Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies

Background The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders. Methods An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting. Results Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged “appropriate”; 19 were judged “uncertain”; and none was judged “inappropriate”. After the second round, 9 “uncertains” changed to “appropriate”. All recommendations rated medians of 6.5–9 on a 1–9 scale (1 = “extremely inappropriate”, 5 = “uncertain”, 9 = “extremely appropriate”). The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest “uncertainty” rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms. Conclusions The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged “appropriate” by all stakeholders involved in the informed consent process.

The Timing of Research Consent

This essay is about the timing of research consent, a process that involves (potential) participants being given information about, among other things, upcoming research interventions and then being invited to waive their claims against those interventions being undertaken. The standard practice, as regards timing, is as follows: (potential) participants are invited to waive all their claims at a single moment in time, and that point in time immediately follows the information-provision. I argue that there we’re not justified in keeping to this practice. What we ought to do is disaggregate the claim-waiving part of the process and move it later, such that the (potential) participant is invited to waive her claim against the undertaking of any given intervention only the immediate moment before that intervention is to be undertaken.

The Participant Journey Map: Understanding the Design of Interactive Augmented Play Spaces

Augmented Play Spaces (APS) are (semi-) public environments where playful interaction is facilitated by enriching the existing environment with interactive technology. APS can potentially facilitate social interaction and physical activity in (semi-)public environments. In controlled settings APS show promising effects. However, people’s willingness to engage with APS in situ, depends on many factors that do not occur in aforementioned controlled settings (where participation is obvious). To be able to achieve and demonstrate the positive effects of APS when implemented in (semi-)public environments, it is important to gain more insight in how to motivate people to engage with them and better understand when and how those decisions can be influenced by certain (design) factors. The Participant Journey Map (PJM) was developed following multiple iterations. First, based on related work, and insights gained from previously developed and implemented APS, a concept of the PJM was developed. Next, to validate and refine the PJM, interviews with 6 experts with extensive experience with developing and implementing APS were conducted. The first part of these interviews focused on influential (design) factors for engaging people into APS. In the second part, experts were asked to provide feedback on the first concept of the PJM. Based on the insights from the expert interviews, the PJM was adjusted and refined. The Participant Journey Map consists of four layers: Phases, States, Transitions and Influential Factors. There are two overarching phases: ‘Onboarding’ and ‘Participation’ and 6 states a (potential) participant goes through when engaging with an APS: ‘Transit,’ ‘Awareness,’ ‘Interest,’ ‘Intention,’ ‘Participation,’ ‘Finishing.’ Transitions indicate movements between states. Influential factors are the factors that influence these transitions. The PJM supports directions for further research and the design and implementation of APS. It contributes to previous work by providing a detailed overview of a participant journey and the factors that influence motivation to engage with APS. Notable additions are the detailed overview of influential factors, the introduction of the states ‘Awareness,’ ‘Intention’ and ‘Finishing’ and the non-linear approach. This will support taking into account these often overlooked, key moments in future APS research and design projects. Additionally, suggestions for future research into the design of APS are given.

Recruitment strategies should not be randomly selected: empirically improving recruitment success and diversity in developmental psychology research

Psychological and developmental research have been critiqued for the lack of diversity of research samples. Because differences in culture, race, and ethnicity can influence participant behavior, limited diversity limits the generalizability of the findings. These differences may also impact how participants behave in response to recruitment attempts, which suggests that recruitment itself may be leveraged to increase sample diversity. The goal of the current study was to determine what factors, within a recruitment interaction, could be leveraged to increase success and diversity when recruiting families with children for developmental research. Study 1 found three factors influenced success: (1) recruitment was more successful when other potential participants were also interested (i.e., recruiters were busy), (2) recruiters of particular races were more successful than recruiters of other races, and (3) differences in success were related to what the recruiter said to engage the potential participant (i.e., the script). The latter two factors interacted, suggesting some recruiters were using less optimal scripts. To improve success rates, study 2 randomly assigned scripts to recruiters and encouraged them to recruit more vigorously during busy periods. Study 2 found that two factors influenced success: (1) some scripts were more successful than others and (2) we were more successful at recruiting non-White potential participants than White participants. These two interacted, with some scripts being more successful with White and other scripts being more successful with non-White families. This intervention significantly increased recruitment success rate by 8.1% and the overall number of families recruited by 15.3%. These findings reveal that empirically evaluating and tailoring recruitment efforts based on the most successful strategies is effective in boosting diversity through increased participation of children from non-White families.

