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ObjectivesTo describe the process and outcomes of using a new evidence base to develop scientific guidelines that specify the type and minimum dose of exercise necessary to improve fitness and cardiometabolic health in adults with spinal cord injury (SCI).SettingInternational.MethodsUsing Appraisal of Guidelines, Research and Evaluation (AGREE) II reporting criteria, steps included (a) determining the guidelines’ scope; (b) conducting a systematic review of relevant literature; (c) holding three consensus panel meetings (European, Canadian and International) to formulate the guidelines; (d) obtaining stakeholder feedback; and (e) process evaluation by an AGREE II consultant. Stakeholders were actively involved in steps (c) and (d).ResultsFor cardiorespiratory fitness and muscle strength benefits, adults with a SCI should engage in at least 20 min of moderate to vigorous intensity aerobic exercise 2 times per week AND 3 sets of strength exercises for each major functioning muscle group, at a moderate to vigorous intensity, 2 times per week (strong recommendation). For cardiometabolic health benefits, adults with a SCI are suggested to engage in at least 30 min of moderate to vigorous intensity aerobic exercise 3 times per week (conditional recommendation).ConclusionsThrough a systematic, rigorous, and participatory process involving international scientists and stakeholders, a new exercise guideline was formulated for cardiometabolic health benefits. A previously published SCI guideline was endorsed for achieving fitness benefits. These guidelines represent an important step toward international harmonization of exercise guidelines for adults with SCI, and a foundation for developing exercise policies and programs for people with SCI around the world.

Objectives The objective of this review was to summarize and appraise evidence on functional electrical stimulation (FES) cycling exercise after spinal cord injury (SCI), in order to inform the development of evidence-based clinical practice guidelines. Methods PubMed, the Cochrane Central Register of Controlled Trials, EMBASE, SPORTDiscus, and CINAHL were searched up to April 2021 to identify FES cycling exercise intervention studies including adults with SCI. In order to capture the widest array of evidence available, any outcome measure employed in such studies was considered eligible. Two independent reviewers conducted study eligibility screening, data extraction, and quality appraisal using Cochranes’ Risk of Bias or Downs and Black tools. Each study was designated as a Level 1, 2, 3 or 4 study, dependent on study design and quality appraisal scores. The certainty of the evidence for each outcome was assessed using GRADE ratings (‘High’, ‘Moderate’, ‘Low’, or ‘Very low’). Results Ninety-two studies met the eligibility criteria, comprising 999 adults with SCI representing all age, sex, time since injury, lesion level and lesion completeness strata. For muscle health (e.g., muscle mass, fiber type composition), significant improvements were found in 3 out of 4 Level 1–2 studies, and 27 out of 32 Level 3–4 studies (GRADE rating: ‘High’). Although lacking Level 1–2 studies, significant improvements were also found in nearly all of 35 Level 3–4 studies on power output and aerobic fitness (e.g., peak power and oxygen uptake during an FES cycling test) (GRADE ratings: ‘Low’). Conclusion Current evidence indicates that FES cycling exercise improves lower-body muscle health of adults with SCI, and may increase power output and aerobic fitness. The evidence summarized and appraised in this review can inform the development of the first international, evidence-based clinical practice guidelines for the use of FES cycling exercise in clinical and community settings of adults with SCI. Registration review protocol : CRD42018108940 (PROSPERO)

Clinical tools for use in practice—such as medicine reconciliation charts, diagnosis support tools and track-and-trigger charts—are endemic in healthcare, but relatively little attention is given to how to optimise their design. User-centred design approaches and co-design principles offer potential for improving usability and acceptability of clinical tools, but limited practical guidance is currently available. We propose a framework (FRamework for co-dESign of Clinical practice tOols or ‘FRESCO’) offering practical guidance based on user-centred methods and co-design principles, organised in five steps: (1) establish a multidisciplinary advisory group; (2) develop initial drafts of the prototype; (3) conduct think-aloud usability evaluations; (4) test in clinical simulations; (5) generate a final prototype informed by workshops. We applied the framework in a case study to support co-design of a prototype track-and-trigger chart for detecting and responding to possible fetal deterioration during labour. This started with establishing an advisory group of 22 members with varied expertise. Two initial draft prototypes were developed—one based on a version produced by national bodies, and the other with similar content but designed using human factors principles. Think-aloud usability evaluations of these prototypes were conducted with 15 professionals, and the findings used to inform co-design of an improved draft prototype. This was tested with 52 maternity professionals from five maternity units through clinical simulations. Analysis of these simulations and six workshops were used to co-design the final prototype to the point of readiness for large-scale testing. By codifying existing methods and principles into a single framework, FRESCO supported mobilisation of the expertise and ingenuity of diverse stakeholders to co-design a prototype track-and-trigger chart in an area of pressing service need. Subject to further evaluation, the framework has potential for application beyond the area of clinical practice in which it was applied.

