Yoga for older adults with multimorbidity (the Gentle Years Yoga Trial): study protocol for a randomised controlled trial.

BACKGROUND: Multimorbidity is common in older adults and associated with high levels of illness burden and healthcare expenditure. The evidence base for how to manage older adults with multimorbidity is weak. Yoga might be a useful intervention because it has the potential to improve health-related quality of life, physical functioning, and several medical conditions. The British Wheel of Yoga's Gentle Years Yoga© (GYY) programme was developed specifically for older adults, including those with chronic medical conditions. Data from a pilot trial suggested feasibility of using GYY in this population, but its effectiveness and cost-effectiveness remain uncertain. METHODS: This is a multi-site, individually randomised, superiority trial with an embedded process evaluation and an economic analysis of cost-effectiveness. The trial will compare an experimental strategy of offering a 12-week GYY programme against a control strategy of no offer in community-dwelling adults aged 65 or over who have multimorbidity, defined as having two or more chronic conditions from a predefined list. The primary outcome is health-related quality of life measured using the EQ-5D-5L, the primary endpoint being the overall difference over 12 months. Both groups will continue to be able to access their usual care from primary, secondary, community, and social services. Participants, care providers, and yoga teachers will not be blinded to the allocated intervention. Outcome measures are primarily self-reported. The analysis will follow intention-to-treat principles. DISCUSSION: This pragmatic randomised controlled trial will demonstrate if the GYY programme is an effective, cost-effective, and viable addition to the management of older adults with multimorbidity. TRIAL REGISTRATION: ISRCTN ISRCTN13567538 . Registered on 18 March 2019.

A 2x2 randomised factorial SWAT of the use of a pen and small, financial incentive to improve recruitment in a randomised controlled trial of yoga for older adults with multimorbidity.

Background: Monetary and other incentives may increase recruitment to randomised controlled trials. Methods: This was a 2x2 factorial 'study within a trial' of including a pen and/or £5 with a postal recruitment pack to improve randomisation rate (primary outcome) into the host Gentle Years Yoga trial in older adults with multimorbidity. Secondary outcomes: return, and time to return, of screening form, and the cost per additional participant recruited. Binary data were analysed using logistic regression and time to return data using Cox proportional hazards regression.  Results: 818 potential host trial participants included. Between those sent a pen (n=409) and not sent a pen (n=409), there was no evidence of a difference in the likelihood of being randomised (15 (3.7%) versus 11 (2.7%); OR 1.38, 95% CI 0.63-3.04), in returning a screening form (66 (16.1%) versus 61 (14.9%); OR 1.10, 95% CI 0.75-1.61) nor in time to return the screening form (HR 1.09, 95% CI 0.77-1.55). There was evidence of improved screening return rates (77 (18.8%) versus 50 (12.2%); OR 1.67, 95% CI 1.13-2.45) and time to return screening form (HR 1.56, 95% CI 1.09-2.22) but not randomisation (14 (3.4%) versus 12 (2.9%); OR 1.18, 95% CI 0.54-2.57) in those sent £5 (n=409) compared with those not sent £5 (n=409). No significant interaction effects between the interventions were observed. The cost per additional participant recruited was £32 for the pen and £1000 for the £5 incentive. Conclusion: Including a small, monetary incentive encouraged increased and faster response to the recruitment invitation but did not result in more participants being randomised into the host trial. Since it is relatively costly, we do not recommend this intervention for use to increase recruitment in this population. Pens are cheaper but did not provide evidence of benefit. Further studies may be required.

Optimising retention success: a research team's experience of following-up participants recruited to a pilot trial through community pharmacies in England.

