Cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (the BICAT-NL study): study design of a prospective multicenter randomised controlled trial

Autor: Carmen D. Dirksen, L. S. Spekreijse, F. J. H. M. van den Biggelaar, Rob W.P. Simons, Bjorn Winkens, Rudy M.M.A. Nuijts
Přispěvatelé: Oogheelkunde, RS: MHeNs - R3 - Neuroscience, MUMC+: MA AIOS Oogheelkunde (9), FHML Methodologie & Statistiek, RS: CAPHRI - R6 - Promoting Health & Personalised Care, MUMC+: KIO Kemta (9), Health Services Research, RS: CAPHRI - R2 - Creating Value-Based Health Care, MUMC+: AB Refractie Chirurgie Oogheelkunde (9), MUMC+: MA Oogheelkunde (9)
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Visual acuity
Complications
genetic structures
Cost effectiveness
IMPACT
medicine.medical_treatment
Cost-Benefit Analysis
EYE
law.invention
Study Protocol
0302 clinical medicine
STANDARD
Quality of life
Randomized controlled trial
Lens Implantation
Intraocular
lcsh:Ophthalmology
law
Clinical endpoint
Prospective Studies
Patient reported outcome measures (PROMs)
Netherlands
OUTCOMES
030503 health policy & services
General Medicine
VISUAL FUNCTION
medicine.symptom
0305 other medical science
medicine.medical_specialty
Immediately sequential bilateral cataract surgery (ISBCS)
Cataract Extraction
PATIENT
Cataract
03 medical and health sciences
medicine
Humans
Phacoemulsification
business.industry
Delayed sequential bilateral cataract surgery (DSBCS)
Cataract surgery
CARE
eye diseases
Surgery
Clinical trial
Ophthalmology
Refraction
lcsh:RE1-994
030221 ophthalmology & optometry
Quality of Life
Cost-effectiveness
POSTOPERATIVE ENDOPHTHALMITIS
business
Zdroj: BMC Ophthalmology, Vol 20, Iss 1, Pp 1-8 (2020)
BMC Ophthalmology
BMC Ophthalmology, 20(1):257. BioMed Central Ltd
ISSN: 1471-2415
DOI: 10.1186/s12886-020-01521-x
Popis: BackgroundCataract surgery is one of the most frequently performed types of surgery. Most patients suffer from bilateral cataract and while cataract surgery of only one eye is effective in restoring functional vision, second-eye surgery leads to further improvements in health-related quality of life, and is cost-effective. At present, most patients undergo cataract surgery in both eyes on separate days as recommended in national guidelines, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves operating both eyes on the same day, but as separate procedures, known as immediately sequential bilateral cataract surgery (ISBCS). The aim of this study is to evaluate the effectiveness and costs of ISBCS compared to DSBCS, in order to test the hypothesis that ISBCS is non-inferior to DSBCS in terms of effectiveness and superior to ISBCS in terms of cost-effectiveness.Methods/designMulticenter non-inferiority randomised controlled clinical trial. Patients (18 years or older) with bilateral cataract and an indication for bilateral cataract surgery with an expected uncomplicated intraoperative and postoperative course are included in the study. Patients are randomly assigned to either ISBCS or DSBCS. The primary endpoint is the proportion of patients with a refractive outcome in the second eye within 1.0 dioptre from the target refraction, at 4 weeks after surgery. Secondary outcomes include corrected and uncorrected distance visual acuity, complications, patient reported outcomes (PROMs), cost-effectiveness, and budget impact. Follow-up visits are planned at 1 week after first-eye surgery and 4 weeks after second-eye surgery. At 3 months after first-eye surgery, the occurrence of complications is checked and patients fill in a final questionnaire.DiscussionThis study protocol describes the design of a multicenter non-inferiority randomised controlled trial. Current studies on ISBCS often lack information on safety regarding refractive outcomes. In addition, there is a lack of well-designed cost-effectiveness studies using established methods. The BICAT-NL study will provide more insight in refractive and cost-effectiveness outcomes for ISBCS compared to DSBCS.Trial registrationThis study was prospectively registered at Clinicaltrials.gov on January 17th 2018. (Identifier:NCT03400124.
Databáze: OpenAIRE
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