'Trying to put a square peg into a round hole': a qualitative study of healthcare professionals' views of integrating complementary medicine into primary care for musculoskeletal and mental health comorbidity.

BACKGROUND: Comorbidity of musculoskeletal (MSK) and mental health (MH) problems is common but challenging to treat using conventional approaches. Integration of conventional with complementary approaches (CAM) might help address this challenge. Integration can aim to transform biomedicine into a new health paradigm or to selectively incorporate CAM in addition to conventional care. This study explored professionals' experiences and views of CAM for comorbid patients and the potential for integration into UK primary care. METHODS: We ran focus groups with GPs and CAM practitioners at three sites across England and focus groups and interviews with healthcare commissioners. Topics included experience of co-morbid MSK-MH and CAM/integration, evidence, knowledge and barriers to integration. Sampling was purposive. A framework analysis used frequency, specificity, intensity of data, and disconfirming evidence. RESULTS: We recruited 36 CAM practitioners (4 focus groups), 20 GPs (3 focus groups) and 8 commissioners (1 focus group, 5 interviews). GPs described challenges treating MSK-MH comorbidity and agreed CAM might have a role. Exercise- or self-care-based CAMs were most acceptable to GPs. CAM practitioners were generally pro-integration. A prominent theme was different understandings of health between CAM and general practitioners, which was likely to impede integration. Another concern was that integration might fundamentally change the care provided by both professional groups. For CAM practitioners, NHS structural barriers were a major issue. For GPs, their lack of CAM knowledge and the pressures on general practice were barriers to integration, and some felt integrating CAM was beyond their capabilities. Facilitators of integration were evidence of effectiveness and cost effectiveness (particularly for CAM practitioners). Governance was the least important barrier for all groups. There was little consensus on the ideal integration model, particularly in terms of financing. Commissioners suggested CAM could be part of social prescribing. CONCLUSIONS: CAM has the potential to help the NHS in treating the burden of MSK-MH comorbidity. Given the challenges of integration, selective incorporation using traditional referral from primary care to CAM may be the most feasible model. However, cost implications would need to be addressed, possibly through models such as social prescribing or an extension of integrated personal commissioning.

Using willingness-to-pay to establish patient preferences for cancer testing in primary care.

BACKGROUND: Shared decision making is a stated aim of several healthcare systems. In the area of cancer, patients' views have informed policy on screening and treatment but there is little information about their views on diagnostic testing in relation to symptom severity. METHODS: We used the technique of willingness-to-pay to determine public preferences around diagnostic testing for colorectal, lung, and pancreatic cancer in primary care in the UK. Participants were approached in general practice waiting rooms and asked to complete a two-stage electronic survey that described symptoms of cancer, the likelihood that the symptoms indicate cancer, and information about the appropriate diagnostic test. Part 1 asked for a binary response (yes/no) as to whether they would choose to have a test if it were offered. Part 2 elicited willingness-to-pay values of the tests using a payment scale followed by a bidding exercise, with the aim that these values would provide a strength of preference not detectable using the binary approach. RESULTS: A large majority of participants chose to be tested for all cancers, with only colonoscopy (colorectal cancer) demonstrating a risk gradient. In the willingness-to-pay exercise participants placed a lower value on an X-ray (lung cancer) than the tests for colorectal or pancreatic cancer and X-ray was the only test where risk was clearly related to the willingness-to-pay value. CONCLUSION: Willingness-to-pay values did not enhance the binary responses in the way intended; participants appeared to be motivated differently when responding to the two parts of the questionnaire. More work is needed to understand how participants perceive risk in this context and how they respond to questions about willingness-to-pay. Qualitative methods could provide useful insights.

A consultation-level intervention to improve care of frequently attending patients: a cluster randomised controlled feasibility trial.

