A risk of bias instrument for non-randomized studies of exposures: A users' guide to its application in the context of GRADE

被引:180
作者
Morgan, Rebecca L. [1 ]
Thayer, Kristina A. [2 ]
Santesso, Nancy [1 ]
Holloway, Alison C. [3 ]
Blain, Robyn [4 ]
Eftim, Sorina E. [4 ]
Goldstone, Alexandra E. [4 ]
Ross, Pam [4 ]
Ansari, Mohammed [5 ]
Akl, Elie [1 ,6 ]
Filippini, Tommaso [7 ]
Hansell, Anna [8 ,9 ,10 ]
Meerpohl, Joerg J. [11 ]
Mustafa, Reem A. [1 ,12 ]
Verbeek, Jos [13 ]
Vinceti, Marco [7 ,14 ]
Whaley, Paul [15 ]
Schunemann, Holger J. [1 ,16 ]
机构
[1] McMaster Univ, Hlth Sci Ctr, Dept Hlth Res Methods Evidence & Impact, Room 2C14,1280 Main St West, Hamilton, ON L8S 4K1, Canada
[2] US EPA, Integrated Risk Informat Syst IRIS Div, Natl Ctr Environm Assessment, Off Res & Dev, Bldg B Room 211i, Res Triangle Pk, NC 27711 USA
[3] McMaster Univ, Hlth Sci Ctr, Dept Obstet & Gynecol, Room 3N52A,1280 Main St West, Hamilton, ON L8S 4K1, Canada
[4] ICF Int Inc, 9300 Lee Highway, Fairfax, VA USA
[5] Univ Ottawa, Fac Med, Sch Epidemiol & Publ Hlth, Ottawa, ON K1H 8M5, Canada
[6] Amer Univ Beirut, Fac Hlth Sci, Dept Internal Med, POB 11-0236, Beirut 11072020, Lebanon
[7] Univ Modena & Reggio Emilia, Dept Biomed Metab & Neural Sci, Modena, Italy
[8] Imperial Coll London, MRC PHE Ctr Environm & Hlth, St Marys Campus,Praed St, London W2 1PG, England
[9] Imperial Coll Healthcare NHS Trust, St Marys Hosp, Publ Hlth Directorate, London W2 1PG, England
[10] Univ Leicester, Ctr Environm Hlth & Sustainabil, George Davies Bldg,Univ Rd, Leicester LE1 7RH, Leics, England
[11] Univ Freiburg, Med Ctr, Inst Evidence Med, Cochrane Germany Fdn, Breisacher Str 153, D-79110 Freiburg, Germany
[12] Univ Kansas, Med Ctr, Dept Med, Div Nephrol & Hypertens, 3901 Rainbow Blvd, Kansas City, KS 66160 USA
[13] Finnish Inst Occupat Hlth, Cochrane Work, Neulaniementie 4, Kuopio 70701, Finland
[14] Boston Univ, Sch Publ Hlth, Dept Epidemiol, Boston, MA USA
[15] Univ Lancaster, Lancaster Environm Ctr, Lancaster LA1 4YQ, England
[16] McMaster Univ, Hlth Sci Ctr, Dept Med, Room 2C14,1280 Main St West, Hamilton, ON L8S 4K1, Canada
关键词
Risk of bias; Environmental health; GRADE; Non-randomized studies; Study limitations; ROBINS; URINARY BISPHENOL-A; QUALITY; MISCLASSIFICATION; SMOKING;
D O I
10.1016/j.envint.2018.11.004
中图分类号
X [环境科学、安全科学];
学科分类号
08 ; 0830 ;
摘要
The objective of this paper is to explain how to apply, interpret, and present the results of a new instrument to assess the risk of bias (RoB) in non-randomized studies (NRS) dealing with effects of environmental exposures on health outcomes. This instrument is modeled on the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) instrument. The RoB instrument for NRS of exposures assesses RoB along a standardized comparison to a randomized target experiment, instead of the study-design directed RoB approach. We provide specific guidance for the integral steps of developing a research question and target experiment, distinguishing issues of indirectness from RoB, making individual-study judgments, and performing and interpreting sensitivity analyses for RoB judgments across a body of evidence. Also, we present an approach for integrating the RoB assessments within the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework to assess the certainty of the evidence in the systematic review. Finally, we guide the reader through an overall assessment to support the rating of all domains that determine the certainty of a body of evidence using the GRADE approach.
引用
收藏
页码:168 / 184
页数:17
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