• Adjusting for Nonadherence or Stopping Treatments in Randomized Clinical Trials

    Type Journal Article
    Author Amanda I. Adler
    Author Nicholas R. Latimer
    URL https://doi.org/10.1001/jama.2021.2433
    Volume 325
    Issue 20
    Pages 2110-2111
    Publication JAMA
    ISSN 0098-7484
    Date May 25, 2021
    Journal Abbr JAMA
    DOI 10.1001/jama.2021.2433
    Accessed 5/29/2021, 8:21:20 AM
    Library Catalog Silverchair
    Abstract Randomized clinical trials allocate individuals to different treatments, or, more generally, to interventions and comparators, to determine whether one is better than another. However, after having been randomized to a given intervention, some study participants may not adhere to the assigned protocol. Treatment nonadherence may result from study participants crossing over to the other randomized treatments, taking nontrial medications, or not adhering to the study protocol. All of these situations introduce postrandomization problems that may have to be accounted for in the analysis of data from the trial.
    Date Added 5/29/2021, 8:21:20 AM
    Modified 5/29/2021, 8:23:02 AM

    Tags:

    • adherence
    • compliance
    • rct
    • reporting
    • reporting-clinical-trials
    • teaching-mds

  • Reporting Bayesian Results

    Type Journal Article
    Author David Rindskopf
    URL https://doi.org/10.1177/0193841X20977619
    Pages 0193841X20977619
    Publication Evaluation Review
    ISSN 0193-841X
    Date December 30, 2020
    Extra Publisher: SAGE Publications Inc
    Journal Abbr Eval Rev
    DOI 10.1177/0193841X20977619
    Accessed 1/5/2021, 9:15:07 AM
    Library Catalog SAGE Journals
    Language en
    Abstract Because of the different philosophy of Bayesian statistics, where parameters are random variables and data are considered fixed, the analysis and presentation of results will differ from that of frequentist statistics. Most importantly, the probabilities that a parameter is in certain regions of the parameter space are crucial quantities in Bayesian statistics that are not calculable (or considered important) in the frequentist approach that is the basis of much of traditional statistics. In this article, I discuss the implications of these differences for presentation of the results of Bayesian analyses. In doing so, I present more detailed guidelines than are usually provided and explain the rationale for my suggestions.
    Date Added 1/5/2021, 9:15:07 AM
    Modified 1/5/2021, 9:15:56 AM

    Tags:

    • rct
    • bayes
    • teaching-mds
    • reporting-statistical-results
    • reporting
    • reporting-guidelines
    • reporting-clinical-trials

  • Improving the quality of reporting of randomized controlled trials. The Consort statement

    Type Journal Article
    Author C. Begg
    Author M. Cho
    Author S. Eastwook
    Author R. Horton
    Author D. Moher
    Author I. Olkin
    Author Em Et Al
    Volume 276
    Pages 637-639
    Publication JAMA
    Date 1996
    Extra Citation Key: beg96imp tex.citeulike-article-id= 13263737 tex.posted-at= 2014-07-14 14:09:22 tex.priority= 0
    Date Added 7/7/2018, 1:38:33 PM
    Modified 11/8/2019, 8:01:59 AM

    Tags:

    • rct
    • teaching-mds
    • reporting
    • clinical-trials
    • statistical-results

  • Profile-specific survival estimates: Making reports of clinical trials more patient-relevant

    Type Journal Article
    Author Marilyse Julien
    Author James A. Hanley
    URL http://dx.doi.org/10.1177/1740774508089511
    Volume 5
    Pages 107-115
    Publication CT
    Date 2008
    Extra Citation Key: jul08pro tex.citeulike-article-id= 13265661 tex.citeulike-linkout-0= http://dx.doi.org/10.1177/1740774508089511 tex.posted-at= 2014-07-14 14:10:01 tex.priority= 0
    DOI 10.1177/1740774508089511
    Date Added 7/7/2018, 1:38:33 PM
    Modified 11/8/2019, 8:01:59 AM

    Tags:

    • rct
    • teaching-mds
    • reporting
    • personalized-medicine
    • prognosis
    • clinical-prediction

    Notes:

    • limitations of clinical trial reports of crude summaries;nomogram;use of Design package;extended nomogram with absolute treatment effect axes