Background: Community pharmacies support a range of patients and medical conditions, and form an important part of comprehensive, holistic healthcare services. The role of a community pharmacist has changed significantly over recent years, developing to include research activities. The CHAMP-1 ( Community pharmacy: Highlighting Alcohol use in Medication a Ppointments) pilot trial aimed to explore an intervention discussing alcohol during medication consultations. It presented various challenges regarding patient retention, and various actions were taken to address these, which are discussed in this manuscript. Methods: Community pharmacists recruited patients aged 18 and over, attending a Medicine Use Review (MUR) or New Medicine Service (NMS) consultation, and drinking alcohol at least twice per week. Pharmacies were randomised to conduct their consultations as usual (control), or to incorporate the Medicines and Alcohol Consultation (MAC) intervention. All participants were followed-up by a researcher after two months to complete data collection via telephone or post. Results: Forty-seven of 51 participants (92%) completed the two month follow-up. Thirty-eight (81%) responses were provided by telephone and nine (19%) by post. Of the 38 follow-up calls completed by telephone, 17 (45%) participants were reached at first attempt; 16 (42%) at second attempt; and five (13%) at the third attempt. Conclusions: The results suggest that patients recruited to a trial by community pharmacists are willing to take part in data collection activities, and follow-up can be successfully conducted by researchers. The techniques employed to encourage high levels of retention should be investigated further in a larger study.

Pharmacological and non-pharmacological interventions for non-respiratory sleep disturbance in children with neurodisabilities: a systematic review.

BACKGROUND: There is uncertainty about the most appropriate ways to manage non-respiratory sleep disturbances in children with neurodisabilities (NDs). OBJECTIVE: To assess the clinical effectiveness and safety of NHS-relevant pharmacological and non-pharmacological interventions to manage sleep disturbance in children and young people with NDs, who have non-respiratory sleep disturbance. DATA SOURCES: Sixteen databases, including The Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE, were searched up to February 2017, and grey literature searches and hand-searches were conducted. REVIEW METHODS: For pharmacological interventions, only randomised controlled trials (RCTs) were included. For non-pharmacological interventions, RCTs, non-randomised controlled studies and before-and-after studies were included. Data were extracted and quality assessed by two researchers. Meta-analysis and narrative synthesis were undertaken. Data on parents' and children's experiences of receiving a sleep disturbance intervention were collated into themes and reported narratively. RESULTS: Thirty-nine studies were included. Sample sizes ranged from 5 to 244 participants. Thirteen RCTs evaluated oral melatonin. Twenty-six studies (12 RCTs and 14 before-and-after studies) evaluated non-pharmacological interventions, including comprehensive parent-directed tailored (n = 9) and non-tailored (n = 8) interventions, non-comprehensive parent-directed interventions (n = 2) and other non-pharmacological interventions (n = 7). All but one study were reported as having a high or unclear risk of bias, and studies were generally poorly reported. There was a statistically significant increase in diary-reported total sleep time (TST), which was the most commonly reported outcome for melatonin compared with placebo [pooled mean difference 29.6 minutes, 95% confidence interval (CI) 6.9 to 52.4 minutes; p = 0.01]; however, statistical heterogeneity was extremely high (97%). For the single melatonin study that was rated as having a low risk of bias, the mean increase in TST was 13.2 minutes and the lower CI included the possibility of reduced sleep time (95% CI -13.3 to 39.7 minutes). There was mixed evidence about the clinical effectiveness of the non-pharmacological interventions. Sixteen studies included interventions that investigated the feasibility, acceptability and/or parent or clinician views of sleep disturbance interventions. The majority of these studies reported the 'family experience' of non-pharmacological interventions. LIMITATIONS: Planned subgroup analysis was possible in only a small number of melatonin trials. CONCLUSIONS: There is some evidence of benefit for melatonin compared with placebo, but the degree of benefit is uncertain. There are various types of non-pharmacological interventions for managing sleep disturbance; however, clinical and methodological heterogeneity, few RCTs, a lack of standardised outcome measures and risk of bias means that it is not possible to draw conclusions with regard to their effectiveness. Future work should include the development of a core outcome, further evaluation of the clinical effectiveness and cost-effectiveness of pharmacological and non-pharmacological interventions and research exploring the prevention of, and methods for identifying, sleep disturbance. Research mapping current practices and exploring families' understanding of sleep disturbance and their experiences of obtaining help may facilitate service provision development. STUDY REGISTRATION: This study is registered as PROSPERO CRD42016034067. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Self-efficacy and self-care-related outcomes following Alexander Technique lessons for people with chronic neck pain in the ATLAS randomised, controlled trial.

