PMID- 27494394
OWN - NLM
STAT- MEDLINE
DCOM- 20170712
LR  - 20181113
IS  - 1365-2060 (Electronic)
IS  - 0785-3890 (Print)
IS  - 0785-3890 (Linking)
VI  - 48
IP  - 7
DP  - 2016 Nov
TI  - Clinical Impact Research - how to choose experimental or observational 
      intervention study?
PG  - 492-495
AB  - BACKGROUND: Interventions directed to individuals by health and social care 
      systems should increase health and welfare of patients and customers. AIMS: This 
      paper aims to present and define a new concept Clinical Impact Research (CIR) and 
      suggest which study design, either randomized controlled trial (RCT) 
      (experimental) or benchmarking controlled trial (BCT) (observational) is 
      recommendable and to consider the feasibility, validity, and generalizability 
      issues in CIR. METHODS: The new concept is based on a narrative review of the 
      literature and on author's idea that in intervention studies, there is a need to 
      cover comprehensively all the main impact categories and their respective 
      outcomes. The considerations on how to choose the most appropriate study design 
      (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and 
      on author's previous work on the concepts benchmarking controlled trial and 
      system impact research (SIR). RESULTS: The CIR covers all studies aiming to 
      assess the impact for health and welfare of any health (and integrated social) 
      care or public health intervention directed to an individual. The impact 
      categories are accessibility, quality, equality, effectiveness, safety, and 
      efficiency. Impact is the main concept, and within each impact category, both 
      generic- and context-specific outcome measures are needed. CIR uses RCTs and 
      BCTs. CONCLUSIONS: CIR should be given a high priority in medical, health care, 
      and health economic research. Clinicians and leaders at all levels of health care 
      can exploit the evidence from CIR. Key messages The new concept of Clinical 
      Impact Research (CIR) is defined as a research field aiming to assess what are 
      the impacts of healthcare and public health interventions targeted to patients or 
      individuals. The term impact refers to all effects caused by the interventions, 
      with particular emphasis on accessibility, quality, equality, effectiveness, 
      safety, and efficiency. CIR uses two study designs: randomized controlled trials 
      (RCTs) (experimental) and benchmarking controlled trials (BCTs) (observational). 
      Suggestions on how to choose between RCT and BCT as the most suitable study 
      design are presented. Simple way of determining the study question in CIR based 
      on the PICO (patient, intervention, control intervention, outcome) framework is 
      presented. CIR creates the scientific basis for clinical decisions. Clinicians 
      and leaders at all levels of health care and those working for public health can 
      use the evidence from CIR for the benefit of patients and the population.
FAU - Malmivaara, Antti
AU  - Malmivaara A
AD  - a Centre for Health and Social Economics, National Institute for Health and 
      Welfare , Mannerheimintie 166 , Helsinki , Finland.
LA  - eng
PT  - Journal Article
DEP - 20160805
PL  - England
TA  - Ann Med
JT  - Annals of medicine
JID - 8906388
SB  - IM
MH  - Benchmarking
MH  - Biomedical Research/methods
MH  - Health Services Research/*methods
MH  - Humans
MH  - Observational Studies as Topic
MH  - Randomized Controlled Trials as Topic
PMC - PMC5152547
OTO - NOTNLM
OT  - Accessibility
OT  - benchmarking controlled trial
OT  - clinical impact research
OT  - effectiveness
OT  - efficiency
OT  - equality
OT  - health care
OT  - quality
OT  - randomized controlled trial
OT  - safety
EDAT- 2016/08/06 06:00
MHDA- 2017/07/14 06:00
PMCR- 2016/12/12
CRDT- 2016/08/06 06:00
PHST- 2016/08/06 06:00 [pubmed]
PHST- 2017/07/14 06:00 [medline]
PHST- 2016/08/06 06:00 [entrez]
PHST- 2016/12/12 00:00 [pmc-release]
AID - 1186828 [pii]
AID - 10.1080/07853890.2016.1186828 [doi]
PST - ppublish
SO  - Ann Med. 2016 Nov;48(7):492-495. doi: 10.1080/07853890.2016.1186828. Epub 2016 
      Aug 5.