Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review

Objective To explore a possible link between authors’ financial conflicts of interest and their position on the association of rosiglitazone with increased risk of myocardial infarction in patients with diabetes

A systematic review and meta-analysis of randomized trials of carotid endarterectomy vs stenting

ObjectiveThe purpose of this systematic review and meta-analysis was to synthesize the available evidence derived from randomized controlled trials (RCTs) regarding the relative efficacy and safety of endarterectomy vs stenting in patients with carotid artery disease.MethodsWe searched MEDLINE, EMBASE, Current Contents, and Cochrane CENTRAL through July 2010 to update previous systematic reviews. Two reviewers determined trial eligibility and extracted descriptive, methodologic, and outcome data (death, nonfatal stroke, and nonfatal myocardial infarction). Random-effects meta-analysis was used to pool relative risks and the I2 statistic was used to assess heterogeneity.ResultsThirteen RCTs proved eligible enrolling 7484 patients, of which 80% had symptomatic disease. Methodological quality was moderate to high, with better quality among RCTs published after 2008. Compared with carotid endarterectomy, stenting was associated with increased risk of any stroke (relative risk [RR], 1.45; 95% confidence interval [CI], 1.06-1.99; I2 = 40%), decreased risk of periprocedural myocardial infarction (MI; RR, 0.43; 95% CI, 0.26- 0.71; I2 = 0%), and nonsignificant increase in mortality (RR, 1.40; 95% CI, 0.85-2.33; I2 = 5%). When analysis was restricted to the two most recent trials with the better methodology and more contemporary technique, we found stenting to be associated with a significant increase in the risk of any stroke (RR, 1.82; 95% CI, 1.35-2.45) and mortality (RR, 2.53; 95% CI, 1.27-5.08) and a nonsignificant reduction of the risk of MI (RR, 0.39; 95% CI, 0.12-1.23). For every 1000 patients opting for stenting rather than endarterectomy, 19 more patients would have strokes and 10 fewer would have MIs. Outcome data in asymptomatic patients were sparse and imprecise; hence, these conclusions apply primarily to symptomatic patients.ConclusionCompared with endarterectomy, carotid artery stenting (CAS) significantly increases the risk of any stroke and decreases the risk of MI

A Decision Aid for COPD patients considering inhaled steroid therapy: development and before and after pilot testing

<p>Abstract</p> <p>Background</p> <p>Decision aids (DA) are tools designed to help patients make specific and deliberative choices among disease management options. DAs can improve the quality of decision-making and reduce decisional conflict. An area not covered by a DA is the decision of a patient with chronic obstructive pulmonary disease (COPD) to use inhaled steroids which requires balancing the benefits and downsides of therapy.</p> <p>Methods</p> <p>We developed a DA for COPD patients considering inhaled steroid therapy using the Ottawa Decision Support Framework, the best available evidence for using inhaled steroid in COPD and the expected utility model. The development process involved patients, pulmonologists, DA developers and decision making experts. We pilot tested the DA with 8 COPD patients who completed an evaluation questionnaire, a knowledge scale, and a validated decisional conflict scale.</p> <p>Results</p> <p>The DA is a computer-based interactive tool incorporating four different decision making models. In the first part, the DA provides information about COPD as a disease, the different treatment options, and the benefits and downsides of using inhaled steroids. In the second part, it coaches the patient in the decision making process through clarifying values and preferences. Patients evaluated 10 out of 13 items of the DA positively and showed significant improvement on both the knowledge scale (p = 0.008) and the decisional conflict scale (p = 0.008).</p> <p>Conclusion</p> <p>We have developed a computer-based interactive DA for COPD patients considering inhaled steroids serving as a model for other DAs in COPD, in particular related to inhaled therapies. Future research should assess the DA effectiveness.</p

Why Do Women Reject Bisphosphonates for Osteoporosis? A Videographic Study

Despite access to effective, safe, and affordable treatment for osteoporosis, at-risk women may choose not to start bisphosphonate therapy. Understanding the reasons women give for rejecting a clinician's offer of treatment during consultations and how clinician's react to these reasons may help clinicians develop more effective strategies for fracture prevention and medication adherence.We conducted a videographic evaluation of encounters in the Osteoporosis Choice randomized trial of a decision aid about bisphosphonates vs. usual primary care. Eligible videos involved consultations with women with an estimated 10-year fragility fracture risk >20% who verbalized at least one reason to not take bisphosphonates. Two reviewers independently reviewed eligible videos and verbatim transcripts, classifying patient views about bisphosphonate use, clinicians response to those views, and patient adherence at 6 months post visit.Eighteen video recordings (12 with decision aid) were eligible for analyses. We identified 37 reasons for and against bisphosphonate therapy. Eleven patients rejected treatment, offering 9 (average of 2 per patient) unique reasons against initiating bisphosphonates (most common: side effects 39% and distrust of medications in general 33%). When physicians conceded to patient views the outcome was no bisphosphonate use. Adherence to choices at 6 months was 100%.The expression of patient preferences is sometimes unfavorable to bisphosphonates treatment even among well-informed patients at high risk for osteoporotic fractures. At 6 months, patients who expressed concerns about these medicines behaved consistently with the decision made during the visit

Perspective: The Role of Numeracy in Health Care

Numeracy, the “ability to understand and use numbers in daily life” is an important but understudied component of literacy. Numeracy-related tasks are common in healthcare and include understanding nutrition information, interpreting blood sugar readings and other clinical data, adjusting medications, and understanding probability in risk communication. While literacy and numeracy are strongly correlated, we have identified many patients with adequate reading ability but poor numeracy skills. Better tools to measure numeracy and more studies to assess the unique contribution of numeracy are needed. This research can contribute to developing interventions to improve outcomes for patients with poor numeracy

What is the effect of a decision aid in potentially vulnerable parents? Insights from the head CT choice randomized trial.

