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Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN' (REGAIN): a structured summary of a study protocol for a randomised controlled trial.
McGregor, G, Sandhu, H, Bruce, J, Sheehan, B, McWilliams, D, Yeung, J, Jones, C, Lara, B, Smith, J, Ji, C, et al
Trials. 2021;(1):8
Abstract
OBJECTIVES The primary objective is to determine which of two interventions: 1) an eight week, online, home-based, supervised, group rehabilitation programme (REGAIN); or 2) a single online session of advice (best-practice usual care); is the most clinically and cost-effective treatment for people with ongoing COVID-19 sequelae more than three months after hospital discharge. TRIAL DESIGN Multi-centre, 2-arm (1:1 ratio) parallel group, randomised controlled trial with embedded process evaluation and health economic evaluation. PARTICIPANTS Adults with ongoing COVID-19 sequelae more than three months after hospital discharge Inclusion criteria: 1) Adults ≥18 years; 2) ≥ 3 months after any hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support; 3) substantial (as defined by the participant) COVID-19 related physical and/or mental health problems; 4) access to, and able/supported to use email and internet audio/video; 4) able to provide informed consent; 5) able to understand spoken and written English, Bengali, Gujarati, Urdu, Punjabi or Mandarin, themselves or supported by family/friends. EXCLUSION CRITERIA 1) exercise contraindicated; 2) severe mental health problems preventing engagement; 3) previous randomisation in the present study; 4) already engaged in, or planning to engage in an alternative NHS rehabilitation programme in the next 12 weeks; 5) a member of the same household previously randomised in the present study. INTERVENTION AND COMPARATOR Intervention 1: The Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) programme: an eight week, online, home-based, supervised, group rehabilitation programme. Intervention 2: A thirty-minute, on-line, one-to-one consultation with a REGAIN practitioner (best-practice usual care). MAIN OUTCOMES The primary outcome is health-related quality of life (HRQoL) - PROMIS® 29+2 Profile v2.1 (PROPr) - measured at three months post-randomisation. Secondary outcomes include dyspnoea, cognitive function, health utility, physical activity participation, post-traumatic stress disorder (PTSD) symptom severity, depressive and anxiety symptoms, work status, health and social care resource use, death - measured at three, six and 12 months post-randomisation. RANDOMISATION Participants will be randomised to best practice usual care or the REGAIN programme on a 1:1.03 basis using a computer-generated randomisation sequence, performed by minimisation and stratified by age, level of hospital care, and case level mental health symptomatology. Once consent and baseline questionnaires have been completed by the participant online at home, randomisation will be performed automatically by a bespoke web-based system. BLINDING (MASKING): To ensure allocation concealment from both participant and REGAIN practitioner at baseline, randomisation will be performed only after the baseline questionnaires have been completed online at home by the participant. After randomisation has been performed, participants and REGAIN practitioners cannot be blind to group allocation. Follow-up outcome assessments will be completed by participants online at home. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 535 participants will be randomised: 263 to the best-practice usual care arm, and 272 participants to the REGAIN programme arm. TRIAL STATUS Current protocol: Version 3.0 (27th October 2020) Recruitment will begin in December 2020 and is anticipated to complete by September 2021. TRIAL REGISTRATION ISRCTN11466448 , 23rd November 2020 FULL PROTOCOL The full protocol Version 3.0 (27th October 2020) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interests of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.
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The impact of Covid-19 on patients with suspected cancer: An analysis of ED presentation and referrals to a quick diagnosis unit.
Bosch, X, Capdevila, A, Grafia, I, Ladino, A, Moreno, PJ, López-Soto, A
The American journal of emergency medicine. 2021;:1-11
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Abstract
PURPOSE Patients evaluated in the emergency department (ED) who have concerning symptoms suggestive of a cancer diagnosis are mostly referred to the quick diagnosis unit of our tertiary hospital. This study analyzed the impact of the Covid-19 pandemic on the volume, disease patterns, and accessibility to essential investigations of patients with suspected cancer referred by the ED to this unit. METHODS Trends in referrals were analyzed from January 1 to July 8, 2020 and the corresponding dates of 2019. Only non-Covid-19 conditions were evaluated. Three time-based cohorts were defined: prepandemic (January 1-February 19), pandemic (February 19-April 22), and postpandemic (April 22-July 8). Along with descriptive statistics, linear regression was used to test for time trends with weekly referrals as the dependent variable. RESULTS There were 384, 193, and 450 patients referred during the prepandemic, pandemic, and postpandemic periods, respectively. Following an increasing rate, referrals decreased to unprecedented levels in the pandemic period (average weekly slope: -2.1 cases), then increasing again until near normalization. Waiting times to most diagnostic procedures including radiology, endoscopic, nuclear medicine, and biopsy/cytology during the pandemic period were significantly delayed and time-to-diagnosis was considerably longer (19.72 ± 10.37 days vs. 8.33 ± 3.94 days in prepandemic and 13.49 ± 6.45 days in postpandemic period; P < 0.001 in both). Compared to other cohorts, pandemic cohort patients were more likely to have unintentional weight loss and fever of unknown origin as referral indications while anemia and lymphadenopathy were less common. Patients from the pandemic cohort had a significantly lower rate of malignancies and higher of benign gastrointestinal disorders (40.93% vs. 19.53% and 20.89% in prepandemic and postpandemic periods, respectively; P < 0.001 in both), most notably irritable bowel disease, and of mental and behavioral disorders (15.54% vs. 3.39% and 6.00% in prepandemic and postpandemic periods, respectively; P < 0.001 in both). CONCLUSIONS As our hospital switched its traditional care to one focused on Covid-19 patients, recognized indicators of healthcare quality of quick diagnosis units were severely disrupted. The clinical patterns of presentation and diagnosis of the pandemic period suggested that mass media-generated mental and behavioral responses with distressing symptoms played a significant role in most of these patients.
