Informing the design of a randomised controlled trial of an exercise-based programme for long term stroke survivors: lessons from a before-and-after case series study

Background: To inform the design of a randomised controlled trial (RCT) of an exercise-based programme for long term stroke survivors, we conducted a mixed methods before-and-after case series with assessment at three time points. We evaluated Action for Rehabilitation from Neurological Injury (ARNI), a personalised, functionally-focussed programme. It was delivered through 24 hours of one-to-one training by an Exercise Professional (EP), plus at least 2 hours weekly unsupervised exercise, over 12- 14 weeks. Assessment was by patient-rated questionnaires addressing function, physical activity, confidence, fatigue and health-related quality of life; objective assessment of gait quality and speed; qualitative individual interviews conducted with participants. Data were collected at baseline, 3 months and 6 months. Fidelity and acceptability was assessed by participant interviews, audit of participant and EP records, and observation of training. Findings: Four of six enrolled participants completed the exercise programme. Quantitative data demonstrated little change across the sample, but marked changes on some measures for some individuals. Qualitative interviews suggested that small benefits in physical outcomes could be of great psychological significance to participants. Participant-reported fatigue levels commonly increased, and non-completers said they found the programme too demanding. Most key components of the intervention were delivered, but there were several potentially important departures from intervention fidelity. Discussion: The study provided data and experience that are helping to inform the design of an RCT of this intervention. It suggested the need for a broader recruitment strategy; indicated areas that could be explored in more depth in the qualitative component of the trial; and highlighted issues that should be addressed to enhance and evaluate fidelity, particularly in the preparation and monitoring of intervention providers. The experience illustrates the value of even small sample before-and-after studies in the development of trials of complex interventions.PenCLAHRC; NIH

Addressing the psychology of weight loss and maintenance: a feasibility study of the Skills for weight loss and Maintenance weight management programme

Objectives: Building on prior theory, we aimed to evaluate the feasibility and acceptability of integrating novel, weight loss maintenance strategies into existing weight management programmes. We also piloted recruitment and data collection procedures for future research. Design: Two phases of action research nested within a single‐arm feasibility study. The intervention was refined between phases using feedback from intervention fidelity analysis and qualitative exploration of patient and provider experiences. Changes in outcomes were assessed up to 18 months post‐baseline. Methods: One hundred adults with a mean body mass index of 37 kg/m2 were offered the Skills for weight loss and Maintenance (SkiM) intervention. This included existing weight management programme content and additional weight loss maintenance techniques delivered fortnightly for 6 months in local community centres to groups of 11–15 people. Results: Of the 100 participants, 65%, 58% and 56% provided data at 7, 12 and 18 months. Across both phases, the mean initial weight loss was 4.2 kg (95% CI: 2.4–5.9) and 3.1 kg at 18 months (95% CI: .8–5.5). In Phase 2, we observed better weight loss maintenance (.5 kg [13.2%] regain from 7 to 18 months, vs. 1.7 kg [36.2%] in Phase 1). Variation in outcomes, high early dropout rates and qualitative feedback indicated that, although delivery of the intervention and trial procedures was feasible and acceptable, there was scope to refine the intervention to engage a wider range of participants. Intervention fidelity was acceptable, particularly in Phase 2. Conclusions: The SkiM intervention seems promising, but more research is needed to improve recruitment and retention prior to further evaluation

Hope and despair: a qualitative exploration of the expereinces and impact of trial processes in a rehabilitation trial

