Conveying Equipoise during Recruitment for Clinical Trials:Qualitative Synthesis of Clinicians’ Practices across Six Randomised Controlled Trials

<div><p>Background</p><p>Randomised controlled trials (RCTs) are essential for evidence-based medicine and increasingly rely on front-line clinicians to recruit eligible patients. Clinicians’ difficulties with negotiating equipoise is assumed to undermine recruitment, although these issues have not yet been empirically investigated in the context of observable events. We aimed to investigate how clinicians conveyed equipoise during RCT recruitment appointments across six RCTs, with a view to (i) identifying practices that supported or hindered equipoise communication and (ii) exploring how clinicians’ reported intentions compared with their actual practices.</p><p>Methods and Findings</p><p>Six pragmatic UK-based RCTs were purposefully selected to include several clinical specialties (e.g., oncology, surgery) and types of treatment comparison. The RCTs were all based in secondary-care hospitals (<i>n =</i> 16) around the UK. Clinicians recruiting to the RCTs were interviewed (<i>n =</i> 23) to understand their individual sense of equipoise about the RCT treatments and their intentions for communicating equipoise to patients. Appointments in which these clinicians presented the RCT to trial-eligible patients were audio-recorded (<i>n =</i> 105). The appointments were analysed using thematic and content analysis approaches to identify practices that supported or challenged equipoise communication. A sample of appointments was independently coded by three researchers to optimise reliability in reported findings. Clinicians and patients provided full written consent to be interviewed and have appointments audio-recorded.</p><p>Interviews revealed that clinicians’ sense of equipoise varied: although all were uncertain about which trial treatment was optimal, they expressed different levels of uncertainty, ranging from complete ambivalence to clear beliefs that one treatment was superior. Irrespective of their personal views, all clinicians intended to set their personal biases aside to convey trial treatments neutrally to patients (in accordance with existing evidence). However, equipoise was omitted or compromised in 48/105 (46%) of the recorded appointments. Three commonly recurring practices compromised equipoise communication across the RCTs, irrespective of clinical context. First, equipoise was overridden by clinicians offering treatment recommendations when patients appeared unsure how to proceed or when they asked for the clinician’s expert advice. Second, clinicians contradicted equipoise by presenting imbalanced descriptions of trial treatments that conflicted with scientific information stated in the RCT protocols. Third, equipoise was undermined by clinicians disclosing their personal opinions or predictions about trial outcomes, based on their intuition and experience. These broad practices were particularly demonstrated by clinicians who had indicated in interviews that they held less balanced views about trial treatments. A limitation of the study was that clinicians volunteering to take part in the research might have had a particular interest in improving their communication skills. However, the frequency of occurrence of equipoise issues across the RCTs suggests that the findings are likely to be reflective of clinical recruiters’ practices more widely.</p><p>Conclusions</p><p>Communicating equipoise is a challenging process that is easily disrupted. Clinicians’ personal views about trial treatments encroached on their ability to convey equipoise to patients. Clinicians should be encouraged to reflect on personal biases and be mindful of the common ways in which these can arise in their discussions with patients. Common pitfalls that recurred irrespective of RCT context indicate opportunities for specific training in communication skills that would be broadly applicable to a wide clinical audience.</p></div

An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment

OBJECTIVES: To explore how the concept of randomization is described by clinicians and understood by patients in randomized controlled trials (RCTs) and how it contributes to patient understanding and recruitment. STUDY DESIGN AND SETTING: Qualitative analysis of 73 audio recordings of recruitment consultations from five, multicenter, UK-based RCTs with identified or anticipated recruitment difficulties. RESULTS: One in 10 appointments did not include any mention of randomization. Most included a description of the method or process of allocation. Descriptions often made reference to gambling-related metaphors or similes, or referred to allocation by a computer. Where reference was made to a computer, some patients assumed that they would receive the treatment that was "best for them". Descriptions of the rationale for randomization were rarely present and often only came about as a consequence of patients questioning the reason for a random allocation. CONCLUSIONS: The methods and processes of randomization were usually described by recruiters, but often without clarity, which could lead to patient misunderstanding. The rationale for randomization was rarely mentioned. Recruiters should avoid problematic gambling metaphors and illusions of agency in their explanations and instead focus on clearer descriptions of the rationale and method of randomization to ensure patients are better informed about randomization and RCT participation

Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of participatory and informed consent (PIC)

