Patient advocacy and patient centredness in participant recruitment to randomized‐controlled trials: implications for informed consent

Context With the routinization of evidence‐based medicine and of the randomized‐controlled trial (RCT), more patients are becoming ‘sites of evidence production’ yet, little is known about how they are recruited as participants; there is some evidence that ‘substantively valid consent’ is difficult to achieve. Objective To explore the views and experiences of nurses recruiting patients to randomized‐controlled trials and to examine the extent to which their recruitment practices were patient‐centred and patient empowering. Design Semi‐structured in‐depth interviews; audio recording of recruitment appointments; thematic interactional analysis (drawing on discourse and conversation analysis). Setting and participants Nurses recruiting patients to five publicly funded RCTs and patients consenting to the recording of their recruitment sessions. Main outcome measures The views of recruiting nurses about their recruitment role; the extent to which nurse–patient interactions were patient‐centred; the nature of the nurses’ interactional strategies and the nature and extent of patient participation in the discussion. Results The nurses had a keen sense of themselves as clinicians and patient advocates and their perceptions of the trial and its interventions were inextricably linked to those of the patients. However, many of their recruitment practices made it difficult for patients to play an active and informed part in the discussion about trial participation, raising questions over the quality of consent decisions. Conclusion Nurses working in patient recruitment to RCTs need to reconcile two different worlds with different demands and ethics. Evidence production, a central task in evidence‐based medicine, poses a challenge to patient‐centred practice and more research and relevant training are needed.     

The relative importance of information items and preferred mode of delivery when disseminating results from trials to participants: A mixed‐methods study

BackgroundParticipants want to receive the results of trials that they have participated in. Dissemination practices are disparate, and there is limited guidance available on what information to provide to participants and how to deliver it.ObjectivesThis study aimed to establish what trial participants believe should be included in a results summary and how this information should be delivered.MethodsA mixed‐methods design was used with focus groups and interviews involving women convenience‐sampled from two host randomized‐controlled trials. Participants ranked information items in order of their importance for inclusion in a trial results summary and potential modes of delivery by preference. All participants provided written informed consent.ResultsSixteen women (mean age [SD] = 71.6 [9.7] years) participated. Participants ranked ‘individual results from the study’ and ‘summary of overall trial results’ as most important. Themes such as reassurance and setting results in context were identified as contributing to participants'' decisions around ranking. ‘A thank you for your contribution to the study’ was ranked the least important. Delivery by post was the preferred mode of receiving results, with receiving a hard copy of results cited as helpful to refer back to.ConclusionOur findings provide insight into what information trial participants deem as important when receiving trial results and how they would like results delivered. Involving patients during development of trial results to be communicated to participants could help to ensure that the right information is delivered in the right way.Patient or Public ContributionPublic partners were involved in focussed aspects of study conduct.     

The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials

ObjectiveThe aim of the study was to investigate how doctors considered and experienced the concept of equipoise while recruiting patients to randomized controlled trials (RCTs).Study Design and SettingIn-depth interviews with 32 doctors in six publicly funded pragmatic RCTs explored their perceptions of equipoise as they undertook RCT recruitment. The RCTs varied in size, duration, type of complex intervention, and clinical specialties. Interview data were analyzed using qualitative content and thematic analytical methods derived from grounded theory and synthesized across six RCTs.ResultsAll six RCTs suffered from poor recruitment. Doctors wanted to gather robust evidence but experienced considerable discomfort and emotion in relation to their clinical instincts and concerns about patient eligibility and safety. Although they relied on a sense of community equipoise to justify participation, most acknowledged having “hunches” about particular treatments and patients, some of which undermined recruitment. Surgeons experienced these issues most intensely. Training and support promoted greater confidence in equipoise and improved engagement and recruitment.ConclusionRecruitment to RCTs is a fragile process and difficult for doctors intellectually and emotionally. Training and support can enable most doctors to become comfortable with key RCT concepts including equipoise, uncertainty, patient eligibility, and randomization, promoting a more resilient recruitment process in partnership with patients.     