Background Unanticipated responses by research participants can influence randomised controlled trials (RCTs) in multiple ways, many of which are poorly understood. This study used qualitative interviews as part of an embedded process evaluation to explore the impact participants may have on the study, but also unintended impacts the study may have on them. Aim The aim of the study was to explore participants’ experiences and the impact of trial involvement in a pilot RCT in order to inform the designing and delivery of a definitive RCT. Methods In-depth interviews with 20 participants (10 in the intervention and 10 in the control group) enrolled in a stroke rehabilitation pilot trial. A modified framework approach was used to analyse transcripts. Results Participation in the study was motivated partly by a desperation to receive further rehabilitation after discharge. Responses to allocation to the control group included an increased commitment to self-treatment, and negative psychological consequences were also described. Accounts of participants in both control and intervention groups challenge the presumption that they were neutral, or in equipoise, regarding group allocation prior to consenting to randomisation. Conclusions Considering and exploring participant and participation effects, particularly in the control group, highlights numerous issues in the interpretation of trial studies, as well as the in ethics of RCTs more generally. While suggestions for a definitive trial design are given, further research is required to investigate the significant implications these findings may have for trial design, monitoring and funding. Trial registration ClinicalTrials.gov, NCT02429180. Registered on 29 April/2015.The Stroke Associatio

Synthesising practice guidelines for the development of community-based exercise programmes after stroke

This is a freely-available open access publication. Please cite the published version which is available via the DOI link in this record.Multiple guidelines are often available to inform practice in complex interventions. Guidance implementation may be facilitated if it is tailored to particular clinical issues and contexts. It should also aim to specify all elements of interventions that may mediate and modify effectiveness, including both their content and delivery. We conducted a focused synthesis of recommendations from stroke practice guidelines to produce a structured and comprehensive account to facilitate the development of community-based exercise programmes after stroke.National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for the South West Peninsul

Measuring clinically important change with the Patient-rated Tennis Elbow Evaluation

Original article can be found at: http://ht.rsmjournals.com/content/ Copyright Royal Society of Medicine Press LtdThe Patient-rated Tennis Elbow Evaluation (PRTEE) enables quantitative rating by the patient of pain and functional impairment associated with tennis elbow or lateral elbow tendinopathy. When used as an outcome measure in trials of therapies, a minimum clinically important difference (MCID) value is required to interpret trial outcomes. This study aimed to calculate the MCID for a sample of patients diagnosed with lateral elbow tendinopathy (LET).Peer reviewe

Bioelectricity and microcurrent therapy for tissue healing - a narrative review

Original article can be found at: http://www.ingentaconnect.com/content/maney/ptr Copyright W.S. Maney & Son Ltd.Microcurrent therapy (MCT) uses electric currents similar to those produced by the body during tissue healing. It may be a particularly beneficial where endogenous healing has failed.Peer reviewedFinal Accepted Versio

Microcurrent Therapy in the Management of Chronic Tennis Elbow

Microcurrent therapy (MCT) involves the application of sub-sensory electric current and can promote tissue repair, possibly by mimicking endogenous electrical cues for healing. It has been used successfully to treat recalcitrant bone fractures and skin ulcers, but its effects on other forms of tissue have received little attention. This study aimed to investigate the potential of MCT to promote healing and alleviate symptoms in a selected soft connective tissue disorder. A systematic review of human studies involving MCT for soft connective tissue damage was conducted. A survey of 93 musculoskeletal physiotherapists was used to help select a common, recalcitrant disorder to treat with microcurrent in a clinical trial. Novel sonographic scales to quantify tendon structural abnormality and tissue healing were developed, and their measurement properties evaluated along with several clinical and patient-rated outcome measures. Two preliminary clinical trials, involving 62 people with the selected disorder – chronic tennis elbow - were conducted, comparing four different types of microcurrent applied daily for 3 weeks. The review found fair quality evidence that certain forms of MCT can relieve symptoms, and low quality evidence that they can promote healing, in several soft connective tissue disorders, including those affecting tendons. Optimal treatment parameters are unknown. In the survey, clinicians identified frozen shoulder, plantar fasciitis and tennis elbow as particularly problematic, and tennis elbow was selected for treatment in the trials. The sonographic scales of hyperaemia had fair-to-good inter-rater and test-retest reliability. Minimum Detectable Change values are calculated for the sonographic scales and for pain-free grip strength measurements. The trials suggest that monophasic microcurrent of peak amplitude 50 µA applied for 35 hours was most effective in symptom alleviation, with a 93% treatment success rate three months after treatment. By final assessment, pain-free grip strength increased by 31% (95%CI:5,57%), pain measured on a multiple-item questionnaire reduced by 27% (95%CI:16,38%) and patient-rated functional disability by 26% (95%CI:14,28%). MCT with a current amplitude of 500 µA was significantly less effective, and varying the waveform appeared less important in determining outcomes. Differences between groups were non-significant on several measurs, though there was a risk of type II error in the tests used. No significant differences between any groups were seen in sonographic assessments, although consistent patterns in bloodflow chage suggested that MCT may modulate hyperaemia levels. Higher baseline hyperaemia was associated with sustained falls in hyperaemia levels after treatment, and with improved clinical outcome. MCT’s analgesic effect does not rely on sensory stimulation, and further investigation of its influence on tendinous blood flow and vascularity, or on the local biochemical milieu, may help elucidate its mechanism of action. On the basis of this investigation, a fully-powered controlled clinical trial is justified. A protocol, combining MCT with an exercise programme, is proposed

