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Background: The proportion of the population aged 65 years or older is increasing. Typically, physical activity and health decline with age, which is why action to promote active ageing is a major public health priority, particularly due to health inequalities in older adults. The aim of this study is to assess the effectiveness and cost-effectiveness of the Walk with Me peer-led walking intervention for older adults. Methods: This study is a two-arm, assessor-blind, randomised controlled trial. The intervention is a 12-week peer-led walking intervention based on social cognitive theory. Participants in the control group will receive information on active ageing and healthy nutrition. The study will target 348 community-dwelling older adults, aged 60 years or over living in areas of socio-economic disadvantage communities. Trained peer mentors will deliver the intervention. The primary outcome will be a mean between-group change in moderate-to-vigorous physical activity at 12 months from baseline, measured using an Actigraph accelerometer. Secondary outcomes will include quality of life, mental wellbeing, blood pressure, BMI and waist circumference. An embedded process evaluation will involve focus groups and participant diaries. Discussion: Evidence-based, cost-effective interventions to promote physical activity in older adults living in socio-economically disadvantaged communities are needed to address health inequalities. [ABSTRACT FROM AUTHOR]

Objective: Despite the available evidence regarding effectiveness of stroke telerehabilitation, there has been little focus on factors influencing its delivery or translation from the research setting into practice. There are complex challenges to embedding telerehabilitation into stroke services and generating transferable knowledge about scaling up and routinising this service model. This review aimed to explore factors influencing the delivery of stroke telerehabilitation interventions, including platforms, technical requirements, training, support, access, cost, usability and acceptability. Methods: MEDLINE, EMBASE, CINAHL, Web of Science and Cochrane Library and Central Registry of Clinical Trials were searched to identify full-text articles of randomised controlled trials (RCTs) and protocols for RCTs published since a Cochrane review on stroke telerehabilitation services. A narrative synthesis was conducted, providing a comprehensive description of the factors influencing stroke telerehabilitation intervention delivery. Results: Thirty-one studies and ten protocols of ongoing studies were included. Interventions were categorised as synchronous telerehabilitation (n = 9), asynchronous telerehabilitation (n = 11) and tele-support (n = 11). Telephone and videoconference were the most frequently used modes of delivery. Usability and acceptability with telerehabilitation were high across all platforms, although access issues and technical challenges may be potential barriers to the use of telerehabilitation in service delivery. Costs of intervention delivery and training requirements were poorly reported. Conclusions: This review synthesises the evidence relating to factors that may influence stroke telerehabilitation intervention delivery at a crucial timepoint given the rapid deployment of telerehabilitation in response to the COVID-19 pandemic. It recommends strategies, such as ensuring adequate training and technical infrastructure, shared learning and consistent reporting of cost and usability and acceptability outcomes, to overcome challenges in embedding and routinising this service model and priorities for research in this area. [ABSTRACT FROM AUTHOR]

PURPOSE: This mixed methods study explored older adults' experience using a bespoke active computer gaming (ACG) system designed to deliver falls prevention exercise. METHODS: Usability, acceptability and safety were evaluated through observation of system use, questionnaires, in-system ratings, and semi-structured interviews. Quantitative and qualitative data were synthesised concurrently to provide a deeper understanding of older adults' experience with the system. RESULTS: N = 7 older adults (aged 73–88 years, most with increased fear of falling, and over half with reduced physical functioning) completed up to six uses of the system. Observations and qualitative feedback suggested that older adults' experience with the system was influenced by physical health changes associated with ageing. Overall feedback after using the system was positive. Social support, from either the clinician or a peer, was a key theme influencing experience. CONCLUSIONS: Findings suggested that autonomous use of the system may not be feasible given the requirement and preference for social support. [ABSTRACT FROM AUTHOR]

