Acceptability of Two Perturbation-Based Balance Training Paradigms: Perturbation Treadmill versus Dynamic Stability Training in the Presence of Perturbations.

INTRODUCTION: Perturbation-based balance training (PBT) is promising for fall prevention in older adults, mimicking real-life fall situations at a person's stability thresholds to improve reactive balance. Hence, it can be associated with anxiety, but knowledge about the acceptability of PBT is scarce. METHOD: This is a secondary analysis of a randomized controlled trial comparing the effects of two different PBT paradigms that aims to evaluate and compare the acceptability of those training paradigms in fall-prone older adults. Participants (74.9 ± 5.7 years) who completed the training (6 weeks, 3x/week) on either a perturbation treadmill (PBTtreadmill: n = 22) or unstable surfaces in the presence of perturbations (PBTstability: n = 27) were surveyed on the acceptability of PBT using a 21-item questionnaire addressing seven domains (perceived effectiveness, tailoring, demand, safety, burden, devices, affective attitude), based on the theoretical framework of acceptability and context-specific factors. Relative scores (% of absolute maximum) for single items and domains were calculated. RESULTS: Median domain scores of perceived effectiveness, tailoring, safety, devices, and affective attitude were all ≥70% for both paradigms. The highest scores were obtained for tailoring (both paradigms = 100% [interquartile range 80-100%]). Domain scores of demand and burden were in the medium range (40-45%) for both paradigms. No significant differences between paradigms were found for any domain score. Two single items of safety differed significantly, with PBTtreadmill perceived as needing less support (p = 0.015) and leading less often to balance loss (p = 0.026) than PBTstability. CONCLUSION: PBT conducted on a perturbation treadmill or unstable surfaces is well accepted in this fall-prone older sample, even though it is conducted at individual stability thresholds. Tailoring may play a key role in achieving high levels of perceived effectiveness, appropriate levels of demand and burden, and a high sense of safety. PBT delivered on treadmills might be more appropriate for more anxious persons.

Real-time evaluation and adaptation to facilitate rapid recruitment in a large, prospective cohort study.

BACKGROUND: Recruiting large cohorts efficiently can speed the translation of findings into care across a range of scientific disciplines and medical specialties. Recruitment can be hampered by factors such as financial barriers, logistical concerns, and lack of resources for patients and clinicians. These and other challenges can lead to underrepresentation in groups such as rural residents and racial and ethnic minorities. Here we discuss the implementation of various recruitment strategies for enrolling participants into a large, prospective cohort study, assessing the need for adaptations and making them in real-time, while maintaining high adherence to the protocol and high participant satisfaction. METHODS: While conducting a large, prospective trial of a multi-cancer early detection blood test at Geisinger, an integrated health system in central Pennsylvania, we monitored recruitment progress, adherence to the protocol, and participants' satisfaction. Tracking mechanisms such as paper records, electronic health records, research databases, dashboards, and electronic files were utilized to measure each outcome. We then reviewed study procedures and timelines to list the implementation strategies that were used to address barriers to recruitment, protocol adherence and participant satisfaction. RESULTS: Adaptations to methods that contributed to achieving the enrollment goal included offering multiple recruitment options, adopting group consenting, improving visit convenience, increasing the use of electronic capture and the tracking of data and source documents, staffing optimization via leveraging resources external to the study team when appropriate, and integrating the disclosure of study results into routine clinical care without adding unfunded work for clinicians. We maintained high protocol adherence and positive participant experience as exhibited by a very low rate of protocol deviations and participant complaints. CONCLUSION: Recruiting rapidly for large studies - and thereby facilitating clinical translation - requires a nimble, creative approach that marshals available resources and changes course according to data. Planning a rigorous assessment of a study's implementation outcomes prior to study recruitment can further ground study adaptations and facilitate translation into practice. This can be accomplished by proactively and continuously assessing and revising implementation strategies.

Applying the 4Ps of social marketing to retain and engage participants in longitudinal cohort studies: generation 2 Raine study participant perspectives.

