Implementing core NICE guidelines for osteoarthritis in primary care with a model consultation (MOSAICS): a cluster randomised controlled trial.

OBJECTIVE: To determine the effectiveness of a model osteoarthritis consultation, compared with usual care, on physical function and uptake of National Institute for Health and Care Excellence (NICE) osteoarthritis recommendations, in adults ≥45 years consulting with peripheral joint pain in UK general practice. METHOD: Two-arm cluster-randomised controlled trial with baseline health survey. Eight general practices in England. PARTICIPANTS: 525 adults ≥45 years consulting for peripheral joint pain, amongst 28,443 population survey recipients. Four intervention practices delivered the model osteoarthritis consultation to patients consulting with peripheral joint pain; four control practices continued usual care. The primary clinical outcome of the trial was the SF-12 physical component score (PCS) at 6 months; the main secondary outcome was uptake of NICE core recommendations by 6 months, measured by osteoarthritis quality indicators. A Linear Mixed Model was used to analyse clinical outcome data (SF-12 PCS). Differences in quality indicator outcomes were assessed using logistic regression. RESULTS: 525 eligible participants were enrolled (mean age 67.3 years, SD 10.5; 59.6% female): 288 from intervention and 237 from control practices. There were no statistically significant differences in SF-12 PCS: mean difference at the 6-month primary endpoint was -0.37 (95% CI -2.32, 1.57). Uptake of core NICE recommendations by 6 months was statistically significantly higher in the intervention arm compared with control: e.g., increased written exercise information, 20.5% (7.9, 28.3). CONCLUSION: Whilst uptake of core NICE recommendations was increased, there was no evidence of benefit of this intervention, as delivered in this pragmatic randomised trial, on the primary outcome of physical functioning at 6 months. TRIAL REGISTRATION: ISRCTN06984617.

Effect of a model consultation informed by guidelines on recorded quality of care of osteoarthritis (MOSAICS): a cluster randomised controlled trial in primary care.

OBJECTIVE: To determine the effect of a model osteoarthritis (OA) consultation (MOAC) informed by National Institute for Health and Care Excellence (NICE) recommendations compared with usual care on recorded quality of care of clinical OA in general practice. DESIGN: Two-arm cluster randomised controlled trial. SETTING: Eight general practices in Cheshire, Shropshire, or Staffordshire UK. PARTICIPANTS: General practitioners and nurses with patients consulting with clinical OA. INTERVENTION: Following six-month baseline period practices were randomised to intervention (n = 4) or usual care (n = 4). Intervention practices delivered MOAC (enhanced initial GP consultation, nurse-led clinic, OA guidebook) to patients aged ≥45 years consulting with clinical OA. An electronic (e-)template for consultations was used in all practices to record OA quality care indicators. OUTCOMES: Quality of OA care over six months recorded in the medical record. RESULTS: 1851 patients consulted in baseline period (1015 intervention; 836 control); 1960 consulted following randomisation (1118 intervention; 842 control). At baseline wide variations in quality of care were noted. Post-randomisation increases were found for written advice on OA (4-28%), exercise (4-22%) and weight loss (1-15%) in intervention practices but not controls (1-3%). Intervention practices were more likely to refer to physiotherapy (10% vs 2%, odds ratio 5.30; 95% CI 2.11, 13.34), and prescribe paracetamol (22% vs 14%, 1.74; 95% CI 1.27, 2.38). CONCLUSIONS: The intervention did not improve all aspects of care but increased core NICE recommendations of written advice on OA, exercise and weight management. There remains a need to reduce variation and uniformly enhance improvement in recorded OA care. TRIAL REGISTRATION NUMBER: ISRCTN06984617.

Should General Practitioners Issue a Sick Certificate to Employees Who Consult for Low Back Pain in Primary Care?