BACKGROUND: Frequent attenders (FAs) to primary care receive considerable NHS resources without necessarily gaining benefit, and may even be harmed. AIM: To assess the feasibility of a consultation-level intervention to improve care and address service use of FAs. DESIGN & SETTING: A cluster randomised controlled feasibility trial was undertaken. The study used a mixed-methods process evaluation and took place in six practices in England. METHOD: All practices screened the top 3% of all attending patients over the previous 12 months for eligibility. Following randomisation, intervention patients were matched with named GPs, trained to use the Background, Affect, Trouble, Handling, Empathy (BATHE) technique during consultations. Telephone consultations were encouraged. Feasibility outcomes assessed were recruitment, retention, data collection and completeness, implementation fidelity, and acceptability. RESULTS: A total of 599/1328 (45.1%) FAs were eligible. Four practices were randomised to the intervention (n = 451) and two to usual care (n = 148). A total of 96 (23.7%) patients were recruited to complete questionnaires. Retention and completeness of data were good; for example, 76% of those agreeing to complete questionnaires did so at the 12-month assessment point. Thirty-four GPs were trained and delivered BATHE ≥1 times to 50.1% of patients (n = 577 consultations). There were minimal increases in continuity and telephone consultations. Patients were positive about the intervention, but noticed little change in their care. Despite valuing BATHE, low adherence to training was indicated and GPs used it less than anticipated. CONCLUSION: It was feasible to identify FAs and collect trial data. GPs were keen to engage and there was evidence that the BATHE technique was taken into practice. Optimising training is likely to improve fidelity. The intervention was low cost and low risk.

Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain.

OBJECTIVE: To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. DESIGN: Factorial randomised trial. Setting 64 general practices in England. PARTICIPANTS: 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription. INTERVENTIONS: Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling. MAIN OUTCOME MEASURES: Roland Morris disability score (number of activities impaired by pain) and number of days in pain. RESULTS: Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks were lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported. CONCLUSIONS: One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons.

Complementary medicine use, views, and experiences: a national survey in England.

BACKGROUND: In 2005,12% of the English population visited a complementary and alternative medicine (CAM) practitioner. AIM: To obtain up-to-date general population figures for practitioner-led CAM use in England, and to discover people's views and experiences regarding access. DESIGN & SETTING: A face-to-face questionnaire survey was commissioned. A nationally representative adult quota sample (aged ≥15 years) was used. METHOD: Ten questions were included within Ipsos MORI's weekly population-based survey. The questions explored 12-month practitioner-led CAM use, reasons for non-use, views on NHS-provided CAM, and willingness to pay. RESULTS: Of 4862 adults surveyed, 766 (16%) had seen a CAM practitioner. People most commonly visited CAM practitioners for manual therapies (massage, osteopathy, chiropractic) and acupuncture, as well as yoga, pilates, reflexology, and mindfulness or meditation. Women, people with higher socioeconomic status (SES) and those in south England were more likely to access CAM. Musculoskeletal conditions (mainly back pain) accounted for 68% of use, and mental health 12%. Most was through self-referral (70%) and self-financing. GPs (17%) or NHS professionals (4%) referred and/or recommended CAM to users. These CAM users were more often unemployed, with lower income and social grade, and receiving NHS-funded CAM. Responders were willing to pay varying amounts for CAM; 22% would not pay anything. Almost two in five responders felt NHS funding and GP referral and/or endorsement would increase their CAM use. CONCLUSION: CAM use in England is common for musculoskeletal and mental health problems, but varies by sex, geography, and SES. It is mainly self-referred and self-financed; some is GP-endorsed and/or referred, especially for individuals of lower SES. Researchers, patients, and commissioners should collaborate to research the effectiveness and cost-effectiveness of CAM and consider its availability on the NHS.

Cost-effectiveness modelling of telehealth for patients with raised cardiovascular disease risk: evidence from a cohort simulation conducted alongside the Healthlines randomised controlled trial.