BACKGROUND: Investigations of participant retention in longitudinal health and medical research, document  strategies that work best but overlook social marketing's capacity to influence participant retention. After applying the social marketing framework: the idea that determining what longitudinal participants 'buy' (product), at what cost (price), in what location (place) and through which communication channels (promotion),  this paper  aims to inform and enhance retention efforts. METHODS: This qualitative study was conducted through in-depth interviews with participants from the Raine Study that began in Western Australia in 1989. The Generation 2 participants, initially enrolled into the Raine Study as babies by their parents (Generation 1), are now young adults invited to attend follow-up studies and tests every few years. Our study defined 'active' participants (n = 17) as those who agreed to attend their 27 year follow-up, and 'inactive' (n = 12) participants as those who had attended neither of the past two follow-ups (22 and 27 years). RESULTS: Raine Study participants experienced core, actual and augmented product benefits. Inactive participants focused on the costs (price) associated with participation, and were more likely to suggest tele-health (place) strategies to overcome barriers to follow-up attendance. Both active and inactive participants found professional processes and friendly staff made the Raine Study environment appealing, suggested that social media (promotion) was underutilised, and offered novel ideas to enhance engagement. CONCLUSIONS: Social marketing can support the development of differentiated strategies addressing the unique needs and wants of active and inactive participants. Sophisticated cohort segmentation can reach participants in a more meaningful way, reinforce the study 'brand' and guard against attrition.

Mixed methods evaluation to explore participant experiences of a pilot randomized trial to facilitate self-management of people living with stroke: Inspiring virtual enabled resources following vascular events (iVERVE).

INTRODUCTION: Despite digital health tools being popular for supporting self-management of chronic diseases, little research has been undertaken on stroke. We developed and pilot tested, using a randomized controlled design, a multicomponent digital health programme, known as Inspiring Virtual Enabled Resources following Vascular Events (iVERVE), to improve self-management after stroke. The 4-week trial incorporated facilitated person-centred goal setting, with those in the intervention group receiving electronic messages aligned to their goals, versus limited administrative messages for the control group. In this paper, we describe the participant experience of the various components involved with the iVERVE trial. METHODS: Mixed method design: satisfaction surveys (control and intervention) and a focus group interview (purposively selected intervention participants). Experiences relating to goal setting and overall trial satisfaction were obtained from intervention and control participants, with feedback on the electronic message component from intervention participants. Inductive thematic analysis was used for interview data and open-text responses, and closed questions were summarized descriptively. Triangulation of data allowed participants' perceptions to be explored in depth. RESULTS: Overall, 27/54 trial participants completed the survey (13 intervention: 52%; 14 control: 48%); and 5/8 invited participants in the intervention group attended the focus group. Goal setting: The approach was considered comprehensive, with the involvement of health professionals in the process helpful in developing realistic, meaningful and person-centred goals. Electronic messages (intervention): Messages were perceived as easy to understand (92%), and the frequency of receipt was considered appropriate (11/13 survey; 4/5 focus group). The content of messages was considered motivational (62%) and assisted participants to achieve their goals (77%). Some participants described the benefits of receiving messages as a 'reminder' to act. Overall trial satisfaction: Messages were acceptable for educating about stroke (77%). Having options for short message services or email to receive messages was considered important. Feedback on the length of the intervention related to specific goals, and benefits of receiving the programme earlier after stroke was expressed. CONCLUSION: The participant experience has indicated acceptance and utility of iVERVE. Feedback from this evaluation is invaluable to inform refinements to future Phase II and III trials, and wider research in the field. PATIENT OR PUBLIC CONTRIBUTION: Two consumer representatives sourced from the Stroke Foundation (Australia) actively contributed to the design of the iVERVE programme. In this study, participant experiences directly contributed to the further development of the iVERVE intervention and future trial design.

Experiences of parents whose children participated in a longitudinal follow-up study.