PURPOSE: Back pain is a common problem and has significant societal impact. Sickness certification is commonly issued to patients consulting their general practitioner with low back pain. The aim of this study was to investigate the association of certification for low back pain with clinical outcomes and cost consequences. METHODS: A prospective cohort study using linked questionnaire and medical record data from 806 low back pain patients in 8 UK general practices: comparison of 116 (14.4%) who received a sickness certificate versus 690 who did not receive certification. The primary clinical measure was the Roland and Morris Disability Questionnaire (RMDQ). Data on back pain consultation and work absenteeism were used to calculate healthcare and societal costs. RESULTS: Participants issued a sickness certificate had higher back-related disability at baseline consultation and 6-month follow-up [mean difference 3.1 (95% CI 1.8, 4.4) on the RMDQ], indicating worse health status. After fully adjusting for baseline differences, most changes in clinical outcomes at 6 months were not significantly different between study groups. Productivity losses were significantly higher for the certification group, with most absence occurring after the expected end of certification; mean difference in costs due to absenteeism over 6 months was £1,956 (95% CI £941, £3040). CONCLUSIONS: There was no clear evidence of a difference in clinical outcomes between individuals issued a sickness certificate and those not issued a certification for their back pain. With little overall contrast in clinical outcomes, policy makers and care providers may wish to draw on the likely difference in societal costs alongside issues in ethical and moral care in their consideration of patient care for low back pain.

Incidence, progression and sequence of development of radiographic knee osteoarthritis in a symptomatic population.

OBJECTIVES: Symptomatic knee osteoarthritis (OA) is a common disabling condition. Attention has tended to focus on the tibiofemoral joint (TFJ). However, there is evidence that the patellofemoral joint (PFJ) is involved in many cases, but its place in the sequence of development and progression of knee OA is unclear. This study estimates the cumulative incidence, progression and inter-relationship of radiographic changes of OA in the TFJ and the PFJ in symptomatic adults. METHODS: A population-based observational cohort of 414 adults aged ≥ 50 years with knee pain who had knee x-rays (weight-bearing posteroanterior semiflexed, skyline and lateral views) in 2002-3 and again in 2005-6 (mean interval 36.7 months) was studied. The outcome measure was the development of incident or progressive radiographic OA. RESULTS: The 3-year cumulative incidences of patellofemoral joint osteoarthritis (PFJOA) and tibiofemoral joint osteoarthritis (TFJOA) were 28.8% and 21.7%, respectively. Corresponding estimates of 3-year cumulative progression were 18.9% and 25.3%. PFJOA at baseline was common and increased the risk of incident TFJOA (adjusted OR 2.2, 95% CI 1.1 to 4.1) but less clearly progression of TFJOA (adjusted OR 1.7, 95% CI 0.3 to 9.0). TFJOA at baseline increased the risk of PFJOA incidence and progression (adjusted OR 3.1, 95% CI 1.2 to 8.4 and OR 4.5, 95% CI 1.8 to 11.2, respectively). CONCLUSIONS: These results suggest a common sequence in the development of radiographic knee OA in symptomatic adults beginning in the PFJ, with subsequent addition and progression of TFJOA. It is proposed that isolated symptomatic PFJOA may be one marker for the future development of TFJOA and a target for the early management of knee OA.

Clinical course and prognostic factors across different musculoskeletal pain sites: A secondary analysis of individual patient data from randomised clinical trials.

BACKGROUND: Previous research has identified similar prognostic factors in patients with musculoskeletal (MSK) conditions regardless of pain presentation, generating opportunities for management based on prognosis rather than specific pain presentation. METHODS: Data from seven RCTs (2483 participants) evaluating a range of primary care interventions for different MSK pain conditions were used to investigate the course of symptoms and explore similarities and differences in predictors of outcome. The value of pain site for predicting changes in pain and function was investigated and compared with that of age, gender, social class, pain duration, widespread pain and level of anxiety/depression. RESULTS: Over the initial three months of follow-up, changes in mean pain intensity reflected an improvement, with little change occurring after this period. Participants with knee pain due to osteoarthritis (OA) showed poorer long-term outcome (mean difference in pain reduction at 12 months -1.85, 95% CI -2.12 to -1.57, compared to low back pain). Increasing age, manual work, longer pain duration, widespread pain and increasing anxiety/depression scores were significantly associated with poorer outcome regardless of pain site. Testing of interactions showed some variation between pain sites, particularly for knee OA, where age, manual work and pain duration were most strongly associated with outcome. CONCLUSIONS: Despite some differences in prognostic factors for trial participants with knee OA who were older and had more chronic conditions, similarity of outcome predictors across regional MSK pain sites provides evidence to support targeting of treatment based on prognostic factors rather than site of pain. SIGNIFICANCE: Individual patient data analysis of trials across different regional musculoskeletal pain sites was used to evaluate course and prognostic factors associated with pain and disability. Overall, similarity of outcome predictors across these different pain sites supports targeting of treatment based on prognostic factors rather than pain site alone.

