A Qualitative Investigation of Provers' Experiences of Participation in Homeopathic Pathogenetic Trials.

BACKGROUND: Information on homeopathic medicines is derived from "provings" or homeopathic pathogenetic trials (HPTs), in which people (often homeopaths and homeopathy students) are invited to take an unnamed and often untested highly diluted and serially succussed substance, and record in detail their experiences and perceived effects. HPTs are assumed to have an "excellent safety record", but there has been no academic research to date into provers' experiences of participating in an HPT. AIMS: This qualitative study aimed to explore the lived experience of participation in an HPT. It is hoped that the results from this study will inform the future conduct of HPTs. METHODS: Semi-structured interviews were conducted in person, by phone or via Skype, according to the interviewees' preferences. Thematic analysis was used for the generation of themes. RESULTS: Eight former provers were interviewed from across the European Union (EU) and Australia. Of these, seven were practicing homeopaths and one was not a practitioner. Overarching themes were identified as: (1) the ethical conduct of HPTs, and (2) the impact of participation in HPTs. CONCLUSION: Former provers who participated in this study reported enthusiasm for, and trust in, the proving process. However, some also reported adverse events, which varied in intensity and duration. The process of gaining fully informed consent for participation in an HPT is complex and there were examples of both failure and inadequacy in terms of informed consent and support mechanisms. RECOMMENDATIONS: The researchers recommend that HPTs are subject to ethical approval processes and that consent is fully informed and ongoing. It is also recommended that appropriate and robust support mechanisms be developed.

The Herts and Minds study: feasibility of a randomised controlled trial of Mentalization-Based Treatment versus usual care to support the wellbeing of children in foster care.

BACKGROUND: There is a lack of well-designed randomized controlled trials (RCTs) to investigate the efficacy of psychological therapies for children in foster care with emotional and behavioural difficulties. Mentalization-based therapy (MBT) focuses on supporting the carer-child relationship by promoting reflective capacity. This study examined the feasibility and acceptability of an RCT of MBT, delivered in a family-format, for children who are in foster care in the UK. METHOD: Herts and Minds was a phase II, blinded feasibility RCT with follow-up of at 12 and 24 weeks post-randomisation. Participants were children (age 5-16) in foster care referred to a targeted mental health service, who had some level of difficulty as identified by the Strengths and Difficulties Questionnaire (SDQ). Aims were to assess: the feasibility of recruitment processes and study uptake; capacity to train mental health practitioners to deliver MBT to an acceptable level of treatment integrity; establish acceptability and credibility of MBT as an intervention for children in foster care; establish feasibility and acceptability to participants of conducting an RCT; and estimate the likely treatment efficacy effect size. Participants were randomly allocated to either MBT (n = 15) or Usual Clinical Care (UCC) (n = 21) individually or in sibling groups. A range of qualitative and quantitative data was gathered to assess feasibility. RESULTS: Feasibility was established with regard to: capacity to recruit participants to a study; capacity to train mental health practitioners to deliver MBT to an acceptable level of treatment integrity; acceptability and credibility of MBT; and feasibility and acceptability to participants of conducting an RCT. A number of issues made it difficult to estimate a likely treatment efficacy effect size. CONCLUSION: With modifications, it is feasible to run an RCT of MBT for children in foster care. Both the therapy and research design were acceptable to participants, but modifications may be needed regarding both the timing of assessments and the identification of appropriate primary outcome measures. Given the lack of evidenced based therapies for this population, such a trial would be a significant contribution to the field. Findings may be useful for other groups planning clinical trials of psychological therapies for children in foster care. TRIAL REGISTRATION: ISRCTN 90349442 . The trial was retrospectively registered on 6 May 2016.

Moving to Another World: Understanding the Impact of Clinical Trial Closure on Research Participants Living With HIV in Uganda.

