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Background: Proven treatments for low back pain, at best, only provide modest overall benefits. Matching people to treatments that are likely to be most effective for them may improve clinical outcomes and makes better use of health care resources.Methods: We conducted an individual participant data meta-analysis of randomised controlled trials of three types of therapist delivered interventions for low back pain (active physical, passive physical and psychological treatments). We applied two statistical methods (recursive partitioning and adaptive risk group refinement) to identify potential subgroups who might gain greater benefits from different treatments from our individual participant data meta-analysis.Results: We pooled data from 19 randomised controlled trials, totalling 9328 participants. There were 5349 (57%) females with similar ratios of females in control and intervention arms. The average age was 49 years (standard deviation, SD, 14). Participants with greater psychological distress and physical disability gained most benefit in improving on the mental component scale (MCS) of SF-12/36 from passive physical treatment than non-active usual care (treatment effects, 4.3; 95% confidence interval, CI, 3.39 to 5.15). Recursive partitioning method found that participants with worse disability at baseline gained most benefit in improving the disability (Roland Morris Disability Questionnaire) outcome from psychological treatment than non-active usual care (treatment effects, 1.7; 95% CI, 1.1 to 2.31). Adaptive risk group refinement did not find any subgroup that would gain much treatment effect between psychological and non-active usual care. Neither statistical method identified any subgroups who would gain an additional benefit from active physical treatment compared to non-active usual care.Conclusions: Our methodological approaches worked well and may have applicability in other clinical areas. Passive physical treatments were most likely to help people who were younger with higher levels of disability and low levels of psychological distress. Psychological treatments were more likely to help those with severe disability. Despite this, the clinical importance of identifying these subgroups is limited. The sizes of sub-groups more likely to benefit and the additional effect sizes observed are small. Our analyses provide no evidence to support the use of sub-grouping for people with low back pain. [ABSTRACT FROM AUTHOR]

BACKGROUND/OBJECTIVES Our aim was to estimate whether baseline participant variables were able to moderate the effect of an exercise intervention on cognition in patients with mild to moderate dementia. DESIGN Subgroup analysis of a multicenter pragmatic randomized controlled trial. SETTING Community‐based gym/rehabilitation centers. PARTICIPANTS A total of 494 community‐dwelling participants with mild to moderate dementia. INTERVENTION Participants were randomized to a moderate‐ to high‐intensity aerobic and strength exercise program or a usual care control group. Experimental group participants attended twice weekly 60‐ to 90‐minute gym sessions for 4 months. Participants were prescribed home exercises for an additional hour per week during the supervised period and 150 minutes each week after the supervised period. MEASUREMENTS Multilevel regression model analyses were undertaken to identify individual moderators of cognitive function measured through the Alzheimer Disease Assessment Scale‐Cognitive Subscale score at 12 months. RESULTS: When tested for a formal interaction effect, only cognitive function assessed by the baseline number cancellation test demonstrated a statistically significant interaction effect (−2.7 points; 95% confidence interval = −5.14 to −0.21). CONCLUSION: People with worse number cancellation test scores may experience greater progression of cognitive decline in response to a moderate‐ to high‐intensity exercise program. Further analyses to examine whether these findings can be replicated in planned sufficiently powered analyses are indicated. [ABSTRACT FROM AUTHOR]

