scholarly journals Pharmacoepidemiology: Using randomised control trials and observational studies in clinical decision‐making

2019 ◽  
Vol 85 (9) ◽  
pp. 1907-1924 ◽  
Author(s):  
Thomas M. Caparrotta ◽  
James W. Dear ◽  
Helen M. Colhoun ◽  
David J. Webb
PeerJ ◽  
2021 ◽  
Vol 9 ◽  
pp. e12598
Author(s):  
Hamzeh Khundaqji ◽  
Wayne Hing ◽  
James Furness ◽  
Mike Climstein

Background The need for health systems that allow for continuous monitoring and early adverse event detection in individuals outside of the acute care setting has been highlighted by the global rise in chronic cardiorespiratory diseases and the recent COVID-19 pandemic. Currently, it is unclear what type of evidence exists concerning the use of physiological data collected from commercially available wrist and textile wearables to assist in clinical decision making. The aim of this review was therefore to systematically map and summarize the scientific literature surrounding the use of these wearables in clinical decision making as well as identify knowledge gaps to inform further research. Methodology Six electronic bibliographic databases were systematically searched (Ovid MEDLINE, EMBASE, CINAHL, PubMed, Scopus, and SportsDiscus). Publications from database inception to May 6, 2020 were reviewed for inclusion. Non-indexed literature relevant to this review was also searched systematically. Results were then collated, summarized and reported. Results A total of 107 citations were retrieved and assessed for eligibility with 31 citations included in the final analysis. A review of the 31 papers revealed three major study designs which included (1) observational studies (n = 19), (2) case control series and reports (n = 8), and (3) reviews (n = 2). All papers examined the use of wearable monitoring devices for clinical decisions in the cardiovascular domain, with cardiac arrhythmias being the most studied. When compared to electrocardiogram (ECG) the performance of the wearables in facilitating clinical decisions varied depending upon the type of wearable, user’s activity levels and setting in which they were employed. Observational studies collecting data in the inpatient and outpatient settings were equally represented. Eight case control series and reports were identified which reported on the use of wrist wearables in patients presenting to an emergency department or clinic to aid in the clinical diagnosis of a cardiovascular event. Two narrative reviews were identified which examined the impact of wearable devices in monitoring cardiovascular disease as well as potential challenges they may pose in the future. Conclusions To date, studies employing wearables to facilitate clinical decisions have largely focused upon the cardiovascular domain. Despite the ability of some wearables to collect physiological data accurately, there remains a need for a specialist physician to retrospectively review the raw data to make a definitive diagnosis. Analysis of the results has also highlighted gaps in the literature such as the absence of studies employing wearables to facilitate clinical decisions in the respiratory domain. The disproportionate study of wearables in atrial fibrillation detection in comparison to other cardiac arrhythmias and conditions, as well as the lack of diversity in the sample populations used prevents the generalizability of results.


2017 ◽  
Vol 35 (16) ◽  
pp. 1845-1854 ◽  
Author(s):  
Kala Visvanathan ◽  
Laura A. Levit ◽  
Derek Raghavan ◽  
Clifford A. Hudis ◽  
Sandra Wong ◽  
...  

ASCO believes that high-quality observational studies can advance evidence-based practice for cancer care and are complementary to randomized controlled trials (RCTs). Observational studies can generate hypotheses by evaluating novel exposures or biomarkers and by revealing patterns of care and relationships that might not otherwise be discovered. Researchers can then test these hypotheses in RCTs. Observational studies can also answer or inform questions that either have not been or cannot be answered by RCTs. In addition, observational studies can be used for postmarketing surveillance of new cancer treatments, particularly in vulnerable populations. The incorporation of observational research as part of clinical decision making is consistent with the position of many leading institutions. ASCO identified five overarching recommendations to enhance the role of observational research in clinical decision making: (1) improve the quality of electronic health data available for research, (2) improve interoperability and the exchange of electronic health information, (3) ensure the use of rigorous observational research methodologies, (4) promote transparent reporting of observational research studies, and (5) protect patient privacy.


2010 ◽  
Vol 122 (3) ◽  
pp. 222-229 ◽  
Author(s):  
JoAnne M. Foody ◽  
Phillip M. Mendys ◽  
Larry Z. Liu ◽  
Ross J. Simpson

2011 ◽  
Vol 20 (4) ◽  
pp. 121-123
Author(s):  
Jeri A. Logemann

Evidence-based practice requires astute clinicians to blend our best clinical judgment with the best available external evidence and the patient's own values and expectations. Sometimes, we value one more than another during clinical decision-making, though it is never wise to do so, and sometimes other factors that we are unaware of produce unanticipated clinical outcomes. Sometimes, we feel very strongly about one clinical method or another, and hopefully that belief is founded in evidence. Some beliefs, however, are not founded in evidence. The sound use of evidence is the best way to navigate the debates within our field of practice.


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