  • The intellectual health of clinical drug evaluation

    Type Journal Article
    Author Lewis B. Sheiner
    URL http://dx.doi.org/10.1038/clpt.1991.97
    Volume 50
    Pages 4-9
    Publication Clin Pharm Ther
    Date 1991
    Extra Citation Key: she91int tex.citeulike-article-id= 13264842 tex.citeulike-linkout-0= http://dx.doi.org/10.1038/clpt.1991.97 tex.posted-at= 2014-07-14 14:09:44 tex.priority= 0
    DOI 10.1038/clpt.1991.97
    Date Added 7/7/2018, 1:38:33 PM
    Modified 11/8/2019, 8:01:59 AM

    Tags:

    • bayesian-inference
    • rct
    • teaching-mds
    • statistical-significance
    • reporting
    • compliance
    • clinical-trials
    • hypothesis-testing
    • review

    Notes:

    • problems with traditional statistical approaches to drug evaluation;problems with under-emphasis of type II error

  • A proposal for structured reporting of randomized controlled trials

    Type Journal Article
    Author The Standards of Reporting Trials Group
    URL http://dx.doi.org/10.1001/jama.272.24.1926
    Volume 272
    Pages 1926-1931
    Publication JAMA
    Date 1994
    Extra Citation Key: sta94pro tex.citeulike-article-id= 13264900 tex.citeulike-linkout-0= http://dx.doi.org/10.1001/jama.272.24.1926 tex.posted-at= 2014-07-14 14:09:45 tex.priority= 0
    DOI 10.1001/jama.272.24.1926
    Date Added 7/7/2018, 1:38:33 PM
    Modified 11/8/2019, 8:01:59 AM

    Tags:

    • rct
    • teaching-mds
    • reporting
    • clinical-trials
    • statistical-results

  • Statistical issues in biologics submissions to the FDA

    Type Journal Article
    Author Cornelius J. Lynch
    Author Peter A. Lachenbruch
    URL http://dx.doi.org/10.1177/009286159603000408
    Volume 30
    Pages 921-932
    Publication Drug Info J
    Date 1996
    Extra Citation Key: lyn96sta tex.citeulike-article-id= 13264552 tex.citeulike-linkout-0= http://dx.doi.org/10.1177/009286159603000408 tex.posted-at= 2014-07-14 14:09:37 tex.priority= 0
    DOI 10.1177/009286159603000408
    Date Added 7/7/2018, 1:38:33 PM
    Modified 11/8/2019, 8:01:59 AM

    Tags:

    • study-design
    • rct
    • teaching-mds
    • reporting
    • clinical-trials
    • checklist

    Notes:

    • checklist for design and reporting of pharmaceutical studies

  • The impact of high-risk patients on the results of clinical trials

    Type Journal Article
    Author John P. A. Ioannidis
    Author Joseph Lau
    URL http://dx.doi.org/10.1016/S0895-4356(97)00149-2
    Volume 50
    Pages 1089-1098
    Publication J Clin Epi
    Date 1997
    Extra Citation Key: ioa97imp tex.citeulike-article-id= 13264354 tex.citeulike-linkout-0= http://dx.doi.org/10.1016/S0895-4356(97)00149-2 tex.posted-at= 2014-07-14 14:09:33 tex.priority= 0
    DOI 10.1016/S0895-4356(97)00149-2
    Date Added 7/7/2018, 1:38:33 PM
    Modified 11/8/2019, 8:01:59 AM

    Tags:

    • rct
    • teaching-mds
    • reporting
    • clinical-trials
    • publication-bias
    • generalizability

    Notes:

    • high risk patients can dominate clinical trials results;high risk patients may be imbalanced even if overall study is balanced;magnesium;differential treatment effect by patient risk;GUSTO;small vs. large trials vs. meta-analysis

  • The miracle of DICE therapy for acute stroke: fact or fictional product of subgroup analysis?