Abstract Background Physical activity and exercise therapy are among the accepted clinical rehabilitation guidelines and are recommended self-management strategies for chronic low back pain. However, many back pain sufferers do not adhere to their physiotherapist’s recommendations. Poor patient adherence may decrease the effectiveness of advice and home-based rehabilitation exercises. According to self-determination theory, support from health care practitioners can promote patients’ autonomous motivation and greater long-term behavioral persistence (e.g., adherence to physiotherapists’ recommendations). The aim of this trial is to assess the effect of an intervention designed to increase physiotherapists’ autonomy-supportive communication on low back pain patients’ adherence to physical activity and exercise therapy recommendations. Methods/Design This study will be a single-blinded cluster randomized controlled trial. Outpatient physiotherapy centers (N =12) in Dublin, Ireland (population = 1.25 million) will be randomly assigned using a computer-generated algorithm to either the experimental or control arm. Physiotherapists in the experimental arm (two hospitals and four primary care clinics) will attend eight hours of communication skills training. Training will include handouts, workbooks, video examples, role-play, and discussion designed to teach physiotherapists how to communicate in a manner that promotes autonomous patient motivation. Physiotherapists in the waitlist control arm (two hospitals and four primary care clinics) will not receive this training. Participants (N = 292) with chronic low back pain will complete assessments at baseline, as well as 1 week, 4 weeks, 12 weeks, and 24 weeks after their first physiotherapy appointment. Primary outcomes will include adherence to physiotherapy recommendations, as well as low back pain, function, and well-being. Participants will be blinded to treatment allocation, as they will not be told if their physiotherapist has received the communication skills training. Outcome assessors will also be blinded. We will use linear mixed modeling to test between arm differences both in the mean levels and the rates of change of the outcome variables. We will employ structural equation modeling to examine the process of change, including hypothesized mediation effects. Discussion This trial will be the first to test the effect of a self-determination theory-based communication skills training program for physiotherapists on their low back pain patients’ adherence to rehabilitation recommendations. Trial Registration Current Controlled Trials ISRCTN63723433

Abstract Background Current evidence supports the use of exercise-based treatment for chronic low back pain that encourages the patient to assume an active role in their recovery. Walking has been shown it to be an acceptable type of exercise with a low risk of injury. However, it is not known whether structured physical activity programmes are any more effective than giving advice to remain active. Methods/Design The proposed study will test the feasibility of using a pedometer-driven walking programme, as an adjunct to a standard education and advice session in participants with chronic low back pain. Fifty adult participants will be recruited via a number of different sources. Baseline outcome measures including self reported function; objective physical activity levels; fear-avoidance beliefs and health-related quality of life will be recorded. Eligible participants will be randomly allocated under strict, double blind conditions to one of two treatments groups. Participants in group A will receive a single education and advice session with a physiotherapist based on the content of the 'Back Book'. Participants in group B will receive the same education and advice session. In addition, they will also receive a graded pedometer-driven walking programme prescribed by the physiotherapist. Follow up outcomes will be recorded by the same researcher, who will remain blinded to group allocation, at eight weeks and six months post randomisation. A qualitative exploration of participants' perception of walking will also be examined by use of focus groups at the end of the intervention. As a feasibility study, treatment effects will be represented by point estimates and confidence intervals. The assessment of participant satisfaction will be tabulated, as will adherence levels and any recorded difficulties or adverse events experienced by the participants or therapists. This information will be used to modify the planned interventions to be used in a larger randomised controlled trial. Discussion This paper describes the rationale and design of a study which will test the feasibility of using a structured, pedometer-driven walking programme in participants with chronic low back pain. Trial Registration [ISRCTN67030896]

Abstract Background Sleep disturbance is becoming increasingly recognised as a clinically important symptom in people with chronic low back pain (CLBP, low back pain >12 weeks), associated with physical inactivity and depression. Current research and international clinical guidelines recommend people with CLBP assume a physically active role in their recovery to prevent chronicity, but the high prevalence of sleep disturbance in this population may be unknowingly limiting their ability to participate in exercise-based rehabilitation programmes and contributing to poor outcomes. There is currently no knowledge concerning the effectiveness of physiotherapy on sleep disturbance in people with chronic low back pain and no evidence of the feasibility of conducting randomized controlled trials that comprehensively evaluate sleep as an outcome measure in this population. Methods/Design This study will evaluate the feasibility of a randomised controlled trial (RCT), exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. A presenting sample of 60 consenting patients will be recruited in the physiotherapy department of Beaumont Hospital, Dublin, Ireland, and randomly allocated to one of the three groups in a concealed manner. The main outcomes will be sleep quality (self-report and objective measurement), and self-reported functional disability, pain, quality of life, fear avoidance, anxiety and depression, physical activity, and patient satisfaction. Outcome will be evaluated at baseline, 3 months and 6 months. Qualitative telephone interviews will be embedded in the research design to obtain feedback from a sample of participants' about their experiences of sleep monitoring, trial participation and interventions, and to inform the design of a fully powered future RCT. Planned analysis will explore trends in the data, effect sizes and clinically important effects (quantitative data), and thematic analysis (qualitative data). Discussion This study will evaluate the feasibility of a randomised controlled trial exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. Trial Registration Current controlled trial ISRCTN54009836