BACKGROUND: Long-term follow-up is necessary to understand the impact of perinatal interventions. Exploring parents' motives and experiences in consenting to their children taking part in longitudinal studies and understanding what outcomes are important to families may enhance participation and mitigate the loss to follow-up. As existing evidence is largely based on investigators' perspectives using Western samples, the present pilot study explored parents' perspectives in a multicultural New Zealand context. METHODS: Data were generated using semi-structured interviews with parents whose children had participated in a longitudinal study after neonatal recruitment. Parents' experiences of being part of the study were analysed thematically using an inductive approach. RESULTS: Parents (n = 16) were generally happy with the outcomes measured. Additionally, parents were interested in lifelong goals such as the impact of parental diabetes. We identified three themes: (1) Facilitators: Research participation was aided by motives and parent and research characteristics such as wishing to help others and straightforward recruitment; (2) Barriers: A hesitancy to participate was due to technical and clinical research aspects, participation burden and cultural barriers, such as complex wording, time commitment and nonindigenous research and (3) Benefits: Children and parents experienced advantages such as the opportunity for education. CONCLUSIONS: Parents reported positive experiences and described the unexpected benefit of increasing families' health knowledge through participation. Improvements for current follow-up studies were identified. Different ethnicities reported different experiences and perspectives, which warrants ongoing research, particularly with indigenous research participants. PATIENT OR PUBLIC CONTRIBUTION: No active partnership with parents of patients took place.

What does engagement mean to participants in longitudinal cohort studies? A qualitative study.

BACKGROUND: Engagement is important within cohort studies for a number of reasons. It is argued that engaging participants within the studies they are involved in may promote their recruitment and retention within the studies. Participant input can also improve study designs, make them more acceptable for uptake by participants and aid in contextualising research communication to participants. Ultimately it is also argued that engagement needs to provide an avenue for participants to feedback to the cohort study and that this is an ethical imperative. This study sought to explore the participants' experiences and thoughts of their engagement with their birth cohort study. METHODS: Participants were recruited from the Children of the 90s (CO90s) study. Qualitative semi-structured interviews were conducted with 42 participants. The interviews were transcribed verbatim, and uploaded onto Nvivo software. They were then analysed via thematic analysis with a constant comparison technique. RESULTS: Participants' experiences of their engagement with CO90s were broadly based on three aspects: communication they received from CO90s, experiences of ethical conduct from CO90s and receiving rewards from CO90s. The communication received from CO90s, ranged from newsletters explaining study findings and future studies, to more personal forms like annual greeting cards posted to each participant. Ethical conduct from CO90s mainly involved participants understanding that CO90s would keep their information confidential, that it was only involved in 'good' ethical research and their expectation that CO90s would always prioritise participant welfare. Some of the gifts participants said they received at CO90s included toys, shopping vouchers, results from clinical tests, and time off from school to attend data collection (Focus) days. Participants also described a temporality in their engagement with CO90s and the subsequent trust they had developed for the cohort study. CONCLUSION: The experiences of engagement described by participants were theorized as being based on reciprocity which was sometimes overt and other times more nuanced. We further provide empirical evidence of participants' expectation for a reciprocal interaction with their cohort study while highlighting the trust that such an interaction fosters. Our study therefore provides key insights for other cohort studies on what participants value in their interactions with their cohort studies.

Disseminating clinical study results to trial participants in Ethiopia: insights and lessons learned.

International regulatory authorities and funders require that research be disseminated promptly and appropriately to all involved stakeholders. However, following completion of clinical trials participants often either do not receive any feedback or materials provided are not appropriate for the context. The investigators of a multicentre anti-malarial clinical trial (the IMPROV study) conducted a dissemination meeting at one of the study sites in Ethiopia; trial participants and medical staff were provided feedback on the study results. This report summarizes the dissemination strategies adopted by the investigators, including a plain language visual aid and simple communication techniques. Lessons learned are reported with a discussion on the operational challenges to dissemination of clinical trials in resource limited settings.

Informing retention in longitudinal cohort studies through a social marketing lens: Raine Study Generation 2 participants' perspectives on benefits and barriers to participation.

