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Introduction: We analysed baseline measures from an RCT involving adults with low back pain (LBP) with or without referred leg pain, to identify self-report items that best identified clinically determined nerve root involvement (sciatica). Methods: Potential indicators of nerve root involvement were gathered using a self-reported questionnaire. Participants underwent a standardised physical examination on the same day as questionnaire completion. Self-reported items were compared to a reference standard (clinical diagnosis) using sensitivity, specificity, predictive values, likelihood ratios (LRs), the area under the receiver operating characteristic curve and logistic regression. Two reference standards are presented: one based on a clinical diagnosis of nerve root problems and excluding possible/inconclusive cases (referred to as a confirmatory reference), and the other being inclusive of possible/inconclusive cases (referred to as an indicative reference). Results: Pain below knee was the best single item for diagnostic accuracy with an area under curve (AUC) of 0.67-0.68, which however is slightly less than the 'acceptable discrimination'. A cluster of three items, including distribution of pain below the knee, leg pain that is worse than back pain, and feeling of numbness or pins and needles in the leg, did improve discrimination to an 'acceptable' level with an AUC of 0.72-0.74 in relation to confirmatory and indicative references, respectively. However, the likelihood ratios from the models were reflective of a 'small' amount of discrimination. Conclusion: In this primary care population seeking treatment for LBP with or without leg pain, we found no clear set of self-report items that accurately identified patients with nerve root pain. When accurate case definition is important, clinical assessment should be the method of choice for identifying LBP with possible nerve root involvement. [ABSTRACT FROM AUTHOR]

Objectives Stratified management for low back pain according to patients' prognosis and matched care pathways has been shown to be an effective treatment approach in primary care. The aim of this within-trial study was to determine the economic implications of providing such an intervention, compared with non- stratified current best practice, within specific risk-defined subgroups (low-risk, medium-risk and high-risk). Methods Within a cost-utility framework, the base-case analysis estimated the incremental healthcare cost per additional quality-adjusted life year (QALY), using the EQ-5D to generate QALYs, for each risk-defined subgroup. Uncertainty was explored with cost-utility planes and acceptability curves. Sensitivity analyses were performed to consider alternative costing methodologies, including the assessment of societal loss relating to work absence and the incorporation of generic (ie, non-back pain) healthcare utilisation. Results The stratified management approach was a cost-effective treatment strategy compared with current best practice within each risk-defined subgroup, exhibiting dominance (greater benefit and lower costs) for medium-risk patients and acceptable incremental cost to utility ratios for low-risk and high-risk patients. The likelihood that stratified care provides a cost-effective use of resources exceeds 90% at willingness-to-pay thresholds of £4000 (~ 4500; $6500) per additional QALY for the medium-risk and high-risk groups. Patients receiving stratified care also reported fewer back pain-related days off work in all three subgroups. Conclusions Compared with current best practice, stratified primary care management for low back pain provides a highly cost-effective use of resources across all risk-defined subgroups. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To investigate methods to determine the size of a pilot study to inform a power calculation for a randomized controlled trial (RCT) using an interval/ratio outcome measure. Study Design: Calculations based on confidence intervals (CIs) for the sample standard deviation (SD). Results: Based on CIs for the sample SD, methods are demonstrated whereby (1) the observed SD can be adjusted to secure the desired level of statistical power in the main study with a specified level of confidence; (2) the sample for the main study, if calculated using the observed SD, can be adjusted, again to obtain the desired level of statistical power in the main study; (3) the power of the main study can be calculated for the situation in which the SD in the pilot study proves to be an underestimate of the true SD; and (4) an “efficient” pilot size can be determined to minimize the combined size of the pilot and main RCT. Conclusion: Trialists should calculate the appropriate size of a pilot study, just as they should the size of the main RCT, taking into account the twin needs to demonstrate efficiency in terms of recruitment and to produce precise estimates of treatment effect. [Copyright &y& Elsevier]

