scholarly journals Relative importance of informational items in participant information leaflets for trials: a Q-methodology approach

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e023303 ◽  
Author(s):  
Karen Innes ◽  
Seonaidh Cotton ◽  
Marion K Campbell ◽  
Jim Elliott ◽  
Katie Gillies
Keyword(s):  
Q Methodology ◽  
Trial Participation ◽  
Sufficient Information ◽  
Think Aloud ◽  
Stakeholder Groups ◽  
Information Leaflets ◽  
Research Nurses ◽  
Trial Participants ◽  
Potential Trial ◽  
Participant Information

ObjectivesTo identify which information items potential participants and research nurses rank as the most important, and the reasons for this, when considering participation in a randomised controlled trial.DesignQ-methodology approach alongside a think-aloud process. Using a vignette outlining a hypothetical trial, participants were asked to rank statements about informational items usually included in a participant information leaflet (PIL) on a Q-grid, while undertaking a real-time think-aloud process to elicit the underpinning decision processes. Analysis of quantitative data was conducted using descriptive statistics and qualitative data was coded using content analysis.Participants20 participants (10 potential trial participants and 10 research nurses).SettingUK-based participants.ResultsTen research nurses and 10 potential trial participants provided data for the study. Both stakeholder groups ranked similar statements in their top three most important statements, with ‘What are the possible disadvantages and risks of taking part?’ featuring in both. However, considerable variability existed between the groups with regard to their ranking of statements of least importance. Participants identified that sufficient information to make a decision was secured using around 14 items. Participants also identified other items of importance not routinely included in PILs.ConclusionsThis study has provided a unique insight into how and why different trial stakeholder groups rank informational items currently contained within PILs. These results have implications for those developing future PILs and those who develop guidance on their content; PILs should focus most on the information items that potential trial participants want and need to make an informed choice about trial participation.

scholarly journals A systematic review of risk communication in clinical trials: How does it influence decisions to participate and what are the best methods to improve understanding in a trial context?

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0242239
Author(s):  
Maeve Coyle ◽  
Katie Gillies
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Risk Communication ◽  
Search Strategy ◽  
Trial Participation ◽  
Probabilistic Information ◽  
Information Leaflets ◽  
Trial Participants ◽  
Potential Trial

Background Effective risk communication is challenging. Ensuring potential trial participants’ understand ‘risk’ information presented to them is a key aspect of the informed consent process within clinical trials, yet minimal research has looked specifically at how to communicate probabilities to support decisions about trial participation. This study reports a systematic review of the literature focusing on presentation of probabilistic information or understanding of risk by potential trial participants. Methods A search strategy for risk communication in clinical trials was designed and informed by systematic reviews of risk communication in treatment and screening contexts and supplemented with trial participation terms. Extracted data included study characteristics and the main interventions/findings of each study. Explanatory studies that investigated the methods for presenting probabilistic information within participant information leaflets for a clinical trial were included, as were interventions that focused on optimising understanding of probabilistic information within the context of a clinical trial. Results The search strategy identified a total of 4931 studies. Nineteen papers were selected for full text screening, and seven studies included. All reported results from risk communication studies that aimed to support potential trial participants’ decision making set within hypothetical trials. Five of these were randomised comparisons of risk communication interventions, and two were prospectively designed, non-randomised studies. Study interventions focused on probability presentation, risk framing and risk interpretation with a wide variety of interventions being evaluated and considerable heterogeneity in terms of outcomes assessed. Studies show conflicting findings when it comes to how best to present information, although numerical, particularly frequency formats and some visual aids appear to have promise. Conclusions The evidence base surrounding risk communication in clinical trials indicates that there is as yet no clear optimal method for improving participant understanding, or clear consensus on how it affects their willingness to participate. Further research into risk communication within trials is needed to help illuminate the mechanisms underlying risk perception and understanding and provide appropriate ways to present and communicate risk in a trial context so as to further promote informed choices about participation. A key focus for future research should be to investigate the potential for learning in the evidence on risk communication from treatment and screening decisions when applied to decisions about trial participation.

scholarly journals Nocebo effects and participant information leaflets: evaluating information provided on adverse effects in UK clinical trials