INTRODUCTION: ATLAS was a pragmatic randomised (1:1:1 ratio), controlled trial recruiting patients with chronic neck pain (N = 517) and evaluating one-to-one Alexander Technique lessons, or acupuncture, each plus usual care, compared with usual care alone. The primary outcome (12-month Northwick Park Neck Pain Questionnaire [NPQ]) demonstrated significant and clinically meaningful reductions in neck pain and associated disability for both interventions compared with usual care alone. Here we describe pre-specified, self-efficacy and other self-care-related outcomes for the Alexander group compared with usual care. METHODS: Participants reported on 11 self-efficacy/self-care-related outcome measures at 6 and 12 months. Linear or logistic regression models evaluated changes in parameters and impact on NPQ. Alexander teachers reported on lesson content. RESULTS: Lesson content reflected standard UK practice. The Alexander group (n = 172) reported significantly greater improvements, compared with usual care alone (n = 172), in most of the self-efficacy/self-care measures (9/11 measures at 6 months, and 8/11 at 12 months), including the ability to reduce pain in daily life. At 6 months, 81% (106/131) of Alexander participants reported significant improvement in the way they lived and cared for themselves (versus 23% for usual care), increasing to 87% (117/135) at 12 months (usual care: 25%). NPQ scores at both 6 and 12 months were related to improvement in self-efficacy and ability to reduce pain during daily life. CONCLUSIONS: Alexander Technique lessons led to long-term improvements in the way participants lived their daily lives and managed their neck pain. Alexander lessons promote self-efficacy and self-care, with consequent reductions in chronic neck pain.

An economic evaluation of Alexander Technique lessons or acupuncture sessions for patients with chronic neck pain: A randomized trial (ATLAS).

OBJECTIVES: To assess the cost-effectiveness of acupuncture and usual care, and Alexander Technique lessons and usual care, compared with usual GP care alone for chronic neck pain patients. METHODS: An economic evaluation was undertaken alongside the ATLAS trial, taking both NHS and wider societal viewpoints. Participants were offered up to twelve acupuncture sessions or twenty Alexander lessons (equivalent overall contact time). Costs were in pounds sterling. Effectiveness was measured using the generic EQ-5D to calculate quality adjusted life years (QALYs), as well as using a specific neck pain measure-the Northwick Park Neck Pain Questionnaire (NPQ). RESULTS: In the base case analysis, incremental QALY gains were 0.032 and 0.025 in the acupuncture and Alexander groups, respectively, in comparison to usual GP care, indicating moderate health benefits for both interventions. Incremental costs were £451 for acupuncture and £667 for Alexander, mainly driven by intervention costs. Acupuncture was likely to be cost-effective (ICER = £18,767/QALY bootstrapped 95% CI £4,426 to £74,562) and was robust to most sensitivity analyses. Alexander lessons were not cost-effective at the lower NICE threshold of £20,000/QALY (£25,101/QALY bootstrapped 95% CI -£150,208 to £248,697) but may be at £30,000/QALY, however, there was considerable statistical uncertainty in all tested scenarios. CONCLUSIONS: In comparison with usual care, acupuncture is likely to be cost-effective for chronic neck pain, whereas, largely due to higher intervention costs, Alexander lessons are unlikely to be cost-effective. However, there were high levels of missing data and further research is needed to assess the long-term cost-effectiveness of these interventions.

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.

