Trial Implementation Research Articles

A Nonrandomized Pilot Implementation Trial of the CLASS PAL (Physically Active Learning) Project

ABSTRACT Purpose To determine the a) implementation of CLASS PAL (Physically Active Learning), b) implementation process of CLASS PAL, and c) influence of the inner setting (i.e., school) and individuals (teachers and pupils) on the implementation of CLASS PAL. Methods CLASS PAL is a co-produced movement integration (MI) intervention that includes a professional development workshop for teachers and bespoke teaching resources. This study was a nonrandomized pragmatic pilot implementation trial using a mixed-methods design. Ten year-5 teachers and 232 pupils from seven state-funded UK primary schools participated. Data were collected over one academic year via mixed methods at multiple levels (school and individual) and timepoints. All qualitative data were analyzed using a priori thematic analyses, and quantitative data were summarized using descriptive statistics. Results Implementation: Teacher-reported MI activities were delivered on average 2 d·wk−1 (and once per day). The most frequently delivered activities were movement breaks (2.8 d·wk−1) and physically active routines (2.4 d·wk−1), with the majority lasting <5 min. One hundred percent of attendees rated both the professional development workshop and practical content of the workshop as “quite useful/very useful;” however, the resources on the website were only utilized by 30% of teachers. Implementation process: Teachers primarily amended personal resources, with only 5% of deliveries supported by resources from the CLASS PAL website/workshop. Inner setting/individuals: Teachers reported barriers including classroom misbehavior, curriculum pressures, and access to resources. Facilitators to MI included the intervention workshop and senior school leadership support. Conclusion Teachers receiving a low touch professional development and resource program reported regular implementation of MI. A key implementation strategy was teacher-level decisions. In relation to the influence of the inner setting/individuals, a range of factors which operated at pupil, school, and teacher levels were identified. Further work is required to understand how best to support MI implementation.

Therapeutic prospects of nectin-4 in cancer: applications and value.

Nectin-4 is a Ca2+-independent immunoglobulin-like protein that exhibits significantly elevated expression in malignant tumors while maintaining extremely low levels in healthy adult tissues. In recent years, overexpression of Nectin-4 has been implicated in tumor occurrence and development of various cancers, including breast cancer, urothelial cancer, and lung cancer. In 2019, the Food and Drug Administration approved enfortumab vedotin, the first antibody-drug conjugate targeting Nectin-4, for the treatment of urothelial carcinoma. This has emphasized the value of Nectin-4 in tumor targeted therapy and promoted the implementation of more clinical trials of enfortumab vedotin. In addition, many new drugs targeting Nectin-4 for the treatment of malignant tumors have entered clinical trials, with the aim of exploring potential new indications. However, the exact mechanisms by which Nectin-4 affects tumorigenesis and progression are still unclear, and the emergence of drug resistance and treatment-related adverse reactions poses challenges. This article reviews the diagnostic potential, prognostic significance, and molecular role of Nectin-4 in tumors, with a focus on clinical trials in the field of Nectin-4-related tumor treatment and the development of new drugs targeting Nectin-4.

PENGEMBANGAN BAHAN AJAR MOBILE LEARNING PADA MATERI PELUANG UNTUK MENINGKATKAN KEMAMPUAN KOMUNIKASI MATEMATIS SISWA SMK

The background of this research is the lack of flexibility in the teaching materials used in learning. The use of less interesting teaching materials reduces students' interest in learning and their mathematical communication skills tend to be low. Technological advances require developers to develop interesting and flexible teaching materials. This research aims to: (1) Describe the process of developing mobile learning teaching materials to improve vocational school students' mathematical communication skills, (2) Find out the feasibility of mobile learning teaching materials to improve vocational school students' mathematical communication skills, (3) Find out the effectiveness of mobile learning teaching materials for improve vocational school students' mathematical communication skills. This research uses the Borg and Gall development model. Validation tests were carried out by 2 material experts and 2 media experts. Product trials were carried out in 2 stages, namely limited group trials and field implementation trials. This development obtained the results of the validity of teaching materials by media experts with a percentage of 85% in the valid category. The results of the validity of teaching materials by material experts with a percentage of 89% are in the valid category. The results of the practicality of teaching materials were obtained from the analysis of user activity observations, the percentage of students asking questions was 20% with the criteria that they could be used without revision. Meanwhile, the results of the teacher response questionnaire obtained a percentage of 97% with very practical criteria for use in learning. The student response questionnaire obtained a percentage of 95%, the criteria were very effectively used.