Despite an increasing need for clinical trials involving people living with HIV (PLWH), little is known about how PLWH experience trial closure, particularly in low-income countries, where the majority of trials take place. We sought to explore the impact of trial closure on PLWH in Uganda. This was an interpretive, grounded theory study using in-depth interviews, conducted between October 2014 and August 2015. Adult participants (N = 23) from 3 trials were included. The findings indicated that trial closure was represented as "moving to another world" and was an emotional transition, linked to a loss of quality care in the research environment, the need to find alternative health facilities, fear of experiencing unwanted side effects, a desire to receive trial feedback, and difficulties linking to posttrial care. We concluded that PLWH leaving trials in a resource-limited setting required holistic care to facilitate their transition back to "usual care."

Who Enrolls in a Quit Smoking Program with Yoga Therapy?

OBJECTIVES: Yoga may improve stress, affect, and weight control, all of which are commonly cited barriers to quitting smoking. However, the importance of these concerns may vary by sex, race, ethnicity, and age. We examined smoking-relevant characteristics of individuals enrolling in an 8-week randomized controlled trial testing yoga as a complementary treatment to standard smoking cessation. METHODS: Of 958 callers, 227 were eligible and enrolled. RESULTS: The sample was 55% female, 86% non-Hispanic white, with a mean age of 46 years (SD = 12). Males smoked more cigarettes/ day than females and had lower motivation to quit smoking. Females were more likely to smoke for weight control, social and mood-related reasons, and had higher expectations for the efficacy of yoga. Age was negatively associated with the presence of other smokers in the household, and smoking in response to negative moods, and was positively associated with smoking rate, and confidence in quitting. CONCLUSIONS: This study demonstrated that both males and females were interested in a program offering yoga as a complementary therapy for smoking cessation. However, there were both sex and age-related differences with respect to smoking-related variables that may suggest a need to adapt the intervention for sub-populations.

Exploring Willingness to Participate in Clinical Trials by Ethnicity.

African-Americans and Hispanic-Americans are disproportionately affected by cancer, yet underrepresented in cancer clinical trials. Because of this, it is important to understand how attitudes and beliefs about clinical trials vary by ethnicity. A national, random sample of 860 adults was given an online survey about attitudes toward clinical trials. We examined willingness to participate in clinical trials, attitudes toward clinical trials, trust in doctors, attitudes toward alternative and complementary medicine, and preferred information channels. Results indicate that African-American and Hispanic-American participants have more negative attitudes about clinical trials, more distrust toward doctors, more interest in complementary and alternative medicine, and less willingness to participate in clinical trials than white/non-Hispanics, although specific factors affecting willingness to participate vary. The channels people turn to for information on clinical trials also varied by ethnicity. These results help explain the ethnic disparities in cancer clinical trial enrollment by highlighting some potential underlying causes and drawing attention to areas of importance to these groups.

How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction).

BACKGROUND: Randomised controlled trials (RCTs) often fail to recruit sufficient participants, despite altruism being cited as their motivation. Previous investigations of factors influencing participation decisions have been methodologically limited. This study evaluated how women weigh up different motivations after initially expressing altruism, and explored their understanding of a trial and its alternatives. The trial was the 'Quality of Life after Mastectomy and Breast Reconstruction' (QUEST) trial. METHODS: Thirty-nine women participated in qualitative interviews 1 month post-surgery. Twenty-seven women (10 trial decliners and 17 acceptors) who spontaneously mentioned 'altruism' were selected for thematic analysis. Verbatim transcripts were coded independently by two researchers. Participants' motivations to accept or decline randomisation were cross-referenced with their understanding of the QUEST trials and the process of randomisation. RESULTS: The seven emerging themes were: (1) altruism expressed by acceptors and decliners; (2) overriding personal needs in decliners; (3) pure altruism in acceptors; (4) 'hypothetical altruism' amongst acceptors; (5) weak altruism amongst acceptors; (6) conditional altruism amongst acceptors; and (7) sense of duty to participate. Poor understanding of the trial rationale and its implications was also evident. CONCLUSIONS: Altruism was a motivating factor for participation in the QUEST randomised controlled trials where the main outcomes comprised quality of life and allocated treatments comprised established surgical procedures. Women's decisions were influenced by their understanding of the trial. Both acceptors and decliners of the trial expressed 'altruism', but most acceptors lacked an obvious treatment preference, hoped for personal benefits regarding a treatment allocation, or did not articulate complete understanding of the trial. TRIAL REGISTRATION: QUEST A, ISRCTN38846532 ; Date assigned 6 January 2010. QUEST B, ISRCTN92581226 ; Date assigned 6 January 2010.