Lifestyle Advice and Self-Care Integral to Acupuncture Treatment for Patients with Chronic Neck Pain: Secondary Analysis of Outcomes Within a Randomized Controlled Trial.

BACKGROUND: Lifestyle advice is widely considered as an integral component of acupuncture treatment. However, it is unclear whether lifestyle advice and related self-care are important for sustaining benefit over the longer term. In a novel secondary analysis of trial data, this paper explores the nature and impact of acupuncture-related diagnosis, and associated lifestyle advice and self-care, in patients with chronic neck pain. DESIGN: In a three-arm, randomized, controlled multicenter trial with 12 months of follow-up, a total of 517 patients with chronic neck pain were randomized in equal proportions to acupuncture, Alexander technique, or usual care alone. METHODS: For each acupuncture patient, practitioners reported treatment components that included an acupuncture-related diagnosis and provision of associated lifestyle advice. Patients reported at baseline, 3, 6, and 12 months on variables related to treatment, which included aspects of self-care, self-efficacy, and lifestyle advice acted upon, as well as pain and disability scores. Congruence between practitioner advice and patient take-up was assessed using chi-squared test. Impact of lifestyle advice and self-efficacy on outcome was evaluated using regression models. RESULTS: Among patients randomized to acupuncture, the most common diagnostic framework involved the Zang-Fu syndromes for 139/160 (87%) patients. Lifestyle advice was provided by practitioners to 134/160 (84%) of patients, most commonly related to exercise, relaxation, diet, rest, and work. Significant congruence with patient take-up was found for diet, rest, and work. Moreover, patients in the acupuncture group improved their ability to use what they had learnt and increased their self-efficacy. In turn, these characteristics were associated with significant reductions in pain and disability scores at 12 months. CONCLUSION: Acupuncture-related lifestyle advice helped patients improve the way they live and care for themselves and enhanced self-efficacy and ability to use what they had learnt. These changes were associated with reductions in pain and disability at 12 months.

Acupuncture for irritable bowel syndrome: 2-year follow-up of a randomised controlled trial.

BACKGROUND: A recent randomised controlled trial (RCT) of acupuncture as a treatment for irritable bowel syndrome (IBS) demonstrated sustained benefits over a period of 12 months post-randomisation. AIM: To extend the trial follow-up to evaluate the effects of acupuncture at 24 months post-randomisation. METHODS: Patients in primary care with ongoing IBS were recruited to a two-arm pragmatic RCT of acupuncture for IBS. Participants were randomised to the offer of up to 10 weekly sessions of acupuncture plus usual care (n=116 patients) or to continue with usual care alone (n=117). The primary outcome was the self-reported IBS symptom severity score (IBS SSS) measured at 24 months post-randomisation. Analysis was by intention-to-treat using an unstructured multivariate linear model incorporating all repeated measures. RESULTS: The overall response rate was 61%. The adjusted difference in mean IBS SSS at 24 months was -18.28 (95% CI -40.95 to 4.40) in favour of the acupuncture arm. Differences at earlier time points estimated from the multivariate model were: -27.27 (-47.69 to -6.86) at 3 months; -23.69 (-45.17 to -2.21) at 6 months; -24.09 (-45.59 to -2.59) at 9 months; and -23.06 (-44.52 to -1.59) at 12 months. CONCLUSIONS: There were no statistically significant differences between the acupuncture and usual care groups in IBS SSS at 24 months post-randomisation, and the point estimate for the mean difference was approximately 80% of the size of the statistically significant results seen at 6, 9 and 12 months. TRIAL REGISTRATION NUMBER: ISRCTN08827905.

Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) protocol: a pragmatic multi-centre randomised controlled trial of cast treatment versus surgical fixation for the treatment of bi-cortical, minimally displaced fractures of the scaphoid waist in adults.

