PROTOKOLL

PROTOCOL

Background and Purpose
The national cataract register was originally established (1992) to monitor the effects of introducing a maximum waiting time guarantee in Sweden for patients awaiting cataract surgery. The core register focuses on demography, waiting time for surgery, and visual function at the time of surgery. The register has been extended to cover outcome data and benefits experienced from the procedure. An important purpose is to document differences in accessibility and outcome throughout Sweden.
The long-term goals of the register are:

	to continuously monitor the availability of cataract surgery
	to form a national base for quality assurance of cataract surgery at individual departments
	to reflect the outcomes of routine medical care as characterized in the total register
	to promote quality improvement and form a basis for comparing and demonstrating good examples
	to enable analysis of rare outcomes, due to the size of the database
	to improve knowledge concerning the appropriate indications and optimal time for surgery by evaluating benefits that patients experience from surgery.

Management Group
Mats Lundström, Professor,(Manager) EyeNet Sweden, Blekinge Hospital,
SE- 371 85 Karlskrona, Sweden.
Ulf Stenevi, Professor, Department of Ophthalmology, Sahlgren’s University Hospital,
SE-43180 Mölndal, Sweden.
Per Montan, MD, S:t Erik Eye Hospital, Polhemsgatan 50, SE-112 82 Stockholm
Sweden
Anders Behndig, Docent, Department of Ophthalmology, Norrland University Hospital, SE-901 85 Umeå

Governing Body
Blekinge County Council, Blekinge Hospital, SE-371 85 Karlskrona, Sweden.

Sponsors
The Swedish Association of Local Authorities and Regions (SALAR)
Blekinge County Council, Sweden.

Application to the Data Inspection Board
The registry of cataract surgery patients in a database with the actual variables has been accepted by the Swedish Data Inspection Board.

Informed Consent Requirements of the Data Inspection Board
According to the Data Inspection Board’s requirements patients included in the study shall be informed about the study.

Application for Ethical Appraisal
The application has been submitted to an ethics committee at Blekinge Hospital in Sweden. The committee has accepted the study program.

Criteria for inclusion
All patients undergoing cataract surgery participate. The operation must be completed before the case is registered. The objective of the register is for all departments in Sweden (public and private) to report their cataract operations. The register includes elective and emergency procedures. The register does not include secondary lens implants after previous cataract operation without an intra-ocular lens. Registration of surgical outcomes and benefits experienced by the patient takes place for part of the total number of operations during the year. Here, the inclusion criterion is all surgery performed in sequence during a calendar month (currently the month of March) corresponding to approximately 10% of the annual number of procedures.

Instructions to Participating Units
There is a written manual about how to do measurements and how to fill out the forms.

Endpoints for follow-up
The endpoint of follow-up is three months after surgery. This means that forms should be completed at the latest three months after surgery. Normally, for each patient, the study period is finished when the final visit after surgery has occurred.

Control Functions, Validation
There are a number of computer-based controls.
- Visual acuity will only be accepted in the range 0.1 – 1.0
- K-values will only be accepted between 35 and 55 diopters
- Date of surgery will always be higher than date on waiting list
- Date of final visit will always be higher than date of surgery
- Date of surgery must be in the study month
- Only one response option is accepted in ‘Type of surgery’ and ‘Type of IOL’.

Planned reports
Written standard reports.
Participants receive standard reports each quarter of a year. These reports include data for the actual Unit/Participant and aggregated data for all participating Units during the actual period and the year.
After the outcome study period in March each Unit/Participant will receive standard reports including
- data for the actual Unit/Participant
- aggregated data for all participating Units during the study period
- diagrams with data for each participating Unit but without names of the Units to preserve anonymity.
An annual report is produced each year.
Meetings.
The results of an outcome study period should be reported to the users meeting.
Scientific reports.
Relevant scientific reports can be produced.

Last uppdate 2008-10-21