The feasibility and acceptability of a physical activity intervention for older people with chronic musculoskeletal pain: The iPOPP pilot trial protocol.

INTRODUCTION: This pilot trial will inform the design and methods of a future full-scale randomized controlled trial (RCT) and examine the feasibility, acceptability and fidelity of the Increasing Physical activity in Older People with chronic Pain (iPOPP) intervention, a healthcare assistant (HCA)-supported intervention to promote walking in older adults with chronic musculoskeletal pain in a primary care setting. METHODS AND ANALYSIS: The iPOPP study is an individually randomized, multicentre, three-parallel-arm pilot RCT. A total of 150 participants aged ≥65 years with chronic pain in one or more index sites will be recruited and randomized using random permuted blocks, stratified by general practice, to: (i) usual care plus written information; (ii) pedometer plus usual care and written information; or (iii) the iPOPP intervention. A theoretically informed mixed-methods approach will be employed using semi-structured interviews, audio recordings of the HCA consultations, self-reported questionnaires, case report forms and objective physical activity data collection (accelerometry). Follow-up will be conducted 12 weeks post-randomization. Collection of the quantitative data and statistical analysis will be performed blinded to treatment allocation, and analysis will be exploratory to inform the design and methods of a future RCT. Analysis of the HCA consultation recordings will focus on the use of a checklist to determine the fidelity of the iPOPP intervention delivery, and the interview data will be analysed using a constant comparison approach in order to generate conceptual themes focused around the acceptability and feasibility of the trial, and then mapped to the Theoretical Domains Framework to understand barriers and facilitators to behaviour change. A triangulation protocol will be used to integrate quantitative and qualitative data and findings.

Comparison of physical treatments versus a brief pain-management programme for back pain in primary care: a randomised clinical trial in physiotherapy practice.

BACKGROUND: Recommendations for the management of low back pain in primary care emphasise the importance of recognising and addressing psychosocial factors at an early stage. We compared the effectiveness of a brief pain-management programme with physiotherapy incorporating manual therapy for the reduction of disability at 12 months in patients consulting primary care with subacute low back pain. METHODS: For this pragmatic, multicentre, randomised clinical trial, eligible participants consulted primary care with non-specific low back pain of less than 12 weeks' duration. They were randomly assigned either a programme of pain management (n=201) or manual therapy (n=201). The primary outcome was change in the score on the Roland and Morris disability questionnaire at 12 months. Analysis was by intention to treat. FINDINGS: Of 544 patients assessed for eligibility, 402 were recruited (mean age 40.6 years) and 329 (82%) reached 12-month follow-up. Mean disability scores were 13.8 (SD 4.8) for the pain-management group and 13.3 (4.9) for the manual-therapy group. The mean decreases in disability scores were 8.8 (6.4) and 8.8 (6.1) at 12 months (difference 0 [95% CI -1.3 to 1.4], p=0.99), and median numbers of physiotherapy visits per patient were three (IQR one to five) and four (two to five), respectively (p=0.001). One adverse reaction (an exacerbation of pain after the initial assessment) was recorded. INTERPRETATION: Brief pain management techniques delivered by appropriately trained clinicians offer an alternative to physiotherapy incorporating manual therapy and could provide a more efficient first-line approach for management of non-specific subacute low back pain in primary care.