BACKGROUND: A scaphoid fracture is the most common type of carpal fracture affecting young active people. The optimal management of this fracture is uncertain. When treated with a cast, 88 to 90 % of these fractures unite; however, for the remaining 10-12 % the non-union almost invariably leads to arthritis. The alternative is surgery to fix the scaphoid with a screw at the outset. METHODS/DESIGN: We will conduct a randomised controlled trial (RCT) of 438 adult patients with a "clear" and "bicortical" scaphoid waist fracture on plain radiographs to evaluate the clinical effectiveness and cost-effectiveness of plaster cast treatment (with fixation of those that fail to unite) versus early surgical fixation. The plaster cast treatment will be immobilisation in a below elbow cast for 6 to 10 weeks followed by mobilisation. If non-union is confirmed on plain radiographs and/or Computerised Tomogram at 6 to 12 weeks, then urgent surgical fixation will be performed. This is being compared with immediate surgical fixation with surgeons using their preferred technique and implant. These treatments will be undertaken in trauma units across the United Kingdom. The primary outcome and end-point will be the Patient Rated Wrist Evaluation (a patient self-reported assessment of wrist pain and function) at 52 weeks and also measured at 6, 12, 26 weeks and 5 years. Secondary outcomes include an assessment of radiological union of the fracture; quality of life; recovery of wrist range and strength; and complications. We will also qualitatively investigate patient experiences of their treatment. DISCUSSION: Scaphoid fractures are an important public health problem as they predominantly affect young active individuals in the more productive working years of their lives. Non-union, if untreated, can lead to arthritis which can disable patients at a very young age. There is a rapidly increasing trend for immediate surgical fixation of these fractures but there is insufficient evidence from existing RCTs to support this. The SWIFFT Trial is a rigorously designed and adequately powered study which aims to contribute to the evidence-base to inform clinical decisions for the treatment of this common fracture in adults. TRIAL REGISTRATION: The trial is registered with the International Standard Randomised Controlled Trial Register ( ISRCTN67901257 ). Date registration assigned was 13/02/2013.

Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial.

BACKGROUND: Management of chronic neck pain may benefit from additional active self-care-oriented approaches. OBJECTIVE: To evaluate clinical effectiveness of Alexander Technique lessons or acupuncture versus usual care for persons with chronic, nonspecific neck pain. DESIGN: Three-group randomized, controlled trial. (Current Controlled Trials: ISRCTN15186354). SETTING: U.K. primary care. PARTICIPANTS: Persons with neck pain lasting at least 3 months, a score of at least 28% on the Northwick Park Questionnaire (NPQ) for neck pain and associated disability, and no serious underlying pathology. INTERVENTION: 12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone. MEASUREMENTS: NPQ score (primary outcome) at 0, 3, 6, and 12 months (primary end point) and Chronic Pain Self-Efficacy Scale score, quality of life, and adverse events (secondary outcomes). RESULTS: 517 patients were recruited, and the median duration of neck pain was 6 years. Mean attendance was 10 acupuncture sessions and 14 Alexander lessons. Between-group reductions in NPQ score at 12 months versus usual care were 3.92 percentage points for acupuncture (95% CI, 0.97 to 6.87 percentage points) (P = 0.009) and 3.79 percentage points for Alexander lessons (CI, 0.91 to 6.66 percentage points) (P = 0.010). The 12-month reductions in NPQ score from baseline were 32% for acupuncture and 31% for Alexander lessons. Participant self-efficacy improved for both interventions versus usual care at 6 months (P < 0.001) and was significantly associated (P < 0.001) with 12-month NPQ score reductions (acupuncture, 3.34 percentage points [CI, 2.31 to 4.38 percentage points]; Alexander lessons, 3.33 percentage points [CI, 2.22 to 4.44 percentage points]). No reported serious adverse events were considered probably or definitely related to either intervention. LIMITATION: Practitioners belonged to the 2 main U.K.-based professional associations, which may limit generalizability of the findings. CONCLUSION: Acupuncture sessions and Alexander Technique lessons both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained. PRIMARY FUNDING SOURCE: Arthritis Research UK.

