A scoping review of 'Pacing' for management of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): lessons learned for the long COVID pandemic.

BACKGROUND: Controversy over treatment for people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a barrier to appropriate treatment. Energy management or pacing is a prominent coping strategy for people with ME/CFS. Whilst a definitive definition of pacing is not unanimous within the literature or healthcare providers, it typically comprises regulating activity to avoid post exertional malaise (PEM), the worsening of symptoms after an activity. Until now, characteristics of pacing, and the effects on patients' symptoms had not been systematically reviewed. This is problematic as the most common approach to pacing, pacing prescription, and the pooled efficacy of pacing was unknown. Collating evidence may help advise those suffering with similar symptoms, including long COVID, as practitioners would be better informed on methodological approaches to adopt, pacing implementation, and expected outcomes. OBJECTIVES: In this scoping review of the literature, we aggregated type of, and outcomes of, pacing in people with ME/CFS. ELIGIBILITY CRITERIA: Original investigations concerning pacing were considered in participants with ME/CFS. SOURCES OF EVIDENCE: Six electronic databases (PubMed, Scholar, ScienceDirect, Scopus, Web of Science and the Cochrane Central Register of Controlled Trials [CENTRAL]) were searched; and websites MEPedia, Action for ME, and ME Action were also searched for grey literature, to fully capture patient surveys not published in academic journals. METHODS: A scoping review was conducted. Review selection and characterisation was performed by two independent reviewers using pretested forms. RESULTS: Authors reviewed 177 titles and abstracts, resulting in 17 included studies: three randomised control trials (RCTs); one uncontrolled trial; one interventional case series; one retrospective observational study; two prospective observational studies; four cross-sectional observational studies; and five cross-sectional analytical studies. Studies included variable designs, durations, and outcome measures. In terms of pacing administration, studies used educational sessions and diaries for activity monitoring. Eleven studies reported benefits of pacing, four studies reported no effect, and two studies reported a detrimental effect in comparison to the control group. CONCLUSIONS: Highly variable study designs and outcome measures, allied to poor to fair methodological quality resulted in heterogenous findings and highlights the requirement for more research examining pacing. Looking to the long COVID pandemic, our results suggest future studies should be RCTs utilising objectively quantified digitised pacing, over a longer duration of examination (i.e. longitudinal studies), using the core outcome set for patient reported outcome measures. Until these are completed, the literature base is insufficient to inform treatment practises for people with ME/CFS and long COVID.

Exploring the perceptions and experiences of community rehabilitation for Long COVID from the perspectives of Scottish general practitioners' and people living with Long COVID: a qualitative study.

OBJECTIVES: To explore the experience of accessing Long COVID community rehabilitation from the perspectives of people with Long COVID and general practitioners (GPs). DESIGN: Qualitative descriptive study employing one-to-one semistructured virtual interviews analysed using the framework method. SETTING: Four National Health Service Scotland territorial health boards. PARTICIPANTS: 11 people with Long COVID (1 male, 10 female; aged 40-65 (mean 53) and 13 GPs (5 male, 8 female). RESULTS: Four key themes were identified: (1) The lived experience of Long COVID, describing the negative impact of Long COVID on participants' health and quality of life; (2) The challenges of an emergent and complex chronic condition, including uncertainties related to diagnosis and management; (3) Systemic challenges for Long COVID service delivery, including lack of clear pathways for access and referral, siloed services, limited resource and a perceived lack of holistic care, and (4) Perceptions and experiences of Long COVID and its management, including rehabilitation. In this theme, a lack of knowledge by GPs and people with Long COVID on the potential role of community rehabilitation for Long COVID was identified. Having prior knowledge of rehabilitation or being a healthcare professional appeared to facilitate access to community rehabilitation. Finally, people with Long COVID who had received rehabilitation had generally found it beneficial. CONCLUSIONS: There are several patient, GP and service-level barriers to accessing community rehabilitation for Long COVID. There is a need for greater understanding by the public, GPs and other potential referrers of the role of community rehabilitation professionals in the management of Long COVID. There is also a need for community rehabilitation services to be well promoted and accessible to the people with Long COVID for whom they may be appropriate. The findings of this study can be used by those (re)designing community rehabilitation services for people with Long COVID.

