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Objectives To determine whether physiotherapist-led exercise intervention and US-guided subacromial CS injection is cost-effective when compared with standard advice and exercise leaflet and unguided injection in patients with subacromial pain (impingement) syndrome. Methods An incremental cost–utility analysis using patient responses to the five-level EuroQoL-5D (EQ-5D-5L) questionnaire was undertaken from a healthcare perspective alongside a 2 × 2 factorial randomized trial with 256 participants over a 12-month follow-up period. Uncertainty was explored through the use of cost-effectiveness acceptability curves. Results The cost–utility analysis indicated that physiotherapist-led exercise was associated with an incremental cost of £155.99 (95% CI 69.02, 241.93) and 0.031 (95% CI −0.01, 0.07) additional quality-adjusted life-years (QALYs), an incremental cost-effectiveness ratio (ICER) of £5031 per QALY gained and an 85% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with the advice and exercise leaflet. US-guided injection was associated with an incremental cost of £15.89 (95% CI −59.36, 109.86) and 0.024 (95% CI −0.02, 0.07) additional QALYs, an ICER of £662 per QALY gained and a 83% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with unguided injection. Conclusion Physiotherapist-led exercise was cost-effective compared with the advice and exercise leaflet, and US-guided injection was cost-effective when compared with unguided injection. Clinical trial registration ISRCTN, http://www.isrctn.com, ISRCTN42399123

BackgroundPolymyalgia rheumatica (PMR) is one of the most common inflammatory arthritic disorders seen in older individuals. Most patients with PMR are diagnosed and managed exclusively in general practice, yet primary care-focused research is lacking.AimTo identify and explore the challenges of diagnosis and management of PMR in general practice.Design and settingA multi-methods study in UK primary care.MethodThe multi-methods study comprised two complementary studies: a national questionnaire survey of 5000 randomly selected GPs from across the UK; and a qualitative semi-structured telephone interview study of UK GPs. Simple descriptive statistics were used to analyse questionnaire data. A thematic approach was used to analyse verbatim transcripts of the GP interviews.ResultsIn total, 1249 (25%) GPs responded to the questionnaire survey. From this total, 24 GPs were interviewed for the qualitative study. Features used by GPs to identify PMR were largely in line with current guidance. Diagnosis was found to be challenging, with GPs relying heavily on response to treatment with glucocorticoids. Investigations advised by current British PMR guidance to attempt to rule out other causes for symptoms were not routinely requested. Concerns surrounding ongoing treatment with glucocorticoids were widespread in relation to both potential adverse effects and ongoing monitoring.ConclusionFocused strategies to investigate and therefore exclude non-PMR differential diagnoses are required for patients with new-onset suspected PMR symptoms. Additionally, ongoing active review for alternative causes for symptoms as well as vigilance for treatment complications needs to be implemented.

Background Management of musculoskeletal conditions in the UK is increasingly delivered in multidisciplinary clinical assessment and treatment services (CATS) at the primary–secondary care interface. However, there is little evidence concerning the characteristics and management of patients attending CATS. Aim To describe the characteristics, investigation, and treatment of adults attending a musculoskeletal CATS. Design and setting Cross-sectional analysis of cohort study baseline data from a musculoskeletal CATS in Stoke-on-Trent Primary Care Trust, UK. Method All patients referred from primary care between February 2008 and June 2009 were mailed a pre-consultation questionnaire concerning pain duration, general health status, anxiety, depression, employment status, and work absence due to musculoskeletal problems. At the consultation, clinical diagnoses, body region(s) affected, investigations, and treatment were recorded. Result A total of 2166 (73%) completed questionnaires were received. Chronic pain duration >1 year (55%), major physical limitation (76%), anxiety (49%), and depression (37%) were common. Of those currently employed, 516 (45%) had taken time off work in the last 6 months because of their musculoskeletal problem; 325 (29%) were unable to do their usual job. The most frequent investigations were X-rays (23%), magnetic resonance imaging (18%), and blood tests (14%): 1012 (48%) received no investigations. Injections were performed in 282 (13%) and 492 (23%) were referred to physiotherapy. Conclusion Although most patients presented with musculoskeletal problems suitable for CATS, chronic pain, physical limitation, anxiety, depression, and work disability were commonplace, highlighting the need for a biopsychosocial model of care that addresses psychological, social, and work-related needs, as well as pain and physical disability.

