Abstract 204: Who Funds “Evidence-Based Medicine” in our Guidelines: Government or Industry? Analysis of the AHA/ACC Class I Secondary Prevention Guidelines in 2011 vs. 2001

Author(s):  
Payal Kohli ◽  
Sabina A Murphy ◽  
Christopher P Cannon

Background: Heated debate on the “influence” of the pharmaceutical industry has led some to question whether trials sponsored by industry provide strong evidence for clinical practice. We sought to analyze this issue by looking at what the independent ACC/AHA Guideline committee cited as the evidence base for Class I (strongest) recommendations, and evaluated the funding source, as well as changes over time. Methods: After importing all citations from the AHA/ACC Secondary Prevention 2011 Update into EndNote citation manager, we excluded those that were not primary publications (e.g. consensus statements or summary guidelines). Funding source was determined from the PubMed database (or if not specified, the primary publication itself). Research support was divided by PubMed categories: U.S. governmental (gov’t), non-U.S. gov’t (typically industry), or mixed. (Note that further division of funding source into any (U.S and foreign) governmental source vs. exclusively industry, is ongoing.) All Class I recommendations were reviewed to determine what percentage of the supporting evidence was funded by U.S. gov’t vs. non-U.S. gov’t, weighting those in the mixed category equally between the other two categories. Chi-square tests were used to statistically compare these percentages. Results: Overall, 62% of studies cited to support Class I recommendations in 2011 were sponsored by non-US gov’t (e.g. industry) sources. Nine of 12 categories of Class I recommendations had the majority of the studies supported by non-gov’t/industry rather than from US gov’t funding (Table 1). This was true both for lifestyle interventions and pharmacological therapies, although the percentage of industry-funded trials for pharmacological therapies was significantly higher as compared to studies for lifestyle interventions (83% vs. 46%, p<0.001). Looking at trends over time, in the 2001 guideline, 51% of studies supporting Class I recommendations were funded by the US gov’t, while of the newer additions since 2001, 78% have been funded by non-gov’t/industry sources (p=0.005). Thus, the time trend for the overall % of recommendations that were sponsored by non-US gov’t/industry has risen from 49% in 2001 to 62% in the 2011 guidelines. Conclusion: Based on this initial categorization from PubMed, it appears that the majority of trials providing the evidence for the ACC/AHA Secondary Prevention guideline comes from non-government/industry-sponsored trials, and this percentage has increased over time. This finding suggests that industry-sponsored trials do provide a positive impact on clinical guidelines.

2012 ◽  
Vol 64 (1) ◽  
pp. 65-82 ◽  
Author(s):  
Christina Harrington ◽  
Bethany Sprowl

Sudden deaths leave families in crisis and interacting with many professionals from notification through to burial. Whether to view the deceased is often central to discussion. Practice guidelines have evolved over time regarding where, when, how, and why viewing should or should not occur. Unfortunately, there is much contradiction in existing recommendations and a marked absence of a supporting evidence base for the practice of viewing itself, and the influence of this practice on the overall bereavement process. Using a qualitative approach, this study explored the perspectives and experiences of the suddenly bereaved with respect to: viewing or not having viewed; whether or not their viewing experiences have impacted on their bereavement process; and explored particular aspects of their experience such as interactions with various professionals. Results of this study are clustered and presented under three core themes: viewing specifics; intrapersonal responses; and professional interactions.


2017 ◽  
Vol 48 (3) ◽  
pp. 12-15 ◽  
Author(s):  
Allen N. Lewis

At 100 years old, rehabilitation counseling (RC) must think systematically about its advancement going forward. Given the increasing demands that professions face these days, it behooves rehabilitation counseling to consider and plan for its sustained viability. This discussion offers the three strategies of leadership, research, and positioning of the profession that if embraced could render rehabilitation counseling (RC) nimble, able to reinvent itself, and relevant over time. For leadership, it is recommended that rehabilitation counseling (RC) embrace Transformational leadership combined with several specific leadership skills. Research should involve using strategic research deployment to target research efforts in a way to advance the rigor of the science and the status of the evidence base. RC also needs to think intentionally about positioning itself, capitalizing on its unique niche and attributes to expand its relevance and influence. Together, leadership, research and positioning could have a positive impact on the profession in 2018 and beyond.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
W B Van Dijk ◽  
E Schuit ◽  
M C De Vries ◽  
R Van Der Graaf ◽  
D E Grobbee

