Scott Garrison

Televised medical talk shows—what they recommend and the evidence to support their recommendations: a prospective observational study

Objective To determine the quality of health recommendations and claims made on popular medical talk shows. Design Prospective observational study. Setting Mainstream television media. Sources Internationally syndicated medical television talk shows that air daily (The Dr Oz Show and The Doctors). Interventions Investigators randomly selected 40 episodes of each of The Dr Oz Show and The Doctors from early 2013 and identified and evaluated all recommendations made on each program. A group of experienced evidence reviewers independently searched for, and evaluated as a team, evidence to support 80 randomly selected recommendations from each show. Main outcomes measures Percentage of recommendations that are supported by evidence as determined by a team of experienced evidence reviewers. Secondary outcomes included topics discussed, the number of recommendations made on the shows, and the types and details of recommendations that were made. Results We could find at least a case study or better evidence to support 54% (95% confidence interval 47% to 62%) of the 160 recommendations (80 from each show). For recommendations in The Dr Oz Show, evidence supported 46%, contradicted 15%, and was not found for 39%. For recommendations in The Doctors, evidence supported 63%, contradicted 14%, and was not found for 24%. Believable or somewhat believable evidence supported 33% of the recommendations on The Dr Oz Show and 53% on The Doctors. On average, The Dr Oz Show had 12 recommendations per episode and The Doctors 11. The most common recommendation category on The Dr Oz Show was dietary advice (39%) and on The Doctors was to consult a healthcare provider (18%). A specific benefit was described for 43% and 41% of the recommendations made on the shows respectively. The magnitude of benefit was described for 17% of the recommendations on The Dr Oz Show and 11% on The Doctors. Disclosure of potential conflicts of interest accompanied 0.4% of recommendations. Conclusions Recommendations made on medical talk shows often lack adequate information on specific benefits or the magnitude of the effects of these benefits. Approximately half of the recommendations have either no evidence or are contradicted by the best available evidence. Potential conflicts of interest are rarely addressed. The public should be skeptical about recommendations made on medical talk shows. Additional details of methods used and changes made to study protocol

The effect of early in-hospital medication review on health outcomes: a systematic review

AIMS Adverse drug events are an important cause of emergency department visits, unplanned admissions and prolonged hospital stays. Our objective was to synthesize the evidence on the effect of early in-hospital pharmacist-led medication review on patient-oriented outcomes based on observed data. METHODS We systematically searched eight bibliographic reference databases, electronic grey literature, medical journals, conference proceedings, trial registries and bibliographies of relevant papers. We included studies that employed random or quasi-random methods to allocate subjects to pharmacist-led medication review or control. Medication review had to include, at a minimum, obtaining a best possible medication history and reviewing medications for appropriateness and adverse drug events. The intervention had to be initiated within 24 h of emergency department presentation or 72 h of admission. We extracted data in duplicate and pooled outcomes from clinically homogeneous studies of the same design using random effects meta-analysis. RESULTS We retrieved 4549 titles of which seven were included, reporting the outcomes of 3292 patients. We pooled data from studies of the same design, and found no significant differences in length of hospital admission (weighted mean difference [WMD] -0.04 days, 95% confidence interval [CI] -1.63, 1.55), mortality (odds ratio [OR] 1.09, 95% CI 0.69, 1.72), readmissions (OR 1.15, 95% CI 0.81, 1.63) or emergency department revisits at 3 months (OR 0.60, 95% CI 0.27, 1.32). Two large studies reporting reductions in readmissions could not be included in our pooled estimates due to differences in study design. CONCLUSIONS Wide confidence intervals suggest that additional research is likely to influence the effect size estimates and clarify the effect of medication review on patient-oriented outcomes. This systematic review failed to identify an effect of pharmacist-led medication review on health outcomes.