Importance: In adults in whom weaning from invasive mechanical ventilation is difficult, noninvasive ventilation may facilitate early liberation, but there is uncertainty about its effectiveness in a general intensive care patient population.Objective: To investigate among patients with difficulty weaning the effects of protocolized weaning with early extubation to noninvasive ventilation on time to liberation from ventilation compared with protocolized invasive weaning.Design, Setting, and Participants: Randomized, allocation-concealed, open-label, multicenter clinical trial enrolling patients between March 2013 and October 2016 from 41 intensive care units in the UK National Health Service. Follow-up continued until April 2017. Adults who received invasive mechanical ventilation for more than 48 hours and in whom a spontaneous breathing trial failed were enrolled.Interventions: Patients were randomized to receive either protocolized weaning via early extubation to noninvasive ventilation (n = 182) or protocolized standard weaning (continued invasive ventilation until successful spontaneous breathing trial, followed by extubation) (n = 182).Main Outcomes and Measures: Primary outcome was time from randomization to successful liberation from all forms of mechanical ventilation among survivors, measured in days, with the minimal clinically important difference defined as 1 day. Secondary outcomes were duration of invasive and total ventilation (days), reintubation or tracheostomy rates, and survival.Results: Among 364 randomized patients (mean age, 63.1 [SD, 14.8] years; 50.5% male), 319 were evaluable for the primary effectiveness outcome (41 died before liberation, 2 withdrew, and 2 were discharged with ongoing ventilation). The median time to liberation was 4.3 days in the noninvasive group vs 4.5 days in the invasive group (adjusted hazard ratio, 1.1; 95% CI, 0.89-1.40). Competing risk analysis accounting for deaths had a similar result (adjusted hazard ratio, 1.1; 95% CI, 0.86-1.34). The noninvasive group received less invasive ventilation (median, 1 day vs 4 days; incidence rate ratio, 0.6; 95% CI, 0.47-0.87) and fewer total ventilator days (median, 3 days vs 4 days; incidence rate ratio, 0.8; 95% CI, 0.62-1.0). There was no significant difference in reintubation, tracheostomy rates, or survival. Adverse events occurred in 45 patients (24.7%) in the noninvasive group compared with 47 (25.8%) in the invasive group.Conclusions and Relevance: Among patients requiring mechanical ventilation in whom a spontaneous breathing trial had failed, early extubation to noninvasive ventilation did not shorten time to liberation from any ventilation.Trial Registration: ISRCTN Identifier: ISRCTN15635197. [ABSTRACT FROM AUTHOR]

Background: Motivated by the setting of clinical trials in low back pain, this work investigated statistical methods to identify patient subgroups for which there is a large treatment effect (treatment by subgroup interaction). Statistical tests for interaction are often underpowered. Individual patient data (IPD) meta-analyses provide a framework with improved statistical power to investigate subgroups. However, conventional approaches to subgroup analyses applied in both a single trial setting and an IPD setting have a number of issues, one of them being that factors used to define subgroups are investigated one at a time. As individuals have multiple characteristics that may be related to response to treatment, alternative exploratory statistical methods are required.Methods: Tree-based methods are a promising alternative that systematically searches the covariate space to identify subgroups defined by multiple characteristics. A tree method in particular, SIDES, is described and extended for application in an IPD meta-analyses setting by incorporating fixed-effects and random-effects models to account for between-trial variation. The performance of the proposed extension was assessed using simulation studies. The proposed method was then applied to an IPD low back pain dataset.Results: The simulation studies found that the extended IPD-SIDES method performed well in detecting subgroups especially in the presence of large between-trial variation. The IPD-SIDES method identified subgroups with enhanced treatment effect when applied to the low back pain data.Conclusions: This work proposes an exploratory statistical approach for subgroup analyses applicable in any research discipline where subgroup analyses in an IPD meta-analysis setting are of interest. [ABSTRACT FROM AUTHOR]

Study Design: Systematic review.Objective: To evaluate the quality, conduct, and reporting of subgroup analyses performed in randomized controlled trials of therapist-delivered interventions for nonspecific low back pain (NSLBP).Summary Of Background Data: Randomized controlled trials of therapist-delivered interventions for NSLBP to date have, at best, shown small to moderate positive effects. Identifying subgroups is an important research priority. This review evaluates the quality, conduct, and reporting of subgroup analyses performed in the NSLBP literature.Methods: Multiple electronic databases were searched for randomized controlled trials of therapist-delivered interventions for NSLBP. Of the identified articles, only articles reporting subgroup analyses (confirmatory or exploratory) were included in the final review. Methodological criteria were used to evaluate the quality of subgroup analyses. The quality of conduct and reporting was also evaluated.Results: Thirty-nine articles were included in the final review. Of these, only 3 (8%) tested hypotheses about moderators (confirmatory findings), 18 (46%) generated hypotheses about moderators to inform future research (exploratory findings), and 18 (46%) provided insufficient findings. The appropriate statistical test for interaction was performed in 27 of the articles, of which 10 reported results from interaction tests, 4 incorrectly reported results within individual subgroups, and the remaining articles reported either P values or nothing at all.Conclusion: Subgroup analyses performed in NSLBP trials have been severely underpowered, are only able to provide exploratory or insufficient findings, and have rather poor quality of reporting. Using current approaches, few definitive trials of subgrouping in back pain are very likely to be performed. There is a need to develop new approaches to subgroup identification in back pain research. [ABSTRACT FROM AUTHOR]

