PMID- 33107006
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210514
IS  - 1525-1497 (Electronic)
IS  - 0884-8734 (Print)
IS  - 0884-8734 (Linking)
VI  - 35
IP  - Suppl 2
DP  - 2020 Nov
TI  - Improving Comparative Effectiveness Research of Complex Health Interventions: 
      Standards from the Patient-Centered Outcomes Research Institute (PCORI).
PG  - 875-881
LID - 10.1007/s11606-020-06093-6 [doi]
AB  - INTRODUCTION: Complex health interventions (CHIs) are increasingly studied in 
      comparative effectiveness research (CER), and there is a need for improvements in 
      CHI research practices. The Patient-Centered Outcomes Research Institute (PCORI) 
      Methodology Committee (MC) launched an effort in 2016 to develop formal guidance 
      on this topic. OBJECTIVE: To develop a set of minimal standards for 
      scientifically valid, transparent, and reproducible CER studies of CHIs. The 
      standards are intended to apply to research examining a broad range of healthcare 
      interventions including delivery system, behavior change, and other 
      non-pharmacological interventions. METHODS: We conducted a literature review, 
      reviewed existing methods guidance, and developed standards through an iterative 
      process involving the MC, two panels of external research methods experts, and a 
      60-day public comment period. The final standards were approved by the PCORI MC 
      and adopted by the PCORI Board of Governors on April 30, 2018. RESULTS: The final 
      standards include the following: (1) fully describe the intervention and 
      comparator and define their core functions, (2) specify the hypothesized causal 
      pathways and their theoretical basis, (3) specify how adaptations to the form of 
      the intervention and comparator will be allowed and recorded, (4) plan 
      and describe a process evaluation, and (5) select patient outcomes informed by 
      the causal pathway. DISCUSSION: The new standards offer three major contributions 
      to research: (1) they provide a simple framework to help investigators address 
      the major methodological features of a CHI study, (2) they emphasize the 
      importance of the causal model and the need to understand how a CHI achieves its 
      effects rather than simply measuring these effects, and (3) they require 
      description of a CHI using the concepts of core functions and forms. While these 
      standards apply formally to PCORI-funded CER studies, they have broad 
      applicability.
FAU - Esmail, Laura C
AU  - Esmail LC
AUID- ORCID: 0000-0003-3684-614X
AD  - Clinical Effectiveness and Decision Science Program, Patient-Centered Outcomes 
      Research Institute (PCORI), Washington, DC, USA. laura.esmail@gmail.com.
AD  - , Washington, DC, USA. laura.esmail@gmail.com.
FAU - Barasky, Rebecca
AU  - Barasky R
AD  - Clinical Effectiveness and Decision Science Program, Patient-Centered Outcomes 
      Research Institute (PCORI), Washington, DC, USA.
FAU - Mittman, Brian S
AU  - Mittman BS
AD  - Health Services Research & Implementation Science, Department of Research & 
      Evaluation, Kaiser Permanente Southern California, Pasadena, CA, USA.
FAU - Hickam, David H
AU  - Hickam DH
AD  - Clinical Effectiveness and Decision Science Program, Patient-Centered Outcomes 
      Research Institute (PCORI), Washington, DC, USA.
LA  - eng
GR  - n/a/PCORI/Patient-Centered Outcomes Research Institute/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20201026
PL  - United States
TA  - J Gen Intern Med
JT  - Journal of general internal medicine
JID - 8605834
SB  - IM
MH  - Academies and Institutes
MH  - *Comparative Effectiveness Research
MH  - Humans
MH  - *Patient Outcome Assessment
MH  - Research Design
MH  - Research Personnel
PMC - PMC7652976
OTO - NOTNLM
OT  - comparative effectiveness research
OT  - complex health interventions
OT  - complex interventions
OT  - patient-centered outcomes research
COIS- The authors declare that they have no conflict of interest.
EDAT- 2020/10/28 06:00
MHDA- 2021/05/15 06:00
PMCR- 2020/10/26
CRDT- 2020/10/27 05:48
PHST- 2019/09/03 00:00 [received]
PHST- 2020/07/30 00:00 [accepted]
PHST- 2020/10/28 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2020/10/27 05:48 [entrez]
PHST- 2020/10/26 00:00 [pmc-release]
AID - 10.1007/s11606-020-06093-6 [pii]
AID - 6093 [pii]
AID - 10.1007/s11606-020-06093-6 [doi]
PST - ppublish
SO  - J Gen Intern Med. 2020 Nov;35(Suppl 2):875-881. doi: 10.1007/s11606-020-06093-6. 
      Epub 2020 Oct 26.