Evaluating an audit and feedback intervention for reducing overuse of pathology test requesting by Australian general practitioners: protocol for a factorial cluster randomised controlled trial.

INTRODUCTION: Consistent evidence shows pathology services are overused worldwide and that about one-third of testing is unnecessary. Audit and feedback (AF) is effective for improving care but few trials evaluating AF to reduce pathology test requesting in primary care have been conducted. The aim of this trial is to estimate the effectiveness of AF for reducing requests for commonly overused pathology test combinations by high-requesting Australian general practitioners (GPs) compared with no intervention control. A secondary aim is to evaluate which forms of AF are most effective. METHODS AND ANALYSIS: This is a factorial cluster randomised trial conducted in Australian general practice. It uses routinely collected Medicare Benefits Schedule data to identify the study population, apply eligibility criteria, generate the interventions and analyse outcomes. On 12 May 2022, all eligible GPs were simultaneously randomised to either no intervention control or to one of eight intervention groups. GPs allocated to an intervention group received individualised AF on their rate of requesting of pathology test combinations compared with their GP peers. Three separate elements of the AF intervention will be evaluated when outcome data become available on 11 August 2023: (1) invitation to participate in continuing professional development-accredited education on appropriate pathology requesting, (2) provision of cost information on pathology test combinations and (3) format of feedback. The primary outcome is the overall rate of requesting of any of the displayed combinations of pathology tests of GPs over 6 months following intervention delivery. With 3371 clusters, assuming no interaction and similar effects for each intervention, we anticipate over 95% power to detect a difference of 4.4 requests in the mean rate of pathology test combination requests between the control and intervention groups. ETHICS AND DISSEMINATION: Ethics approval was received from the Bond University Human Research Ethics Committee (#JH03507; approved 30 November 2021). The results of this study will be published in a peer-reviewed journal and presented at conferences. Reporting will adhere to Consolidated Standards of Reporting Trials. TRIAL REGISTRATION NUMBER: ACTRN12622000566730.

A Community Jury on initiating weight management conversations in primary care.

BACKGROUND: Current guidelines recommend that patients attending general practice should be screened for excess weight, and provided with weight management advice. OBJECTIVE: This study sought to elicit the views of people with overweight and obesity about the role of GPs in initiating conversations about weight management. METHODS: Participants with a body mass index ≥25 were recruited from a region in Australia to take part in a Community Jury. Over 2 days, participants (n = 11) deliberated on two interconnected questions: 'Should GPs initiate discussions about weight management?' And 'if so, when: (a) opportunistically, (b) in the context of disease prevention, (c) in the context of disease management or (d) other?' The jury deliberations were analysed qualitatively to elicit their views and recommendations. RESULTS: The jury concluded GPs should be discussing weight management, but within the broader context of general health. The jury were divided about the utility of screening. Jurors felt GPs should initiate the conversation if directly relevant for disease prevention or management, otherwise GPs should provide opportunities for patients to consent to the issue being raised. CONCLUSION: The jury's verdict suggests informed people affected by overweight and obesity believe GPs should discuss weight management with their patients. GPs should feel reassured that discussions are likely to be welcomed by patients, particularly if embedded within a more holistic focus on person-centred care. PUBLIC CONTRIBUTION: Members of the public took part in the conduct of this study as jurors, but were not involved in the design, analysis or write-up.

Blue-Light Therapy for Acne Vulgaris: A Systematic Review and Meta-Analysis.

PURPOSE: Antibiotic use in acne treatment raises concerns about increased resistance, necessitating alternatives. We assessed the effectiveness of blue-light therapy for acne. METHODS: We analyzed randomized controlled trials comparing blue light with nonlight interventions. Studies included people of any age, sex, and acne severity, in any setting, and reported on investigator-assessed change in acne severity, patients' assessment of improvement, change in inflammatory or noninflammatory lesions, and adverse events. Where data were sufficient, mean differences were calculated. RESULTS: Eighteen references (14 trials) including 698 participants were included. Most of the trials were small and short (<12 weeks) and had high risk of bias. Investigator-assessed improvement was quantitatively reported in 5 trials, of which 3 reported significantly greater improvement in blue light than comparator, and 2 reported improvement. Patients' assessments of improvement were quantitatively reported by 2 trials, favoring blue light. Mean difference in the mean number of noninflammatory lesions was nonsignificant between groups at weeks 4, 8, and 10-12 and overall (mean difference [MD] = 3.47; 95% CI, -0.76 to 7.71; P = 0.11). Mean difference in the mean number of inflammatory lesions was likewise nonsignificant between groups at any of the time points and overall (MD = 0.16; 95% CI, -0.99 to 1.31; P = 0.78). Adverse events were generally mild and favored blue light or did not significantly differ between groups. CONCLUSION: Methodological and reporting limitations of existing evidence limit conclusions about the effectiveness of blue light for acne. Clinicians and patients should therefore consider the balance between its benefits and adverse events, as well as costs.