Abstract Background Activity advice and prescription are commonly used in the management of low back pain (LBP). Although there is evidence for advising patients with LBP to remain active, facilitating both recovery and return to work, to date no research has assessed whether objective measurements of free living physical activity (PA) can predict outcome, recovery and course of LBP. Methods An observational longitudinal study will investigate PA levels in a cohort of community-dwelling working age adults with acute and sub-acute LBP. Each participant's PA level, functional status, mood, fear avoidance behaviours, and levels of pain, psychological distress and occupational activity will be measured on three occasions during for 1 week periods at baseline, 3 months, and 1 year. Physical activity levels will be measured by self report, RT3 triaxial accelerometer, and activity recall questionnaires. The primary outcome measure of functional recovery will be the Roland Morris Disability Questionnaire (RMDQ). Free living PA levels and changes in functional status will be quantified in order to look at predictive relationships between levels and changes in free living PA and functional recovery in a LBP population. Discussion This research will investigate levels and changes in activity levels of an acute LBP cohort and the predictive relationship to LBP recovery. The results will assess whether occupational, psychological and behavioural factors affect the relationship between free living PA and LBP recovery. Results from this research will help to determine the strength of evidence supporting international guidelines that recommend restoration of normal activity in managing LBP. Trial registration [Clinical Trial Registration Number, ACTRN12609000282280]

Abstract Background Chronic low back pain (CLBP) is a persistent disabling condition with rising significant healthcare, social and economic costs. Current research supports the use of exercise-based treatment approaches that encourage people with CLBP to assume a physically active role in their recovery. While international clinical guidelines and systematic reviews for CLBP support supervised group exercise as an attractive first-line option for treating large numbers of CLBP patients at low cost, barriers to their delivery include space and time restrictions in healthcare settings and poor patient attendance. The European Clinical Guidelines have identified the need for research in the use of brief/minimal contact self-activation interventions that encourage participation in physical activity for CLBP. Walking may be an ideally suited form of individualized exercise prescription as it is easy to do, requires no special skills or facilities, and is achievable by virtually all ages with little risk of injury, but its effectiveness for LBP is unproven. Methods and design This study will be an assessor-blinded randomized controlled trial that will investigate the difference in clinical effectiveness and costs of an individualized walking programme and a supervised general exercise programme compared to usual physiotherapy, which will act as the control group, in people with chronic low back pain. A sample of 246 patients will be recruited in Dublin, Ireland through acute general hospital outpatient physiotherapy departments that provide treatment for people with CLBP. Patients will be randomly allocated to one of the three groups in a concealed manner. The main outcomes will be functional disability, pain, quality of life, fear avoidance, back beliefs, physical activity, satisfaction and costs, which will be evaluated at baseline, and 3, 6 and 12 months [follow-up by pre-paid postage]. Qualitative telephone interviews and focus groups will be embedded in the research design to obtain feedback about participants' experiences of the interventions and trial participation, and to inform interpretation of the quantitative data. Planned analysis will be by intention to treat (quantitative data) and thematic analysis (qualitative data) Discussion The trial will evaluate the effectiveness of a walking programme and a supervised general exercise programme compared to usual physiotherapy in people with CLBP. Trial registration Current controlled trial ISRCTN17592092