Study Design. Systematic review. Objective. To evaluate the quality, conduct, and reporting of subgroup analyses performed in randomized controlled trials of therapist-delivered interventions for nonspecific low back pain (NSLBP). Summary of Background Data. Randomized controlled trials of therapist-delivered interventions for NSLBP to date have, at best, shown small to moderate positive effects. Identifying subgroups is an important research priority. This review evaluates the quality, conduct, and reporting of subgroup analyses performed in the NSLBP literature. Methods. Multiple electronic databases were searched for randomized controlled trials of therapist-delivered interventions for NSLBP. Of the identified articles, only articles reporting subgroup analyses (confirmatory or exploratory) were included in the final review. Methodological criteria were used to evaluate the quality of subgroup analyses. The quality of conduct and reporting was also evaluated. Results. Thirty-nine articles were included in the final review. Of these, only 3 (8%) tested hypotheses about moderators (confirmatory findings), 18 (46%) generated hypotheses about moderators to inform future research (exploratory findings), and 18 (46%) provided insufficient findings. The appropriate statistical test for interaction was performed in 27 of the articles, of which 10 reported results from interaction tests, 4 incorrectly reported results within individual subgroups, and the remaining articles reported either P values or nothing at all. Conclusion. Subgroup analyses performed in NSLBP trials have been severely underpowered, are only able to provide exploratory or insufficient findings, and have rather poor quality of reporting. Using current approaches, few definitive trials of subgrouping in back pain are very likely to be performed. There is a need to develop new approaches to subgroup identification in back pain research. [ABSTRACT FROM AUTHOR]

Abstract: Group cognitive behavioural intervention (CBI) is effective in reducing low back pain and disability over a 12-month period, in comparison to best practice advice in primary care. The aim was to study the effects of this CBI beyond 12 months. We undertook an extended follow-up of our original randomised, controlled trial of a group CBI and best practice advice in primary care, in comparison to best practice advice alone. Participants were mailed a questionnaire including measures of disability, pain, health services resource use, and health-related quality of life. The time of extended follow-up ranged between 20 and 50 months (mean 34 months). Fifty-six percent (395 of 701) of the original cohort provided extended follow-up. Those who responded were older and had less disability and pain at baseline than did the original trial cohort. After 12 months, the improvements in pain and disability observed with CBI were sustained. For disability measures, the treatment difference in favour of CBI persisted (mean difference 1.3 Roland and Morris Disability Questionnaire points, 95% confidence interval 0.27 to 2.26; 5.5 Modified von Korff Scale disability points, 95% confidence interval 0.27 to 10.64). There was no between-group difference in Modified von Korff Scale pain outcomes. The results suggest that the effects of a group CBI are maintained up to an average of 34 months. Although pain improves in response to best practice advice, longer-term recovery of disability remains substantially less. [Copyright &y& Elsevier]

Abstract: Objective: Follow-up data were collected using postal questionnaires and if participants did not respond, then data was collected using telephone interviews. The objectives of this study were to examine, for the two methods, how respondents differed in characteristics and whether the observed treatment difference varied. Study Design and Setting: A large clinical trial of lower back pain. Results: About 60% (98/163) of the nonresponders to postal questionnaire provided data by telephone, which increased the overall response rate by 14% (from 71% to 85%). A consistent treatment difference was found across the methods for the outcome measures at 12 months, implying that the observed treatment effect had not been modified. There were some differences between the participants: responders of postal questionnaire were older, likely to be female, white (ethnic origin), not working, with less disability of back pain, compared with those who responded by a telephone interview. At 12 months, there was greater improvement in back pain, disability, and general health for those who responded by postal questionnaires. Conclusion: Researchers should consider the use of more than one method of collecting data as this increases response rate, participant representativeness, and enhances precision of effect estimates. [Copyright &y& Elsevier]