BACKGROUND: Longitudinal cohort studies have made significant contributions to medical discoveries and provide the impetus for health interventions which reduce the risk of disease. Establishing and maintaining these cohorts is challenging and costly. While some attrition is unavoidable, maintaining a sufficient number of participants ensures that results remain representative and free from bias. Numerous studies have investigated ways to reduce attrition but few studies have sought to understand the experience of participants, and none have examined this through a social marketing framework. This first paper in a two part-series describes participants' experiences according to: benefits, barriers, motivators and influencers. The second paper uses this understanding to address issues relating to the 4Ps (product, price, place, promotion) of social marketing. METHODS: Participants were recruited from the Raine Study, a pregnancy cohort study that has been running in Western Australia since 1989. Qualitative interviews were conducted with 29 active and inactive participants from the Generation 2 cohort, who were originally enrolled in the Raine Study at birth by their parents (Generation 1). 'Active' participants (n = 17) were defined as those who agreed to attend their 27 year follow-up, while 'inactive' (n = 12) participants were defined as those who had not attended either of the past two follow-ups (at 22 and 27 years). RESULTS: There were considerable differences between active and inactive participants, with active participants perceiving far more personal and collective benefits from their participation. Inactive participants described being constrained by structural barriers around work and life, whereas active participants were able to overcome them to attend follow-ups. Inactive participants also described the value of extrinsic incentives which might motivate their attendance, and active participants described the role of their parents as significant influencers in their propensity to remain in the study. CONCLUSIONS: This paper provides rich descriptions of what participation in a long-running study means to participants. Use of a social marketing framework ensured that participants were constructed as 'human consumers' who are influenced by individual and broader social systems. Understanding participants in this way means that differentiated strategies can be tailored to enhance retention.

"It's a hard thing to manage when you're homeless": the impact of the social environment on smoking cessation for smokers experiencing homelessness.

BACKGROUND: Up to 80% of the adult homeless population use tobacco, and smoking cessation programs could offer an important opportunity to address preventable mortality and morbidity for this population. This population faces serious challenges to smoking cessation, including the impact of the social environment. METHODS: Forty participants (11 female; 29 male) from an ongoing smoking cessation randomized clinical trial conducted at 2 urban homeless shelters in the Upper Midwest were invited to take part in semi-structured interviews in 2016-2017. An interviewer used a semi-structured interview guide asking participants to describe their experience of how the social environment impacted their attempt to quit smoking. RESULTS: Participants described feeling pressure to smoke and drink in and around shelters, and that this pressure had led some to start smoking or resume smoking, along with making it very challenging to quit. Participants described being motivated to quit, and seeing smoking cessation as positively impacting the time and focus they felt they had for finding housing. However many felt more interested in reducing their smoking, rather than quitting. CONCLUSIONS: Addressing smoking cessation for people experiencing homelessness is both an important public health opportunity, and a challenge. There is a need to consider cessation in the context of the social and environmental factors impacting smokers who are experiencing homelessness. In particular, there is a need to address the collective value placed on smoking in social interactions. Despite these challenges, there are high levels of motivation and interest in addressing smoking. TRIAL REGISTRATION: NCT01932996 . Date of registration 30th August 2013. Prospectively registered.

Participant experiences in a feasibility trial of supervised exercise training in adults with venous leg ulcers: A qualitative study.

Exercise training can improve lower-limb cutaneous microvascular reactivity in adults with venous leg ulceration; however, there is a lack of research on patients' views about the acceptability and feasibility of exercise interventions. The aim of this study was to explore participants' experiences of the trial "Exploring the Feasibility of Implementing a Supervised Exercise Training and Compression Hosiery Intervention in Patients with Venous Ulceration" (FISCU). Semi-structured face-to-face and telephone interviews were used to investigate participants' experiences (n = 16) of taking part in the FISCU trial. Data were analysed using thematic analysis. Three overarching themes were identified, along with 11 sub-themes: (a) sedentary cautious living (because of pain and reduced mobility, treatment and perceived control, and advice to rest and be careful), (b) key components of the exercise trial (including motivation, an individualised intervention supervised by a specialist exercise professional, and satisfaction with the intervention), and (c) benefits of exercise (physical benefits and healing, psychological well-being, positive impact on comorbidities, and an improved self-management strategy). This study found that an exercise intervention was viewed by participants as positive, acceptable, and feasible while living with a venous leg ulcer. An individualised and supervised exercise programme was key to build confidence to exercise.