Abstract: We evaluated whether patients with self-reported whiplash differed in perceived pain, functional limitation and prognosis from patients with other painful neck complaints. Data from three Dutch trials and an English trial were used all evaluating conservative treatment in neck pain patients in primary care. All patients had non-specific neck pain. Information on any trauma or injury came from self-report at baseline. We compared frequencies of baseline variables and outcome at short-term and long term for whiplash and non-trauma neck pain patients separately. The total study population consisted of 804 neck pain patients. Of these patients 133 reported (16.5%) that an injury was the cause of their neck pain. In all trials there were 17–18% more male patients in the whiplash group. At follow-up pain decreased between 12 and 28%, function 10%, and 25–50% of patients recovered in all trials. Post-treatment improvements in pain, function and recovery were comparable between whiplash and non-trauma patients. We also found no different prognostic factors between whiplash and non-trauma patients. Overall we found in a population with mild to moderate pain no clinically relevant differences between patients with self-reported whiplash and patients with other painful neck complaints. The findings suggest that whiplash patients with mild to moderate pain should not be considered a specific subgroup of patients with non-specific neck pain. [Copyright &y& Elsevier]

Abstract: Background: The rise in the number of patients with arthritis coupled with understaffing of medical services has seen the deployment of Clinical Nurse Specialists in running nurse-led clinics alongside the rheumatologist clinics. There are no systematic reviews of nurse-led care effectiveness in rheumatoid arthritis. Few published RCTs exist and they have shown positive results for nurse-led care but they have several limitations and there has been no economic assessment of rheumatology nurse-led care in the UK. Objective: This paper outlines the study protocol and methodology currently being used to evaluate the outcomes and cost effectiveness for patients attending rheumatology nurse-led clinics. Design and methods: A multi-centred, pragmatic randomised controlled trial with a non-inferiority design; the null hypothesis being that of ‘inferiority’ of nurse-led clinics compared to physician-led clinics. The primary outcome is rheumatoid arthritis disease activity (measured by DAS28 score) and secondary outcomes are quality of life, self-efficacy, disability, psychological well-being, satisfaction, pain, fatigue and stiffness. Cost effectiveness will be measured using the EQ-5D, DAS28 and cost profile for each centre. Power calculations: In this trial, a DAS28 change of 0.6 is considered to be the threshold for clinical distinction of ‘inferiority’. A sample size of 180 participants (90 per treatment arm) is needed to reject the null hypothesis of ‘inferiority’, given 90% power. Primary analysis will focus on 2-sided 95% confidence interval evaluation of between-group differences in DAS28 change scores averaged over 4 equidistant follow up time points (13, 26, 39 and 52 weeks). Cost effectiveness will be evaluated assessing the joint parameterisation of costs and effects. Results: The study started in July 2007 and the results are expected after July 2011. Trial registration: The International Standard Randomised Controlled Trial Number ISRCTN29803766. [Copyright &y& Elsevier]

In previous work we described a modified version of goal scaling, which enabled patients to identify a meaningful change in their condition within important areas of their lives affected by low back pain. The aim of this study was to explore the associations between goal attainment scores and disability, general health and global change in condition, with particular reference to minimal important change. This was an observational cohort study. Patients attending a multidisciplinary clinic to manage unresolving acute low back pain were interviewed using the modified goal scaling schedule, completed the Roland-Morris Disability Questionnaire and rated their general health status. They were reassessed at 3 and 6 months. Thirty-five patients were recruited. Minimal important change was identified on 67% of the goals. At follow-up, goal attainment scores were able to distinguish between 'improvers' and 'non-improvers', and these categories showed significant agreement with change in disability (Kappa = 0.865). Goal attainment was highly correlated with satisfaction (Spearman's rho = 0.88) and moderately associated with general health status (Spearman's rho = 0.40). The modified version of Goal Attainment Scaling used here may provide useful additional information about both the problems associated with, and the progress of patients who consult with low back pain in Primary Care. [ABSTRACT FROM AUTHOR]