Background: Between 2015 and 2019 the Chronic Headache Education and Self-management Study (CHESS) developed and tested a supportive self-management approach that aimed to improve outcomes for people with chronic migraine or chronic tension type headache with/without episodic migraine. However, a paucity of qualitative research which explored the lived experiences of people with chronic headache was evidenced. In response, we undertook to explore the experiences of living with chronic headaches of people who participated in the CHESS study. Methods: We adopted qualitative methodologies, inviting participants in the CHESS study to participate in semi-structured interviews. In phase 1 (feasibility study), a thematic analysis was conducted. In phase 2 (main CHESS trial), interviews were informed by topic guides developed from our learning from the phase 1 interviews. Pen portrait methodology and thematic analysis was employed allowing us to explore the data longitudinally. Results: Phase 1, 15 interviews (10 female) age range 29 to 69 years (median 47 years) revealed the complexities of living with chronic headache. Six overarching themes were identified including the emotional impact and the nature of their headaches. Phase 2, included 66 interviews (26 participants; median age group 50s (range 20s-60s); 20 females. 14 were interviewed at three points in time (baseline, 4 and 12 months) Through an iterative process four overlapping categories of headache impact emerged from the data and were agreed: i) 'I will not let headaches rule my life'; ii) 'Headaches rule my life'; iii) 'Headaches out of control—something needs to change'; and iv) 'Headaches controlled—not ruling my life'. One of these categories was assigned to each pen portrait at each timepoint. The remaining 12 participants were interviewed at two time points during a year; pen portraits were again produced. Analysis revealed that the headache impact categories developed above held true in this sample also providing some validation of the categories. Conclusions: These data give an insight into the complexities of living with chronic headache. Chronic headache is unpredictable, permeating all aspects of an individual's life; even when an individual feels that their headache is controlled and not interfering, this situation can rapidly change. It shows us that more work needs to be done both medically and societally to help people living with this often-hidden condition. Trial registration: ISRCTN79708100 [ABSTRACT FROM AUTHOR]

Key Points: Question: Among patients with chronic pain, does a multicomponent intervention consisting of group meetings, education, individual support, and skill-based learning reduce opioid use and improve pain interference with daily activities compared with usual care? Findings: In this multicentered, randomized clinical trial that included 608 participants with chronic pain due to nonmalignant causes from primary care settings in the UK, at 12-month follow-up, 29% of people in the intervention group, compared with 7% in the usual care group, discontinued opioids, but there were no statistically significant differences in pain interference with daily life activities between the 2 groups at 12 months. Meaning: Among patients with chronic pain due to nonmalignant causes, a group-based educational intervention significantly reduced opioid use had no effect on perceived pain compared with usual care. Importance: Opioid use for chronic nonmalignant pain can be harmful. Objective: To test whether a multicomponent, group-based, self-management intervention reduced opioid use and improved pain-related disability compared with usual care. Design, Setting, and Participants: Multicentered, randomized clinical trial of 608 adults taking strong opioids (buprenorphine, dipipanone, morphine, diamorphine, fentanyl, hydromorphone, methadone, oxycodone, papaveretum, pentazocine, pethidine, tapentadol, and tramadol) to treat chronic nonmalignant pain. The study was conducted in 191 primary care centers in England between May 17, 2017, and January 30, 2019. Final follow-up occurred March 18, 2020. Intervention: Participants were randomized 1:1 to either usual care or 3-day–long group sessions that emphasized skill-based learning and education, supplemented by 1-on-1 support delivered by a nurse and lay person for 12 months. Main Outcomes and Measures: The 2 primary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) score (T-score range, 40.7-77; 77 indicates worst pain interference; minimal clinically important difference, 3.5) and the proportion of participants who discontinued opioids at 12 months, measured by self-report. Results: Of 608 participants randomized (mean age, 61 years; 362 female [60%]; median daily morphine equivalent dose, 46 mg [IQR, 25 to 79]), 440 (72%) completed 12-month follow-up. There was no statistically significant difference in PROMIS-PI-SF-8a scores between the 2 groups at 12-month follow-up (−4.1 in the intervention and −3.17 in the usual care groups; between-group difference: mean difference, −0.52 [95% CI, −1.94 to 0.89]; P =.15). At 12 months, opioid discontinuation occurred in 65 of 225 participants (29%) in the intervention group and 15 of 208 participants (7%) in the usual care group (odds ratio, 5.55 [95% CI, 2.80 to 10.99]; absolute difference, 21.7% [95% CI, 14.8% to 28.6%]; P <.001). Serious adverse events occurred in 8% (25/305) of the participants in the intervention group and 5% (16/303) of the participants in the usual care group. The most common serious adverse events were gastrointestinal (2% in the intervention group and 0% in the usual care group) and locomotor/musculoskeletal (2% in the intervention group and 1% in the usual care group). Four people (1%) in the intervention group received additional medical care for possible or probable symptoms of opioid withdrawal (shortness of breath, hot flushes, fever and pain, small intestinal bleed, and an overdose suicide attempt). Conclusions and Relevance: In people with chronic pain due to nonmalignant causes, compared with usual care, a group-based educational intervention that included group and individual support and skill-based learning significantly reduced patient-reported use of opioids, but had no effect on perceived pain interference with daily life activities. Trial Registration: isrctn.org Identifier: ISRCTN49470934 This randomized clinical trial compares the efficacy of a multicomponent, group-based, self-management intervention vs usual care in reducing opioid use and improving pain-related disability in patients taking strong opioids to treat chronic pain from nonmalignant causes. [ABSTRACT FROM AUTHOR]