The Effect of Magnesium Infusion on Rest Cramps: Randomized Controlled Trial

BACKGROUND Rest cramps (also known as nocturnal leg cramps) are very common in a geriatric population. Oral magnesium supplements are marketed for prophylaxis of such cramps but clinical trials exploring the efficacy of oral magnesium conflict. A therapeutic trial of intravenous magnesium overcomes the limited oral bioavailability of magnesium and better assesses its therapeutic potential. METHODS A double blind, placebo controlled randomized controlled trial was conducted on 46 community-dwelling older adult (69.3 ± 7.7 years) rest cramp sufferers to determine whether 5 consecutive days infusion of 20-mmol (5 g) magnesium sulfate would reduce the frequency of leg cramps per week in the 30 days immediately pre and post infusions. It was also determined whether the response to treatment varied with the extent to which infused magnesium was retained (as measured by 24-hour urinary magnesium excretion). RESULTS The study population averaged 8.0 cramps per week at baseline. The mean change in number of cramps per week, magnesium versus placebo arms, was -2.4 versus -1.7, p = .51, 95% confidence interval of the difference -3.1 to 1.7. Magnesium retention did not correlate with treatment response. CONCLUSIONS Intravenous magnesium infusion did not reduce the frequency of leg cramps in a group of older adult rest cramp sufferers regardless of the extent to which infused magnesium was retained. Although oral magnesium is widely marketed to older adults for the prophylaxis of leg cramps, our data suggest that magnesium therapy is not indicated for the treatment of rest cramps in a geriatric population.

Comparison of cardiovascular disease risk calculators.

Purpose of review The cardiovascular benefit of many preventive interventions (like statins) is strongly dependent on the baseline cardiovascular risk of the patient. Many lipid and vascular primary prevention guidelines advocate for the use of cardiovascular risk calculators. Recent findings There are over 100 cardiovascular risk prediction models, and some of these models have spawned scores of calculators. Only about 25 of these models/calculators have been externally validated. The ability to identify who will have events frequently varies little (<5%) between models. However, disagreement between risk calculators is common with one in three paired comparisons disagreeing on risk category. In part, this disagreement is because calculators vary according to the database they are derived from, choice of clinical endpoints and risk interval duration upon which the estimate is based. Additional risk factors do little to improve the basic risk predictions performance, except perhaps coronary artery calcium which still requires further study before regular use. Summary The estimates provided by cardiovascular risk calculators are ballpark approximations and have a margin of error. Physicians should use models derived from, or calibrated for, populations similar to theirs and understand the endpoints, duration, and special features of their selected calculator.

Seasonal effects on the occurrence of nocturnal leg cramps: a prospective cohort study

Background: It has been anecdotally reported that nocturnal leg cramps in pregnant women are worse in summer. We analyzed population-level data to determine whether the symptom burden of nocturnal leg cramps is seasonal in the general population. Methods: We examined time-series data for 2 independent measures of the symptom burden of leg cramps: (a) new quinine prescriptions (reflecting new or escalating treatment of leg cramps) from December 2001 to October 2007 among adults aged 50 years and older, which were obtained from linked health care databases that contain the prescribing information for the 4.2 million residents of British Columbia, Canada; and (b) the Internet search volume from February 2004 to March 2012 for the term “leg cramps” (reflecting public interest), which we obtained from Google Trends data and geographically limited to the United States and Australia. We assessed seasonality by determining how well a least-squares sinusoidal model predicted variability in the outcomes. Results: New quinine prescriptions and Internet searches related to leg cramps were both seasonal, with highs in mid-summer and lows in mid-winter, and a peak-to-peak variability that was about two-thirds of the mean. Seasonality accounted for 88% of the observed monthly variability in new quinine prescriptions (p < 0.001) and 70% of the observed variability in Internet searches related to leg cramps (p < 0.001). Interpretation: New quinine prescriptions and Internet searches related to leg cramps were seasonal and roughly doubled between the winter lows and summer highs. Why a disorder of peripheral motor neurons displays such strong seasonality warrants exploration.