Abstract Background Cryotherapy (the application of ice for therapeutic purposes) is one of the most common treatment modalities employed in the immediate management of acute soft tissue injury. Despite its widespread clinical use, the precise physiological responses to therapeutic cooling have not been fully elucidated, and effective evidence-based treatment protocols are yet to be established. Intermittent ice applications are thought to exert a significant analgesic effect. This could facilitate earlier therapeutic exercise after injury, potentially allowing for a quicker return to activity. The primary aim of the forthcoming study is therefore to examine the safety and effectiveness of combining intermittent ice applications with periods of therapeutic exercise in the first week after an acute ankle sprain. Methods/Design The study is a randomised controlled trial. 120 subjects with an acute grade I or grade II ankle sprain will be recruited from Accident & Emergency and a University based Sports Injury Clinic. Subjects will be randomised under strict double-blind conditions to either a standard cryotherapy (intermittent ice applications with compression) or cryokinetic treatment group (intermittent ice applications with compression and therapeutic exercise). After the first week, treatment will be standardised across groups. Assessor blinding will be maintained throughout the trial. Primary outcome will be function, assessed using the Lower Extremity Functional Scale (LEFS). Additional outcomes will include pain (10 cm Visual Analogue Scale), swelling (modified figure-of-eight method) and activity levels (activPAL™ physical activity monitor, PAL Technologies, Glasgow, UK). Diagnostic Ultrasound (Episcan-1-200 high frequency ultrasound scanning system, Longport International Ltd, PA) will also be used to assess the degree of soft tissue injury. After baseline assessment subjects will be followed up at 1, 2, 3 & 4 weeks post injury. All data will be analysed using repeated measures analysis of co-variance (ANCOVA). Discussion This paper describes the rationale and design of a randomised controlled trial which will examine the effectiveness of two different cryotherapy protocols in the early management of acute ankle sprain. Trial Registration ISRCTN13903946

Purpose: To assess the inter-rater reliability and concurrent validity of the Communication Evaluation in Rehabilitation Tool, which aims to externally assess physiotherapists competency in using Self-Determination Theory-based communication strategies in practice. Materials and methods: Audio recordings of initial consultations between 24 physiotherapists and 24 patients with chronic low back pain in four hospitals in Ireland were obtained as part of a larger randomised controlled trial. Three raters, all of whom had Ph.Ds in psychology and expertise in motivation and physical activity, independently listened to the 24 audio recordings and completed the 18-item Communication Evaluation in Rehabilitation Tool. Inter-rater reliability between all three raters was assessed using intraclass correlation coefficients. Concurrent validity was assessed using Pearson's r correlations with a reference standard, the Health Care Climate Questionnaire. Results: The total score for the Communication Evaluation in Rehabilitation Tool is an average of all 18 items. Total scores demonstrated good inter-rater reliability (Intraclass Correlation Coefficient (ICC) = 0.8) and concurrent validity with the Health Care Climate Questionnaire total score (range: r = 0.7–0.88). Item-level scores of the Communication Evaluation in Rehabilitation Tool identified five items that need improvement. Conclusion: Results provide preliminary evidence to support future use and testing of the Communication Evaluation in Rehabilitation Tool. Promoting patient autonomy is a learned skill and while interventions exist to train clinicians in these skills there are no tools to assess how well clinicians use these skills when interacting with a patient. The lack of robust assessment has severe implications regarding both the fidelity of clinician training packages and resulting outcomes for promoting patient autonomy. This study has developed a novel measurement tool Communication Evaluation in Rehabilitation Tool and a comprehensive user manual to assess how well health care providers use autonomy-supportive communication strategies in real world-clinical settings. This tool has demonstrated good inter-rater reliability and concurrent validity in its initial testing phase. The Communication Evaluation in Rehabilitation Tool can be used in future studies to assess autonomy-supportive communication and undergo further measurement property testing as per our recommendations. [ABSTRACT FROM AUTHOR]