Reconstructing communities in cluster trials?

BACKGROUND: There is growing interest in the ethics of cluster trials, but no literature on the uncertainties in defining communities in relation to the scientific notion of the cluster in collaborative biomedical research. METHODS: The views of participants in a community-based cluster randomised trial (CRT) in Mumbai, India, were solicited regarding their understanding and views on community. We conducted two focus group discussions with local residents and 20 semi-structured interviews with different respondent groups. On average, ten participants took part in each focus group, most of them women aged 18-55. We conducted semi-structured interviews with ten residents (nine women and one man) lasting approximately an hour each and seven individuals (five men and two women) identified by residents as local leaders or decision-makers. In addition, we interviewed two Municipal Corporators (locally elected government officials involved in urban planning and development) and one representative of a political party located in a slum community. RESULTS: Residents' sense of community largely matched the scientific notion of the cluster, defined by the investigators as a geographic area, but their perceived needs were not entirely met by the trial. CONCLUSION: We examined whether the possibility of a conceptual mismatch between 'clusters' and 'communities' is likely to have methodological implications for a study or to lead to potential social disharmony because of the research interventions, arguing that it is important to take social factors into account as well as statistical efficiency when choosing the size and type of clusters and designing a trial. One method of informing such a design would be to use existing forums for community engagement to explore individuals' primary sense of community or social group and, where possible, to fit clusters around them. TRIAL REGISTRATION: ISRCTN Register: ISRCTN56183183 Clinical Trials Registry of India: CTRI/2012/09/003004 .

African-American and Hispanic perceptions of HIV vaccine clinical research: a qualitative study.

PURPOSE: To examine perceptions of phase-I human immunodeficiency virus (HIV) vaccine trial participation among African-Americans and Hispanics in San Francisco, California. DESIGN: Qualitative, semistructured interviews. SETTING: San Francisco Department of Health. PARTICIPANTS: Thirty-six African-American and Hispanic men and women, 18 to 50 years of age, residing in the San Francisco Bay Area. METHOD: Purposive sampling using advertisements, community-based organization rosters, and snowball referrals. Thematic analysis of transcripts identified salient themes and patterns. RESULTS: Participants viewed participation in HIV research as important; however, they held that HIV was not a health priority given limited awareness about HIV research or beliefs that only infected or high-risk persons were eligible for participation. Altruism and personal gain, trustworthy trial staff, convenient schedules and facilities, and involvement of trusted community groups in recruitment were perceived to motivate participants. Concerns about the social consequences of participating in HIV research and product-related side effects were seen as discouraging participation. Limitations include the possibility that participants in interview research have more favorable views of biomedical research than those who refuse to participate. CONCLUSION: Historically, African-Americans and Hispanics in the United States have had limited participation in HIV trials. Understanding their perceptions of HIV biomedical research, identifying facilitators and barriers to participation, addressing misinformation about HIV, distorted risk perceptions, HIV stigma, and providing accessible opportunities to participate are imperative to ensure health equity and generalizability of findings.

Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto.

OBJECTIVES: This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM). DESIGN: Participants randomized to receive saw palmetto were instructed to take one 320 mg gelcap daily for the first 24 weeks, two 320 mg gelcaps daily for the second 24 weeks, and three 320 mg gelcaps daily for the third 24 weeks. Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period. At 24, 48, and 72 weeks postrandomization, the American Urological Association Symptom Index (AUA-SI) was administered and participants were asked to guess their treatment assignment. SETTINGS: The study was conducted at 11 clinical centers in North America. PARTICIPANTS: Study participants were men, 45 years and older, with moderate to low severe BPH symptoms, randomized to saw palmetto (N=151) or placebo (N=155). OUTCOME MEASURES: Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment. RESULTS: For participants assigned to saw palmetto, 22.5%, 24.7%, and 29.8% correctly thought they were taking saw palmetto, and 37.3%, 40.0%, and 44.4% incorrectly thought they were on placebo at 24, 48, and 72 weeks, respectively. For placebo participants, 21.8%, 27.4%, and 25.2% incorrectly thought they were on saw palmetto, and 41.6%, 39.9%, and 42.6% correctly thought they were on placebo at 24, 48, and 72 weeks, respectively. The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto (p=0.823) or placebo (p=0.893). Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto. CONCLUSIONS: Blinding of treatment assignment was successful in this study. Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto.

