Risk of Bias Assessment

Ethan M Balk; Alexandra G Ellis; Mengyang Di; Gaelen P Adam; Thomas A Trikalinos

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Balk EM, Ellis AG, Di M, et al. Venous Thromboembolism Prophylaxis in Major Orthopedic Surgery: Systematic Review Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 Jun. (Comparative Effectiveness Reviews, No. 191.)

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Venous Thromboembolism Prophylaxis in Major Orthopedic Surgery: Systematic Review Update [Internet].

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Appendix CRisk of Bias Assessment

Table C1RCT risk of bias (total hip replacement)

Study	Adequate generation of a randomized sequence	Allocation concealment	Blinding of PATIENTS	Blinding of PROVIDERS	Blinding of OUTCOME ASSESSORS	Intention-to-treat-analysis	Incomplete results data (attrition bias)	Selective Reporting (reporting bias)	Group similarity at baseline (selection bias)	Compliance with interventions	Outcome assessment timing (across interventions)	Assessment of outcome	Adverse events precisely defined
Alfaro 1986	Unclear	Unclear	Unclear	Unclear	Unclear	Low	Unclear	NR	Low	NR	NR	Low	NR
Andersen 1997	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Anderson 2013	Low	Low	Low	Low	Low	Low	Low	High	Low	Low	Unclear	High	Low
Avikainen 1995	Unclear	High	High	High	Unclear	Low	Low	NR	Low	NR	NR	Low	NR
Bailey 1991	Low	Low	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR
Barre 1987	Unclear	Unclear	High	High	Unclear	Low	Low	NR	Low	NR	NR	Low	NR
Borgen 2012	Low	Low	Low	Low	Low	Low	Low	High	Low	Low	Low	High	High
Bramlage 2012	Unclear	Unclear	Low	Low	Low	Unclear	High	High	High	Unclear	Unclear	High	High
Colwell 1994	Low	Low	High	High	Unclear	Low	Low	NR	Low	NR	NR	Low	NR
Colwell 1999	Unclear	Unclear	High	High	Unclear	Low	Low	NR	Low	NR	NR	Low	NR
Colwell 2010	Low	High	High	High	Low	Low	Low	High	Low	Unclear	Low	Low	Low
Comp 2001	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Dahl 1997	Unclear	Unclear	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Dechavanne 1989	Unclear	Low	Unclear	Unclear	Unclear	Low	Low	NR	Low	NR	NR	Low	NR
Edwards 2008	Unclear	Unclear	High	High	High	Low	Low	NR	Low	NR	NR	Low	NR
Eisele 2006	Unclear	Unclear	Unclear	Unclear	High	Low	Low	High	Unclear	Unclear	High	Low	NR
Eriksson 1991	Unclear	Unclear	Low	Low	Low	High	Low	NR	Low	NR	NR	Low	NR
Eriksson 1996	Unclear	Unclear	Low	Low	High	Low	Low	NR	Low	NR	NR	Low	NR
Eriksson 1997A	Low	Low	Low	Low	High	High	Low	NR	Low	NR	NR	Low	NR
Eriksson 1997B	Unclear	Unclear	Low	Low	High	High	High	NR	Low	NR	NR	Low	NR
Eriksson 2005	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Eriksson 2007B	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Eriksson 2010	Low	Unclear	Unclear	Unclear	Low	Unclear	Unclear	Low	Low	Low	High	Low	Low
Eriksson 2011	Low	Low	Low	Low	Low	Low	High	Low	Low	Low	Unclear	Low	Unclear
Eriksson 2014	Low	Unclear	Low	Low	Low	Low	High	High	Low	Low	Low	Low	Low
Francis 1992	Low	Low	High	High	Low	High	Low	NR	Low	NR	NR	Low	NR
Francis 1997	Unclear	Unclear	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR
Fuji 2008	Unclear	Unclear	Low	Low	High	Low	Low	NR	Low	NR	NR	Low	NR
Fuji 2014A	Low	High	High	High	Low	High	High	Low	Low	Low	High	Low	Low
Fuji 2014D	Unclear	Unclear	High	High	Unclear	High	High	Low	Low	Unclear	Unclear	High	Low
Fuji 2015	Unclear	Unclear	Low	Low	Low	Low	Unclear	Low	Low	Low	Unclear	Low	Low
Hull 1993	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Hull 2000	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Kim 2016	Low	Unclear	Low	Unclear	Low	High	Low	High	Low	Unclear	High	High	Low
Kim 2016A	Low	Unclear	Low	Unclear	Low	High	Low	High	Low	Unclear	High	High	Low
Kalodiki 1996	Low	Low	NR	NR	Low	High	Low	NR	Low	NR	NR	NR	NR
Lassen 1998	Unclear	Unclear	Low	Low	Low	High	Low	NR	Low	NR	NR	Low	NR
Lassen 2002	Low	Low	Low	Low	Low	High	High	NR	Low	NR	NR	Low	NR
Lassen 2010A	Low	Low	Low	Low	Low	High	Mixed^*	Low	Low	Low	Low	Low	Low
Lassen 2012	Low	Low	Low	Unclear	Low	High	High	High	Low	Unclear	Unclear	Low	Low
Levine 1991	Unclear	Unclear	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Lieberman 1994	Low	Unclear	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR
Lotke 1996	Unclear	Unclear	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR
Menzin 1994	Unclear	Unclear	High	High	Unclear	Low	Low	NR	Low	NR	NR	Low	NR
Nilsson 1997	Unclear	Unclear	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Paiement 1987	Unclear	Unclear	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR
Planès 1988	Unclear	Unclear	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Planès 1997	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Planès 1999	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Prandoni 2002	Low	Low	Unclear	Unclear	Low	Low	Low	NR	Low	NR	NR	Low	NR
Rader 1998	Unclear	Unclear	Unclear	Unclear	Unclear	Low	Low	NR	Low	NR	NR	Low	NR
Raskob 2010	Low	Low	Low	Low	Low	Unclear	Unclear	High	Low	Unclear	Unclear	Low	Low
Ryan 2002	Unclear	Unclear	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR
Santori 1994	Low	Low	High	High	Unclear	Low	Low	NR	Low	NR	NR	Low	NR
Schwartsmann 1996	Unclear	Unclear	High	High	Unclear	Low	Low	NR	Low	NR	NR	Low	NR
Senaran 2006	Unclear	Unclear	High	High	Unclear	Low	Low	NR	Low	NR	NR	Low	NR
Silbersack 2004	Unclear	Unclear	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR
Stannard 1996	Unclear	Unclear	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR
Stone 1996	Unclear	Unclear	Low	Low	Unclear	Low	Low	NR	Low	NR	NR	Low	NR
Turpie 2002	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Verhamme 2013	Unclear	Unclear	Low	Low	Low	Low	Unclear	Low	Low	Unclear	Low	Low	Low
Warwick 1998	Low	Low	High	High	High	Low	Low	NR	Low	NR	NR	Low	NR
Woolson 1991	Low	Low	High	High	Unclear	Low	Low	NR	Low	NR	NR	Low	NR
Yokote 2011	Unclear	Unclear	Unclear	Unclear	High	Low	Low	NR	Low	NR	NR	Low	NR
Zhang 2013	Unclear	Unclear	Unclear	Unclear	Unclear	Low	High	High	Unclear	Unclear	Unclear	Low	NR
Zhang 2014	Low	Unclear	High	High	Unclear	Low	Low	High	Unclear	Unclear	Low	Low	NR
Zhirova 2014	Unclear	Unclear	Unclear	Unclear	Unclear	Unclear	Unclear	High	Unclear	Unclear	Unclear	Unclear	High

