Using Randomized Controlled Trials in the Sports Medicine and Performance Environment: Is It Time to Reconsider and Think Outside the Methodological Box?

SYNOPSIS: Randomized controlled trials (RCTs) are ubiquitous in medicine and have facilitated great strides in clinical care. However, when applied in sport, RCTs have limitations that hinder implementing effective interventions in the real-world clinical setting. Pragmatic clinical trials offer some solutions. Yet due to the competitive, high-pressure nature of sport at the individual, team, and governing body level, RCTs are likely infeasible in certain sport settings. The small number of athletes at the elite team level, along with the potential financial consequences of randomizing at the individual athlete and team level, also restricts study power and feasibility, limiting conclusions. Consequently, researchers may need to "think outside the box" and consider other research methodology, to help improve athlete care. In this Viewpoint, we detail alternative study designs that can help solve real-world problems in sports medicine and performance, while maintaining robust research standards and accounting for the challenges that RCTs pose. We also provide practical examples of alternative designs. J Orthop Sports Phys Ther 2023;53(6):1-4. Epub: 18 April 2023. doi:10.2519/jospt.2023.11824.

Elbow Injuries Among MLB Pitchers Increased During Covid-19 Disrupted Season, But Not Other Baseball Injuries.

Background: The 2020 Major League Baseball Season (MLB) demonstrated season disruptions due to the COVID-19 pandemic. Changes in training and seasonal time frames may be associated with higher rates of injury. Purpose: To use publicly available data to compare injury rates during the 2015-2019 seasons, COVID-19 shortened season (2020), and the 2021 season stratified by body region and position (pitchers versus position players). Study Design: A retrospective cohort study utilizing publicly available data. Methods: MLB players who competed in 1+ seasons between 2015-2021 were included and stratified by position (pitcher, position player). Incidence rate (IR), reported by 1000 x Athlete-Game Exposures (AGEs), was calculated for each season, and stratified by position and body region. Poisson regressions were performed for all injuries and stratified by position to determine association between season and injury incidence. Subgroup analyses were performed on the elbow, groin/hip/thigh, shoulder. Results: Four thousand, two hundred and seventy-four injuries and 796,502 AGEs across 15,152 players were documented. Overall IR was similar across seasons (2015-2019:5.39; 2020:5.85; 2021:5.04 per 1000 AGEs). IR remained high for the groin/hip/thigh for position players (2015-2019:1.7; 2020:2.0; 2021:1.7 per 1000 AGEs). There was no difference in injury rates between 2015-2019 and 2020 seasons [1.1 (0.9-1.2), p=0.310]. The 2020 season demonstrated a significant increase in elbow injuries [2.7 (1.8-4.0), p<0.001]; when stratified by position, this increase remained significant for pitchers [pitchers: 3.5 (2.1-5.9), p<0.001; position players: 1.8 (0.9-3.6), p=0.073]. No other differences were observed. Conclusion: The groin/hip/thigh demonstrated the highest IR in 2020 among position players across all season time frames, indicating that continued injury mitigation for this region is necessary. When stratified by body region, elbow injury rates among pitchers demonstrated 3.5 times the rate of injury in 2020 compared to previous seasons, impacting injury burden for the most vulnerable body region among pitchers. Level of Evidence: Level III.

Upper Quarter Injury Rates and Risk in United States High School Athletes Prior To and During the Prolonged Sport Stoppage.

Background: Upper quarter injuries are a serious problem in high school sports. The distinctive differences in males and females and within sports concerning specific upper quarter body parts necessitates the need to evaluate these injuries across these groups. The COVID-19 pandemic has created an opportunity to evaluate the potential added burden abrupt and prolonged sport stoppage had on upper quarter injury risk. Hypothesis/Purpose: To 1) describe and compare upper quarter injury rates and risk in high school athletes in the 2019-2020 and 2020-2021 academic school years; 2) examine injuries by gender, sport, injury type, and location of injury. Methods: An ecological study of the athletes from 176 high schools over six states, matching high schools between 2019-2020 (19-20) and 2020-2021 (20-21) years was performed. Injuries were reported by at least one high school athletic trainer assigned to each school into a centralized database and data collected from July 1, 2019, to June 30, 2021. Injury rates were calculated per 1,000 athletes per academic year. Interrupted time series models assessed the incidence ratio between academic years. Results: A total of 98,487 athletes from all sports participated in 19-20 and 72,521 in 20-21. Upper quarter injury rates increased in from 19-20 [41.9 (40.6, 43.1)] to 20-21 [50.7 (48.1, 51.3)]. Upper quarter injury risk [1.5 (1.1, 2.2)] was greater in 20-21 compared to 19-20. Females did not demonstrate increased injury rates between 19-20 [31.1 (29.4, 32.7)] to 20-21 [28.1 (26.4, 30.0)]. Males reported increased injury rates from 19-20 [50.3 (48.5, 52.2)] to 20-21 [67.7 (65.2, 70.2)]. Increased injury for the shoulder, elbow, and hand were reported in 20-21. Collision, field, and court upper quarter injury rates were increased in 20-21. Discussion: Upper quarter injury rates and injury risk were greater during the 2020-2021 school year than in the prior year. Males demonstrated increased upper quarter injury rates, while females did not. Return to play protocols for high school athletes should be considered following abrupt sport stoppage. Level of Evidence: 2.

