| Type | Journal Article |
|---|---|
| Author | Richard D. Riley |
| Author | Tim J. Cole |
| Author | Jon Deeks |
| Author | Jamie J. Kirkham |
| Author | Julie Morris |
| Author | Rafael Perera |
| Author | Angie Wade |
| Author | Gary S. Collins |
| URL | https://www.bmj.com/content/379/bmj-2022-072883 |
| Rights | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions |
| Volume | 379 |
| Pages | e072883 |
| Publication | BMJ |
| ISSN | 1756-1833 |
| Date | 2022/12/20 |
| Extra | Publisher: British Medical Journal Publishing Group Section: Feature |
| Journal Abbr | BMJ |
| DOI | 10.1136/bmj-2022-072883 |
| Accessed | 12/20/2022, 7:05:15 AM |
| Library Catalog | www.bmj.com |
| Language | en |
| Abstract | <p><i>The BMJ’s</i> statistical editors relish a quiet Christmas, so make their wish come true and pay attention to the list of common statistical faux pas presented here by Riley and colleagues</p> |
| Date Added | 12/20/2022, 7:05:15 AM |
| Modified | 12/20/2022, 7:09:02 AM |
| Type | Journal Article |
|---|---|
| Author | Jody D. Ciolino |
| Author | Cathie Spino |
| Author | Walter T. Ambrosius |
| Author | Shokoufeh Khalatbari |
| Author | Shari Messinger Cayetano |
| Author | Jodi A. Lapidus |
| Author | Paul J. Nietert |
| Author | Robert A. Oster |
| Author | Susan M. Perkins |
| Author | Brad H. Pollock |
| Author | Gina-Maria Pomann |
| Author | Lori Lyn Price |
| Author | Todd W. Rice |
| Author | Tor D. Tosteson |
| Author | Christopher J. Lindsell |
| Author | Heidi Spratt |
| URL | https://www.cambridge.org/core/journals/journal-of-clinical-and-translational-science/article/guidance-for-biostatisticians-on-their-essential-contributions-to-clinical-and-translational-research-protocol-review/49B4D365DC2676532BDBDD922298D273# |
| Volume | 5 |
| Issue | 1 |
| Publication | Journal of Clinical and Translational Science |
| ISSN | 2059-8661 |
| Date | 2021/ed |
| Extra | Publisher: Cambridge University Press |
| DOI | 10.1017/cts.2021.814 |
| Accessed | 10/28/2021, 7:19:22 AM |
| Library Catalog | Cambridge University Press |
| Language | en |
| Abstract | Rigorous scientific review of research protocols is critical to making funding decisions, and to the protection of both human and non-human research participants. Given the increasing complexity of research designs and data analysis methods, quantitative experts, such as biostatisticians, play an essential role in evaluating the rigor and reproducibility of proposed methods. However, there is a common misconception that a statistician’s input is relevant only to sample size/power and statistical analysis sections of a protocol. The comprehensive nature of a biostatistical review coupled with limited guidance on key components of protocol review motived this work. Members of the Biostatistics, Epidemiology, and Research Design Special Interest Group of the Association for Clinical and Translational Science used a consensus approach to identify the elements of research protocols that a biostatistician should consider in a review, and provide specific guidance on how each element should be reviewed. We present the resulting review framework as an educational tool and guideline for biostatisticians navigating review boards and panels. We briefly describe the approach to developing the framework, and we provide a comprehensive checklist and guidance on review of each protocol element. We posit that the biostatistical reviewer, through their breadth of engagement across multiple disciplines and experience with a range of research designs, can and should contribute significantly beyond review of the statistical analysis plan and sample size justification. Through careful scientific review, we hope to prevent excess resource expenditure and risk to humans and animals on poorly planned studies. |