Importance: Ankle fractures cause substantial morbidity in older persons. Surgical fixation is the contemporary intervention but is associated with infection and other healing complications.Objective: To determine whether initial fracture treatment with close contact casting, a molded below-knee cast with minimal padding, offers outcome equivalent to that with immediate surgery, with fewer complications and less health resource use.Design, Setting, and Participants: This was a pragmatic, equivalence, randomized clinical trial with blinded outcome assessors. A pilot study commenced in May 2004, followed by multicenter recruitment from July 2010 to November 2013; follow-up was completed May 2014. Recruitment was from 24 UK major trauma centers and general hospitals. Participants were 620 adults older than 60 years with acute, overtly unstable ankle fracture. Exclusions were serious limb or concomitant disease or substantial cognitive impairment.Interventions: Participants were randomly assigned to surgery (n = 309) or casting (n = 311). Casts were applied in the operating room under general or spinal anesthesia by a trained surgeon.Main Outcomes and Measures: The primary 6-month, per-protocol outcome was the Olerud-Molander Ankle Score at 6 months (OMAS; range, 0-100; higher scores indicate better outcomes and fewer symptoms), equivalence prespecified as ±6 points. Secondary outcomes were quality of life, pain, ankle motion, mobility, complications, health resource use, and patient satisfaction.Results: Among 620 adults (mean age, 71 years; 460 [74%] women) who were randomized, 593 (96%) completed the study. Nearly all participants (579/620; 93%) received allocated treatment; 52 of 275 (19%) who initially received casting later converted to surgery, which was allowable in the casting treatment pathway to manage early loss of fracture reduction. At 6 months, casting resulted in ankle function equivalent to that with surgery (OMAS score, 66.0 [95% CI, 63.6-68.5] for surgery vs 64.5 [95% CI, 61.8-67.2] for casting; mean difference, -0.6 [95% CI, -3.9 to 2.6]; P for equivalence = .001). Infection and wound breakdown were more common with surgery (29/298 [10%] vs 4/275 [1%]; odds ratio [OR], 7.3 [95% CI, 2.6-20.2]), as were additional operating room procedures (18/298 [6%] for surgery and 3/275 [1%] for casting; OR, 5.8 [95% CI, 1.8-18.7]). Radiologic malunion was more common in the casting group (38/249 [15%] vs 8/274 [3%] for surgery; OR, 6.0 [95% CI, 2.8-12.9]). Casting required less operating room time compared with surgery (mean difference [minutes/participant], -54 [95% CI, -58 to -50]). There were no significant differences in other secondary outcomes: quality of life, pain, ankle motion, mobility, and patient satisfaction.Conclusions and Relevance: Among older adults with unstable ankle fracture, the use of close contact casting compared with surgery resulted in similar functional outcomes at 6 months. Close contact casting may be an appropriate treatment for such patients.Trial Registration: isrctn.com Identifier: ISRCTN04180738. [ABSTRACT FROM AUTHOR]