Background. Active computer gaming (ACG) is a method of facilitating physical activity in older people to improve health outcomes. Purpose. The purpose of this study was to update and extend a systematic review of the evidence for ACG to determine its effects on physical and cognitive health in older adults. Data Sources. MEDLINE, EMBASE, CENTRAL in the Cochrane Library, and PsycINFO databases were searched from the date of the previous review (2011) to May 2016. Study Selection. Eligible articles were randomized controlled trials (RCTs) investigating the effect of ACG in adults aged 65 and older. Data Extraction. Thirty-five studies were eligible for inclusion. Two review authors independently conducted data extraction, risk-of-bias assessment, and coding of behavior change techniques. Outcomes of interest were analyzed as continuous data and pooled as standardized mean differences (SMD) and 95% confidence intervals (CI). The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to determine the quality of the evidence. Data Synthesis. Behavior change techniques (N = 106) were coded in the included studies (mean = 3.02). Data were pooled for 5 main outcomes of interest. Significant moderate effects in favor of ACG were observed for balance (SMD = 0.52, 95% CI = 0.24 to 0.79; 17 studies; 743 participants), for functional exercise capacity when intervention delivery was >120 minutes per week (SMD = 0.53, 95% CI = 0.15 to 0.90; 5 studies; 116 participants), and for cognitive function (SMD = -0.48, 95% CI = -0.80 to 0.17; 8 studies; 459 participants). There was no significant effect observed for functional mobility or fear of falling. Limitations. The quality of the evidence for all comparisons was graded low or very low. Conclusions. At present there is very little confidence that ACG improves physical and cognitive outcomes in older adults. [ABSTRACT FROM AUTHOR]

Background: Individuals with persistent musculoskeletal pain (PMP) have an increased risk of developing co-morbid health conditions and for early-mortality compared to those without pain. Despite irrefutable evidence supporting the role of physical activity in reducing these risks; there has been limited synthesis of the evidence, potentially impacting the optimisation of these forms of interventions. This review examines the effectiveness of interventions in improving levels of physical activity and the components of these interventions.Methods: Randomised and quasi-randomised controlled trials were included in this review. The following databases were searched from inception to March 2016: CENTRAL in the Cochrane Library, Cochrane Database of Systematic Reviews (CDSR), MEDLINE, Embase, CINAHL, PsycINFO and AMED. Two reviewers independently screened citations, assessed eligibility, extracted data, assessed risk of bias and coded intervention content using the behaviour change taxonomy (BCTTv1) of 93 hierarchically clustered techniques. GRADE was used to rate the quality of the evidence.Results: The full text of 276 articles were assessed for eligibility, twenty studies involving 3441 participants were included in the review. Across the studies the mean number of BCTs coded was eight (range 0-16); with 'goal setting' and 'instruction on how to perform the behaviour' most frequently coded. For measures of subjective physical activity: interventions were ineffective in the short term, based on very low quality evidence; had a small effect in the medium term based on low quality evidence (SMD 0.25, 95% CI 0.01 to 0.48) and had a small effect in the longer term (SMD 0.21 95% CI 0.08 to 0.33) based on moderate quality evidence. For measures of objective physical activity: interventions were ineffective - based on very low to low quality evidence.Conclusions: There is some evidence supporting the effectiveness of interventions in improving subjectively measured physical activity however, the evidence is mostly based on low quality studies and the effects are small. Given the quality of the evidence, further research is likely/very likely to have an important impact on our confidence in effect estimates and is likely to change the estimates. Future studies should provide details on intervention components and incorporate objective measures of physical activity. [ABSTRACT FROM AUTHOR]

