. 2015 Nov 2:4:143.

doi: 10.1186/s13643-015-0134-z.

Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol

Evan Mayo-Wilson¹, Susan Hutfless^{2

3}, Tianjing Li², Gillian Gresham², Nicole Fusco², Jeffrey Ehmsen⁴, James Heyward², Swaroop Vedula⁵, Diana Lock⁶, Jennifer Haythornthwaite⁷, Jennifer L Payne⁸, Theresa Cowley⁹, Elizabeth Tolbert¹⁰, Lori Rosman¹¹, Claire Twose¹¹, Elizabeth A Stuart¹², Hwanhee Hong¹², Peter Doshi¹³, Catalina Suarez-Cuervo⁶, Sonal Singh¹⁴, Kay Dickersin²

Affiliations

¹ Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA. evan.mayo-wilson@jhu.edu.
² Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
³ Department of Gastroenterology and Hepatology, Johns Hopkins School of Medicine, 600 North Wolfe Street, Blalock 449, Baltimore, MD, 21287, USA.
⁴ Department of Neurology, Johns Hopkins School of Medicine, 855 North Wolfe Street, Baltimore, MD, 21205, USA.
⁵ Laboratory for Computational Sensing and Robotics, Johns Hopkins Whiting School of Engineering, 3400 North Charles St., Baltimore, MD, 21218, USA.
⁶ Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
⁷ Behavioral Biology, Center for Mind-Body Research, Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, 21224, MD, USA.
⁸ Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, 500 North Broadway, Suite 305, Baltimore, MD, 21205, USA.
⁹ The TMJ Association, Ltd., P.O. Box 26770, Milwaukee, WI, 53226-0770, USA.
¹⁰ Peabody Institute, Johns Hopkins University, 1 East Mount Vernon Place, Baltimore, MD, 21202, USA.
¹¹ Welch Medical Library, Johns Hopkins School of Medicine, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
¹² Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Baltimore, MD, 21205, USA.
¹³ University of Maryland School of Pharmacy, 220 Arch Street, Baltimore, MD, 21201, USA.
¹⁴ Center for Public Health and Human Rights, Johns Hopkins School of Medicine, 615 N Wolfe St, Baltimore, MD, 21205, USA.

PMID: 26525044
PMCID: PMC4630908
DOI: 10.1186/s13643-015-0134-z

Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol

Evan Mayo-Wilson et al. Syst Rev. 2015.

. 2015 Nov 2:4:143.

doi: 10.1186/s13643-015-0134-z.

Authors

Affiliations

¹ Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA. evan.mayo-wilson@jhu.edu.
² Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
³ Department of Gastroenterology and Hepatology, Johns Hopkins School of Medicine, 600 North Wolfe Street, Blalock 449, Baltimore, MD, 21287, USA.
⁴ Department of Neurology, Johns Hopkins School of Medicine, 855 North Wolfe Street, Baltimore, MD, 21205, USA.
⁵ Laboratory for Computational Sensing and Robotics, Johns Hopkins Whiting School of Engineering, 3400 North Charles St., Baltimore, MD, 21218, USA.
⁶ Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
⁷ Behavioral Biology, Center for Mind-Body Research, Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, 21224, MD, USA.
⁸ Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, 500 North Broadway, Suite 305, Baltimore, MD, 21205, USA.
⁹ The TMJ Association, Ltd., P.O. Box 26770, Milwaukee, WI, 53226-0770, USA.
¹⁰ Peabody Institute, Johns Hopkins University, 1 East Mount Vernon Place, Baltimore, MD, 21202, USA.
¹¹ Welch Medical Library, Johns Hopkins School of Medicine, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
¹² Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Baltimore, MD, 21205, USA.
¹³ University of Maryland School of Pharmacy, 220 Arch Street, Baltimore, MD, 21201, USA.
¹⁴ Center for Public Health and Human Rights, Johns Hopkins School of Medicine, 615 N Wolfe St, Baltimore, MD, 21205, USA.

PMID: 26525044
PMCID: PMC4630908
DOI: 10.1186/s13643-015-0134-z

Erratum in

Correction to: Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol for a systematic review.
Mayo-Wilson E, Hutfless S, Li T, Gresham G, Fusco N, Ehmsen J, Heyward J, Vedula S, Lock D, Haythornthwaite J, Payne JL, Cowley T, Tolbert E, Rosman L, Twose C, Stuart EA, Hong H, Doshi P, Suarez-Cuervo C, Singh S, Dickersin K. Mayo-Wilson E, et al. Alzheimers Res Ther. 2018 Feb 16;10(1):20. doi: 10.1186/s13195-018-0351-5. Alzheimers Res Ther. 2018. PMID: 29452606 Free PMC article.
Correction to: Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol.
Mayo-Wilson E, Hutfless S, Li T, Gresham G, Fusco N, Ehmsen J, Heyward J, Vedula S, Lock D, Haythornthwaite J, Payne JL, Cowley T, Tolbert E, Rosman L, Twose C, Stuart EA, Hong H, Doshi P, Suarez-Cuervo C, Singh S, Dickersin K. Mayo-Wilson E, et al. Syst Rev. 2018 Mar 19;7(1):48. doi: 10.1186/s13643-018-0711-z. Syst Rev. 2018. PMID: 29554959 Free PMC article.