Background Despite recognition of the importance of patient and public involvement (PPI) in healthcare improvement, compelling examples of “what good looks like” for PPI in co-design of improvement efforts, how it might be done, and formalisation of methods and reporting are lacking. In this article, we sought to address these gaps through a case study to illustrate a principled approach to integrating PPI into the co-design of healthcare improvement. Methods The case study aimed to involve maternity service users in the co-design of clinical resources for a maternity improvement programme, using a four-stage approach: 1) establishing guiding principles for PPI in the programme, 2) structuring PPI for the programme, 3) co-designing improvements with PPI, and 4) seeking feedback on PPI in the co-design process. Results Partnership-focused frameworks and other literature on PPI and co-design informed the guiding principles. The structure included a five-member PPI group who provided continuous input, and an additional 15-member PPI group who met twice to discuss experiences of obstetric emergency. PPI in the co-design processes shaped the development of the resources in multiple ways, such as strengthening the prominence given to listening to those in labour and their birth partners, ensuring inclusivity of visuals and language, and developing communication principles informing all resources. Feedback suggested that PPI members felt valued, listened to, and supported to provide unanticipated contributions. Conclusions The case study demonstrated how a principled approach to PPI enabled service users to play a key role in co-design of clinical resources aimed at improving the quality and safety of maternity care in the UK. Further case studies, across different clinical areas and with varying levels of resources, are needed to validate this approach.

The objective of this scoping review was to map the evidence on measurement properties of body composition tools to assess whole-body and regional fat and fat-free mass in adults with SCI, and to identify research gaps in order to set future research priorities. Electronic databases of PubMed, EMBASE and the Cochrane library were searched up to April 2020. Included studies employed assessments related to whole-body or regional fat and/or fat-free mass and provided data to quantify measurement properties that involved adults with SCI. All searches and data extractions were conducted by two independent reviewers. The scoping review was designed and conducted together with an expert panel (n = 8) that represented research, clinical, nutritional and lived SCI experience. The panel collaboratively determined the scope and design of the review and interpreted its findings. Additionally, the expert panel reached out to their professional networks to gain further stakeholder feedback via interactive practitioner surveys and workshops with people with SCI. The research gaps identified by the review, together with discussions among the expert panel including consideration of the survey and workshop feedback, informed the formulation of future research priorities. A total of 42 eligible articles were identified (1,011 males and 143 females). The only tool supported by studies showing both acceptable test-retest reliability and convergent validity was whole-body dual-energy x-ray absorptiometry (DXA). The survey/workshop participants considered the measurement burden of DXA acceptable as long as it was reliable, valid and would do no harm (e.g. radiation, skin damage). Practitioners considered cost and accessibility of DXA major barriers in applied settings. The survey/workshop participants expressed a preference towards simple tools if they could be confident in their reliability and validity. This review suggests that future research should prioritize reliability and validity studies on: (1) DXA as a surrogate ‘gold standard’ tool to assess whole-body composition, regional fat and fat-free mass; and (2) skinfold thickness and waist circumference as practical low-cost tools to assess regional fat mass in persons with SCI, and (3) females to explore potential sex differences of body composition assessment tools. Registration review protocol: CRD42018090187 (PROSPERO).

IntroductionThe COVID-19 pandemic has impacted specialty chronic obstructive pulmonary disease (COPD) care. We examined the degree to which care has moved to remote approaches, eliciting clinician and patient perspectives on what is appropriate for ongoing remote delivery.MethodsUsing an online research platform, we conducted a survey and consensus-building process involving clinicians and patients with COPD.ResultsFifty-five clinicians and 19 patients responded. The majority of clinicians felt able to assess symptom severity (n=52, 95%), reinforce smoking cessation (n=46, 84%) and signpost to other healthcare resources (n=44, 80%). Patients reported that assessing COPD severity and starting new medications were being addressed through remote care. Forty-three and 31 respondents participated in the first and second consensus-building rounds, respectively. When asked to rate the appropriateness of using remote delivery for specific care activities, respondents reached consensus on 5 of 14 items: collecting information about COPD and overall health status (77%), providing COPD education and developing a self-management plan (74%), reinforcing smoking cessation (81%), deciding whether patients should seek in-person care (72%) and initiating a rescue pack (76%).ConclusionAdoption of remote care delivery appears high, with many care activities partially or completely delivered remotely. Our work identifies strengths and limitations of remote care delivery.

