PhysAgeNet Deliverable D3.1 Guidelines on requirements and strategical improvement of recruitment and sampling for different target groups, using a formal consensus procedure

CA20104 – Network on evidence-based physical activity in old age (PhysAgeNet) Deliverable D3.1 D3.1 Guidelines on requirements and strategical improvement of recruitment and sampling for different target groups, using a formal consensus procedure RCO 7 Develop guidelines for recruitment and sampling of different target ageing groups. Improving planning and monitoring the recruitment processes will reduce bias and enable generalisaztion of study results (EBR), thus improving the ground for intervention designs (ICT). Achievement: guidelines submitted for publication (D3.1). This publication is based upon work from COST Action PhysAgeNet, CA20104, supported by COST (European Cooperation in Science and Technology). COST (European Cooperation in Science and Technology) is a funding agency for research and innovation networks. Our Actions help connect research initiatives across Europe and enables scientists to grow their ideas by sharing them with their peers. This boosts their research, career and innovation. Contributors – WG3 Lead authors Sunwoo Lee Palacky University Olomouc Czechia Magdalena Cyma-Wejchenig Poznań University of Physical Education Poland Ana Morais University of Évora Portugal Veysel Alcan Tarsus University Türkiye Iuliia Pavlova Lviv State University of Physical Culture Ukraine Rafał Stemplewski Poznan University of Physical Education Poland Panel experts Michael Brach University of Münster Germany Elpidio Attoh-Mensah Université de Limoges France Eleni Epiphaniou European University Cyprus Cyprus Zaur Gasimov Scientific-research institute of Cardiology Azerbaijan Sebahat Gözüm Akdeniz University Türkiye Aysegul ILGAZ Akdeniz University Türkiye Antoine Langeard Université de Caen France Melanie Mack University of Geneva Switzerland Hugo Rosado University of Évora Portugal Giacomo Pietro Vigezzi University of Pavia Italy Advisory committee Jana Pelclová Palacky University Olomouc Czechia Rosemary Dubbeldam University of Münster Germany Chris McCrum Universiteit Maastricht Netherlands Patrick Esser Oxford Brookes University United Kingdom Yael Netz Levinsky-Wingate Academic College Israel Corresponding Sunwoo Lee, Faculty of Physical Culture, Palacký University Olomouc, Třída Míru 117, 771 11 Olomouc, Czech Republic; +420 585 636 113; [email protected] * PhysAgeNet members who participated in the two-round Delphi survey have contributed to Deliverable 3.1. A full list of participants will be acknowledged in the publications. Table of Content 1. Introduction ......................................................................................................................................... 0 2. Methodology ......................................................................................................................................... 3 3. Results ............................................................................................. Fehler! Textmarke nicht definiert. 1. INTRODUCTION – BACKGROUND AND PURPOSE Despite substantial evidence supporting the benefits of physical activity (PA) in older adults, engaging this population in PA remains challenging. Gaps persist, including: 1) unique barriers faced by older adults at individual, community, and institutional levels, 2) insufficient evidence addressing the diverse needs of ageing populations, particularly the most vulnerable groups, and 3) a lack of clear guidelines for researchers and health professionals on effective recruitment and retention strategies to tackle these challenges. D3.1 aimed to develop evidence-informed requirement and strategies for designing, developing, and implementing the recruitment of older participants in PA interventions, equipping researchers and professionals with advanced understanding and techniques across diverse fields. 2. METHODOLOGY To achieve the goal for D3.1, we employed a mixed consensus methodology, integrating a formal consensus procedure and the Delphi technique. The formal consensus involved face to face discussions within an expert panel through iterative on-line meetings that aimed to develop initial recommendations and reach a final consensus on the guidelines. The Delphi method was used to collect anonymous feedback on the recommendations through a two-round survey (one round for the initial proposal and another for the revised proposal), which further provided external validation on the guidelines. While guideline development processes typically adopt a single approach, this multistep consensus method ensures a well-rounded perspective and fosters expert agreement, with each approach complementing the other. 2.1 Participants A total of 399 PhysAgeNet members were invited via email between July and August 2023; The initial invitation outlined the purpose of the guidelines, as well as the roles and responsibilities associated with each working group, (Steering Group, Panel of Experts Group, and External Review Group). Network members were asked to register for the one of the groups of their interest. Participation was voluntary, and the working group members declared no potential conflicts of interest regarding the research, authorship, or publication of these guidelines. The Steering Group (N=6) was responsible for coordinating the guideline development process. Tasks included defining the scope of the guidelines, formulating key questions for the panel experts, gathering panel input through semi-structured online surveys and discussions, facilitating consensus-building sessions, and preparing dissemination documents. The Panel of Experts Group (N=12) was tasked with developing the initial proposal for the guidelines, incorporating expertise and feedback from the external review group, and reaching consensus on the final guidelines. The group consisted of academics and health professionals with direct involvement in the target population. Panel members were qualified based on their expertise in fields relevant to the guidelines and their clinical and research experience, reflecting diversity in gender, geography, and practice areas. The External Review Group (N=42) provided peer review of the proposed guidelines, assessing their relevance and importance using a 2-round Delphi survey. 