Design and Conduct of Randomized Clinical Trials Evaluating Surgical Innovations in Ophthalmology: A Systematic Review

Azuara‐Blanco, Augusto; Carlisle, Aaron; O’Donnell, Matthew; Jayaram, Hari; Gazzard, Gus; Larkin, D.F.; Wickham, Louisa; Lois, Noemi

doi:10.1016/j.ajo.2022.12.010

Cited by 4 publications

(1 citation statement)

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“…Furthermore, there are clinical questions for which a randomized trial is infeasible, such as for rare conditions or for procedures where shams are not possible, and in these circumstances, lower levels of evidence ought to be weighted more heavily [ 16 , 17 ]. Since many ophthalmologic diseases have a low incidence and a heavy reliance on surgical management in certain subspecialties, performing randomized controlled trials may be especially challenging [ 18 , 19 ]. By acknowledging this and including varied levels of evidence in ophthalmology PPPs, authors may be able to more easily adopt the Institute of Medicine’s recommendation about LOE reporting in clinical practice guidelines.…”

Section: Discussionmentioning

confidence: 99%

Systematic analysis of levels of evidence supporting American Academy of Ophthalmology Preferred Practice Pattern guidelines, 2012–2021

et al. 2023

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Background Despite the increased emphasis on evidence-based medicine, the current state of evidence behind ophthalmology clinical practice guidelines is unknown. The purpose of this systematic analysis was to understand the levels of evidence (LOE) supporting American Academy of Ophthalmology (AAO) Preferred Practice Pattern (PPP) guidelines, assess changes over time, and compare LOE across ophthalmology subspecialties. Methods All current PPP guidelines and their immediate predecessors were comprehensively reviewed to identify all recommendations with LOE provided (I [randomized controlled trials], II [case–control or cohort studies], and III [nonanalytic studies]). Results Twenty-three out of 24 current PPPs had a prior edition. Among the PPPs with a prior edition, the number of recommendations with LOE decreased from 1254 in prior PPPs to 94 in current PPPs. The number of recommendations with LOE I decreased from 114 to 83, LOE II decreased from 147 to 2, and LOE III decreased from 993 to 9. However, the proportion of LOE I recommendations increased from 9 to 88%, driven by a disproportionate decrease in reporting of evidence lower than LOE I. Subgroup analysis by subspecialty showed similar trends (LOE I recommendations in prior PPPs vs current PPPs: retina: 57 [12%] vs 19 [100%]; cornea: 33 [5%] vs 24 [100%]; glaucoma: 9 [23%] vs 17 [100%]; cataract: 13 [17%] vs 18 [100%]). Conclusions Trends in LOE reporting in PPP guidelines indicate an increasing emphasis on evidence from randomized controlled trials from 2012 to 2021. The decline in the number of recommendations with LOE reported suggests an area for improvement in future guidelines as the presence of LOE is crucial to facilitate interpretation of clinical practice guidelines.

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