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Women's reasons for participation in a clinical trial for menstrual pain: a qualitative study.

ABSTRACT: OBJECTIVES:The aim of the study was to explore women's motivations for participating in a clinical trial and to evaluate how financial compensation impacts women's explanations for participation. DESIGN, SETTING AND PARTICIPANTS:Semistructured interviews were conducted face to face or by telephone with 25 of 220 women who participated in a pragmatic randomised trial for app-administered self-care acupressure for dysmenorrhoea (AKUD). Of these 25 women, 10 had entered AKUD knowing they would receive a financial compensation of €30. A purposive sampling strategy was used. RESULTS:Women had a long history of seeking help and were unsatisfied with the options available, namely painkillers and oral contraceptives. While interviewees were open to painkillers, they were uneasy about taking them on a monthly basis. The AKUD trial offered the possibility to find an alternative solution. A second reason for participation was the desire to add a new treatment to routine medical care, for which the interviewees considered randomised trials a prerequisite. The financial incentive was a subsidiary motivation in the interviewees' narratives. CONCLUSIONS:Our results contribute to the ongoing discussion of the impact of financial compensation on research participants' assessment of risk. The interviewed women considered all research participants able to make their own choices regarding trial participation, even in the face of financial compensation or payment of study participants. Furthermore, the importance of clinical trials providing new treatments that could change medical practice might be an overlooked reason for trial participation and could be used in future recruitment strategies.

SUBMITTER: Blodt S

PROVIDER: S-EPMC5168611 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Women's reasons for participation in a clinical trial for menstrual pain: a qualitative study.

Blödt Susanne S Witt Claudia M CM Holmberg Christine C

BMJ open 20161213 12

<h4>Objectives</h4>The aim of the study was to explore women's motivations for participating in a clinical trial and to evaluate how financial compensation impacts women's explanations for participation.<h4>Design, setting and participants</h4>Semistructured interviews were conducted face to face or by telephone with 25 of 220 women who participated in a pragmatic randomised trial for app-administered self-care acupressure for dysmenorrhoea (AKUD). Of these 25 women, 10 had entered AKUD knowing ...[more]

PMID: 27965251

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Project description:To explore reasons for non-participation in a primary care-based physical activity trial and understand how these may contribute to recruitment of non-representative research samples. We also aimed to elicit non-participants' own recommendations for enhancing trial uptake in primary care.Semistructured telephone interviews with non-participants to a randomised controlled trial of a very brief intervention for promoting physical activity conducted in primary care (the Very Brief Interventions trial), with thematic analysis of interview transcripts.5 general practice (GP) surgeries in the East of England, UK.Interviews were completed with 10 female and 6 male non-participants of white ethnicity and aged between 40 and 71 years. 13 of the 16 interviewees were either active or moderately active according to the GP Physical Activity Questionnaire (GPPAQ).Interviewees discussed a range of reasons for non-participation. These included beliefs surrounding the personal relevance of the trial based on preconceptions of intervention content. Many interviewees considered themselves either sufficiently active or too functionally limited to increase activity levels further, so rendering participation pointless in their view. Other identified barriers included a lack of free time, for trial participation and for increasing physical activity, and dissatisfaction with appointment scheduling systems in place at GP surgeries. Interviewees questioned the appropriateness of primary care as a context for delivering interventions to promote physical activity. In general, interviewees were positively disposed towards the idea of trial participation, especially if personal benefits are made salient, but suggested that interventions could be delivered in a different setting such as the internet.To increase participation in physical activity promotion trials conducted in primary care, the content of invitation materials and procedures for contacting potential participants require reconsideration. Specific recommendations include streamlining intervention materials and enhancing their relevance to the health concerns of invitees.ISRCTN72691150; Pre-results.

Project description:BackgroundDepression, the world's leading cause of disability, disproportionately affects women. Women in India, one of the most gender unequal countries worldwide, face systemic gender disadvantage that significantly increases the risk of common mental disorders. This study's objective was to examine the factors influencing women's participation in psychosocial support groups, within an approach where community members work together to collectively strengthen their community's mental health.MethodsThis community-based qualitative study was conducted from May to July 2016, across three peri-urban sites in Dehradun district, Uttarakhand, Northern India. Set within an NGO-run mental health project, data were collected through focus group discussions with individuals involved in psychosocial support groups including women with psychosocial disabilities as well as caregivers (N = 10, representing 59 women), and key informant interviews (N = 8) with community members and mental health professionals. Data were analyzed using a thematic analysis approach.ResultsThe principal barrier to participating in psychosocial support groups was restrictions on women's freedom of movement. Women in the community are not normally permitted to leave home, unless going to market or work, making it difficult for women to leave their home to participate in the groups. The restrictions emanated from the overall community's attitude toward gender relations, the women's own internalized gender expectations, and most significantly, the decision-making power of husbands and mothers-in-law. Other factors including employment and education shaped women's ability to participate in psychosocial support groups; however, the role of these additional factors must be understood in connection to a gender order limiting women's freedom of movement.ConclusionsMental health access and gender inequality are inseparable in the context of Northern India, and women's mental health cannot be addressed without first addressing underlying gender relations. Community-based mental health programs are an effective tool and can be used to strengthen communities collectively; however, attention towards the gender constraints that restrict women's freedom of movement and their ability to access care is required. To our knowledge, this is the first study to clearly document and analyze the connection between access to community mental health services in South Asia and women's freedom of movement.