Optimizing Vaccine Trials for Enteric Diseases: The Enterics for Global Health (EFGH) Shigella Surveillance Study.

In this introductory article, we describe the rationale for the Enterics for Global Health (EFGH) Shigella surveillance study, which is largely to optimize the design and implementation of pivotal Shigella vaccine trials in the target population of infants and young children living in low- and middle-income countries. Such optimization will ideally lead to a shorter time to vaccine availability in the target population. We also provide a brief description of the articles included in the supplement.

Diarrhea Case Surveillance in the Enterics for Global Health Shigella Surveillance Study: Epidemiologic Methods.

Shigella is a leading cause of acute watery diarrhea, dysentery, and diarrhea-attributed linear growth faltering, a precursor to stunting and lifelong morbidity. Several promising Shigella vaccines are in development and field efficacy trials will require a consortium of potential vaccine trial sites with up-to-date Shigella diarrhea incidence data. The Enterics for Global Health (EFGH) Shigella surveillance study will employ facility-based enrollment of diarrhea cases aged 6-35 months with 3 months of follow-up to establish incidence rates and document clinical, anthropometric, and financial consequences of Shigella diarrhea at 7 country sites (Mali, Kenya, The Gambia, Malawi, Bangladesh, Pakistan, and Peru). Over a 24-month period between 2022 and 2024, the EFGH study aims to enroll 9800 children (1400 per country site) between 6 and 35 months of age who present to local health facilities with diarrhea. Shigella species (spp.) will be identified and serotyped from rectal swabs by conventional microbiologic methods and quantitative polymerase chain reaction. Shigella spp. isolates will undergo serotyping and antimicrobial susceptibility testing. Incorporating population and healthcare utilization estimates from contemporaneous household sampling in the catchment areas of enrollment facilities, we will estimate Shigella diarrhea incidence rates. This multicountry surveillance network will provide key incidence data needed to design Shigella vaccine trials and strengthen readiness for potential trial implementation. Data collected in EFGH will inform policy makers about the relative importance of this vaccine-preventable disease, accelerating the time to vaccine availability and uptake among children in high-burden settings.

Global Disparities in Access to Vaccine Clinical Trials: A Review of the Literature.

Vaccines are an effective tool to reduce the disease burden from infectious diseases on a population, infrastructural, and individual level. Before vaccines can be administered to populations at large, they must go through rigorous testing in the form of clinical trials. While vaccine trials can be used to assess the efficacy of interventions on a local populace as well as target local endemic diseases, most clinical trials are sponsored and conducted by companies in high-income countries (HICs). This can lead to vaccines that are not optimized for low- and middle-income countries (LMICs) and that often neglect to address diseases specific to the local population. This narrative review aims to explore the factors leading to discrepancies in the execution of and access to vaccine trials between HICs and LMICs, thus guiding future efforts in confronting them. This review was written using the literature sourced from the PubMed database and supplemented with articles from Google Scholar along with grey literature. Several themes are highlighted including poorly defined regulatory and ethical guidelines, staff shortages, lack of research infrastructure, and logistical barriers. We discuss how these challenges have affected vaccine development in various capacities through case examples of SARS-CoV-2, poliovirus, and malaria. Many challenges remain in equitable vaccine clinical trial development and implementation. Facilitating the implementation of locally sponsored vaccine clinical trials in LMICs may be one avenue to address these challenges. In doing so, LMICs can become active stakeholders in the health of their citizens by addressing endemic diseases, tailoring vaccine specifications based on local needs, and implementing wide-scale vaccine access and delivery.

