Dataset Information

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.

ABSTRACT:

Background

Cataract 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/design

Multicenter 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.

Discussion

This 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 registration

This study was prospectively registered at Clinicaltrials.gov on January 17th 2018. (Identifier: NCT03400124 .

SUBMITTER: Spekreijse LS

PROVIDER: S-EPMC7323372 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ImportanceApproximately 2 million cataract operations are performed annually in the US, and patterns of cataract surgery delivery are changing to meet the increasing demand. Therefore, a comparative analysis of visual acuity outcomes after immediate sequential bilateral cataract surgery (ISBCS) vs delayed sequential bilateral cataract surgery (DSBCS) is important for informing future best practices.ObjectiveTo compare refractive outcomes of patients who underwent ISBCS, short-interval (1-14 days between operations) DSBCS (DSBCS-14), and long-interval (15-90 days) DSBCS (DSBCS-90) procedures.Design, setting, and participantsThis retrospective cohort study used population-based data from the American Academy of Ophthalmology Intelligent Research in Sight (IRIS) Registry. A total of 1 824 196 IRIS Registry participants with bilateral visual acuity measurements who underwent bilateral cataract surgery were assessed.ExposuresParticipants were divided into 3 groups (DSBCS-90, DSBCS-14, and ISBCS groups) based on the timing of the second eye surgery. Univariable and multivariable linear regression models were used to analyze the refractive outcomes of the first and second surgery eye.Main outcomes and measuresMean postoperative uncorrected visual acuity (UCVA) and best-corrected visual acuity (BCVA) after cataract surgery.ResultsThis study analyzed data from 1 824 196 patients undergoing bilateral cataract surgery (mean [SD] age for those <87 years, 70.03 [7.77]; 684 916 [37.5%] male). Compared with the DSBCS-90 group, after age, self-reported race, insurance status, history of age-related macular degeneration, diabetic retinopathy, and glaucoma were controlled for, the UCVA of the first surgical eye was higher by 0.41 (95% CI, 0.36-0.45; P < .001) letters, and the BCVA was higher by 0.89 (95% CI, 0.86-0.92; P < .001) letters in the DSBCS-14 group, whereas in the ISBCS group, the UCVA was lower by 2.79 (95% CI, -2.95 to -2.63; P < .001) letters and the BCVA by 1.64 (95% CI, -1.74 to -1.53; P < .001) letters. Similarly, compared with the DSBCS-90 group for the second eye, in the DSBCS-14 group, the UCVA was higher by 0.79 (95% CI, 0.74-0.83; P < .001) letters and the BCVA by 0.48 (95% CI, 0.45-0.51; P < .001) letters, whereas in the ISBCS group, the UCVA was lower by -1.67 (95% CI, -1.83 to -1.51; P < .001) letters and the BCVA by -1.88 (95% CI, -1.98 to -1.78; P < .001) letters.Conclusions and relevanceThe results of this cohort study of patients in the IRIS Registry suggest that compared with DSBCS-14 or DSBCS-90, ISBCS is associated with worse visual outcomes, which may or may not be clinically relevant, depending on patients' additional risk factors. Nonrandom surgery group assignment, confounding factors, and large sample size could account for the small but statistically significant differences noted. Further studies are warranted to determine whether these factors should be considered clinically relevant when counseling patients before cataract surgery.

