How can we improve Comprehensive Geriatric Assessment for older people living with frailty in primary care and community settings? A qualitative study.

OBJECTIVE: With advancing age comes the increasing prevalence of frailty and increased risk of adverse outcomes (eg, hospitalisation). Evidence for comprehensive geriatric assessment (CGA), a multidimensional holistic model of care, is mixed in community settings. Uncertainties remain, such as the key components of CGA, who delivers it, and the use of technology. This study aimed to understand the perspectives, beliefs and experiences, of both older people and health professionals, to improve the current CGA and explore factors that may impact on CGA delivery in community settings. DESIGN: A qualitative interview study was conducted with older people and healthcare professionals (HCPs) identified using a maximum variation strategy. Data were analysed using an abductive analysis approach. The non-adoption, abandonment, scale-up, spread and sustainability framework and the theoretical framework of acceptability guided the categorisation of the codes and identified categories were mapped to the two frameworks. SETTING: England, UK. RESULTS: 27 people were interviewed, constituting 14 older people and 13 HCPs. We identified limitations in the current CGA: a lack of information sharing between different HCPs who deliver CGA; poor communication between older people and their HCPs and a lack of follow-up as part of CGA. When we discussed the potential for CGA to use technology, HCPs and older people varied in their readiness to engage with it. CONCLUSIONS: Viable solutions to address gaps in the current delivery of CGA include the provision of training and support to use digital technology and a designated comprehensive care coordinator. The next stage of this research will use these findings, existing evidence and stakeholder engagement, to develop and refine a model of community-based CGA that can be assessed for feasibility and acceptability.

Rehabilitation to enable recovery from COVID-19: a rapid systematic review.

OBJECTIVES: To establish the evidence for rehabilitation interventions tested in populations of patients admitted to ICU and critical care with severe respiratory illness, and consider whether the evidence is generalizable to patients with COVID-19. METHODS: The authors undertook a rapid systematic review. Medline (via OvidSP), CINAHL Complete (via EBSCOhost), Cochrane Library, Cochrane Database of Systematic Reviews and CENTRAL (via Wiley), Epistemonikos (via Epistemonikos.org), PEDro (via pedro.org.au) and OTseeker (via otseeker.com) searched to 7 May 2020. The authors included systematic reviews, RCTs and qualitative studies involving adults with respiratory illness requiring intensive care who received rehabilitation to enhance or restore resulting physical impairments or function. Data were extracted by one author and checked by a second. TIDier was used to guide intervention descriptions. Study quality was assessed using Critical Skills Appraisal Programme (CASP) tools. RESULTS: Six thousand nine hundred and three titles and abstracts were screened; 24 systematic reviews, 11 RCTs and eight qualitative studies were included. Progressive exercise programmes, early mobilisation and multicomponent interventions delivered in ICU can improve functional independence. Nutritional supplementation in addition to rehabilitation in post-ICU hospital settings may improve performance of activities of daily living. The evidence for rehabilitation after discharge from hospital following an ICU admission is inconclusive. Those receiving rehabilitation valued it, engendering hope and confidence. CONCLUSIONS: Exercise, early mobilisation and multicomponent programmes may improve recovery following ICU admission for severe respiratory illness that could be generalizable to those with COVID-19. Rehabilitation interventions can bring hope and confidence to individuals but there is a need for an individualised approach and the use of behaviour change strategies. Further research is needed in post-ICU settings and with those who have COVID-19. Registration: Open Science Framework https://osf.io/prc2y.

Monitoring, implementation and reporting of interventions in a selection of trials assessing exercise therapy for the management of shoulder subacromial pain: a cross-sectional investigation.

OBJECTIVES: To review the reporting of monitoring and implementation of interventions in a selection of trials that assessed the effectiveness of manual therapy and exercise in the management of shoulder subacromial pain. DESIGN: A review of trials assessing the effectiveness of manual therapy and exercise in the management of patients with shoulder subacromial pain. METHODS: We included in our review a selection of 10 trials that were included in a Cochrane review and compared manual therapy and exercise intervention with another intervention. Trials were assessed independently by two reviewers using two checklists: the Template for Intervention Description and Replication (TIDieR) and the Health Behavior Change Consortium treatment fidelity (National Institutes of Health Behaviour Change Consortium/NIHBCC). RESULTS: TIDieR overall scores for individual trials ranged from 11.1% to 45% and fidelity scores ranged from 7% to 50%. On average, trials scored the following within each domain of NIHBCC: study design 51%; training of providers 8%; treatment delivery 15%; treatment receipt 14% and treatment enactment 2.5%. CONCLUSIONS: Little information about the monitoring, implementation and reporting of interventions was provided by trials and that is a barrier for implementing or replicating these interventions. The lack of information regarding the implementation of interventions needs to be taken into account when assessing whether effectiveness of interventions was impacted by their design or due to deviations from the protocol within trials.

Protocolised non-invasive compared with invasive weaning from mechanical ventilation for adults in intensive care: the Breathe RCT.