2.2 Guideline Development Procedure In general, we followed three steps: 1) a pre-consultation round to develop an initial list of recruitment strategies and recommendations proposed by the panel experts, 2) a two-round survey to evaluate the relevance and importance of each measure, and 3) a panel meeting to finalize the consensus. Figure 1 presents the procedure followed in the method. 2.2.1 Preconsultation and construction of the guidelines Once the panel group was established/constructed, a preconsultation meeting was proceeded to introduce panel members and outline the consensus procedure. Given geographic and time constraints, pre-consultation meetings were organized online to facilitate effective collaboration among panel members from different locations. For the similar reasons, and to reduce the bias that might occur in face-to-face discussions, and to combine diverse perspectives, produce well-rounded conclusions, the Steering Group developed an open-ended, semi structured questions based on themes and topics on specific recruitment strategies and techniques that can facilitate older adults' participation in physical interventions and research that emerged during the preconsultation meetings. This on-line questionnaire was sent out to each panel member. This approach helped ensure that all panel members had the opportunity to reflect on their knowledge and experiences and provide in depth and varied perspectives in proposing guidelines. All suggestions from panel members were shared with the group before reaching the initial consensus on the guidelines, allowing for further reflection and refinement. The panel members then met online to finalize consensus on the listed items. Some clearly repeating items were combined based upon agreement among the Panel of Expert Group and Steering Group. 2.2.2 First round Delphi survey Based on the consensus reached by the Panel of Experts Group on the initial recommendations, the Steering Group transformed these proposals into a set of items for evaluation by the External Review Group. The initial proposal listed 112 items across several key domains: stakeholder involvement, ethical principles and informed consent, inclusion/exclusion criteria, participant retention, and sociocultural diversity and differences. Each recommendation was evaluated for relevancy and importance using a 3-point scale (relevant, somewhat relevant, or not relevant) and a 10-point scale (1 = least important, 10 = most important), respectively. The first round of the survey took approximately 40 - 50 minutes to complete. Data collection took place between March and April 2024, with potential participants invited via email. All participants provided informed consent prior to completing the questionnaire. A total of 42 experts participated in the first round. Based on the first-round Delphi survey, the panel group reached a consensus on those to be retained for a second round of expert review. To establish consensus, the Panel of Experts and Steering Groups prioritized the percentage of agreement as the primary criterion for inclusion, while also considering mean scores. A 70% agreement threshold was set as the cutoff, in line with documented standards for practice guidelines (Kirk et al., 2024). For items that did not meet the 70% agreement threshold, the panel experts had two options: either to remove the recommendation or, if they unanimously agreed, to propose revisions for a second-round review. The panel also refined the initial proposal by merging duplicate measures and incorporating qualitative responses from the first survey to address gaps in the recommendations. 2.2.3 Second round Delphi survey A new set of items was used for next round of the external review survey. The questionnaire included a total of 60 items, which were evaluated for relevance and importance as in previous round. Experts from the External Review Group who had completed the first round of the survey were invited to participate. Responses were obtained from 31 of the 42 experts (a 74% response rate) between May and June 2024. The second-round survey used identical assessment scales as the first round. Following this round, the Steering Group conducted a descriptive analysis percentage of agreement, mean/SD) for each item. A summary of the descriptive analysis was then circulated among the Panel of Experts Group for final consensus on the guidelines. 2.2.4 Final consensus Based on the second-round Delphi results, the panel experts engaged in reiterative online discussions to reach a final consensus on the rated recommendations. Several key considerations guided this process: 1) the outcomes from each round of expert review, in particular, where external reviewers provided sufficient agreement, 2) the professional knowledge and practical experience of the panel members, and 3) the level of available evidence. The guidelines were subsequently formed based on these consensus points. It is important to note that following a side by side approach, we balanced the quantitative evidence from external reviews with the panel experts’ opinions and perspectives as they provide more nuanced, contextual justification for the guidelines. Figure 1 Guidelines development process using a formal consensus procedure and Delphi technique Data processing (steering group) Panel meetings: discussion of Delphi results Modifying initial proposal Final consensus meetings Panel meetings: Discussion of Delphi results