[Use of standardized patients in the psycho-social subjects of medical studies--applicability of standardized patients in postgraduate psychotherapy training curricula?]. / Einsatz von Schauspielpatienten in den "Psych-"Fächern des Medizinstudiums--Verwendungsmöglichkeiten in der Psychotherapieausbildung?

Due to the successful use of standardized patients (SPs) in medical studies, possible fields of application for SPs in postgraduate psychotherapy training were examined on the basis of a systematic literature research (ranging from 1982 to 2011) on the use of SPs in the fields of psychotherapy, medical psychology, psychosomatic medicine, and psychiatry. The results show that SPs are used predominantly for teaching communication and counseling techniques, history taking, and assessment of psychopathology and are commonly used to portray patients with affective disorders, neurotic, stress and somatoform disorders and schizophrenia, as well as schizotypal and delusional disorders. The use of SPs is generally rated positively with regard to subjective learning effects, satisfaction, and authenticity. Hence, the results suggest that postgraduate psychotherapy training curricula might benefit from the implementation of SPs.

Feasibility trial of a Spanish-language multimedia educational intervention.

BACKGROUND: Hispanic cancer patients are underrepresented in clinical trials; research suggests lack of knowledge and language barriers contribute to low accrual. Multimedia materials offer advantages to Hispanic populations because they have high acceptability, are easy to disseminate, and can be viewed with family. PURPOSE: Hispanic cancer patients and caregivers participated in focus groups to aid in developing a Spanish-language multimedia intervention to educate Hispanic cancer patients about clinical trials. We explored the feasibility of delivering the intervention in medical oncology clinics. METHODS: A total of 35 patients were randomized to either the multimedia intervention group (n = 18) or a control group (n = 17) who were asked to read the National Cancer Institute's Spanish-language clinical trials brochure. Self-reported data on knowledge about and attitudes toward clinical trials, self-efficacy for participating in a clinical trial, intention to participate in a clinical trial if asked, and receptivity to information about a clinical trial were collected at baseline and 10 days later. RESULTS: Delivery of the multimedia presentation in oncology clinics was feasible. The intervention group had more knowledge about clinical trials at follow-up than the control group; scores for intention to participate in a clinical trial by participants in the intervention group increased from 3.8 to 4.0 of a possible 5, but declined in the control group from 4.5 to 4.1. No statistically significant difference was detected between groups in scores for attitudes or self-efficacy for making a decision to participate in a clinical trial. LIMITATIONS: Our sample size was inadequate to identify differences between the informational methods. Although all patients were asked about their willingness to participate in a clinical trial, this decision was hypothetical. In addition, the study was conducted with a sample of Spanish-speaking Hispanic cancer patients at a comprehensive cancer center in Florida. Thus, the results may not generalize to other Hispanic populations. CONCLUSION: In the pilot project, we demonstrated the feasibility of delivering multimedia information to patients in medical oncology clinics. Because delivery in a clinical setting was found to be feasible, a larger study should be conducted to evaluate the efficacy of the multimedia intervention with respect to promoting accrual of Hispanic patients to clinical trials.

Scientific tools, fake treatments, or triggers for psychological healing: how clinical trial participants conceptualise placebos.