BACKGROUND: Invasive mechanical ventilation (IMV) is a life-saving intervention. Following resolution of the condition that necessitated IMV, a spontaneous breathing trial (SBT) is used to determine patient readiness for IMV discontinuation. In patients who fail one or more SBTs, there is uncertainty as to the optimum management strategy. OBJECTIVE: To evaluate the clinical effectiveness and cost-effectiveness of using non-invasive ventilation (NIV) as an intermediate step in the protocolised weaning of patients from IMV. DESIGN: Pragmatic, open-label, parallel-group randomised controlled trial, with cost-effectiveness analysis. SETTING: A total of 51 critical care units across the UK. PARTICIPANTS: Adult intensive care patients who had received IMV for at least 48 hours, who were categorised as ready to wean from ventilation, and who failed a SBT. INTERVENTIONS: Control group (invasive weaning): patients continued to receive IMV with daily SBTs. A weaning protocol was used to wean pressure support based on the patient's condition. Intervention group (non-invasive weaning): patients were extubated to NIV. A weaning protocol was used to wean inspiratory positive airway pressure, based on the patient's condition. MAIN OUTCOME MEASURES: The primary outcome measure was time to liberation from ventilation. Secondary outcome measures included mortality, duration of IMV, proportion of patients receiving antibiotics for a presumed respiratory infection and health-related quality of life. RESULTS: A total of 364 patients (invasive weaning, n = 182; non-invasive weaning, n = 182) were randomised. Groups were well matched at baseline. There was no difference between the invasive weaning and non-invasive weaning groups in median time to liberation from ventilation {invasive weaning 108 hours [interquartile range (IQR) 57-351 hours] vs. non-invasive weaning 104.3 hours [IQR 34.5-297 hours]; hazard ratio 1.1, 95% confidence interval [CI] 0.89 to 1.39; p = 0.352}. There was also no difference in mortality between groups at any time point. Patients in the non-invasive weaning group had fewer IMV days [invasive weaning 4 days (IQR 2-11 days) vs. non-invasive weaning 1 day (IQR 0-7 days); adjusted mean difference -3.1 days, 95% CI -5.75 to -0.51 days]. In addition, fewer non-invasive weaning patients required antibiotics for a respiratory infection [odds ratio (OR) 0.60, 95% CI 0.41 to 1.00; p = 0.048]. A higher proportion of non-invasive weaning patients required reintubation than those in the invasive weaning group (OR 2.00, 95% CI 1.27 to 3.24). The within-trial economic evaluation showed that NIV was associated with a lower net cost and a higher net effect, and was dominant in health economic terms. The probability that NIV was cost-effective was estimated at 0.58 at a cost-effectiveness threshold of £20,000 per quality-adjusted life-year. CONCLUSIONS: A protocolised non-invasive weaning strategy did not reduce time to liberation from ventilation. However, patients who underwent non-invasive weaning had fewer days requiring IMV and required fewer antibiotics for respiratory infections. FUTURE WORK: In patients who fail a SBT, which factors predict an adverse outcome (reintubation, tracheostomy, death) if extubated and weaned using NIV? TRIAL REGISTRATION: Current Controlled Trials ISRCTN15635197. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 48. See the NIHR Journals Library website for further project information.

Patients who become very unwell may require help from a breathing machine. This requires the patient to be given drugs to put them to sleep (sedation) and have a tube placed through their mouth directly into the windpipe (tube ventilation). This can be life-saving, but may cause harm if used for long periods of time. Non-invasive ventilation (mask ventilation) provides breathing support through a mask that covers the face. Mask ventilation has several advantages over tube ventilation, such as less need for sedation, and it enables the patient to cough and communicate. In previous studies, switching patients from tube to mask ventilation when they start to get better seemed to improve survival rates and reduce complications. The Breathe trial tested if using a protocol to remove tube ventilation and replace it with mask ventilation is better than continuing with tube ventilation until the patient no longer needs breathing machine support. The trial recruited 364 patients. Half of these patients were randomly selected to have the tube removed and replaced with mask ventilation and half were randomly selected to continue with tube ventilation until they no longer needed breathing machine support. The mask group spent 3 fewer days receiving tube ventilation, although the overall time needing breathing machine help (mask and tube) did not change. Fewer patients in the mask group needed antibiotics for chest infections. After removing the tube, twice as many patients needed the tube again in the mask group as in the tube group. There were no differences between the groups in the number of adverse (harm) events or the number of patients who survived to leave hospital. Mask ventilation was no more expensive than tube ventilation. In conclusion, mask ventilation may be an effective alternative to continued tube ventilation when patients start to get better in intensive care.

Exercise for preventing falls in older people living in the community.