The Contribution of Individual Exercise Training Components to Clinical Outcomes in Randomised Controlled Trials of Cardiac Rehabilitation: A Systematic Review and Meta-regression.

BACKGROUND: While the clinical benefits of exercise-based cardiac rehabilitation are well established, there is extensive variation in the interventions used within these trials. It is unknown whether variations in individual components of these exercise interventions provide different relative contributions to overall clinical outcomes. This study aims to systematically examine the relationship between individual components of the exercise intervention in cardiac rehabilitation (such as intensity and frequency) and clinical outcomes for people with coronary heart disease. METHODS: In this systematic review, eligible trials were identified via searches of databases (PubMed, Allied and Complementary Medicine, EMBASE, PEDro, Science Citation Index Expanded, CINAHL, The Cochrane Library, SPORTDiscus) from citation tracking and hand-searching. Studies were included if they were randomised trials of a structured exercise intervention (versus usual care) for participants with coronary heart disease and reported at least one of cardiovascular mortality, total mortality, myocardial infarction or revascularisation outcomes. Each included trial was assessed using the Cochrane Risk of Bias Tool. Authors were also contacted for missing intervention details or data. Random effects meta-analysis was performed to calculate a summary risk ratio (RR) with 95% confidence interval (CI) for the effect of exercise on outcomes. Random effects meta-regression and subgroup analyses were conducted to examine the association between pre-specified co-variates (exercise components or trial characteristics) and each clinical outcome. RESULTS: Sixty-nine trials were included, evaluating 72 interventions which differed markedly in terms of exercise components. Exercise-based cardiac rehabilitation was effective in reducing cardiovascular mortality (RR 0.74, 95% CI 0.65 to 0.86), total mortality (RR 0.90, 95% CI 0.83 to 0.99) and myocardial infarction (RR 0.80, 95% CI 0.70 to 0.92). This effect generally demonstrated no significant differences across subgroups of patients who received various types of usual care, more or less than 150 min of exercise per week and of differing cardiac aetiologies. There was however some heterogeneity observed in the efficacy of cardiac rehabilitation in reducing total mortality based on the presence of lipid lowering therapy (I 2 = 48%, p = 0.15 for subgroup treatment interaction effect). No single exercise component was identified through meta-regression as a significant predictor of mortality outcomes, although reductions in both total (RR 0.81, p = 0.042) and cardiovascular mortality (RR 0.72, p = 0.045) were observed in trials which reported high levels of participant exercise adherence, versus those which reported lower levels. A dose-response relationship was found between an increasing exercise session time and increasing risk of myocardial infarction (RR 1.01, p = 0.011) and the highest intensity of exercise prescribed and an increasing risk of percutaneous coronary intervention (RR 1.05, p = 0.047). CONCLUSIONS: Exercise-based cardiac rehabilitation is effective at reducing important clinical outcomes in patients with coronary heart disease. While our analysis was constrained by the quality of included trials and missing information about intervention components, there appears to be little differential effect of variations in exercise intervention, particularly on mortality outcomes. Given the observed effect between higher adherence and improved outcomes, it may be more important to provide exercise-based cardiac rehabilitation programs which focus on achieving increased adherence to the exercise intervention.

Implementing novel trial methods to evaluate surgery for essential tremor.

