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Week 4 Discussion Article: McGregor et al. (2024) Link: https://www.bmj.com/content/384/bmj-2023-076506Links to an external site. Purpose The purpose of this pragmatic, multicenter, randomized controlled trial was to assess whether a structured, online, supervised group physical and mental health rehabilitation program (REGAIN) could enhance health-related quality of life (HRQoL) when compared to usual care in adults experiencing post-COVID-19 mental and physical health-related conditions. McGregor et al. (2024) wanted to address clinical gaps in rehabilitation interventions for COVID-19 patients to enhance their HRQoL. The pragmatic approach design adopted by the authors ensured that the findings of this study are transferrable to clinical practice and applicable in addressing emerging public health needs. Study Population McGregor et al. (2024) recruited 585 participants aged 26-86 years from England and Wales and specifically targeted those discharged from NHS hospitals. The data collection process started with 39,697 invitations, but 725 were eligible, and finally, 585 completed the survey questionnaire. However, targeting participants discharged from NHS hospitals potentially contributes to selection bias, and findings obtained from this research are not applicable to the broader COVID population. The reliance on self-reported symptoms, as illustrated by Shipman et al. (2023), can possibly introduce subjectivity that limits the reliability of the findings. Length of the Trial The length of the REGAIN intervention was eight weeks, followed by outcome measurements at three, six, and twelve months. The multi-timepoint follow-up was the notable strength, as it allowed the researchers to assess immediate efficacy (three months) and long-term benefits of up to twelve months. For a chronic and mutating condition like COVID-19, establishing sustainable improvement is a critical aspect of clinical relevance, but a longer follow-up could be necessary to investigate the persistent effects of COVID. Data Collection Methods McGregor et al. (2024) predominantly collected data through online patient-reported outcomes (PROs) and included HRQoL scores. PROs data was appropriate for this study as it allowed the researchers to document patients’ perspectives and measure HRQoL. Even though PROs data was efficient, over-reliance on self-reports might be subjective to biased reporting. Nonetheless, a blind follow-up assessment for some participants allowed for the reduction of bias. Collecting data using online platforms also allowed a broader geographic reach, but there was a possibility of limited reach for participants without internet connectivity, which impacts generalizability. Outcome Measures The primary outcome of this study is the PROMIS preference (PROPr) score at three months, which is also a validated measure for HRQoL. The strength of this measure is that it enables compassion across different health aspects, increasing the generalizability of the findings. The inclusion of other secondary outcomes, like specific PROMIS sub-scores for depression, fatigue, and pain interference, enabled the researchers to comprehensively investigate the impact of REGAIN on overall HRQoL change. Results and Conclusions McGregor et al. (2024) established a statistically significant improvement in HRQoL for the REGAIN group at three months, which was also sustained up to 12 months. The positive effect was mostly due to improvements in depression and a reduction in fatigue and pain interference. Even though these findings showed statistical significance, the mean difference of 0.03 may not be considered clinically important to persuade policymakers and decision-makers to scale up these interventions. In other words, the findings demonstrate a positive trend in managing COVID, but the practical significance of this study necessitates further consideration. Nonetheless, the adherence rate of 47% (complete adherence) may suggest challenges in translating the findings of this study to real-world settings. Addressing some of the challenges encountered by participants and researchers should be a priority before considering adopting these results. Ethical Issues Associated with the Study McGregor et al. (2024) adopted a compressive ethical protocol, including informed consent, data privacy, and safety of participants. For these reasons, the study secured NHS Trust site-specific approval, including meeting the criteria for Good Clinical Practice (GCP) principles for adverse reporting. Nonetheless, using NHS Digi-Trials raises privacy concerns that require careful ethical and legal scrutiny, which the researchers confirm they obtained. Further, providing translated trial and intervention materials in non-English languages increases access to the study, which also demonstrates a commitment to reducing health disparities caused by lack of inclusivity. Nevertheless, the findings of this study carry inherent representation bias due to the underrepresentation of minorities as few participants (11% were non-white) and the researchers excluded disabled patients, which limits generalizability (McGregor et al., 2024). At the same time, collecting data online requires robust data protection protocols to enhance data privacy, which is a potential that this study has. Benefits of Experimental Design and Randomization Researchers often adopt experimental designs when investigating the relationship between variables, particularly when they want to produce credible and reliable findings. In this study, a randomized controlled trial (RCT) design was adopted primarily to maximize internal validity and establish the efficacy of the evidence. Randomization was particularly useful in achieving unbiased participant selection and determining specific factors influencing overall health (Krauss, 2018), especially between the REGAIN and control groups. Without randomization, the researchers could not have confidently observed differences in outcomes between the REGAIN and control groups, thereby making their conclusions much less reliable for clinical decision-making.

References

Krauss, A. (2018). Why all randomized controlled trials produce biased results. Annals of Medicine, 50(4), 312-322. https://doi.org/10.1080/07853890.2018.1453233Links to an external site. McGregor, G., Sandhu, H., Bruce, J., Sheehan, B., McWilliams, D., Yeung, J., Jones, C., Lara, B., Alleyne, S., Smith, J., Lall, R., Ji, C., Ratna, M., Ennis, S., Heine, P., Patel, S., Abraham, C., Mason, J., Nwankwo, H., … Underwood, M. (2024). Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): Multicentre randomized controlled trial. BMJ, e076506. https://doi.org/10.1136/bmj-2023-076506Links to an external site. Shipman, A., Dezecache, G., & Majumdar, A. (2023). A quantification of the reliability of self-reports following a simulated stressful event. International Journal of Disaster Risk Reduction, 86, 103502. https://doi.org/10.1016/j.ijdrr.2022.103502Links to an external site.

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