Background Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure has been identified that evaluates participant understanding for IC based on their contributions during consent interactions. This paper outlines the development and formative evaluation of the Participatory and Informed Consent (PIC) measure for application to recorded recruitment appointments. The PIC allows the evaluation of recruiter information provision and evidence of participant understanding. Methods Published guidelines for IC were reviewed to identify potential items for inclusion. Seventeen purposively sampled trial recruitment appointments from three diverse trials were reviewed to identify the presence of items relevant to IC. A developmental version of the measure (DevPICv1) was drafted and applied to six further recruitment appointments from three further diverse trials to evaluate feasibility, validity, stability and inter-rater reliability. Findings guided revision of the measure (DevPICv2) which was applied to six further recruitment appointments as above. Results DevPICv1 assessed recruiter information provision (detail and clarity assessed separately) and participant talk (detail and understanding assessed separately) over 20 parameters (or 23 parameters for three-arm trials). Initial application of the measure to six diverse recruitment appointments demonstrated promising stability and inter-rater reliability but a need to simplify the measure to shorten time for completion. The revised measure (DevPICv2) combined assessment of detail and clarity of recruiter information and detail and evidence of participant understanding into two single scales for application to 22 parameters or 25 parameters for three-arm trials. Application of DevPICv2 to six further diverse recruitment appointments showed considerable improvements in feasibility (e.g. time to complete) with good levels of stability (i.e. test-retest reliability) and inter-rater reliability maintained. Conclusions The DevPICv2 provides a measure for application to trial recruitment appointments to evaluate quality of recruiter information provision and evidence of patient understanding and participation during IC discussions. Initial evaluation shows promising feasibility, validity, reliability and ability to discriminate across a range of recruiter practice and evidence of participant understanding. More validation work is needed in new clinical trials to evaluate and refine the measure further

”Medialle pitäis kertoa positiivisiakin asioita eikä vaan niitä kamalia ja huonoja” : lastensuojeluun liittyviä mielikuvia, niiden taustaa ja tulevaisuutta

Tämän opinnäytetyön tarkoituksena oli selvittää ihmisten mielikuvia ja tietämystä lastensuojelusta sekä tietämystä viime vuonna voimaan tulleesta uudesta sosiaalihuoltolaista. Lisäksi tarkoituksena oli kartoittaa mistä lähteestä saatuun tietoon heidän mielikuvansa lastensuojelusta heidän omasta mielestään perustuvat sekä miten lastensuojelun tulisi toimia, jotta se heidän mielikuvissaan toimisi kaikilta osin hyvin. Työssä haluttiin vielä selvittää, mitä ajatuksia sosiaalihuoltolain muutokset ihmisissä herättävät sekä miten heidän mielestään lastensuojelusta ja lakimuutoksista tiedottaminen tulisi hoitaa. Tutkimusotteena käytettiin laadullista tutkimusta. Tutkimusaineisto kerättiin haastattelemalla ihmisiä Tampereen keskustassa ja lähialueilla huhti-toukokuussa 2016. Haastatteluita tehtiin kaksikymmentä, joista saatu aineisto analysoitiin aineistolähtöisen sisällönanalyysin keinoin. Opinnäytetyön teoreettinen viitekehys käsittelee lastensuojelua sekä mielikuvia. Opinnäytetyön tulosten mukaan sellaiset ihmiset, joilla ei ole lastensuojelusta henkilökohtaista kokemusta, eivät tiedä alalla tehtävästä käytännön työstä tai lakimuutoksesta paljoakaan. Mielikuvat lastensuojelusta ovat rakentuneet hyvin vahvasti median kautta tai muista arjen tietolähteistä, kuten muiden ihmisten puheista, saadun informaation perusteella. Faktatietoa lastensuojelun toiminnasta tai edes sen tehtävistä yhteiskunnassa ei ihmisillä juurikaan ole. Tulosten mukaan lastensuojelutyöhön kaivataan lisää avoimuutta ja läpinäkyvyyttä sekä positiivista julkisuutta. Mielikuvat lastensuojelusta olisivat paremmat, mikäli työssä olisi enemmän ja tehokkaammin kohdistettuja resursseja, siinä panostettaisiin enemmän ennaltaehkäisevään työhön ja apua olisi helpommin ja nopeammin saatavilla. Lakimuutokset herättivät ihmisissä positiivisia ajatuksia, ja he kokivat, että ne vievät työtä oikeaan suuntaan. Lastensuojeluun liittyvistä asioista tiedottamisessa haastatellut toivoivat käytettävän monipuolisesti eri medioita sekä muun muassa kouluja ja neuvoloita. Johtopäätöksenä voidaan todeta, että median rooli lastensuojeluun liittyvän tiedon jakamisessa ja siihen liittyvien mielikuvien parantamisessa on keskeinen. Sosiaalihuoltolain muutokset ovat viemässä työn painopistettä oikeaan suuntaan, ja tämän positiivisen muutoksen tukemisessa tarvitaan paitsi riittäviä resursseja, myös panostusta tiedottamiseen sekä avoimeen ja positiiviseen julkisuuteen työntekijätahon puolelta.The purpose of was to collect data on people's knowledge and mental image regarding Child welfare services, and their knowledge and opinion about changes in Social welfare law that came into effect last year. Also the purpose was to find out from what source they have gotten the information their mental image is founded on, how Child welfare services should change to make people's mental image better, and how municipalities should inform public about these matters. The study was qualitative in nature and the data were collected interviewing people in Tampere center and nearby areas. The data were content analysed. The results show that people not in contact with Child welfare services in their everyday life do not know many facts about their function, nore about the changes in Social welfare law. Mental images people have are founded on information from the media or ordinary life sources like other people's stories. Child welfare services should be more transparent, have more positive visibility in media, have better resources and invest more to preventive work. Interviewees found that the changes in Social welfare law take this line of work to the right direction. As sources of information they thought that different medias, schools and child health centers would be most efficient. The conclusion was that media has a central role in sharing information and improving the mental image concerning Child welfare. Changes in the Social welfare law are taking the focus of Child welfare services to the right direction. Supporting this positive change requires not only sufficient resources but also investment from workers in providing more information and taking part in positive publicity

