Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN' (REGAIN): a structured summary of a study protocol for a randomised controlled trial.

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: ISRCTN:11466448 , 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.

Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm: a randomised controlled feasibility trial (COMPRESS-RCT).

BACKGROUND: Mechanical chest compression devices consistently deliver high-quality chest compressions. Small very low-quality studies suggest mechanical devices may be effective as an alternative to manual chest compressions in the treatment of adult in-hospital cardiac arrest patients. The aim of this feasibility trial is to assess the feasibility of conducting an effectiveness trial in this patient population. METHODS: COMPRESS-RCT is a multi-centre parallel group feasibility randomised controlled trial, designed to assess the feasibility of undertaking an effectiveness to compare the effect of mechanical chest compressions with manual chest compressions on 30-day survival following in-hospital cardiac arrest. Over approximately two years, 330 adult patients who sustain an in-hospital cardiac arrest and are in a non-shockable rhythm will be randomised in a 3:1 ratio to receive ongoing treatment with a mechanical chest compression device (LUCAS 2/3, Jolife AB/Stryker, Lund, Sweden) or continued manual chest compressions. It is intended that recruitment will occur on a 24/7 basis by the clinical cardiac arrest team. The primary study outcome is the proportion of eligible participants randomised in the study during site operational recruitment hours. Participants will be enrolled using a model of deferred consent, with consent for follow-up sought from patients or their consultee in those that survive the cardiac arrest event. The trial will have an embedded qualitative study, in which we will conduct semi-structured interviews with hospital staff to explore facilitators and barriers to study recruitment. DISCUSSION: The findings of COMPRESS-RCT will provide important information about the deliverability of an effectiveness trial to evaluate the effect on 30-day mortality of routine use of mechanical chest compression devices in adult in-hospital cardiac arrest patients. TRIAL REGISTRATION: ISRCTN38139840 , date of registration 9th January 2017.

The role of evidence, context, and facilitation in an implementation trial: implications for the development of the PARIHS framework.

BACKGROUND: The case has been made for more and better theory-informed process evaluations within trials in an effort to facilitate insightful understandings of how interventions work. In this paper, we provide an explanation of implementation processes from one of the first national implementation research randomized controlled trials with embedded process evaluation conducted within acute care, and a proposed extension to the Promoting Action on Research Implementation in Health Services (PARIHS) framework. METHODS: The PARIHS framework was prospectively applied to guide decisions about intervention design, data collection, and analysis processes in a trial focussed on reducing peri-operative fasting times. In order to capture a holistic picture of implementation processes, the same data were collected across 19 participating hospitals irrespective of allocation to intervention. This paper reports on findings from data collected from a purposive sample of 151 staff and patients pre- and post-intervention. Data were analysed using content analysis within, and then across data sets. RESULTS: A robust and uncontested evidence base was a necessary, but not sufficient condition for practice change, in that individual staff and patient responses such as caution influenced decision making. The implementation context was challenging, in which individuals and teams were bounded by professional issues, communication challenges, power and a lack of clarity for the authority and responsibility for practice change. Progress was made in sites where processes were aligned with existing initiatives. Additionally, facilitators reported engaging in many intervention implementation activities, some of which result in practice changes, but not significant improvements to outcomes. CONCLUSIONS: This study provided an opportunity for reflection on the comprehensiveness of the PARIHS framework. Consistent with the underlying tenant of PARIHS, a multi-faceted and dynamic story of implementation was evident. However, the prominent role that individuals played as part of the interaction between evidence and context is not currently explicit within the framework. We propose that successful implementation of evidence into practice is a planned facilitated process involving an interplay between individuals, evidence, and context to promote evidence-informed practice. This proposal will enhance the potential of the PARIHS framework for explanation, and ensure theoretical development both informs and responds to the evidence base for implementation.

WITHDRAWN: Antibiotics / anti-inflammatories for reducing acute inflammatory episodes in lymphoedema of the limbs.

BACKGROUND: Lymphoedema is a chronic, progressive condition and one area of debate is the optimum management for infective/inflammatory episodes (AIE's). OBJECTIVES: To determine whether antibiotic/anti-inflammatory drugs given prophylactically reduce the number and severity of AIE's in patients with lymphoedema. SEARCH STRATEGY: We searched the Cochrane Breast Cancer Group register in September 2003, the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2003), CINAHL, MEDLINE, PASCAL, SIGLE, UnCover, reference lists produced by The British Lymphology Society, the National Research Register (NRR) and the International Society of Lymphology congress proceedings. SELECTION CRITERIA: Randomised controlled trials testing an antibiotic or anti-inflammatory drug against placebo (with or without physical therapies) were included. DATA COLLECTION AND ANALYSIS: Eligibility for inclusion was confirmed by two blinded reviewers. The papers were screened independently using a checklist of criteria relating to quality. Both reviewers extracted data from the eligible studies using a data extraction form. MAIN RESULTS: Four studies (364 randomised patients) were included. Two studied the effects of intensive physical treatment plus selenium or placebo in preventing AIE's, and two studied the effects of Ivermectin, Diethylcarbamazine (DEC) (anti-filarial agents) and penicillin as prophylactic treatment for adeno lymphangitis(ADL) versus placebo.Both selenium trials reported no inflammatory episodes during the trial period in the treated group but one case of infection in the two placebo groups respectively. Seven additional cases of infection in trial one and 14 cases in trial two required treatment in the three month follow up period.One anti-filarial trial reported 127 ADL episodes for all groups during the treatment year (compared with 684 episodes during the pre-treatment year). There were 228 ADL episodes during the trial follow-up year but no findings were significant. No link was found between the grade of oedema and the frequency of ADL episodes. There was a significant link between increased episodes and the rainy season. Penicillin reduced the mean number of inflammatory episodes from 4.6 to 0.5 after treatment, which increased to 1.9 at the end of follow-up. AUTHORS' CONCLUSIONS: The effectiveness of selenium in preventing AIE in lymphoedema remains inconclusive in the absence of properly conducted randomised-controlled trials. Anti-filarials do not appear to reduce ADL episodes in filarial lymphoedema. Penicillin appears to contribute to a significant reduction in ADL when combined with foot-care. The importance of foot-care should be recommended, which may also apply to care of the arm following breast cancer treatment. Properly conducted trials are needed to demonstrate any efficacy of these interventions.

