Standardization of Autologous Serum Eye Drops Preparation Practices in France: Delphi Method

Dry eye disease affects quality of life and generates significant health care costs. Severe forms, refractory to conventional treatments, are responsible for visual impairment and disability. Autologous serum eye drops (ASEDs) are proven to be a therapeutic alternative. We carried out a national inventory of ASEDs preparation practices that highlights low supply (13 producer centers in France) and preparation heterogeneity. The general objective was to develop a national consensus-based protocol for ASEDs preparation in French university hospitals using a Delphi method, with the goal of improving ASEDs quality, safety, and supply.

Method for consensus reaching is Delphi method. Four protocol parts are covered: blood sampling and controls, preparing and packaging the eye drops, postproduction controls, and storage and conservation. Expert panel are hospital pharmacists. Steps were as follows: questionnaire construction, mailing with link access to Google Forms^®, response analyses, consensus rate calculation, result synthesis, and anonymous referral to experts.

With 12 answering experts, after 4 rounds: out of 39 proposals initially submitted, the work resulted in a 26 validated item protocol at the final. In sampling and controls: 15 items were validated, 5 dropped. Preparation: 5 were validated, 1 dropped. Postcompounding Control: 3 were validated, 4 dropped. Storage and Conservation: 3 were validated. The four rounds took 86 days.

A standardized protocol for ASEDs preparation was proposed. This could improve the supply of care across the country. Method strengths are a consultation of dedicated experts on the draft questionnaire of the Delphi survey and qualified experts on the topic, anonymity avoiding opinion leader.