Care home resident and staff perceptions of the acceptability of nutrition intervention trial procedures: A qualitative study embedded within a cluster randomised feasibility trial

Objectives To examine care home resident and staff perceptions of the acceptability of participating in a feasibility trial evaluating nutritional interventions in the treatment of malnutrition. Design Exploratory qualitative methodology was used to gather descriptions of resident and staff perceptions of trial procedures, using semi-structured interviews with residents and focus groups with staff. The interviews were used to explore individual perceptions of the acceptability of the assigned intervention and the outcomes measured. Focus groups were used to explore staff experiences of trial participation and perspectives of nutritional support interventions. Setting The study was embedded within a cluster randomised feasibility trial, which randomised six care homes to provide standard care (SC), food-based (FB) intervention or oral nutritional supplement (ONS) intervention to residents with, or at risk of, malnutrition. Participants Residents in the trial with capacity to consent (n=7) formed the sampling frame for inclusion. Four agreed to be approached by the researcher and to take part in the individual interviews. All were women, representing two arms of the trial (ONS and SC). Twelve staff participated in six focus groups, one at each care home. All participants were women, representing all three arms of the trial. Results Major themes that emerged from both interviews and focus groups included the perceived acceptability of trial involvement, the value of residents completing participant-reported outcome measures and the challenges associated with outcomes measurement in this setting. Themes that emerged from the focus groups alone, included the importance of individualising an intervention, and the perceived value of FB and ONS interventions and dietetic input. Conclusions Residents and staff perceived involvement in a trial evaluating nutritional interventions to be acceptable, although the challenges associated with research in this setting were acknowledged. Resident preferences were highlighted by staff as an important consideration when implementing a nutrition support plan. Trial registration number ISRCTN3804792

Measures of central sensitisation and their measurement properties in the adult musculoskeletal trauma population: A protocol for a systematic review and data synthesis

Introduction Pain following musculoskeletal trauma is common with poor outcomes and disability well documented. Pain is complex in nature and can include the four primary mechanisms of pain: nociceptive, neuropathic, inflammatory and central sensitisation (CS). CS can be measured in multiple ways; however, no systematic review has evaluated the measurement properties of such measures in the musculoskeletal trauma population. This systematic review aims to evaluate the measurement properties of current measures of CS in this population. Methods/analysis This protocol is informed and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis-P. MEDLINE, EMBASE, CINAHL, ZETOC, Web of Science, PubMed and Google Scholar as well as key journals and grey literature will be searched in two stages to (1) identify what measures are being used to assess CS in this population and (2) evaluate the measurement properties of the identified measures. Two independent reviewers will conduct the search, extract the data, assess risk of bias for included studies and assess overall quality. The Consensus-based Standards for the selection of Health Measurement Instruments Risk of Bias Checklist and a modified Grading of Recommendations, Assessment, Development and Evaluation guidelines will be used. Meta-Analysis will be conducted if deemed appropriate. Alternatively, a narrative synthesis will be conducted and summarised per measurement property per outcome measure. Ethics and dissemination This review will aid clinicians in using the most appropriate tool for assessing central sensitisation in this population and is the first step towards a more standardised approach in pain assessment. The results of this study will be submitted to a peer reviewed journal and presented at conferences. PROSPERO registrationnumber CRD42018091531

Physical prognostic factors predicting outcome following anterior cruciate ligament reconstruction: Protocol for a systematic review

Introduction Injuries of the anterior cruciate ligament (ACL) are a common musculoskeletal complication and can cause significant reduction in patient function and quality of life. Many undergo ACL reconstruction, with high-quality rehabilitation key to successful outcome. Knowledge of physical prognostic factors, such as quadriceps strength, is crucial to inform rehabilitation and has important implications for outcome following ACL reconstruction. However, these factors predicting outcome are poorly defined. Therefore, the aim of this systematic review is to establish physical prognostic factors predictive of outcome in adults following ACL reconstruction. Outcome will be subdivided into two groups of outcome measures, patient-reported and performance-based. Physical prognostic factors of interest will reflect a range of domains and may be modifiable/non-modifiable. Results will help decide most appropriate management and assist in planning and tailoring preoperative and postoperative rehabilitation. Methods and analysis This systematic review protocol is reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. MEDLINE, CINAHL and EMBASE databases, key journals and grey literature will be searched from inception to July 2019. Prospective cohort studies including participants aged ≥16 years who have undergone ACL reconstruction will be included, with articles focusing on multi-ligament reconstructions and ACL repair surgery, or not published in English excluded. Two independent reviewers will conduct searches, assess study eligibility, extract data, assess risk of bias (Quality in Prognostic Studies tool) and quantify overall quality of evidence (modified Grading of Recommendations, Assessment, Development and Evaluation guidelines). If possible, a meta-analysis will be conducted, otherwise a narrative synthesis will ensue focusing on prognostic factors, risk of bias of included studies and strength of association with outcomes. Ethics and dissemination Findings will be published in a peer-reviewed journal, presented at conferences and locally to physiotherapy departments. Ethical approval is not required for this systematic review. PROSPERO registration number CRD42019127732

The biopsychosocial factors associated with development of chronic musculoskeletal pain. An umbrella review and meta-analysis of observational systematic reviews.