Project description:We conducted a retrospective comparative-effectiveness study of best-corrected visual acuity (BCVA) and refractive error (RE) after immediate sequential (ISBCS) and delayed sequential (DSBCS) bilateral cataract surgery. We tested 2 hypotheses: (1) among DSBCS patients, second-eye outcomes were no different than first-eye outcomes; (2) averaged between each patient's 2 eyes, outcomes did not differ between ISBCS and DSBCS patients.Retrospective comparative-effectiveness study.Kaiser Permanente Northern California members who underwent noncomplex bilateral cataract surgery from January 1, 2013, through June 30, 2015.We performed an intention-to-treat analysis comparing ISBCS to DSBCS using conditional logistic regression analysis, accounting for surgeon and patient-level factors.BCVA, RE.The analysis of visual outcomes included both eyes of 13?711 DSBCS and 3561 ISBCS patients. Because of the large sample size, some statistical differences lacked clinical significance. Ocular comorbidities were slightly more prevalent in DSBCS patients. Postoperative BCVA was 20/20 or better in 48% of DSBCS first eyes, 49% of DSBCS second eyes, 53% of ISBCS right eyes, and 51% of ISBCS left eyes. The within-person difference in postoperative BCVA averaged zero (0.00) between the first and second DSBCS eyes, and between the ISBCS right and left eyes. After adjustment, average postoperative BCVA was better in ISBCS patients, although the difference was not statistically significant (compared with 20/20 or better: odds ratio for worse than 20/20 was 0.91, 95% confidence interval 0.83-1.01). Emmetropia (spherical equivalent -0.5 to 0 diopter) was achieved in 61% of first DSBCS eyes, 61% of second DSBCS eyes, 63% of ISBCS right eyes, and 63% of ISBCS left eyes. After adjustment, average postoperative RE was no different in ISBCS compared with DSBCS patients (compared with emmetropia: odds ratio for ametropia was 1.02, confidence interval 0.92-1.12). We confirmed 1 case of postoperative endophthalmitis in 10?494 ISBCS eyes (1.0 per 10?000 eyes) and 2 cases in 38?736 DSBCS eyes (0.5 per 10?000 eyes) (P = 0.6), and no patient had bilateral endophthalmitis.Compared with DSBCS, we found no evidence that ISBCS was associated with worse postoperative BCVA or RE, or with an increased complication risk.

Project description:BackgroundImmediately sequential bilateral cataract surgery (ISBCS), the cataract surgery that is performed in both eyes simultaneously, is gaining popularity worldwide compared to the traditional treatment paradigm: delayed sequential bilateral cataract surgery (DSBCS), the surgery that is performed in each eye on a different day as a completely separate operation. ISBCS provides advantages to patients and patients' families in the form of fewer hospital visits. Additionally, patients enjoy rapid rehabilitation, lack of anisometropia - potentially reducing accidents and falls, and avoid suboptimal visual function in daily life. The hospital may benefit due to lower cost.ObjectiveTo perform a systematic review and meta-analysis to evaluate ISBCS and DSBCS.Data sourcesDatabases including MEDLINE, EMBASE, BIOSIS, CINAHL, Health Economic Evaluations Database (HEED), ISI Web of Science (Thomson-Reuters) and the Cochrane Library were searched.ParticipantsNot applicable.MethodsLiterature was systematically reviewed using EPPI-Reviewer 4 gateway. Meta-analysis was conducted using STATA v. 13.0. Standardized mean difference (SMD) and 95% confidence intervals (CI) were calculated and heterogeneity was assessed using I2 statistics. Fixed-effect and random-effect models were computed based on heterogeneity. Meta-analysis was done by instrument used to calculate utility score.ResultsIn total, 9,133 records were retrieved from multiple databases and an additional 128 records were identified through grey literature search. Eleven articles with 3,657 subjects were included for analysis. Our meta-analysis results indicated significant improvement in post-operative utility score using TTO, EQ5D, HUI3, VF-7, and VF-14 and a non-significant improvement using Catquest questionnaire for both surgeries. For ISBCS versus DSBCS, utility-specific fixed-effect model provided an overall SMD of the utility score using the TTO method as 0.12 (95% CI: -0.15, 0.40), EQ5D as 0.14 (95% CI: -0.14, 0.41), HUI3 as 0.12 (95% CI: -0.15, 0.40), VF-7 as -0.02 (95% CI: -0.15, 0.10), and Catquest Questionnaire as 1.45 (95% CI: -0.88, 2.01). The results for utility score, which were measured using various instruments, indicated non-significant improvement in the utility due to DSBCS compared to ISBCS. However, a significant improvement in post-operative utility score was seen using Catquest questionnaire for ISBCS compared to DSBCS. The included studies using VF-14 instrument were highly heterogeneous (I2 = 97.1%). Results provided SMD of -0.25 (95% CI:-1.06, 0.57) using VF-14 indicating non-significant improvement in the utility due to DSBCS compared to ISBCS surgery. Best corrected visual acuity (BCVA) significantly improved after both surgeries (overall SMD of BCVA due to ISBCS was -1.79 (95% CI: -2.45, -1.14) and due to DSBCS was -1.53 (95% CI: -2.25, -0.81)). A non-significant improvement was seen in BCVA due to ISBCS when compared to DSBCS (SMD = -0.18; 95% CI: -0.37, 0.01).ConclusionBoth surgeries, ISBCS and DSBCS significantly improve patients' quality of life and visual acuity. Further, ISBCS may deliver certain additional benefits at the individual and societal levels as well.