Reliability of sonographic assessment of tendinopathy in tennis elbow

To assess the reliability and compute the minimum detectable change using sonographic scales to quantify the extent of pathology and hyperaemia in the common extensor tendon in people with tennis elbow. The lateral elbows of 19 people with tennis elbow were assessed sonographically twice, 1-2 weeks apart. Greyscale and power Doppler images were recorded for subsequent rating of abnormalities. Tendon thickening, hypoechogenicity, fibrillar disruption and calcification were each rated on four-point scales, and scores were summed to provide an overall rating of structural abnormality; hyperaemia was scored on a five point scale. Inter-rater reliability was established using the intraclass correlation coefficient (ICC) to compare scores assigned independently to the same set of images by a radiologist and a physiotherapist with training in musculoskeletal imaging. Test-retest reliability was assessed by comparing scores assigned by the physiotherapist to images recorded at the two sessions. The minimum detectable change (MDC) was calculated from the test-retest reliability data. ICC values for inter-rater reliability ranged from 0.35 (95% CI: 0.05, 0.60) for fibrillar disruption to 0.77 (0.55, 0.88) for overall greyscale score, and 0.89 (0.79, 0.95) for hyperaemia. Test-retest reliability ranged from 0.70 (0.48, 0.84) for tendon thickening to 0.82 (0.66, 0.90) for overall greyscale score and 0.86 (0.73, 0.93) for calcification. The MDC for the greyscale total score was 2.0/12 and for the hyperaemia score was 1.1/5. The sonographic scoring system used in this study may be used reliably to quantify tendon abnormalities and change over time. A relatively inexperienced imager can conduct the assessment and use the rating scales reliably.Peer reviewe

Frailty scales – their potential in interprofessional working with older people: a discussion paper

Original article can be found at : http://informahealthcare.com/ Copyright Informa Healthcare [Full text of this article is not available in the UHRA]New models of interprofessional working are continuously being proposed to address the burgeoning health and social care needs of older people with complex and long-term health conditions. Evaluations of the effectiveness of these models tend to focus on process measures rather than outcomes for the older person. This discussion paper argues that the concept of frailty, and measures based on it, may provide a more user-centred tool for the evaluation of interprofessional services -- a tool that cuts across unidisciplinary preoccupations and definitions of effectiveness. Numerous frailty scales have been developed for case identification and stratification of risk of adverse outcomes. We suggest that they may also be particularly suitable for evaluating the effectiveness of interprofessional working with community-dwelling older people. Several exemplars of frailty scales that might serve this purpose are identified, and their potential contributions and limitations are discussed. Further work is required to establish which is the most suitable scales for this application. The development of an appropriate frailty scale could provide an opportunity for interprofessional debate about the forms of care and treatment that should be prioritised to improve the health and well-being of this population.Peer reviewe