Seasonality of Ankle Swelling: Population Symptom Reporting Using Google Trends

In our experience, complaints of ankle swelling are more common in summer, typically from patients with no obvious cardiovascular disease. Surprisingly, this observation has never been reported. To objectively establish this phenomenon, we sought evidence of seasonality in the public’s Internet searches for ankle swelling. Our data, obtained from Google Trends, consisted of all related Google searches in the United States from January 4, 2004, to January 26, 2016. Consistent with our expectations and confirmed by similar data for Australia, Internet searches for information on ankle swelling are highly seasonal (highest in midsummer), with seasonality explaining 86% of search volume variability.

Associations between polypharmacy and treatment intensity for hypertension and diabetes: a cross-sectional study of nursing home patients in British Columbia, Canada

Objectives Describe nursing home polypharmacy prevalence in the context of prescribing for diabetes and hypertension and determine possible associations between lower surrogate markers for treated hypertension and diabetes (overtreatment) and polypharmacy. Design Cross-sectional study. Setting 6 nursing homes in British Columbia, Canada. Participants 214 patients residing in one of the selected facilities during data collection period. Primary and secondary outcome measures Polypharmacy was defined as ≥9 regular medications. Overtreatment of diabetes was defined as being prescribed at least one hypoglycaemic medication and a glycosylated haemoglobin (HbA1c) ≤7.5%. Overtreatment of hypertension required being prescribed at least one hypertension medication and having a systolic blood pressure ≤128 mm Hg. Polypharmacy prescribing, independent of overtreatment, was calculated by subtracting condition-specific medications from total medications prescribed. Results Data gathering was completed for 214 patients, 104 (48%) of whom were prescribed ≥9 medications. All patients were very frail. Patients with polypharmacy were more likely to have a diagnosis of hypertension (p=0.04) or congestive heart failure (p=0.003) and less likely to have a diagnosis of dementia (p=0.03). Patients with overtreated hypertension were more likely to also experience polypharmacy (Relative Risk (RR))1.77 (1.07 to 2.96), p=0.027). Patients with overtreated diabetes were prescribed more non-diabetic medications than those with a higher HbA1c (11.0±3.7vs 7.2±3.1, p=0.01). Conclusion Overtreated diabetes and hypertension appear to be prevalent in nursing home patients, and the presence of polypharmacy is associated with more aggressive treatment of these risk factors. The present study was limited by its small sample size and cross-sectional design. Further study of interventions designed to reduce overtreatment of hypertension and diabetes is needed to fully understand the potential links between polypharmacy and potential of harms of condition-specific overtreatment.

Effect of incentive payments on chronic disease management and health services use in British Columbia, Canada: Interrupted time series analysis

We studied the effects of incentive payments to primary care physicians for the care of patients with diabetes, hypertension, and Chronic Obstructive Pulmonary Disease (COPD) in British Columbia, Canada. We used linked administrative health data to examine monthly primary care visits, continuity of care, laboratory testing, pharmaceutical dispensing, hospitalizations, and total h ealth care spending. We examined periods two years before and two years after each incentive was introduced, and used segmented regression to assess whether there were changes in level or trend of outcome measures across all eligible patients following incentive introduction, relative to pre-intervention periods. We observed no increases in primary care visits or continuity of care after incentives were introduced. Rates of ACR testing and antihypertensive dispensing increased among patients with hypertension, but none of the other modest increases in laboratory testing or prescriptions dispensed reached statistical significance. Rates of hospitalizations for stroke and heart failure among patients with hypertension fell relative to pre-intervention patterns, while hospitalizations for COPD increased. Total hospitalizations and hospitalizations via the emergency department did not change. Health care spending increased for patients with hypertension. This large-scale incentive scheme for primary care physicians showed some positive effects for patients with hypertension, but we observe no similar changes in patient management, reductions in hospitalizations, or changes in spending for patients with diabetes and COPD.

