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

Evan R Mayo-Wilson, Susan Hutfless, Tianjing Li, Gillian Gresham, Nicole Fusco, Jeffrey Ehmsen, James Heyward, Swaroop Vedula, Diana Lock, Jennifer Haythornthwaite, Jennifer Payne, Theresa Cowley, Elizabeth Tolbert, Lori Rosman, Claire Twose, Elizabeth Stuart, Hwanhee Hong, Peter Doshi, Catalina Suarez-Cuervo, Sonal SinghKay Dickersin

Research output: Contribution to journalArticle

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 Although there are many potential sources of published and unpublished data for systematic reviews, there are no established methods for choosing among multiple reports or data sources about the same trial.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by the inclusion of data from multiple published sources (e.g., journal articles and conference abstracts) as well as unpublished aggregate data (e.g., "clinical study reports") and individual participant data (IPD).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

Original languageEnglish (US)
Article number143
JournalSystematic Reviews
Volume4
Issue number1
DOIs
StatePublished - Nov 2 2015

Fingerprint

Patient Outcome Assessment
Information Storage and Retrieval
Neuralgia
Bipolar Disorder
Meta-Analysis
National Academies of Science, Engineering, and Medicine (U.S.) Health and Medicine Division
Mechanical Ventilators
Software
Placebos
Outcome Assessment (Health Care)
Clinical Trials
Databases
Guidelines
Safety
Pharmaceutical Preparations
Quetiapine Fumarate
gabapentin

Keywords

  • Bipolar disorder
  • Depression
  • Gabapentin
  • Guidance
  • Meta-analysis
  • Pain
  • Publication bias
  • Quetiapine
  • Reporting bias
  • Systematic reviews

ASJC Scopus subject areas

  • Medicine (miscellaneous)

Cite this

Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research : A protocol for a systematic review. / Mayo-Wilson, Evan R; Hutfless, Susan; Li, Tianjing; Gresham, Gillian; Fusco, Nicole; Ehmsen, Jeffrey; Heyward, James; Vedula, Swaroop; Lock, Diana; Haythornthwaite, Jennifer; Payne, Jennifer; Cowley, Theresa; Tolbert, Elizabeth; Rosman, Lori; Twose, Claire; Stuart, Elizabeth; Hong, Hwanhee; Doshi, Peter; Suarez-Cuervo, Catalina; Singh, Sonal; Dickersin, Kay.

In: Systematic Reviews, Vol. 4, No. 1, 143, 02.11.2015.

Research output: Contribution to journalArticle

Mayo-Wilson, ER, Hutfless, S, Li, T, Gresham, G, Fusco, N, Ehmsen, J, Heyward, J, Vedula, S, Lock, D, Haythornthwaite, J, Payne, J, Cowley, T, Tolbert, E, Rosman, L, Twose, C, Stuart, E, Hong, H, Doshi, P, Suarez-Cuervo, C, Singh, S & Dickersin, K 2015, 'Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: A protocol for a systematic review', Systematic Reviews, vol. 4, no. 1, 143. https://doi.org/10.1186/s13643-015-0134-z
Mayo-Wilson, Evan R ; Hutfless, Susan ; Li, Tianjing ; Gresham, Gillian ; Fusco, Nicole ; Ehmsen, Jeffrey ; Heyward, James ; Vedula, Swaroop ; Lock, Diana ; Haythornthwaite, Jennifer ; Payne, Jennifer ; Cowley, Theresa ; Tolbert, Elizabeth ; Rosman, Lori ; Twose, Claire ; Stuart, Elizabeth ; Hong, Hwanhee ; Doshi, Peter ; Suarez-Cuervo, Catalina ; Singh, Sonal ; Dickersin, Kay. / Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research : A protocol for a systematic review. In: Systematic Reviews. 2015 ; Vol. 4, No. 1.
@article{7a99af13ce984239964fffc2d69c47ee,
title = "Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: A protocol for a systematic review",
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",
keywords = "Bipolar disorder, Depression, Gabapentin, Guidance, Meta-analysis, Pain, Publication bias, Quetiapine, Reporting bias, Systematic reviews",
author = "Mayo-Wilson, {Evan R} and Susan Hutfless and Tianjing Li and Gillian Gresham and Nicole Fusco and Jeffrey Ehmsen and James Heyward and Swaroop Vedula and Diana Lock and Jennifer Haythornthwaite and Jennifer Payne and Theresa Cowley and Elizabeth Tolbert and Lori Rosman and Claire Twose and Elizabeth Stuart and Hwanhee Hong and Peter Doshi and Catalina Suarez-Cuervo and Sonal Singh and Kay Dickersin",
year = "2015",
month = "11",
day = "2",
doi = "10.1186/s13643-015-0134-z",
language = "English (US)",
volume = "4",
journal = "Systematic Reviews",
issn = "2046-4053",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research

T2 - A protocol for a systematic review

AU - Mayo-Wilson, Evan R

AU - Hutfless, Susan

AU - Li, Tianjing

AU - Gresham, Gillian

AU - Fusco, Nicole

AU - Ehmsen, Jeffrey

AU - Heyward, James

AU - Vedula, Swaroop

AU - Lock, Diana

AU - Haythornthwaite, Jennifer

AU - Payne, Jennifer

AU - Cowley, Theresa

AU - Tolbert, Elizabeth

AU - Rosman, Lori

AU - Twose, Claire

AU - Stuart, Elizabeth

AU - Hong, Hwanhee

AU - Doshi, Peter

AU - Suarez-Cuervo, Catalina

AU - Singh, Sonal

AU - Dickersin, Kay

PY - 2015/11/2

Y1 - 2015/11/2

N2 - 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

AB - 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

KW - Bipolar disorder

KW - Depression

KW - Gabapentin

KW - Guidance

KW - Meta-analysis

KW - Pain

KW - Publication bias

KW - Quetiapine

KW - Reporting bias

KW - Systematic reviews

UR - http://www.scopus.com/inward/record.url?scp=84945945676&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84945945676&partnerID=8YFLogxK

U2 - 10.1186/s13643-015-0134-z

DO - 10.1186/s13643-015-0134-z

M3 - Article

C2 - 26525044

AN - SCOPUS:84945945676

VL - 4

JO - Systematic Reviews

JF - Systematic Reviews

SN - 2046-4053

IS - 1

M1 - 143

ER -