Abstract Background The clinical practice guidelines of the European Society of Cardiology (ESC) have a tremendous impact on cardiological practice. To enable clinicians to deliver the best care, substantiated knowledge has to ground these guidelines. However, recently many have voiced questions about the evidence levels forming the basis of guidelines. The latest analysis of cardiovascular guidelines was performed in the United States in 2009 and revealed that they were mainly based on lower level evidence or expert opinion. Moreover, a systematic analysis of the evidence base supporting the ESC guidelines has not been performed before, such an analysis is needed to embody the trust placed in them. Purpose To systemically evaluate the scientific evidence base underlying ESC guidelines. Methods We extracted all recommendations from ESC guidelines published on the ESC website since 2009, with their class of recommendation (treatment is beneficial [class I]; uncertain [class IIa/b]; harmful [class III]) and their level of evidence (multiple randomized controlled trials (RCTs)/meta-analyses [level A]; single RCT/large non-randomized studies [level B]; expert opinions/small studies [level C]). We assessed the distributions of recommendation classes, the underlying evidence levels and their ratios. Furthermore, we compared subsequent guidelines to investigate if evidence levels substantiating recommendations improved over time. Results In the past decade, 43 documents were published as guidelines on the ESC website; 5 were excluded because they concerned definitions, focused updates or position papers, leaving 38 for analysis. A total of 4704 recommendations were extracted, including 2313 (49%) class I, 1341 (29%) class IIa, 677 (14%) class IIb and 373 (8%) class III recommendations. 800 (17%) recommendations were supported by level A evidence; 1439 (31%) by level B, and 2465 (52%) by level C evidence (figure 1a). The majority of class I recommendations (i.e. treatment is beneficial) were based on level C evidence. The same was true for class II and III recommendations. When guidelines were updated there was a median increase of 32 (IQR, 14–40) recommendations. Overall, the number of recommendations supported by level A evidence fell by 1%, while level B and C evidence rose (17% and 16%) (figure 1b). Despite introducing 50 class I recommendations, only a minority of the recommendations were supported by level A evidence (3), less by level B evidence (−7) and the majority by level C evidence (54). Figure 1 Conclusion(s) This first systematic analysis of the ESC guidelines shows that half of its recommendations are grounded in expert opinions or based on small studies. Over time the number of recommendations increased, this increase was primarily based in expert opinions and small studies. To maintain professional and public trust in the ESC guidelines further research is essential to enlighten whether, why and which gaps exist in the cardiovascular knowledge base. Acknowledgement/Funding ZonMw Top-grant


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Tijssen ◽  
M Snaterse ◽  
H.T Jorstad ◽  
W.J.M Scholte Op Reimer ◽  
R.J.G Peters