Are potentially clinically meaningful benefits misinterpreted in cardiovascular randomized trials? A systematic examination of statistical significance, clinical significance, and authors’ conclusions

BackgroundWhile journals and reporting guidelines recommend the presentation of confidence intervals, many authors adhere strictly to statistically significant testing. Our objective was to determine what proportions of not statistically significant (NSS) cardiovascular trials include potentially clinically meaningful effects in primary outcomes and if these are associated with authors’ conclusions.MethodsCardiovascular studies published in six high-impact journals between 1 January 2010 and 31 December 2014 were identified via PubMed. Two independent reviewers selected trials with major adverse cardiovascular events (stroke, myocardial infarction, or cardiovascular death) as primary outcomes and extracted data on trial characteristics, quality, and primary outcome. Potentially clinically meaningful effects were defined broadly as a relative risk point estimate ≤0.94 (based on the effects of ezetimibe) and/or a lower confidence interval ≤0.75 (based on the effects of statins).ResultsWe identified 127 randomized trial comparisons from 3200 articles. The primary outcomes were statistically significant (SS) favoring treatment in 21% (27/127), NSS in 72% (92/127), and SS favoring control in 6% (8/127). In 61% of NSS trials (56/92), the point estimate and/or lower confidence interval included potentially meaningful effects. Both point estimate and confidence interval included potentially meaningful effects in 67% of trials (12/18) in which authors’ concluded that treatment was superior, in 28% (16/58) with a neutral conclusion, and in 6% (1/16) in which authors’ concluded that control was superior. In a sensitivity analysis, 26% of NSS trials would include potential meaningful effects with relative risk thresholds of point estimate ≤0.85 and/or a lower confidence interval ≤0.65.ConclusionsPoint estimates and/or confidence intervals included potentially clinically meaningful effects in up to 61% of NSS cardiovascular trials. Authors’ conclusions often reflect potentially meaningful results of NSS cardiovascular trials. Given the frequency of potentially clinical meaningful effects in NSS trials, authors should be encouraged to continue to look beyond significance testing to a broader interpretation of trial results.

Effect of medication timing on anticoagulation stability in users of warfarin (the INRange RCT): Study protocol for a randomized controlled trial

BackgroundWarfarin is an oral anticoagulant medication that disrupts the liver’s production of clotting factors. While this medication is highly effective for the prevention of thromboembolic events, it also has a narrow therapeutic range and a vulnerability to interactions with other drugs and vitamin K-containing foods. Warfarin is commonly ingested at dinnertime, the same time of day that dietary vitamin K consumption (found largely in green leafy vegetables) is most variable. While the long half-life of warfarin might make this irrelevant, the ultra short half-life of vitamin K and the possibility of a hepatic first-pass effect for warfarin make it worth evaluating whether morning ingestion of warfarin, when vitamin K levels are consistently low, leads to greater stability of its anticoagulant effect. An examination of the timing of administration on the effectiveness of warfarin has never before been conducted.Methods/designThis is a 7-month Prospective Randomized Open Blinded End-point (PROBE) study in which established evening warfarin users (primary care managed Canadian outpatients in the provinces of British Columbia and Alberta) will be randomized to either switch to morning ingestion of warfarin (the intervention) or to continue with evening use (the control). The primary outcome is the percent change in the proportion of time spent outside the therapeutic range of the international normalized ratio (INR) blood test. Secondary outcomes include change in proportion of time spent within the therapeutic INR range (TTR), percentage of patients with TTR >75 %, percentage of patients with TTR <60 %, and major warfarin-related cardiovascular events (including all-cause mortality, hospitalization for stroke, hospitalization for GI bleeding, and deep venous thrombosis/pulmonary embolism). We will also compare whether day-to-day variability in the consumption of high vitamin K-containing foods at baseline affects the baseline TTR in this cohort of evening warfarin users.DiscussionThis study addresses whether the timing of warfarin ingestion influences the stability of its anticoagulant effect. Should morning ingestion prove superior, the safety and effectiveness of this medication, and hence the prevention of stroke, pulmonary embolus, and major hemorrhage, could potentially be improved with no added cost or inconvenience to the patient.Trial registrationClinicalTrials.gov: NCT02376803. Registered on 25 February 2015.