Exploring treatment preferences facilitated recruitment to randomized controlled trials

Objective

To explore how patients' treatment preferences were expressed and justified during recruitment to a randomized controlled trial (RCT) and how they influenced participation and treatment decisions.

Study Design and Setting

Qualitative analysis of audio recordings of recruitment appointments with 93 participants aged 51-70 years in a UK multicenter RCT of localized prostate cancer treatments.

Results

Treatment preferences at recruitment were more complex and dynamic than previously assumed. Most participants expressed views about treatments early in appointments, ranging on a continuum from hesitant to well-formed opinions. As recruiters elicited men’s views and provided detailed evidence-based treatment and study information, some opted for their preference, but many became uncertain and open to RCT recruitment, often accepting a different treatment from their original “preference.” Discussion of treatment preferences did not act as the expected barrier to recruitment but actively enabled many to express their concerns and reach an informed decision that often included RCT participation.

Conclusion

Exploring treatment preferences and providing evidence-based information can improve levels of informed decision making and facilitate RCT participation. Treatment preferences should be reconceptualized from a barrier to recruitment to an integral part of the information exchange necessary for informed decision making about treatments and RCT participation.     

Confusions in the equipoise concept and the alternative of fully informed overlapping rational decisions

Despite its several variations, the central position of equipoise is that subjects in clinical experiments should not be randomized to conditions when others believe that better alternatives exist. This position has been challenged over issues of which group in the medical or research community is authorized to make that determination, and it has been argued that informed consent provides sufficient ethical protection for participants independent of equipoise. In this paper I frame ethical participation in clinical research as a two-party decision process involving offering and accepting participation under informed consent. Nine conditions are identified in which it is possible that potential participants and researchers or care professionals can rationally choose divergent actions based on identical understandings of the situation. Under such circumstances, researchers or care professionals cannot ethically substitute their understanding of equipoise in the situation for the patients’ choices, or vice versa.     

Expanding the boundaries of previously obtained informed consent in research: Views from participants in the Personalised Risk-based Mammascreening study

Introduction

Understanding participants' concerns and information needs regarding broadened consent is crucial to ensure transparency and participant autonomy. Our study qualitatively examined these issues in women participating in the Personalized RISk-based MAmmascreening study (PRISMA). The original PRISMA informed consent was project-specific (i.e., breast cancer research), limiting the scope of secondary research. We explored participants' needs for broadened consent to preserve informed decision-making while maximising the potential re-use of data.

Methods

Focus groups (FGs) were performed following a semistructured discussion guide. Two independent researchers analysed the data thematically using an inductive approach.

Findings

Twenty-three asymptomatic women and 13 women diagnosed with breast cancer were randomly divided into six FGs. Four superordinate themes were identified: (1) Normalization, (2) Attitude towards the pharmaceutical industry, (3) Privacy and (4) Knowledge. Our participants viewed data sharing as an important conduit for advancing medical science. Perceived integrity was more often attributed to noncommercial than commercial parties, with a marked mistrust towards the pharmaceutical industry. Most requested information needs related to data protection. Participants' ideal consent process would confer a range of options; for example, they would be able to choose with whom data can be shared, whether data will be de-identified or anonymous, the expiration date of their consent and how, if requested, general and personal study results would be disclosed.

Conclusion

Our participants expressed clear information needs and a strong desire to be actively engaged in future data sharing decisions. Given that many researchers collaborate with commercial parties, building public confidence in these institutions would be beneficial. Illustrative examples addressing privacy concerns and clarifying difficult terms would aid consent decision-making. Although our participants displayed great altruism in sharing their data and accepted that broad consent would ultimately facilitate future research, broad consent did not reflect their ideal situation. Dynamic consent may be an option but warrants further feasibility research.

