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Quality standards for real-world research. Focus on observational database studies of comparative effectiveness

Quality standards for real-world research. Focus on observational database studies of comparative effectiveness
Quality standards for real-world research. Focus on observational database studies of comparative effectiveness
Real-world research can use observational or clinical trial designs, in both cases putting emphasis on high external validity, to complement the classical efficacy randomized controlled trials (RCTs) with high internal validity. Real-world research is made necessary by the variety of factors that can play an important a role in modulating effectiveness in real life but are often tightly controlled in RCTs, such as comorbidities and concomitant treatments, adherence, inhalation technique, access to care, strength of doctor–caregiver communication, and socio-economic and other organizational factors. Real-world studies belong to two main categories: pragmatic trials and observational studies, which can be prospective or retrospective. Focusing on comparative database observational studies, the process aimed at ensuring high-quality research can be divided into three parts: preparation of research, analyses and reporting, and discussion of results. Key points include a priori planning of data collection and analyses, identification of appropriate database(s), proper outcomes definition, study registration with commitment to publish, bias minimization through matching and adjustment processes accounting for potential confounders, and sensitivity analyses testing the robustness of results. When these conditions are met, observational database studies can reach a sufficient level of evidence to help create guidelines (i.e., clinical and regulatory decision-making).
real-world research, observational studies, quality, methodology, database
2329-6933
S99-S104
Roche, N.
0aa0a8aa-062e-4f49-897f-88ba1c195771
Reddel, H.
d4e02631-bc7e-44e3-8270-d21d9434195c
Martin, R.
72c6ffa1-39b1-4032-bb67-f0c72390f573
Brusselle, G.
6a11c83d-d4a3-4e2f-8eb3-10816201b182
Papi, A.
e64601e5-163a-416d-867d-c548aa80dd75
Thomas, M.
997c78e0-3849-4ce8-b1bc-86ebbdee3953
Rand, C.
3fda2934-7efa-4779-9f65-b4e1c31e111c
Chilsholm, A.
a5cd133d-bb5c-4120-912e-5b40ef2a8b6e
Price, D.
7534eb51-9b20-4840-9604-f34a428c855c
Roche, N.
0aa0a8aa-062e-4f49-897f-88ba1c195771
Reddel, H.
d4e02631-bc7e-44e3-8270-d21d9434195c
Martin, R.
72c6ffa1-39b1-4032-bb67-f0c72390f573
Brusselle, G.
6a11c83d-d4a3-4e2f-8eb3-10816201b182
Papi, A.
e64601e5-163a-416d-867d-c548aa80dd75
Thomas, M.
997c78e0-3849-4ce8-b1bc-86ebbdee3953
Rand, C.
3fda2934-7efa-4779-9f65-b4e1c31e111c
Chilsholm, A.
a5cd133d-bb5c-4120-912e-5b40ef2a8b6e
Price, D.
7534eb51-9b20-4840-9604-f34a428c855c

Roche, N., Reddel, H., Martin, R., Brusselle, G., Papi, A., Thomas, M., Rand, C., Chilsholm, A. and Price, D. (2014) Quality standards for real-world research. Focus on observational database studies of comparative effectiveness. Annals of the American Thoracic Society, 11, supplement 2, S99-S104. (doi:10.1513/AnnalsATS.201309-300RM). (PMID:24559028)

Record type: Article

Abstract

Real-world research can use observational or clinical trial designs, in both cases putting emphasis on high external validity, to complement the classical efficacy randomized controlled trials (RCTs) with high internal validity. Real-world research is made necessary by the variety of factors that can play an important a role in modulating effectiveness in real life but are often tightly controlled in RCTs, such as comorbidities and concomitant treatments, adherence, inhalation technique, access to care, strength of doctor–caregiver communication, and socio-economic and other organizational factors. Real-world studies belong to two main categories: pragmatic trials and observational studies, which can be prospective or retrospective. Focusing on comparative database observational studies, the process aimed at ensuring high-quality research can be divided into three parts: preparation of research, analyses and reporting, and discussion of results. Key points include a priori planning of data collection and analyses, identification of appropriate database(s), proper outcomes definition, study registration with commitment to publish, bias minimization through matching and adjustment processes accounting for potential confounders, and sensitivity analyses testing the robustness of results. When these conditions are met, observational database studies can reach a sufficient level of evidence to help create guidelines (i.e., clinical and regulatory decision-making).

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More information

Published date: February 2014
Keywords: real-world research, observational studies, quality, methodology, database
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 362925
URI: https://eprints.soton.ac.uk/id/eprint/362925
ISSN: 2329-6933
PURE UUID: dda26e0c-a56c-4d06-83a7-1b63ab942242

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Date deposited: 10 Mar 2014 16:50
Last modified: 16 Jul 2019 21:10

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Contributors

Author: N. Roche
Author: H. Reddel
Author: R. Martin
Author: G. Brusselle
Author: A. Papi
Author: M. Thomas
Author: C. Rand
Author: A. Chilsholm
Author: D. Price

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