OBJECTIVES: To investigate the long-term cost-effectiveness (measured as the ratio of incremental NHS cost to incremental quality-adjusted life years) of a telehealth intervention for patients with raised cardiovascular disease (CVD) risk. DESIGN: A cohort simulation model developed as part of the economic evaluation conducted alongside the Healthlines randomised controlled trial. SETTING: Patients recruited through primary care, and intervention delivered via telehealth service. PARTICIPANTS: Participants with a 10-year CVD risk ≥20%, as measured by the QRISK2 algorithm, and with at least 1 modifiable risk factor, individually randomised from 42 general practices in England. INTERVENTION: A telehealth service delivered over a 12-month period. The intervention involved a series of responsive, theory-led encounters between patients and trained health information advisors who provided access to information resources and supported medication adherence and coordination of care. PRIMARY AND SECONDARY OUTCOME MEASURES: Cost-effectiveness measured by net monetary benefit over the simulated lifetime of trial participants from a UK National Health Service perspective. RESULTS: The probability that the intervention was cost-effective depended on the duration of the effect of the intervention. The intervention was cost-effective with high probability if effects persisted over the lifetime of intervention recipients. The probability of cost-effectiveness was lower for shorter durations of effect. CONCLUSIONS: The intervention was likely to be cost-effective under a lifetime perspective. TRIAL REGISTRATION NUMBER: ISRCTN27508731; Results.

Cost-effectiveness of telehealth for patients with depression: evidence from the Healthlines randomised controlled trial.

BACKGROUND: Depression is a prevalent long-term condition that is associated with substantial resource use. Telehealth may offer a cost-effective means of supporting the management of people with depression. AIMS: To investigate the cost-effectiveness of a telehealth intervention ('Healthlines') for patients with depression. METHOD: A prospective patient-level economic evaluation conducted alongside a randomised controlled trial. Patients were recruited through primary care, and the intervention was delivered via a telehealth service. Participants with a confirmed diagnosis of depression and PHQ-9 score ≥10 were recruited from 43 English general practices. A series of up to 10 scripted, theory-led, telephone encounters with health information advisers supported participants to effect a behaviour change, use online resources, optimise medication and improve adherence. The intervention was delivered alongside usual care and was designed to support rather than duplicate primary care. Cost-effectiveness from a combined health and social care perspective was measured by net monetary benefit at the end of 12 months of follow-up, calculated from incremental cost and incremental quality-adjusted life years (QALYs). Cost-consequence analysis included cost of lost productivity, participant out-of-pocket expenditure and the clinical outcome. RESULTS: A total of 609 participants were randomised - 307 to receive the Healthlines intervention plus usual care and 302 to receive usual care alone. Forty-five per cent of participants had missing quality of life data, 41% had missing cost data and 51% of participants had missing data on either cost or utility, or both. Multiple imputation was used for the base-case analysis. The intervention was associated with incremental mean per-patient National Health Service/personal social services cost of £168 (95% CI £43 to £294) and an incremental QALY gain of 0.001 (95% CI -0.023 to 0.026). The incremental cost-effectiveness ratio was £132 630. Net monetary benefit at a cost-effectiveness threshold of £20 000 was -£143 (95% CI -£164 to -£122) and the probability of the intervention being cost-effective at this threshold value was 0.30. Productivity costs were higher in the intervention arm, but out-of-pocket expenses were lower. CONCLUSIONS: The Healthlines service was acceptable to patients as a means of condition management, and response to treatment after 4 months was higher for participants randomised to the intervention. However, the positive average intervention effect size was modest, and incremental costs were high relative to a small incremental QALY gain at 12 months. The intervention is not likely to be cost-effective in its current form. DECLARATION OF INTEREST: None. COPYRIGHT AND USAGE: © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence.

Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention.