Patient and Public Contribution

Women were recruited from the general breast cancer screening population. Their perceptions and information needs, as reported in this study, will not only inform broadened consent for PRISMA but ideally guide other consent templates and decisions regarding consent processes.     

Insights into how Malaysian adults with limited health literacy self‐manage and live with asthma: A Photovoice qualitative study

BackgroundAdjusting to life with a chronic condition is challenging, especially for people with limited health literacy, which is associated with low compliance with self‐management activities and poor clinical outcomes.ObjectiveWe explored how people with limited health literacy understand asthma and undertake self‐management practices.DesignWe adapted the arts‐based qualitative methodology Photovoice.Setting and ParticipantsWe sampled ethnically diverse adults with asthma and limited health literacy from four primary healthcare clinics in Malaysia. After a semistructured in‐depth interview, a subset of participants took part in the Photovoice component in which participants undertook a 2‐week photo‐taking activity and subsequent photo‐interview. Interviews, conducted in participants'' preferred language, were audio‐recorded, transcribed verbatim, translated and analysed thematically. We used the Sorensen''s framework (Domains: access, understand, appraise, apply) to describe participants'' experience of living with asthma, what they understood about asthma and how they decided on self‐management practices.ResultsTwenty‐six participants provided interviews; eight completed the Photovoice activities. Participants with limited health literacy used various sources to access information about asthma and self‐management. Doctor–patient communication had a pivotal role in helping patients understand asthma. The lack of appraisal skills was significant and experiential knowledge influenced how they applied information. Self‐management decisions were influenced by sociocultural norms/practices, stigmatizing experiences, and available social support.ConclusionLocally tailored multilevel interventions (interpersonal, health system, community and policy) will be needed to support people with limited health literacy to live optimally with their asthma in an ethnically diverse population.Patient/Public ContributionPatients were involved in the study design, recruitment, analysis and dissemination.     

Mothers' attitudes to the randomized controlled trial (RCT): the case of acute lymphoblastic leukaemia (ALL) in children

OBJECTIVES: Survival rates for childhood cancer have improved substantially partly as a result of national and international randomized clinical trials (RCT). However, the decision for families is complex and emotional. Our aim was to describe the views of mothers of children newly diagnosed with ALL regarding consent to randomized controlled trials. DESIGN: Qualitative interview to explore mothers knowledge, and reasons for involving their child in RCTs. Interviews took place in mothers' homes. PARTICIPANTS: Fifty mothers of children with newly diagnosed ALL (age 4-16 years; mean = 7.4) recruited through research nurses at outpatient appointments. RESULTS: All but three families had consented for their child to be treated in the RCT, although there was wide variation in their understanding of the aims, costs and benefits. Most mothers reported the aim of the trial to compare 'old' and 'new' treatments. CONCLUSION: Despite detailed verbal and written information, mothers were poorly informed about the purpose of the trial, and possibility of side effects. Individual preferences for either standard or new treatment were routinely reported. The data raise questions about the extent to which families give truly informed consent to recruitment of their child to an RCT.     

The influence of informed consent content on study participants' contraceptive knowledge and concerns

Little is known about how the information presented in the informed consent process influences study outcomes among participants. This study examines the influence of informed consent content on reported baseline contraceptive knowledge and concerns among two groups of HIV-serodiscordant and seroconcordant HIV-positive couples enrolled in research projects at an HIV research center in Lusaka, Zambia. We found significant differences in the reporting of contraceptive knowledge and concerns between couples viewing consent materials that included detailed information about contraception and those viewing consent materials that lacked the detailed information. We conclude that the design of informed consent materials should strike a balance between ensuring that participants give truly informed consent and educating participants in ways that do not compromise the assessment of the impact of behavioral interventions.     