Empowering the Participant Voice (EPV): Design and implementation of collaborative infrastructure to collect research participant experience feedback at scale.

Empowering the Participant Voice (EPV) is an NCATS-funded six-CTSA collaboration to develop, demonstrate, and disseminate a low-cost infrastructure for collecting timely feedback from research participants, fostering trust, and providing data for improving clinical translational research. EPV leverages the validated Research Participant Perception Survey (RPPS) and the popular REDCap electronic data-capture platform. This report describes the development of infrastructure designed to overcome identified institutional barriers to routinely collecting participant feedback using RPPS and demonstration use cases. Sites engaged local stakeholders iteratively, incorporating feedback about anticipated value and potential concerns into project design. The team defined common standards and operations, developed software, and produced a detailed planning and implementation Guide. By May 2023, 2,575 participants diverse in age, race, ethnicity, and sex had responded to approximately 13,850 survey invitations (18.6%); 29% of responses included free-text comments. EPV infrastructure enabled sites to routinely access local and multi-site research participant experience data on an interactive analytics dashboard. The EPV learning collaborative continues to test initiatives to improve survey reach and optimize infrastructure and process. Broad uptake of EPV will expand the evidence base, enable hypothesis generation, and drive research-on-research locally and nationally to enhance the clinical research enterprise.

Participant Perceptions in a Long-term Clinical Trial of Autosomal Dominant Polycystic Kidney Disease.

Rationale & Objective: The development of new therapies for autosomal dominant polycystic kidney disease requires clinical trials to be conducted efficiently. In this study, the factors affecting the recruitment and retention of participants enrolled in a 3-year randomized controlled trial in autosomal dominant polycystic kidney disease were investigated. Study Design: Qualitative study. Setting & Participants: All participants (N=187) were invited to complete a 16-item questionnaire at the final study visit of the primary trial. Participants were recruited to complete a semistructured interview using purposeful sampling according to age, self-reported gender, and randomization group. Analytical Approach: Descriptive statistics were used for demographic data and questionnaires. The interview transcripts underwent inductive thematic coding. Results: One hundred and forty-six of the 187 randomized participants (79%) completed the post-trial questionnaire, and 31 of the 187 participants (21%) completed the interview. Most participants (94%) rated their global satisfaction with the trial as high (a score of 8 or more out of 10). Altruism, knowledge gain, and access to new treatments were the main motivators for recruitment. The main reasons for considering leaving the study were concerns about the risk of intervention and family or work issues. Strategies that favored retention included flexibility in attending different study sites, schedule flexibility, staff interactions, and practical support with parking and reminders. The main burden was time away from work with lost wages, and burden associated with magnetic resonance imaging scans and 24-hour urine output collections. Limitations: The study population was restricted to participants in a single nondrug clinical trial, and the results could be influenced by selection and possible social desirability bias. Conclusions: Participants reported high levels of satisfaction that occurred as a function of the trial meeting participants' expectations. Furthermore, retention was a balance between the perceived benefits and burden of participation. Consideration of these perspectives in the design of future clinical trials will improve their efficiency and conduct. Plain-Language Summary: Advances in the clinical practice of autosomal dominant polycystic kidney disease (ADPKD) require affected individuals to voluntarily participate in long-term multicenter randomized controlled trials (RCTs). In this qualitative post hoc study of a 3-year RCT of increased water intake in ADPKD, altruism, knowledge gain, and access to a nondrug treatment positively influenced the decision to volunteer. Ongoing participation was enabled by building flexibility into the study protocol and staff prioritizing a participant's needs during study visits. Although participants completed the required tests, most were considered burdensome. This study highlights the importance of incorporating protocol flexibility into trial design; the preference for interventions with a low risk of adverse effects; and the urgent requirement for robust surrogate noninvasive biomarkers to enable shorter RCTs in ADPKD.