AIM: The aim of this umbrella review was to establish which biopsychosocial factors are associated with development of chronic musculoskeletal pain. METHODS: Ovid Medline, Embase, Web of Science Core Collection, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, PsycINFO, CINAHL, PEDro, PROSPERO, Google Scholar and grey literature were searched from database inception to 4th April 2023. Systematic reviews of observational prospective longitudinal studies, including populations with 3 months) musculoskeletal pain. Two reviewers searched the literature, assessed risk of bias (Assessing the Methodological Quality of Systematic Reviews-2), and evaluated quality (Grading of Recommendations, Assessment, Development and Evaluation) to provide an overall statement on the certainty of evidence for each biopsychosocial factor. Data analysis was performed through random effects meta-analysis (including meta-analysis of meta-analyses where possible) and descriptive synthesis. RESULTS: 13 systematic reviews were included comprising 185 original research studies (n = 489,644 participants). Thirty-four biopsychosocial factors are associated with development of chronic musculoskeletal pain. Meta-analyses of odds and/or likelihood ratios were possible for 25 biopsychosocial factors. There is moderate certainty evidence that smoking (OR 1.24 [95%CI, 1.14-1.34), fear avoidance (LR+ 2.11 [95%CI, 1.59-2.8]; LR- 0.5 [95%CI, 0.35-0.71]) poorer support networks (OR 1.21 [95%CI, 1.14-1.29]), lower socioeconomic status (OR 2.0 [95%CI, 1.64-2.42]), and high levels of pain (OR 5.61 [95%CI, 3.74-8.43]) are associated with development of chronic musculoskeletal pain (all P<0.001). Remaining factors are of low or very low certainty evidence. CONCLUSIONS AND RELEVANCE: There is moderate certainty evidence that smoking, fear avoidance, poorer support networks, lower socioeconomic status, and high levels of pain are associated with development of chronic musculoskeletal pain. High risk of bias was evident in most included reviews; this highlights the need for higher quality systematic reviews

Measures of central sensitization and their measurement properties in musculoskeletal trauma: A systematic review

Background and Objective: Chronic pain following musculoskeletal trauma is common, which may partially be attributed to the early presence of central sensitization (CS). Multiple measures are suggested to assess clinical features of CS, yet no systematic review has evaluated the measurement properties of these measures in a musculoskeletal trauma population. Databases and Data Treatment: This systematic review, which followed a published and PROSPERO registered protocol (CRD42018091531), aimed to establish the scope of CS measures used within a musculoskeletal trauma population and evaluate their measurement properties. Searches were conducted in two stages by two independent reviewers. The Consensus-based Standards for the selection of Health Measurement Instruments (COSMIN) checklist was used to evaluate risk of bias and overall quality was assessed using the modified Grading of Recommendations Assessment, Development and Evaluation. Results: From 86 studies, 30 different CS outcome measures were identified. Nine studies evaluated measurement properties of nine outcome measures; eight evaluated reliability and one evaluated construct validity. Measures included seven quantitative sensory testing methods (pressure, cold and electrical pain thresholds; warm, cold and vibration detection thresholds; vibration perception thresholds), pain drawings and a pinwheel. Risk of bias was assessed as doubtful/inadequate for all but one study, overall quality of evidence was low/very low for all measures. Reliability of measures ranged from poor to excellent. Conclusions: Many measures are used to evaluate CS but with limited established measurement properties in musculoskeletal trauma. High quality research to establish measurement properties of CS outcome measures is required

Successful recovery following musculoskeletal trauma: protocol for a qualitative study of patients’ and physiotherapists’ perceptions