Background: The Chronic Headache Education and Self-Management Study (CHESS) multicentre randomised trial evaluated the impact a group education and self-management support intervention with a best usual care plus relaxation control for people living with chronic headache disorders (tension type headaches or chronic migraine, with or without medication overuse headache). Here we report the process evaluation exploring potential explanations for the lack of positive effects from the CHESS intervention. Methods: The CHESS trial included 736 (380 intervention: 356 control) people across the Midlands and London UK. We used a mixed methods approach. Our extensive process evaluation looked at context, reach, recruitment, dose delivered, dose received, fidelity and experiences of participating in the trial, and included participants and trial staff. We also looked for evidence in our qualitative data to investigate whether the original causal assumptions underpinning the intervention were realised. Results: The CHESS trial reached out to a large diverse population and recruited a representative sample. Few people with chronic tension type headaches without migraine were identified and recruited. The expected 'dose'of the intervention was delivered to participants and intervention fidelity was high. Attendance ("dose received") fell below expectation, although 261/380 (69%) received at least at least the pre-identified minimum dose. Intervention participants generally enjoyed being in the groups but there was little evidence to support the causal assumptions underpinning the intervention were realised. Conclusions: From a process evaluation perspective despite our extensive data collection and analysis, we do not have a clear understanding of why the trial outcome was negative as the intervention was delivered as planned. However, the lack of evidence that the intervention causal assumptions brought about the planned behaviour change may provide some insight. Our data suggests only modest changes in managing headache behaviours and some disparity in how participants engaged with components of the intervention within the timeframe of the study. Moving forwards, we need a better understanding of how those who live with chronic headache can be helped to manage this disabling condition more effectively over time. Trial registration: ISRCTN79708100. [ABSTRACT FROM AUTHOR]

This study reports 3-year outcomes of a randomized trial that compared close contact casting vs the usual surgery for unstable ankle fractures in older adults and that found equivalent ankle function outcomes at 6 months. [ABSTRACT FROM AUTHOR]

Purpose: Psychiatric hospitals or mental asylums grew across the world in the colonial era. Despite concerns over quality of care and human rights violations, these hospitals continue to provide the majority of mental health care in most low- and middle-income countries (LMICs). We sought to review the evidence of reform of mental hospitals and associated patient outcomes. Methods: We adopted an integrative review methodology by including experimental and non-experimental research. The review protocol was registered on PROSPERO (CRD42019130399). A range of databases and systematic hand searches were conducted by two independent reviewers. Research conducted between 1980 and May 2019, that focused on any aspect of reform in mental hospitals for adults (age 18 and upwards) with severe mental illness and published in English, were considered. Results: 16 studies were included in the review. 12 studies met inclusion criteria, and four additional reports emerged from the hand search. Studies covered—India, China, South Africa, Grenada, Georgia, Sri Lanka, Argentina and Brazil. Key findings emphasise the role of judicial intervention as a critical trigger of reform. Structural reform composed of optimisation of resources and renovations of colonial structures to cater to diverse patient needs. Process reforms include changes in medical management, admission processes and a move from closed to open wards. Staff engagement and capacity building have also been used as a modality of reform in mental hospital settings. Conclusion: There is some documentation of reform in psychiatric hospitals. However, poor methodological quality and variation in approach and outcomes measured, make it challenging to extrapolate specific findings on process or outcomes of reform. Despite being integral service providers, psychiatric hospitals still do not adopt patient centric, recovery-oriented processes. Hence, there is an urgent need to generate robust evidence on psychiatric reform and its effect on patient outcomes. [ABSTRACT FROM AUTHOR]