BACKGROUND: At least one-third of community-dwelling people over 65 years of age fall each year. Exercises that target balance, gait and muscle strength have been found to prevent falls in these people. An up-to-date synthesis of the evidence is important given the major long-term consequences associated with falls and fall-related injuries OBJECTIVES: To assess the effects (benefits and harms) of exercise interventions for preventing falls in older people living in the community. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, three other databases and two trial registers up to 2 May 2018, together with reference checking and contact with study authors to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating the effects of any form of exercise as a single intervention on falls in people aged 60+ years living in the community. We excluded trials focused on particular conditions, such as stroke. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Our primary outcome was rate of falls. MAIN RESULTS: We included 108 RCTs with 23,407 participants living in the community in 25 countries. There were nine cluster-RCTs. On average, participants were 76 years old and 77% were women. Most trials had unclear or high risk of bias for one or more items. Results from four trials focusing on people who had been recently discharged from hospital and from comparisons of different exercises are not described here.Exercise (all types) versus control Eighty-one trials (19,684 participants) compared exercise (all types) with control intervention (one not thought to reduce falls). Exercise reduces the rate of falls by 23% (rate ratio (RaR) 0.77, 95% confidence interval (CI) 0.71 to 0.83; 12,981 participants, 59 studies; high-certainty evidence). Based on an illustrative risk of 850 falls in 1000 people followed over one year (data based on control group risk data from the 59 studies), this equates to 195 (95% CI 144 to 246) fewer falls in the exercise group. Exercise also reduces the number of people experiencing one or more falls by 15% (risk ratio (RR) 0.85, 95% CI 0.81 to 0.89; 13,518 participants, 63 studies; high-certainty evidence). Based on an illustrative risk of 480 fallers in 1000 people followed over one year (data based on control group risk data from the 63 studies), this equates to 72 (95% CI 52 to 91) fewer fallers in the exercise group. Subgroup analyses showed no evidence of a difference in effect on both falls outcomes according to whether trials selected participants at increased risk of falling or not.The findings for other outcomes are less certain, reflecting in part the relatively low number of studies and participants. Exercise may reduce the number of people experiencing one or more fall-related fractures (RR 0.73, 95% CI 0.56 to 0.95; 4047 participants, 10 studies; low-certainty evidence) and the number of people experiencing one or more falls requiring medical attention (RR 0.61, 95% CI 0.47 to 0.79; 1019 participants, 5 studies; low-certainty evidence). The effect of exercise on the number of people who experience one or more falls requiring hospital admission is unclear (RR 0.78, 95% CI 0.51 to 1.18; 1705 participants, 2 studies, very low-certainty evidence). Exercise may make little important difference to health-related quality of life: conversion of the pooled result (standardised mean difference (SMD) -0.03, 95% CI -0.10 to 0.04; 3172 participants, 15 studies; low-certainty evidence) to the EQ-5D and SF-36 scores showed the respective 95% CIs were much smaller than minimally important differences for both scales.Adverse events were reported to some degree in 27 trials (6019 participants) but were monitored closely in both exercise and control groups in only one trial. Fourteen trials reported no adverse events. Aside from two serious adverse events (one pelvic stress fracture and one inguinal hernia surgery) reported in one trial, the remainder were non-serious adverse events, primarily of a musculoskeletal nature. There was a median of three events (range 1 to 26) in the exercise groups.Different exercise types versus controlDifferent forms of exercise had different impacts on falls (test for subgroup differences, rate of falls: P = 0.004, I² = 71%). Compared with control, balance and functional exercises reduce the rate of falls by 24% (RaR 0.76, 95% CI 0.70 to 0.81; 7920 participants, 39 studies; high-certainty evidence) and the number of people experiencing one or more falls by 13% (RR 0.87, 95% CI 0.82 to 0.91; 8288 participants, 37 studies; high-certainty evidence). Multiple types of exercise (most commonly balance and functional exercises plus resistance exercises) probably reduce the rate of falls by 34% (RaR 0.66, 95% CI 0.50 to 0.88; 1374 participants, 11 studies; moderate-certainty evidence) and the number of people experiencing one or more falls by 22% (RR 0.78, 95% CI 0.64 to 0.96; 1623 participants, 17 studies; moderate-certainty evidence). Tai Chi may reduce the rate of falls by 19% (RaR 0.81, 95% CI 0.67 to 0.99; 2655 participants, 7 studies; low-certainty evidence) as well as reducing the number of people who experience falls by 20% (RR 0.80, 95% CI 0.70 to 0.91; 2677 participants, 8 studies; high-certainty evidence). We are uncertain of the effects of programmes that are primarily resistance training, or dance or walking programmes on the rate of falls and the number of people who experience falls. No trials compared flexibility or endurance exercise versus control. AUTHORS' CONCLUSIONS: Exercise programmes reduce the rate of falls and the number of people experiencing falls in older people living in the community (high-certainty evidence). The effects of such exercise programmes are uncertain for other non-falls outcomes. Where reported, adverse events were predominantly non-serious.Exercise programmes that reduce falls primarily involve balance and functional exercises, while programmes that probably reduce falls include multiple exercise categories (typically balance and functional exercises plus resistance exercises). Tai Chi may also prevent falls but we are uncertain of the effect of resistance exercise (without balance and functional exercises), dance, or walking on the rate of falls.

Is Vitamin D Supplementation Effective for Low Back Pain? A Systematic Review and Meta-Analysis.