Preconsultation Drafted guidelines proposal Panel of Experts Group (N = 12) 1st round of Delphi survey (response, N = 42) External Review Group (N = 42) Data processing (steering group) 2nd round of Delphi Survey (response, N = 31) October 2023 January 2024 March 2024 March to April 2024 April to May 2024 June 2024 July to August 2024 September to October 2024 3. RESULTS Achievement: Developed guidelines have been published in BMC Medical Research Methodology. D3.1, which aimed at guideline development, has been completed, and its results have been published in BMC Medical Research Methodology: Lee, S., Cyma-Wejchenig, M., Alcan, V. et al. Key considerations and recommendations for recruiting older adults in physical activity studies. BMC Med Res Methodol 25, 207 (2025). https://doi.org/10.1186/s12874-025-02659-2 In addition, D3.1 dissemination task was accomplished by presenting the results at 1) the PhysAgeNet & EGRAPA Conference 2025 (Trabzon, Turkey; May 7–9, 2025); and 2) the PhysAgeNet Training School (Gdansk, Poland; September 9–11, 2025). A summary of the results The panel experts, incorporating results from the Delphi survey (external review), reached a consensus on three key domains related to planning and implementing the recruitment of older adults. These include adherence to ethical principles, informed consent, and the involvement of stakeholders. In addition, to address key barriers—poor health and limited e-literacy, which are directly linked to techassisted PA interventions, a set of recommendations was proposed to facilitate older adults’ consent and participation. A total of 38 items were retained based on the final consensus. For the parsimony of the guidelines, the steering group and panel experts refined the (highly) duplicated measures. The guidelines reinforce the ethical approaches in research and practice, attaining the highest level of consensus among both panel experts and the external review. This includes considerations for privacy, confidentiality, and safety that align with autonomy and respect for older adults. Also, the voluntary nature of participation should be emphasized, and measures should be in place to address any concerns or questions that may arise throughout the recruitment process. Selected recommendations and experts’ agreement (%) and rating (Mean, SD) follows: Strength of the recommendation: strong Recommendation 1: Ensure anonymity and privacy are maintained when communicating with older adults. 93.5%, 9.23 (1.36) Recommendation 2: Ensure privacy when communicating information and assessing decision-making capacity. 83.9%, 8.58 (1.52) Recommendation 3: Provide assurance of confidentiality to participants and explain data handling protocols. 93.5%, 9.06 (1.36) Recommendation 4: Respect older adults as autonomous individuals and avoid treating them in a patronizing manner. 87.1%, 9.23 (1.38) Recommendation 5: Consent should be freely given and ongoing, without any negative consequences for withdrawal. 87.1%, 9.23 (1.31) Recommendation 6: 87.1%, 8.58 (1.31) Reassure participants about the privacy and security measures to build trust and reduce hesitancy related to data misuse, providing detailed information on data encryption, secure storage practices, and how their data will be used and accessed only by authorized personnel. Recommendation 7: Establish trust and clear communication channels with older adults. 80.6%, 8.77 (1.56) Relatedly, panel experts reached a strong consensus that informed consent should only be obtained after the researcher is confident that the participants understand the information. To ensure that both participants and caregivers are well-informed during the recruitment process, improving accessibility of information and consent materials is a priority. Consent materials should be tailored for participants with low literacy, using straightforward language and a simplified structure. Consent forms should be written in plain language, avoiding jargon and technical terms that may be difficult for non-medical audiences to understand. A clear timeline of procedures and activities, from recruitment to study completion, should be provided to participants in organized and clear format. This includes details on the purpose, how the data will be collected and used, and the measures in place to protect privacy. Visual aids such as pictures, diagrams or pictograms could be added to the information and consent form to improve comprehensibility. Selected recommendations and experts’ agreement (%) and rating (Mean, SD) follows: Strength of the recommendation: strong Recommendation 8: Make consent forms easier to understand by using clear, simple language instead of technical terms. 96.8%, 9.55 (0.85) Recommendation 9: Guarantee clarity and easy access to consent materials. 96.8%, 9.32 (1.14) Recommendation 10: Provide a clear description of the activities that older adults will undertake during their involvement in the research, from inclusion to conclusion. 96.8%, 9.00 (1.21) Recommendation 11: Emphasize in a lay description the potential immediate, long-term individual and group benefit(s) of the intervention. 96.8%, 8.97 (1.28) Recommendation 12: Explain in lay language the challenges older adults might face while taking part in the intervention tasks (physical limitations, time constraints, etc.) and the benefits. 93.5%, 8.97 (1.22) Recommendation 13: Tailor consent forms and informed sheets to a low literacy level, using clear, simple language instead of technical terms to ensure understanding. 90.3%, 9.00 (1.34) Recommendation 14: Improve accessibility for participants with impairments by using visual aids such as diagrams, pictures, videos, or audio presentations, and incorporating a large font size. 83.9%, 8.68 (1.45) Recommendation 15: Ensure explicit consent is obtained for observation or recording in home settings. 80.6%, 8.71 (1.44) Recommendation 16: 71.0%, 8.58 (1.41)