Evaluation of a Theory-Informed Implementation Intervention for the Management of Acute Low Back Pain in General Medical Practice: The IMPLEMENT Cluster Randomised Trial

Introduction: This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP) in general practice. Methods: General practices were randomised to either access to a guideline for acute LBP (control) or facilitated interactive workshops (intervention). We measured behavioural predictors (e.g. knowledge, attitudes and intentions) and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP) level: behavioural simulation (clinical decision about vignettes) and rates of x-ray and CT-scan (medical administrative data). All those not involved in the delivery of the intervention were blinded to allocation. Results: 47 practices (53 GPs) were randomised to the control and 45 practices (59 GPs) to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05) and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60). Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10) for x-ray or CT-scan. Conclusions: The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant changes in actual behaviour. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN01260600009853

Vitamin D and the risk of uterine fibroids

BACKGROUND: Uterine leiomyomata, benign tumors of uterine smooth muscle that are characterized by overproduction of extracellular matrix (fibroids), are the leading indication for hysterectomy in the United States. The active metabolite of Vitamin D has been shown to inhibit cell proliferation and extracellular matrix production in fibroid tissue culture and to reduce fibroid volume in the Eker rat. No previous epidemiologic study has examined whether vitamin D is related to fibroid status in women. METHODS: The National Institute of Environmental Health Sciences Uterine Fibroid Study enrolled randomly selected 35–49 year-old members of an urban health plan during 1996–1999. Fibroid status was determined by ultrasound screening of premenopausal women (620 blacks, 416 whites). Vitamin D status was assessed in stored plasma by radioimmunoassay of 25-hydroxyvitamin D (25(OH)D) and questionnaire data on sun exposure. Associations were evaluated with logistic regression, controlling for potential confounders. RESULTS: Only 10% of blacks and 50% of whites had sufficient 25(OH)D levels [>20 ng/ml]. Women with sufficient vitamin D had an estimated 32% reduced odds of fibroids compared with those with vitamin D insufficiency (adjusted odds ration, aOR=0.68, 95% confidence interval, CI=0.48, 0.96). The association was similar for blacks and whites. Self-reported sun exposure ≥1 hr/day (weather permitting) was also associated with reduced odds of fibroids (aOR=0.6, 95% CI=0.4, 0.9) with no evidence of heterogeneity by ethnicity. CONCLUSIONS: The consistency of findings for questionnaire and biomarker data, the similar patterns seen in blacks and whites, and the biological plausibility provide evidence that sufficient vitamin D is associated with a reduced risk of fibroids

Patient Safety in the Ambulatory Setting: A Clinician-based Approach

BACKGROUND: Voluntary reporting of near misses/adverse events is an important but underutilized source of information on errors in medicine. To date, there is very little information on errors in the ambulatory setting and physicians have not traditionally participated actively in their reporting or analysis. OBJECTIVES: To determine the feasibility and effectiveness of clinician-based near miss/adverse event voluntary reporting coupled with systems analysis and redesign as a model for continuous quality improvement in the ambulatory setting. DESIGN: We report the initial 1-year experience of voluntary reporting by clinicians in the ambulatory setting, coupled with root cause analysis and system redesign by a patient safety committee made up of clinicians from the practice. SETTING: Internal medicine practice site of a large teaching hospital with 25,000 visits per year. MEASUREMENTS AND MAIN RESULTS: There were 100 reports in the 1-year period, increased from 5 in the previous year. Faculty physicians reported 44% of the events versus 22% by residents, 31% by nurses, and 3% by managers. Eighty-three percent were near misses and 17% were adverse events. Errors involved medication (47%), lab or x-rays (22%), office administration (21%), and communication (10%) processes. Seventy-two interventions were recommended with 75% implemented during the study period. CONCLUSION: This model of clinician-based voluntary reporting, systems analysis, and redesign was effective in increasing error reporting, particularly among physicians, and in promoting system changes to improve care and prevent errors. This process can be a powerful tool for incorporating error reporting and analysis into the culture of medicine