Background: High levels of sedentary behaviour (SB) are associated with negative health consequences. Technology enhanced solutions such as mobile applications, activity monitors, prompting software, texts, emails and websites are being harnessed to reduce SB. The aim of this paper is to evaluate the effectiveness of such technology enhanced interventions aimed at reducing SB in healthy adults and to examine the behaviour change techniques (BCTs) used. Methods: Five electronic databases were searched to identify randomised-controlled trials (RCTs), published up to June 2016. Interventions using computer, mobile or wearable technologies to facilitate a reduction in SB, using a measure of sedentary time as an outcome, were eligible for inclusion. Risk of bias was assessed using the Cochrane Collaboration's tool and interventions were coded using the BCT Taxonomy (v1). Results: Meta-analysis of 15/17 RCTs suggested that computer, mobile and wearable technology tools resulted in a mean reduction of -41.28 min per day (min/day) of sitting time (95% CI -60.99, -21.58, I2 = 77%, n = 1402), in favour of the intervention group at end point follow-up. The pooled effects showed mean reductions at short (≤ 3 months), medium (>3 to 6 months), and long-term follow-up (>6 months) of -42.42 min/day, -37.23 min/day and -1.65 min/day, respectively. Overall, 16/17 studies were deemed as having a high or unclear risk of bias, and 1/17 was judged to be at a low risk of bias. A total of 46 BCTs (14 unique) were coded for the computer, mobile and wearable components of the interventions. The most frequently coded were "prompts and cues", "self-monitoring of behaviour", "social support (unspecified)" and "goal setting (behaviour)". Conclusion: Interventions using computer, mobile and wearable technologies can be effective in reducing SB. Effectiveness appeared most prominent in the short-term and lessened over time. A range of BCTs have been implemented in these interventions. Future studies need to improve reporting of BCTs within interventions and address the methodological flaws identified within the review through the use of more rigorously controlled study designs with longer-term follow-ups, objective measures of SB and the incorporation of strategies to reduce attrition. Trial registration: The review protocol was registered with PROSPERO: CRD42016038187 [ABSTRACT FROM AUTHOR]

Background: The Medical Research Council framework provides a useful general approach to designing and evaluating complex interventions, but does not provide detailed guidance on how to do this and there is little evidence of how this framework is applied in practice. This study describes the use of intervention mapping (IM) in the design of a theory-driven, group-based complex intervention to support self-management (SM) of patients with osteoarthritis (OA) and chronic low back pain (CLBP) in Ireland's primary care health system.Methods: The six steps of the IM protocol were systematically applied to develop the self-management of osteoarthritis and low back pain through activity and skills (SOLAS) intervention through adaptation of the Facilitating Activity and Self-management in Arthritis (FASA) intervention. A needs assessment including literature reviews, interviews with patients and physiotherapists and resource evaluation was completed to identify the programme goals, determinants of SM behaviour, consolidated definition of SM and required adaptations to FASA to meet health service and patient needs and the evidence. The resultant SOLAS intervention behavioural outcomes, performance and change objectives were specified and practical application methods selected, followed by organised programme, adoption, implementation and evaluation plans underpinned by behaviour change theory.Results: The SOLAS intervention consists of six weekly sessions of 90-min education and exercise designed to increase participants' physical activity level and use of evidence-based SM strategies (i.e. pain self-management, pain coping, healthy eating for weight management and specific exercise) through targeting of individual determinants of SM behaviour (knowledge, skills, self-efficacy, fear, catastrophizing, motivation, behavioural regulation), delivered by a trained physiotherapist to groups of up to eight individuals using a needs supportive interpersonal style based on self-determination theory. Strategies to support SOLAS intervention adoption and implementation included a consensus building workshop with physiotherapy stakeholders, development of a physiotherapist training programme and a pilot trial with physiotherapist and patient feedback.Conclusions: The SOLAS intervention is currently being evaluated in a cluster randomised controlled feasibility trial. IM is a time-intensive collaborative process, but the range of methods and resultant high level of transparency is invaluable and allows replication by future complex intervention and trial developers. [ABSTRACT FROM AUTHOR]

Introduction: International clinical guidelines consistently endorse the promotion of selfmanagement (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. Methods/analysis: This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. Ethics/dissemination: This feasibility trial protocol was approved by the UCD Human Research Ethics-- Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health [ABSTRACT FROM AUTHOR]