2020 ◽  
Author(s):  
Nigel Kirby ◽  
Victoria Shepherd ◽  
Jeremy Howick ◽  
Sophie Betteridge ◽  
Kerenza Hood
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Adverse Events ◽  
Medicinal Products ◽  
Flesch Reading Ease ◽  
Information Leaflets ◽  
Potential Benefits ◽  
Nocebo Effects ◽  
Trial Participants ◽  
Participant Information

Abstract Background Nocebo effects (‘negative placebo’ effects) experienced by clinical trial participants can arise from an underlying condition or through communication about side effects in the participant information leaflets (or elsewhere). However, little is known about how information on potential side effects is provided to trial participants. In this study we aimed to increase the evidence-base in this area by identifying the way in which potential side effects from investigational medicinal products used in trials are presented in written information to potential participants. Methods Trials were identified from the International Standard Randomised Controlled Trials Number (ISRCTN) clinical trial registry. Eligible studies were placebo controlled clinical trials of investigational medicinal products (IMP) in adults conducted in the UK in three targeted clinical areas (cancer, musculoskeletal conditions and mental and behavioural disorders). Ongoing and recently completed (within three years) trials were included. We assessed readability using the Flesch Reading Ease scale, Gunning-Fog Index and Flesch-Kincaid Grade. Data extracted from the PILs were divided into 8 predefined qualitative themes for analysis in NVivo11. Results PILs from 33 studies were included. Most of the patient information leaflets were ranked as ‘fairly easy to read’ or ‘difficult to read’ according to the Flesch Reading Ease scale. All studies presented information about adverse events, whereas only a third presented information about intervention benefits. Where intervention or study benefits were presented, they were usually after adverse events (21/33 64%). Discussion Participant information leaflets scored poorly on ease of readability and had more content relating to adverse effects than any potential beneficial effects. The way in which adverse events were presented was heterogeneous in terms of their likelihood and severity and the amount and level of detail provided. In comparison to the adverse effects, potential benefits from the intervention and/or study were described less often and by shorter text. Participants were commonly presented with adverse effects ahead of any potential benefits.

Are Well-Informed Potential Trial Participants More Likely to Participate?

2017 ◽  
Vol 12 (5) ◽  
pp. 363-371 ◽  
Author(s):  
Lucas Lentini Herling de Oliveira ◽  
Joao Ricardo Nickenig Vissoci ◽  
Wagner de Lara Machado ◽  
Clarissa G. Rodrigues ◽  
Alexander T. Limkakeng
Keyword(s):  
Trial Participants ◽  
Potential Trial

scholarly journals Informal professionalization of healthy participants in phase I clinical trials in Russia

2019 ◽  
Vol 16 (6) ◽  
pp. 563-570 ◽  
Author(s):  
Olga Zvonareva ◽  
Igor Pimenov ◽  
Natalia Kutishenko ◽  
Igor Mareev ◽  
Sergey Martsevich ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Trial ◽  
Trial Participation ◽  
Phase I Trials ◽  
Phase I Clinical Trials ◽  
Skilled Workers ◽  
Structured Interviews ◽  
Two Phase ◽  
Trial Participants ◽  
Healthy Participants

Background: Previous social science research has shown how some healthy phase I trial participants identify themselves as workers and rely on trials as a major source of income. The term “professionalization” has been used to denote this phenomenon. Purpose: We aim to examine a component of healthy trial participants’ professionalization that has not yet been systematically studied: how repeat phase I trial participants develop and claim expertise that distinguishes them from others and makes them uniquely positioned to perform high-quality clinical trial labor. We also aim to explain the significance of these research results for protection of healthy participants in phase I trials. Methods: This qualitative exploratory study was conducted in Russia, in two phase I trial units. It involved semi-structured interviews with 28 healthy trial participants with varying lengths of experience in trials, observations of work done in trial units, and interpretive conversations with investigative staff. Results: Interviewed healthy individuals who repeatedly participate in phase I trials describe developing knowledge and skills that involve appreciating the meaning of trial procedures, coming up with techniques to efficiently follow them, organizing themselves and others in the course of a trial, and sharing tacit ways of doing trial work well with other less experienced participants. Our results suggest that a prerequisite for such expertise-centered professionalization is the emergence of a positive identity linked to seeing value in trial participation work. A crucial component of professionalization thus understood is the development of a work ethic that entails caring about results and being reliable partners for investigators. Limitations: The attitudes and behaviors presented in this article are not suggested to be universally shared among healthy trial participants, but rather represent a particular instance of professionalization that coexists with other views and tactics. Conclusions: A way of better protecting healthy trial participants begins with recognizing their skills, knowledge, and the centrality of the contribution they are making to pharmaceutical research. Currently, the expertise of experienced trial participants is recognized on the work floor only; therefore, the professionalization we described is informal. Yet, the informal professionalization process is inherently risky as it does not involve any change in the formal conditions of trial participants’ work. Instituting formal measures for protecting healthy trial participants as skilled workers combined with recognition of their expertise is essential.