Project description:IntroductionIn China, the demand for implantable collamer lens (ICL) surgery is booming. Immediate sequential bilateral ICL surgery (ISBICLS) benefits patients and clinics, but it remains controversial and lacks standardization. We aim to investigate the prevalence of, factors for, and surgeon attitudes toward ISBICLS.MethodsIn this cross-sectional survey study, an electronic questionnaire about the practice and attitudes toward performing ISBICLS or delayed sequential bilateral ICL surgery (DSBICLS) was distributed to 792 qualified ICL surgeons in Mainland China, between 4 April and 22 April 2022.ResultsA total of 531 surgeons (66.79%) from 30 provinces in Mainland China responded. Among them, 374 (67.23%) were currently performing ISBICLS. Fifty-two percent (277) of surgeons reported performing ISBICLS more than 50% of the time, while 85.05% of surgeons chose to perform the second eye surgery 1 day after the first eye surgery. Seventy percent (248) of surgeons performing ISBICLS chose to perform the second eye surgery less than 30 min after the first eye surgery. Surgeons who started ICL surgery earlier (before 2010, OR = 2.772, 95% CI = 1.290-5.957, P = 0.009; 2011-2013, OR = 2.479, 95% CI = 1.060-5.800, P = 0.036), completed one-eye ICL surgery faster (< 3 min, OR = 3.936, 95% CI = 1.505-10.293, P = 0.005) and modified the second eye ICL selection less frequently (1-25%, OR = 0.203, 95% CI = 0.054-0.771, P = 0.019; 26-50%, OR = 0.173, 95% CI = 0.041-0.726, P = 0.017; 51-75%, OR = 0.299, 95% CI = 0.041-0.726, P = 0.123; 76-100%, OR = 0.163, 95% CI = 0.039-0.688, P = 0.014) tended to perform ISBICLS. No significant association was found among clinical settings, preoperative measurement devices, and hospital policies with performing ISBICLS. Regarding their attitudes toward ISBICLS, 54.63% preferred ISBICLS and 45.37% preferred DSBICLS. The main supporting reasons were patient convenience (98.64%), faster vision rehabilitation (73.56%), and improved perioperative compliance (73.22%). The concerns regarding ISBICLS included the risk of endophthalmitis (62.22%), lack of recommendation in expert consensus (61.67%), and decreased vault predictability (60.93%). The most common desires for further adoption were expert consensus on surgical criteria and patient indicators for ISBICLS (82.3%).ConclusionsISBICLS has been gradually adopted in Mainland China, but has not been widely accepted as a routine procedure. Surgeons' experience and skills mainly influence whether ISBICLS is performed. Further research is needed to explore standardized protocols to prevent endophthalmitis, the appropriate time interval of two eye surgery, and requisitions for surgeon skills.

Project description:PurposeThe Netherlands Longitudinal Study on Hearing (NL-SH) was set up to examine associations of hearing ability with psychosocial, work and health outcomes in working age adults.ParticipantsInclusion started in 2006 and is ongoing. Currently the sample comprises 2800 adults with normal and impaired hearing, aged 18-70 years at inclusion. Five-year follow-up started in 2011, 10-year follow-up in 2016 and 15-year follow-up in 2021. All measurements are web-based. Participants perform a speech-in-noise recognition test to measure hearing ability and fill out questionnaires about their hearing status, hearing aid use, self-reported hearing disability and coping, work status and work-related outcomes (work performance, need for recovery), physical and psychosocial health (depression, anxiety, distress, somatisation, loneliness), healthcare usage, lifestyle (smoking, alcohol), and technology use.Findings to dateThe NL-SH has shown the vast implications of reduced hearing ability for the quality of life and health of working-age adults. A selection of results published in 27 papers is presented. Age-related deterioration of hearing ability accelerates after the age of 50 years. Having a history of smoking is associated with a faster decline in hearing ability, but this relationship is not found for other cardiovascular risk factors. Poorer hearing ability is associated with increased distress, somatisation, depression and loneliness. Adults with impaired hearing ability are more likely to be unemployed or unfit for work, and need more time to recuperate from work effort.Future plansParticipant data will be linked to a national database to enable research on the association between hearing ability and mortality. Linking to environmental exposure data will facilitate insight in relations between environmental factors, hearing ability and psychosocial outcomes. The unique breadth of the NL-SH data will also allow for further research on other functional problems, for instance, hearing ability and fall risk.Trial registration numberNL12015.029.06.