BACKGROUND: The aim was to characterise the sociodemographic, general health and polymyalgia rheumatica (PMR)-specific features of participants in a large inception cohort of patients with PMR diagnosed in UK primary care. METHODS: Patients (n = 739) with a new diagnosis of PMR were referred into the study and mailed a questionnaire detailing their general health and sociodemographic characteristics in addition to the symptoms of and treatment for PMR. Characteristics of responders and non-responders were compared and descriptive statistics were used to characterise the health of the cohort. RESULTS: A total of 654 individuals responded to the questionnaire (adjusted response 90.1 %). Responders and non-responders were similar in age, gender and deprivation (based on postcode). The mean (standard deviation) age of the recruited cohort was 72.4 (9.3) years; 62.2 % were female. The sample reported high levels of pain and stiffness (8 out of 10 on numerical rating scales) and reported stiffness that lasted throughout the day. High levels of functional impairment, fatigue, insomnia and polypharmacy were also reported. Overall, women reported worse general and PMR-specific health than did men. CONCLUSIONS: This first primary care cohort of patients with incident PMR is similar in demographic terms to cohorts recruited in secondary care. However, the extent of symptoms, particularly reported stiffness, is higher than has been described previously. Given the majority of patients with PMR are exclusively managed in primary care, this cohort provides important information on the course of PMR in the community that will help clinicians managing this painful and disabling condition.

Objectives To determine (1) reconsultation frequency, (2) change in self-reported health status, (3) baseline factors associated with reconsultation and change in health status and (4) associated healthcare costs and quality-adjusted life-years (QALYs), following assessment at a musculoskeletal Clinical and Assessment Treatment Service (CATS). Design Prospective cohort study. Setting Single musculoskeletal CATS at the primary–secondary care interface. Participants 2166 CATS attenders followed-up by postal questionnaires at 6 and 12 months and review of medical records. Outcome measures Primary outcome was consultation in primary care with the same musculoskeletal problem within 12 months. Secondary outcome measures were consultation at the CATS with the same musculoskeletal problem within 12 months, physical function and pain (Short Form-36), anxiety and depression (Hospital Anxiety and Depression Scale), time off work, healthcare costs and QALYs. Results Over 12 months, 507 (38%) reconsulted for the same problem in primary care and 345 (26%) at the CATS. Primary care reconsultation in the first 3 months was associated with baseline pain interference (relative risk ratio 5.33; 95% CI 3.23 to 8.80) and spinal pain (1.75; 1.09 to 2.82), and after 3–6 months with baseline assessment by a hospital specialist (2.06; 1.13 to 3.75). Small mean improvements were seen in physical function (1.88; 95% CI 1.44 to 2.32) and body pain (3.86; 3.38 to 4.34) at 6 months. Poor physical function at 6 months was associated with obesity, chronic pain and poor baseline physical function. Mean (SD) 6-month cost and QALYs per patient were £422.40 (660.11) and 0.257 (0.144), respectively. Conclusions While most patients are appropriate for a ‘one-stop shop’ model, those with troublesome, disabling pain and spinal pain commonly reconsult and have ongoing problems. Services should be configured to identify and address such clinical complexity.

Background Polymyalgia Rheumatica (PMR) is the commonest inflammatory condition seen in older patients in primary care. To date, however, research has been focused on secondary care cohorts rather than primary care where many patients are exclusively managed. This two year prospective inception cohort study of PMR patients will enable us to understand the full spectrum of this condition. Methods Patients diagnosed with PMR in primary care will be identified via Read codes and mailed a series of postal questionnaires over a two-year period to assess their levels of pain, stiffness and functioning, as well as medication usage and other health-related and socio-demographic characteristics. In addition, participants will be asked for permission to link their survey data to their general practice electronic medical record and to national mortality and cancer registers. Discussion This will be the first large-scale, prospective, observational cohort of PMR patients in primary care. The combination of survey data with medical records and national registers will allow for a full investigation of the natural history and prognosis of this condition in the primary care setting, in which the majority of patients are treated, but where little research on the treatment and outcome of consultation has been undertaken. This will provide information that may lead to improved primary care management of PMR.

This study assessed the feasibility of a 12-week program of exercise, with and without intramuscular testosterone supplementation, in male patients with chronic heart failure (CHF) and low testosterone status and collected preliminary data for key health outcomes.Male patients with CHF (n = 41, age 67.2 years, range 51-84 years) with mean ± SD testosterone levels of 10.7 ± 2.6 nmol/L (309 ± 76 ng/dL) were randomly allocated to exercise with testosterone or placebo groups. Feasibility was assessed in terms of recruitment, intervention compliance, and attrition. Outcomes included an incremental shuttle walk test, peak oxygen uptake, muscular strength, echocardiographic measures, N-terminal pro-brain natriuretic peptide, inflammatory markers, depression (Beck Depression Inventory), and health-related quality of life (Minnesota Living with Heart Failure Questionnaire and Medical Outcomes Study Short-Form).Attrition was 30% but with 100% compliance to exercise and injections in patients who completed the study. Similar improvements in shuttle walk test (18% vs 19%), body mass (-1.3 kg vs -1.0 kg), and hand grip strength (2.1 kg vs 2.5 kg) from baseline were observed in both groups. The exercise with testosterone group showed improvements from baseline in peak oxygen uptake (P.01), Beck Depression Inventory (P.05), leg strength (P.05), and several Medical Outcomes Study Short-Form quality of life domains (P.05), which were generally not apparent in the exercise with placebo group. Echocardiographic measures, N-terminal pro-brain natriuretic peptide, and inflammatory markers were mostly unchanged.This study shows for the first time that testosterone supplementation during a program of exercise rehabilitation is feasible and can positively impact on a range of key health outcomes in elderly male patients with CHF who have a low testosterone status.