    Type Journal Article
    Author Carl E. Counsell
    Author Mike J. Clarke
    Author Jim Slattery
    Author Peter A. G. Sandercock
    Volume 309
    Pages 1677-1681
    Publication BMJ
    Date 1994
    Extra Citation Key: cou94mir tex.citeulike-article-id= 13263932 tex.posted-at= 2014-07-14 14:09:25 tex.priority= 0
    Date Added 7/7/2018, 1:38:33 PM
    Modified 11/8/2019, 8:01:59 AM

    Tags:

    • rct
    • meta-analysis
    • teaching-mds
    • reporting
    • clinical-trials
    • publication-bias
    • subgroup-analysis
    • systematic-review

  • How to decide on the applicability of clinical trial results to your patient

    Type Journal Article
    Author Antonio L. Dans
    Author Leonila F. Dans
    Author Gordon H. Guyatt
    Author Scott Richardson
    Author The Evidence-Based Medicine Working Group
    URL http://dx.doi.org/10.1001/jama.279.7.545
    Volume 279
    Pages 545-549
    Publication JAMA
    Date 1998
    Extra Citation Key: dan98how tex.citeulike-article-id= 13263969 tex.citeulike-linkout-0= http://dx.doi.org/10.1001/jama.279.7.545 tex.posted-at= 2014-07-14 14:09:26 tex.priority= 0
    DOI 10.1001/jama.279.7.545
    Date Added 7/7/2018, 1:38:33 PM
    Modified 11/8/2019, 8:01:59 AM

    Tags:

    • rct
    • teaching-mds
    • reporting
    • clinical-trials
    • generalizability

  • Rating the quality of evidence for clinical practice guidelines

    Type Journal Article
    Author David C. Hadorn
    Author David Baker
    Author James S. Hodges
    Author Nicholas Hicks
    URL http://dx.doi.org/10.1016/0895-4356(96)00019-4
    Volume 49
    Pages 749-754
    Publication J Clin Epi
    Date 1996
    Extra Citation Key: had96rat tex.citeulike-article-id= 13264195 tex.citeulike-linkout-0= http://dx.doi.org/10.1016/0895-4356(96)00019-4 tex.posted-at= 2014-07-14 14:09:30 tex.priority= 0
    DOI 10.1016/0895-4356(96)00019-4
    Date Added 7/7/2018, 1:38:33 PM
    Modified 11/8/2019, 8:01:59 AM

    Tags:

    • evidence
    • rct
    • teaching-mds
    • reporting
    • bias
    • clinical-trials
    • observational-studies
    • clinical-practice-guidelines
    • quallity-of-studies

  • Checklist of information for inclusion in reports of clinical trials

    Type Journal Article
    Author The Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature
    URL http://dx.doi.org/10.7326/0003-4819-124-8-199604150-00007
    Volume 124
    Pages 741-743
    Publication Ann Int Med
    Date 1996
    Extra Citation Key: asi96che tex.citeulike-article-id= 13263712 tex.citeulike-linkout-0= http://dx.doi.org/10.7326/0003-4819-124-8-199604150-00007 tex.posted-at= 2014-07-14 14:09:21 tex.priority= 0
    DOI 10.7326/0003-4819-124-8-199604150-00007
    Date Added 7/7/2018, 1:38:33 PM
    Modified 11/8/2019, 8:01:59 AM

    Tags:

    • rct
    • teaching-mds
    • reporting
    • clinical-trials
    • statistical-results

  • A randomized controlled trial of epoprostenol therapy for severe congestive heart failure: The Flolan International Randomized Survival Trial (FIRST)

    Type Journal Article
    Author R. M. Califf
    Author K. F. Adams
    Author W. J. McKenna
    Author M. Gheorghiade
    Author B. F. Uretsky
    Author S. E. McNulty
    Author H. Darius
    Author K. Schulman
    Author F. Zannad
    Author E. Handberg-Thurmond
    Author F. E. Harrell
    Author W. Wheeler
    Author J. Soler-Soler
    Author K. Swedberg
    URL http://dx.doi.org/10.1016/S0002-8703(97)70105-4
    Pages 44-54
    Publication Am Heart J
    Date 1997
    Extra Citation Key: cal97ran tex.citeulike-article-id= 13263854 tex.citeulike-linkout-0= http://dx.doi.org/10.1016/S0002-8703(97)70105-4 tex.posted-at= 2014-07-14 14:09:24 tex.priority= 0
    DOI 10.1016/S0002-8703(97)70105-4
    Date Added 7/7/2018, 1:38:33 PM
    Modified 11/8/2019, 8:01:59 AM

    Tags:

    • rct
    • teaching-mds
    • reporting
    • clinical-trials
    • interim-analysis
    • box-charts
    • import
    • stopping-boundaries

    Notes:

    • reporting results (although several typos);tables with quantiles; odds ratio chart showing lack of differential treatment effect;results of interim analyses, with stopping boundaries