Conveying Equipoise during Recruitment for Clinical Trials: Qualitative Synthesis of Clinicians' Practices across Six Randomised Controlled Trials.

BackgroundRandomised controlled trials (RCTs) are essential for evidence-based medicine and increasingly rely on front-line clinicians to recruit eligible patients. Clinicians' difficulties with negotiating equipoise is assumed to undermine recruitment, although these issues have not yet been empirically investigated in the context of observable events. We aimed to investigate how clinicians conveyed equipoise during RCT recruitment appointments across six RCTs, with a view to (i) identifying practices that supported or hindered equipoise communication and (ii) exploring how clinicians' reported intentions compared with their actual practices.Methods and findingsSix pragmatic UK-based RCTs were purposefully selected to include several clinical specialties (e.g., oncology, surgery) and types of treatment comparison. The RCTs were all based in secondary-care hospitals (n = 16) around the UK. Clinicians recruiting to the RCTs were interviewed (n = 23) to understand their individual sense of equipoise about the RCT treatments and their intentions for communicating equipoise to patients. Appointments in which these clinicians presented the RCT to trial-eligible patients were audio-recorded (n = 105). The appointments were analysed using thematic and content analysis approaches to identify practices that supported or challenged equipoise communication. A sample of appointments was independently coded by three researchers to optimise reliability in reported findings. Clinicians and patients provided full written consent to be interviewed and have appointments audio-recorded. Interviews revealed that clinicians' sense of equipoise varied: although all were uncertain about which trial treatment was optimal, they expressed different levels of uncertainty, ranging from complete ambivalence to clear beliefs that one treatment was superior. Irrespective of their personal views, all clinicians intended to set their personal biases aside to convey trial treatments neutrally to patients (in accordance with existing evidence). However, equipoise was omitted or compromised in 48/105 (46%) of the recorded appointments. Three commonly recurring practices compromised equipoise communication across the RCTs, irrespective of clinical context. First, equipoise was overridden by clinicians offering treatment recommendations when patients appeared unsure how to proceed or when they asked for the clinician's expert advice. Second, clinicians contradicted equipoise by presenting imbalanced descriptions of trial treatments that conflicted with scientific information stated in the RCT protocols. Third, equipoise was undermined by clinicians disclosing their personal opinions or predictions about trial outcomes, based on their intuition and experience. These broad practices were particularly demonstrated by clinicians who had indicated in interviews that they held less balanced views about trial treatments. A limitation of the study was that clinicians volunteering to take part in the research might have had a particular interest in improving their communication skills. However, the frequency of occurrence of equipoise issues across the RCTs suggests that the findings are likely to be reflective of clinical recruiters' practices more widely.ConclusionsCommunicating equipoise is a challenging process that is easily disrupted. Clinicians' personal views about trial treatments encroached on their ability to convey equipoise to patients. Clinicians should be encouraged to reflect on personal biases and be mindful of the common ways in which these can arise in their discussions with patients. Common pitfalls that recurred irrespective of RCT context indicate opportunities for specific training in communication skills that would be broadly applicable to a wide clinical audience