BACKGROUND: Low back pain (LBP) is the leading cause of years lived with disability worldwide. Current intervention strategies are failing to reduce the enormous global burden of LBP and are prompting researchers to investigate alternative management strategies, such as vitamin D supplementation. Vitamin D supplementation appears to down regulate pro-inflammatory cytokines which lead to pain and up regulate anti-inflammatory cytokines that reduce inflammation. These mechanisms might explain the increasing interest in the use of vitamin D supplementation for LBP. OBJECTIVES: To determine whether vitamin D supplementation improves pain more than a control intervention for individuals with LBP. STUDY DESIGN: This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. METHODS: We performed searches in numerous electronic databases combining key words relating to "vitamin D" and "LBP" until March 2017. Studies were included if they investigated vitamin D supplementation in participants with LBP, provided there was a comparison intervention. There was no restriction on the type of LBP, the intervention parameters investigated, or the type of clinical trial (e.g., randomized, non-randomized). Two reviewers independently performed the selection of studies, extracted data, rated the methodological quality of the included studies, and evaluated the overall quality of the evidence using the Grading of Recommendations Assessment, Delevopment, and Evaulation (GRADE) approach. RESULTS: After screening 3,534 articles, 8 clinical trials were included in this systematic review. There is very low quality evidence (based on the GRADE approach) that vitamin D supplementation is not more effective than any intervention (including placebo, no intervention, and other conservative/pharmacological interventions) (continuous pain measures [0-100]: mean difference [MD] = -2.65, 95% confidence interval [CI]: -10.42 to 5.12, P = 0.504, n = 5; self-reported reduction in pain: pooled odds ratio [OR] = 1.07, 95% CI: 0.35 to 3.26, P = 0.906, n = 5) or placebo/no intervention for individuals with LBP (continuous pain measures: MD = 1.29, 95% CI: -3.81 to 6.39, P = 0.620, n = 4; self-reported reduction in pain: pooled OR = 1.53, 95% CI: 0.38 to 6.20, P = 0.550, n = 4), where 'n' is the number of studies included in the meta-analysis. These results did not change when we stratified the meta-analyses by the type of vitamin supplementation (vitamin D3 vs. alfacalcidol) or the type of LBP (non-specific vs. LBP resulting from osteoporosis or vertebral fractures). LIMITATIONS: The overall quality of evidence was "very low" due to the poor methodological quality and small sample sizes of the included studies. CONCLUSIONS: Vitamin D supplementation is not more effective than placebo, no intervention, or other conservative/pharmacological interventions for LBP (based on very low quality evidence). These results are consistent, regardless of the type of LBP or vitamin D supplementation. Until well-designed and adequately powered clinical trials suggest otherwise, the prescription of vitamin D for LBP cannot be recommended. PROSPERO Registration No: CRD42016046874. www.crd.york.ac.uk/PROSPERO/display_record.asp?ID = CRD42016046874. KEY WORDS: Vitamin D, low back pain, chronic low back pain, alfacalcidol, osteoporosis, vertebral fractures, serum 25-hydroxyvitamin D, systematic review.

United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial.

BACKGROUND: Frozen shoulder (also known as adhesive capsulitis) occurs when the capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder tight, painful and stiff. It affects around 1 in 12 men and 1 in 10 women of working age. Although this condition can settle with time (typically taking 1 to 3 years), for some people it causes severe symptoms and needs referral to hospital. Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly used in secondary care in the National Health Service (NHS) compared with a non-surgical comparator of Early Structured Physiotherapy. METHODS: We will conduct a randomised controlled trial (RCT) of 500 adult patients with a clinical diagnosis of frozen shoulder, and who have radiographs that exclude other pathology. Early Structured Physiotherapy with an intra-articular steroid injection will be compared with manipulation under anaesthesia with a steroid injection or arthroscopic (keyhole) capsular release followed by manipulation. Both surgical interventions will be followed with a programme of post-procedural physiotherapy. These treatments will be undertaken in NHS hospitals across the United Kingdom. The primary outcome and endpoint will be the Oxford Shoulder Score (a patient self-reported assessment of shoulder function) at 12 months. This will also be measured at baseline, 3 and 6 months after randomisation; and on the day that treatment starts and 6 months later. Secondary outcomes include the Disabilities of Arm Shoulder and Hand (QuickDASH) score, the EQ-5D-5 L score, pain, extent of recovery and complications. We will explore the acceptability of the different treatments to patients and health care professionals using qualitative methods. DISCUSSION: The three treatments being compared are the most frequently used in secondary care in the NHS, but there is uncertainty about which one works best and at what cost. UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common condition in adults. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508 . Registered on 25 July 2014.

Platelet rich Plasma in Achilles Tendon Healing 2 (PATH-2) trial: protocol for a multicentre, participant and assessor-blinded, parallel-group randomised clinical trial comparing platelet-rich plasma (PRP) injection versus placebo injection for Achilles tendon rupture.

BACKGROUND: Achilles tendon injuries give rise to substantial long-lasting morbidity and pose considerable challenges for clinicians and patients during the lengthy healing period. Current treatment strategies struggle to curb the burden of this injury on health systems and society due to lengthy rehabilitation, work absence and reinjury risk. Platelet-rich plasma (PRP) is an autologous preparation that has been shown to improve the mechanobiological properties of tendons in laboratory and animal studies. The use of PRP in musculoskeletal injuries is on the increase despite the lack of adequately powered clinical studies. METHODS AND DESIGN: This is a multicentre randomised controlled trial to evaluate the efficacy and mechanism of PRP in patients with acute Achilles tendon rupture (ATR). All adults with acute ATR presenting within 12 days of the injury who are to be treated non-operatively are eligible. A total of 230 consenting patients will be randomly allocated via a remote web-based service to receive PRP injection or placebo injection to the site of the injury. All participants will be blinded to the intervention and will receive standardised rehabilitation to reduce efficacy interference.Participants will be followed up with blinded assessments of muscle-tendon function, quality of life, pain and overall patient's functional goals at 4, 7, 13, 24 weeks and 24 months post-treatment. The primary outcome is the heel-rise endurance test (HRET), which will be supervised by a blinded assessor at 24 weeks. A subgroup of 16 participants in one centre will have needle biopsy under ultrasound guidance at 6 weeks. Blood and PRP will be analysed for cell count, platelet activation and growth factor concentrations. ETHICS AND DISSEMINATION: The protocol has been approved by the Oxfordshire Research Ethics Committee (Oxfordshire Research Ethics Committee A, reference no 14/SC/1333). The trial will be reported in accordance with the CONSORT statement and published in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: ISRCTN: 54992179, assigned 12 January 2015. ClinicalTrials.gov: NCT02302664, received 18 November 2014. UK Clinical Research Network Study Portfolio Database: ID 17850.