Abstract Background We performed an extended follow-up of the RESPONSE-2 trial, which evaluated a new secondary prevention strategy for patients with coronary artery disease (CAD). Selective loss to follow-up (LTFU) however, may induce biased results. Objectives To assess LTFU and its implications on the internal validity of the trial at extended follow-up. Methods RESPONSE-2 (N=824) was a randomised trial of nurse-coordinated referral of CAD patients to ≤3 commercial lifestyle interventions, on top of usual-care, or to usual-care alone. The primary outcome was assessed at 1-year follow-up, after which the interventions were discontinued. An extended follow-up was performed two years later. We evaluated overall selective LTFU, between-group selective LTFU and within-group selective LTFU, by comparing baseline characteristics, compliance with the lifestyle interventions (intervention group only) and achievement of lifestyle-related risk factor (LRF) targets at 1-year follow-up for attendees and non-attendees of the extended follow-up. In all variables a standardized mean difference (SMD) of ≥0.2 with a p-value &lt;0.05, based on an independent t-test for continuous data and fisher's test for discrete data, was considered evidence of selective LTFU. Results In total, 520 patients attended the extended follow-up: 266/411 in the intervention and 254/413 in the control group. Patients LTFU were generally younger (56.5 vs. 59.3 years; SMD=0.299), more often baseline smokers (37% vs. 22%; SMD=0.334) and had less often quit smoking directly after hospitalization (17% vs. 25%; SMD=0.203). We found no evidence of between-group selective LTFU and several indications of within-group selective LTFU (table). Intervention group attendees were more compliant with the lifestyle interventions compared with non-attendees (weight loss: SMD=0.450; p≤0.05 and physical activity: SMD=0.516; p≤0.01) Conclusion Baseline LRF control, compliance with the lifestyle interventions and achievement of LRF targets were less favourable for non-attendees of the extended follow-up. Effective handling of missing data is recommended to minimize loss of contrast due to within-group selective LTFU and to ensure generalizability of results. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The RESPONSE-2 trial was sponsored by Weight Watchers International, Inc. (New York, New York) and Philips Consumer Lifestyle (the Netherlands). The sponsors had no role in the design, data collection, data analysis, data interpretation, and writing of the manuscript.


2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
E Daketsey ◽  
M Elkawafi ◽  
A Khallaf ◽  
R Makar

Abstract Introduction According to NICE Guidelines, the Best medical therapy (BMT) for secondary prevention of peripheral arterial disease includes antiplatelet and statin therapy unless contraindicated. Junior Doctors are usually allocated the job of prescribing patients’ medications. Due to discrepancies in their exposure to vascular surgery in earlier training, we implemented an introductory teaching session for them regarding this BMT and audited the efficacy of this intervention. Method A retrospective review of admission and discharge medications of all vascular ward patients from August 12th to 30th September 2019 was done, and the data was analysed via Excel. Results Out of 127 patients (median age 70), 67% and 64% had antiplatelet and statin medications respectively,while on admission. 1 in each patient cohort was found discharged without either medication. The GP of the patient discharged without antiplatelets was contacted to ensure this was rectified. The other patient had refused statin therapy and thus a discharge note to their GP was conducted to reflect this. Conclusions A teaching session as part of a vascular departmental induction emphasising the evidence base for antiplatelet and statin therapy can contribute to improving prescription practices of junior doctors starting in the department.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
X.T Cui ◽  
E Thunstrom ◽  
U Dahlstrom ◽  
J.M Zhou ◽  
J.B Ge ◽  
...  

Abstract Background It remains unclear whether the readmission of heart failure (HF) patients has decreased over time and how it differs among HF with preserved ejection fraction (EF) (HFpEF) versus reduced EF (HFrEF) and mid-range EF (HFmrEF). Methods We evaluated HF patients index hospitalized from January 2004 to December 2011 in the Swedish Heart Failure Registry with 1-year follow-up. Outcome measures were the first occurring all-cause, cardiovascular (CV) and HF readmissions. Results Totally 20,877 HF patients (11,064 HFrEF, 4,215 HFmrEF, 5,562 HFpEF) were included in the study. All-cause readmission was highest in patients with HFpEF, whereas CV and HF readmissions were highest in HFrEF. From 2004 to 2011, HF readmission rates within 6 months (from 22.3% to 17.3%, P=0.003) and 1 year (from 27.7% to 23.4%, P=0.019) in HFpEF declined, and the risk for 1-year HF readmission in HFpEF was reduced by 7% after adjusting for age and sex (P=0.022). Likewise, risk factors for HF readmission in HFpEF changed. However, no significant changes in cause-specific readmissions were observed in HFrEF. Time to the first readmission did not change significantly from 2004 to 2011, regardless of EF subgroup (all P-values&gt;0.05). Conclusions Although the burden of all-cause readmission remained highest in HFpEF versus HFrEF and HFmrEF, a declining temporal trend in 6-month and 1-year HF readmission rates was found in patients with HFpEF, suggesting that non-HF-related readmission represents a big challenge for clinical practice. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): The SwedeHF was funded by the Swedish National Board of Health and Welfare, the Swedish Association of Local Authorities and Regions.