Abstract: In psychological health treatment studies it has been shown that differences between therapists account for some of the non-specific effect of treatment but this phenomenon has not so far systematically been investigated in musculoskeletal disorders. In this study we evaluated and compared the size and potential influence of the ‘practitioner effect’ (or ‘therapist effect’) in three randomised treatment trials of low back pain and neck pain patients in primary care. We calculated the proportion of variance in outcomes attributable to differences across practitioners, i.e. the practitioner–variance partition coefficient (p–vpc). As measures of outcome, we focused on self-reported disability as the primary outcome, but we also investigated assessed psychological outcomes. The p–vpc for the disability measures ranged from 2.6% to 7.1% across trials and time points (post treatment and follow up). Estimates differed between treatment subgroups within trials; being highest in treatment subgroups assigned to psychosocial-based interventions. A ‘practitioner effect’ does exist and is more pronounced in treatments involving greater psychosocial emphasis. This has implications for both practice and research in this clinical area. It highlights the importance of patient–practitioner interactions, and the need to address practitioner effects in designing and analysing outcome studies in low back pain and neck pain in primary care. [Copyright &y& Elsevier]

The authors reflect on the guidelines in improving the quality and consistency of reporting research studies in Great Britain. They argue that most of the failed research studies are due to its poor reporting of methodological features. An overview of the guidelines in improving its quality, such as the Equator, Consort and Coreq is offered. The authors highlight that reporting research is the vital part of the study design and analysis and recommend to use the guidelines mentioned.

To investigate the co-influences of age and morbidity severity on physical health in adult family practice populations. Morbidity data in a 12-month period for 7,833 older English consulters aged 50 years and over and 6,846 Dutch consulters aged 18 years and over was linked to their physical health status obtained from cross-sectional health surveys. Individual patients were categorised using 78 consulting morbidities classified by a chronicity measure (acute, acute-on-chronic and chronic) into an ordinal scale of morbidity severity ranging from single to multiple chronicity groups. Associations between morbidity severity, age and SF-12 Physical Component Summary (PCS) score were assessed using linear regression methods. Increased age and higher morbidity severity were significantly associated with poorer physical health. Of the explained total variance in adjusted PCS scores, an estimated 43% was attributed to increasing age, 40% to morbidity severity and 17% to deprivation for English consulters; the figures were 21, 42 and 31%, respectively for Dutch consulters. The largest differences in PCS scores between severity categories were observed in the younger age groups. Morbidity severity and age mainly act separately in adversely influencing physical health. In ageing populations who will experience higher multimorbidity, this study underlines the importance that health care and public health will need to address morbidity severity and ageing as related but distinct issues. [ABSTRACT FROM AUTHOR]

Risk factors for the development of carpal tunnel syndrome in women were studied by means of a nested case-control analysis of a prospective cohort study of the health effects of oral contraception in British women. A total of 1,264 women who had a diagnosis of carpal tunnel syndrome reported by their general practitioner between 1968 and 1993 were compared with 1,264 age-matched control women who did not have this diagnosis. The syndrome was associated in older women with some hormonal factors, notably past use of oral contraception (adjusted odds ratio in women aged 40 years and over = 1.38, 95 percent confidence interval: 1.08, 1.76) and more generally with obesity (adjusted odds ratio = 1.68, 95 percent confidence interval: 1.29, 2.18). However, the strongest link was with a previous history of another musculoskeletal complaint for which consultation had been sought (adjusted odds ratio = 1.98, 95 percent confidence interval: 1.61, 2.42). Previous findings of a higher risk in women with diabetes and myxoedema were confirmed, but these contribute only a small proportion of all cases in women. There was no link with psychologic problems or nonmusculoskeletal pain complaints. The previously described increased incidence of carpal tunnel syndrome in women may be partly due to hormonal factors, but is also related to an underlying propensity to musculoskeletal problems and their higher overall frequency in women. Am J Epidemiol 2000;151:566–74. [ABSTRACT FROM PUBLISHER]

The article discusses a study which aims to develop and validate a back pain screening tool relevant to primary care settings. The study assessed the psychometric properties of the tool including concurrent and discriminant validity, internal consistency, and repeatability. Bothersomeness, catastrophizing, fear, anxiety and depression were identified as a psychosocial subscale. It was found that the tool demonstrated good reliability and validity and was acceptable to patients and clinicians.

