Randomized controlled trials in de-implementation research: a systematic scoping review.

Clinical trials Cluster randomized trial De-implementation Low-value care Methods Overuse Randomized controlled trial Scoping review Trial design

Journal

Implementation science : IS
ISSN: 1748-5908
Titre abrégé: Implement Sci
Pays: England
ID NLM: 101258411

Informations de publication

Date de publication:
01 10 2022
Historique:
received: 30 06 2022
accepted: 19 09 2022
entrez: 1 10 2022
pubmed: 2 10 2022
medline: 5 10 2022
Statut: epublish

Résumé

Healthcare costs are rising, and a substantial proportion of medical care is of little value. De-implementation of low-value practices is important for improving overall health outcomes and reducing costs. We aimed to identify and synthesize randomized controlled trials (RCTs) on de-implementation interventions and to provide guidance to improve future research. MEDLINE and Scopus up to May 24, 2021, for individual and cluster RCTs comparing de-implementation interventions to usual care, another intervention, or placebo. We applied independent duplicate assessment of eligibility, study characteristics, outcomes, intervention categories, implementation theories, and risk of bias. Of the 227 eligible trials, 145 (64%) were cluster randomized trials (median 24 clusters; median follow-up time 305 days), and 82 (36%) were individually randomized trials (median follow-up time 274 days). Of the trials, 118 (52%) were published after 2010, 149 (66%) were conducted in a primary care setting, 163 (72%) aimed to reduce the use of drug treatment, 194 (85%) measured the total volume of care, and 64 (28%) low-value care use as outcomes. Of the trials, 48 (21%) described a theoretical basis for the intervention, and 40 (18%) had the study tailored by context-specific factors. Of the de-implementation interventions, 193 (85%) were targeted at physicians, 115 (51%) tested educational sessions, and 152 (67%) multicomponent interventions. Missing data led to high risk of bias in 137 (60%) trials, followed by baseline imbalances in 99 (44%), and deficiencies in allocation concealment in 56 (25%). De-implementation trials were mainly conducted in primary care and typically aimed to reduce low-value drug treatments. Limitations of current de-implementation research may have led to unreliable effect estimates and decreased clinical applicability of studied de-implementation strategies. We identified potential research gaps, including de-implementation in secondary and tertiary care settings, and interventions targeted at other than physicians. Future trials could be improved by favoring simpler intervention designs, better control of potential confounders, larger number of clusters in cluster trials, considering context-specific factors when planning the intervention (tailoring), and using a theoretical basis in intervention design. OSF Open Science Framework hk4b2.

Sections du résumé

BACKGROUND
Healthcare costs are rising, and a substantial proportion of medical care is of little value. De-implementation of low-value practices is important for improving overall health outcomes and reducing costs. We aimed to identify and synthesize randomized controlled trials (RCTs) on de-implementation interventions and to provide guidance to improve future research.
METHODS
MEDLINE and Scopus up to May 24, 2021, for individual and cluster RCTs comparing de-implementation interventions to usual care, another intervention, or placebo. We applied independent duplicate assessment of eligibility, study characteristics, outcomes, intervention categories, implementation theories, and risk of bias.
RESULTS
Of the 227 eligible trials, 145 (64%) were cluster randomized trials (median 24 clusters; median follow-up time 305 days), and 82 (36%) were individually randomized trials (median follow-up time 274 days). Of the trials, 118 (52%) were published after 2010, 149 (66%) were conducted in a primary care setting, 163 (72%) aimed to reduce the use of drug treatment, 194 (85%) measured the total volume of care, and 64 (28%) low-value care use as outcomes. Of the trials, 48 (21%) described a theoretical basis for the intervention, and 40 (18%) had the study tailored by context-specific factors. Of the de-implementation interventions, 193 (85%) were targeted at physicians, 115 (51%) tested educational sessions, and 152 (67%) multicomponent interventions. Missing data led to high risk of bias in 137 (60%) trials, followed by baseline imbalances in 99 (44%), and deficiencies in allocation concealment in 56 (25%).
CONCLUSIONS
De-implementation trials were mainly conducted in primary care and typically aimed to reduce low-value drug treatments. Limitations of current de-implementation research may have led to unreliable effect estimates and decreased clinical applicability of studied de-implementation strategies. We identified potential research gaps, including de-implementation in secondary and tertiary care settings, and interventions targeted at other than physicians. Future trials could be improved by favoring simpler intervention designs, better control of potential confounders, larger number of clusters in cluster trials, considering context-specific factors when planning the intervention (tailoring), and using a theoretical basis in intervention design.
REGISTRATION
OSF Open Science Framework hk4b2.

Identifiants

pubmed: 36183140
doi: 10.1186/s13012-022-01238-z
pii: 10.1186/s13012-022-01238-z
pmc: PMC9526943
doi:

Types de publication

Journal Article Systematic Review Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

65

Informations de copyright

© 2022. The Author(s).

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Auteurs

Aleksi J Raudasoja (AJ)

Faculty of Medicine, University of Helsinki, Helsinki, Finland. raudasoja.aleksi@gmail.com.
Finnish Medical Society Duodecim, Helsinki, Finland. raudasoja.aleksi@gmail.com.

Petra Falkenbach (P)

Finnish Coordinating Center for Health Technology Assessment, Oulu University Hospital, Oulu, Finland.
University of Oulu, Oulu, Finland.

Robin W M Vernooij (RWM)

Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.

Jussi M J Mustonen (JMJ)

Occupational Health Helsinki, Helsinki, Finland.

Arnav Agarwal (A)

Division of General Internal Medicine, Department of Medicine and Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.

Yoshitaka Aoki (Y)

Department of Urology, University of Fukui Faculty of Medical Sciences, Fukui, Japan.

Marco H Blanker (MH)

Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.

Rufus Cartwright (R)

Department of Gynaecology, Chelsea & Westminster NHS Foundation Trust, London, UK.
Department of Epidemiology & Biostatistics, Imperial College London, London, UK.

Herney A Garcia-Perdomo (HA)

Division of Urology/Uro-oncology, Department of Surgery, School of Medicine, Universidad del Valle, Cali, Colombia.

Tuomas P Kilpeläinen (TP)

Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.

Olli Lainiala (O)

Department of Radiology, Tampere University Hospital and Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland.

Tiina Lamberg (T)

Finnish Medical Society Duodecim, Helsinki, Finland.

Olli P O Nevalainen (OPO)

Faculty of Medicine, University of Helsinki, Helsinki, Finland.
Hatanpää Health Center, City of Tampere, Finland.
Unit of Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland.

Eero Raittio (E)

Oral Health Care, Tampere, Finland.
Institute of Dentistry, University of Eastern Finland, Kuopio, Finland.
Nordic Healthcare Group Ltd., Helsinki, Finland.

Patrick O Richard (PO)

Division of Urology, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada.

Philippe D Violette (PD)

Departments of Surgery and Health Research Methods Evidence and Impact, McMaster University, Hamilton, Canada.

Jorma Komulainen (J)

Finnish Medical Society Duodecim, Helsinki, Finland.

Raija Sipilä (R)

Finnish Medical Society Duodecim, Helsinki, Finland.

Kari A O Tikkinen (KAO)

Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Department of Surgery, South Karelian Central Hospital, Lappeenranta, Finland.

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