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IntroductionBedMed-Frail explores risks and benefits of switching antihypertensives from morning to bedtime in a frail population at greater risk of hypotensive adverse effects.Methods and analysisDesign: Prospective parallel randomised, open-label, blinded end-point trial.Participants: Hypertensive continuing care residents, in either long-term care or supportive living, who are free from glaucoma, and using ≥1 once daily antihypertensive.Setting: 16 volunteer continuing care facilities in Alberta, Canada, with eligible residents identified using electronic health claims data.Intervention: All non-opted out eligible residents are randomised centrally by the provincial health data steward to bedtime versus usual care (typically morning) administration of once daily antihypertensives. Timing changes are made (maximum one change per week) by usual care facility pharmacists.Follow-up: Via linked governmental healthcare databases tracking hospital, continuing care and community medical services.Primary outcome: Composite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke, or congestive heart failure.Secondary outcomes: Each primary outcome element on its own, all-cause unplanned hospitalisation or emergency department visit, non-vertebral fracture and, as assessed roughly 135 days postrandomisation, fall in the last 30 days, deteriorated cognition, urinary incontinence, decubitus skin ulceration, inappropriate or disruptive behaviour a minimum of 4 days per week, and receipt of antipsychotic medication or physical restraints in the last 7 days.Process outcome: Proportion of blood pressure medication doses taken at bedtime (broken down monthly).Primary outcome analysis: Cox-Proportional Hazards Survival Analysis.Sample size: The trial will continue until a projected 368 primary outcome events have occurred.Current status: Enrolment is ongoing with 642 randomisations to date (75% female, mean age 88 years).Ethics and disseminationBedMed-Frail has ethical approval from the University of Alberta Health Ethics Review Board (Pro00086129) and will publish results in a peer-reviewed journal.Trial registration numberNCT04054648.

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

IntroductionAlthough antihypertensive medication use is common among frail older adults, observational studies in this population suggest blood pressure (BP) lowering may convey limited benefit and perhaps even harm. This protocol describes an antihypertensive deprescribing trial in frail older adults powered for mortality and morbidity outcomes.Methods and analysisDesign: Prospective, parallel, randomised, open-label pragmatic trial.Participants: Long-term care (LTC) residents ≥70 years of age, diagnosed with hypertension, with mean systolic BP <135 mm Hg, ≥1 daily antihypertensive medication and no history of congestive heart failure.Setting: 18 LTC facilities in Alberta, Canada, with eligible residents identified using electronic health services data.Intervention: All non-opted-out eligible residents are randomised centrally by a provincial health data steward to either usual care, or continually reducing antihypertensives provided an upper systolic threshold of 145 mm Hg is not exceeded. Deprescribing is carried out by pharmacists/nurse practitioners, using an investigator-developed algorithm.Follow-up: Provincial healthcare databases tracking hospital, continuing care and community medical services.Primary outcome: All-cause mortality.Secondary outcome: Composite of all-cause mortality or all-cause unplanned hospitalisation/emergency department visit.Tertiary outcomes: All-cause unplanned hospitalisation/emergency department visit, non-vertebral fracture, renal insufficiency and cost of care. Also, as assessed roughly 135-days postrandomisation, fall in the last 30 days, worsening cognition, worsening activities of daily living and skin ulceration.Process outcomes: Number of daily antihypertensive medications (broken down by antihypertensive class) and average systolic and diastolic BP over study duration.Primary outcome analysis: Cox proportional hazards survival analysis.Sample size: The trial will continue until observation of 247 primary outcome events has occurred.Current status: Enrolment is ongoing with ~400 randomisations to date (70% female, mean age 86 years).Ethics and disseminationEthics approval was obtained from the University of Alberta Health Ethics Review Board (Pro00097312) and results will be published in a peer-reviewed journal.Trial registration numberNCT05047731.

Introduction Opioids are routinely used to treat a variety of chronic conditions associated with pain. However, they are a class of medications with a significant potential for adverse health effects, with and without misuse. Opioid misuse, as defined as inappropriate use of appropriately prescribed opioids, is becoming more well-recognized publicly but does not have clear treatment options. Opioid misuse has been linked to variety of poor outcomes and its consequences have a significant impact on healthcare resource utilization. The evidence on harm reduction strategies to mitigate adverse events prompting presentation to acute care settings for patients presenting with long-term opioid use is sparse. Methods and analysis We will perform a systematic review and meta-analysis to catalog effective harm reduction strategies and identify the most effective ones to reduce avoidable healthcare utilization in patients on long-term opioid therapy who present to acute health care settings with complications attributed to opioid misuse. A search strategy will be developed and executed by an information specialist; electronic databases (MEDLINE, EMBASE, CINAHL, Cochrane Library) and additional sources will be searched. Search themes will include opioids, chronic drug use, and acute healthcare settings. Citation screening, selection, quality assessment, and data abstraction will be performed in duplicate. A comprehensive inventory of harm reduction strategies will be developed. Data will be collected on patient-related outcomes associated with each identified harm reduction strategy. When sufficiently homogeneous data on interventions, population, and outcomes is available, it will be pooled for aggregate analysis. Evaluation of the methodological quality of individual studies and of the quality of the body of evidence will be performed. Our primary objective will be to identify harm reduction strategies that have been shown to result in clinically relevant and statistically significant improvements in patient outcomes and/or decreased healthcare utilization. Discussion This study will better characterize harm reduction strategies for patients on long-term prescribed opioids presenting to acute healthcare settings. It will also add new knowledge and generate greater understanding of key knowledge gaps of the long-term prescribed opioid use and its impact on healthcare utilization. Systematic review registration CRD42018088962 .