Context Self-assessment promotes reflective practice, helps students identify gaps in their learning and is used in curricular evaluations. Currently, there is a dearth of validated self-assessment tools in rheumatology. We present a new musculoskeletal self-assessment tool (MSAT) that allows students to assess their confidence in their skills in and knowledge of knee and shoulder examination. Objectives We aimed to validate the 15-item MSAT, addressing its construct validity, internal consistency, responsiveness, repeatability and relationship with competence. Methods Participants were 241 Year 3 students in Newcastle upon Tyne and 113 Year 3 students at University College London, who were starting their musculoskeletal skills placement. Factor analysis explored the construct validity of the MSAT; Cronbach's α assessed its internal consistency; standardised response mean (SRM) evaluated its responsiveness, and test-retest, before and after a pathology lecture, assessed its repeatability. Its relationship with competence was explored by evaluating its correlation with shoulder and knee objective structured clinical examinations (OSCEs). Results The MSAT was valid in distinguishing the 5 domains it intended to measure: clinical examination of the knee; clinical examination of the shoulder; clinical anatomy of the knee and shoulder; history taking, and generic musculoskeletal anatomical and clinical terms. It was internally consistent (α = 0.93), responsive (SRM 0.6 in Newcastle and 2.2 in London) and repeatable (intraclass correlation coefficient 0.97). Correlations between MSAT scores and OSCE scores were weak ( r < 0.2). Conclusions The MSAT has strong psychometric properties, thereby offering a valid approach to evaluating the self-assessment of confidence in examination skills by students. Confidence does not necessarily reflect competence; future research should clarify what underpins confidence. [ABSTRACT FROM AUTHOR]

Background Community pharmacies are widely used in the UK, but the services they provide are changing, with pharmacists expected to take on wider roles and responsibilities. The impact of such changes will partly depend on who uses pharmacies and their illnesses. [ABSTRACT FROM PUBLISHER]

STUDY OBJECTIVE The prevalence of respiratory symptoms has been found in some studies to vary with social class. One explanation of this link may be the effect of exposure to cigarette smoke. To investigate this, the relation between social class, smoking and respiratory symptoms was explored in a population based survey. DESIGN A cross sectional survey using a validated questionnaire. SETTING Two general practices in Staffordshire, United Kingdom. PATIENTS A random sample of 4237 patients aged 16 and over from two general practices in Staffordshire were mailed a questionnaire enquiring about respiratory symptoms and their severity. MAIN RESULTS The severity of respiratory symptoms increased with increasing exposure to cigarette smoke and was greater among manual social classes. Current smokers (odds ratio (OR) = 2.9, 95% confidence limits (CI) 2.3, 3.6), past smokers (OR = 1.5, 95% CI 1.2, 1.8) and passive smokers (OR = 1.4, 95% CI 1.0, 1.8) were more likely to report the more severe respiratory symptoms compared with non-smokers. Responders from social class V (OR = 2.4, 95% CI 1.3, 4.4) were more likely to report the more severe respiratory symptoms compared with social class I, as were responders from social classes IIIM (OR = 1.3, 95% CI 0.9, 1.9) and IV (OR = 1.4, 95% CI 0.9, 2.1). These effects were independent of each other. CONCLUSIONS This study has shown that social class is linked to the severity of respiratory symptoms, independently of smoking. Although the need to reduce and quit smoking in manual class households remains a crucial preventive issue, other mechanisms by which social class differences may influence symptom occurrence and severity need to be explored. [ABSTRACT FROM PUBLISHER]

Many factors are known to influence length of stay on psychiatric wards. Korner returns were used to ascertain length of stay for all psychiatric admissions for patients aged 16–64 years to acute wards in North Staffordshire 1987–1993. Predictor variables were derived from Korner returns or obtained from the 1991 Census data. Fitting a Cox’s regression model showed that females, older patients, those with psychotic diagnoses, elective admissions, weekday admissions and admissions from relatively affluent areas had longer lengths of stay. The study demonstrates that survival techniques can be used to model length of stay on acute psychiatric wards. The predictor variables used in the study are readily available and the derived models may have value in service planning, audit and resource allocation and may be relevant to individual patient management. [ABSTRACT FROM AUTHOR]