Participant and research team perspectives on the conduct of a remote therapeutic COVID-19 clinical trial: A mixed methods approach.

Background: Responding to the need to investigate potential treatments of COVID-19, a research team employed a telehealth platform to determine whether niclosamide, an oral anthelmintic drug that had shown antiviral activity, reduced SARS-CoV-2 shedding and duration of symptoms in patients with mild-to-moderate symptoms of COVID-19. To encourage compliance with patient self-quarantine, this randomized placebo-controlled clinical trial was conducted utilizing a remote telehealth design to complete all study visits, monitor symptoms, and coordinate participant self-collected specimens. Methods: A mixed methods approach employing surveys and interviews of trial participants and interviews of research team members was used to collect their experiences with and perspectives on the acceptability of the remote clinical trial design and delivery. Results: Of the 67 eligible trial participants invited to take part in a study to evaluate the telehealth platform, 46% (n = 31) completed a post-participation survey. While 97% (n = 30) of respondents had not previously participated in a clinical trial, 77% (n = 24) reported they would consider taking part in a future remote research study. The majority of respondents were moderately or very comfortable (93%) with using the technology. Conclusions: The COVID-19 crisis was a call to action to expand understanding of the conduct of remote clinical trials, including the experiences of research participants. Our findings showed that this approach can be both effective for the conduct of research and positive for participants. Further research on the use of telehealth research platforms seems warranted in rural, underserved populations, and remote trials of prevention, screening, and treatment.

Digital prevention of depression for farmers? A qualitative study on participants' experiences regarding determinants of acceptance and satisfaction with a tailored guided internet intervention program.

Introduction: Farmers, forest workers and gardeners have a higher risk of developing depression compared to other occupational populations. As part of the German pilot project "With us in balance", the potential of six guided internet- and mobile-based interventions (IMIs) to prevent depression among their insurants is examined. The IMI program is tailored to various risk factors of depression, individual symptoms, and needs. Although IMIs have been shown to be effective in reducing depressive symptoms, there is little qualitative research about the acceptance of digital preventive IMIs. The aim of this qualitative study is to gain insights into participants' experiences with the guided IMIs by focusing on determinants for acceptance and satisfaction. Methods: Semi-structured interviews were conducted with 22/171 (13 %) intervention group (IG) participants of a randomized controlled trial. The interview guide was developed based on theoretical models of user acceptance (Unified Theory of Acceptance and Use of Technology) and patient satisfaction (evaluation model, discrepancy theory). The interviews were evaluated independently by two coders performing a deductive-inductive content analysis and attaining a substantial level of agreement (K = 0.73). Results: The qualitative analysis revealed 71 determinants for acceptance and satisfaction across ten dimensions: performance expectancy, organisation, e-coach, usability, training content and structure, training usage, training outcome, financing, social influence, and behavioural intention. The most frequently identified drivers for the IMI use include "location independence", "positive relationship to the e-coach" (each n = 19, 86 %), "personal e-coach guidance", "expertise of the e-coach", "target group specific adaptation" (each n = 18, 82 %), "flexibility", "high willingness for renewed participation" (each n = 17, 77 %), "fast and easy availability", "training of health enhancing attitudes and behaviours" and "content with figurative expressions" (each n = 16, 73 %). Discussion: The qualitative findings predominantly suggest the acceptance of and satisfaction with the IMI program for the prevention of depression in famers and related lines of work. Many identified positive drivers are related to the e-coach guidance, which emphasizes its importance in the preventive setting from the perspective of the participants. Nevertheless, some negative aspects have been identified which help to understand potential weaknesses of the IMI program. Participants indicated different needs in terms of IMI content and usage, which points towards the potential benefit of individualisation. The possibility of being able to use IMIs anonymously, flexibly and independently of location might be highly relevant for this specific target group.

How does qualitative data collection modality affect disclosure of sensitive information and participant experience? Findings from a quasi-experimental study.