Bespoke smoking cessation for people with severe mental ill health (SCIMITAR): a pilot randomised controlled trial.

BACKGROUND: People with severe mental ill health are three times more likely to smoke but typically do not access conventional smoking cessation services, contributing to widening health inequalities and reduced life expectancy. We aimed to pilot an intervention targeted at smokers with severe mental ill health and to test methods of recruitment, randomisation, and follow up before implementing a full trial. METHODS: The Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR) is a pilot randomised controlled trial of a smoking cessation strategy designed specifically for people with severe mental ill health, to be delivered by mental health nurses and consisting of behavioural support and drugs, compared with a conventional smoking cessation service (ie, usual care). Adults (aged 18 years or older) with bipolar disorder or schizophrenia, who were current smokers, were recruited from NHS primary care and mental health settings in the UK (York, Scarborough, Hull, and Manchester). Eligible participants were randomly allocated to either usual care (control group) or usual care plus the bespoke smoking cessation strategy (intervention group). Randomisation was done via a central telephone system, with computer-generated random numbers. We could not mask participants, family doctors, and researchers to the treatment allocation. Our primary outcome was smoking status at 12 months, verified by carbon monoxide measurements or self-report. Only participants who provided an exhaled CO measurement or self-reported their smoking status at 12 months were included in the primary analysis. The trial is registered at ISRCTN.com, number ISRCTN79497236. FINDINGS: Of 97 people recruited to the pilot study, 51 were randomly allocated to the control group and 46 were assigned to the intervention group. Participants engaged well with the bespoke smoking cessation strategy, but no individuals assigned to usual care accessed NHS smoking cessation services. At 12 months, 35 (69%) controls and 33 (72%) people assigned to the intervention group provided a CO measurement or self-reported their smoking status. Smoking cessation was highest among individuals who received the bespoke intervention (12/33 [36%] vs 8/35 [23%]; adjusted odds ratio 2·9, 95% CI 0·8-10·5). INTERPRETATION: We have shown the feasibility of recruiting and randomising people with severe mental ill health in a trial of this nature. The level of engagement with a bespoke smoking cessation strategy was higher than with a conventional approach. The effectiveness and safety of a smoking cessation programme designed particularly for people with severe mental ill health should be tested in a fully powered randomised controlled trial. FUNDING: National Institute of Health Research Health Technology Assessment Programme.

A pragmatic multicentered randomized controlled trial of yoga for chronic low back pain: economic evaluation.

STUDY DESIGN: Multicentered randomized controlled trial with quality of life and resource use data collected. OBJECTIVE: The objective of this study was to evaluate the cost-effectiveness of yoga intervention plus usual care compared with usual care alone for chronic or recurrent low back pain. SUMMARY OF BACKGROUND DATA: Yoga has been shown as an effective intervention for treating chronic or recurrent low back pain. However, there is little evidence on its cost-effectiveness. The data are extracted from a pragmatic, multicentered, randomized controlled trial that has been conducted to evaluate the effectiveness and cost-effectiveness of a 12-week progressive program of yoga plus usual care in patients with chronic or recurrent low back pain. METHODS: With this trial data, a cost-effectiveness analysis during the time period of 12 months from both perspectives of the UK National Health Service and the societal is presented. Main outcome measure is an incremental cost per quality-adjusted life-year (QALY). RESULTS: From the perspective of the U.K. National Health Service, yoga intervention yields an incremental cost-effectiveness ratio of £13,606 per QALY. Given a willingness to pay for an additional QALY of £20,000, the probability of yoga intervention being cost-effective is 72%. From the perspective of the society, yoga intervention is a dominant treatment compared with usual care alone. This result is surrounded by fewer uncertainties-the probability of yoga being cost-effective reaches 95% at a willingness to pay for an additional QALY of £20,000. Sensitive analyses suggest the same results that yoga intervention is likely to be cost-effective in both perspectives. CONCLUSION: On the basis of this trial, 12 weekly group classes of specialized yoga are likely to be a cost-effective intervention for treating patients with chronic or recurrent low back pain.