Background Testosterone deficiency is a common occurrence in men with chronic heart failure (CHF) and may underpin features of advanced disease, including reduced skeletal muscle mass and fatigue. It is positively correlated with cardiac output and exercise capacity in patients with CHF, whereas a significant improvement in both these parameters has been observed following testosterone replacement therapy. Testosterone therapy has also been shown to reduce circulating levels of inflammatory markers, (TNF-α, sICAM-1 and sVCAM-1) in patients with established coronary artery disease and testosterone deficiency. This pilot study will assess the feasibility of a combined exercise rehabilitation and adjunctive testosterone therapy intervention for evoking improvements in exercise capacity, circulating inflammatory markers, cardiac and skeletal muscle function, indices of psychological health status and quality of life in hypogonadal males with chronic heart failure. Methods/design Following ethical approval, 36 patients will be randomly allocated to one of two groups: testosterone or placebo therapy during exercise rehabilitation. A combined programme of moderate intensity aerobic exercise and resistance (strength) training will be used. The primary outcome measure is exercise capacity, assessed using an incremental shuttle walk test. Secondary outcome measures include measures of peak oxygen uptake, cardiac function, lower-limb skeletal muscle contractile function and oxygenation during exercise, circulating inflammatory markers, psychological health status and quality of life. Discussion Exercise rehabilitation can safely increase exercise capacity in stable CHF patients but there is a need for studies which are aimed at evaluating the long-term effects of physical training on functional status, morbidity and mortality. This pilot study will provide valuable preliminary data on the efficacy of testosterone therapy as an adjunct to exercise rehabilitation on a range of functional, physiological and health-related outcomes in this patient population. Preliminary data will be used in the design of a large-scale randomised controlled trial, aimed at informing clinical practice with respect to optimisation of exercise rehabilitation in this patient group.

ObjectivesTo investigate the effects of a 24-week program of upper- and lower-limb aerobic exercise training on walking performance in patients with symptomatic peripheral arterial disease (PAD) and to study the mechanisms that could influence symptomatic improvement.MethodsAfter approval from the North Sheffield Local Research Ethics Committee, 104 patients (median age, 69 years; range, 50 to 85 years) with stable PAD were randomized into an upper- or lower-limb aerobic exercise training group (UL-Ex or LL-Ex), or to a nonexercise training control group. Training was performed twice weekly for 24 weeks at equivalent relative exercise intensities. An incremental arm- and leg-crank test (ACT and LCT) to maximum exercise tolerance was performed before and at 6, 12, 18, and 24 weeks of the intervention to determine peak oxygen consumption (V̇O2). Walking performance, defined as the claudicating distance (CD) and maximum walking distance (MWD) achieved before intolerable claudication pain, was assessed at the same time points by using a shuttle-walk protocol. Peak blood lactate concentration, Borg ratings of perceived exertion (RPE) and pain category ratio (CR-10) were recorded during all assessments.ResultsCD and MWD increased over time (P < .001) in both training groups. At 24 weeks, CD had improved by 51% and 57%, and MWD had improved by 29% and 31% (all P < .001) in the UL-Ex and LL-Ex groups, respectively. An increase in peak heart rate at MWD in the UL-Ex group (109 ± 4 vs 115 ± 4 beats/min; P < .01) and LL-Ex group (107 ± 3 vs 118 ± 3 beats/min; P = .01) was accompanied by an increase in the amount of pain experienced in both groups (P < .05), suggesting that exercising patients could tolerate a higher level of cardiovascular stress and an increased intensity of claudication pain before test termination after training. Patients assigned to exercise training also showed an increase in LCT peak V̇O2 at the 24-week time point in relation to baseline (P < .01) and control patients (P < .01), whereas ACT peak V̇O2 was only improved in the UL-Ex group (P < .05).ConclusionsOur results suggest that a combination of physiologic adaptations and improved exercise pain tolerance account for the improvement in walking performance achieved through upper-limb aerobic exercise training in patients with PAD. Furthermore, that both arm- and leg-crank training could be useful exercise training modalities for improving cardiovascular function, walking performance, and exercise pain tolerance in patients with symptomatic PAD.