Background: Acupuncture is considered a clinically effective and cost-effective treatment option for chronic low back pain. However, few clinical trials have evaluated the dose dependence of acupuncture for chronic low back pain based on the number of sessions. Conclusions are conflicting and there is little high-quality evidence to support the cumulative effects of repeated interventions. A randomized controlled trial to investigate the optimal number of sessions of acupuncture in addition to usual care for adults with chronic low back pain is required; a feasibility study to test the rationale and method for the full-scale trial is the first step in that process. Design:A pragmatic parallel three-armed randomized, controlled feasibility study. Methods:Forty-five participants with chronic low back pain will be recruited locally and randomized on a 1:1:1 basis to receive usual care plus 4 (n = 15), 7 (n = 15) or 10 sessions (n = 15) of semi-standardized acupuncture. Primary outcomes are acceptability of and adherence to different numbers of sessions of acupuncture, as well as the feasibility of the recruitment approach and completion of the specific outcome measures. Secondary outcomes include pain intensity and patient satisfaction. Follow-up questionnaires will be collected at discharge, 6, and 12 weeks after randomization. Discussion:Outcomes will inform the decision to conduct a full-scale trial to definitively test the dose dependence of acupuncture. Findings will add to the limited evidence available regarding the optimal number of sessions of acupuncture in the management of chronic low back pain, as well as being clinically relevant to clinicians, researchers and policy makers. [ABSTRACT FROM AUTHOR]

Background: Assessing methodological quality of primary studies is an essential component of systematic reviews. Following a systematic review which used a domain based system [United States Preventative Services Task Force (LJSPSTF)] to assess methodological quality, a commonly used numerical rating scale (Downs and Black) was also used to evaluate the included studies and comparisons were made between quality ratings assigned using the two different methods. Both tools were used to assess the 20 randomized and quasi-randomized controlled trials examining an exercise intervention for chronic musculoskeletal pain which were included in the review. Inter-rater reliability and levels of agreement were determined using intraclass correlation coefficients (ICC). Influence of quality on pooled effect size was examined by calculating the between group standardized mean difference (SMD). Results: Inter-rater reliability indicated at least substantial levels of agreement for the LJSPSTF system (ICC 0.85; 95% Cl 0.66,0.94) and Downs and Black scale (ICC 0.94; 95% Cl 0.84, 0.97). Overall level of agreement between tools (ICC 0.80; 95% Cl 0.57,0.92) was also good. However, the LJSPSTF system identified a number of studies (n = 3/20) as"poor" due to potential risks of bias. Analysis revealed substantially greater pooled effect sizes in these studies (SMD -2.51; 95% Cl -4.21,-0.82) compared to those rated as "fair" (SMD -0.45; 95% Cl -0.65, -0.25) or "good" (SMD -0.38; 95% Cl -0.69, -0.08). Conclusions: In this example, use of a numerical rating scale failed to identify studies at increased risk of bias, and could have potentially led to imprecise estimates of treatment effect. Although based on a small number of included studies within an existing systematic review, we found the domain based system provided a more structured framework by which qualitative decisions concerning overall quality could be made, and was useful for detecting potential sources of bias in the available evidence. [ABSTRACT FROM AUTHOR]

Background: In order to facilitate the completeness and transparency of reporting on randomized controlled trials undertaken using acupuncture interventions, a consensus group of international experts developed the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) in 2002. This reporting guideline was updated in 2010, and was applicable to a broader range of acupuncture research, including uncontrolled trials and case reports. Subsequent evaluations have noted limitations on the impact of STRICTA in the reporting quality of acupuncture trials, and the description of acupuncture details remains poor. Thus improvement in the efficacy of the STRICTA guidelines is called for. Discussion: We explored the STRICTA guidelines from four aspects, including the development procedure, validity assessment, endorsement and adherence, and citation situation. Based upon these findings, we provided five potential suggestions for further development of STRICTA. Summary: STRICTA are valid reporting guidelines based on robust methodology and scientific content. However specific implementation strategies including: updating the STRICTA checklist; improving the STRICTA reporting efficiency; consistency with implementing the "Instructions for authors" for journals; establishing global STRICTA research centers; and expanding the STRICTA website, are needed. Such strategies will improve their utilization and impact positively on the quality of reporting on acupuncture research outcomes. [ABSTRACT FROM AUTHOR]