BACKGROUND: Many countries are exploring the potential of telehealth interventions to manage the rising number of people with chronic disorders. However, evidence of the effectiveness of telehealth is ambiguous. Based on an evidence-based conceptual framework, we developed an integrated telehealth service (the Healthlines Service) for chronic disorders and assessed its effectiveness in patients with depression. We aimed to compare the Healthlines Depression Service plus usual care with usual care alone. METHODS: This study was a pragmatic, multicentre, randomised controlled trial with participants recruited from 43 general practices in three areas of England. To be eligible, participants needed to have access to the internet and email, a Patient Health Questionnaire 9 (PHQ-9) score of at least 10, and a confirmed diagnosis of depression. Participants were individually assigned (1:1) to either the Healthlines Depression Service plus usual care or usual care alone. Random assignment was done by use of a web-based automated randomisation system, stratified by site and minimised by practice and PHQ-9 score. Participants were aware of their allocation, but outcomes were analysed masked. The Healthlines Service consisted of regular telephone calls from non-clinical, trained health advisers who followed standardised scripts generated by interactive software. After an initial assessment and goal-setting telephone call, the advisers called each participant on six occasions over 4 months, and then made up to three more calls at intervals of roughly 2 months to provide reinforcement and to detect relapse. Advisers supported participants in the use of online resources (including computerised cognitive behavioural therapy) and sought to encourage healthier lifestyles, optimise medication, and improve treatment adherence. The primary outcome was the proportion of participants responding to the intervention (defined as PHQ-9 <10 and reduction in PHQ-9 of ≥5 points) at 4 months after randomisation. The primary analysis was based on the intention-to-treat principle without imputation and all serious adverse events were investigated. This trial is registered with Current Controlled Trials, number ISRCTN 14172341. FINDINGS: Between July 24, 2012, and July 31, 2013, we recruited 609 participants, randomly assigning 307 to the Healthlines Service plus usual care and 302 to usual care. Primary outcome data were available for 525 (86%) participants. At 4 months, 68 (27%) of 255 individuals in the intervention group had a treatment response compared with 50 (19%) of 270 individuals in the usual care group (adjusted odds ratio 1·7, 95% CI 1·1-2·5, p=0·019). Compared with usual care alone, intervention participants reported improvements in anxiety, better access to support and advice, greater satisfaction with the support they received, and improvements in self-management and health literacy. During the trial, 70 adverse events were reported by participants, one of which was related to the intervention (increased anxiety from discussing depression) and was not serious. INTERPRETATION: This telehealth service based on non-clinically trained health advisers supporting patients in use of internet resources was both acceptable and effective compared with usual care. Our results provide support for the development and assessment of similar interventions in other chronic disorders to expand care provision. FUNDING: National Institute for Health Research (NIHR).

Targeted routine asthma care in general practice using telephone triage.

BACKGROUND: There is a high non-attendance rate for traditional clinic-based routine asthma care in general practice. Alternative methods of providing routine asthma care need to be examined. AIM: To examine the cost and effectiveness of targeted routine asthma care in general practice using telephone triage, compared to usual clinic care. DESIGN OF STUDY: An open randomised controlled trial. SETTING: A single semi-rural practice in the southwest of England. METHOD: Adult patients with asthma were randomised to receive either their routine asthma care in the surgery or care by telephone triage. Asthma control parameters, health status and NHS resource utilisation were measured over the 12-month study period. RESULTS: One hundred and ninety-four patients were randomised and 35% per cent more patients (n = 84 versus n = 62) received more than one consultation in the telephone group. Asthma control as measured by the asthma control questionnaire (ACQ) was similar in the clinic and telephone groups: mean change in ACQ = -0.11 (95% CI = -0.32 to 0.11) versus -0.18 (95% CI = -0.38 to 0.02). Mean NHS costs were 210 pounds sterling per patient per year in the telephone group compared to 334 pounds sterling in the clinic group (P-value of bootstrapped difference = 0.071). CONCLUSION: Targeted routine asthma care by telephone triage of adult asthmatics can lead to more asthma patients being reviewed, at less cost per patient and without loss of asthma control compared to usual routine care in the surgery.

The CHICO (Children's Cough) Trial protocol: a feasibility randomised controlled trial investigating the clinical and cost-effectiveness of a complex intervention to improve the management of children presenting to primary care with acute respiratory tract infection.