Project description:BackgroundPoor participant recruitment is the most frequent reason for premature discontinuation of randomized clinical trials (RCTs), particularly if they are investigator-initiated. The aims of this qualitative study were to investigate (1) the views of clinical trial stakeholders from three different countries regarding reasons for recruitment failure in RCTs and (2) how these compare and contrast with the causes identified in a previous systematic review of RCT publications.MethodsFrom August 2015 to November 2016, we conducted 49 semi-structured interviews with a purposive sample of clinical trial stakeholders. This included investigators based in Germany (n = 9), Switzerland (n = 6) and Canada (n = 1) with personal experience of a discontinued RCT and 33 other stakeholders (e.g., representatives of ethics committees, clinical trial units, pharmaceutical industry) in Switzerland. Individual semi-structured qualitative interviews were conducted and analyzed using thematic analysis.ResultsInterviewees identified a total of 29 different reasons for recruitment failure. Overoptimistic recruitment estimates, too narrow eligibility criteria, lack of engagement of recruiters/trial team, lack of competence/training/experience of recruiters, insufficient initial funding, and high burden for trial participants were mentioned most frequently. The interview findings largely confirm the previous systematic review on published reasons for recruitment failure. However, eight new reasons for recruitment failure were identified in the interviews, which led to the checklist of reasons for recruitment failure being revised and a new category describing research environment-related factors being added.ConclusionsThis study highlights the diversity of often interlinked reasons for recruitment failure in RCTs. Integrating the findings of this interview study with a previous systematic review of RCT publications led to a comprehensive, structured checklist of empirically-informed reasons for recruitment failure. The checklist may be useful to guide further research on interventions to improve participant recruitment in RCTs and helpful for trial investigators, research ethics committees, and funding agencies when assessing trial feasibility with respect to recruitment.

Project description:BACKGROUND:People with chronic pain use a range of healthcare services, but they also report a high degree of dissatisfaction with treatments. One reason for dissatisfaction might be participants' expectations towards treatments. The aim of this study was to explore expectations of people with chronic pain towards participation in easily accessible pain management interventions delivered in public primary care. METHODS:A qualitative study using semi-structured individual face-to-face interviews with 21 informants. The informants were recruited among participants enrolled in a randomised controlled trial on the effect of an easily accessible self-management course for people with chronic pain. The data were analysed thematically using Systematic Text Condensation. RESULTS:Having experienced pain for a long time, there was no specific expectation of a cure or a significant alleviation of the pain. The informants' expectations mainly concerned a hope that participation could lead to a better everyday life. The informants said that hope was important as it motivated them to keep going and continue self-care activities. The hope acted as a driving force towards trying new interventions and maintaining motivation to do activities they experienced as beneficial. Both concrete aspects of the current intervention and an understanding of what interventions in general could offer contributed to the informants hope. The expectations centred about the interventions being something new, as they had not previously tried this service, an opportunity to gain and reinforce skills, to help them continue to grow as a person, to meet others in similar situations, and to access professional support in an easy manner. Participating in interventions provided by healthcare services was seen by some as an act of self-care, where they did something active to manage their health. CONCLUSIONS:Expectations towards the interventions were related to a hope for participation leading to a better everyday life. The role of hope for peoples' motivation to self-care implies that service providers should be aware of and help to maintain hope for a better everyday life. The importance of social support as part of self-care should be acknowledged when developing interventions targeting chronic pain. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02531282 . Registered on August 21 2015.