Matters of Fidelity: School Provider Adherence and Competence in a Clustered Study of Adaptive Implementation Strategies

ABSTRACT Schools are a promising access point for youth with mental health concerns, but school-based mental health professionals (SPs) often need ongoing support to provide high-fidelity cognitive behavioral therapy (CBT). Adherence and competence, two critical elements of fidelity, were examined in a cluster-randomized implementation trial. We evaluated CBT adherence and then triangulated CBT adherence with end-of-study competence. We then evaluated the effects of two implementation supports, Coaching and (for slower-responding schools) Facilitation, on adherence and competence. By the end of the 43-week study period, 27.8% of SPs met adherence criteria. Adherent SPs scored higher on the competence measure, the CBT Competence Scale (t(116.2) = 3.71, p < .001). No significant difference in adherence was found among SPs at schools assigned to Coaching vs. not (Δ = 6.0%, p = .385), however SPs at schools randomized to Coaching scored significantly higher on two of the four competence subscales (Non-Behavioral and Behavioral skills). Among slower-responder schools, SPs at schools assigned to Facilitation were more likely to demonstrate adherence (Δ = 16.3%, p = .022), but there was no effect of Facilitation on competence. Approximately one quarter of SPs met adherence criteria in the trial; adequate delivery of exposure was a primary obstacle to reaching adherence. Facilitation may be especially suited to help SPs overcome barriers to delivery, whereas Coaching may be especially suited to help SPs improve CBT competence. Both are likely needed to build a mental health work force with the competence and ability to deliver EBPs in schools.

Abstract 999: Clinical trial matchmaking: Connecting sites to sponsors

Abstract Background: Oncology programs may encounter many challenges engaging in clinical trials. The Association of Community Cancer Center’s (ACCC) Community Oncology Research Institute (ACORI) conducted a survey to gather insights on barriers to clinical trial provision and implementation, patient recruitment, and identifying resources to support cancer programs. Methods: A survey of 29 questions was administered via Qualtrics. The survey focused on research-naïve sites (i.e., sites with little to no clinical research experience). Survey recipients were identified from ACCC’s membership database, and the survey was open from May 5 to October 10, 2023. One survey response was captured per program. Results: Of the 350 respondents, most were physicians, investigators, or oncology fellows (20%), directors/administrators (16%), patient navigators (12%), and APPs (12%). Responding programs were categorized as a comprehensive community cancer program (28%), community practice (26%), or academic medical center (21%). Eighty percent of respondents indicated their program currently conducts clinical research. The most common challenges included: patient recruitment (40%), limited staffing (36%), limited clinician time (32%), and lack of training in research administration and conduct (25%). The top 3 resources desired were communication about clinical research opportunities (65%), connections to clinical trial sponsors (49%), and clinical research coordinator training (41%). Conclusions: Survey results showed a clear need for improved communication regarding clinical research opportunities, connections to clinical trial sponsors, and education around clinical trial implementation. Data from this survey will be used to match sites with trial sponsors, especially sites that serve patients with cancer from under resourced geographic, socioeconomic, racial, and ethnic groups. Future efforts will seek to engage clinical trial sponsors in improving trial engagement and feasibility, workforce support, training, and clinical mentorship. Citation Format: Lyndsey Griffin, Latha Shivakumar, Leigh Boehmer, Savannah Dodson, Elana Plotkin, Sumanta Pal, Al B. Benson. Clinical trial matchmaking: Connecting sites to sponsors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 999.

Clinical Outcomes With Electronic Nudges to Increase Influenza Vaccination : A Prespecified Analysis of a Nationwide, Pragmatic, Registry-Based, Randomized Implementation Trial.