Purpose: Cauda equina syndrome (CES) may have significant individual consequences if diagnostic delays occur. Our aim was to evaluate the presenting subjective and objective features of patients with suspected CES in comparison to those with radiologically confirmed cauda equina compression (CEC).. Methods: This was a retrospective analysis of all cases presenting with suspected CES to a tertiary emergency care unit over a two-year period. CEC was defined as radiological confirmation of CEC by Consultant Musculoskeletal (MSK) Radiologist report (MSK-CEC) and by measured canal occupancy due to an acute disc extrusion (> 75%)[measured by a Senior Spinal Surgeon (SP-CEC)]. Routine data collection was compared between categories. Chi square, multivariate regression analyses and ROC analysis of multiple predictors was performed. Results: 530 patients were included in this analysis, 60 (11.3%) had MSK-CEC, and 470 had NO- CEC. Only 43/60 (71.7%) had emergent surgery. Those with MSK-CEC and SP-CEC were statistically more likely to present with bilateral leg pain [(MSK-CEC OR 2.6, 95%CI 1.2, 5.8; p = 0.02)(SP-CEC OR 4.7, 95%CI 1.7, 12.8; p = 0.003)]; and absent bilateral ankle reflexes [(MSK-CEC OR 4.3; 95% CI 2.0, 9.6; p < 0.001)(SP CEC OR 2.5; 95%CI 1.0, 6.19; p = 0.05)] on multivariate analysis. The ROC curve analysis acceptable diagnostic utility of having SP-CEC when both are present [Area under the curve 0.72 (95%CI 0.61, 0.83); p < 0.0001]. Conclusion: This study suggests that in those presenting with CES symptoms, the presence of both bilateral leg pain and absent ankle reflexes pose an acceptable diagnostic tool to predict a large acute disc herniation on MRI scan.. Highlights: The most predictive features of radiological cauda equina compression were bilateral leg pain and absent bilateral ankle reflexes when patients present with other features of suspected CES (including any of urinary, bowel, sexual dysfunction and/or perineal sensory change). Radiological definitions of cauda equina compression vary across studies making comparisons difficult across existing evidence. In cases where there is progression of symptoms, in severity, distribution or laterality of symptoms, we would suggest a low threshold for same-day emergency imaging. [ABSTRACT FROM AUTHOR]

Background: People with low health literacy (HL) are at increased risk of poor health outcomes, and receive less benefit from healthcare services. However, healthcare practitioners can effectively adapt healthcare information if they are aware of their patients' HL. Measurements are available to assess HL levels but may not be practical for use within primary care settings. New alternative methods based on demographic indicators have been successfully developed, and we aim to test if such methodology can be applied to routinely collected consultation records. Methods: Secondary analysis was carried out from a recently completed prospective cohort study that investigated a primary care population who had consulted about a musculoskeletal pain problem. Participants completed questionnaires (assessing general health, HL, pain, and demographic information) at baseline and 6 months, with linked data from the participants' consultation records. The Single Item Literacy Screener was used as a benchmark for HL. We tested the performance of an existing demographic assessment of HL, whether this could be refined/improved further (using questionnaire data), and then test the application in primary care consultation data. Tests included accuracy, sensitivity, specificity, and area under the curve (AUC). Finally, the completed model was tested prospectively using logistic regression producing odds ratios (OR) in the prediction of poor health outcomes (physical health and pain intensity). Results: In total 1501 participants were included within the analysis and 16.1% were categorised as having low HL. Tests for the existing demographic assessment showed poor performance (AUC 0.52), refinement using additional components derived from the questionnaire improved the model (AUC 0.69), and the final model using data only from consultation data remained improved (AUC 0.64). Tests of this final consultation model in the prediction of outcomes showed those with low HL were 5 times more likely to report poor health (OR 5.1) and almost 4 times more likely to report higher pain intensity (OR 3.9). Conclusions: This study has shown the feasibility of the assessment of HL using primary care consultation data, and that people indicated as having low HL have poorer health outcomes. Further refinement is now required to increase the accuracy of this method. [ABSTRACT FROM AUTHOR]

