PMID- 23406262
OWN - NLM
STAT- MEDLINE
DCOM- 20130614
LR  - 20211021
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 13
DP  - 2013 Feb 14
TI  - Systematic evaluation of the methodology of randomized controlled trials of 
      anticoagulation in patients with cancer.
PG  - 76
LID - 10.1186/1471-2407-13-76 [doi]
AB  - BACKGROUND: Randomized controlled trials (RCTs) that are inappropriately designed 
      or executed may provide biased findings and mislead clinical practice. In view of 
      recent interest in the treatment and prevention of thrombotic complications in 
      cancer patients we evaluated the characteristics, risk of bias and their time 
      trends in RCTs of anticoagulation in patients with cancer. METHODS: We conducted 
      a comprehensive search, including a search of four electronic databases (MEDLINE, 
      EMBASE, ISI the Web of Science, and CENTRAL) up to February 2010. We included 
      RCTs in which the intervention and/or comparison consisted of: vitamin K 
      antagonists, unfractionated heparin (UFH), low molecular weight heparin (LMWH), 
      direct thrombin inhibitors or fondaparinux. We performed descriptive analyses and 
      assessed the association between the variables of interest and the year of 
      publication. RESULTS: We included 67 RCTs with 24,071 participants. In twenty one 
      trials (31%) DVT diagnosis was triggered by clinical suspicion; the remaining 
      trials either screened for DVT or were unclear about their approach. 41 (61%), 22 
      (33%), and 11 (16%) trials respectively reported on major bleeding, minor 
      bleeding, and thrombocytopenia. The percentages of trials satisfying risk of bias 
      criteria were: adequate sequence generation (85%), adequate allocation 
      concealment (61%), participants' blinding (39%), data collectors' blinding (44%), 
      providers' blinding (41%), outcome assessors' blinding (75%), data analysts' 
      blinding (15%), intention to treat analysis (57%), no selective outcome reporting 
      (12%), no stopping early for benefit (97%). The mean follow-up rate was 96%. 
      Adequate allocation concealment and the reporting of intention to treat analysis 
      were the only two quality criteria that improved over time. CONCLUSIONS: Many 
      RCTs of anticoagulation in patients with cancer appear to use insufficiently 
      rigorous outcome assessment methods and to have deficiencies in key 
      methodological features. It is not clear whether this reflects a problem in the 
      design, conduct or the reporting of these trials, or both. Future trials should 
      avoid the shortcomings described in this article.
FAU - Rada, Gabriel
AU  - Rada G
AD  - Evidence Based Health Care Program, Faculty of Medicine, Pontificia Universidad 
      Catolica de Chile, Santiago, Chile.
FAU - Schunemann, Holger J
AU  - Schunemann HJ
FAU - Labedi, Nawman
AU  - Labedi N
FAU - El-Hachem, Pierre
AU  - El-Hachem P
FAU - Kairouz, Victor F
AU  - Kairouz VF
FAU - Akl, Elie A
AU  - Akl EA
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20130214
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
RN  - 0 (Anticoagulants)
SB  - IM
MH  - Anticoagulants/adverse effects/*therapeutic use
MH  - Bias
MH  - Chi-Square Distribution
MH  - Early Termination of Clinical Trials
MH  - Endpoint Determination
MH  - Hemorrhage/chemically induced
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Linear Models
MH  - Neoplasms/blood/*complications/mortality
MH  - Randomized Controlled Trials as Topic/*methods
MH  - *Research Design
MH  - Risk Assessment
MH  - Risk Factors
MH  - Thrombocytopenia/chemically induced
MH  - Time Factors
MH  - Treatment Outcome
MH  - Venous Thrombosis/blood/*drug therapy/etiology/mortality
PMC - PMC3579688
EDAT- 2013/02/15 06:00
MHDA- 2013/06/15 06:00
PMCR- 2013/02/14
CRDT- 2013/02/15 06:00
PHST- 2012/07/06 00:00 [received]
PHST- 2013/02/04 00:00 [accepted]
PHST- 2013/02/15 06:00 [entrez]
PHST- 2013/02/15 06:00 [pubmed]
PHST- 2013/06/15 06:00 [medline]
PHST- 2013/02/14 00:00 [pmc-release]
AID - 1471-2407-13-76 [pii]
AID - 10.1186/1471-2407-13-76 [doi]
PST - epublish
SO  - BMC Cancer. 2013 Feb 14;13:76. doi: 10.1186/1471-2407-13-76.