Focus groups (FGs) and individual interviews (IDIs) can be conducted in-person or in several different online contexts. We conducted a quasi-experimental study and assessed sharing of sensitive or dissenting information and participant comfort in FGs and IDIs across four modalities: (1) in-person, (2) online video-based, (3) online chat-based (synchronous), and (4) online email/message board-based (asynchronous). Participants were systematically assigned to one of the four modalities and randomized to one of 24 FGs or 48 IDIs (N = 171). The study topic was medical risk during pregnancy. All participants also completed a survey on their perceptions of the data collection process. We found no significant difference in the frequency of disclosure of sensitive information by modality. Text-based FGs (chat and message board) were more likely to contain dissenting opinions than visually-based FGs (in-person and video). Participants also reported feeling less rapport and personal comfort in sharing information in the FG video modality than other modalities. These findings provide initial data that can guide researchers in choosing among data collection modalities to maximize participant engagement and comfort.

User Experience of the Co-design Research Approach in eHealth: Activity Analysis With the Course-of-Action Framework.

BACKGROUND: The cocreation of eHealth solutions with potential users, or co-design, can help make the solution more acceptable. However, the co-design research approach requires substantial investment, and projects are not always fruitful. Researchers have provided guidelines for the co-design approach, but these are either applicable only in specific situations or not supported by empirical data. Ways to optimize the experience of the co-design process from the point of view of the participants are also missing. Scientific literature in the co-design field generally provides an extrinsic description of the experience of participants in co-design projects. OBJECTIVE: We addressed this issue by describing a co-design project and focusing on the participants' experiences looking at what was significant from their point of view. METHODS: We used a qualitative situated cognitive anthropology approach for this study. Data were collected on a co-design research project that aimed to support the help-seeking process of caregivers of functionally dependent older adults. The methodology was based on the perspective of experience by Dewey and used the course-of-action theoretical and methodological framework. Data collection was conducted in 2 phases: observation of participants and recording of sessions and participant self-confrontation interviews using the session recordings. We interviewed 27% (20/74) of the participants. We analyzed the data through nonexclusive emerging categorization of themes using the constant comparative method. RESULTS: In total, 5 emerging themes were identified. The perception of extrinsic constraints and the effects of the situation was central and the most important theme, affecting other themes (frustrating interactions with others, learning together, destabilization, and getting personal benefits). Co-occurrences between codes allowed for a visual and narrative understanding of what was significant for the participants during this project. The results highlighted the importance of the role of the research team in preparing and moderating the sessions. They also provided a detailed description of the interactions between participants during the sessions, which is a core aspect of the co-design approach. There were positive and negative aspects of the participants' experiences during this co-design project. Reflecting on our results, we provided potential affordances to shape the experience of participants in co-design. CONCLUSIONS: Potential users are an essential component of the co-design research approach. Researchers and designers should seek to offer these users a positive and contributory experience to encourage participation in further co-design initiatives. Future research should explore how the proposed affordances influence the success of the intervention.

Telemedicine compared to standard face-to-face care for continuous positive airway pressure treatment: real-world Australian experience.

STUDY OBJECTIVES: We tested a telemedicine model of care to initiate continuous positive airway pressure (CPAP) for patients with obstructive sleep apnea (OSA) living in remote Western Australia. METHODS: A prospective study comparing telemedicine for CPAP initiation in a remote population versus standard face-to-face CPAP initiation in a metropolitan population. The primary outcome was average nightly CPAP use in the final week of a CPAP trial. RESULTS: A total of 186 participants were allocated to either telemedicine (n = 56) or standard care (n = 130). The average distance from the study center for the telemedicine group was 979 km (±792 km) compared to 19 km (±14 km) for the standard care group. The CPAP trial duration in the standard care group was less than the telemedicine group (37.6 vs 69.9 days, p < .001). CPAP adherence in the telemedicine group was not inferior to standard care (Standard 4.7 ± 0.2 h, Telemedicine 4.7 ± 0.3 h, p = 0.86). No differences were found between groups in residual apnea-hypopnea index, symptom response, sleep specific quality of life at the end of the trial, and continued CPAP use (3-6 months). Participant satisfaction was high in both groups. Total health care costs of the telemedicine model were less than the standard model of care. An estimated A$4538 per participant in travel costs was saved within the telemedicine group by reducing the need to travel to the sleep center for in-person management. CONCLUSIONS: In remote dwelling adults starting CPAP for the treatment of OSA, outcomes using telemedicine were comparable to in-person management in a metropolitan setting.