In the NUDGE-FLU (Nationwide Utilization of Danish Government Electronic letter system for increasing inFLUenza vaccine uptake) trial, electronic letters incorporating cardiovascular (CV) gain-framing and repeated messaging increased influenza vaccination by approximately 1 percentage point. To evaluate the effects of the successful nudging interventions on downstream clinical outcomes. Prespecified exploratory analysis of a nationwide randomized implementation trial. (ClinicalTrials.gov: NCT05542004). The 2022 to 2023 influenza season. 964 870 Danish citizens aged 65 years or older. Usual care or 9 different electronically delivered behavioral nudging letters. Cardiovascular, respiratory, and other clinical end points during follow-up from intervention delivery (16 September 2022) through 31 May 2023. The analysis set included 691 820 participants. Hospitalization for pneumonia or influenza occurred in 3354 of 346 327 (1.0%) participants in the usual care group, 396 of 38 586 (1.0%) in the CV gain-framing group (hazard ratio [HR], 1.06 [95% CI, 0.95 to 1.18]; versus usual care), and 403 of 38 231 (1.1%) in the repeated letter group (HR, 1.09 [CI, 0.98 to 1.21]; versus usual care). In the usual care group, 44 682 (12.9%) participants were hospitalized for any cause, compared with 5002 (13.0%) in the CV gain-framing group (HR, 1.00 [CI, 0.97 to 1.03]; versus usual care) and 4965 (13.0%) in the repeated letter group (HR, 1.01 [CI, 0.98 to 1.04]; versus usual care). A total of 6341 (1.8%) participants died in the usual care group, compared with 721 (1.9%) in the CV gain-framing group (HR, 1.02 [CI, 0.94 to 1.10]; versus usual care) and 646 (1.7%) in the repeated letter group (HR, 0.92 [CI, 0.85 to 1.00]; versus usual care). Prespecified but exploratory analysis, potential misclassification of events in routinely collected registry data, and results may not be generalizable to other health systems or countries with other racial compositions and/or cultural or societal norms. In a prespecified exploratory analysis, modest increases in influenza vaccination rates seen with electronic nudges did not translate into observable improvements in clinical outcomes. Seasonal influenza vaccination should remain strongly recommended. Sanofi.

Virtual Court Communication Implementation: Studies on the Implementation of Online Criminal Trials in Courts

Virtual Court Communication Implementation: Studies on the Implementation of Online Criminal Trials in Courts

Leveraging digital agriculture for on-farm testing of technologies

The Precision Nitrogen Project (PNP) worked with more than 80 corn and winter wheat producers to inexpensively design and implement randomized, replicated field strip trials on whole commercial farm fields, and to provide site-specific testing of current nitrogen (N) technologies. This article proposes a conceptual framework and detailed procedure to select the N technology to be tested; design and implement field trials; generate, process, and manage field trial data; and automatically analyze, report, and share benefits from precision N technology. The selection of the N technology was farmer-driven to ensure a good fit and to increase the likelihood of future technology adoption. The technology selection method was called the “N tiered approach”, which consisted of selecting a technology that progressively increases the level of complexity without exceeding the farmer’s learning process or farm logistic constraints. The N tools were classified into (1) crop model-based, (2) remote sensing-based, (3) enhanced efficiency fertilizers, and (4) biologicals. Field strip trials comparing producers’ traditional management and the selected N technology were combined with site-specific N rate blocks placed in contrasting areas of the fields. Yield data from the N rate blocks was utilized to derive the site-specific optimal N rate. The benefits of current N technologies were quantified by comparing their yield, profit, and N use efficiency (NUE) to growers’ traditional management and to the estimated site-specific optimal N rate. Communication of the trial results back to the growers was crucial to ensure the promotion and adoption of these N technologies farm wide. The framework and overall benefits from N technologies was presented and discussed. The proposed framework allowed researchers, agronomists, and farmers to carry out on-farm precision N experimentation using novel technologies to quantify benefits of digital ag technology and promote adoption.

Pengembangan Media Pembelajaran Berbasis Video Menggunakan Aplikasi Tiktok pada Materi Akhlaq Berpakaian

This study aims to develop video-based learning media using the TikTok application for clothing morals material. This research refers to the development research method with the ADDIE model. Data collection techniques used learning expert validation tests and product trials on research subjects (class XI B students at MA Al-Hasyimiyah). Meanwhile, data analysis uses qualitative and quantitative analysis. The development results obtained a feasibility percentage of 95% (expert validation test) and 89.7% (group test questionnaire), so it was declared valid or suitable for use. Meanwhile, based on product implementation trials, it was found that it was effectively able to increase student learning outcomes by 12.4%. So this development study concludes that the clothing morals learning video product developed is valid and suitable for use in improving students' understanding and learning outcomes.