scholarly journals Investigating modifications to participant information materials to improve recruitment into a large randomized trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Richard Haynes ◽  
◽  
Fang Chen ◽  
Elizabeth Wincott ◽  
Rejive Dayanandan ◽  
...  
Keyword(s):  
Focus Groups ◽  
Randomized Trial ◽  
Randomized Trials ◽  
Trial Participation ◽  
Efficacy And Safety ◽  
Information Leaflet ◽  
Potential Participant ◽  
Information Materials ◽  
Large Randomized Trial ◽  
Participant Information

Abstract Background Large randomized trials are the best method to test the efficacy and safety of treatments expected to have moderate effects. We observed a significant decline in potential participants’ response to mailed invitations to participate in such trials over a 10-year period and investigated possible reasons behind this and potential modifications to the invitation process to mitigate it. Methods Participants who declined to participate in the HPS2-THRIVE trial were asked to give a reason. Formal focus groups were conducted to explore the reasons that potential participants might have for not participating. In addition, two embedded randomized comparisons around the timing of provision of the full participant information leaflet (PIL) and its style were conducted during recruitment into this large randomized trial. HPS2-THRIVE is registered at ClinicalTrials.gov (NCT00461630). Results The commonest reason given for declining invitations related to mobility and transportation (despite the offer of travel expenses). Both the focus groups and potential participants who declined their invitation indicated concern about side-effects of the treatment (as presented in the PIL) as a reason for declining the invitation. Neither delaying provision of the full PIL until the potential participant attended the trial clinic, nor modifying the style of the PIL improved the proportion of potential participants entering the trial: odds ratio (OR) 1.05 (95% confidence interval (CI) 0.94–1.17) and 1.10 (95% CI 0.94–1.28), respectively. However, modifying the style of the PIL did increase the proportion of participants attending screening appointments (OR 1.17, 95% CI 1.03–1.33). Conclusions Many reasons given for not participating in trials are not tractable to individual trials. However, modification of the PIL does show potential to modestly improve participation. If further trials could identify similar simple interventions that were beneficial, their net effects could substantially improve trial participation and facilitate recruitment into large trials.

scholarly journals The Spirit of OMERACT: Q Methodology Analysis of Conference Characteristics Valued by Delegates

2015 ◽  
Vol 42 (10) ◽  
pp. 1982-1992 ◽  
Author(s):  
Caroline A. Flurey ◽  
John R. Kirwan ◽  
Phillip Hadridge ◽  
Pamela Richards ◽  
Shawna Grosskleg ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Q Methodology ◽  
Research Collaboration ◽  
Distribution Grid ◽  
Grid Data ◽  
Stakeholder Collaboration ◽  
Stakeholder Groups ◽  
Global Standardization ◽  
Common Goals ◽  
Level Of Agreement

Objective.To identify the major features of OMERACT meetings as valued by frequent participants and to explore whether there are groups of participants with different opinions.Methods.Using Q methodology (a qualitative and quantitative approach to grouping people according to subjective opinion), participants (who attended more than 1 OMERACT conference) sorted 66 statements relating to the “spirit of OMERACT” according to level of agreement across a normal distribution grid. Data were examined using Q factor analysis.Results.Of 226 potential participants, 105 responded (46%). All participants highly ranked the focus on global standardization of methods, outcome measures, data-driven research, methodological discussion, and international collaboration. Four factors describing the “spirit of OMERACT” were identified: “Evidence not eminence” (n = 31) valued the data- and evidence-driven research above personality and status; “Collaboration and collegiality” (n = 19) valued the international and cross-stakeholder collaboration, interaction, and collegiality; “Equal voices, equal votes, common goals” (n = 12) valued equality in discussion and voting, with everyone striving toward the same goal; “principles and product, not process” (n = 8) valued the principles of focusing on outcome measures and the product of guiding clinical trials, but were unsure whether the process is necessary to reach this. The factors did not segregate different stakeholder groups.Conclusion.Delegates value different elements of OMERACT, and thus the “spirit of OMERACT” encompasses evidence-based research, collaboration, and equality, although a small group are unsure whether the process is necessary to achieve the end result. Q methodology may prove useful for conference organizers to identify their delegates’ different needs to tailor conference content.