Yoga for chronic low back pain: a randomized trial.

BACKGROUND: Previous studies indicate that yoga may be an effective treatment for chronic or recurrent low back pain. OBJECTIVE: To compare the effectiveness of yoga and usual care for chronic or recurrent low back pain. DESIGN: Parallel-group, randomized, controlled trial using computer-generated randomization conducted from April 2007 to March 2010. Outcomes were assessed by postal questionnaire. (International Standard Randomised Controlled Trial Number Register: ISRCTN 81079604) SETTING: 13 non-National Health Service premises in the United Kingdom. PATIENTS: 313 adults with chronic or recurrent low back pain. INTERVENTION: Yoga (n = 156) or usual care (n = 157). All participants received a back pain education booklet. The intervention group was offered a 12-class, gradually progressing yoga program delivered by 12 teachers over 3 months. MEASUREMENTS: Scores on the Roland-Morris Disability Questionnaire (RMDQ) at 3 (primary outcome), 6, and 12 (secondary outcomes) months; pain, pain self-efficacy, and general health measures at 3, 6, and 12 months (secondary outcomes). RESULTS: 93 (60%) patients offered yoga attended at least 3 of the first 6 sessions and at least 3 other sessions. The yoga group had better back function at 3, 6, and 12 months than the usual care group. The adjusted mean RMDQ score was 2.17 points (95% CI, 1.03 to 3.31 points) lower in the yoga group at 3 months, 1.48 points (CI, 0.33 to 2.62 points) lower at 6 months, and 1.57 points (CI, 0.42 to 2.71 points) lower at 12 months. The yoga and usual care groups had similar back pain and general health scores at 3, 6, and 12 months, and the yoga group had higher pain self-efficacy scores at 3 and 6 months but not at 12 months. Two of the 157 usual care participants and 12 of the 156 yoga participants reported adverse events, mostly increased pain. LIMITATION: There were missing data for the primary outcome (yoga group, n = 21; usual care group, n = 18) and differential missing data (more in the yoga group) for secondary outcomes. CONCLUSION: Offering a 12-week yoga program to adults with chronic or recurrent low back pain led to greater improvements in back function than did usual care. PRIMARY FUNDING SOURCE: Arthritis Research UK.

Electronic reminders did not improve postal questionnaire response rates or response times: a randomized controlled trial.

OBJECTIVE: We aim to evaluate the effectiveness of electronic reminders (ERs) to improve the response rates and time to response of postal questionnaires in a health research setting. STUDY DESIGN AND SETTING: This pragmatic randomized controlled trial (RCT) was nested within a multicenter RCT of yoga for lower back pain. Participants who provided an electronic mail address and/or mobile phone number were randomized to receive an ER or no reminder (controls) on the day they were due to receive a follow-up questionnaire. RESULTS: One hundred twenty-five participants (32 males and 93 females) mean age 46 (standard deviation: 11, range: 20-65) were randomized to ER (n=62) or controls (n=63). Overall 85.6% of participants returned postal questionnaires (87.1% ER group and 84.1% from controls). No significant differences were found between the two groups for response rate (difference between groups=3.0%, 95% confidence interval [CI]=-10, 16; P=0.64) or time to response after adjusting for age, gender, and treatment allocation (χ(2) ([3df])=7.10; P=0.07). CONCLUSION: In the present RCT, we found little evidence for the effectiveness of ERs to increase response rates or time to respond for the return of questionnaires in this study population group.

A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: trial protocol.