A qualitative analysis of community health worker perspectives on the implementation of the preconception and pregnancy phases of the Bukhali randomised controlled trial.

Community health workers (CHWs) play an important role in health systems in low- and middle-income countries, including South Africa. Bukhali is a CHW-delivered intervention as part of a randomised controlled trial, to improve the health trajectories of young women in Soweto, South Africa. This study aimed to qualitatively explore factors influencing implementation of the preconception and pregnancy phases of Bukhali, from the perspective of the CHWs (Health Helpers, HHs) delivering the intervention. As part of the Bukhali trial process evaluation, three focus group discussions were conducted with the 13 HHs employed by the trial. A thematic approach was used to analyse the data, drawing on elements of a reflexive thematic and codebook approach. The following six themes were developed, representing factors impacting implementation of the HH roles: interaction with the existing public healthcare sector; participant perceptions of health; health literacy and language barriers; participants' socioeconomic constraints; family, partner, and community views of trial components; and the HH-participant relationship. HHs reported uses of several trial-based tools to overcome implementation challenges, increasing their ability to implement their roles as planned. The relationship of trust between the HH and participants seemed to function as one important mechanism for impact. The findings supported a number of adaptations to the implementation of Bukhali, such as intensified trial-based follow-up of referrals that do not receive management at clinics, continued HH training and community engagement parallel to trial implementation, with an increased emphasis on health-related stigma and education. HH perspectives on intervention implementation highlighted adaptations across three broad strategic areas: navigating and bridging healthcare systems, adaptability to individual participant needs, and navigating stigma around disease. These findings provide recommendations for the next phases of Bukhali, for other CHW-delivered preconception and pregnancy trials, and for the strengthening of CHW roles in clinical settings with similar implementation challenges. Trial registration: Pan African Clinical Trials Registry; PACTR201903750173871, Registered March 27, 2019.

Breast Cancer Management: The Role of Nutrition, Exercise and Psychosocial Well-being

Background: Breast cancer incidence and mortality rates are rising worldwide, which presents a formidable challenge for women. The advancement of targeted drug therapies offers promising avenues for treatment, but resource constraints prevent their widespread implementation in advanced clinical trials, highlighting the need for sustained research funding. Nutritional support is critical in cancer management, affecting key cancer hallmarks. The anti-inflammatory effects of exercise and a healthy diet are critical in reducing cancer incidence and tumor growth. A comprehensive approach to breast cancer treatment requires addressing health challenges and psychological symptoms. Objective: In this context, we aim to address modifiable risk factors, including nutrition, physical activity, and psychosocial factors, which can serve as non-pharmacological adjuncts in reducing breast cancer risk, incidence, and mortality. Methods: This study conducted a thorough literature search on breast cancer, nutrition, physical activity, psychosocial problems, clinical trial/study, mechanisms, in-vitro and in-vivo. The search was performed using multiple search engines and the main keywords, and only English publications until August 2023 were included. Results: Nutrition plays a critical role in influencing breast cancer risk, but its exact role needs to be explored. Diet diversity and exercise are recommended to reduce risk, while psychosocial support is vital for patient well-being. Conclusion: In light of rising global breast cancer challenges, our study underscores the urgent need for enhanced clinical trial availability, exploration of nutrition-cancer links, and refined psychosocial interventions to comprehensively address prevention and treatment.

Rationale and design of NUDGE-FLU-CHRONIC and NUDGE-FLU-2: Two nationwide randomized trials of electronic nudges to increase influenza vaccination among patients with chronic diseases and older adults during the 2023/2024 influenza season