Background Workplace programmes to test staff for asymptomatic COVID-19 infection have become common, but raise a number of ethical challenges. In this article, we report the findings of a consultation that informed the development of an ethical framework for organisational decision-making about such programmes. Methods We conducted a mixed-method consultation – a survey and semi-structured interviews during November–December 2020 in a UK case study organisation that had introduced asymptomatic testing for all staff working on-site in its buildings. Analysis of closed-ended survey data was conducted descriptively. An analysis approach based on the Framework Method was used for the open-ended survey responses and interview data. The analyses were then integrated to facilitate systematic analysis across themes. Inferences were based on the integrated findings and combined with other inputs (literature review, ethical analysis, legal and public health guidance, expert discussions) to develop an ethical framework. Results The consultation involved 61 staff members from the case study organisation (50 survey respondents and 11 interview participants). There was strong support for the asymptomatic testing programme: 90% of the survey respondents viewed it as helpful or very helpful. Open-ended survey responses and interviews gave insight into participants’ concerns, including those relating to goal drift, risk of false negatives, and potential negative impacts for household members and people whose roles lacked contractual and financial stability. Integration of the consultation findings and the other inputs identified the importance of a whole-system approach with appropriate support for the key control measure of isolation following positive tests. The need to build trust in the testing programme, for example through effective communication from leaders, was also emphasised. Conclusions The consultation, together with other inputs, informed an ethical framework intended to support employers. The framework may support organisational decision-making in areas ranging from design and operation of the programme through to choices about participation. The framework is likely to benefit from further consultation and refinement in new settings.

ObjectivesDetecting and responding to deterioration of a baby during labour is likely to benefit from a standardised approach supported by principles of track-and-trigger systems. To inform co-design of a standardised approach and associated implementation strategies, we sought the views of UK-based maternity professionals.DesignTwo successive cross-sectional surveys were hosted on an online collaboration platform (Thiscovery) between July 2021 and April 2022.SettingUK.ParticipantsAcross both surveys, 765 UK-based maternity professionals.Primary and secondary outcome measuresCount and percentage of participants selecting closed-ended response options, and categorisation and counting of free-text responses.ResultsMore than 90% of participants supported the principle of a standardised approach that systematically considers a range of intrapartum risk factors alongside fetal heart rate features. Over 80% of participants agreed on the importance of a proposed set of evidence-based risk factors underpinning such an approach, but many (over 75%) also indicated a need to clarify the clinical definitions of the proposed risk factors. A need for clarity was also suggested by participants’ widely varying views on thresholds for actions of the proposed risk factors, particularly for meconium-stained liquor, rise in baseline fetal heart rate and changes in fetal heart rate variability. Most participants (>75%) considered a range of resources to support good practice as very useful when implementing the approach, such as when and how to escalate in different situations (82%), how to create a supportive culture (79%) and effective communication and decision-making with those in labour and their partners (75%).ConclusionsWe found strong professional support for the principle of a standardised approach to detection and response to intrapartum fetal deterioration and high agreement on the clinical importance of a set of evidence-based risk factors. Further work is needed to address: (1) clarity of clinical definitions of some risk factors, (2) building evidence and agreement on thresholds for action and (3) deimplementation strategies for existing local practices.

Study designProtocol for a pragmatic randomized controlled trial (the Exercise guideline Promotion and Implementation in Chronic SCI [EPIC-SCI] Trial).Primary objectivesTo test if home-/community-based exercise, prescribed according to the international SCI exercise guidelines, significantly reduces chronic bodily pain in adults with SCI.Secondary objectivesTo investigate: (1) the effects of exercise on musculoskeletal and neuropathic chronic pain; (2) if reduced inflammation and increased descending inhibitory control are viable pathways by which exercise reduces pain; (3) the effects of chronic pain reductions on subjective well-being; and (4) efficiency of a home-/community-based exercise intervention.SettingExercise in home-/community-based settings; assessments in university-based laboratories in British Columbia, Canada.MethodEighty-four adults with chronic SCI, reporting chronic musculoskeletal or neuropathic pain, and not meeting the current SCI exercise guidelines, will be recruited and randomized to a 6-month Exercise or Wait-List Control condition. Exercise will occur in home/community settings and will be supported through behavioral counseling. All measures will be taken at baseline, 3-months and 6-months. Analyses will consist of linear mixed effect models, multiple regression analyses and a cost–utility analysis. The economic evaluation will examine the incremental costs and health benefits generated by the intervention compared with usual care.Ethics and disseminationThe University of British Columbia Clinical Research Ethics Board approved the protocol (#H19–01650). Using an integrated knowledge translation approach, stakeholders will be engaged throughout the trial and will co-create and disseminate evidence-based recommendations and messages regarding the use of exercise to manage SCI chronic pain.Trial registrationClinicalTrials.gov identifier NCT04160858.