Key ethical issues encountered during COVID-19 research: a thematic analysis of perspectives from South African research ethics committees.

BACKGROUND: The COVID-19 pandemic presents significant challenges to research ethics committees (RECs) in balancing urgency of review of COVID-19 research with careful consideration of risks and benefits. In the African context, RECs are further challenged by historical mistrust of research and potential impacts on COVID-19 related research participation, as well as the need to facilitate equitable access to effective treatments or vaccines for COVID-19. In South Africa, an absent National Health Research Ethics Council (NHREC) also left RECs without national guidance for a significant duration of the COVID-19 pandemic. We conducted a qualitative descriptive study that explored the perspectives and experiences of RECs regarding the ethical challenges of COVID-19 research in South Africa. METHODS: We conducted in-depth interviews with 21 REC chairpersons or members from seven RECs at large academic health institutions across South Africa that were actively involved in the review of COVID-19 related research from January to April 2021. In-depth interviews were conducted remotely via Zoom. Interviews (60-125 min) were conducted in English using an in-depth interview guide, until data saturation was achieved. Audio-recordings were transcribed verbatim and field notes were converted into data documents. Line-by-line coding of transcripts was performed, and data were organised into themes and sub-themes. An inductive approach to thematic analysis was used to analyse data. RESULTS: Five main themes were identified, namely: rapidly evolving research ethics landscape, extreme vulnerability of research participants, unique challenges to informed consent, challenges to community engagement during COVID-19, and overlapping research ethics and public health equity issues. Sub-themes were identified for each main theme. CONCLUSIONS: Numerous, significant ethical complexities and challenges were identified by South African REC members in the review of COVID-19 related research. While RECs are resilient and adaptable, reviewer and REC member fatigue were major concerns. The numerous ethical issues identified also highlight the need for research ethics teaching and training, especially in informed consent, as well as the urgent requirement for the development of national guidelines for research ethics during public health emergencies. Further, comparative analysis between different countries is needed to develop the discourse around African RECs and COVID-19 research ethics issues.

Benefits of Activity-Based Interventions Among Female Adolescents Who Are Overweight and Obese.

PURPOSE: The purpose of this study was to compare the effects of 2 activity-based motor interventions among female adolescents who are overweight and obese. METHODS: This study was conducted in a low-income community of Cape Town, South Africa. The study involved 52 participants classified as overweight and obese. Participants were randomly assigned to task-oriented functional training or Wii Fit intervention. Both interventions were 45 minutes of active training once a week for 14 weeks. Outcome measures included aerobic fitness, motor coordination, and self-efficacy. Data were collected before and after the interventions. RESULTS: Participants in both groups demonstrated significant improvement in aerobic fitness and motor coordination but not self-efficacy. However, no between-group differences were observed on any of the outcomes. CONCLUSIONS: Activity-based interventions may improve aerobic fitness and motor coordination in female adolescents who are overweight and obese and may also help prevent declines in physical fitness and coordination in this population.

Undergraduate students' choices around community service and internship: A single faculty study.

Background: The Internship and Community Service Programme (ICSP) places newly graduated health professionals for a compulsory training period. Universities adopt multiple strategies to encourage students to select rural placements for ICSP. Objectives: This study describes ICSP choices among final-year MBChB and Health and Rehabilitation Science students at a South African university and the factors influencing their decisions. Method: A cross-sectional qualitative descriptive study was conducted using a self-developed online questionnaire. Eighty-five final-year students were recruited. Results: Most respondents (n = 38, 45.8%) chose the Western Cape (WC) as their first choice placement. There was a significant difference between MBChB and other health science students' choice of level of healthcare (χ = 10.39, p = 0.006), with MBChB less likely to choose primary healthcare (PHC) level placements. District and tertiary care options were perceived as better sites for learning and practice, while PHC and rural sites, considered underresourced and understaffed, were avoided. Although MBChB students indicated a lower preference for rural placements, this was not significant.Factors influencing ICSP application decisions included professional support, work environment, and social and personal considerations. Conclusion: Students' placement choices were based on their perceptions of clinical exposure, learning opportunities, mentorship and supervision. Placements closer to home were preferred. UG clinical exposure and rural background seem to have some impact on choice but need further investigation. Clinical implications: Universities should continue to explore ways to improve students' readiness for practice in underresourced settings. Improved exposure to rural and PHC sites during training could encourage better uptake during ICSP placement.

Return to rugby following musculoskeletal injuries: A survey of views, practices and barriers among health and sport practitioners.

