The willingness of women to participate in a long-term trial of hormone replacement therapy: A qualitative study using focus groups

Abstract

The actual proportion of eligible people who participate in clinical trials is low. Consequently, a qualitative study of the willingness of women who are postmenopausal to participate in a long-term randomized control trial of hormone replacement therapy (HRT) designed to investigate the prevention of degenerative diseases was conducted. Focus group methodology was employed to explore the personal and social aspects of decision making about trial participation. Participants were randomly selected from the patient age-sex registers of four University of Adelaide general practices. Twenty-one women participated in four focus groups. The reasons for and against trial participation were examined using qualitative content analysis; (n 5 18) women were unwilling to participate in the trial. The lack of perceived individual bene t, minimal altruism, the risk of breast cancer and side effects, not wanting to take unnecessary medication, a ten-year commitment, and negative experiences of HRT use, were the main reasons given for not entering the trial. Of the few women (n 5 3) who clearly would enter the trial, free prescriptions and a positive history of using HRT were the main reasons for participation. The perceived disadvantages of clinical trials of HRT deter women from participating in a long-term clinical trial of HRT. An investment in education and information to eligible participants about both the risks and potential bene ts of HRT may improve trial recruitment.

Duty, desire or indifference? A qualitative study of patient decisions about recruitment to an epilepsy treatment trial

“…In the study by Searight & Miller [14], patients often emphasised taking part in clinical trials as performing a valuable service to the community of sufferers to which they belonged. However, studies exploring motivations for taking part in medical research, including trials, have found that patients are also driven by reasons of self-interest, seeing it as a means of ensuring treatment by a specialist or securing the best available therapies and medical care [6-13,15,16,26]. Schutta and Burnett [18] note that in their investigation, patients expressed surprise that people would participate in clinical trials for altruistic reasons.…”

“…Potential barriers to participation in clinical trials have been identified as: unwillingness to accept the possibility of clinical uncertainty and equipoise [4,20,25]; unwillingness to accept the idea of treatment allocation at random [4-6,17,19,23], the possibility of being randomised to placebo rather than active treatment [13,21,23] and holding clear preferences for a particular method of management [26]; worry about receiving 'experimental' treatments [6] or being used as 'guinea pigs' [8,24]; reluctance to change treatment [7]; the belief that trial participants might be denied access to new treatments or that the trial did not offer the best available treatment [21,23] and the view that any benefits of taking part would not outweigh the risks [15,21,24,26]. Distrust of the medical profession and lack of knowledge of what is required of trial participants have also been highlighted as potential barriers [22]; as has inconvenience and discomfort [2,12] and fear of side-effects [7,26].…”

Cancer-related psychosocial research: what are the perspectives of cancer care centre users on participation?

“…The questions focused on four main areas: [1] practical barriers to participation, [2] types of research design, [3] motivation to join research, and [4] the conduct of recruitment and research at the centre. The interviews were fully transcribed and independently read several times by researchers.…”

“…The study aimed to explore the perspectives of users of a cancer care centre in Edinburgh, Scotland, on research participation in relation to four questions [1]. What practical barriers, if any, are there to participation?…”

“…Recruitment of participants who have been diagnosed with cancer and their caregivers present particular ethical considerations because of serious illness. The identification, recruitment and retention of participants are difficult in general [1] and may be a major hurdle for vulnerable populations such as seriously ill patients and their caregivers [2][3][4][5][6]. Examining the recruitment process in greater detail is crucial in establishing scientific research and generalisability [7] and important in qualitative research because of meeting international and local ethical standards and to inform research design.…”