Core Outcome Measures in Effectiveness Trials

A Proposed Minimum Standard Set of Outcome Measures for Cataract Surgery

General Information

Abstract:
IMPORTANCE

Aligning outcome measures for cataract surgery, one of the most frequently
performed procedures globally,may facilitate international comparisons that can drive improvements in the outcomes most meaningful to patients.

OBJECTIVE

To propose a minimum standard set of outcome measures for cataract surgery
that enables global comparisons.

DESIGN, SETTING, AND PARTICIPANTS

Aworking group of international experts in cataract outcomes and registries was convened, along with a patient advocate, to agree on a consensus of outcome measures for cataract surgery. In a modified Delphi process, the group met regularly between November 10, 2012, and November 21, 2013, to discuss which outcomes to include in a standard set. Included factors were based on extant literature, existing registries, and the experience of group members. Similarly, a series of consensus discussions were held to determine a set of risk factors to be gathered for each patient. The final shortlist was compiled into a standard set. Analysis was performed from November 22,
2013, to April 5, 2014.

MAIN OUTCOMES AND MEASURES

Development of a recommended standard set encompassing preoperativemetrics including patient risk factors, intraoperative factors including surgical complications, and postoperative cataract surgery outcomes.

RESULTS

The recommended standard set encompasses all patients treated for cataracts by 1 of 4 surgical approaches (phacoemulsification, sutured manual extracapsular cataract extraction, sutureless manual extracapsular cataract extraction, or intracapsular cataract extraction). The recommended metrics to be recorded preoperatively include demographics, ocular history and comorbidities, preoperative visual acuity, and patient-reported visual
function. The recommended outcomes were split into intraoperative and postoperative metrics. Intraoperative outcomes include capsule-related problems, dislocation of lens nucleus fragments into the vitreous, and other complications. Postoperative outcomes include visual acuity, refractive error, patient-reported visual function, and early and late complications of surgery. The suggested follow-up for collection of postoperative outcomes is
up to 3 months.

CONCLUSIONS AND RELEVANCE

A minimum standard set of outcome measures for cataract surgery is important for meaningful comparison across contexts. The proposed data set is a compromise between all useful data and the practicalities of data collection.

Authors:
Imran Mahmud, MD, MPH; Thomas Kelley, MD, MBA; Caleb Stowell, MD; Aravind Haripriya, MD, MS; Anders Boman, MD; Ingrid Kossler, MBA; Nigel Morlet, FRANZCO, FRACS; Suzann Pershing, MD, MS; Konrad Pesudovs, PhD; Pik Pin Goh, MD, MS; John M. Sparrow, DPhil, FRCOphth; Mats Lundström, MD, PhD

Publication

Journal:
JAMA Opthalmology
Volume:
133
Issue:
11
Pages:
1247 - 1252
Year:
2015
DOI:
Further Study Information

Date:
Funding source(s):
This work was supported by the International Consortium for Health Outcomes Measurement (ICHOM).

Health Area

Disease Category
Eyes & vision

Disease Name
Cataracts

Target Population

Age Range
-

Sex
Unknown


Nature / type of Intervention
Unknown

Method(s)

Consensus meeting
Delphi process
Literature review

Stakeholders Involved

Unknown

Study Type

COS for practice

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