Background: Assessing methodological quality of primary studies is an essential component of systematic reviews. Following a systematic review which used a domain based system [United States Preventative Services Task Force (USPSTF)] to assess methodological quality, a commonly used numerical rating scale (Downs and Black) was also used to evaluate the included studies and comparisons were made between quality ratings assigned using the two different methods. Both tools were used to assess the 20 randomized and quasi-randomized controlled trials examining an exercise intervention for chronic musculoskeletal pain which were included in the review. Inter-rater reliability and levels of agreement were determined using intraclass correlation coefficients (ICC). Influence of quality on pooled effect size was examined by calculating the between group standardized mean difference (SMD). Results: Inter-rater reliability indicated at least substantial levels of agreement for the USPSTF system (ICC 0.85; 95% CI 0.66, 0.94) and Downs and Black scale (ICC 0.94; 95% CI 0.84, 0.97). Overall level of agreement between tools (ICC 0.80; 95% CI 0.57, 0.92) was also good. However, the USPSTF system identified a number of studies (n = 3/20) as “poor” due to potential risks of bias. Analysis revealed substantially greater pooled effect sizes in these studies (SMD −2.51; 95% CI −4.21, −0.82) compared to those rated as “fair” (SMD −0.45; 95% CI −0.65, −0.25) or “good” (SMD −0.38; 95% CI −0.69, −0.08). Conclusions: In this example, use of a numerical rating scale failed to identify studies at increased risk of bias, and could have potentially led to imprecise estimates of treatment effect. Although based on a small number of included studies within an existing systematic review, we found the domain based system provided a more structured framework by which qualitative decisions concerning overall quality could be made, and was useful for detecting potential sources of bias in the available evidence. [ABSTRACT FROM AUTHOR]

Background: In order to facilitate the completeness and transparency of reporting on randomized controlled trials undertaken using acupuncture interventions, a consensus group of international experts developed the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) in 2002. This reporting guideline was updated in 2010, and was applicable to a broader range of acupuncture research, including uncontrolled trials and case reports. Subsequent evaluations have noted limitations on the impact of STRICTA in the reporting quality of acupuncture trials, and the description of acupuncture details remains poor. Thus improvement in the efficacy of the STRICTA guidelines is called for. Discussion: We explored the STRICTA guidelines from four aspects, including the development procedure, validity assessment, endorsement and adherence, and citation situation. Based upon these findings, we provided five potential suggestions for further development of STRICTA. Summary: STRICTA are valid reporting guidelines based on robust methodology and scientific content. However specific implementation strategies including: updating the STRICTA checklist; improving the STRICTA reporting efficiency; consistency with implementing the “Instructions for authors” for journals; establishing global STRICTA research centers; and expanding the STRICTA website, are needed. Such strategies will improve their utilization and impact positively on the quality of reporting on acupuncture research outcomes. [ABSTRACT FROM AUTHOR]

Background: Low back pain is highly prevalent and a significant public health burden in Western society. Feasibility studies suggest personalised pedometer-driven walking is an acceptable and effective motivating tool in the management of chronic low back pain (CLBP≥12 weeks). The proposed study will investigate pedometer-driven walking as a low cost, easily accessible, and sustainable means of physical activity to improve disability and clinical outcomes for people with CLBP in Saskatchewan, Canada. Methods/design: A fully-powered single-blinded randomised controlled trial will compare back care advice and education with back care advice and education followed by a 12-week pedometer-driven walking programme in adults with CLBP. Adults with self-reported CLBP will be recruited from the community and screened for elibility. Two-hundred participants will be randomly allocated to one of two intervention groups. All participants will receive a single back care advice and education session with a physiotherapist. Participants in the walking group will also receive a physiotherapist-facilitated pedometer based walking programme. The physiotherapist will facilitate the participant to monitor and progress the walking programme, by phone, on a weekly basis over 10 weeks following two face-to-face sessions. Outcome measures of self-reported disability, physical activity, participantsf low back pain beliefs/perceptions, quality of life and direct/indirect cost estimates will be gathered at baseline, three months, six months, and 12 months by a different physiotherapist blinded to group allocation. Following intervention, focus groups will be used to explore participantsf thoughts and experiences of pedometer-driven walking as a management tool for CLBP. Discussion: This paper describes the design of a community-based RCT to determine the effectiveness of a pedometer-driven walking programme in the management of CLBP. [ABSTRACT FROM AUTHOR]