BackgroundYearly influenza vaccination is strongly recommended for older adults and patients with chronic diseases including cardiovascular disease (CVD); however, vaccination rates remain suboptimal, particularly among younger patients. Electronic letters incorporating behavioral nudges are highly scalable public health interventions which can potentially increase vaccination, but further research is needed to determine the most effective strategies and to assess effectiveness across different populations. The purpose of NUDGE-FLU-CHRONIC and NUDGE-FLU-2 are to evaluate the effectiveness of electronic nudges delivered via the Danish governmental electronic letter system in increasing influenza vaccination among patients with chronic diseases and older adults, respectively. MethodsBoth trials are designed as pragmatic randomized implementation trials enrolling all Danish citizens in their respective target groups and conducted during the 2023/2024 influenza season. NUDGE-FLU-CHRONIC enrolls patients aged 18-64 years with chronic diseases. NUDGE-FLU-2 builds upon the NUDGE-FLU trial conducted in 2022/2023 and aims to expand the evidence by testing both previously successful and new nudges among adults ≥65 years during a subsequent influenza season. Persons with exemptions from the electronic letter system are excluded from both trials. In both trials, participants are randomized in a 2.45:1:1:1:1:1:1 ratio to either receive no electronic letter (usual care) or to receive one of 6 different behaviorally informed electronic letters. NUDGE-FLU-CHRONIC has randomized 299,881 participants with intervention letters delivered on September 24, 2023, while NUDGE-FLU-2 has randomized 881,373 participants and delivered intervention letters on September 13, 2023. Follow-up is currently ongoing. In both trials, the primary endpoint is receipt of influenza vaccination on or before January 1, 2024, and the secondary endpoint is time to vaccination. Clinical outcomes including respiratory and cardiovascular hospitalizations, all-cause hospitalization, and mortality are included as prespecified exploratory endpoints. Prespecified individual-level pooled analyses will be conducted across NUDGE-FLU, NUDGE-FLU-CHRONIC, and NUDGE-FLU-2. DiscussionNUDGE-FLU-CHRONIC is the first nationwide randomized trial of electronic nudges to increase influenza vaccination conducted among 18-64-year-old high-risk patients with chronic diseases. NUDGE-FLU-2 will provide further evidence on the effectiveness of electronic nudges among older adults ≥65 years. Collectively, the NUDGE-FLU trials will provide an extensive evidence base for future public health communications. Trial RegistrationNUDGE-FLU-CHRONIC: Clinicaltrials.gov: NCT06030739, registered September 11, 2023, https://clinicaltrials.gov/study/NCT06030739. NUDGE-FLU-2: Clinicaltrials.gov: NCT06030726, registered September 11, 2023,https://clinicaltrials.gov/study/NCT06030726.

Current status of immunological therapies for rheumatoid arthritis with a focus on antigen-specific therapeutic vaccines.

Rheumatoid arthritis (RA) is recognized as an autoimmune joint disease driven by T cell responses to self (or modified self or microbial mimic) antigens that trigger and aggravate the inflammatory condition. Newer treatments of RA employ monoclonal antibodies or recombinant receptors against cytokines or immune cell receptors as well as small-molecule Janus kinase (JAK) inhibitors to systemically ablate the cytokine or cellular responses that fuel inflammation. Unlike these treatments, a therapeutic vaccine, such as CEL-4000, helps balance adaptive immune homeostasis by promoting antigen-specific regulatory rather than inflammatory responses, and hence modulates the immunopathological course of RA. In this review, we discuss the current and proposed therapeutic products for RA, with an emphasis on antigen-specific therapeutic vaccine approaches to the treatment of the disease. As an example, we describe published results of the beneficial effects of CEL-4000 vaccine on animal models of RA. We also make a recommendation for the design of appropriate clinical studies for these newest therapeutic approaches, using the CEL-4000 vaccine as an example. Unlike vaccines that create or boost a new immune response, the clinical success of an immunomodulatory therapeutic vaccine for RA lies in its ability to redirect autoreactive pro-inflammatory memory T cells towards rebalancing the "runaway" immune/inflammatory responses that characterize the disease. Human trials of such a therapy will require alternative approaches in clinical trial design and implementation for determining safety, toxicity, and efficacy. These approaches include adaptive design (such as the Bayesian optimal design (BOIN), currently employed in oncological clinical studies), and the use of disease-related biomarkers as indicators of treatment success.