ObjectiveTo test the hypotheses that use of the Head CT Choice decision aid would be similarly effective in all parent/patient dyads but parents with high (vs low) numeracy experience a greater increase in knowledge while those with low (vs high) health literacy experience a greater increase in trust.MethodsThis was a secondary analysis of a cluster randomized trial conducted at seven sites. One hundred seventy-two clinicians caring for 971 children at intermediate risk for clinically important traumatic brain injuries were randomized to shared decision making facilitated by the DA (n = 493) or to usual care (n = 478). We assessed for subgroup effects based on patient and parent characteristics, including socioeconomic status (health literacy, numeracy and income). We tested for interactions using regression models with indicators for arm assignment and study site.ResultsThe decision aid did not increase knowledge more in parents with high numeracy (P for interaction [Pint ] = 0.14) or physician trust more in parents with low health literacy (Pint  = 0.34). The decision aid decreased decisional conflict more in non-white parents (decisional conflict scale, -8.14, 95% CI: -12.33 to -3.95; Pint  = 0.05) and increased physician trust more in socioeconomically disadvantaged parents (trust in physician scale, OR: 8.59, 95% CI: 2.35-14.83; Pint  = 0.04).ConclusionsUse of the Head CT Choice decision aid resulted in less decisional conflict in non-white parents and greater physician trust in socioeconomically disadvantaged parents. Decision aids may be particularly effective in potentially vulnerable parents

Improving the interpretation of quality of life evidence in meta-analyses: the application of minimal important difference units

Systematic reviews of randomized trials that include measurements of health-related quality of life potentially provide critical information for patient and clinicians facing challenging health care decisions. When, as is most often the case, individual randomized trials use different measurement instruments for the same construct (such as physical or emotional function), authors typically report differences between intervention and control in standard deviation units (so-called "standardized mean difference" or "effect size"). This approach has statistical limitations (it is influenced by the heterogeneity of the population) and is non-intuitive for decision makers. We suggest an alternative approach: reporting results in minimal important difference units (the smallest difference patients experience as important). This approach provides a potential solution to both the statistical and interpretational problems of existing methods

Impact of the 2009 US Preventive Services Task Force Guidelines on Screening Mammography Rates on Women in Their 40s

Background: The 2009 US Preventive Services Task Force breast cancer screening update recommended against routine screening mammography for women aged 40–49; confusion and release of conflicting guidelines followed. We examined the impact of the USPSTF update on population-level screening mammography rates in women ages 40–49. Methods and Findings: We conducted a retrospective, interrupted time-series analysis using a nationally representative, privately-insured population from 1/1/2006-12/31/2011. Women ages 40–64 enrolled for ≥1 month were included. The primary outcome was receipt of screening mammography, identified using administrative claims-based algorithms. Time-series regression models were estimated to determine the effect of the guideline change on screening mammography rates. 5.5 million women ages 40–64 were included. A 1.8 per 1,000 women (p = 0.003) decrease in monthly screening mammography rates for 40–49 year-old women was observed two months following the guideline change; no initial effect was seen for 50–64 year-old women. However, two years following the guideline change, a slight increase in screening mammography rates above expected was observed in both age groups. Conclusions: We detected a modest initial drop in screening mammography rates in women ages 40–49 immediately after the 2009 USPSTF guideline followed by an increase in screening rates. Unfavorable public reactions and release of conflicting statements may have tempered the initial impact. Renewal of the screening debate may have brought mammography to the forefront of women's minds, contributing to the observed increase in mammography rates two years after the guideline change. This pattern is unlikely to reflect informed choice and underscores the need for improved translation of evidence-based care and guidelines into practice

Creating a Conversation: Insights from the Development of a Decision Aid

The authors share lessons learned from their development ofStatin Choice, a decision aid for patients with diabetes who are considering using statins to reduce their cardiovascular risk

A Risk Prediction Index for Amiodarone-Induced Thyrotoxicosis in Adults with Congenital Heart Disease

Amiodarone therapy in adults with congenital heart disease (CHD) is associated with a significant risk of amiodarone-induced thyrotoxicosis (AIT). We developed a risk index to identify those patients being considered for amiodarone treatment who are at high risk for AIT. We reviewed the health records of adults with CHD and assessed the association between potential clinical predictors and AIT. Significant predictors were included in multivariate analyses. The parameter estimates from multivariate analysis were subsequently used to develop a risk index. 169 adults met eligibility criteria and 23 developed AIT. The final model included age, cyanotic heart disease and BMI. The risk index developed identified 3 categories of risk. Their AIT likelihood ratios were: 0.37 for low risk (95% CI 0.15–0.92); 1.12 for medium risk (95% CI 0.65–1.91); and 3.47 for high risk (95% CI 1.7–7.11). The AIT predicted risk in our population was 5% for the low risk group, 15% for the medium risk group and 47% for the high risk group. Conclusions. We derived the first model to quantify the risk for developing AIT among adults with CHD. Before using it clinically to help selecting among alternative antiarrhythmic options, it needs validation in an independent population