Consent to epistemic interventions: a contribution to the debate on the right (not) to know

The debate on the ‘right (not) to know’ has simmered on for over 30 years. New examples where a right to be informed is contrasted to a right to be kept in ignorance occasionally surface and spark disagreement on the extent to which patients and research subjects have a right to be self-determining concerning the health related information they receive. Up until now, however, this debate has been unsatisfactory with regard to the question what type of rights—if any—are in play here and to what extent they can provide a normative basis for informed consent. This paper provides an analysis of informed consent in the context of ‘epistemic interventions’: interventions which involve the communication of (health-related) information. First, I offer an analysis of the concept of a ‘right not to know’ in the context of consent to epistemic interventions. I argue that the scope of the consent is determined by the extent to which this intervention can be seen as an infringement of the private sphere. After that I show how this analysis affects the scope and standards of informed consent.     

Informed consent: a pragmatic view

The author highlights some pragmatic aspects of informed consent that could help to bridge the gap between the currently valid legal requirements and the practical realities of providing medical information in Hungarian health-care settings. One of the crucial point of informed consent is whether the patient properly understood the provided medical information. Consequently, effective communication becomes an inevitable condition of providing informed consent. The results and insights coming from psychological research--concerning lay understanding of medical information, of the readability of consent forms, and especially of the lay understanding of statistical information, and risk communication--could help to create a better practice of medical communication that could satisfy both ethical and legal requirements. The author argues as well for creating more concrete and practically oriented guidelines concerning informed consent that would also help to increase the quality of medical information giving. These might help us approach the medical ideal that was conceptualised in the doctrine of informed consent.     

Informed consent: a pragmatic view

The author highlights some pragmatic aspects of informed consent, express consent and implied consent--by the cases of the Data Protection Commissioner of Hungary - that could help to bridge the gap between the currently valid legal requirements and the practical realities of providing medical information in Hungarian health-care settings. One of the crucial point of informed consent is whether the patient properly understood the provided medical information. Consequently, effective communication becomes an inevitable condition of providing informed consent. The author argues as well for creating more concrete and practically oriented guidelines concerning informed consent that would also help to increase the quality of medical information giving. These might help us approach the medical ideal that was conceptualised in the doctrine of informed consent.     

The engagement of older people living with chronic lung disease in a peer support community-based exercise programme: A qualitative study

Background

Chronic lung disease is a common and complex condition. Pulmonary rehabilitation programmes—either hospital-based or in the community are recommended in evidence-based clinical practice guidelines.

Aim

To explore the experience of older people with chronic lung disease involved in a peer support community-based exercise maintenance programme.

Design and Method

Participants were a part of the Lungs in Action programme run in a local community leisure centre through Lung Foundation Australia. All the programme participants (n = 25) were invited by an independent person through email and/or letter to participate in the study and provided with a participant information and consent form. Participants who returned consent forms were scheduled for group interviews. Participants were recruited over a 2-week period between 30 August and 13 September 2022. We conducted qualitative group interviews using a semi-structured interview guide to explore the experiences of older people living with chronic lung disease. Data were analysed using reflexive thematic analysis.

Results

A total of 14 participants (eight female and six male) aged between 64 and 86 years were interviewed. Three themes emerged from the data: motivation, authentic social engagement, and sustainable achievement. Motivation stemmed from the participants' perceived health benefits, and from the trainers' motivation and encouragement. Participants discussed how sharing experiences created an environment of trust and understanding, fun and friendship. Social engagement and creating authentic relationships were key aspects raised by participants. Feeling more confident in themselves and being able to accomplish physical tasks, making activities of daily living more manageable featured highly in participants' responses.

Discussion and Conclusion

Community-based peer support exercise groups enable environments for people with chronic lung disease to maintain physical fitness, and to connect with others to form friendships and have fun.     

