PMID- 32638670
OWN - NLM
STAT- Publisher
LR  - 20240227
IS  - 1471-6348 (Electronic)
IS  - 0266-4623 (Linking)
DP  - 2020 Jun 24
TI  - Review of real-world evidence studies in type 2 diabetes mellitus: Lack of good 
      practices.
PG  - 1-8
LID - 10.1017/S0266462320000392 [doi]
AB  - OBJECTIVES: Unlike randomized controlled trials, lack of methodological rigor is 
      a concern about real-world evidence (RWE) studies. The objective of this study 
      was to characterize methodological practices of studies collecting 
      pharmacoeconomic data in a real-world setting for the management of type 2 
      diabetes mellitus (T2DM). METHODS: A systematic literature review was performed 
      using the PICO framework: population consisted of T2DM patients, interventions 
      and comparators were any intervention for T2DM care or absence of intervention, 
      and outcomes were resource utilization, productivity loss or utility. Only RWE 
      studies were included, defined as studies that were not clinical trials and that 
      collected de novo data (no retrospective analysis). RESULTS: The literature 
      search identified 1,158 potentially relevant studies, among which sixty were 
      included in the literature review. Many studies showed a lack of transparency by 
      not mentioning the source for outcome and exposure measurement, source for 
      patient selection, number of study sites, recruitment duration, sample size 
      calculation, sampling method, missing data, approbation by an ethics committee, 
      obtaining patient's consent, conflicts of interest, and funding. A significant 
      proportion of studies had poor quality scores and was at high risk of bias. 
      CONCLUSIONS: RWE from T2DM studies lacks transparency and credibility. There is a 
      need for good procedural practices that can increase confidence in RWE studies. 
      Standardized methodologies specifically adapted for RWE studies collecting 
      pharmacoeconomic data for the management of T2DM could help future reimbursement 
      decision making in this major public health problem.
FAU - Lambert-Obry, Veronique
AU  - Lambert-Obry V
AUID- ORCID: 0000-0002-2499-1377
AD  - The Faculty of Pharmacy, Universite de Montreal, 2940, Chemin de Polytechnique, 
      Montreal, QuebecH3T 1J4, Canada.
FAU - Lafrance, Jean-Philippe
AU  - Lafrance JP
AD  - The Faculty of Medicine, Universite de Montreal, 2900, Boulevard 
      Edouard-Montpetit, Montreal, QuebecH3T 1J4, Canada.
FAU - Savoie, Michelle
AU  - Savoie M
AD  - The Faculty of Pharmacy, Universite de Montreal, 2940, Chemin de Polytechnique, 
      Montreal, QuebecH3T 1J4, Canada.
FAU - Henri, Sandrine
AU  - Henri S
AD  - The Faculty of Pharmacy, Universite de Montreal, 2940, Chemin de Polytechnique, 
      Montreal, QuebecH3T 1J4, Canada.
FAU - Lachaine, Jean
AU  - Lachaine J
AD  - The Faculty of Pharmacy, Universite de Montreal, 2940, Chemin de Polytechnique, 
      Montreal, QuebecH3T 1J4, Canada.
LA  - eng
PT  - Journal Article
DEP - 20200624
PL  - England
TA  - Int J Technol Assess Health Care
JT  - International journal of technology assessment in health care
JID - 8508113
SB  - IM
OTO - NOTNLM
OT  - Costs
OT  - Health-related quality of life
OT  - Real-world evidence
OT  - Resource use
OT  - Work productivity
EDAT- 2020/07/09 06:00
MHDA- 2020/07/09 06:00
CRDT- 2020/07/09 06:00
PHST- 2020/07/09 06:00 [entrez]
PHST- 2020/07/09 06:00 [pubmed]
PHST- 2020/07/09 06:00 [medline]
AID - S0266462320000392 [pii]
AID - 10.1017/S0266462320000392 [doi]
PST - aheadofprint
SO  - Int J Technol Assess Health Care. 2020 Jun 24:1-8. doi: 
      10.1017/S0266462320000392.