STUDY DESIGN AND SETTING: Returning rugby players to the sport following musculoskeletal injuries is a multi-factorial and challenging process. A cross-sectional observational study was conducted among health and sport practitioners involved with injured rugby players in South Africa. OBJECTIVES AND OUTCOME MEASURES: The views, current practices and barriers encountered by health and sport practitioners during return to rugby were investigated using a self-developed online survey. RESULTS: 64 practitioners participated in the survey including physiotherapists, orthopaedic surgeons, biokineticists and sports physicians. Return to sport (RTS) protocols were considered important, however, participants also indicated that they were slightly more likely to use anecdotal protocols compared to published protocols. Time frames, stages of healing, pain and subjective ratings along with functional outcome measures (such as range of motion, muscle function and proprioception) and sport-specific skills were rated as important and commonly utilised in different RTS phases (i.e., return to non-contact, return to contact and return to matches). The most commonly perceived barriers encountered were related to lack of access and time-constraints. CONCLUSION: Return to rugby guidelines with consideration of a broad range of criteria and common barriers encountered should be developed to facilitate safe, practical and time-efficient return to rugby following musculoskeletal injuries.

Injury and Illness Incidence in 2017 Super Rugby Tournament: A Surveillance Study on a Single South African Team.

Background: Professional rugby presents significant injury and illness risks to players, which need to be regularly assessed to monitor the effects of interventions and competition rules changes. Hypothesis/Purpose: The purpose of this study was to determine the incidence and nature of time-loss injuries and illness during the pre-season and competition period of the 2017 Super Rugby tournament in a single South African team. Study Design: Descriptive Epidemiology Study. Methods: Forty-five adult players were recruited from one 2017 Super Rugby South African team, with 39 included in the final data set. Daily injury and illness data were routinely collected during the season by support staff over a 28-week period (January to July 2017), based on standardized injury and illness definitions. Retrospective analyses of the data were performed. Results: The incidence of match injuries (241.0 per 1000 player hours) was significantly higher than training injuries (3.3 per 1000 player hours). Twenty one percent of all injuries occurred during the tackle; 37.5% of all injuries were of a "moderate" severity. The proportion of players who sustained a time-loss injury was 76.9% (n=30). The overall incidence of illness was 1.8 per 1000 player days. Acute respiratory tract infection (28.6%) was the most common diagnosis, and the majority of illnesses (64.3%) did not result in time-loss. Conclusion: This study presented a longer study period than previous research by including the pre-season training, but represented only one single team. The incidence of match injuries was significantly higher than previously reported in Super Rugby tournaments, whereas illness rates were significantly lower. Support staff in professional rugby need to be trained on the standardized Orchard System of Classifications to ensure good quality data that can be compared to other teams within the same or other sporting codes. Level of evidence: Level 3.

A Masterclass on developing clinical tools in sport and exercise medicine using principles of clinimetrics.

Musculoskeletal assessment and skill screening tests are regularly used in sports and exercise science to determine performance levels or injury risk in athletes. Many of these tests are used without having undergone clinimetric evaluation. The steps to develop these screening tests and assessment tools should include a structured process according to the clinimetric principles (conceptual and measurement model, reliability, validity, responsiveness, interpretability, burden, alternative forms, and cultural and language adaptation). This systematic process ensures the test measures what it intends to measure and also quantifies the error around the measurement. In this Masterclass we discuss the systematic development and clinimetric evaluation of clinical and performance tests used in sports and exercise science. We use the sport of mountain biking to provide a contextual example of how these principles may be practically applied.

Return to play protocols for musculoskeletal upper and lower limb injuries in tackle-collision team sports: A systematic review.

Athletes in tackle-collision teams are at high risk of musculoskeletal injuries resulting in absence from play due to the high impact nature of the sport. There is a paucity of research to guide the management and assessment methods needed to facilitate the return to play (RTP) process. This review aimed to describe, synthesise and evaluate RTP protocols implemented for musculoskeletal injuries in tackle-collision teams. A systematic search of Scopus, PubMed, Web of Science and Ebsco Host was conducted for RTP management protocols and assessment modalities following upper and lower limb musculoskeletal injuries in tackle-collision team athletes. Prospective and retrospective quantitative controlled trials, cohort, case-control, case-series and cross-sectional observation studies published between January 2000 and March 2020 were considered. The main outcome measures were the proportion of athletes to RTP, associated time-loss and reinjury risk. 5265 articles were screened. 34 studies met the eligibility criteria of which 23 involved management and 11 assessment modalities. Management involved surgical or conservative strategies along with exercise-based rehabilitation. Assessment modalities included radiographic assessment, clinical evaluation and subjective ratings. Promising RTP management included progressive weight-bearing and exercised-based rehabilitation for ankle sprains as well as surgery, the use of a sling and exercise-based rehabilitation for shoulder instability. MRI scans showed promise in predicting time-loss following hamstring and calf strains in tackle-collision athletes. There are currently no clear guidelines for RTP after musculoskeletal injuries in tackle-collision sports. Future research should investigate efficient management strategies evaluated through valid and reliable assessment methods to better guide clinicians.

