The need for more pragmatic trials in glaucoma research

Area of Science:

• Ophthalmology
• Clinical Trials
• Evidence-Based Medicine

Background:

• Numerous clinical trials in glaucoma have been published over the last two decades.
• Many glaucoma trials focus on specific issues in select populations, leaning towards the explanatory end of the pragmatic-explanatory continuum.

Purpose of the Study:

• To evaluate the degree of pragmatism in published randomized controlled trials (RCTs) in glaucoma research.

Main Methods:

• A systematic PubMed search identified glaucoma RCTs published between 1995 and 2022.
• Three independent reviewers assessed each study using the Pragmatic-Explanatory Continuum Indicator Summary version 2 (PRECIS-2) toolkit.
• A summed score of ≥36 indicated a highly pragmatic study.

Main Results:

• The analysis included 32 articles representing 13 landmark trials.
• The median PRECIS-2 score was 32, with scores ranging from 25 (Early Manifest Glaucoma Trial) to 34 (Collaborative Normal Tension Glaucoma Study, Ocular Hypertension Treatment Study).
• The Treatment of Advanced Glaucoma Study (TAGS) scored 33, indicating a high level of pragmatism.

Conclusions:

• While numerous RCTs exist in glaucoma, there remains a significant need for more pragmatic research.
• Increasing the pragmatism of glaucoma trials can enhance their relevance to clinical practice and patient outcomes.