Consent revisited: the impact of return of results on participants' views and expectations about trial participation

BackgroundIncreasingly, the sharing of study results with participants is advocated as an element of good research practice. Yet little is known about how receiving the results of trials may impact on participants'' perceptions of their original decision to consent.ObjectiveWe explored participants'' views of their decision to consent to a clinical trial after they received results showing adverse outcomes in some arms of the trial.MethodSemi‐structured interviews were conducted with a purposive sample of 38 women in the UK who participated in a trial of antibiotics in pregnancy. All had received results from a follow‐up study that reported increased risk of adverse outcomes for children of participants in some of the trial intervention arms. Data analysis was based on the constant comparative method.ResultsParticipants'' original decisions to consent to the trial had been based on hope of personal benefit and assumptions of safety. On receiving the results, most made sense of their experience in ways that enabled them to remain content with their decision to take part. But for some, the results provoked recognition that their original expectations might have been mistaken or that they had not understood the implications of their decision to participate. These participants experienced guilt, a sense of betrayal by the maternity staff and researchers involved in the trial, and damage to trust.ConclusionsSharing of study results is not a wholly benign practice, and requires careful development of suitable approaches for further evaluation before widespread adoption.     

The communication process in clinical settings

The communication of information in clinical settings is fraught with problems despite avowed common aims of practitioners and patients. Some reasons for the problematic nature of clinical communication are incongruent frames of reference about what information ought to be shared, sociolinguistic differences and social distance between practitioners and patients. Communication between doctors and nurses is also problematic, largely due to differences in ideology between the professions about what ought to be communicated to patients about their illness and who is ratified to give such information.Recent social changes, such as the Patient Bill of Rights and informed consent which assure access to information, and new conceptualizations of the nurse's role, warrant continued study of the communication process especially in regard to what constitutes appropriate and acceptable information about a patient's illness and who ought to give such information to patients.The purpose of this paper is to outline characteristics of communication in clinical settings and to provide a literature review of patient and practitioner interaction studies in order to reflect on why information exchange is problematic in clinical settings. A framework for presentation of the problems employs principles from interaction and role theory to investigate clinical communication from three viewpoints: (1) the level of shared knowledge between participants; (2) the effect of status, role and ideology on transactions; and (3) the regulation of communication imposed by features of the institution.     

Information Seeking and Satisfaction With Physician–Patient Communication Among Prostate Cancer Survivors

Relatively little is known about prostate cancer patients' information seeking after diagnosis, how they use such information in making a treatment decision, or what role information plays in adjusting to quality-of-life issues posttreatment. This research sought to explore some of these issues by examining prostate cancer patients' information seeking and its relationship to assessments of feeling informed and satisfied with physician–patient communication about prostate cancer. Respondents felt reasonably informed about prostate cancer, although over one third of them reported being less then informed. Similarly, many respondents were generally satisfied with their communication with physicians, but nearly 40% of them reported being less than satisfied. However, there was no relationship between respondents' information seeking about prostate cancer and their assessments of being informed or satisfied with physician–patient communication. These and other results are discussed with respect to future research on prostate cancer patients' information needs and uses of such information.     

Quantifying and documenting prior beliefs in clinical trials

Collecting and documenting subjective prior beliefs from knowledgeable clinicians about the potential results of a clinical trial has many advantages. Two large trials of prophylactic treatments in an HIV-positive population are used as examples. The trials recruited patients of primary care physicians and compared treatments which were in use in clinical practice. Opinions about these trials were elicited from 58 practising HIV clinicians. It is shown how the documented opinions can be used to augment the monitoring process; the prior opinions are updated with interim data using approximate Bayesian methods to give posterior opinions incorporating interim results. These posterior opinions can be used by the monitoring board to anticipate the clinicians' reaction to the results. Eliciting prior beliefs is also ethically important for documenting the nature of the uncertainty or equipoise. Important information is provided for the informed consent process and Institutional Review Board (IRB).     

