Although a safe and effective vaccine holds the greatest promise for resolving the COVID-19 pandemic, hesitancy to accept vaccines remains common. To explore vaccine acceptance decisions, we ...conducted a national survey of 1,000 people from all US states in August of 2020 and a replication in December of 2020. Using a 3 × 3 × 3 factorial experimental design, we estimated the impact of three factors: probability of 1) protection against COVID-19, 2) minor side effects, and 3) a serious adverse reactions. The outcome was respondents' reported likelihood of receiving a vaccine for the coronavirus. Probability of vaccine efficacy (50%, 70%, or 90%) had the largest effect among the three factors. The probability of minor side effects (50%, 75%, 90%) including fever and sore arm, did not significantly influence likelihood of receiving the vaccine. The chances of a serious adverse reaction, such as temporary or permanent paralysis, had a small but significant effect. A serious adverse reaction rate of 1/100,000 was more likely to discourage vaccine use in comparison to rates of 1/million or 1/100 million. All interactions between the factors were nonsignificant. A replication following the announcement that vaccines were 95% effective showed small, but significant increases in the likelihood of taking a vaccine. The main effects and interactions in the model remained unchanged. Expected benefit was more influential in respondents' decision making than expected side effects. The absence of interaction effects suggests that respondents consider the side effects and benefits independently.
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BFBNIB, NMLJ, NUK, PNG, SAZU, UL, UM, UPUK
We explore whether the number of null results in large National Heart Lung, and Blood Institute (NHLBI) funded trials has increased over time.
We identified all large NHLBI supported RCTs between ...1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease. Trials were included if direct costs >$500,000/year, participants were adult humans, and the primary outcome was cardiovascular risk, disease or death. The 55 trials meeting these criteria were coded for whether they were published prior to or after the year 2000, whether they registered in clinicaltrials.gov prior to publication, used active or placebo comparator, and whether or not the trial had industry co-sponsorship. We tabulated whether the study reported a positive, negative, or null result on the primary outcome variable and for total mortality.
17 of 30 studies (57%) published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 (8%) trials published after 2000 (χ2=12.2,df= 1, p=0.0005). There has been no change in the proportion of trials that compared treatment to placebo versus active comparator. Industry co-sponsorship was unrelated to the probability of reporting a significant benefit. Pre-registration in clinical trials.gov was strongly associated with the trend toward null findings.
The number NHLBI trials reporting positive results declined after the year 2000. Prospective declaration of outcomes in RCTs, and the adoption of transparent reporting standards, as required by clinicaltrials.gov, may have contributed to the trend toward null findings.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
American science produces the best medical treatments in the world. Yet U.S. citizens lag behind in life expectancy and quality of life. Robert Kaplan marshals extensive data to make the case that ...U.S. health care priorities are sorely misplaced—invested in attacking disease, not in solving social problems that engender disease in the first place.
Patient-reported outcomes are recognized as essential for the evaluation of medical and public health interventions. Over the last 50 years, health-related quality of life (HRQoL) research has grown ...exponentially from 0 to more than 17,000 papers published annually. We provide an overview of generic HRQoL measures used widely in epidemiological studies, health services research, population studies, and randomized clinical trials e.g., Medical Outcomes Study SF-36 and the Patient-Reported Outcomes Measurement Information System (PROMIS
®
)-29. In addition, we review methods used for economic analysis and calculation of the quality-adjusted life year (QALY). These include the EQ-5D, the Health Utilities Index (HUI), the self-administered Quality of Well-being Scale (QWB-SA), and the Health and Activities Limitation Index (HALex). Furthermore, we consider hybrid measures such as the SF-6D and the PROMIS-Preference (PROPr). The plethora of HRQoL measures has impeded cumulative science because incomparable measures have been used in different studies. Linking among different measures and consensus on standard HRQoL measurement should now be prioritized. In addition, enabling widespread access to common measures is necessary to accelerate future progress.
To address the vast gap between current knowledge and practice in the area of dissemination and implementation research, we address terminology, provide examples of successful applications of this ...research, discuss key sources of support, and highlight directions and opportunities for future advances. There is a need for research testing approaches to scaling up and sustaining effective interventions, and we propose that further advances in the field will be achieved by focusing dissemination and implementation research on 5 core values: rigor and relevance, efficiency, collaboration, improved capacity, and cumulative knowledge.
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CEKLJ, DOBA, FSPLJ, IZUM, KILJ, NUK, ODKLJ, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. ...We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials.
Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.
Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).
The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Purpose Health care expenditures and biomedical research funding are often justified by the belief that modern health care powerfully improves life expectancy in wealthy countries. We ...examined 4 different methods of estimating the effect of health care on health outcomes. Methods We reviewed the contributions of medical care to health outcomes using 4 methods: (1) analyses by McGinnis and Schroeder, (2) Wennberg and colleagues’ studies of small area variation, (3) Park and colleagues’ analysis of County Health Rankings and Roadmaps, and (4) the RAND Health Insurance Experiment. Results The 4 methods, using different data sets, produced estimates ranging from 0% to 17% of premature mortality attributable to deficiencies in health care access or delivery. Estimates of the effect of behavioral factors ranged from 16% to 65%. Conclusions The results converge to suggest that restricted access to medical care accounts for about 10% of premature death or other undesirable health outcomes. Health care has modest effects on the extension of US life expectancy, while behavioral and social determinants may have larger effects.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
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