Recruitment strategies should not be randomly selected: empirically improving recruitment success and diversity in developmental psychology research

Psychological and developmental research have been critiqued for the lack of diversity of research samples. Because differences in culture, race, and ethnicity can influence participant behavior, limited diversity limits the generalizability of the findings. These differences may also impact how participants behave in response to recruitment attempts, which suggests that recruitment itself may be leveraged to increase sample diversity. The goal of the current study was to determine what factors, within a recruitment interaction, could be leveraged to increase success and diversity when recruiting families with children for developmental research. Study 1 found three factors influenced success: (1) recruitment was more successful when other potential participants were also interested (i.e., recruiters were busy), (2) recruiters of particular races were more successful than recruiters of other races, and (3) differences in success were related to what the recruiter said to engage the potential participant (i.e., the script). The latter two factors interacted, suggesting some recruiters were using less optimal scripts. To improve success rates, study 2 randomly assigned scripts to recruiters and encouraged them to recruit more vigorously during busy periods. Study 2 found that two factors influenced success: (1) some scripts were more successful than others and (2) we were more successful at recruiting non-White potential participants than White participants. These two interacted, with some scripts being more successful with White and other scripts being more successful with non-White families. This intervention significantly increased recruitment success rate by 8.1% and the overall number of families recruited by 15.3%. These findings reveal that empirically evaluating and tailoring recruitment efforts based on the most successful strategies is effective in boosting diversity through increased participation of children from non-White families.

Assessment of the Appropriateness of the i-CONSENT Guideline Recommendations for Improving Understanding of the Informed Consent Process in Clinical Studies

Background: The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.Methods: An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.Results: Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged appropriate; 19 were judged uncertain; and none was judged inappropriate. After the second round, 9 uncertains changed to appropriate. All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = extremely inappropriate, 5 = uncertain, 9 = extremely appropriate).The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest uncertainty rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.Conclusions: The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged appropriate by all stakeholders involved in the informed consent process.

External Disruptions to Qualitative Data Collection: Addressing Risks Relating to Brexit and Researcher-Participant Rapport

In this paper we present the importance of detailing the contextual conditions of a qualitative study to highlight any potential participant-researcher tensions. We emphasize the importance of understanding context in rich detail to expose societal complexities while maintaining positive participant-research rapport. Through two cases, this paper considers that bracketing, reflexivity, and transparency can be applied to form appropriate strategies to deal with external disruptions to qualitative fieldwork. The cases draw on Brexit’s impact on two studies conducted in the United Kingdom. In so doing, we argue that time, relevance, and the individuals involved can coalesce to express varied influences on a study. Thus, bracketing, reflexivity and transparency become vital to dealing with such influences; particularly when they are disruptive to a study. Overall, the strategic approach outlined by this paper can be used to maximise awareness of potential sources of tension in the field and to deal with any tensions that do arise.

Telehealth sounds a bit challenging, but it has potential: participant and physiotherapist experiences of gym-based exercise intervention for Achilles tendinopathy monitored via telehealth

Background Although telehealth is becoming more popular for delivery of care for individuals with musculoskeletal pain, to our knowledge telehealth has not been used to manage Achilles tendinopathy. This research aimed to explore the experience of participants and physiotherapists with gym-based exercise interventions for Achilles tendinopathy monitored via videoconference. Methods A qualitative, interpretive description design was performed using semi-structured interviews (8 participants) and a focus group (7 physiotherapists). Participants and physiotherapists were interviewed about their experiences of the use of telehealth during a gym-based exercise intervention incorporating different calf load parameters for Achilles tendinopathy. We employed an inductive thematic analysis approach to analyse the data. Results Three themes identified from both participants and physiotherapists included i) acceptability of telehealth; ii) enablers to adherence with telehealth; and iii) barriers to adherence with telehealth. Two extra themes arose from participants regarding adherence with gym-based exercise, including enablers to adherence with the exercise intervention, and barriers to adherence with the exercise intervention. Both participants and physiotherapists expressed overall satisfaction and acceptability of telehealth monitoring of gym-based exercise. Conclusion Gym-based exercise intervention for Achilles tendinopathy involving weekly telehealth monitoring was acceptable to both participants and physiotherapists. Potential enablers and barriers were identified that may improve adherence to this type of intervention.

The DSR Scheme in the Capacity Market of Industrial Enterprises in Poland—Participation Determinants

The purpose of this article is to present the key differences between the Polish Guaranteed DSR (demand-side response) Scheme operating from 2017 to 2020 and the Polish Capacity Market DSR Scheme operating from 2021, and their impacts on the decision to participate in the DSR scheme. The present study attempts to compare the rules of the old and new schemes and their impacts on the participation decision depending on the industry of the potential scheme participant. The study was conducted on a group of 50 randomly selected companies. A structured interview was used to collect information, and a chi-quadrant independence test and a Wilcoxon–Mann–Whitney test were used in the analysis of the collected data. The study was conducted in selected enterprises located in Poland. The results of the study indicate the elements that are similar to the literature on the subject, and key aspects arising from the unique characteristics of the Polish market and the industry of the potential participant. A detailed analysis of the collected data showed that the position of the respondent in the company and the size of the company do not affect the level of knowledge of the DSR market, or the decision concerning cooperation or the manner of reduction. All the respondents have higher opinions about the new Capacity Market DSR Scheme, which confirms the proper direction of the changes in relation to the ending Guaranteed DSR Scheme.