Investigating Scottish Long COVID community rehabilitation service models from the perspectives of people living with Long COVID and healthcare professionals: a qualitative descriptive study.

OBJECTIVES: This study aimed to explore the perceptions and experiences of barriers and facilitators to accessing Long COVID community rehabilitation. DESIGN: We used a qualitative descriptive design over two rounds of data collection with three participant groups: (1) people with experience of rehabilitation for Long COVID (PwLC); (2) National Health Service (NHS) staff delivering and/or managing community rehabilitation services (allied health professionals (AHPs)) and (3) NHS staff involved in strategic planning around Long COVID in their health board (Long COVID leads). SETTING: Four NHS Scotland territorial health boards. PARTICIPANTS: 51 interviews: eight Long COVID leads (11 interviews); 15 AHPs (25 interviews) and 15 PwLC (15 interviews). RESULTS: Three key themes were identified: (1) accessing care for PwLC, (2) understanding Long COVID and its management and (3) strengths and limitations of existing Long COVID rehabilitation services. CONCLUSIONS: Organisational delivery of Long COVID community rehabilitation is complex and presents multiple challenges. In addition, access to Long COVID community rehabilitation can be challenging. When accessed, these services are valued by PwLC but require adequate planning, publicity and resource. The findings presented here can be used by those developing and delivering services for people with Long COVID.

Considerations for patient and public involvement and engagement in health research.

Patient and public involvement and engagement (PPIE) can provide valuable insights into the experiences of those living with and affected by a disease or health condition. Inclusive collaboration between patients, the public and researchers can lead to productive relationships, ensuring that health research addresses patient needs. Guidelines are available to support effective PPIE; however, evaluation of the impact of PPIE strategies in health research is limited. In this Review, we evaluate the impact of PPIE in the 'Therapies for Long COVID in non-hospitalised individuals' (TLC) Study, using a combination of group discussions and interviews with patient partners and researchers. We identify areas of good practice and reflect on areas for improvement. Using these insights and the results of a survey, we synthesize two checklists of considerations for PPIE, and we propose that research teams use these checklists to optimize the impact of PPIE for both patients and researchers in future studies.

The remote diet intervention to reduce Long COVID symptoms trial (ReDIRECT): protocol for a randomised controlled trial to determine the effectiveness and cost-effectiveness of a remotely delivered supported weight management programme for people with Long COVID and excess weight, with personalised improvement goals.

Objectves: The Remote Diet Intervention to Reduce Long COVID Symptoms Trial (ReDIRECT) evaluates whether the digitally delivered, evidence-based, cost-effective Counterweight-Plus weight management programme improves symptoms of Long COVID in people with overweight/obesity. Methods: Baseline randomised, non-blinded design with 240 participants allocated in a 1:1 ratio either to continue usual care or to add the remotely delivered Counterweight-Plus weight management programme, which includes a Counterweight dietitian supported delivery of 12 weeks total diet replacement, food reintroduction, and long-term weight loss maintenance. Randomisation is achieved by accessing a web-based randomisation system incorporated into the study web portal developed by a registered Clinical Trials Unit. We are using an innovative approach to outcome personalisation, with each participant selecting their most dominant Long COVID symptom as their primary outcome assessed at six months. Participants in the control arm enter the weight management programme after six months. We are recruiting participants from social media and existing networks (e.g., Long COVID Scotland groups), through newspaper advertisements and from primary care. Main inclusion criteria: people with Long COVID symptoms persisting > three months, aged 18 years or above, body mass index (BMI) above 27kg/m 2 (>25kg/m 2 for South Asians). The trial includes a process evaluation (involving qualitative interviews with participants and analysis of data on dose, fidelity and reach of the intervention) and economic evaluation (within-trial and long-term cost-utility analyses). Anticipated results: The recruitment for this study started in December 2021 and ended in July 2022. Project results are not yet available and will be shared via peer-reviewed publication once the six-months outcomes have been analysed. Trial registration: Current Controlled Trials ISRCTN12595520.

