A Call for Electronic Health Record-based Data Sharing for Clinical Trials in Critical Care
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Medical Systems"
DOI: 10.1007/s10916-018-0984-8
Abstract: Two recent, high-impact publications of pragmatic, clusterrandomized clinical trials highlight the risks of normal saline administration in hospitalized patients [1, 2]. For clinical informaticians and clinical trialists, they raise larger questions about how clinical trials… read more here.
Keywords: data sharing; pragmatic clinical; clinical trials; health ... See more keywords
Patients’ Reactions to Letters Communicating Collateral Findings of Pragmatic Clinical Trials: a National Web-Based Survey
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DOI: 10.1007/s11606-021-07087-8
Abstract: Collateral findings in pragmatic clinical trials are findings that may have implications for patients’ health but were not generated to address a trial’s primary research questions. It is uncertain how best to communicate these collateral… read more here.
Keywords: communicating collateral; findings pragmatic; pragmatic clinical; clinical trials ... See more keywords
Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial
Sign Up to like & getrecommendations! Published in 2020 at "Contemporary Clinical Trials"
DOI: 10.1016/j.cct.2020.106045
Abstract: Abstract Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate… read more here.
Keywords: intervention; clinical trial; lifestyle intervention; self directed ... See more keywords
Evaluating fitness-for-use of electronic health records in pragmatic clinical trials: reported practices and recommendations
Sign Up to like & getrecommendations! Published in 2022 at "Journal of the American Medical Informatics Association : JAMIA"
DOI: 10.1093/jamia/ocac004
Abstract: OBJECTIVE To empirically explore how pragmatic clinical trials (PCTs) that used real-world data (RWD) assessed study-specific fitness-for-use. METHODS We conducted interviews and surveys with PCT teams who used electronic health record (EHR) data to ascertain… read more here.
Keywords: clinical trials; fitness use; pragmatic clinical; use ... See more keywords
Design and analytic considerations for using patient-reported health data in pragmatic clinical trials: report from an NIH Collaboratory roundtable
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DOI: 10.1093/jamia/ocz226
Abstract: Pragmatic clinical trials often entail the use of electronic health record (EHR) and claims data, but bias and quality issues associated with these data can limit their fitness for research purposes particularly for study end… read more here.
Keywords: reported health; pragmatic clinical; data pragmatic; clinical trials ... See more keywords
A first step towards best practice recommendations for the design and statistical analyses of pragmatic clinical trials: A modified Delphi approach
Sign Up to like & getrecommendations! Published in 2022 at "British Journal of Clinical Pharmacology"
DOI: 10.1111/bcp.15441
Abstract: Pragmatic clinical trials (PCTs) are randomized trials implemented through routine clinical practice, where design parameters of traditional randomized controlled trials are modified to increase generalizability. However, this may introduce statistical challenges. We aimed to identify… read more here.
Keywords: practice; clinical trials; trials modified; best practice ... See more keywords
Protecting seriously ill populations during pragmatic clinical trials.
Sign Up to like & getrecommendations! Published in 2023 at "Journal of the American Geriatrics Society"
DOI: 10.1111/jgs.18333
Abstract: Pragmatic clinical trials (PCTs) emphasize real-world effectiveness methodology to address the limitations of results from explanatory randomized clinical trials (RCTs), which often fail to translate to real-world medical practice. An inherent tension in the conduct… read more here.
Keywords: data collection; clinical trials; ill populations; pragmatic clinical ... See more keywords
Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial)
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DOI: 10.1136/bmjopen-2021-054681
Abstract: Introduction Postoperative pain remains incompletely controlled for decades. Recently, multimodal analgesia is emerging as a potential approach in the management of postoperative pain. Therein, S(+)-ketamine is appealing as an adjuvant drug in multimodal analgesia due… read more here.
Keywords: ketamine; postoperative pain; trial; clinical trial ... See more keywords
Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations
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DOI: 10.1177/17407745211048178
Abstract: Pragmatic clinical trials are increasingly used to generate knowledge about real-world clinical interventions. However, they involve some distinctive ethical and regulatory challenges. In this article, we examine a set of issues related to incentives and… read more here.
Keywords: trials scientific; pragmatic clinical; payments pragmatic; clinical trials ... See more keywords
Ethics challenges in sharing data from pragmatic clinical trials
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DOI: 10.1177/17407745221110881
Abstract: Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trials data, and trial sponsors and journals are increasingly requiring it. However, data sharing in pragmatic clinical trials presents ethical challenges related to the… read more here.
Keywords: data sharing; sharing data; clinical trials; pragmatic clinical ... See more keywords
Multiprofessional intervention and telenursing in the treatment of obese people in the COVID-19 pandemic: a pragmatic clinical trial.
Sign Up to like & getrecommendations! Published in 2022 at "Revista brasileira de enfermagem"
DOI: 10.1590/0034-7167-2021-0059
Abstract: OBJECTIVES to analyze the effects of a multiprofessional remote intervention and telenursing in the treatment of obesity. METHODS pragmatic clinical trial of intervention, conducted with obese adults. The multiprofessional remote intervention with a nurse occurred… read more here.
Keywords: clinical trial; intervention telenursing; intervention; pragmatic clinical ... See more keywords