Dataset Information

Failure Modes and Effects Analysis of bilateral same-day cataract surgery.

ABSTRACT: PURPOSE:To systematically analyze potential process failures related to bilateral same-day cataract surgery toward the goal of improving patient safety. SETTING:Twenty-one Kaiser Permanente surgery centers, Northern California, USA. DESIGN:Retrospective cohort study. METHODS:Quality experts performed a Failure Modes and Effects Analysis (FMEA) that included an evaluation of sterile processing, pharmaceuticals, perioperative clinic and surgical center visits, and biometry. Potential failures in human factors and communication (modes) were identified. Rates of endophthalmitis, toxic anterior segment syndrome (TASS), and unintended intraocular lens (IOL) implantation were assessed in eyes having bilateral same-day surgery from 2010 through 2014. RESULTS:The study comprised 4754 eyes. The analysis identified 15 significant potential failure modes. These included lapses in instrument processing and compounding errors of intracameral antibiotics that could lead to endophthalmitis or TASS, and ambiguous documentation of IOL selection by surgeons, which could lead to unintended IOL implantation. Of the study sample, 1 eye developed endophthalmitis, 1 eye had unintended IOL implantation (rates, 2 per 10?000; 95% confidence interval [CI], 0.1-12.0 per 10?000), and no eyes developed TASS (upper 95% CI, 8 per 10?000). Recommendations included improving oversight of cleaning and sterilization practices, separating lots of compounded drugs for each eye, and enhancing IOL verification procedures. CONCLUSIONS:Potential failure modes and recommended actions in bilateral same-day cataract surgery were determined using an FMEA. These findings might help improve the reliability and safety of bilateral same-day cataract surgery based on current evidence and standards.

SUBMITTER: Shorstein NH

PROVIDER: S-EPMC5419427 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Failure Modes and Effects Analysis of bilateral same-day cataract surgery.

Shorstein Neal H NH Lucido Carol C Carolan James J Liu Liyan L Slean Geraldine G Herrinton Lisa J LJ

Journal of cataract and refractive surgery 20170301 3

<h4>Purpose</h4>To systematically analyze potential process failures related to bilateral same-day cataract surgery toward the goal of improving patient safety.<h4>Setting</h4>Twenty-one Kaiser Permanente surgery centers, Northern California, USA.<h4>Design</h4>Retrospective cohort study.<h4>Methods</h4>Quality experts performed a Failure Modes and Effects Analysis (FMEA) that included an evaluation of sterile processing, pharmaceuticals, perioperative clinic and surgical center visits, and biom ...[more]

PMID: 28410711

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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: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:PurposeTo identify high-priority risks in a clinical trial investigating the use of radiation to alleviate COVID-19 pneumonia using a multi-phase failure modes and effects analysis (FMEA).MethodsA comprehensive FMEA survey of 133 possible causes of failure was developed for the clinical trial workflow (Phase I). The occurrence, severity, and detection risk of each possible cause of failure was scored by three medical physicists. High-risk potential failure modes were identified using the risk priority number (RPN) and severity scores, which were re-scored by 13 participants in radiation oncology (Phase II). Phase II survey scores were evaluated to identify steps requiring possible intervention and examine risk perception patterns. The Phase II participants provided consensus scores as a group.ResultsThirty high-priority failure modes were selected for the Phase II survey. Strong internal consistency was shown in both surveys using Cronbach's alpha (αc ≥ 0.85). The 10 failures with the largest median RPN values concerned SARS-CoV-2 transmission (N = 6), wrong treatment (N = 3), and patient injury (N = 1). The median RPN was larger for COVID-related failures than other failure types, primarily due to the perceived difficulty of failure detection. Group re-scoring retained 8/10 of the highest-priority risk steps that were identified in the Phase II process, and discussion revealed interpretation differences of process steps and risk evaluation. Participants who were directly involved with the trial working group had stronger agreement on severity scores than those who were not.ConclusionsThe high ranking of failures concerning SARS-CoV-2 transmission suggest that these steps may require additional quality management intervention when treating critically ill COVID-19+ patients. The results also suggest that a multi-phase FMEA survey led by a facilitator may be a useful tool for assessing risks in radiation oncology procedures, supporting future efforts to adapt FMEA to clinical procedures.

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:ImportanceIdentification of geographic population-based differences in genotype and phenotype heterogeneity are important for targeted and patient-specific diagnosis and treatment, counseling, and screening strategies.ObjectiveTo report disease-causing variants and their detailed phenotype in patients with bilateral congenital cataract from a single center in Switzerland and thereby draw a genetic map and perform a genotype-phenotype comparison of this cohort.Design, setting, and participantsThis clinical and molecular-genetic cohort study took place through the collaboration of the Department of Ophthalmology at the University Hospital Zurich and the Institute of Medical Molecular Genetics, University of Zurich, Schlieren, Switzerland. Thirty-seven patients from 25 families with different types of bilateral congenital cataract were included. All participating family members received a comprehensive eye examination. Whole exome sequencing was performed in the index patients, followed by a filtering process to detect possible disease-associated variants in genes previously described in association with congenital cataract. Probable disease-causing variants were confirmed by Sanger sequencing in available family members. All data were collected from January 2018 to June 2020, and the molecular-genetic analyses were performed from January 2019 to July 2020.Main outcomes and measuresIdentification of the underlying genetic causes of bilateral congenital cataract, including novel disease-causing variants and phenotype correlation.ResultsAmong the 37 patients (18 [49%] male and 19 [51%] female; mean [SD] age, 17.3 [15.9] years) from 25 families, pathogenic variants were detected in 20 families (80% detection rate), which included 13 novel variants in the following genes: BCOR, COL4A1, CRYBA2, CRYBB2, CRYGC, CRYGS, GJA3, MAF, NHS, and WFS1. Putative disease-causing variants were identified in 14 of 20 families (70%) as isolated cases and in 6 of 20 families (30%) with syndromic cases. A recessive variant in the CRYBB2 gene in a consanguineous family with 2 affected siblings showing a nuclear and sutural cataract was reported in contrast to previously published reports. In addition, the effect on splicing in a minigene assay of a novel splice site variant in the NHS gene (c.[719-2A>G]) supported the pathogenicity of this variant.Conclusions and relevanceThis study emphasizes the importance of genetic testing of congenital cataracts. Known dominant genes need to be considered for recessive inheritance patterns. Syndromic types of cataract may be underdiagnosed in patients with mild systemic features.

Dataset Information

Failure Modes and Effects Analysis of bilateral same-day cataract surgery.

Publications

Failure Modes and Effects Analysis of bilateral same-day cataract surgery.

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