Placebos are an essential tool in randomised clinical trials, where they are used to control for bias and contextual healing effects. Placebos and their effects are also studied from multiple diverse perspectives, but the perspectives of placebo recipients are seldom considered. Research shows that people form cognitive and affective representations of active treatments such as medicines, and that they use these representations to guide their behaviour; it seems reasonable to suggest that people might also think about and develop representations of placebos. We adopted a qualitative approach to examine in detail how participants in one RCT, conducted in the USA, conceptualised placebos. 12 people were interviewed 3 times each, at the start, middle, and end of a trial of placebo effects and acupuncture for Irritable Bowel Syndrome (IBS). The interview data were analysed inductively and we identified four ways in which the participants conceptualised placebos: placebos are necessary for research; placebo effects are fake; placebo acupuncture is not real acupuncture; placebos have real effects mediated by psychological mechanisms. Participants' conceptualisations of placebos were dynamic and situated in a broader psychological and socio-cultural context. Seeing placebo effects as legitimate seemed to be facilitated by having more holistic models of healing, viewing IBS as psychological, and seeing treatment as multifactorial. However, some participants maintained a negative view of placebo effects (e.g. as illusions) that was apparently inconsistent with their other beliefs (e.g. in mind-body healing mechanisms). This may indicate a dominance of negative discourses around placebos at a socio-cultural level. Negative views of placebos are inconsistent with evidence that placebo treatments can have positive effects on symptoms. RCT participants should be informed about potential benefits of placebo treatments to avoid misunderstandings and unease. Future work should improve methods of providing participants with full accurate information about placebos and their effects.

Forging convictions: the effects of active participation in a clinical trial.

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.

Electronic reminders did not improve postal questionnaire response rates or response times: a randomized controlled trial.

OBJECTIVE: We aim to evaluate the effectiveness of electronic reminders (ERs) to improve the response rates and time to response of postal questionnaires in a health research setting. STUDY DESIGN AND SETTING: This pragmatic randomized controlled trial (RCT) was nested within a multicenter RCT of yoga for lower back pain. Participants who provided an electronic mail address and/or mobile phone number were randomized to receive an ER or no reminder (controls) on the day they were due to receive a follow-up questionnaire. RESULTS: One hundred twenty-five participants (32 males and 93 females) mean age 46 (standard deviation: 11, range: 20-65) were randomized to ER (n=62) or controls (n=63). Overall 85.6% of participants returned postal questionnaires (87.1% ER group and 84.1% from controls). No significant differences were found between the two groups for response rate (difference between groups=3.0%, 95% confidence interval [CI]=-10, 16; P=0.64) or time to response after adjusting for age, gender, and treatment allocation (χ(2) ([3df])=7.10; P=0.07). CONCLUSION: In the present RCT, we found little evidence for the effectiveness of ERs to increase response rates or time to respond for the return of questionnaires in this study population group.

Conceptual, holistic, and pragmatic considerations for interviewing research participants.

Interviews are commonly used as data collection method in many types of studies. Interviewers and researchers may be challenged to take a holistic view of the interviewing process and to acknowledge participants' perspectives and experiences, understand the implications of dialogue between interviewers and participants, guide data collection to address research questions and aims of a study, and ensure that high-quality data is collected for analysis. This article addresses the need to integrate a holistic perspective into data collection and reviews general and specific interviewing considerations, including assessment and conceptualization of potential research vulnerability of participants, factors that may influence the quality of data collected through interviews, interviewing strategies, interview facilitation, and specific strategies to acknowledge a specialized population in terms of vulnerability, dialogue, power, and study rigor. Data and exemplars from a grounded theory study of mothers of medically fragile infants are used to illustrate some of the challenges inherent in the use of interviews for data collection.

Enrolling older adults with cognitive impairment in research: lessons from a study of Tai Chi for osteoarthritis knee pain.

Exercise is an adjunct intervention for treating osteoarthritis (OA) knee pain, but many older adults, especially those with cognitive impairment, refuse to participate because of their frailty. Tai chi is a gentle alternative to Western-style aerobic exercise. In this article, we report recruitment experiences based on older adults' comments and on staff's observations and reports in a pilot randomized controlled trial (RCT) using tai chi as an intervention to reduce OA knee pain in a population of older adults with cognitive impairment. Recruitment challenges included issues with retirement apartment site staff, the older adults, study criteria or study design, and insufficient research staff. Strategies included networking and staying connected with site staff, using various recruiting approaches, providing incentives/motivation, and using informal leaders or residents as a way to recruit participants. Finally, modifying strict study criteria, securing staff for recruiting, and considering alternative designs to the classical RCT can also help overcome recruitment challenges.