Higher rates of concussion following COVID-19 infection in high school athletes.

OBJECTIVE: To compare concussion rates (CRs) over one academic year in high school athletes with and without a COVID-19 infection prior to concussion. METHODS: Illness and concussion were prospectively reported for male and female high school athletes across six states over one academic year in the Players Health Rehab surveillance system. Concussion was truncated to 60 days following recovery and return to sport from COVID-19. CRs were estimated per 1000 athletes per academic year and stratified by those who tested positive for COVID-19 infection (with COVID-19) and those who did not (no COVID-19). Poisson regression analyses estimated rate ratio (RR) of concussion controlling for state, gender and an offset of the log athlete participation (with COVID-19 and no COVID-19). RESULTS: Of 72 522 athletes, 430 COVID-19 infections and 1273 concussions were reported. The CR was greater in athletes who reported COVID-19 (CR=74.4/1000 athletes/year, 95% CI 49.6 to 99.3) compared with those who did not (CR=17.2, 95% CI 16.3 to 18.2). Athletes with recent COVID-19 had a threefold higher rate of concussion (RR=3.1, 95% CI 2.0 to 4.7). CONCLUSION: Athletes returning from COVID-19 had higher CRs than those who did not experience COVID-19. This may be related to ongoing COVID-19 sequelae or deconditioning related to reduced training and competition load during the illness and when returning to sport. Further research is needed to understand the association of recent COVID-19 infection and concussion in order to inform preventive strategies.

Influence of High School Socioeconomic Status on Athlete Injuries during the COVID-19 Pandemic: An Ecological Study.

Background: It is presently unclear how the cessation of high school sport has affected injury incidence at different socioeconomic levels. The COVID-19 pandemic may have disproportionately affected athletes of lower socioeconomic status, potentially increasing injury risk in this population. Purpose: To 1) Describe athlete injury incidence prior to and during the 2019-2020 and 2020-2021 school years in high school athletes by socioeconomic status; 2) Investigate the association between socioeconomic status and injury incidence in high school athletes. Study Design: Ecological Study. Methods: High schools were matched between the 2019-2020 and 2020-2021 school years. All athletes from all sports were included. High school socioeconomic status was determined by the school district median household income. Socioeconomic strata were defined as <$30,000, $30,000-50,000, $50,001-100,000, and >$100,000. Injury incidence proportion with 95% confidence interval (95% CI) was calculated for each academic year. Mixed effects negative binomial models with robust errors were performed to assess the association between the incidence proportion ratio and high school median household income. Six states and 176 high schools were included (2019-2020: 98,487 athletes; 2020-2021: 72,521 athletes). Results: Injury incidence increased in three of four socioeconomic strata during the 2020-2021 year (<$30,000: 2019-2020: 15.6 (13.1-18.1), 2020-2021: 26.3 (23.1-29.6); $30,000-50,000: 2019-2020: 7.8 (7.1-8.6), 2020-2021: 14.9 (13.8-15.9); $50,001-100,000: 2019-2020: 15.1 (14.7-15.4), 2020-2021: 21.3 (20.9-21.8); >$100,000: 2019-2020: 18.4 (18.1-18.8), 2020-2021: 17.3 (16.8-17.7)). An association was observed between injury incidence ratio and log median high school household income in 2019-2020 [1.6 (1.1-2.5)] but not 2020-2021 [1.1 (0.8-1.6)] school years. Conclusions: Athletes from lower socioeconomic high schools reported increased injury incidence compared to higher socioeconomic high schools during the 2020-2021 academic school year. These results highlight the increased COVID-19 pandemic vulnerability in athletes from lower socioeconomic high schools. High school sport stakeholders should consider how abrupt sport stoppage can affect lower socioeconomic athletes. Level of Evidence: 2.