INTRODUCTION: Deep brain stimulation (DBS) can provide dramatic essential tremor (ET) relief, however no Class I evidence exists. MATERIALS AND METHODS: Analysis methods: I) traditional cohort analysis; II) N-of-1 single patient randomised control trial and III) signal-to-noise (S/N) analysis. 20 DBS electrodes in ET patients were switched on and off for 3-min periods. Six pairs of on and off periods in each case, with the pair order determined randomly. Tremor severity was quantified with tremor evaluator and patient was blinded to stimulation. Patients also stated whether they perceived the stimulation to be on after each trial. RESULTS: I) Mean end-of-trial tremor severity 0.84 out of 10 on, 6.62 Off, t = - 13.218, p < 0.0005. II) N-of-1: 60% of cases had 12 correct perceptions (p = 0.001), 20% had 11 correct perceptions (p = 0.013). III) S/N: > 80% tremor reduction occurred in 99/114 'On' trials (87%), and 3/114 'Off' trials (3%). S/N ratio for 80% improvement with DBS versus spontaneous improvement was 487,757-to-1. CONCLUSIONS: DBS treatment effect on ET is too large for bias to be a plausible explanation. Formal N-of-1 trial design, and S/N ratio method for presenting results, allows this to be demonstrated convincingly where conventional randomised controlled trials are not possible. CLASSIFICATION OF EVIDENCE: This study is the first to provide Class I evidence for the efficacy of DBS for ET.

Do individualized medication effectiveness tests (n-of-1 trials) change clinical decisions about which drugs to use for osteoarthritis and chronic pain?

To assess the impact of individualized medication effectiveness tests (IMETs, or n-of-1 trials), on patients' short-term decision making about medications for chronic pain. Survey evaluation of patients undergoing a double-blind, crossover comparison of drug versus placebo, drug versus drug, or drug versus drug combination using paracetamol and ibuprofen in 3 pairs of treatment periods, randomized within pairs. General practice patients (supplemented by a few from 2 tertiary pain clinics) with either chronic pain (> or =3 months), or osteoarthritis (with pain for > or =1 month) severe enough to warrant consideration of long-term nonsteroidal antiinflammatory drug (NSAID) use but for whom there was doubt about the efficacy of NSAID or alternative. Pain and stiffness in sites nominated by the patient, global pain, use of escape analgesia, and side effects. Of 116 IMETs started, 71 were completed. Drug management changed for 46 of 71 (65%). The most common change was to add paracetamol or to substitute the NSAID or COX-2 inhibitor with paracetamol (25 of 71 patients and 54% of changes). Of the 37 who were using NSAIDs or COX-2 inhibitors before the IMET, 12 (32%) ceased these afterward. Paracetamol was as effective or more effective than ibuprofen in 37 (68%) of the 54 IMETs directly comparing these drugs. IMETs provide useful information for clinical decisions. Paracetamol continues to be useful for patients with chronic pain whose optimal drug choice is in doubt. Our results provide a new (individual) perspective on the well-known recommendation for paracetamol as first-line treatment for chronic pain and demonstrate that it is feasible to provide IMETs nationally by mail and telephone.

Prolotherapy injections, saline injections, and exercises for chronic low-back pain: a randomized trial.

OBJECTIVES: To assess the efficacy of a prolotherapy injection and exercise protocol in the treatment of chronic nonspecific low back pain. DESIGN: Randomized controlled trial with two-by-two factorial design, triple-blinded for injection status, and single-blinded for exercise status. SETTING: General practice. PARTICIPANTS: One hundred ten participants with nonspecific low-back pain of average 14 years duration were randomized to have repeated prolotherapy (20% glucose/0.2% lignocaine) or normal saline injections into tender lumbo-pelvic ligaments and randomized to perform either flexion/extension exercises or normal activity over 6 months. MAIN OUTCOME MEASURES: Pain intensity (VAS) and disability scores (Roland-Morris) at 2.5, 4, 6, 12, and 24 months. RESULTS: Follow-up was achieved in 96% at 12 months and 80% at 2 years. Ligament injections, with exercises and with normal activity, resulted in significant and sustained reductions in pain and disability throughout the trial, but no attributable effect was found for prolotherapy injections over saline injections or for exercises over normal activity. At 12 months, the proportions achieving more than 50% reduction in pain from baseline by injection group were glucose-lignocaine: 0.46 versus saline: 0.36. By activity group these proportions were exercise: 0.41 versus normal activity: 0.39. Corresponding proportions for >50% reduction in disability were glucose-lignocaine: 0.42 versus saline 0.36 and exercise: 0.36 versus normal activity: 0.38. There were no between group differences in any of the above measures. CONCLUSIONS: In chronic nonspecific low-back pain, significant and sustained reductions in pain and disability occur with ligament injections, irrespective of the solution injected or the concurrent use of exercises.