Abstract
Purpose
Surgical innovations are necessary to improve patient care. After an initial exploratory phase novel surgical technique should be compared with alternative options or standard care in randomized clinical trials (RCTs). However surgical RCTs have unique methodological challenges. Our study sought to investigate key aspects of the design, conduct and reporting of RCTs of novel surgeries.
Design
Systematic Review
Methods
The protocol was prospectively registered in PROSPERO (CRD42021253297). RCTs evaluating novel surgeries for cataract, vitreoretinal, glaucoma and corneal diseases were included. Medline, EMBASE, Cochrane Library and Clinicaltrials.gov were searched. The search period was January 1, 2016, to June 16, 2021.
Results
Fifty-two ophthalmic surgery RCTs were identified in the fields of glaucoma (n=12), vitreoretinal surgery (n=5) cataract (n=19) and cornea (n=16). A description defining the surgeon's experience or level of expertise was reported in 30 RCTs (57%); and was presented in both, control and intervention groups, in eleven (21%). Specification of number of cases performed in the particular surgical innovation being assessed prior to the trial was reported in 10 RCTs (19%); and an evaluation of quality of the surgical intervention in seven (13%). Prospective trial registration was recorded in 12 RCTs (23%), retrospective registration in 13 (25%) and there was no registration record in the remaining 28 (53%) studies.
Conclusion
Important aspects of the study design such as surgical learning curve, surgeon's previous experience, quality assurance, and trial registration details were often missing in novel ophthalmic surgical procedures. The IDEAL framework aims to improve the quality of study design.
Surgical innovations are necessary to improve patient care. After an initial exploratory phase novel surgical technique should be compared with alternative options or standard care in randomized clinical trials (RCTs). However surgical RCTs have unique methodological challenges. Our study sought to investigate key aspects of the design, conduct and reporting of RCTs of novel surgeries.
Design
Systematic Review
Methods
The protocol was prospectively registered in PROSPERO (CRD42021253297). RCTs evaluating novel surgeries for cataract, vitreoretinal, glaucoma and corneal diseases were included. Medline, EMBASE, Cochrane Library and Clinicaltrials.gov were searched. The search period was January 1, 2016, to June 16, 2021.
Results
Fifty-two ophthalmic surgery RCTs were identified in the fields of glaucoma (n=12), vitreoretinal surgery (n=5) cataract (n=19) and cornea (n=16). A description defining the surgeon's experience or level of expertise was reported in 30 RCTs (57%); and was presented in both, control and intervention groups, in eleven (21%). Specification of number of cases performed in the particular surgical innovation being assessed prior to the trial was reported in 10 RCTs (19%); and an evaluation of quality of the surgical intervention in seven (13%). Prospective trial registration was recorded in 12 RCTs (23%), retrospective registration in 13 (25%) and there was no registration record in the remaining 28 (53%) studies.
Conclusion
Important aspects of the study design such as surgical learning curve, surgeon's previous experience, quality assurance, and trial registration details were often missing in novel ophthalmic surgical procedures. The IDEAL framework aims to improve the quality of study design.
| Original language | English |
|---|---|
| Pages (from-to) | 164-175 |
| Number of pages | 12 |
| Journal | American Journal of Ophthalmology |
| Volume | 248 |
| Early online date | 06 Feb 2023 |
| DOIs | |
| Publication status | Published - Apr 2023 |
Keywords
- systematic review
- Randomized clinical trial
- surgery