Mapping the Association between Vitamin D and Low Back Pain: A Systematic Review and Meta-Analysis of Observational Studies.

BACKGROUND: Low back pain (LBP) is the highest contributor to disability worldwide, with current intervention strategies only providing small to moderate analgesic effects. The use of vitamin D supplementation for LBP has gained interest due to its proposed anti-inflammatory and neuromodulatory properties. However, it is still unclear whether vitamin D levels differ between those with and without LBP or if vitamin D levels are associated with pain intensity. OBJECTIVES: We aim to investigate the association between vitamin D levels and LBP and to determine if vitamin D levels correlate with pain intensity in individuals with LBP. STUDY DESIGN: This study was conducted in accordance with the guidelines for performing a Meta-analysis and Systematic Review Of Observational Studies in Epidemiology (MOOSE). METHODS: We performed electronic database searches combined keywords relating to vitamin D and LBP in MEDLINE, CINAHL, EMBASE, AMED, WEB OF SCIENCE, and SCOPUS from the earliest record to March 2017. Studies were included if they reported any quantitative measure of vitamin D, such as serum 25-hydroxyvitamin D [25(OH)D], with adequate data in patients with and without LBP or adequate data on pain intensity in patients with LBP. No restriction on the type or duration of LBP, nor the age and gender of patients was applied. Two reviewers independently performed the selection of studies, extracted data, and assessed the methodological quality of the included studies using a modified 15-item Downs and Black checklist. RESULTS: After the removal of duplicates and the screening of titles and abstracts, 105 full texts were evaluated. There were 29 articles included in this systemic review (22 entered into a meta-analysis), including 19 cross-sectional studies, 9 case-control studies, and one single-arm surgical trial where the pre-operative data were used in our analyses. The pooled results from 19 studies showed that individuals with LBP were more likely to have vitamin D deficiency (pooled OR = 1.60, 95% CI: 1.20 - 2.12, P = 0.001, n = 19), severe deficiency (pooled OR = 2.08, 95% CI: 1.19 - 3.64, P = 0.010, n = 7), and lower serum concentrations of 25(OH)D (weighted MD = 3.86, 95% CI: 0.20 - 7.52, P = 0.039, n = 12) compared to those without LBP (where "n" is the number of studies). The association between vitamin D deficiency (pooled OR = 1.83, 95% CI: 1.26 - 2.66, P = 0.002, n = 9) or serum 25(OH)D (weighted MD = 7.64, 95% CI: 4.02 - 11.26, P < 0.001, n = 4) and LBP was stronger for women but failed to be statistically significant for men (pooled OR = 1.06, 95% CI: 0.62 - 1.81, P = 0.213, n = 3). In addition, there were strong associations between vitamin D deficiency and LBP in patients < 60 years old (particularly women). We found minimal evidence to support an association between vitamin D levels and pain intensity in patients with LBP. LIMITATIONS: We were unable to investigate whether vitamin D deficiency increases the risk of developing LBP as there were no longitudinal studies included in this review. CONCLUSION: Vitamin D deficiency is associated with LBP, with stronger associations observed in younger women and those with severe levels of deficiency. The association between vitamin D levels and pain intensity is inconsistent. These results may guide the implementation of future studies on vitamin D supplementation for LBP. PROSPERO Registration No: CRD42016046874. KEY WORDS: Vitamin D, low back pain, deficiency, pain intensity, serum 25-hydroxyvitamin D, supplementation, cross-sectional study, case-control study.

Exercise for depression in elderly residents of care homes: a cluster-randomised controlled trial.

BACKGROUND: Depression is common and is associated with poor outcomes among elderly care-home residents. Exercise is a promising low-risk intervention for depression in this population. We tested the hypothesis that a moderate intensity exercise programme would reduce the burden of depressive symptoms in residents of care homes. METHODS: We did a cluster-randomised controlled trial in care homes in two regions in England; northeast London, and Coventry and Warwickshire. Residents aged 65 years or older were eligible for inclusion. A statistician independent of the study randomised each home (1 to 1·5 ratio, stratified by location, minimised by type of home provider [local authority, voluntary, private and care home, private and nursing home] and size of home [<32 or ≥32 residents]) into intervention and control groups. The intervention package included depression awareness training for care-home staff, 45 min physiotherapist-led group exercise sessions for residents (delivered twice weekly), and a whole home component designed to encourage more physical activity in daily life. The control consisted of only the depression awareness training. Researchers collecting follow-up data from individual participants and the participants themselves were inevitably aware of home randomisation because of the physiotherapists' activities within the home. A researcher masked to study allocation coded NHS routine data. The primary outcome was number of depressive symptoms on the geriatric depression scale-15 (GDS-15). Follow-up was for 12 months. This trial is registered with ISRCTN Register, number ISRCTN43769277. FINDINGS: Care homes were randomised between Dec 15, 2008, and April 9, 2010. At randomisation, 891 individuals in 78 care homes (35 intervention, 43 control) had provided baseline data. We delivered 3191 group exercise sessions attended on average by five study participants and five non-study residents. Of residents with a GDS-15 score, 374 of 765 (49%) were depressed at baseline; 484 of 765 (63%) provided 12 month follow-up scores. Overall the GDS-15 score was 0·13 (95% CI -0·33 to 0·60) points higher (worse) at 12 months for the intervention group compared with the control group. Among residents depressed at baseline, GDS-15 score was 0·22 (95% CI -0·52 to 0·95) points higher at 6 months in the intervention group than in the control group. In an end of study cross-sectional analysis, including 132 additional residents joining after randomisation, the odds of being depressed were 0·76 (95% CI 0·53 to 1·09) for the intervention group compared with the control group. INTERPRETATION: This moderately intense exercise programme did not reduce depressive symptoms in residents of care homes. In this frail population, alternative strategies to manage psychological symptoms are required. FUNDING: National Institute for Health Research Health Technology Assessment.