Background: Shoulder pain is a highly prevalent complaint and disorders of the rotator cuff, including tears, are thought to be the most common cause. The number of operations repair the torn rotator cuff has risen significantly in recent years. While surgical techniques have progressed, becoming less invasive and more secure, rehabilitation programmes have remained largely like those initially developed when surgical techniques were less advanced and more invasive. Uncertainty remains in relation to the length of post-surgical immobilisation and the amount of early load permitted at the repair site. In the context of this uncertainty, current practice is to follow a generally cautious approach, including long periods of immobilisation in a sling and avoidance of early active rehabilitation. Systematic review evidence suggests early mobilisation might be beneficial but further high-quality studies are required to evaluate this.Methods/design: RaCeR is a two-arm, multi-centre pilot and feasibility randomised controlled trial with nested qualitative interviews. A total of 76 patients with non-traumatic rotator cuff tears who are scheduled to have a surgical repair will be recruited from up to five UK NHS hospitals and randomly allocated to either early patient-directed rehabilitation or standard rehabilitation that incorporates sling immobilisation. RaCeR will assess the feasibility of a future, substantive, multi-centre randomised controlled trial to test the hypothesis that, compared to standard rehabilitation incorporating sling immobilisation, early patient-directed rehabilitation is both more clinically effective and more cost-effective. In addition, a sample of patients and clinicians will be interviewed to understand the acceptability of the interventions and the barriers and enablers to adherence to the interventions.Discussion: Research to date suggests that there is the possibility of reducing the patient burden associated with post-operative immobilisation following surgery to repair the torn rotator cuff and improve clinical outcomes. There is a clear need for a high-quality, adequately powered, randomised trial to better inform clinical practice. Prior to a large-scale trial, we first need to undertake a pilot and feasibility trial to address current uncertainties about recruitment, retention and barriers to adherence to the interventions, particularly in relation to whether patients will be willing to begin moving their arm early after their operation.Trial Registration: ISRCTN Registry, 18357968 . Registered on 10 August 2018. [ABSTRACT FROM AUTHOR]

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 [ABSTRACT FROM AUTHOR]

Background: Osteoarthritis (OA) is a leading cause of pain and disability. NICE OA guidelines (2008) recommend that patients with OA should be offered core treatments in primary care. Assessments of OA management have identified a need to improve primary care of people with OA, as recorded use of interventions concordant with the NICE guidelines is suboptimal in primary care. The aim of this study was to i) describe the patient-reported uptake of non-pharmacological and pharmacological treatments recommended in the NICE OA guidelines in older adults with a self-reported consultation for joint pain and ii) determine whether patient characteristics or OA diagnosis impact uptake.Methods: A cross-sectional survey mailed to adults aged ≥45 years (n = 28,443) from eight general practices in the UK as part of the MOSAICS study. Respondents who reported the presence of joint pain, a consultation in the previous 12 months for joint pain, and gave consent to medical record review formed the sample for this study.Results: Four thousand fifty-nine respondents were included in the analysis (mean age 65.6 years (SD 11.2), 2300 (56.7%) females). 502 (12.4%) received an OA diagnosis in the previous 12 months. More participants reported using pharmacological treatments (e.g. paracetamol (31.3%), opioids (40.4%)) than non-pharmacological treatments (e.g. exercise (3.8%)). Those with an OA diagnosis were more likely to use written information (OR 1.57; 95% CI 1.26,1.96), paracetamol (OR 1.30; 95% CI 1.05,1.62) and topical NSAIDs (OR 1.30; 95% CI 1.04,1.62) than those with a joint pain code. People aged ≥75 years were less likely to use written information (OR 0.56; 95% CI 0.40,0.79) and exercise (OR 0.37; 95% CI 0.25,0.55) and more likely to use paracetamol (OR 1.91; 95% CI 1.38,2.65) than those aged < 75 years.Conclusion: The cross-sectional population survey was conducted to examine the uptake of the treatments that are recommended in the NICE OA guidelines in older adults with a self-reported consultation for joint pain and to determine whether patient characteristics or OA diagnosis impact uptake. Non-pharmacological treatment was suboptimal compared to pharmacological treatment. Implementation of NICE guidelines needs to examine why non-pharmacological treatments, such as exercise, remain under-used especially among older people. [ABSTRACT FROM AUTHOR]

Background: Evidence on the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis is limited and conflicting. The primary objective of the Hip Injection Trial (HIT) is to compare pain intensity over 6 months, in people with hip OA between those receiving an ultrasound-guided intra-articular hip injection of corticosteroid with 1% lidocaine hydrochloride plus best current treatment with those receiving best current treatment alone. Secondary objectives are to determine specified comparative clinical and cost-effectiveness outcomes, and to explore, in a linked qualitative study, the lived experiences of patients with hip OA and experiences and impact of, ultrasound-guided intra-articular hip injection.Methods: The HIT trial is a pragmatic, three-parallel group, single-blind, superiority, randomised controlled trial in patients with painful hip OA with a linked qualitative study. The current protocol is described, in addition to details and rationale for amendments since trial registration. 204 patients with moderate-to-severe hip OA will be recruited. Participants are randomised on an equal basis (1:1:1 ratio) to one of three interventions: (1) best current treatment, (2) best current treatment plus ultrasound-guided intra-articular hip injection of corticosteroid (triamcinolone acetonide 40 mg) with 1% lidocaine hydrochloride, or (3) best current treatment plus an ultrasound-guided intra-articular hip injection of 1% lidocaine hydrochloride alone. The primary endpoint is patient-reported hip pain intensity across 2 weeks, 2 months, 4 months and 6 months post-randomisation. Recruitment is over 29 months with a 6-month follow-up period. To address the primary objective, the analysis will compare participants' 'average' follow-up pain NRS scores, based on a random effects linear repeated-measures model. Data on adverse events are collected and reported in accordance with national guidance and reviewed by external monitoring committees. Individual semi-structured interviews are being conducted with up to 30 trial participants across all three arms of the trial.Discussion: To ensure healthcare services improve outcomes for patients, we need to ensure there is a robust and appropriate evidence-base to support clinical decision making. The HIT trial will answer important questions regarding the clinical and cost-effectiveness of intra-articular corticosteroid injections.Trial Registration: ISRCTN: 50550256 , 28th July 2015. [ABSTRACT FROM AUTHOR]

Background Pregnancy-related low back pain and pelvic girdle pain (LBP/PGP) are common and negatively impact the lives of many pregnant women. Several patient-based outcome instruments measure treatment effect, but there is no consensus about which measure to use with women who have these pain presentations. Objective The objective was to compare the responsiveness of 3 outcome measures in LBP/PGP: Oswestry Disability Index-version 2.0 (ODI), Pelvic Girdle Questionnaire (PGQ), and 0 to 10 numerical rating scale for pain severity (NRS); and to estimate a minimal important change (MIC) for these measures in pregnancy-related LBP/PGP. Design This was a methodology study using data from a pilot randomized controlled trial. Methods Women (N = 124) with pregnancy-related LBP/PGP were recruited to a pilot randomized controlled trial evaluating the benefit of adding acupuncture to standard care, of whom 90 completed an 8-week follow-up. Responsiveness was evaluated by examining correlation between change score and the external anchor (6-point global perceived effect scale) and by using receiver operating characteristic curve analysis. MIC was estimated using anchor-based methods. Results All measures showed good responsiveness, with areas under the receiver operating characteristic curve ranging from 0.77 to 0.90. The estimated MICs were 3.1, 11.0, 9.4, 13.3, and 1.3 for the ODI, PGQ-total, PGQ-activity, PGQ-symptoms, and NRS, respectively. All the measures, apart from ODI, had MICs larger than the measurement error. Limitations The lack of an optimal "gold standard" or external criterion for assessing responsiveness and MIC was a limitation of this study. Conclusion All 3 outcome measures demonstrated good responsiveness. MICs were derived for each instrument. The PGQ at 8 weeks postrandomization was identified as an appropriate outcome measure for pregnancy-related LBP / PGP because it is specific to these pain presentations and assesses both activity limitations and symptoms. The NRS is an efficient, shorter alternative. [ABSTRACT FROM AUTHOR]