INTRODUCTION: While most respiratory tract infections (RTIs) will resolve without treatment, many children will receive antibiotics and some will develop severe symptoms requiring hospitalisation. There have been calls for evidence to reduce uncertainty regarding the identification of children who will and will not benefit from antibiotics. The aim of this feasibility trial is to test recruitment and the acceptance of a complex behavioural intervention designed to reduce antibiotic prescribing, and to inform how best to conduct a larger trial. METHODS AND ANALYSIS: The CHICO (Children's Cough) trial is a single-centre feasibility cluster randomised controlled trial (RCT) comparing a web-based, within-consultation, behavioural intervention with usual care for children presenting to general practitioner practices with RTI and acute cough. The trial aims to recruit at least 300 children between October 2014 and April 2015, in a single area in South West England. Following informed consent, demographic information will be recorded, and symptoms and signs measured. Parents/carers of recruited children will be followed up on a weekly basis to establish symptom duration, resource use and cost of the illness to the parent until the child's cough has resolved or up to 8 weeks, whichever occurs earlier. A review of medical notes, including clinical history, primary care reconsultations and hospitalisations will be undertaken 2 months after recruitment. The trial feasibility will be assessed by: determining acceptability of the intervention to clinicians and parent/carers; quantifying differential recruitment and follow-up; determining intervention fidelity; the success in gathering the data necessary to conduct a cost-effectiveness analysis; and collecting data about antibiotic prescribing rates to inform the sample size needed for a fully powered RCT. ETHICS AND DISSEMINATION: The study was approved by the North West-Haydock Research Ethics Committee, UK (reference number: 14/NW/1034). The findings from this feasibility trial will be disseminated through research conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN23547970.

A pragmatic randomised controlled trial of 'PhysioDirect' telephone assessment and advice services for patients with musculoskeletal problems: economic evaluation.

OBJECTIVES: To compare the cost-effectiveness of PhysioDirect with usual physiotherapy care for patients with musculoskeletal problems. DESIGN: (1) Cost-consequences comparing cost to the National Health Service (NHS), to patients, and the value of lost productivity with a range of outcomes. (2) Cost-utility analysis comparing cost to the NHS with Quality-Adjusted Life Years (QALYs). SETTING: Four physiotherapy services in England. PARTICIPANTS: Adults (18+) referred by their general practitioner or self-referred for physiotherapy. INTERVENTIONS: PhysioDirect involved telephone assessment and advice followed by face-to-face care if needed. Usual care patients were placed on a waiting list for face-to-face care. PRIMARY AND SECONDARY OUTCOMES: Primary clinical outcome: physical component summary from the SF-36v2 at 6 months. Also included in the cost-consequences: Measure Yourself Medical Outcomes Profile; a Global Improvement Score; response to treatment; patient satisfaction; waiting time. Outcome for the cost-utility analysis: QALYs. RESULTS: 2249 patients took part (1506 PhysioDirect; 743 usual care). (1) Cost-consequences: there was no evidence of a difference between the two groups in the cost of physiotherapy, other NHS services, personal costs or value of time off work. Outcomes were also similar. (2) Cost-utility analysis based on complete cases (n=1272). Total NHS costs, including the cost of physiotherapy were higher in the PhysioDirect group by £19.30 (95% CI -£37.60 to £76.19) and there was a QALY gain of 0.007 (95% CI -0.003 to 0.016). The incremental cost-effectiveness ratio was £2889 and the net monetary benefit at λ=£20 000 was £117 (95% CI -£86 to £310). CONCLUSIONS: PhysioDirect may be a cost-effective alternative to usual physiotherapy care, though only with careful management of staff time. Physiotherapists providing the service must be more fully occupied than was possible under trial conditions: consideration should be given to the scale of operation, opening times of the service and flexibility in the methods used to contact patients.

Economic evaluation of the DiAMOND randomized trial: cost and outcomes of 2 decision aids for mode of delivery among women with a previous cesarean section.