2021 ◽  
pp. 155982762110066
Author(s):  
Liana Lianov

Burnout rates among physicians are rapidly rising. Leaders in the movement to address burnout have made the case that health care workplaces need to foster a culture of well-being, including trusting coworker interactions, collaborative and transparent leadership, work-life balance, flexibility, opportunities for meaningful work and for professional development, and effective 2-way communication. The rationale for focusing on organizational change to prevent burnout has pointed to persistent symptoms of burnout even when individual healthy lifestyle interventions are adopted. However, a case can be made that the lifestyle interventions were not implemented at the level of intensity recommended by the lifestyle medicine evidence-base to secure the desired improvement in physical and mental health when facing significant personal and environmental stressors. The lifestyle medicine community has the ethical mandate to advocate for intensive healthy lifestyle approaches to burnout prevention, in conjunction with organizational supports. By combining comprehensive and intensive lifestyle changes with organizational cultures of well-being, we can more effectively turn the tide of physician burnout.


Breathe ◽  
2016 ◽  
Vol 12 (2) ◽  
pp. 113-119 ◽  
Author(s):  
Phyllis Murphie ◽  
Nick Hex ◽  
Jo Setters ◽  
Stuart Little

“Non-delivery” home oxygen technologies that allow self-filling of ambulatory oxygen cylinders are emerging. They can offer a relatively unlimited supply of ambulatory oxygen in suitably assessed people who require long-term oxygen therapy (LTOT), providing they can use these systems safely and effectively. This allows users to be self-sufficient and facilitates longer periods of time away from home. The evolution and evidence base of this technology is reported with the experience of a national service review in Scotland (UK). Given that domiciliary oxygen services represent a significant cost to healthcare providers globally, these systems offer potential cost savings, are appealing to remote and rural regions due to the avoidance of cylinder delivery and have additional lower environmental impact due to reduced fossil fuel consumption and subsequently reduced carbon emissions. Evidence is emerging that self-fill/non-delivery oxygen systems can meet the ambulatory oxygen needs of many patients using LTOT and can have a positive impact on quality of life, increase time spent away from home and offer significant financial savings to healthcare providers.Educational aimsProvide update for oxygen prescribers on options for home oxygen provision.Provide update on the evidence base for available self-fill oxygen technologies.Provide and update for healthcare commissioners on the potential cost-effective and environmental benefits of increased utilisation of self-fill oxygen systems.


Author(s):  
Christian Steinberg ◽  
Nicolas Dognin ◽  
Amit Sodhi ◽  
Catherine Champagne ◽  
John A. Staples ◽  
...  

Background: Regulatory authorities of most industrialized countries recommend 6-months of private driving restriction after implantation of a secondary prevention ICD. These driving restrictions result in significant inconvenience and social implications. The purpose of this study was to assess the incidence rate of appropriate device therapies in contemporary recipients of a secondary prevention ICD. Methods: A retrospective study at three Canadian tertiary care centers enrolling consecutive patients with new secondary prevention ICD implants between 2016-2020. Results: 721 patients were followed for a median of 760 days (324, 1190). The risk of recurrent ventricular arrhythmia was highest during the first three months after device insertion (34.4%), and decreased over time (10.6% between 3−6 months, 11.7% between 6-12 months). The corresponding incidence rate per 100 patient-days was 0.48 (95% CI 0.35-0.64) at 90 days, 0.28 (95% CI 0.18−0.48) at 180 days and 0.20 (95% CI 0.13−0.31) between 181-365 days after ICD insertion (p<0.001). The cumulative incidence of arrhythmic syncope resulting in sudden cardiac incapacitation was 1.8% within the first 90 days and subsequently dropped to 0.4% between 91-180 days (p<0.001) after ICD insertion. Conclusions: The incidence rate of appropriate therapies resulting in sudden cardiac incapacitation in contemporary recipients of a secondary prevention ICD is much lower than previously reported, and significantly declines after the first three months. Lowering driving restrictions to three months after the index cardiac event seems safe and revision of existing guidelines recommending should be considered in countries still adhering to a 6-months period. Existing restrictions for private driving after implantation of a secondary prevention ICD should be reconsidered.


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