Abstract

Background: Systematic reviews should provide trustworthy guidance to decision-makers, but their credibility is challenged by the selective reporting of trial results and outcomes. Some trials are not published, and even among clinical trials that are published partially (e.g., as conference abstracts), many are never published in full. Although there are many potential sources of published and unpublished data for systematic reviews, there are no established methods for choosing among multiple reports or data sources about the same trial.

Methods: We will conduct systematic reviews of the effectiveness and safety of two interventions following the Institute of Medicine (IOM) guidelines: (1) gabapentin for neuropathic pain and (2) quetiapine for bipolar depression. For the review of gabapentin, we will include adult participants with neuropathic pain who do not require ventilator support. For the review of quetiapine, we will include adult participants with acute bipolar depression (excluding mixed or rapid cycling episodes). We will compare these drugs (used alone or in combination with other interventions) with placebo or with the same intervention alone; direct comparisons with other medications will be excluded. For each review, we will conduct highly sensitive electronic searches, and the results of the searches will be assessed by two independent reviewers. Outcomes, study characteristics, and risk of bias ratings will be extracted from multiple reports by two individuals working independently, stored in a publicly available database (Systematic Review Data Repository) and analyzed using commonly available statistical software. In each review, we will conduct a series of meta-analyses using data from different sources to determine how the results are affected by the inclusion of data from multiple published sources (e.g., journal articles and conference abstracts) as well as unpublished aggregate data (e.g., "clinical study reports") and individual participant data (IPD). We will identify patient-centered outcomes in each report and identify differences in the reporting of these outcomes across sources.

Systematic review registration: CRD42015014037 , CRD42015014038.

PubMed Disclaimer

Cited by

Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events.
Mayo-Wilson E, Fusco N, Hong H, Li T, Canner JK, Dickersin K. Mayo-Wilson E, et al. Trials. 2019 Sep 5;20(1):553. doi: 10.1186/s13063-019-3581-3. Trials. 2019. PMID: 31488200 Free PMC article.
Methods to identify and prioritize patient-centered outcomes for use in comparative effectiveness research.
Mayo-Wilson E, Golozar A, Cowley T, Fusco N, Gresham G, Haythornthwaite J, Tolbert E, Payne JL, Rosman L, Hutfless S, Canner JK, Dickersin K. Mayo-Wilson E, et al. Pilot Feasibility Stud. 2018 Jun 12;4:95. doi: 10.1186/s40814-018-0284-6. eCollection 2018. Pilot Feasibility Stud. 2018. PMID: 30026961 Free PMC article.
Participants' outcomes gone missing within a network of interventions: Bayesian modeling strategies.
Spineli LM, Kalyvas C, Pateras K. Spineli LM, et al. Stat Med. 2019 Sep 10;38(20):3861-3879. doi: 10.1002/sim.8207. Epub 2019 May 27. Stat Med. 2019. PMID: 31134664 Free PMC article.
Caveat emptor: the combined effects of multiplicity and selective reporting.
Li T, Mayo-Wilson E, Fusco N, Hong H, Dickersin K. Li T, et al. Trials. 2018 Sep 17;19(1):497. doi: 10.1186/s13063-018-2888-9. Trials. 2018. PMID: 30223876 Free PMC article.
Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses.
Wallach JD, Wang K, Zhang AD, Cheng D, Grossetta Nardini HK, Lin H, Bracken MB, Desai M, Krumholz HM, Ross JS. Wallach JD, et al. BMJ. 2020 Feb 5;368:l7078. doi: 10.1136/bmj.l7078. BMJ. 2020. PMID: 32024657 Free PMC article.

See all "Cited by" articles

References

1. Scherer RW, Langenberg P, von Elm E. Full publication of results initially presented in abstracts. Cochrane Database Syst Rev. 2007(2):MR000005. doi:10.1002/14651858.MR000005.pub3. - PubMed
1. Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton AJ, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess. 2010;14(8):1–193. doi: 10.3310/hta14080. - DOI - PubMed
1. Goodman S, Dickersin K. Metabias: a challenge for comparative effectiveness research. Ann Intern Med. 2011;155(1):61–2. doi: 10.7326/0003-4819-155-1-201107050-00010. - DOI - PubMed
1. Vedula SS, Li T, Dickersin K. Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin. PLoS Med. 2013;10(1):e1001378. doi: 10.1371/journal.pmed.1001378. - DOI - PMC - PubMed
1. Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gotzsche PC, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet. 2014;383(9913):257–66. doi: 10.1016/S0140-6736(13)62296-5. - DOI - PMC - PubMed

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions
Actions
Actions
Actions
Actions
Actions
Actions

Grants and funding

UL1 TR001079/TR/NCATS NIH HHS/United States

LinkOut - more resources

Full Text Sources
Other Literature Sources
- scite Smart Citations

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol

Affiliations

Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol

Authors

Affiliations

Erratum in

Abstract

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Erratum in

Abstract

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

Related information

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources