Julius Sim

Systematic review of randomized controlled trials of nonpharmacological interventions for fibromyalgia

ObjectiveLittle is known of the effectiveness of nonpharmacological interventions for fibromyalgia syndrome (FMS). The authors therefore carried out a systematic review from 1980 to May 2000 of randomized controlled trials (RCTs) of nonpharmacological interventions for FMS. MethodA search of computerized databases was supplemented by hand searching of bibliographies of key publications. The methodological quality of studies included in the review was evaluated independently by two researchers according to a set of formal criteria. Discrepancies in scoring were resolved through discussion. ResultsThe review yielded 25 RCTs, and the main categories of interventions tested in the studies were exercise therapy, educational intervention, relaxation therapy, cognitive–behavioral therapy, acupuncture, and forms of hydrotherapy. Methodological quality of studies was fairly low (mean score = 49.5/100). Most studies had small samples (median n for individual treatment groups after randomization = 20), and the mean power of the studies to detect a medium effect (d ≥ 0.5) was 0.36. Sixteen studies had blinded outcome assessment, but patients were blinded in only 6 studies. The median longest follow-up was 16 weeks. Statistically significant between-group differences on at least one outcome variable were reported in 17 of the 24 studies. ConclusionsThe varying combinations of interventions studied in the RCTs and the wide range of outcome measures used make it hard to form conclusions across studies. Strong evidence did not emerge in respect to any single intervention, though preliminary support of moderate strength existed for aerobic exercise. There is a need for larger, more methodologically rigorous RCTs in this area.

Effectiveness of community physiotherapy and enhanced pharmacy review for knee pain in people aged over 55 presenting to primary care: pragmatic randomised trial

Objectives To evaluate the effectiveness of two primary care strategies for delivering evidence based care to people aged 55 or over with knee pain: enhanced pharmacy review and community physiotherapy. Design Pragmatic multicentre randomised clinical trial. Setting 15 general practices in North Staffordshire. Participants 325 adults aged 55 years or over (mean 68 years) consulting with knee pain; 297 (91%) reached six month follow-up. Interventions Enhanced pharmacy review (pharmacological management in accordance with an algorithm); community physiotherapy (advice about activity and pacing and an individualised exercise programme); control (advice leaflet reinforced by telephone call). Main outcome measure Change in Western Ontario and McMaster Universities osteoarthritis index (WOMAC) at 3, 6, and 12 months. Results Mean baseline WOMAC pain score was 9.1 (SD 3.7), and mean baseline function score was 29.9 (SD 12.8). At three months, the mean reductions in pain scores were 0.41 (SD 2.8) for control, 1.59 (3.2) for pharmacy, and 1.56 (3.4) for physiotherapy; reductions in function scores were 0.80 (8.5), 2.61 (9.8), and 4.79 (10.8). Compared with control, mean differences in change scores for physiotherapy were 1.15 (95% confidence interval 0.2 to 2.1) for pain and 3.99 (1.2 to 6.8) for function; those for pharmacy were 1.18 (0.3 to 2.1) for pain and 1.80 (−0.8 to 4.5) for function. These differences were not sustained to six or 12 months. Significantly fewer participants in the physiotherapy group reported consulting their general practitioner for knee pain in the follow-up period, and use of non-steroidal anti-inflammatory drugs was lower in the physiotherapy and pharmacy groups than in the control group. Conclusions Evidence based care for older adults with knee pain, delivered by primary care physiotherapists and pharmacists, resulted in short term improvements in health outcomes, reduced use of non-steroidal anti-inflammatory drugs, and high patient satisfaction. Physiotherapy seemed to produce a shift in consultation behaviour away from the traditional general practitioner led model of care. Trial registration UK National Research Register N0286046917; Current Controlled Trials ISRCTN55376150.

Intention-to-treat approach to data from randomized controlled trials: a sensitivity analysis

The intention-to-treat (ITT) approach to randomized controlled trials analyzes data on the basis of treatment assignment, not treatment receipt. Alternative approaches make comparisons according to the treatment received at the end of the trial (as-treated analysis) or using only subjects who did not deviate from the assigned treatment (adherers-only analysis). Using a sensitivity analysis on data for a hypothetical trial, we compare these different analytical approaches in the context of two common protocol deviations: loss to follow-up and switching across treatments. In each case, two rates of deviation are considered: 10% and 30%. The analysis shows that biased estimates of effect may occur when deviation is nonrandom, when a large percentage of participants switch treatments or are lost to follow-up, and when the method of estimating missing values accounts inadequately for the process causing loss to follow-up. In general, ITT analysis attenuates between-group effects. Trialists should use sensitivity analyses on their data and should compare the characteristics of participants who do and those who do not deviate from the trial protocol. The ITT approach is not a remedy for unsound design, and imputation of missing values is not a substitute for complete, good quality data.

The Effectiveness of Physiotherapy Exercises in Subacromial Impingement Syndrome: A Systematic Review and Meta-Analysis

OBJECTIVE To evaluate the effectiveness of exercise in the treatment of people with subacromial impingement syndrome (SAIS). METHODS A systematic review and meta-analysis were conducted. Ten electronic databases were searched from the dates of their inception until August 2010. Included studies were randomized controlled trials investigating exercise in the management of SAIS. Outcomes were pain, strength, function, and quality of life. Data were summarized qualitatively using a best evidence synthesis. Treatment effect size and variance of individual studies were used to give an overall summary effect and data were converted to standardized mean difference with 95% confidence intervals (standardized mean difference (SMD) (CI)). RESULTS Sixteen studies were included (n = 1162). There was strong evidence that exercise decreases pain and improves function at short-term follow-up. There was also moderate evidence that exercise results in short-term improvement in mental well-being and a long-term improvement in function for those with SAIS. The most common risk of bias across the studies was inadequately concealed treatment allocation. Six studies in the review were suitable for meta-analysis. Exercise had a small positive effect on strength of the rotator cuff in the short term (SMD -0.46 (-0.76, 0.16); P = 0.003) and a small positive effect on long-term function (SMD -0.31 (-0.57, 0.04); P = 0.02). CONCLUSIONS Physiotherapy exercises are effective in the management of SAIS. However, heterogeneity of the exercise interventions, coupled with poor reporting of exercise protocols, prevented conclusions being drawn about which specific components of the exercise protocols (ie, type, intensity, frequency and duration) are associated with best outcomes.

Interviewing one's peers: methodological issues in a study of health professionals

Objective. Although health professionals are increasingly undertaking qualitative interviews with professional peers, there is little literature regarding the methodological implications of this process. The aim of the study was to elicit from informants their views on being interviewed by a fellow health professional. Design. Semi-structured interviews with nine general practitioners (GPs), three rheumatologists, and three physical therapists, with a substantive focus on perceptions of osteoarthritis. The interviewer was a GP, and informants were asked for their reactions to being interviewed by a fellow professional. Data were analysed by hand, using a thematic approach. Setting. Primary care clinics and practices in the UK. Results. Although reassured to the contrary, many informants viewed the interview as a test of their professional knowledge. The interview was also seen by some GPs as serving an educational process, with the interviewer as an authoritative source of clinical information. There were some indications of professional vulnerability among informants in relation to possible scrutiny of their practice or knowledge, though none reported a negative experience of the interview. Notions of professional identity appeared central to many of the issues that emerged. Conclusion. The nature of the relationship in interviews involving professional peers creates specific methodological issues, which have important implications for qualitative research in primary healthcare. There are both advantages and disadvantages to interviewing professional peers, which should be considered in the light of the objectives of a particular study.

Reliability and validity of measures taken during the Chester step test to predict aerobic power and to prescribe aerobic exercise

Objectives: To evaluate the reliability and validity of measures taken during the Chester step test (CST) used to predict VO2max and prescribe subsequent exercise. Methods: The CST was performed twice on separate days by 7 males and 6 females aged 22.4 (SD 4.6) years. Heart rate (HR), ratings of perceived exertion (RPE), and oxygen uptake (VO2) were measured at each stage of the CST. Results: RPE, HR, and actual VO2 were the same at each stage for both trials but each of these measures was significantly different between CST stages (p<0.0005). Intertrial bias ±95% limits of agreement (95% LoA) of HR reached acceptable limits at CST stage IV (−2±10 beats/min) and for RPE at stages III (0.2±1.4) and IV (0.5±1.9). Age estimated HRmax significantly overestimated actual HRmax of 5 beats/min (p = 0.016) and the 95% LoA showed that this error could range from an underestimation of 17 beats/min to an overestimation of 7 beats/min. Estimated versus actual VO2 at each CST stage during both trials showed errors ranging between 11% and 19%. Trial 1 underestimated actual VO2max by 2.8 ml/kg/min (p = 0.006) and trial 2 by 1.6 ml/kg/min (not significant). The intertrial agreement in predicted VO2max was relatively narrow with a bias ±95% LoA of −0.8±3.7 ml/kg/min. The RPE and %HRmax (actual) correlation improved with a second trial. At all CST stages in trial 2 RPE:%HRmax coefficients were significant with the highest correlations at CST stages III (r = 0.78) and IV (r = 0.84). Conclusion: CST VO2max prediction validity is questioned but the CST is reliable on a test-retest basis. VO2max prediction error is due more to VO2 estimation error at each CST stage compared with error in age estimated HRmax. The HR/RPE relation at >50% VO2max reliably represents the recommended intensity for developing cardiorespiratory fitness, but only when a practice trial of the CST is first performed.

The impact of workplace risk factors on the occurrence of neck and upper limb pain: a general population study

BackgroundWork-related neck and upper limb pain has mainly been studied in specific occupational groups, and little is known about its impact in the general population. The objectives of this study were to estimate the prevalence and population impact of work-related neck and upper limb pain.MethodsA cross-sectional survey was conducted of 10 000 adults in North Staffordshire, UK, in which there is a common local manual industry. The primary outcome measure was presence or absence of neck and upper limb pain. Participants were asked to give details of up to five recent jobs, and to report exposure to six work activities involving the neck or upper limbs. Psychosocial measures included job control, demand and support. Odds ratios (ORs) and population attributable fractions were calculated for these risk factors.ResultsThe age-standardized one-month period prevalence of neck and upper limb pain was 44%. There were significant independent associations between neck and upper limb pain and: repeated lifting of heavy objects (OR = 1.4); prolonged bending of neck (OR = 2.0); working with arms at/above shoulder height (OR = 1.3); little job control (OR = 1.6); and little supervisor support (OR = 1.3). The population attributable fractions were 0.24 (24%) for exposure to work activities and 0.12 (12%) for exposure to psychosocial factors.ConclusionNeck and upper limb pain is associated with both physical and psychosocial factors in the work environment. Inferences of cause-and-effect from cross-sectional studies must be made with caution; nonetheless, our findings suggest that modification of the work environment might prevent up to one in three of cases of neck and upper limb pain in the general population, depending on current exposures to occupational risk.

Attitudes and beliefs within the Sikh community regarding organ donation: A pilot study

The current shortage of organs for transplantation is a matter of considerable concern in the United Kingdom (U.K.). Whilst issues of histocompatibility create particular problems in this respect for the Asian population in the U.K., it is sometimes suggested that there is also a resistance to the idea of organ transplantation among this community. To explore this issue, a small-scale interview study was conducted in Coventry among members of the Sikh community. A judgemental sample of 22 individuals, from different strata of the local Sikh community, were interviewed either in one-to-one interviews or in a focus group. These interviews had two broad aims: to determine the prevailing attitudes towards organ transplantation, and to gauge the impact and acceptability of the current Department of Health campaign literature. It was found that, whilst there were a number of misgivings to do with notions of mutilation and reincarnation, and anxieties as to technical or clinical aspects of the transplantation process, the prevailing view was supportive of transplantation, and organ donation was seen as a highly appropriate means of exhibiting the altruistic tradition within Sikhism. Such barriers that exist to the idea of transplantation seem to have more to do with knowledge and understanding than with cultural or religious factors. Concerning the campaign literature, informants identified a number of shortcomings, and indicated ways in which the impact of the leaflets and posters might be enhanced. Although the generalizability of these findings is limited, and despite possible threats to the validity of the data collected, this study has produced findings with significant implications for future policy in this area.

Bias, precision and statistical power of analysis of covariance in the analysis of randomized trials with baseline imbalance: a simulation study

BackgroundAnalysis of variance (ANOVA), change-score analysis (CSA) and analysis of covariance (ANCOVA) respond differently to baseline imbalance in randomized controlled trials. However, no empirical studies appear to have quantified the differential bias and precision of estimates derived from these methods of analysis, and their relative statistical power, in relation to combinations of levels of key trial characteristics. This simulation study therefore examined the relative bias, precision and statistical power of these three analyses using simulated trial data.Methods126 hypothetical trial scenarios were evaluated (126 000 datasets), each with continuous data simulated by using a combination of levels of: treatment effect; pretest-posttest correlation; direction and magnitude of baseline imbalance. The bias, precision and power of each method of analysis were calculated for each scenario.ResultsCompared to the unbiased estimates produced by ANCOVA, both ANOVA and CSA are subject to bias, in relation to pretest-posttest correlation and the direction of baseline imbalance. Additionally, ANOVA and CSA are less precise than ANCOVA, especially when pretest-posttest correlation ≥ 0.3. When groups are balanced at baseline, ANCOVA is at least as powerful as the other analyses. Apparently greater power of ANOVA and CSA at certain imbalances is achieved in respect of a biased treatment effect.ConclusionsAcross a range of correlations between pre- and post-treatment scores and at varying levels and direction of baseline imbalance, ANCOVA remains the optimum statistical method for the analysis of continuous outcomes in RCTs, in terms of bias, precision and statistical power.

Determinants of quality of life amongst older people in deprived neighbourhoods

This article analyses the determinants of the quality of life in a sample of 600 people aged 60 or more years living in deprived areas of three English cities. Data were collected by means of a face-to-face administered questionnaire. Two standardised measures, the ‘Satisfaction With Life Scale’ (SWLS) and the ‘Philadelphia Geriatric Center Morale Scale’ (PGCMS), and a single-item question were used to produce outcome measures of the quality of life. Using a conceptual model of quality of life factors, 21 socio-demographic, objective and subjective variables were correlated with each of the measures. Thirteen of these variables were subsequently entered in three multiple regression models. Subjective variables correlated significantly with all three quality of life measures, but socio-demographic and objective life condition variables correlated less strongly. Regression analysis revealed perception of own health, perceived ability to cope financially, perception of poverty over time and loneliness to be important determinants of the quality of life across all three quality of life measures. Variables that described characteristics of the urban environment had limited direct influence on the quality of life. The findings support the conceptual framework and highlight the key role played by subjective variables in determining the quality of life of older people in deprived urban areas.