How young people find out about their family history of Huntington's disease

Family communication about adult-onset hereditary illness can be problematic, leaving some relatives inadequately informed or ignorant of their risk. Although studies have explored the barriers and facilitators in family communication about genetic risk, questions remain about when, what, how and indeed whether to tell relatives. The process of disclosure is also dependent upon the way in which genetic information is realized and understood by recipients, but research here is limited. Our paper explores young people's experiences of finding out about a family history of the hereditary disorder Huntington's disease (HD). In-depth interviews explored how and when young people found out, their reactions to different communication styles and any impact on family relations. We recruited young people through the North of Scotland regional genetics clinic and the Scottish Huntington's Association (SHA). Thirty-three young people (aged 9–28) were interviewed. A qualitative analysis was undertaken which revealed four types of disclosure experiences: (1) having always been told, (2) gradually told, (3) HD was kept a secret, or (4) HD as a new diagnosis. In particular, the timing and style of disclosure from relatives, and one's stage of awareness, were fundamental in structuring participants' accounts. This article focuses on questions of when, how and indeed whether to tell children, and sits within a broader set of research and practice issues about what professionals and families (should) tell children about parental illness and genetic risk.     

Views of US researchers about informed consent in international collaborative research

Informed consent poses challenges in all settings. Challenges may be particularly great in international collaborative research, where cultural perspectives may differ, and where education levels and language may be barriers to participant understanding. We conducted a written survey and focus groups with US health researchers doing research in developing countries, asking about informed consent and other ethical issues in their research. We present here both qualitative and quantitative data relevant to informed consent. Qualitative data revealed that researchers' experiences and beliefs about informed consent fell into three paradigms: regulatory, community, and individual. The regulatory paradigm refers to researchers' views and practices relating to informed consent requirements of institutional review boards and other oversight bodies. The community paradigm refers to researchers' approach to the content and methodology of informed consent in the context of long-term relationships between research teams and study communities. Researchers emphasized the importance of these relationships for creating and maintaining communication fundamental to the informed consent process. Finally, the individual paradigm refers to researchers' views about individual participants' understanding and decision-making process regarding research. Researchers described community-level influences on participants' decision-making, but stressed the need for individual comprehension and voluntary participation. While these paradigms are distinct, they also are intertwined. Quantitative data supported the existence of these three paradigms in respondents' characterization of informed consent. Researchers frequently stated that legal language on the consent forms was meaningless (52%). Forty-four percent of researchers had consulted with community leaders, and 23% believed the consent process focuses too much on the individual, rather than on family or community. Most researchers (82%) reported that the consent process was an important means of educating participants about the study. Fifty-four percent of researchers believed participants did not understand placebos. Further research is needed to understand how culture and relationships affect research participation, and to provide information and dialogue among researchers, oversight bodies and community representatives about appropriate ways to approach informed consent in international research.     

医学期刊编辑对生物医学研究伦理问题的处理方式调研及建议

【目的】 探讨医学期刊编辑处理生物医学研究伦理问题的方式,为推动确立医学期刊伦理审查规范提供参考。【方法】 通过问卷星向国内医学期刊编辑发放调查问卷,对审稿时和论文出版后处理医学伦理相关问题的方式展开调研。【结果】 共回收问卷230份。调查显示:在审稿阶段,在保护患者隐私方面,英文期刊、中英双语期刊的编辑更注重要求作者提供授权同意相关证明材料;中、英文期刊以及中英双语期刊的编辑对涉及人体试验伦理问题的处理方式都比较规范。但是,对于研究是否获得患者知情同意、动物实验研究是否经过伦理委员会审查、回顾性研究是否需要伦理审查、涉及人的研究是否在临床试验注册中心注册等问题,编辑还需要进一步重视。在论文出版后,编辑发现的医学伦理问题主要是“涉及人的研究未说明是否经过伦理委员会审查”。对论文出版后发现的没有保护患者隐私和没有在临床试验注册中心注册的问题,大部分期刊缺乏相关处理方案。【结论】 编辑应加强对论文知情同意、动物实验伦理、回顾性研究伦理的审查,并审查涉及人的研究是否在临床试验注册中心注册,以推动我国医学期刊的高质量发展。