Project description:IntroductionAs Zika virus infection during pregnancy can cause a range of congenital anomalies, pregnant women may be a target population for vaccination in future outbreaks. Their inclusion in vaccine trials is critical to ensure safe and effective vaccines in pregnancy. Though many vaccine candidates are in development, pregnant women's willingness to participate in Zika virus vaccine research is unknown. This study aims to describe pregnant women's attitudes toward Zika virus vaccine research participation, as well as perceived barriers to and facilitators of enrollment.MethodsPregnant and recently postpartum women (n = 128) attending prenatal care at Massachusetts General Hospital completed surveys querying their willingness to participate in four hypothetical Zika virus vaccine trials and their motivations for participation. Demographics, information on prior Zika virus exposure, and vaccine acceptance were collected.ResultsMost women (77%) accepted participation in at least one hypothetical Zika virus vaccine trial, and women were significantly more likely to accept prospective enrollment in an inactivated vaccine trial compared to a live-attenuated vaccine trial (p-value <0.0001) or a nucleic acid-based vaccine trial (p-value <0.0444). Important motivators for participation included evidence from research with pregnant and non-pregnant people, a desire to protect the baby from Zika, perceptions of vaccine safety, and provider recommendation.ConclusionsA majority of women in this cohort were willing to participate in a Zika virus vaccine trial while pregnant, however, differences in acceptance exist between vaccine platforms. The high value placed on evidence by participants highlights the importance of gathering and communicating pregnancy-specific data to potential research participants and their providers. Women's motivations for accepting research participation during pregnancy are important to inform the Zika virus vaccine research agenda, candidate prioritization, and trial design.

Project description:This study sought to assess perceptions towards and reasons for participation in research bronchoscopy studies in a high TB burden urban setting. Additionally, the study aimed to identify areas of pre- and post-procedural concern among healthy adults approached to participate in research bronchoscopy. A cross sectional qualitative study was undertaken at the Uganda-Case Western Reserve University Collaboration Tuberculosis Research Project Clinic at Mulago National Referral Hospital in Kampala, Uganda. In-depth interviews were conducted with participants at their pre-bronchoscopy visit (n = 17) and after they had undergone bronchoscopy (n = 23) to examine their perceptions and experiences with the procedure. Following consent, all interviews were audio recorded and later transcribed and typed in MS WORD. Local language interviews were translated into English by the social science interviewers. Qualitative analysis was performed manually following an inductive and emergent approach typical in thematic analysis. This study was approved by the Makerere University School of Social Sciences Research Ethics Committee (MAKSS REC 09.18.220) and registered with the Uganda National Council for Science and Technology (UNCST SS4785). Overall willingness to participate in bronchoscopy was high as many participants viewed the study as primarily a means of getting free health checks and determining their health status. Notably, despite extensive face to face counseling for this study coupled with the fact that our participants had been involved in prior research at the site, therapeutic misconception still played a pivotal role in willingness to participate in research bronchoscopy. Therapeutic misconception has important ethical and research implications in clinical research, which requires strategies to tackle it, even among a pool of potential participants who are knowledgeable about a disease or clinical care procedures. Continuous awareness and knowledge building about the difference between being a trial participant and therapeutic misconception must become a mainstay in trials to improve the process of informed consent for future research bronchoscopy studies.

Project description:BackgroundBack pain is an increasingly prevalent health concern amongst Australian women for which a wide range of treatment options are available, offered by biomedical, allied health and complementary and alternative medicine (CAM) providers. Although there is an emerging literature on patterns of provider utilisation, less is known about the reasons why women with back pain select their chosen practitioner. In this paper we explore the influences on back pain sufferers' decision-making about treatment seeking with practitioners for their most recent episode of back pain.MethodsDrawing on 50 semi-structured interviews with women aged 60-65 years from the Australian Longitudinal Study on Women's Health (ALSWH) who have chronic back pain, we focus on the factors which influence their choice of practitioner. Analysis followed a framework approach to qualitative content analysis, augmented by NVivo 9 qualitative data analysis software. Key themes were identified and tested for rigour through inter-rater reliability and constant comparison.ResultsThe women identified four predominant influences on their choice of practitioner for back pain: familiarity with treatment or experiences with individual practitioners; recommendations from social networks; geographical proximity of practitioners; and, qualifications and credentials of practitioners. The therapeutic approach or evidence-base of the practices being utilised was not reported by the women as central to their back pain treatment decision making.ConclusionsChoice of practitioner appears to be unrelated to the therapeutic approaches, treatment practices or the scientific basis of therapeutic practices. Moreover, anecdotal lay reports of effectiveness and the 'treatment experience' may be more influential than formal qualifications in guiding women's choice of practitioner for their back pain. Further work is needed on the interpersonal, collective and subjective underpinnings of practitioner choice, particularly over time, in order to better understand why women utilise certain practitioners for back pain.

Dataset Information

Women's reasons for participation in a clinical trial for menstrual pain: a qualitative study.

Publications

Women's reasons for participation in a clinical trial for menstrual pain: a qualitative study.

Similar Datasets

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