The Implementation of Keenious at Carnegie Mellon University

In the fall of 2022, the Carnegie Mellon University (CMU) Libraries began investigating Keenious—an artificial intelligence (AI)-based article recommender tool—for a possible trial implementation to improve pathways to resource discovery and assist researchers in more effectively searching for relevant research. This process led to numerous discussions within the library regarding the unique nature of AI-based tools when compared with traditional library resources, including ethical questions surrounding data privacy, algorithmic transparency, and the impact on the research process. This case study explores these topics and how they were negotiated up to and immediately following CMU’s implementation of Keenious in January, 2023, and highlights the need for more frameworks for evaluating AI-based tools in academic settings.

In-Season Test-Retest Reliability of Visual Smooth-Pursuit (EyeGuide Focus) Baseline Assessment in Female and Male Field-Sport Athletes.

Sport-related concussions (SRCs) are a mild traumatic brain injury (mTBI) that induces transient symptoms in athletes. These symptoms provide avenues for developing emerging technologies to diagnose SRCs, in particular ocular and vestibular dysfunction. The following study aims to assess the reliability of visual smooth-pursuit technology (EyeGuide Focus) in amateur field-sport athletes. A convenience sample of 30 mixed-gender athletes (mean age = 24.89 ± 6.81 years) completed two testing sessions separated by 2-7 days. Participants were tested at rest, free from distraction, and completed a 10 s smooth pursuit while seated. Participants completed 2-4 practice trials before completing three tests at each session. Appropriate difference, reliability, and repeatability tests were performed in Statistical Packages for the Social Sciences. No significant difference existed between the time points (p > 0.05). The reliability between sessions was poor (ICC = 0.24; 95% CI = 0.03-0.42), and the mean coefficients of variation were 20% and 21% for each session, indicating poor repeatability. However, the implementation of practice trials did prevent the familiarization effects that are evident in the previous literature (p > 0.05). The within-session reliability of EyeGuide Focus has varied from poor (ICC ≤ 0.50) to good (ICC = 0.75-0.90) in the previous literature, indicating the fact that greater research is required before this tool can be implemented in applied settings.

Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators

BackgroundHarms, also known as adverse events (AEs), are recorded and monitored in randomised controlled trials (RCTs) to ensure participants’ safety. Harms are recorded poorly or inconsistently in RCTs of Behaviour Change Interventions (BCI); however, limited guidance exists on how to record harms in BCI trials. This qualitative study explored experiences and perspectives from multi-disciplinary trial experts on recording harms in BCI trials.MethodsData were collected through fifteen in-depth semi-structured qualitative interviews and three focus groups with thirty-two participants who work in the delivery and oversight of clinical trials. Participants included multi-disciplinary staff from eight CTUs, Chief investigators, and patient and public representatives. Interviews and focus group recordings were transcribed verbatim and thematic analysis was used to analyse the transcripts.ResultsFive themes were identified, namely perception and understanding of harm, proportionate reporting and plausibility, the need for a multi-disciplinary approach, language of BCI harms and complex harms for complex interventions. Participants strongly believed harms should be recorded in BCI trials; however, making decisions on “how and what to record as harms” was difficult. Recording irrelevant harms placed a high burden on trial staff and participants, drained trial resources and was perceived as for little purpose. Participants believed proportionate recording was required that focused on events with a strong plausible link to the intervention. Multi-disciplinary trial team input was essential for identifying and collecting harms; however, this was difficult in practice due to lack of knowledge on harms from BCIs, lack of input or difference in opinion. The medical language of harms was recognised as a poor fit for BCI trial harms but was familiar and established within internal processes. Future guidance on this topic would be welcomed and could include summarised literature.ConclusionsRecording harms or adverse events in behaviour change intervention trials is complex and challenging; multi-disciplinary experts in trial design and implementation welcome forthcoming guidance on this topic. Issues include the high burden of recording irrelevant harms and use of definitions originally designed for drug trials. Proportionate recording of harms focused on events with a strong plausible link to the intervention and multi-disciplinary team input into decision making are essential.

Decentralising chronic disease management in sub-Saharan Africa: a protocol for the qualitative process evaluation of community-based integrated management of HIV, diabetes and hypertension in Tanzania and Uganda

IntroductionSub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living...