Interventions for preventing falls in older people living in the community.

BACKGROUND: Approximately 30% of people over 65 years of age living in the community fall each year. This is an update of a Cochrane review first published in 2009. OBJECTIVES: To assess the effects of interventions designed to reduce the incidence of falls in older people living in the community. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (February 2012), CENTRAL (The Cochrane Library 2012, Issue 3), MEDLINE (1946 to March 2012), EMBASE (1947 to March 2012), CINAHL (1982 to February 2012), and online trial registers. SELECTION CRITERIA: Randomised trials of interventions to reduce falls in community-dwelling older people. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias and extracted data. We used a rate ratio (RaR) and 95% confidence interval (CI) to compare the rate of falls (e.g. falls per person year) between intervention and control groups. For risk of falling, we used a risk ratio (RR) and 95% CI based on the number of people falling (fallers) in each group. We pooled data where appropriate. MAIN RESULTS: We included 159 trials with 79,193 participants. Most trials compared a fall prevention intervention with no intervention or an intervention not expected to reduce falls. The most common interventions tested were exercise as a single intervention (59 trials) and multifactorial programmes (40 trials). Sixty-two per cent (99/159) of trials were at low risk of bias for sequence generation, 60% for attrition bias for falls (66/110), 73% for attrition bias for fallers (96/131), and only 38% (60/159) for allocation concealment.Multiple-component group exercise significantly reduced rate of falls (RaR 0.71, 95% CI 0.63 to 0.82; 16 trials; 3622 participants) and risk of falling (RR 0.85, 95% CI 0.76 to 0.96; 22 trials; 5333 participants), as did multiple-component home-based exercise (RaR 0.68, 95% CI 0.58 to 0.80; seven trials; 951 participants and RR 0.78, 95% CI 0.64 to 0.94; six trials; 714 participants). For Tai Chi, the reduction in rate of falls bordered on statistical significance (RaR 0.72, 95% CI 0.52 to 1.00; five trials; 1563 participants) but Tai Chi did significantly reduce risk of falling (RR 0.71, 95% CI 0.57 to 0.87; six trials; 1625 participants).Multifactorial interventions, which include individual risk assessment, reduced rate of falls (RaR 0.76, 95% CI 0.67 to 0.86; 19 trials; 9503 participants), but not risk of falling (RR 0.93, 95% CI 0.86 to 1.02; 34 trials; 13,617 participants).Overall, vitamin D did not reduce rate of falls (RaR 1.00, 95% CI 0.90 to 1.11; seven trials; 9324 participants) or risk of falling (RR 0.96, 95% CI 0.89 to 1.03; 13 trials; 26,747 participants), but may do so in people with lower vitamin D levels before treatment.Home safety assessment and modification interventions were effective in reducing rate of falls (RR 0.81, 95% CI 0.68 to 0.97; six trials; 4208 participants) and risk of falling (RR 0.88, 95% CI 0.80 to 0.96; seven trials; 4051 participants). These interventions were more effective in people at higher risk of falling, including those with severe visual impairment. Home safety interventions appear to be more effective when delivered by an occupational therapist.An intervention to treat vision problems (616 participants) resulted in a significant increase in the rate of falls (RaR 1.57, 95% CI 1.19 to 2.06) and risk of falling (RR 1.54, 95% CI 1.24 to 1.91). When regular wearers of multifocal glasses (597 participants) were given single lens glasses, all falls and outside falls were significantly reduced in the subgroup that regularly took part in outside activities. Conversely, there was a significant increase in outside falls in intervention group participants who took part in little outside activity.Pacemakers reduced rate of falls in people with carotid sinus hypersensitivity (RaR 0.73, 95% CI 0.57 to 0.93; three trials; 349 participants) but not risk of falling. First eye cataract surgery in women reduced rate of falls (RaR 0.66, 95% CI 0.45 to 0.95; one trial; 306 participants), but second eye cataract surgery did not.Gradual withdrawal of psychotropic medication reduced rate of falls (RaR 0.34, 95% CI 0.16 to 0.73; one trial; 93 participants), but not risk of falling. A prescribing modification programme for primary care physicians significantly reduced risk of falling (RR 0.61, 95% CI 0.41 to 0.91; one trial; 659 participants).An anti-slip shoe device reduced rate of falls in icy conditions (RaR 0.42, 95% CI 0.22 to 0.78; one trial; 109 participants). One trial (305 participants) comparing multifaceted podiatry including foot and ankle exercises with standard podiatry in people with disabling foot pain significantly reduced the rate of falls (RaR 0.64, 95% CI 0.45 to 0.91) but not the risk of falling.There is no evidence of effect for cognitive behavioural interventions on rate of falls (RaR 1.00, 95% CI 0.37 to 2.72; one trial; 120 participants) or risk of falling (RR 1.11, 95% CI 0.80 to 1.54; two trials; 350 participants).Trials testing interventions to increase knowledge/educate about fall prevention alone did not significantly reduce the rate of falls (RaR 0.33, 95% CI 0.09 to 1.20; one trial; 45 participants) or risk of falling (RR 0.88, 95% CI 0.75 to 1.03; four trials; 2555 participants).No conclusions can be drawn from the 47 trials reporting fall-related fractures.Thirteen trials provided a comprehensive economic evaluation. Three of these indicated cost savings for their interventions during the trial period: home-based exercise in over 80-year-olds, home safety assessment and modification in those with a previous fall, and one multifactorial programme targeting eight specific risk factors. AUTHORS' CONCLUSIONS: Group and home-based exercise programmes, and home safety interventions reduce rate of falls and risk of falling.Multifactorial assessment and intervention programmes reduce rate of falls but not risk of falling; Tai Chi reduces risk of falling.Overall, vitamin D supplementation does not appear to reduce falls but may be effective in people who have lower vitamin D levels before treatment.