Background The B uilding on E xisting T ools t o Improv e Chronic Disease P r evention and Screening in Family Practice (BETTER) trial demonstrated the effectiveness of an approach to chronic disease prevention and screening (CDPS) through a new skilled role of a ‘prevention practitioner’(PP). The PP has appointments with patients 40–65 years of age that focus on primary prevention activities and screening of cancer (breast, colorectal, cervical), diabetes and cardiovascular disease and associated lifestyle factors. There are numerous and occasionally conflicting evidence-based guidelines for CDPS, and the majority of these guidelines are focused on specific diseases or conditions; however, primary care providers often attend to patients with multiple conditions. To ensure that high-level evidence guidelines were used, existing clinical practice guidelines and tools were reviewed and integrated into blended BETTER tool kits. Building on the results of the BETTER trial, the BETTER tools were updated for implementation of the BETTER 2 program into participating urban, rural and remote communities across Canada. Methods A clinical working group consisting of PPs, clinicians and researchers with support from the Centre for Effective Practice reviewed the literature to update, revise and adapt the integrated evidence algorithms and tool kits used in the BETTER trial. These resources are nuanced, based on individual patient risk, values and preferences and are designed to facilitate decision-making between providers across the target diseases and lifestyle factors included in the BETTER 2 program. Using the updated BETTER 2 toolkit, clinicians 1) determine which CDPS actions patients are eligible to receive and 2) develop individualized ‘prevention prescriptions’ with patients through shared decision-making and motivational interviewing. Results The tools identify the patients’ risks and eligible primary CDPS activities: the patient survey captures the patient’s health history; the prevention visit form and integrated CDPS care map identify eligible CDPS activities and facilitate decisions when certain conditions are met; and the ‘bubble diagram’ and ‘prevention prescription’ promote shared decision-making. Conclusion The integrated clinical decision-making tools of BETTER 2 provide resources for clinicians and policymakers that address patients’ complex care needs beyond single disease approaches and can be adapted to facilitate CDPS in the urban, rural and remote clinical setting. Trial registration The registration number of the original RCT BETTER trial was ISRCTN07170460 .

Background Warfarin 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/design This 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. Discussion This 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 registration ClinicalTrials.gov: NCT02376803 . Registered on 25 February 2015.

Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs) routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. We randomly sampled 188 RCTs spanning three years (2003-2005) from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188) of RCTs; any actual costs were included in 7.4% (14/188) of RCTs; and any mention of costs was included in 27.7% (52/188) of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005) and any mention of costs (Cochran-Armitage test, p = 0.02). Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009) or any mention of costs (OR = 0.63, p = 0.02). Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

IntroductionSleep-time blood pressure correlates more strongly with adverse cardiovascular events than does daytime blood pressure. The BedMed trial evaluates whether bedtime antihypertensive administration, as compared with conventional morning use, reduces major adverse cardiovascular events.Methods and analysisDesignProspective randomised, open-label, blinded end-point trial.ParticipantsHypertensive primary care patients using blood pressure lowering medication and free from glaucoma.SettingCommunity primary care providers in 5 Canadian provinces (British Columbia, Alberta, Saskatchewan, Manitoba and Ontario) are mailing invitations to their eligible patients. Social media campaigns (Google, Facebook) are additionally running in the same provinces.InterventionConsenting participants are allocated via central randomisation to bedtime vs morning use of all antihypertensives.Follow-up(1) Telephone or email questionnaire at 1 week, 6 weeks, 6 months and every 6 months thereafter, and (2) accessing linked governmental healthcare databases tracking hospital and community medical services.Primary outcomeComposite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke or congestive heart failure.Secondary outcomesEach primary outcome element on its own, all-cause hospitalisation or emergency department visit, long-term care admission, non-vertebral fracture, new glaucoma diagnosis, 18-month cognitive decline from baseline (via Short Blessed Test).Select other outcomesSelf-reported nocturia burden at 6 weeks and 6 months (no, minor or major burden), 1-year self-reported overall health score (EQ-5D-5L), self-reported falls, total cost of care (acute and community over study duration) and mean sleep-time systolic blood pressure after 6 months (via 24-hour monitor in a subset of 302 sequential participants).Primary outcome analysisCox proportional hazards survival analysis.Sample sizeThe trial will continue until a projected 254 primary outcome events have occurred.Current statusEnrolment ongoing (3227 randomised to date).Ethics and disseminationBedMed has ethics approval from six research ethics review boards and will publish results in a peer-reviewed journal.Trial registration numberNCT02990663.