The Impact of Statewide Limitations of Practice on High School Injury Incidence During the COVID-19 Season: An Ecological Study.

BACKGROUND: Abrupt training stoppage can increase injury incidence and risk following return to sport. The rate of coronavirus disease 2019 (COVID-19) infections in the general population has resulted in the abrupt stoppage of high school education and sport. The objective of this study was to (1) compare injury incidence proportion (IP) and excess injury in high school athletes before and during the COVID-19 pandemic; and (2) stratify by identified gender. HYPOTHESIS: The COVID-19 academic year will demonstrate increased injury incidence, and injury incidence will be similar between genders. STUDY DESIGN: Ecological. LEVEL OF EVIDENCE: Level 2. METHODS: High schools (6 states; 176 high schools) were matched between prepandemic and pandemic years. Injury IP with 95% confidence interval (CI) was calculated. Interrupted time series models with robust errors were performed to assess the IP ratio and excess injury incidence between prepandemic and pandemic academic calendar years. RESULTS: A total of 98,487 athletes participated in high school sport in the prepandemic year and 72,521 athletes in the pandemic year; 15,477 injuries were reported in the prepandemic year compared with 14,057 injuries during the pandemic year. Injury IP (CI) was 15.7 (15.5-15.9) and 19.4 (19.1-19.7) for the prepandemic and pandemic years, respectively. Injury incidence ratio increased by 1.3 (1.2-1.5) between the prepandemic and pandemic years. Excess injuries were 1812 greater in the pandemic year compared with the prepandemic year. Female and male athlete incidence ratios were similar. CONCLUSION: Prolonged sport stoppage due to the COVID-19 pandemic resulted in increased injury incidence compared with the previous high school academic year. CLINICAL RELEVANCE: High school sports stakeholders should consider longer periods of ramp up for training in lieu of future sport stoppages compared with usual preseason training. These data may also have more generalizable implications to other abrupt sport and physical activity stoppage scenarios such as earthquakes and hurricanes.

Subsequent Musculoskeletal Injury Incidence Are Similar Between General Infection and COVID-19 Among High School Athletes in the Unites States Despite Higher Illness Incidence During Academic Years 2019-2020 and 2020-2021.

OBJECTIVES: To describe overall illness and COVID-19- specific illness in high school athletes in the 2019-2020 and 2020-2021 academic school years, and to describe and assess the risk of musculoskeletal injury following general infection and after COVID-19. DESIGN: Ecological study. METHODS: High schools (6 states; 176 high schools) were matched between the 2019-2020 and 2020-2021 academic school years, based on 2020-2021 high school sport participation. Illness and injury data were collected from the high school athletic trainers. Illness was stratified by overall illness, general infection, and COVID-19. Injuries following moderate or severe infections or COVID-19 were recorded. Illness and injury incidence rate per 100 athletes per year, with 95% confidence intervals (95% CIs), were calculated. Negative binomial models comparing injury following general infections and COVID-19 infections were calculated. RESULTS: A total of 98 487 and 72 521 athletes participated in the 2019-2020 and 2020-2021 years. Illness incidence rate was less in the 2019-2020 academic school year [0.30 (95% CI: 0.27, 0.34)] than the 2020-2021 academic school year [1.1 (1.0-1.2)], resulting in a difference of 0.8 (95% CI: 0.7, 0.9). COVID-19 incidence rate was 0.52 (0.47-0.58) in the 2020-2021 year. Injury following general infection incidence rate was 27.9 injuries (21.4-34.5) per 100 athletes in 2019-2020, and 22.5 injuries (19.3-25.7) per 100 athletes in 2020-2021. There was no difference in injury risk following general infection and COVID-19 [rate ratio: 1.2 (95% CI: 0.7, 2.4)]. CONCLUSIONS: The incidence rate for all illnesses in high school athletes was slightly (0.8) greater in the 2020-2021 academic compared to the 2019-2020 year. Most of the incidence increase was due to infections and COVID-19. Subsequent injury incidence following moderate and severe infections were similar between years and between general infections and COVID-19. J Orthop Sports Phys Ther 2022;52(8):546-553. Epub: 19 June 2022. doi:10.2519/jospt.2022.11200.