Background: Annually in the UK, 40,000–90,000 people are involved in a traumatic incident. Severity of injury and how well people recover from their injuries varies, with physiotherapy playing a key role in the rehabilitation process. Recovery is evaluated using multiple outcome measures for perceived levels of pain severity and quality of life. It is unclear however, what constitutes a successful recovery from injury throughout the course of recovery from the patient perspective, and whether this aligns with physiotherapists’ perspectives. Methods: A qualitative study using two approaches: Interpretive Phenomenological Analysis (IPA) using semi-structured interviews and thematic analysis following the Kreuger framework for focus groups. A purposive sample of 20 patients who have experienced musculoskeletal trauma within the past 4 weeks and 12 physiotherapists who manage this patient population will be recruited from a single trauma centre in the UK. Semi-structured interviews with patients at 4 weeks, 6 and 12 months following injury, and 2 focus groups with physiotherapists will be undertaken at one time point. Views and perceptions on the definition of recovery and what constitutes a successful recovery will be explored using both methods, with a focus on the lived experience and patient journey following musculoskeletal trauma, and how this changes through the process of recovery. Data from both the semi-structured interviews and focus groups will be analysed separately and then integrated and synthesised into key themes ensuring similarities and differences are identified. Strategies to ensure trustworthiness e.g., reflexivity will be employed. Discussion: Recovery following musculoskeletal trauma is complex and understanding of the concept of successful recovery and how this changes over time following an injury is largely unknown. It is imperative to understand the patient perspective and whether these perceptions align with current views of physiotherapists. A greater understanding of recovery following musculoskeletal trauma has potential to change clinical care, optimise patient centred care and improve efficiency and clinical decision making during rehabilitation. This in turn can contribute to improved clinical effectiveness, patient outcome and patient satisfaction with potential service and economic cost savings. This study has ethical approval (IRAS 287781/REC 20/PR/0712)

Development of a screening tool to predict the risk of chronic pain and disability following musculoskeletal trauma: Protocol for a prospective observational study in the United Kingdom

Introduction Pain is an expected and appropriate experience following traumatic musculoskeletal injury. By contrast, chronic pain and disability are unhelpful yet common sequelae of trauma-related injuries. Presently, the mechanisms that underlie the transition from acute to chronic disabling post-traumatic pain are not fully understood. Such knowledge would facilitate the development and implementation of precision rehabilitation approaches that match interventions to projected risk of recovery, with the aim of preventing poor long-term outcomes. The aim of this study is to identify a set of predictive factors to identify patients at risk of developing ongoing post-traumatic pain and disability following acute musculoskeletal trauma. To achieve this, we will use a unique and comprehensive combination of patient-reported outcome measures, psychophysical testing and biomarkers. Methods and analysis A prospective observational study will recruit two temporally staggered cohorts (n=250 each cohort; at least 10 cases per candidate predictor) of consecutive patients with acute musculoskeletal trauma aged ≥16 years, who are emergency admissions into a Major Trauma Centre in the United Kingdom, with an episode inception defined as the traumatic event. The first cohort will identify candidate predictors to develop a screening tool to predict development of chronic and disabling pain, and the second will allow evaluation of the predictive performance of the tool (validation). The outcome being predicted is an individual's absolute risk of poor outcome measured at a 6-month follow-up using the Chronic Pain Grade Scale (poor outcome ≥grade II). Candidate predictors encompass the four primary mechanisms of pain: nociceptive (eg, injury location), neuropathic (eg, painDETECT), inflammatory (biomarkers) and nociplastic (eg, quantitative sensory testing). Concurrently, patient-reported outcome measures will assess general health and psychosocial factors (eg, pain self-efficacy). Risk of poor outcome will be calculated using multiple variable regression analysis. Ethics and dissemination Approved by the NHS Research Ethics Committee (17/WA/0421)

Virtual Patients and Sensitivity Analysis of the Guyton Model of Blood Pressure Regulation: Towards Individualized Models of Whole-Body Physiology

Mathematical models that integrate multi-scale physiological data can offer insight into physiological and pathophysiological function, and may eventually assist in individualized predictive medicine. We present a methodology for performing systematic analyses of multi-parameter interactions in such complex, multi-scale models. Human physiology models are often based on or inspired by Arthur Guyton's whole-body circulatory regulation model. Despite the significance of this model, it has not been the subject of a systematic and comprehensive sensitivity study. Therefore, we use this model as a case study for our methodology. Our analysis of the Guyton model reveals how the multitude of model parameters combine to affect the model dynamics, and how interesting combinations of parameters may be identified. It also includes a “virtual population” from which “virtual individuals” can be chosen, on the basis of exhibiting conditions similar to those of a real-world patient. This lays the groundwork for using the Guyton model for in silico exploration of pathophysiological states and treatment strategies. The results presented here illustrate several potential uses for the entire dataset of sensitivity results and the “virtual individuals” that we have generated, which are included in the supplementary material. More generally, the presented methodology is applicable to modern, more complex multi-scale physiological models