Value of information (VOI) techniques can provide estimates of the expected benefits from clinical research studies that can inform decisions about the design and priority of those studies. Most VOI studies use decision-analytic models to characterize the uncertainty of the effects of interventions on health outcomes, but the complexity of constructing such models can pose barriers to some practical applications of VOI. However, because some clinical studies can directly characterize uncertainty in health outcomes, it may sometimes be possible to perform VOI analysis with only minimal modeling. This article 1) develops a framework to define and classify minimal modeling approaches to VOI, 2) reviews existing VOI studies that apply minimal modeling approaches, and 3) illustrates and discusses the application of the minimal modeling to two new clinical applications to which the approach appears well suited because clinical trials with comprehensive outcomes provide preliminary estimates of the uncertainty in outcomes. We conclude that minimal modeling approaches to VOI can be readily applied to in some instances to estimate the expected benefits of clinical research.Background. Federal regulations specify that print advertisements for prescription drugs and biological products must provide a true statement of information “in brief summary” about each advertised product’s “side effects, contraindications, and effectiveness.” Some of the current approaches to fulfilling the brief summary requirement, although adequate from a regulatory perspective, result in ads that may be difficult to read and understand when used in consumer-directed promotion. Objective. To explore ways in which the brief summary might be improved. Design. We conducted an experimental study that examined 300 consumers’ (mall visitors ever told that they were overweight) understanding of and preference for 4 different brief summary formats: traditional (a plain-language version of the risk sections from professional labeling), question and answer (with headings framed in the form of questions), highlights (a summary section from revised professional labeling), and prescription drug facts box (similar to the current over-the-counter drug facts label). Results. Format had several effects. For instance, participants who viewed the drug facts format were better able to recall risks (P < 0.01) and reported greater confidence to perform the tasks (P < 0.01) than those who saw the traditional format. Differences in preference were noted; for example, the drug facts format was ranked highest, followed by the question-and-answer format, the traditional format, and finally the highlights format (P < 0.001). Conclusions. Taken together, these data suggest that the traditional method of conveying information in the brief summary is neither the most comprehensible nor the most preferred by consumers. These data provide policy makers and researchers with important information regarding the role of format in consumers’ understanding of the brief summary.Background. Group mean estimates and their underlying distributions are the focus of assessment for cost and outcome variables in economic evaluation. Research focusing on the comparability of alternative preference–based measures of health-related quality of life has typically focused on analysis of individual-level data within specific clinical specialties or community-based samples. Purpose. To explore the relationship between group mean scores for the EQ-5D and SF-6D across the utility scoring range. Data Sources. Studies were identified via a systematic search of 13 online electronic databases, a review of reference lists of included papers, and hand searches of key journals. Study Selection. Studies were included if they reported contemporaneous mean EQ-5D and SF-6D health state scores. Data Extraction. All (sub)group comparisons of group mean EQ-5D and SF-6D ... [ABSTRACT FROM PUBLISHER]

Objectives: The Hip Injection Trial (HIT) compared the effectiveness of adding a single ultrasound‐guided intra‐articular injection of either corticosteroid and local anaesthetic or local anaesthetic alone to advice and education among people with hip osteoarthritis (OA). This nested qualitative study explored participants' experiences of living with hip OA and of the trial treatment they received. Method: Semi‐structured telephone interviews were undertaken with a purposeful sample of trial participants after a 2‐month trial follow‐up. Interviewers were blinded to which injection participants had received. Thematic analysis using constant comparison was undertaken prior to knowing the trial results. Results: 34 trial participants were interviewed across all arms. OA causes pain, physical limitations, difficulties at work, lowered mood, and disrupted sleep. Those who received advice and education alone felt that they had not received 'treatment' and described little/no benefit. Participants in both injection groups described marked improvements in pain, physical function, and other aspects of life (e.g., sleep, confidence). The perceived magnitude of benefit appeared greater among those who received the corticosteroid injection; however, the length of benefit varied in both injection groups. There was uncertainty about the longer‐term benefits of injection and repeated injections. Conclusion: Hip OA is highly burdensome. Participants perceived little/no benefit from advice and education alone but reported marked improvements when combined with either injection. However, the magnitude of benefit was greater among those who received corticosteroid. The varying duration of response to injection and uncertainty regarding longer‐term benefits of injection and repeated injections suggests that these areas are important for future research. Trial registration: EudraCT 2014‐003412‐37; ISRCTN50550256. [ABSTRACT FROM AUTHOR]