BACKGROUND: Maternal preferences should be considered in decisions about mode of delivery following a previous cesarean, but risks and benefits are unclear. Decision aids can help decision making, although few studies have assessed costs in conjunction with effectiveness. OBJECTIVE: Economic evaluation of 2 decision aids for women with 1 previous cesarean. DESIGN: Cost-consequences analysis. MATERIALS AND METHODS: Data sources were self-reported resource use and outcome and published national unit costs. The target population was women with 1 previous cesarean. The time horizon was 37 weeks' gestation and 6 weeks postnatal. The perspective was health care delivery system. The interventions were usual care, usual care plus an information program, and usual care plus a decision analysis program. The outcome measures were costs to the National Health Service (NHS) in the United Kingdom (UK), score on the Decisional Conflict Scale, and mode of delivery. RESULTS OF MAIN ANALYSIS: Cost of delivery represented 84% of the total cost; mode of delivery was the most important determinant of cost differences across the groups. Mean (SD) total cost per mother and baby: 2033 (677) for usual care, 2069 (738) for information program, and 2019 (741) for decision analysis program. Decision aids reduced decisional conflict. Women using the decision analysis program had fewest cesarean deliveries. RESULTS OF SENSITIVITY ANALYSIS: Applying a cost premium to emergency cesareans over electives had little effect on group comparisons. Conclusions were unaffected. LIMITATIONS: Disparity in timing of outcomes and costs, data completeness, and quality. CONCLUSIONS: Decision aids can reduce decisional conflict in women with a previous cesarean section when deciding on mode of delivery. The information program could be implemented at no extra cost to the NHS. The decision analysis program might reduce the rate of cesarean sections without any increase in costs.

Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial.

OBJECTIVE: To investigate whether paracetamol (acetaminophen) plus ibuprofen are superior to either drug alone for increasing time without fever and the relief of fever associated discomfort in febrile children managed at home. DESIGN: Individually randomised, blinded, three arm trial. SETTING: Primary care and households in England. PARTICIPANTS: Children aged between 6 months and 6 years with axillary temperatures of at least 37.8 degrees C and up to 41.0 degrees C. INTERVENTION: Advice on physical measures to reduce temperature and the provision of, and advice to give, paracetamol plus ibuprofen, paracetamol alone, or ibuprofen alone. MAIN OUTCOME MEASURES: Primary outcomes were the time without fever (<37.2 degrees C) in the first four hours after the first dose was given and the proportion of children reported as being normal on the discomfort scale at 48 hours. Secondary outcomes were time to first occurrence of normal temperature (fever clearance), time without fever over 24 hours, fever associated symptoms, and adverse effects. RESULTS: On an intention to treat basis, paracetamol plus ibuprofen were superior to paracetamol for less time with fever in the first four hours (adjusted difference 55 minutes, 95% confidence interval 33 to 77; P<0.001) and may have been as good as ibuprofen (16 minutes, -7 to 39; P=0.2). For less time with fever over 24 hours, paracetamol plus ibuprofen were superior to paracetamol (4.4 hours, 2.4 to 6.3; P<0.001) and to ibuprofen (2.5 hours, 0.6 to 4.4; P=0.008). Combined therapy cleared fever 23 minutes (2 to 45; P=0.025) faster than paracetamol alone but no faster than ibuprofen alone (-3 minutes, 18 to -24; P=0.8). No benefit was found for discomfort or other symptoms, although power was low for these outcomes. Adverse effects did not differ between groups. CONCLUSION: Parents, nurses, pharmacists, and doctors wanting to use medicines to supplement physical measures to maximise the time that children spend without fever should use ibuprofen first and consider the relative benefits and risks of using paracetamol plus ibuprofen over 24 hours. TRIAL REGISTRATION: Current Controlled Trials ISRCTN26362730.

Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): economic evaluation of a randomised controlled trial.

OBJECTIVE: To estimate the cost to the NHS and to parents and carers of treating febrile preschool children with paracetamol, ibuprofen, or both, and to compare these costs with the benefits of each treatment regimen. DESIGN: Cost consequences analysis and cost effectiveness analysis conducted as part of a three arm, randomised controlled trial. PARTICIPANTS: Children between the ages of 6 months and 6 years recruited from primary care and the community with axillary temperatures >or=37.8 degrees C and

Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain.

OBJECTIVE: To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. DESIGN: Factorial randomised trial. SETTING: 64 general practices in England. PARTICIPANTS: 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription. INTERVENTIONS: Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling. MAIN OUTCOME MEASURES: Roland Morris disability score (number of activities impaired by pain) and number of days in pain. RESULTS: Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks was lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported. CONCLUSIONS: One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons. TRIAL REGISTRATION: National Research Register N0028108728.