Mixed-methods approach to develop an agreed concept on patient relevance: study protocol for the 'PRO patients study'.
health services administration & management
public health
qualitative research
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
09 07 2021
09 07 2021
Historique:
entrez:
10
7
2021
pubmed:
11
7
2021
medline:
5
8
2021
Statut:
epublish
Résumé
With respect to patient-centred care and shared decision-making, measuring care effects based on outcomes relevant to patients is becoming increasingly important. Recently, a scoping review of the international literature revealed a wide range of supposedly patient-relevant outcomes and found that there is neither a sound definition of patient relevance nor a consistent set of outcomes relevant to patients. To close this gap, this study aims to develop an agreed concept on patient relevance including a set of outcomes relevant to patients irrespective of diseases, which grades outcomes according to their importance. This prospective mixed-methods study will integrate the perspectives of patients across diseases, healthcare professionals and researchers. The consensus process will consist of four phases. Based on the results of the recent scoping review, a patient survey will be conducted first, followed by a multiprofessional group discussion. Finally, a two-round online Delphi approach based on data from the previous phases will be applied to agree on a concept. Ethics approval for the study was granted on 26 August 2020 by the Ethics Commission of Witten/Herdecke University (reference number: 156/2020). In the long run, the implementation of an agreed concept on patient relevance will help improve the comparability of study results regarding the patient benefit and thereby strengthen the role of patients in the decision-making process. Also, the experiences regarding grading outcomes according to importance will help to develop a method on how to individualise clinical trial outcomes according to each patient's individual specifics and priorities in order to more adequately represent the patient perspective in clinical research. Core Outcome Measures in Effectiveness Trials Initiative (registration number: 1685).
Identifiants
pubmed: 34244269
pii: bmjopen-2020-047679
doi: 10.1136/bmjopen-2020-047679
pmc: PMC8273474
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e047679Informations de copyright
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Patient Educ Couns. 2006 May;61(2):292-8
pubmed: 15896943
PLoS Med. 2011 Jan 25;8(1):e1000393
pubmed: 21283604
JAMA. 2008 Jun 4;299(21):2543-9
pubmed: 18523223
J Gen Intern Med. 2012 Oct;27(10):1361-7
pubmed: 22618581
Ann Intensive Care. 2017 Dec;7(1):28
pubmed: 28271450
Med Decis Making. 1995 Apr-Jun;15(2):101-6
pubmed: 7783569
BMC Health Serv Res. 2020 Jun 29;20(1):596
pubmed: 32600321
J Clin Epidemiol. 2021 Mar 6;136:26-36
pubmed: 33689837
Pharmacoeconomics. 2017 Dec;35(Suppl 1):21-31
pubmed: 29052157
Can J Surg. 2017 Apr;60(2):86-93
pubmed: 28234219
J Am Geriatr Soc. 2016 Jan;64(1):15-8
pubmed: 26626262
Patient Educ Couns. 2006 Nov;63(3):268-78
pubmed: 16875797
Trials. 2019 Feb 11;20(1):116
pubmed: 30744706