Table C2RCT risk of bias (total knee replacement)

Study	Adequate generation of a randomized sequence	Allocation concealment	Blinding of PATIENTS	Blinding of PROVIDERS	Blinding of OUTCOME ASSESSORS	Intention-to-treat-analysis	Incomplete results data (attrition bias)	Selective Reporting (reporting bias)	Group similarity at baseline (selection bias)	Compliance with interventions	Outcome assessment timing (across interventions)	Assessment of outcome	Adverse events precisely defined
Barrellier 2010	Unclear	Low	High	High	High	Low	Low	High	Low	Low	Low	Low	Low
Bauer 2001	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Bonneux 2006	Low	Low	High	High	Unclear	High	Low	NR	Low	NR	NR	Low	NR
Büller 2015	Low	Low	High	High	Low	High	Unclear	Low	Low	Low	High	Low	Low
Choi 2015	Unclear	Unclear	Low	High	High	Low	Low	High	High	Low	Low	Low	NR
Cohen 2013	Unclear	Unclear	Unclear	Unclear	Low	High	High	Low	Low	Low	Unclear	Low	Low
Colwell 1995	Unclear	Unclear	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR
Comp 2001	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Edwards 2008	Unclear	Unclear	High	High	High	Low	Low	NR	Low	NR	NR	Low	NR
Eisele 2006	Unclear	Unclear	Unclear	Unclear	High	Low	Low	High	Unclear	Unclear	High	Low	NR
Eriksson 2005	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Eriksson 2007A	Low	Low	Low	Low	Low	High	Low	NR	Low	NR	NR	Low	NR
Faunø 1994	Low	Low	High	Unclear	High	Low	Low	NR	Low	NR	NR	Low	NR
Fitzgerald 2001	Low	Low	High	High	High	Low	Low	NR	Low	NR	NR	Low	NR
Fuji 2008	Unclear	Unclear	Low	Low	High	Low	Low	NR	Low	NR	NR	Low	NR
Fuji 2010A	Low	Low	Low	Low	High	Unclear	Low	NR	Low	NR	NR	Low	NR
Fuji 2010B	Low	Unclear	Low	Unclear	Low	Low	High	Low	Low	Low	Low	High	Low
Fuji 2014C	Low	Unclear	Low	Low	Low	High	High	Low	Low	Unclear	Unclear	Low	Low
Fuji 2014D	Unclear	Unclear	High	High	Unclear	High	High	Low	Low	Low	Low	High	Low
Ginsberg 2009	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Haas 1990	Unclear	Unclear	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR
Hu 2015	Unclear	Unclear	High	High	Unclear	Low	Low	High	Unclear	Unclear	Unclear	Low	NR
Hull 1993	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Iliopoulos 2011	Unclear	Unclear	Unclear	Unclear	Unclear	Unclear	Unclear	High	Low	Unclear	Unclear	Unclear	Unclear
Jiang 2014	Low	Unclear	High	High	Unclear	Low	Low	High	Low	Unclear	Low	Unclear	Low
Koo 2014	Low	Unclear	Unclear	Unclear	Unclear	Low	Low	High	High	Unclear	Low	Low	NR
Lachiewicz 2004	Low	Low	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR
Lassen 2007	Low	Low	High	Unclear	Low	Low	Low	NR	Low	NR	NR	Low	NR
Lassen 2010B	Low	Low	Low	Unclear	Low	Low	High	Low	Low	Unclear	Low	High	Low
Lassen 2012	Low	Low	Low	Unclear	Low	High	High	High	Low	Unclear	Unclear	Low	Low
Leclerc 1996	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Lotke 1996	Unclear	Unclear	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR
Mirdamadi 2014	Low	Unclear	High	High	Low	Low	Low	High	Low	Unclear	Low	Low	Low
Rader 1998	Unclear	Unclear	Unclear	Unclear	Unclear	Low	Low	NR	Low	NR	NR	Low	NR
Sakai 2016	Low	Unclear	High	High	High	Low	Low	High	Low	Low	Low	Unclear	Low
Silbersack 2004	Unclear	Unclear	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR
Verhamme 2011	Low	Low	High	High	Low	Low	Unclear	Low	Low	Low	Low	High	Low
Warwick 2002	Low	Low	High	High	Low	High	Low	NR	Low	NR	NR	Low	NR
Weitz 2010	Unclear	Low	Unclear	Unclear	Low	High	High	Low	Low	Unclear	Low	Low	Low
Westrich 1996	Low	Low	High	High	Low	Low	Low	High	Unclear	Unclear	Low	Low	NR
Westrich 2006	Unclear	Unclear	Unclear	Unclear	Unclear	High	High	High	Low	Low	Low	High	High
Windisch 2011	Unclear	Unclear	High	High	Low	Low	Low	High	Unclear	Unclear	Low	Low	NR
Yilmaz 2015	Low	Unclear	High	High	Low	Low	Low	Low	Low	Unclear	Unclear	Unclear	NR
Zou 2014	Low	High	High	High	Unclear	Low	Low	High	Low	Unclear	Low	Low	Low
NCT00595426	Unclear	Unclear	Low	Low	High	Unclear	Unclear	High	Unclear	Unclear	Unclear	Unclear	High
NCT00246025	Unclear	Unclear	Low	Low	High	Low	Low	Unclear	Unclear	Unclear	Low	Unclear	Low

