Development of an evidence-based complex intervention for community rehabilitation of patients with hip fracture using realist review, survey and focus groups.

OBJECTIVES: To develop an evidence and theory-based complex intervention for improving outcomes in elderly patients following hip fracture. DESIGN: Complex-intervention development (Medical Research Council (MRC) framework phase I) using realist literature review, surveys and focus groups of patients and rehabilitation teams. SETTING: North Wales. PARTICIPANTS: Surveys of therapy managers (n=13), community and hospital-based physiotherapists (n=129) and occupational therapists (n=68) throughout the UK. Focus groups with patients (n=13), their carers (n=4) and members of the multidisciplinary rehabilitation teams in North Wales (n=13). RESULTS: The realist review provided understanding of how rehabilitation interventions work in the real-world context and three programme theories were developed: improving patient engagement by tailoring the intervention to individual needs; reducing fear of falling and improving self-efficacy to exercise and perform activities of daily living; and coordination of rehabilitation delivery. The survey provided context about usual rehabilitation practice; focus groups provided data on the experience, acceptability and feasibility of rehabilitation interventions. An intervention to enhance usual rehabilitation was developed to target these theory areas comprising: a physical component consisting of six additional therapy sessions; and a psychological component consisting of a workbook to enhance self-efficacy and a patient-held goal-setting diary for self-monitoring. CONCLUSIONS: A realist approach may have advantages in the development of evidence-based interventions and can be used in conjunction with other established methods to contribute to the development of potentially more effective interventions. A rehabilitation intervention was developed which can be tested in a future randomised controlled trial (MRC framework phases II and III). TRIAL REGISTRATION NUMBER: ISRCTN22464643, Pre-results.

Health professionals' perspectives on exercise referral and physical activity promotion in primary care: Findings from a process evaluation of the National Exercise Referral Scheme in Wales.

BACKGROUND AND OBJECTIVES: Referring clinicians' experiences of exercise referral schemes (ERS) can provide valuable insights into their uptake. However, most qualitative studies focus on patient views only. This paper explores health professionals' perceptions of their role in promoting physical activity and experiences of a National Exercise Referral Scheme (NERS) in Wales. DESIGN: Qualitative semi-structured group interviews. SETTING: General practice premises. METHODS: Nine semi-structured group interviews involving 46 health professionals were conducted on general practice premises in six local health board areas. Purposive sampling taking into account area deprivation, practice size and referral rates was employed. Interviews were transcribed verbatim and analysed using the Framework method of thematic analysis. RESULTS: Health professionals described physical activity promotion as important, although many thought it was outside of their expertise and remit, and less important than other health promotion activities such as smoking cessation. Professionals linked decisions on whether to advise physical activity to patients to their own physical activity levels and to subjective judgements of patient motivation. While some described ERS as a holistic alternative to medication, with potential social benefits, others expressed concerns regarding their limited reach and potential to exacerbate inequalities. Barriers to referral included geographic isolation and uncertainties about patient selection criteria, medico-legal responsibilities and a lack of feedback about patient progress. CONCLUSION: Clinicians' concerns about expertise, priority setting and time constraints should be addressed to enhance physical activity promotion in primary care. Further research is needed to fully understand decision making relating to provision of physical activity advice and use of ERS.

The expanding role of primary care in cancer control.

The nature of cancer control is changing, with an increasing emphasis, fuelled by public and political demand, on prevention, early diagnosis, and patient experience during and after treatment. At the same time, primary care is increasingly promoted, by governments and health funders worldwide, as the preferred setting for most health care for reasons of increasing need, to stabilise health-care costs, and to accommodate patient preference for care close to home. It is timely, then, to consider how this expanding role for primary care can work for cancer control, which has long been dominated by highly technical interventions centred on treatment, and in which the contribution of primary care has been largely perceived as marginal. In this Commission, expert opinion from primary care and public health professionals with academic and clinical cancer expertise­from epidemiologists, psychologists, policy makers, and cancer specialists­has contributed to a detailed consideration of the evidence for cancer control provided in primary care and community care settings. Ranging from primary prevention to end-of-life care, the scope for new models of care is explored, and the actions needed to effect change are outlined. The strengths of primary care­its continuous, coordinated, and comprehensive care for individuals and families­are particularly evident in prevention and diagnosis, in shared follow-up and survivorship care, and in end-of-life care. A strong theme of integration of care runs throughout, and its elements (clinical, vertical, and functional) and the tools needed for integrated working are described in detail. All of this change, as it evolves, will need to be underpinned by new research and by continuing and shared multiprofessional development.

A pilot randomised controlled trial of personalised care after treatment for prostate cancer (TOPCAT-P): nurse-led holistic-needs assessment and individualised psychoeducational intervention: study protocol.

INTRODUCTION: Prostate cancer is common and the incidence is increasing, but more men are living longer after diagnosis, and die with their disease rather than of it. Nonetheless, specific and substantial physical, sexual, emotional and mental health problems often lead to a poor quality of life. Urology services increasingly struggle to cope with the demands of follow-up care, and primary care is likely to play the central role in long-term follow-up. The present phase II trial will evaluate the feasibility and acceptability of a nurse-led, person-centred psychoeducational intervention, delivered in community or primary care settings. METHODS AND ANALYSIS: Prostate cancer survivors diagnosed in the past 9-48 months and currently biochemically stable will be identified from hospital records by their treating clinician. Eligible men would have either completed radical treatment, or would be followed up with prostate specific antigen monitoring and symptom reporting. We will recruit 120 patients who will be randomised to receive either an augmented form of usual care, or an additional nurse-led intervention for a period of 36 weeks. Following the health policy in Wales, the intervention is offered by a key worker, is promoting prudent healthcare and is using a holistic needs assessment. Outcome measures will assess physical symptoms, psychological well-being, confidence in managing own health and quality of life. Healthcare service use will be measured over 36 weeks. Feedback interviews with patients and clinicians will further inform the acceptability of the intervention. Recruitment, attrition, questionnaire completion rates and outcome measures variability will be assessed, and results will inform the design of a future phase III trial and accompanying economic evaluation. ETHICS AND DISSEMINATION: Ethics approval was granted by Bangor University and North Wales REC (13/WA/0291). Results will be reported in peer-reviewed publications, at scientific conferences, and directly through national cancer and primary care networks. TRIAL REGISTRATION NUMBER: ISRCTN 34516019.

Activity Increase Despite Arthritis (AIDA): design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946].

BACKGROUND: Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity. METHODS/DESIGN: This paper describes the design of a Phase II randomised controlled trial (RCT) to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months. DISCUSSION: We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric properties of the primary outcome measures concurrently with the trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN24554946.

Psychological response in spinal manipulation (PRISM): a systematic review of psychological outcomes in randomised controlled trials.

BACKGROUND: The most important risk factors for back and neck pain are psychosocial. Nevertheless, systematic reviews of spinal manipulation have concentrated on pain and spine related disability, and ignored psychological outcomes. OBJECTIVE: To assess whether spinal manipulation was effective in improving psychological outcome. DESIGN: Systematic review of randomised controlled trials (RCTs). METHODS: RCTs were identified by searching Medline, CINAHL, Embase, CENTRAL, AMED, PsycINFO until November 2005. Trials reporting psychological outcomes including the mental health components of generic outcomes were extracted, and combined where appropriate in meta-analyses. RESULTS: One hundred and twenty nine RCTs of spinal manipulation were identified; 12 had adequately reported psychological outcomes. Six trials with a verbal intervention comparator were combined in a meta-analysis, and found a mean benefit from spinal manipulation equivalent to 0.34 of the population standard deviation (S.D.) [95% confidence interval (CI) 0.23-0.45] at 1-5 months; 0.27 of the S.D. [95% CI 0.14-0.40] at 6-12 months. Eight trials with a physical treatment comparator were combined in a meta-analysis and found a mean benefit of 0.13 of the S.D. [95% CI 0.01-0.24] in favour of manipulation at 1-5 months; 0.11 of the S.D. [95% CI -0.02 to 0.25] at 6-12 months. CONCLUSIONS: There was some evidence that spinal manipulation improved psychological outcomes compared with verbal interventions.

Should your GP be an osteopath? Patients' views of an osteopathy clinic based in primary care.

BACKGROUND: Spinal pain is a common reason for consulting general practitioners (GPs), and complementary therapists such as osteopaths and chiropractors. Patients express greater satisfaction with the care from chiropractors and osteopaths, because they are perceived as having more empathy, diagnostic skill and effective treatment, but their attitude to a GP providing an osteopathy service is unknown. AIM: To explore patients' views of receiving osteopathy in contrast with usual GP care, to provide insight into the psychological benefit of treatment, and to explore their views on how such a service should be provided and funded. DESIGN OF STUDY: Qualitative study using semi-structured interviews preceded by short questionnaires. SETTING: Primary care osteopathy clinic treating patients from Llanfairfechan Health Centre, which also accepted referrals from neighbouring practices in North West Wales in a randomised controlled trial. METHOD: Short questionnaires followed by semi-structured interviews with 20 participants. The interview transcripts were analysed by open coding into categories, axial coding to define the categories' properties and selective coding for the final thematic account. RESULTS: Traditional GP skills were valued, but GP care for spinal pain was perceived as limited and ineffective. Osteopathy was attractive because it did not involve drugs, but it had short-term painful side effects, and some found it frightening. Physical benefits included increased mobility and reduced pain; psychological benefits included removal of fear and improved understanding. Provision of osteopathy by a GP was welcomed, so long as the GP was properly qualified, and had sufficient time. CONCLUSION: A GP run osteopathy clinic provided additional physical and psychological benefit. GP consultation might be improved by adopting some features from the osteopathic consultation.