Adverse reactions to disease-modifying anti-rheumatic drugs in clinical practice.

We analysed computerized records of disease-modifying anti-rheumatic drug (DMARD) monotherapy to determine how long rheumatoid arthritis (RA) patients continued on five commonly prescribed DMARDs, and the incidence and time-course of adverse drug reactions (ADRs) they experienced. We studied the records for 3923 courses of DMARDs given to a cohort of 2170 patients monitored for a total of 9378 treatment-years. Methotrexate (MTX) was the DMARD most likely to be continued long-term; <45% of patients had discontinued the drug after 96 months. For the other DMARDs, the time until 50% discontinued due to ADRs or inefficacy was 43.3 months for sulphasalazine (SAS), 33.9 months for D-penicillamine (DPN) and 26 months for myocrisin. Most monitored ADRs requiring drug discontinuation were seen early in therapy, with a median time to onset of <6 months; the important exceptions to this were haematological ADRs to MTX, where the median delay to neutropenia was 16.9 months, and that to thrombocytopenia was 9.4 months. Monitored ADRs (identified by blood or urine tests) were seen least frequently with SAS (one ADR in every 35 patient-years of monitoring) but this apparent advantage was offset by a high incidence of gastrointestinal ADRs and inefficacy. Overall, one toxicity reaction requiring drug discontinuation was identified for every 15.9 patient-years of monitoring.

Corticosteroid injections for lateral epicondylitis: a systematic overview.

BACKGROUND: Lateral epicondylitis (tennis elbow) is a common complaint, for which corticosteroid injections are a frequently applied therapy. However, there were no up-to-date reviews available that systematically addressed the effectiveness and adverse effects, including questions concerning optimal timing of injections and composition of the injection fluid. AIM: The aim of the study was to assess the effectiveness of corticosteroid injections in the treatment of lateral epicondylitis (tennis elbow) by systematic review of the available randomized clinical trials. DATA SOURCES: The data sources used were randomized clinical trials identified by literature searches of the MedLine (1966-1994) and Embase (Exerpta Medica) (1980-1994) databases for the keywords epicondylitis, tendinitis and elbow, injection. References given in relevant publications were further examined. STUDY SELECTION: The criteria for selecting studies were as follows: randomized clinical trials (treatment allocation in random or alternate order); one of the treatments to include one or more corticosteroid injections (additional interventions were allowed); participants suffering from lateral epicondylitis; and publication in English, German or Dutch. Abstracts and unpublished studies were not included. DATA SYNTHESIS: Methodological quality was assessed by means of a standardized criteria list (range 1-100 points). The extracted outcomes were the general conclusion drawn by the authors of the reports on the trials, and the success rates at the various follow-up points as (re)calculated by us. The success rates were subsequently graphically displayed and statistically pooled. Separate stratified analyses were conducted according to a predetermined analysis plan. RESULTS: Twelve randomized clinical trials were identified. The median methodological score was 40 points, indicating an overall poor to moderate quality. The pooled analysis indicated short-term effectiveness (2-6 weeks): pooled odds ratio (OR) = 0.15 [95% confidence interval (CI) 0.10-0.23], chi 2 [degrees of freedom (df = 5) = 13.3], indicating statistical heterogeneity. At longer term follow-up, no difference could be detected. The studies of better methodological quality indicated more favourable results than those of lesser methodological quality. The most suitable corticosteroid to use as well as dosage, injection interval and injection volume could not be derived from the various trials. CONCLUSION: The existing evidence on corticosteroid injections for the treatment of tennis elbow is not conclusive. Many trials were conducted in a secondary care setting and clearly had serious methodological flaws, and there was statistical heterogeneity among the trials. Corticosteroid injections appear to be relatively safe and seem to be effective in the short term (2-6 weeks). Although the treatment seems to be suitable for application in general practice, further trials in this setting are needed. As yet, questions regarding the optimal timing, dosage, injection technique and injection volume remain unanswered.