Background: Dementia is more common in older than in younger people, and as a result of the ageing of the population in developed countries, it is becoming more prevalent. Drug treatments for dementia are limited, and the main support offered to people with dementia and their families is generally services to mitigate against loss of function. Physical exercise is a candidate non-pharmacological treatment for dementia.Methods/design: DAPA is a randomised controlled trial funded by the National Institute for Health Research Health Technology Assessment programme to estimate the effect of a 4-month, moderate- to hard-intensity exercise training programme and subsequent advice to remain active, on cognition (primary outcome) at 12 months in people with mild to moderate dementia. Community-dwelling participants (with their carers where possible), who are able to walk 3 metres without human assistance, able to undertake an exercise programme and do not have any unstable or terminal illness are recruited. Participants are then randomised by an independent statistician using a computerised random number generator to usual care or exercise at a 2:1 ratio in favour of exercise. The exercise intervention comprises 29, 1-hour-long exercise classes, run twice weekly at suitable venues such as leisure centres, which include aerobic exercise (on static bikes) and resistance exercise (using weights). Goals for independent exercise are set while the classes are still running, and supported thereafter with phone calls. The primary outcome is measured using ADAS-cog. Secondary outcome measures include behavioural symptoms, functional ability, quality of life and carer burden. Primary and secondary outcomes will be measured at baseline and at 6 and 12 months after randomisation, by researchers masked to participant randomisation in the participants' own homes. An economic evaluation will be carried out in parallel to the RCT, as will a qualitative study capturing the experiences of participants, carers and staff delivering the intervention.Discussion: The DAPA study will be the first large, randomised trial of the cognitive effects of exercise on people with dementia. The intervention is designed to be capable of being delivered within the constraints of NHS service provision, and the economic evaluation will allow assessment of its cost-effectiveness.Trial Registration: DAPA was registered with the ISRCTN database on 29 July 2011, registration number ISRCTN32612072 . [ABSTRACT FROM AUTHOR]

Group cognitive behavioural intervention (CBI) is effective in reducing low back pain and disability over a 12-month period, in comparison to best practice advice in primary care. The aim was to study the effects of this CBI beyond 12 months. We undertook an extended follow-up of our original randomised, controlled trial of a group CBI and best practice advice in primary care, in comparison to best practice advice alone. Participants were mailed a questionnaire including measures of disability, pain, health services resource use, and health-related quality of life. The time of extended follow-up ranged between 20 and 50 months (mean 34 months). Fifty-six percent (395 of 701) of the original cohort provided extended follow-up. Those who responded were older and had less disability and pain at baseline than did the original trial cohort. After 12 months, the improvements in pain and disability observed with CBI were sustained. For disability measures, the treatment difference in favour of CBI persisted (mean difference 1.3 Roland and Morris Disability Questionnaire points, 95% confidence interval 0.27 to 2.26; 5.5 Modified von Korff Scale disability points, 95% confidence interval 0.27 to 10.64). There was no between-group difference in Modified von Korff Scale pain outcomes. The results suggest that the effects of a group CBI are maintained up to an average of 34 months. Although pain improves in response to best practice advice, longer-term recovery of disability remains substantially less. [ABSTRACT FROM AUTHOR]

Background: Acute lung injury complicates approximately 25-30% of subjects undergoing oesophagectomy. Experimental studies suggest that treatment with beta agonists may prevent the development of acute lung injury by decreasing inflammatory cell infiltration, activation and inflammatory cytokine release, enhancing basal alveolar fluid clearance and improving alveolar capillary barrier function. Methods/Design: The Beta Agonist Lung Injury TrIal (prevention) is a multi-centre, randomised, double blind, placebo-controlled trial. The aim of the trial is to determine in patients undergoing elective transthoracic oesphagectomy, if treatment with inhaled salmeterol 100 mcg twice daily started at induction of anaesthesia and continued for 72 hours thereafter compared to placebo affect the incidence of early acute lung injury and other clinical, resource and patient focused outcomes. The primary outcome will be the development of acute lung injury within 72 hours of oesophagectomy. The trial secondary outcomes are the development of acute lung injury during the first 28 days post operatively; PaO2: FiO2 ratio; the number of ventilator and organ failure free days, 28 and 90 day survival; health related quality of life and resource utilisation. The study aims to recruit 360 patients from 10 UK centres. [ABSTRACT FROM AUTHOR]