UNLABELLED: A systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a randomised controlled trial (RCT) to determine the effectiveness and cost-effectiveness of Yoga for chronic Low Back Pain, which is funded by Arthritis Research Campaign (arc) and is being conducted by the University of York. 262 patients will be recruited from GP practices in 5 centres in England. Patients will be randomised to receive usual care or 12 weekly classes of yoga. A yoga programme will be devised that can be delivered by yoga teachers of the two main national yoga organisations in the UK (British Wheel of Yoga and Iyengar Yoga Association (UK)). TRIAL REGISTRATION: Current controlled trials registry ISRCTN81079604 (date registered 30/03/2007).

Screening for postnatal depression in primary care: cost effectiveness analysis.

OBJECTIVE: To evaluate the cost effectiveness of routine screening for postnatal depression in primary care. DESIGN: Cost effectiveness analysis with a decision model of alternative methods of screening for depression, including standardised postnatal depression and generic depression instruments. The performance of screening instruments was derived from a systematic review and bivariate meta-analysis at a range of instrument cut points; estimates of other relevant parameters were derived from literature sources and relevant databases. A decision tree considered the full treatment pathway from the possible onset of postnatal depression through identification, treatment, and possible relapse. SETTING: Primary care. PARTICIPANTS: A hypothetical population of women assessed for postnatal depression either via routine care only or supplemented by use of formal identification methods six weeks postnatally, as recommended in recent guidelines. MAIN OUTCOME MEASURES: Costs expressed in 2006-7 prices and impact on health outcomes expressed in terms of quality adjusted life years (QALYs). The time horizon of the analysis was one year. RESULTS: The routine application of either postnatal or general depression questionnaires did not seem to be cost effective compared with routine care only. The Edinburgh postnatal depression scale (at a cut point of 16) had an incremental cost effectiveness ratio (ICER) of pound 41,103 (euro 45,398, $67,130) per QALY compared with routine care only. The ICER for all other strategies ranged from pound 49,928 to pound 272,463 per QALY versus routine care only, while the probability that no formal identification strategy was cost effective was 88% (59%) at a cost effectiveness threshold of pound 20,000 ( pound 30,000) per QALY. While sensitivity analysis indicated that the cost of managing incorrectly identified depression (false positive result) was an important driver of the model, formal identification approaches did not seem to be cost effective at any feasible estimate of this cost. CONCLUSIONS: Formal identification methods for postnatal depression do not seem to represent value for money for the NHS. The major determinant of cost effectiveness seems to be the potential additional costs of managing women incorrectly diagnosed as depressed. Formal identification methods for postnatal depression do not currently satisfy the National Screening Committee's criteria for the adoption of a screening strategy as part of national health policy.

Dietary protein and bone health: a systematic review and meta-analysis.

BACKGROUND: There has been a resurgence of interest in the controversial relation between dietary protein and bone health. OBJECTIVE: This article reports on the first systematic review and meta-analysis of the relation between protein and bone health in healthy human adults. DESIGN: The MEDLINE (January 1966 to September 2007) and EMBASE (1974 to July 2008) databases were electronically searched for all relevant studies of healthy adults; studies of calcium excretion or calcium balance were excluded. RESULTS: In cross-sectional surveys, all pooled r values for the relation between protein intake and bone mineral density (BMD) or bone mineral content at the main clinically relevant sites were significant and positive; protein intake explained 1-2% of BMD. A meta-analysis of randomized placebo-controlled trials indicated a significant positive influence of all protein supplementation on lumbar spine BMD but showed no association with relative risk of hip fractures. No significant effects were identified for soy protein or milk basic protein on lumbar spine BMD. CONCLUSIONS: A small positive effect of protein supplementation on lumbar spine BMD in randomized placebo-controlled trials supports the positive association between protein intake and bone health found in cross-sectional surveys. However, these results were not supported by cohort study findings for hip fracture risk. Any effects found were small and had 95% CIs that were close to zero. Therefore, there is a small benefit of protein on bone health, but the benefit may not necessarily translate into reduced fracture risk in the long term.