Zoom, Zoom, Baby! Assessing Mother-Infant Interaction During the Still Face Paradigm and Infant Language Development via a Virtual Visit Procedure.

The COVID-19 pandemic has necessitated innovations in data collection protocols, including use of virtual or remote visits. Although developmental scientists used virtual visits prior to COVID-19, validation of virtual assessments of infant socioemotional and language development are lacking. We aimed to fill this gap by validating a virtual visit protocol that assesses mother and infant behavior during the Still Face Paradigm (SFP) and infant receptive and expressive communication using the Bayley-III Screening Test. Validation was accomplished through comparisons of data (i.e., proportions of missing data for a given task; observed infant and maternal behaviors) collected during in-person laboratory visits and virtual visits conducted via Zoom. Of the 119 mother-infant dyads who participated, 73 participated in lab visits only, 13 participated in virtual visits only, and 33 dyads participated in a combination of lab and virtual visits across four time points (3, 6, 9, and 12 months). Maternal perspectives of, and preferences for, virtual visits were also assessed. Proportions of missing data were higher during virtual visits, particularly for assessments of infant receptive communication. Nonetheless, comparisons of virtual and laboratory visits within a given time point (3, 6, or 9 months) indicated that mothers and infants showed similar proportions of facial expressions, vocalizations and directions of gaze during the SFP and infants showed similar and expected patterns of behavioral change across SFP episodes. Infants also demonstrated comparable expressive and receptive communicative abilities across virtual and laboratory assessments. Maternal reports of ease and preference for virtual visits varied by infant age, with mothers of 12-month-old infants reporting, on average, less ease of virtual visits and a preference for in-person visits. Results are discussed in terms of feasibility and validity of virtual visits for assessing infant socioemotional and language development, and broader advantages and disadvantages of virtual visits are also considered.

Mindfulness as Relational: Participants' Experience of Mindfulness-based Programs Are Critical to Fidelity Assessments.

Mindfulness outcome research has been criticized for issues in research design, precision of outcome measures, and reporting overoptimistically their power to effect change. Although mindfulness programs are a complex interaction of teachers, teachings, and participants, it is of some concern that current assessments of program fidelity focus primarily on teacher skills and program content delivery. Although ensuring that teachers are trained to criteria and adhere to program elements, the participants' engagement, a critical parameter contributing to outcomes of mindfulness programs, has been neglected. Furthermore, the assessment measures are primarily actuarial even when assessing experiential or difficult-to-define aspects of teacher-participant interactions. The inclusion of the participants' experience of the program as a component of fidelity assessments creates several opportunities to deepen our understanding of how mindfulness impacts the lives of practitioners. By investigating the teacher-participant relationship, determining how participants process the core elements, and exploring the implementation of the practices in their lives, a more nuanced understanding of the capacity of mindfulness-based programs to effect positive change may be possible.

Evaluation of Nasopharyngeal Swab Collection Techniques for Nucleic Acid Recovery and Participant Experience: Recommendations for COVID-19 Diagnostics.

Nasopharyngeal swabs are critical to the diagnosis of respiratory infections including coronavirus disease 2019, but collection techniques vary. We compared 2 recommended nasopharyngeal swab collection techniques in adult volunteers and found that swab rotation following nasopharyngeal contact did not recover additional nucleic acid (as measured by human DNA/RNA copy number). Rotation was also less tolerable for participants. Notably, both discomfort and nucleic acid recovery were significantly higher in Asian participants, consistent with nasal anatomy differences. Our results suggest that it is unnecessary to rotate the swab in place following contact with the nasopharynx and reveal that procedural discomfort levels can differ by ethnicity.