.1186/1472-6882-13-260 · 2.02 Impact Factor
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