Development and delivery of a physiotherapy intervention for the early management of whiplash injuries: the Managing Injuries of Neck Trial (MINT) Intervention.

This paper describes the development and implementation of a physiotherapy intervention for a large multicentred randomised controlled trial of the early management of whiplash injuries in a National Health Service setting. Participants were eligible if they were classified as having whiplash-associated disorder grades I to III and self-referred for treatment within 6 weeks of injury. The intervention development was informed through a variety of methods including the current evidence base, published guidelines, clinician opinion, a pilot study and expert opinion. The intervention was targeted at known, potentially modifiable risk factors for poor recovery, and utilised manual therapy, exercises and psychological strategies. The treatment was individually tailored, with a maximum of six treatments allowed within the trial protocol over an 8-week period. The intervention was delivered to 300 participants. The amount and types of treatments delivered are described.

WITHDRAWN: Interventions for preventing falls in elderly people.

BACKGROUND: Approximately 30 per cent of people over 65 years of age and living in the community fall each year; the number is higher in institutions. Although less than one fall in 10 results in a fracture, a fifth of fall incidents require medical attention. OBJECTIVES: To assess the effects of interventions designed to reduce the incidence of falls in elderly people (living in the community, or in institutional or hospital care). SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (January 2003), Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2003), MEDLINE (1966 to February 2003), EMBASE (1988 to 2003 Week 19), CINAHL (1982 to April 2003), The National Research Register, Issue 2, 2003, Current Controlled Trials (www.controlled-trials.com accessed 11 July 2003) and reference lists of articles. No language restrictions were applied. Further trials were identified by contact with researchers in the field. SELECTION CRITERIA: Randomised trials of interventions designed to minimise the effect of, or exposure to, risk factors for falling in elderly people. Main outcomes of interest were the number of fallers, or falls. Trials reporting only intermediate outcomes were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Data were pooled using the fixed effect model where appropriate. MAIN RESULTS: Sixty two trials involving 21,668 people were included.Interventions likely to be beneficial:Multidisciplinary, multifactorial, health/environmental risk factor screening/intervention programmes in the community both for an unselected population of older people (4 trials, 1651 participants, pooled RR 0.73, 95%CI 0.63 to 0.85), and for older people with a history of falling or selected because of known risk factors (5 trials, 1176 participants, pooled RR 0.86, 95%CI 0.76 to 0.98), and in residential care facilities (1 trial, 439 participants, cluster-adjusted incidence rate ratio 0.60, 95%CI 0.50 to 0.73) A programme of muscle strengthening and balance retraining, individually prescribed at home by a trained health professional (3 trials, 566 participants, pooled relative risk (RR) 0.80, 95% confidence interval (95%CI) 0.66 to 0.98) Home hazard assessment and modification that is professionally prescribed for older people with a history of falling (3 trials, 374 participants, RR 0.66, 95% CI 0.54 to 0.81) Withdrawal of psychotropic medication (1 trial, 93 participants, relative hazard 0.34, 95%CI 0.16 to 0.74) Cardiac pacing for fallers with cardioinhibitory carotid sinus hypersensitivity (1 trial, 175 participants, WMD -5.20, 95%CI -9.40 to -1.00) A 15 week Tai Chi group exercise intervention (1 trial, 200 participants, risk ratio 0.51, 95%CI 0.36 to 0.73). Interventions of unknown effectiveness:Group-delivered exercise interventions (9 trials, 1387 participants) Individual lower limb strength training (1 trial, 222 participants) Nutritional supplementation (1 trial, 46 participants) Vitamin D supplementation, with or without calcium (3 trials, 461 participants) Home hazard modification in association with advice on optimising medication (1 trial, 658 participants), or in association with an education package on exercise and reducing fall risk (1 trial, 3182 participants) Pharmacological therapy (raubasine-dihydroergocristine, 1 trial, 95 participants) Interventions using a cognitive/behavioural approach alone (2 trials, 145 participants) Home hazard modification for older people without a history of falling (1 trial, 530 participants) Hormone replacement therapy (1 trial, 116 participants) Correction of visual deficiency (1 trial, 276 participants).Interventions unlikely to be beneficial:Brisk walking in women with an upper limb fracture in the previous two years (1 trial, 165 participants). AUTHORS' CONCLUSIONS: Interventions to prevent falls that are likely to be effective are now available; less is known about their effectiveness in preventing fall-related injuries. Costs per fall prevented have been established for four of the interventions and careful economic modelling in the context of the local healthcare system is important. Some potential interventions are of unknown effectiveness and further research is indicated.