Table C3RCT risk of bias (hip fracture surgery)

Study	Adequate generation of a randomized sequence	Allocation concealment	Blinding of PATIENTS	Blinding of PROVIDERS	Blinding of OUTCOME ASSESSORS	Intention-to-treat-analysis	Incomplete results data (attrition bias)	Selective Reporting (reporting bias)	Group similarity at baseline (selection bias)	Compliance with interventions	Outcome assessment timing (across interventions)	Assessment of outcome	Adverse events precisely defined
Eriksson 2001	Low	Low	Low	Low	Low	High	High	NR	Low	NR	NR	Low	NR
Eriksson 2003	Low	Low	Low	Low	Low	Low	Low	NR	Low	NR	NR	Low	NR
Fisher 2013	Low	Low	Low	Low	Low	High	High	High	Low	Low	High	Unclear	Low
Fuji 2014B	Unclear	Unclear	High	High	Unclear	Unclear	High	Low	Low	Low	High	Low	Low
Kennedy 2000	Unclear	Unclear	High	High	Low	High	Low	NR	Low	NR	NR	Low	NR
Lassen 2012	Low	Low	Low	Unclear	Low	High	High	High	Low	Unclear	Unclear	Low	Low
Monreal 1989	Low	Low	Low	Low	Unclear	High	High	NR	Low	NR	NR	Low	NR
Powers 1989	Low	Low	High	High	High	Low	Low	NR	Low	NR	NR	Low	NR
Sasaki 2011	High	High	High	High	Unclear	Low	Low	High	Low	Unclear	Unclear	High	Low
The TIFDED Study Group 1999	Unclear	Unclear	High	High	Low	Low	Low	NR	Low	NR	NR	Low	NR

Table C4NRCS risk of bias

Author Year PMID Country/Region	Blinding of outcome assessors	Incomplete results data	Selective Reporting	Group similarity at baseline	Compliance with interventions	Outcome assessment timing	Assessment of outcome	Patients selected in equivalent manner	Adverse events precisely defined
Total hip replacement
Bloch 2014 24395322 UK	High	Low	Low	Unclear	Low	Unclear	Low	Low	Low
Bottle 2015	Unclear	Low	High	Unclear	Low	Low	High	Low	Low
Ishibe 2011 22101618 Japan	High	Low	High	Low	Low	Low	Unclear	Low	Unclear
Jameson 2011 22058295 UK	High	Low	Low	High	Unclear	Low	High	Low	Low
Khatod 2011 22005861 U.S.	Low	Low	High	Low	Low	Low	High	Low	Low
Pedersen 2015 25511580 Denmark	High	Low	Low	Low	Low	Low	High	Low	Low
Vulcano 2012 22684546 U.S.	Low	Low	High	High	High	Low	Low	High	Low
Wells 2010 21348557 U.S.	Unclear	Unclear	High	High	Low	Low	Unclear	Low	Low
Total knee replacement
Bloch 2014 24395322 UK	High	Low	Low	Unclear	Low	Unclear	Low	Low	Low
Bottle 2015	Unclear	Low	High	Unclear	Low	Low	High	Low	Low
Bozic 2010 19679434 US	Unclear	Low	NR	High	NR	NR	High	Low	NR
Jameson 2012 22733945 UK	High	Low	Low	High	Unclear	Low	High	Low	Low
Kang 2015 25963358 China	Unclear	Low	High	Unclear	Low	Low	Low	Low	NR
Khatod 2012 21641758 U.S.	Low	Low	High	High	Low	Low	Unclear	Low	Low
Llau 2011 Abstract 6AP3-2 Spain	Unclear	Low	High	Unclear	Low	Low	Unclear	Unclear	NR
Rath 2013 23566737 UK	High	Low	Low	Unclear	Low	Low	Low	Low	Low
Wells 2010 21348557 U.S.	Unclear	Unclear	High	High	Low	Low	Unclear	Low	Low
Hip fracture surgery
Tsuda 2014 25034972 Japan	High	Low	Low	Low	Low	Unclear	High	Low	High

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Balk EM, Ellis AG, Di M, et al. Venous Thromboembolism Prophylaxis in Major Orthopedic Surgery: Systematic Review Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 Jun. (Comparative Effectiveness Reviews, No. 191.) Appendix C, Risk of Bias Assessment.
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