Pragmatic randomised controlled trial of local corticosteroid injection and naproxen for treatment of lateral epicondylitis of elbow in primary care.

OBJECTIVE: To compare the clinical effectiveness of local corticosteroid injection, standard non-steroidal anti-inflammatory drugs, and simple analgesics for the early treatment of lateral epicondylitis in primary care. DESIGN: Multicentre pragmatic randomised controlled trial. SETTING: 23 general practices in North Staffordshire and South Cheshire. PARTICIPANTS: 164 patients aged 18-70 years presenting with a new episode of lateral epicondylitis. INTERVENTIONS: Local injection of 20 mg methylprednisolone plus lignocaine, naproxen 500 mg twice daily for two weeks, or placebo tablets. All participants received a standard advice sheet and co-codamol as required. MAIN OUTCOME MEASURES: Participants' global assessment of improvement (five point scale) at four weeks. Pain, function, and "main complaint" measured on 10 point Likert scales at 4 weeks, 6 months, and 12 months. RESULTS: Over 2 years, 53 subjects were randomised to injection, 53 to naproxen, and 58 to placebo. Prognostic variables were similar between groups at baseline. At 4 weeks, 48 patients (92%) in the injection group were completely better or improved compared with 30 (57%) in the naproxen group (P<0.001) and 28 (50%) in the placebo group (P<0.001). At 12 months, 43 patients (84%) in the injection group had pain scores 0.05). CONCLUSIONS: Early local corticosteroid injection is effective for lateral epicondylitis. Outcome at one year was good in all groups, and effective early treatment does not seem to influence this.

Integrating physical and psychological approaches to treatment in low back pain: the development and content of the STarT Back trial's 'high-risk' intervention (StarT Back; ISRCTN 37113406).

A new randomised controlled trial of intervention in low back pain has been described recently. In this trial, a screening and targeted approach was found to be more effective and cost-effective than current best practice. Nested within the intervention arm were three different interventions targeting patients identified as 'low', 'medium' or 'high' risk dependent on the presence of (mainly) psychosocial risk factors. In this paper, the development and content of the STarT Back trial's 'high-risk' intervention is described. It offers a systematic approach, termed 'psychologically informed practice', to the integration of physical and psychological approaches to treatment for the management of people with low back pain by physiotherapists. The term 'disability' is used to refer to self-reported pain-associated functional limitations, and 'psychological' is used to refer to the beliefs/expectations, emotional responses and behavioural responses associated with low back pain.

A systematic search and narrative review of radiographic definitions of hand osteoarthritis in population-based studies.

OBJECTIVE: Currently there is no agreed "gold standard" definition of radiographic hand osteoarthritis (RHOA) for use in epidemiological studies. We therefore undertook a systematic search and narrative review of community-based epidemiological studies of hand osteoarthritis (OA) to identify (1) grading systems used, (2) definitions of radiographic OA for individual joints and (3) definitions of overall RHOA. METHODS: The following electronic databases were searched: Medline, Embase, Science Citation Index and Ageline (inception to Dec 2006). The search strategy combined terms for "hand" and specific joint sites, OA and radiography. Inclusion and exclusion criteria were applied. Data were extracted from each paper covering: hand joints studied, grading system used, definitions applied for OA at individual joints and overall RHOA. RESULTS: Titles and abstracts of 829 publications were reviewed and the full texts of 399 papers were obtained. One hundred fifty-two met the inclusion criteria and 24 additional papers identified from screening references. Kellgren and Lawrence (K&L) was the most frequently applied grading system used in 80% (n=141) of studies. In 71 studies defining OA at the individual joint level 69 (97%) used a definition of K&L grade > or = 2. Only 53 publications defined overall RHOA, using 21 different definitions based on five grading systems. CONCLUSION: The K&L scheme remains the most frequently used grading system. There is a consistency in defining OA in a single hand joint as K&L grade > or = 2. However, there are substantial variations in the definitions of overall RHOA in epidemiological studies.

A brief pain management program compared with physical therapy for low back pain: results from an economic analysis alongside a randomized clinical trial.

OBJECTIVE: Guidelines for the management of acute low back pain in primary care recommend early intervention to address psychosocial risk factors associated with long-term disability. We assessed the cost utility and cost effectiveness of a brief pain management program (BPM) targeting psychosocial factors compared with physical therapy (PT) for primary care patients with low back pain of <12 weeks' duration. METHODS: A total of 402 patients were randomly assigned to BPM or PT. We adopted a health care perspective, examining the direct health care costs of low back pain. Outcome measures were quality-adjusted life years (QALYs) and 12-month change scores on the Roland and Morris disability questionnaire. Resource use data related to back pain were collected at 12-month followup. Cost effectiveness was expressed as incremental ratios, with uncertainty assessed using cost-effectiveness planes and acceptability curves. RESULTS: There were no statistically significant differences in mean health care costs or outcomes between treatments. PT had marginally greater effectiveness at 12 months, albeit with greater health care costs (BPM 142 pounds, PT 195 pounds). The incremental cost-per-QALY ratio was 2,362 pounds. If the UK National Health Service were willing to pay 10,000 pound per additional QALY, there is only a 17% chance that BPM provides the best value for money. CONCLUSION: PT is a cost-effective primary care management strategy for low back pain. However, the absence of a clinically superior treatment program raises the possibility that BPM could provide an additional primary care approach, administered in fewer sessions, allowing patient and doctor preferences to be considered.

Prevalence of radiographic osteoarthritis--it all depends on your point of view.

OBJECTIVES: Knee pain and disability in older people may occur in the apparent absence of radiographic osteoarthritis. However, the view chosen to define radiographic osteoarthritis may be critical. We have investigated the prevalence and compartmental distribution of radiographic osteoarthritis in people with knee pain using different combinations of three separate radiographic views. METHODS: We performed a population-based study of 819 adults aged 50 yr and over with knee pain (part of the Clinical Assessment Study - Knee [CAS(K)]). Three radiographic views were obtained: weight-bearing posteroanterior (PA) semiflexed/metatarsophalangeal view; supine skyline; and supine lateral. RESULTS: Complete data for all three views were available on 777 subjects. The distribution of compartmental radiographic osteoarthritis was 314 (40%) combined tibiofemoral/patellofemoral, 186 (24%) isolated patellofemoral, 31 (4%) isolated tibiofemoral and 246 (32%) normal. Hence, the overall prevalence of radiographic osteoarthritis was 531/777 (68.3%) in this symptomatic population. Using a PA view alone (reflecting tibiofemoral osteoarthritis only) would identify 56.7% of the 531, whilst the addition of a skyline or lateral view increased this to 87.0%. When using both skyline and lateral views in addition to the PA view, 98.7% cases of radiographic osteoarthritis were identified. In addition to prevalence, compartmental distribution altered markedly when different combinations of views were used. CONCLUSIONS: Multiple views detect more radiographic osteoarthritis than single views alone. When different combinations of views are used, the prevalence and compartmental distribution of osteoarthritis changes and this may alter the accepted relationship, or lack of it, between symptoms and radiographic change.

A systematic search and critical review of measures of disability for use in a population survey of hand osteoarthritis (OA).

OBJECTIVE: In order to develop a hand assessment questionnaire for a population survey, a systematic review was undertaken of measures of hand disability. The purpose of this review was to identify valid measures to evaluate hand osteoarthritis (HOA) in the general population and primary care and to perform a quality appraisal of them. METHOD: Measurement tools were identified from an online search of databases (Medline, CINAHL and Institute for Scientific Information (ISI), 1990-2002) restricted to English language and adult population. Search terms combined "osteoarthritis" and "arthritis" with "hand" and ["function" or "disability" or "outcome"]. Instruments used in the evaluation of HOA were identified following application of strict eligibility criteria. The use of these tools in HOA was rated by pairs of independent reviewers according to criteria developed by the Medical Outcomes Trust. RESULTS: The initial search yielded a list of articles which were not mutually exclusive (ISI, 127; Medline, 64; CINAHL, 61). Full journal articles were ordered from relevant abstracts (ISI, 28; Medline, 3; CINAHL, 5). Further hand searching of articles produced an additional 34 references. A total of 61 references were identified, 18 measurement tools, 5 of which met the inclusion criteria [Algofunctional Index (FIHOA), Arthritis Impact Measurement Scale 2 (AIMS2), Stanford Health Assessment Questionnaire (HAQ), Australian/Canadian Osteoarthritis Hand Index (AUSCAN), Cochin]. Overall, the AIMS2 and AUSCAN were more highly rated than the FIHOA, Cochin and HAQ. CONCLUSIONS: The aim of this review was not to recommend any one instrument over another but to provide an overall summary of the robustness of commonly used measures. The choice of instrument will depend on many factors, and will differ from project to project depending on the question asked.

A cost consequences analysis of local corticosteroid injection and physiotherapy for the treatment of new episodes of unilateral shoulder pain in primary care.

OBJECTIVE: Local steroid injections and community-based physiotherapy have been shown to be of similar benefit for treating shoulder pain presenting to primary care. This paper presents a cost consequences analysis of a prospective economic evaluation, conducted alongside a randomized clinical trial (RCT) of corticosteroid injections versus physiotherapy for new episodes of unilateral shoulder pain, to determine the economic implications of injection versus physiotherapy. METHODS: A pragmatic RCT with 207 patients randomized to either physiotherapy (n = 103) or local steroid injection (n = 104) was conducted. The resource inputs required were identified for each treatment arm in terms of capital, staff and consumables. These were measured for the period up to 6 months post-randomization. Outcome measures included shoulder disability, shoulder pain, global assessment of health change and the EQ5D, all at 6 months. A sensitivity analysis was performed around the general practitioner minor surgical fee. RESULTS: Analysis is presented on the 199 patients for which the general practice record review (101 physiotherapy, 98 injection) was available. The total mean costs, per patient, were 71.28 pound sterling for the injection group and 114.60 pound sterling for the physiotherapy group. The difference in average total cost per patient was 43.32 pound sterling (95% bootstrap confidence interval: 16.21 pound sterling, 68.03 pound sterling ). This is a statistically significant difference in cost. Outcome was similar in both groups across all measures following intervention. Smaller mean differences in cost were observed between the treatment groups in the sensitivity analysis, but the difference remained in favour of injection over physiotherapy. CONCLUSIONS: This study has shown, given similar clinical outcomes across the treatment groups, that corticosteroid injections were the cost-effective option for patients presenting with new episodes of unilateral shoulder pain in primary care.

A comparison of two primary care trials on tennis elbow: issues of external validity.

OBJECTIVE: To assess clinical heterogeneity across two studies with respect to study population, interventions, and outcome measures, and to evaluate the influence of these sources of heterogeneity on the results of the studies. METHODS: The individual patient data were used from two randomised controlled trials investigating the effectiveness of conservative treatments in patients with tennis elbow in primary care. Patients were allocated at random to treatment with steroid injection, wait and see policy, non-steroidal anti-inflammatory drugs, placebo tablets, or physiotherapy. Outcome measures included severity of the main complaint, inconvenience of the elbow complaints, pain during the day, elbow disability, pain-free grip strength, and global improvement. All outcomes were assessed at 1, 6, and 12 months after randomisation. RESULTS: The two study populations were similar with respect to age, sex, comorbid neck/shoulder complaints, and baseline scores for the severity of pain. However, significant differences were observed for employment status, duration of elbow complaints, dominant side affected, previous history of elbow complaints, and use of analgesics. Local injections differed between the two studies with respect to volume, number, and steroid preparation. However, after 1, 6, and 12 months, the treatment effects of steroid injections were very similar between the study populations. CONCLUSIONS: Despite large differences in study population at baseline, the responses to steroid injections were remarkably similar. Also the responses to other conservative interventions and the placebo treatment were very consistent, suggesting a uniform course of a tennis elbow and a lack of influence of clinical heterogeneity.