Titre
Reporting of Complications in Retinal Detachment Surgical Trials: A Systematic Review Using the CONSORT Extension for Harms.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Xu, Z.Y.
Auteure/Auteur
Azuara-Blanco, A.
Auteure/Auteur
Kadonosono, K.
Auteure/Auteur
Murray, T.
Auteure/Auteur
Natarajan, S.
Auteure/Auteur
Sii, S.
Auteure/Auteur
Smiddy, W.
Auteure/Auteur
Steel, D.H.
Auteure/Auteur
Wolfensberger, T.J.
Auteure/Auteur
Lois, N.
Auteure/Auteur
Contributrices/contributeurs
Arevalo, F.J.
Assi, A.
Aylward, G.W.
Barile, G.
Baumal, C.
Azuara-Blanco, A.
Silvia, B.
Christensen, U.C.
Crafoord, S.
de Smet, M.
Essex, R.W.
Fawzi, A.
Figueroa, M.
Flaxel, C.
Gottlieb, J.
Haynes, R.
Hillier, R.
Jackson, T.
Joussen, A.M.
Kadonosono, K.
Kruger, L.
Le Mer, Y.
Lim, J.
Lowenstein, A.
Lois, N.
Lorenzo-Carrero, J.
Martinez-Castillo, V.
Murray, T.
Natarajan, S.
Rivett, K.
Ruiz-Casas, D.
Saidkasimova, S.
Sandri, L.
Sato, S.
Shunmugam, M.
Sii, S.
Smiddy, W.
Spiteri-Cornish, K.
Steel, D.H.
Tornambe, P.
Upendran, M.
Valldeperas, X.
van Meurs, J.C.
Veckener, M.
Wickham, L.
Wolfensberger, T.J.
Xu, Z.Y.
Yorston, D.
Groupes de travail
CORDS Study Group
Liens vers les personnes
Liens vers les unités
ISSN
2168-6173
Statut éditorial
Publié
Date de publication
2021-06-30
Volume
139
Numéro
8
Première page
898
Dernière page/numéro d’article
905
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Journal Article
Résumé
Knowledge on the frequency and severity of complications in surgical trials for rhegmatogenous retinal detachment (RRD) is essential to determine whether surgical procedures are developed and compared adequately, taking into account not only efficacy but also harms.
To review standards of reporting of complications in recent randomized clinical trials of RRD surgery.
This systematic review included randomized clinical trials on RRD surgery published between January 2008 and January 2021 in Embase, MEDLINE, and Web of Science Core Collection databases. Titles, abstracts, and full-text articles retrieved were reviewed for eligibility by 2 independent authors. Eligible studies were evaluated against checklist items from the Consolidated Standards of Reporting Trials Extension for Harms criteria by 2 independent authors, and discrepancies were resolved by discussion with a third author.
Fifty studies were included. The median number of checklist items fulfilled was 8 (range, 0-15), of a possible total of 18. Frequently reported items were discussions balanced with regard to efficacy and adverse events (42 studies [84%]) and inclusions of harm-associated timing of data collection (41 studies [82%]). The least frequently reported items were distinctions between expected and unexpected adverse events (1 study [2%]) and mentions of the use of a validated instrument to report adverse event severity (4 studies [8%]). Frequency of complications was commonly reported (29 studies [58%]) in contrast with complication severity (10 studies [20%]).
This review suggests that severity of complications of RRD surgery has been infrequently quantified and reported in randomized clinical trials and potentially represents an important area of improvement in future RRD surgical trials.
To review standards of reporting of complications in recent randomized clinical trials of RRD surgery.
This systematic review included randomized clinical trials on RRD surgery published between January 2008 and January 2021 in Embase, MEDLINE, and Web of Science Core Collection databases. Titles, abstracts, and full-text articles retrieved were reviewed for eligibility by 2 independent authors. Eligible studies were evaluated against checklist items from the Consolidated Standards of Reporting Trials Extension for Harms criteria by 2 independent authors, and discrepancies were resolved by discussion with a third author.
Fifty studies were included. The median number of checklist items fulfilled was 8 (range, 0-15), of a possible total of 18. Frequently reported items were discussions balanced with regard to efficacy and adverse events (42 studies [84%]) and inclusions of harm-associated timing of data collection (41 studies [82%]). The least frequently reported items were distinctions between expected and unexpected adverse events (1 study [2%]) and mentions of the use of a validated instrument to report adverse event severity (4 studies [8%]). Frequency of complications was commonly reported (29 studies [58%]) in contrast with complication severity (10 studies [20%]).
This review suggests that severity of complications of RRD surgery has been infrequently quantified and reported in randomized clinical trials and potentially represents an important area of improvement in future RRD surgical trials.
PID Serval
serval:BIB_82D790C8181F
PMID
Date de création
2021-06-29T09:33:48.845Z
Date de création dans IRIS
2025-05-21T04:15:58Z