| Date Added | 10/28/2021, 7:19:22 AM |
| Modified | 10/28/2021, 7:24:35 AM |
| Type | Journal Article |
|---|---|
| Author | John C. Bailar III |
| Author | Frederick Mosteller |
| Volume | 108 |
| Pages | 266-273 |
| Publication | Ann Int Med |
| Date | 1988 |
| Extra | Citation Key: bai88gui tex.citeulike-article-id= 13263716 tex.posted-at= 2014-07-14 14:09:21 tex.priority= 0 |
| Date Added | 7/7/2018, 1:38:33 PM |
| Modified | 11/8/2019, 8:01:59 AM |
| Type | Journal Article |
|---|---|
| Author | Amy C. Justice |
| Author | Kenneth E. Covinsky |
| Author | Jesse A. Berlin |
| Volume | 130 |
| Pages | 515-524 |
| Publication | Ann Int Med |
| Date | 1999 |
| Extra | Citation Key: jus99ass tex.citeulike-article-id= 13265148 tex.posted-at= 2014-07-14 14:09:50 tex.priority= 0 |
| Date Added | 7/7/2018, 1:38:33 PM |
| Modified | 11/8/2019, 8:01:59 AM |
| 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 |
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
| Type | Book |
|---|---|
| Author | B. S. Everitt |
| Place | New York |
| Publisher | Cambridge University Press |
| Date | 1995 |
| Extra | Citation Key: eve95cam tex.citeulike-article-id= 13264057 tex.posted-at= 2014-07-14 14:09:28 tex.priority= 0 |
| Date Added | 7/7/2018, 1:38:33 PM |
| Modified | 11/8/2019, 8:01:59 AM |
| Type | Book |
|---|---|
| Author | Jane L. Garb |
| Place | Boston |
| Publisher | Little, Brown |
| Date | 1996 |
| Extra | Citation Key: gar96und tex.citeulike-article-id= 13264121 tex.posted-at= 2014-07-14 14:09:29 tex.priority= 0 |
| Date Added | 7/7/2018, 1:38:33 PM |
| Modified | 11/8/2019, 8:01:59 AM |
1997 review-in-jasa-92798
| 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 |
| Type | Book |
|---|---|
| Author | John C. Bailar III |
| Author | Frederick Mosteller |
| Edition | Second |
| Place | Boston |
| Publisher | NEJM Books |
| Date | 1995 |
| Extra | Citation Key: bai95med tex.citeulike-article-id= 13263718 tex.posted-at= 2014-07-14 14:09:21 tex.priority= 0 |
| Date Added | 7/7/2018, 1:38:33 PM |
| Modified | 11/8/2019, 8:01:59 AM |
| Type | Book |
|---|---|
| Author | Thomas A. Lang |
| Author | Michelle Secic |
| Place | Philadelphia |
| Publisher | American College of Physicians |
| ISBN | 0-9431 2644-4 |
| Date | 1997 |
| Extra | Citation Key: lan97how tex.citeulike-article-id= 13264459 tex.posted-at= 2014-07-14 14:09:35 tex.priority= 0 ISBN 0-9431-2644-4 |
| Date Added | 7/7/2018, 1:38:33 PM |
| Modified | 11/8/2019, 8:01:59 AM |
statistical review of medical articles; see Chapter 11 for publication bias
| Type | Journal Article |
|---|---|
| Author | Douglas G. Altman |
| Author | Steven N. Goodman |
| Author | Sara Schroter |
| Volume | 287 |
| Pages | 2817-2820 |
| Publication | JAMA |
| Date | 2002 |
| Extra | Citation Key: alt02how tex.citeulike-article-id= 13265291 tex.posted-at= 2014-07-14 14:09:53 tex.priority= 0 |
| Date Added | 7/7/2018, 1:38:33 PM |
| Modified | 11/8/2019, 8:01:59 AM |
"Statistical input to medical research is widely recommended but inconsistently obtained. Individuals providing such expertise are often not involved until the analysis of data and many go unrecognized by either authorship or acknowledgement."; no association between authorship by methodologist and whether methodologist was paid for her contribution; research without assistance by methodologist had a greater chance of being rejected by the editor (0.71 vs 0.57) and possibly a lower chance of being accepted for publication (0.07 vs 0.11); epidemiologists more likely to be co-authors than biostatisticians;analysis presented of what stage methodologists first got involved with the research