Effectiveness of relaxation for postoperative pain and anxiety: randomized controlled trial.

AIM: This paper is a report of a study to determine the effectiveness of jaw and total body relaxation for postoperative pain, anxiety and level of relaxation, and to determine any patient expectancy effects. BACKGROUND: Relaxation is increasingly suggested as a pain control technique that can be used by nurses in daily practice. A systematic review of the effectiveness of relaxation for postoperative pain relief revealed many poorly designed studies and only some weak evidence supporting the use of relaxation for postoperative pain. METHOD: A randomized controlled trial (n = 118) was conducted between 2002 and 2003 to compare total body relaxation, jaw relaxation, attention control and usual care. Consenting patients admitted for elective orthopaedic surgery aged 18 or over, able to speak English and able to tense and relax more than two muscle groups were included. Pain at rest and on movement, anxiety and relaxation were assessed at pre-admission clinic, pre-intervention, immediately post-intervention and 1, 2, 3 and 4 hours later. However, the trial was under-powered. FINDINGS: There were statistically significant reductions in pain at rest from pre- to post-intervention for both the relaxation groups and the attention control group. The usual care group had a small increase in pain, whilst the other three groups had similar small decreases in pain. There was no statistically significant difference in anxiety or relaxation scores pre- to post-intervention between groups. CONCLUSION: Jaw relaxation could give these orthopaedic patients a small, very short-lasting additional amount of pain relief, and it may be that staff and patients feel this small benefit to be worthwhile.

An exploration of the concept of comfort.

This paper explores the concept of comfort within conceptual frameworks that identify comfort as a key component. The paper focuses on two main issues: firstly, descriptions of comfort and how comfort is defined; secondly, the relationship between comfort and other core concepts and how it is similar to, or differs from these concepts. The descriptions of comfort identify the difficulty of defining comfort and note that historical interpretations of comfort have changed over time. Key authors provide different perspectives of comfort and hence a uniform definition is not evident. The degree to which patients' perspectives are represented varies within the frameworks which suggests that further clarity is needed in this area. The relationship between comfort and other concepts considers the boundaries between comfort and two concepts: nursing as therapy and caring. Comfort tends to be seen as a minor aspect of these concepts focusing on relief of discomfort or actions that demonstrate caring. The paper concludes that there is a lack of clarity around the use of the term comfort which fits with a view of comfort as an emerging concept. Descriptions of comfort are clearly evident in the literature but differ in relation to the authors' views of nursing. The relationship between comfort and nursing as therapy and caring is also complex and highlights the debate in relation to comfort as a part of caring or as the overall focus of care.

Getting evidence into practice: the role and function of facilitation.

AIM OF PAPER: This paper presents the findings of a concept analysis of facilitation in relation to successful implementation of evidence into practice. BACKGROUND: In 1998, we presented a conceptual framework that represented the interplay and interdependence of the many factors influencing the uptake of evidence into practice. One of the three elements of the framework was facilitation, alongside the nature of evidence and context. It was proposed that facilitators had a key role in helping individuals and teams understand what they needed to change and how they needed to change it. As part of the on-going development and refinement of the framework, the elements within it have undergone a concept analysis in order to provide theoretical and conceptual clarity. METHODS: The concept analysis approach was used as a framework to review critically the research literature and seminal texts in order to establish the conceptual clarity and maturity of facilitation in relation to its role in the implementation of evidence-based practice. FINDINGS: The concept of facilitation is partially developed and in need of delineation and comparison. Here, the purpose, role and skills and attributes of facilitators are explored in order to try and make distinctions between this role and other change agent roles such as educational outreach workers, academic detailers and opinion leaders. CONCLUSIONS: We propose that facilitation can be represented as a set of continua, with the purpose of facilitation ranging from a discrete task-focused activity to a more holistic process of enabling individuals, teams and organizations to change. A number of defining characteristics of facilitation are proposed. However, further research to clarify and evaluate different models of facilitation is required.