Ethically acceptable consent approaches to adolescent research in South Africa.

Background: Adolescents are a unique population with significant unmet health needs. They are often excluded from research that may benefit them as they are perceived as vulnerable and needing protection from research participation. For Research Ethics Committees, conflicting positions in statutes, regulations and ethical guidelines about who provides informed consent for adolescent involvement in health research can be a significant barrier to approving adolescent research. For researchers, the requirement for parental/guardian proxy consent or prolonged approval processes may potentially result in the exclusion of those adolescents most vulnerable and at risk, particularly if issues such as gender-based violence, gender identity, sexuality and sexual practices are in question. Objectives: To describe the challenges to adolescent research and suggest strategies to address these. Method: We consider the legal and ethical framework in South Africa regarding the consenting age for adolescents in research, outline the challenges and, using examples of best practices, suggest strategies to address the current conundrum. Results: We suggest three principles to guide Research Ethics Committees on their approach to reviewing health research involving adolescents. Strategies to develop ethically acceptable approaches to adolescent research and consent processes are described, which include community involvement. We elaborate on examples of nuanced approaches to adolescent research. Conclusion: The inclusion of adolescents in research is critical in informing appropriate and effective health services for this vulnerable population, whilst providing an opportunity to link them into care and services where relevant.

Effect of the FIFA 11+ soccer specific warm up programme on the incidence of injuries: A cluster-randomised controlled trial.

BACKGROUND: Soccer players incur injuries that typically affect their performance. Injuries are caused by intrinsic and extrinsic factors that call for multifactorial preventive interventions. The study examines the impact of the FIFA 11+ warm up programme on the incidence and severity of injuries in second division soccer players in Rwanda. METHODS: Twelve teams (309 players) were randomised in the intervention group and 12 teams (317 players) in the control group using a cluster randomized controlled trial with teams as the unit of randomization. Intervention group teams implemented the FIFA 11+ soccer specific warm-up programme during training and matches at least three times a week over seven months of the Rwandan soccer season. Control group teams continued with usual warm up exercises. The primary outcome of this study was the overall incidence of training and match injuries. Injuries, training and match exposure as well as severity categories were recorded per the F-MARC guidelines. RESULTS: A lower proportion of players sustained injuries in the intervention group (52%) compared to the control group (63%) (Odd ratio: 0.7; 95%CI: 0.5-0.9). A significantly lower rate ratio was observed in the intervention group for overall (RR = 0.6; 95%CI: 0.5-0.8) and match (RR = 0.6; 95%CI: 0.5-0.8) injuries. Compliance to the injury prevention programme was 77%. In the intervention group, the incidence of injury was similar across all teams and across the medium and highly compliant teams. There was a statistically significant 55% and 71% reduction of the rate of moderate and severe injuries in the intervention group respectively. CONCLUSION: The 11+ warm up injury prevention programme resulted in a significant reduction in the odds of sustaining injuries. In addition, injuries sustained were less severe. The programme should be rolled out to all teams in Rwanda and may well result in a decrease in the incidence and severity of injury in similar contexts. TRIAL REGISTRATION: Pan African Clinical Trial Registry (PACTR201505001045388).

Incidence of Injuries, Illness and Related Risk Factors in Cross-Country Marathon Mountain Biking Events: A Systematic Search and Review.