scholarly journals Association of Clinical Trial Participation After Myocardial Infarction with Socioeconomic Status, Clinical Characteristics, and Outcomes

2021 ◽  
Author(s):  
Joel Ohm ◽  
Tomas Jernberg ◽  
David Johansson ◽  
Anna Warnqvist ◽  
Margrét Leosdottir ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Trial ◽  
Socioeconomic Status ◽  
Heart Disease ◽  
Clinical Characteristics ◽  
Left Ventricular ◽  
Trial Participation ◽  
Real World Data ◽  
Individual Level ◽  
Trial Participants

Abstract Aims To investigate whether participants in clinical trials after myocardial infarction (MI) are representable for the post-MI population concerning characteristics, secondary prevention, and prognosis. Methods and Results Cohort study on 31,792 attendants to 1-year revisits after MI throughout Sweden (n = 2941 clinical trial participants) between 2008 and 2013 identified in the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART). Individual-level data on socioeconomic status (SES) (disposable income, educational level, and marital status) and outcomes (first recurrent nonfatal MI, coronary heart disease death, fatal or nonfatal stroke until study end 2018) were linked from other national registries. Trial participants were more likely to be men (risk ratio 1.09; 95% confidence interval 1.07-1.11), to be married (1.07; 1.04-1.10), have a highest-quintile income (1.42; 1.36-1.48), and post-secondary education (1.25; 1.18-1.33) while less likely to have a history of MI (0.88; 0.80-0.97), be persistent smokers (0.83; 0.75-0.92) and have left ventricular dysfunction (0.59; 0.44-0.79) compared to non-participants. During a mean 6.7-year follow-up, 5,206 outcome events occurred. Risk was lower in trial participants (hazard ratio 0.80; 95% CI 0.72-0.89), also after adjusting for clinical characteristics and post-MI therapies (0.85; 0.77-0.94) and additionally for SES (0.88; 0.79-0.97). Conclusions Clinical trial participants post-MI are more often male, have higher SES, a more advantageous risk profile, and better prognosis. Additional unmeasured participation bias was implied. Questionable external validity of post-MI trials highlights the importance of complementary studies using real-world data.

scholarly journals Are investigators’ access to trial data and rights to publish restricted and are potential trial participants informed about this? A comparison of trial protocols and informed consent materials

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Asger S. Paludan-Müller ◽  
Michelle C. Ogden ◽  
Mikkel Marquardsen ◽  
Karsten J. Jørgensen ◽  
Peter C. Gøtzsche
Keyword(s):  
Informed Consent ◽  
Ethics Committees ◽  
Freedom Of Information ◽  
Trial Conduct ◽  
Industry Partner ◽  
Trial Protocols ◽  
Information Requests ◽  
Trial Participants ◽  
Specific Reason ◽  
Potential Trial

Abstract Objectives To determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators. Methods Cohort study of trial protocols, publication agreements and other documents obtained through Freedom of Information requests, for a sample of 42 trials with industry involvement approved by ethics committees in Denmark. The main outcome measures used were: proportion of trials where data was owned by the industry partner, where the investigators right to publish were constrained and if this was mentioned in informed consent documents, and where the industry partner could review data while the trial was ongoing and stop the trial early. Results The industry partner owned all data in 20 trials (48%) and in 16 trials (38%) it was unclear. Publication constraints were described for 30 trials (71%) and this was not communicated to trial participants in informed consent documents in any of the trials. In eight trials (19%) the industry partner could review data during the trial, for 20 trials (48%) it was unclear. The industry partner could stop the trial early without any specific reason in 23 trials (55%). Conclusions Publication constraints are common, and data is often owned by industry partners. This is rarely communicated to trial participants. Such constraints might contribute to problems with selective outcome reporting. Patients should be fully informed about these aspects of trial conduct.

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