Interventions for preventing falls in older people living in the community.

BACKGROUND: Approximately 30% of people over 65 years of age living in the community fall each year. OBJECTIVES: To assess the effects of interventions to reduce the incidence of falls in older people living in the community. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL (The Cochrane Library 2008, Issue 2), MEDLINE, EMBASE, CINAHL, and Current Controlled Trials (all to May 2008). SELECTION CRITERIA: Randomised trials of interventions to reduce falls in community-dwelling older people. Primary outcomes were rate of falls and risk of falling. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. Data were pooled where appropriate. MAIN RESULTS: We included 111 trials (55,303 participants).Multiple-component group exercise reduced rate of falls and risk of falling (rate ratio (RaR) 0.78, 95%CI 0.71 to 0.86; risk ratio (RR) 0.83, 95%CI 0.72 to 0.97), as did Tai Chi (RaR 0.63, 95%CI 0.52 to 0.78; RR 0.65, 95%CI 0.51 to 0.82), and individually prescribed multiple-component home-based exercise (RaR 0.66, 95%CI 0.53 to 0.82; RR 0.77, 95%CI 0.61 to 0.97).Assessment and multifactorial intervention reduced rate of falls (RaR 0.75, 95%CI 0.65 to 0.86), but not risk of falling.Overall, vitamin D did not reduce falls (RaR 0.95, 95%CI 0.80 to 1.14; RR 0.96, 95%CI 0.92 to 1.01), but may do so in people with lower vitamin D levels. Overall, home safety interventions did not reduce falls (RaR 0.90, 95%CI 0.79 to 1.03); RR 0.89, 95%CI 0.80 to 1.00), but were effective in people with severe visual impairment, and in others at higher risk of falling. An anti-slip shoe device reduced rate of falls in icy conditions (RaR 0.42, 95%CI 0.22 to 0.78).Gradual withdrawal of psychotropic medication reduced rate of falls (RaR 0.34, 95%CI 0.16 to 0.73), but not risk of falling. A prescribing modification programme for primary care physicians significantly reduced risk of falling (RR 0.61, 95%CI 0.41 to 0.91).Pacemakers reduced rate of falls in people with carotid sinus hypersensitivity (RaR 0.42, 95%CI 0.23 to 0.75). First eye cataract surgery reduced rate of falls (RaR 0.66, 95%CI 0.45 to 0.95).There is some evidence that falls prevention strategies can be cost saving. AUTHORS' CONCLUSIONS: Exercise interventions reduce risk and rate of falls. Research is needed to confirm the contexts in which multifactorial assessment and intervention, home safety interventions, vitamin D supplementation, and other interventions are effective.

EuroQol EQ-5D and condition-specific measures of health outcome in women with urinary incontinence: reliability, validity and responsiveness.

OBJECTIVES: To evaluate the measurement properties of the EuroQoL EQ-5D and two condition-specific patient-reported outcome measures--the Symptom Severity Index (SSI) and the Urinary Incontinence-Specific Quality of Life instrument (I-QoL)--in women with urinary incontinence. METHODS: A questionnaire comprising all instruments was completed by women taking part in a clinical trial of physiotherapy for urinary incontinence. Follow-up questionnaires were at 6 weeks and 5 months. Data quality, internal consistency reliability, validity and responsiveness were assessed. RESULTS: One hundred and seventy-four patients taking part in the clinical trial completed the questionnaire. Instruments had low levels of missing data. The EQ-5D had a large ceiling effect and poor responsiveness. The SSI had poor validity and responsiveness. The I-QoL had levels of reliability that supported application in group assessment, and in some cases, individual assessment, and good evidence of validity. The I-QoL was the most responsive instrument at both 6 weeks and 5 months. CONCLUSION: The I-QoL was the best performing instrument and is recommended as a continence-specific measure of quality of life in a clinical trial setting. The SSI and EQ-5D are not recommended. Alternative generic instruments, which support economic evaluation, require further evaluation in trials of female urinary incontinence.

Neuromuscular stimulation of the quadriceps muscle after hip fracture: a randomized controlled trial.

OBJECTIVE: To study the feasibility and effect of neuromuscular stimulation on recovery of mobility after surgical fixation for hip fracture. DESIGN: Double-blind study with stratified randomization. SETTING: Home-based rehabilitation program. PARTICIPANTS: Twenty-four women over the age of 75 years with hip fracture. INTERVENTIONS: Neuromuscular or placebo stimulation of the quadriceps muscle of the fractured leg, applied for 3 hours a day, for 6 weeks, commencing 1 week after surgery. MAIN OUTCOME MEASURES: Recovery of walking speed and ability, postural stability, lower-limb muscle power, and pain at 7 and 13 weeks after surgery. RESULTS: Women in the neuromuscular stimulation group showed faster recovery of mobility. Of the women receiving stimulation, 9 of 12 recovered their prior levels of indoor mobility ability by 13 weeks compared with 3 of 12 in the placebo group (Fisher exact test, P=.046). There were no differences in recovery of walking speed in the first 7 weeks, but women in the stimulation group had greater recovery between 7 and 13 weeks (mean difference=-.13m/s; 95% confidence interval, -.23 to -.01). CONCLUSIONS: Neuromuscular stimulation at home is feasible and may be effective in speeding recovery of mobility after surgical fixation of hip fracture.