BACKGROUND: Cycling is a popular global sport and method of transportation and a significant contributor to admissions to hospital emergency units following an injury. Mountain biking events present additional challenges with remote venues and isolated courses, for which on-site medical care is often provided, for both injury and illness occurring during races. National health data may not represent these unique events, and specific data on incidence of injury and illness in mountain biking events are essential. Therefore, the aim of this study was to review the available injury and illness literature, reporting methods and risk factors in cross-country mountain biking. METHODS: Search engines PubMed, Scopus, CINAHL (EBSCOhost), Scopus, PEDro and the Cochrane Library were systematically searched, and a grey literature search was performed. Narrative analyses of the types, severity and area of injuries and illness type and severity were performed as pooling of data was impossible due to insufficient high-quality studies with the same injury and illness definitions. RESULTS: Seven studies comprising 28,021 participants were included for analysis. Four to 71% of participants sustained an injury in a cross-country mountain bike event. Injuries to the skin were the most common, followed by bony injuries and concussion. Five to 47% of cyclists reported the onset of gastrointestinal symptoms post-event. The prevalence of illness during events ranged from 0.5 to 23.0%. CONCLUSION: The injury and illness definitions were varied and prevented clear comparisons between studies. Injury and illness present a concern in cross-country marathon mountain biking and should be investigated further to provide the true burden of these during race events. Registration: This protocol has been registered with PROSPERO International prospective register of systematic reviews (No: CRD42019134586).

Motivation and Behaviour Change in Parkrun Participants in the Western Cape Province, South Africa.

Mass participation events are promoted in South Africa as a positive public health initiative. Parkrun has grown to be one of the most popular. The present study identifies the motives of residents in the Western Cape Province to join parkrun and how their involvement influences future physical activity levels. Participants (N = 1787) completed a survey consisting of demographic history, parkrun participation history, motivations for participation, and physical activity-related behaviour changes associated with parkrun participation. The majority of participants were female (n = 952) and over 50 years of age (median = 50; IQR = 38-59). Along with health-related benefits, the provision of a safe and organised event was reported as a key motive to participate. The social connectedness developed by parkrun encouraged continued participation and promoted uptake of more physical activity. Close to half the participants reported increases in physical activity levels after joining parkrun, which demonstrates the benefit obtained from participation in structured mass participation events. With the large diversity in socioeconomic status in South Africa related to physical activity levels, parkrun provides a protected and engaging environment that provides opportunity for increased physical activity and potentially reducing the burden on the healthcare system.

Electro-membrane microcurrent therapy reduces signs and symptoms of muscle damage.

PURPOSE: Delayed onset muscle soreness (DOMS) occurs after unaccustomed physical activity or competitive sport, resulting in stiff, painful muscles with impaired function. Acustat electro-membrane microcurrent therapy has been used to treat postoperative pain and soft tissue injury; however, its efficacy in reducing symptoms of muscle damage is not known. METHODS: Thirty healthy men were recruited for a double-blind, placebo-controlled trial. The muscles of their nondominant arms were damaged using an eccentric-exercise protocol. Subjects were then randomly assigned to treatment with either Acustat or a matching placebo membrane for 96 h and monitored for a total of 168 h. RESULTS: Subjects in both groups experienced severe pain and swelling of the elbow flexors after the eccentric exercise. After 24 h, the elbow joint angle of the placebo group had increased significantly more than those in the Acustat group (13.7 +/- 8.9 degrees vs 7.5 +/- 5.5 degrees; placebo vs Acustat, P < 0.05), possibly as a consequence of the elbow flexor muscles shortening. For the first 48 h after exercise, maximum voluntary contraction of the elbow flexor muscles was significantly impaired in the placebo group by up to 25% (P < 0.05), whereas muscle function was unchanged in the Acustat group. Peak plasma creatine kinase activity was also lower in the Acustat group (peak = 777 +/- 1438 U.L-1) versus the placebo group (peak = 1918 +/- 2067 U.L-1; (P < 0.05). The membranes were well tolerated by the subjects in both groups without any adverse effects. CONCLUSION: These data show that treatment of muscle damage with Acustat electro-membrane microcurrent therapy reduces the severity of the symptoms. The mechanisms of action are unknown but are likely related to maintenance of intracellular Ca2+ homeostasis after muscle damaging exercise.

Does the requirement of getting active consent from parents in school-based research result in a biased sample? An empirical study.

Active parental consent is a requirement that may threaten the validity of including minors in research. This study investigated possible sources of bias between the responses of children whose parents actively consented to their participation in a school-based survey and those of children whose parents were nonresponders. Due to a serious administrative error in a study to examine health-related quality of life (HRQoL), all 514 eligible schoolchildren were tested, although only 177 parents signed consent. After deliberation, the relevant human research ethics committee gave permission to include all results in the analysis. The HRQoL was not different between the groups. Male children returned significantly fewer consent forms (p=.026). More of the nonresponding group reported that their parents "Never had enough time for them" (p=.023). The high nonresponse rate and associations between response and parental interest and gender indicate that some bias may be introduced through the need for active consent, but overall there were no differences in responses to the quality of life questionnaire.