Background: Approximately 9% of a trauma surgeon's workload in the UK is managing ankle fractures. Following an ankle fracture immobilisation with a plaster cast or removable orthotic is usual. The aim of this research was to assess the feasibility of a large multi-centre randomised controlled trial (RCT) to evaluate the difference between plaster cast and a removable orthotic for the management of adults with an ankle fracture. Methods: A feasibility randomised controlled trial was undertaken in a UK trauma hospital in adults with an ankle fracture for which the treating clinician would consider plaster cast a reasonable management option. Exclusions included open or pathological fracture, unable to adhere to trial procedures, had other lower limb injury or required close contact casting. Participants were randomised using an independent telephone service to receive either plaster cast or removable orthotic. The primary outcome was to determine the recruitment and follow-up rates at 6 weeks, 3 and 6 months to assess the feasibility of a full RCT. Results: Eighty five eligible patients presented during the 10-month recruitment period, 50 consented. Two patients were randomised who did not fulfil the eligibility criteria (protocol deviations), and 1 patient from each group crossed over. Follow-up at each time point was 92% at 6 weeks; 74% at 3 months and 83% at 6 months. Conclusions: Recruitment and follow-up data demonstrated feasibility of conducting a larger-scale randomised controlled trial. The distributional properties of the patient-reported outcome measures will be used to determine future sample sizes. Trial registrations: This study is registered with the ISRCTN (ISRCTN17809322), assigned 5 November 2015 and approved by the NRES Committee (The Black Country, 15/WM/0340), protocol version 2.0 (17 November 2015). It is co-sponsored by the University Hospitals Coventry and Warwickshire NHS Trust and University of Warwick and funded by the NIHR Research for Patient Benefit (PB-PG-0614-34,009). The trial sponsors have no direct involvement in any aspects of study design, conduct or decision to submit the report for publication. [ABSTRACT FROM AUTHOR]

Background: Self-management support programmes are effective in a range of chronic conditions however there is limited evidence for their use in the treatment of chronic headaches. The aim of this study was to test the feasibility of four key aspects of a planned, future evaluative trial of a new education and self-management intervention for people with chronic headache: 1) recruiting people with chronic headache from primary care; 2) a telephone interview for the classification of chronic headaches; 3) the education and self-management intervention itself; and 4) the most appropriate patient reported outcomes (PROMS).Methods: Participants were identified and recruited from general practices in the West Midlands of the UK. We developed a nurse-led chronic headache classification interview and assessed agreement with an interview with headache specialists. We developed and tested a group based education and self-management intervention to assess training and delivery receipt using observation, facilitator, and participant feedback. We explored the acceptability and relevance of PROMs using postal questionnaires, interviews and a smartphone app.Results: Fourteen practices took part in the study and participant recruitment equated to 1.0/1000 registered patients. Challenges to recruitment were identified. We did 107 paired headache classification interviews. The level of agreement between nurse and doctor interviews was very good. We piloted the intervention in four groups with 18 participants. Qualitative feedback from participants and facilitators helped refine the intervention including shortening the overall intervention and increasing the facilitator training time. Participants completed 131 baseline questionnaires, measurement data quality, reliability and validity for headache-specific and generic measures was acceptable.Conclusion: This study indicated that recruiting people with chronic headache from primary care is feasible but challenging, our headache classification interview is fit for purpose, our study intervention is viable, and that our choice of outcome measures is acceptable to participants in a future randomised controlled trial (RCT).Trial Registration: ISRCTN, ISRCTN79708100. Registered 16th December 2015, http://www.isrctn.com/ISRCTN79708100. [ABSTRACT FROM AUTHOR]

Background: Acute lung injury complicates approximately 25-30% of subjects undergoing oesophagectomy. Experimental studies suggest that treatment with beta agonists may prevent the development of acute lung injury by decreasing inflammatory cell infiltration, activation and inflammatory cytokine release, enhancing basal alveolar fluid clearance and improving alveolar capillary barrier function.Methods/design: The Beta Agonist Lung Injury TrIal (prevention) is a multi-centre, randomised, double blind, placebo-controlled trial. The aim of the trial is to determine in patients undergoing elective transthoracic oesphagectomy, if treatment with inhaled salmeterol 100 mcg twice daily started at induction of anaesthesia and continued for 72 hours thereafter compared to placebo affect the incidence of early acute lung injury and other clinical, resource and patient focused outcomes. The primary outcome will be the development of acute lung injury within 72 hours of oesophagectomy. The trial secondary outcomes are the development of acute lung injury during the first 28 days post operatively; PaO2: FiO2 ratio; the number of ventilator and organ failure free days, 28 and 90 day survival; health related quality of life and resource utilisation. The study aims to recruit 360 patients from 10 UK centres.Trial Registration Number: Current Controlled Trials ISRCTN47481946. [ABSTRACT FROM AUTHOR]