While most people infected with COVID-19 recover within a short amount of time, some people continue to have symptoms for 12 weeks or longer. This condition is known as Long COVID. Roughly two-thirds of people with Long COVID are overweight, a proportion similar to that found in the general population. Being overweight may worsen symptoms such as fatigue, breathlessness and pains. Weight management programmes in adults with overweight/obesity can reduce such symptoms, however we do not know how effective intentional weight loss is to reduce symptoms for people with Long COVID. The aim of this project is to test a well-established weight management programme, delivered and supported remotely, in people with Long COVID. The trial is conducted with 240 people with Long COVID, identified through their GP, patient groups, social media, or newspaper advertisements. A total of 120 individuals will receive the personalised, professionally supported weight management programme (treatment group), and 120 participants are allocated to usual care (control group). The one-year long weight management programme involves 12 weeks of total diet replacement (TDR) using soups and shakes, followed by food reintroduction and weight maintenance. Food based alternatives are available to those who are unable, or prefer not to, follow the TDR approach. The two groups will be compared for Long COVID symptoms, weight loss, quality of life and value for money after six months. After six months, the weight management programme will also be provided for the control group. Experiences while on the programme will be documented for 12 months for all participants. People with Long COVID have been involved extensively in developing this project. Their priorities are to reduce symptoms like fatigue, breathlessness and pain. They are keen to explore if effective weight management would help their symptoms and overall functioning, especially a programme that can be followed remotely from home. A group of patients and other stakeholders has been set up to provide advice throughout the project.

Development and validation of the symptom burden questionnaire for long covid (SBQ-LC): Rasch analysis.

OBJECTIVE: To describe the development and validation of a novel patient reported outcome measure for symptom burden from long covid, the symptom burden questionnaire for long covid (SBQ-LC). DESIGN: Multiphase, prospective mixed methods study. SETTING: Remote data collection and social media channels in the United Kingdom, 14 April to 1 August 2021. PARTICIPANTS: 13 adults (aged ≥18 years) with self-reported long covid and 10 clinicians evaluated content validity. 274 adults with long covid field tested the draft questionnaire. MAIN OUTCOME MEASURES: Published systematic reviews informed development of SBQ-LC's conceptual framework and initial item pool. Thematic analysis of transcripts from cognitive debriefing interviews and online clinician surveys established content validity. Consensus discussions with the patient and public involvement group of the Therapies for Long COVID in non-hospitalised individuals: From symptoms, patient reported outcomes and immunology to targeted therapies (TLC Study) confirmed face validity. Rasch analysis of field test data guided item and scale refinement and provided initial evidence of the SBQ-LC's measurement properties. RESULTS: SBQ-LC (version 1.0) is a modular instrument measuring patient reported outcomes and is composed of 17 independent scales with promising psychometric properties. Respondents rate their symptom burden during the past seven days using a dichotomous response or 4 point rating scale. Each scale provides coverage of a different symptom domain and returns a summed raw score that can be transformed to a linear (0-100) score. Higher scores represent higher symptom burden. After rating scale refinement and item reduction, all scales satisfied the Rasch model requirements for unidimensionality (principal component analysis of residuals: first residual contrast values <2.00 eigenvalue units) and item fit (outfit mean square values within 0.5 -1.5 logits). Rating scale categories were ordered with acceptable category fit statistics (outfit mean square values <2.0 logits). 14 item pairs had evidence of local dependency (residual correlation values >0.4). Across the 17 scales, person reliability ranged from 0.34 to 0.87, person separation ranged from 0.71 to 2.56, item separation ranged from 1.34 to 13.86, and internal consistency reliability (Cronbach's alpha) ranged from 0.56 to 0.91. CONCLUSIONS: SBQ-LC (version 1.0) is a comprehensive patient reported outcome instrument developed using modern psychometric methods. It measures symptoms of long covid important to people with lived experience of the condition and may be used to evaluate the impact of interventions and inform best practice in clinical management.