A pilot study of adherence with light treatment for seasonal affective disorder.

Non-adherence with antidepressant medication regimens is now recognised as a substantial problem when evaluating depression outcome. Given the behavioural demands of light treatment (LT), it might be expected that non-adherence would be even more pronounced in LT, a form of intervention for seasonal affective disorder (SAD). However, little research has focused upon the extent to which patients in light treatment protocols adhere to set regimens. Nineteen patients with SAD were allocated to either treatment with bright white light (intervention) or dim red light (control condition) in a four-week protocol. Light exposure was estimated automatically (without participants' knowledge) with elapsed time meters built into the light box. Daily diaries were also used to measure self-reported light box use. Participants were instructed to use the light box for 30 min each day during week 1, 45 during week 2 and one hour during weeks 3 and 4 (total duration of prescribed light exposure 1365 min). The results indicated that mean duration of light box operation for the entire sample was 59.3% of the prescribed 1365 min. Six of nineteen (31.6%) patients dropped out of treatment. Amongst those completing treatment, adherence to the prescribed duration of exposure averaged 83.3% (S.D.=31.4). A trend was found for the intervention condition to generate a lower dropout rate, as well as a trend for the degree of adherence to be greater in the intervention condition. Importantly, there was no association between adherence as measured automatically and the higher rates of self-reported adherence as measured in diaries. In summary, the results of this pilot study suggest that adherence with light treatment is of a similar order of magnitude to antidepressant medication adherence. Patient self-report was found to be unrelated to objectively estimated duration of light box use, a finding with significant research and clinical implications. Future research studies should routinely measure and evaluate adherence with light therapy and evidence-based techniques for maximising treatment adherence should be incorporated into routine clinical practice.

Cost-utility analysis of osteopathy in primary care: results from a pragmatic randomized controlled trial.

BACKGROUND: Spinal pain is common and costly to health services and society. Management guidelines have encouraged primary care referral for spinal manipulation, but the evidence base is weak. More economic evaluations alongside pragmatic trials have been recommended. OBJECTIVE: Our aim was to assess the cost-utility of a practice-based osteopathy clinic for subacute spinal pain. METHODS: A cost-utility analysis was performed alongside a pragmatic single-centre randomized controlled trial in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. Patients with back pain of 2-12 weeks duration were randomly allocated to treatment with osteopathy plus usual GP care or usual GP care alone. Costs were measured from a National Health Service (NHS) perspective. All primary and secondary health care interventions recorded in GP notes were collected for the study period. We calculated quality adjusted life year (QALY) gains based on EQ-5D responses from patients in the trial, and then cost per QALY ratios. Confidence intervals (CIs) were estimated using non-parametric bootstrapping. RESULTS: Osteopathy plus usual GP care was more effective but resulted in more health care costs than usual GP care alone. The point estimate of the incremental cost per QALY ratio was 3560 pounds (80% CI 542 pounds-77,100 pounds). Sensitivity analysis examining spine-related costs alone and total costs excluding outliers resulted in lower cost per QALY ratios. CONCLUSION: A primary care osteopathy clinic may be a cost-effective addition to usual GP care, but this conclusion was subject to considerable random error. Rigorous multi-centre studies are needed to assess the generalizability of this approach.

Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care.

BACKGROUND: Spinal pain is common and frequently disabling. Management guidelines have encouraged referral from primary care for spinal manipulation. However, the evidence base for these recommendations is weak. More pragmatic trials and economic evaluations have been recommended. OBJECTIVES: Our aim was to assess the effectiveness and health care costs of a practice-based osteopathy clinic for subacute spinal pain. METHODS: A pragmatic randomized controlled trial was carried out in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. A total of 201 patients with neck or back pain of 2-12 weeks duration were allocated at random between usual GP care and an additional three sessions of osteopathic spinal manipulation. The primary outcome measure was the Extended Aberdeen Spine Pain Scale (EASPS). Secondary measures included SF-12, EuroQol and Short-form McGill Pain Questionnaire. Health care costs were estimated from the records of referring GPs. RESULTS: Outcomes improved more in the osteopathy group than the usual care group. At 2 months, this improvement was significantly greater in EASPS [95% confidence interval (CI) 0.7-9.8] and SF-12 mental score (95% CI 2.7-10.7). At 6 months, this difference was no longer significant for EASPS (95% CI -1.5 to 10.4), but remained significant for SF-12 mental score (95% CI 1.0-9.9). Mean health care costs attributed to spinal pain were significantly greater by 65 UK pounds in the osteopathy group (95% CI 32-155 UK pounds). Though osteopathy also cost 22 UK pounds more in mean total health care cost, this was not significant (95% CI - 159 to 142 UK pounds). CONCLUSION: A primary care osteopathy clinic improved short-term physical and longer term psychological outcomes, at little extra cost. Rigorous multicentre studies are now needed to assess the generalizability of this approach.