The cost evaluation of day-case compared to inpatient cochlear implantation in adults: subanalysis of a randomized controlled trial.

OBJECTIVE: To investigate the assumption that day-case cochlear implantation is associated with lower costs, compared to inpatient cochlear implantation, while maintaining equal quality of life (QoL) and hearing outcomes, for the Dutch healthcare setting. STUDY DESIGN: A single-center, non-blinded, randomized controlled trial in a tertiary referral center. METHODS: Thirty adult patients with post-lingual bilateral sensorineural hearing loss eligible for unilateral cochlear implantation surgery were randomly assigned to either the day-case or inpatient treatment group (i.e., one night admission). We performed an intention-to-treat evaluation of the difference of the total health care-related costs, hospital and out of hospital costs, between day-case and inpatient cochlear implantation, from a hospital and patient perspective over the course of one year. Audiometric outcomes, assessed using CVC scores, and QoL, assessed using the EQ-5D and HUI3 questionnaires, were taken into account. RESULTS: There were two drop-outs. The total health care-related costs were €41,828 in the inpatient group (n = 14) and €42,710 in the day-case group (n = 14). The mean postoperative hospital stay was 1.2 days (mean costs of €1,069) in the inpatient group and 0.7 days (mean costs of €701) for the day-case group. There were no statistically significant differences in postoperative hospital and out of hospital costs. The QoL at 2 months and 1 year postoperative, measured by the EQ-5D index value and HUI3 showed no statistically significant difference. The EQ-5D VAS score measured at 1 year postoperatively was statistically significantly higher in the inpatient group (84/100) than in the day-case group (65/100). There were no differences in postoperative complications, objective hearing outcomes, and number of postoperative hospital and out of hospital visits. CONCLUSION: A day-case approach to cochlear implant surgery does not result in a statistically significant reduction of health care-related costs compared to an inpatient approach and does not affect the surgical outcome (complications and objective hearing measurements), QoL, and postoperative course (number of postoperative hospital and out of hospital visits).

Quality of life, hearing results, patient satisfaction and postoperative complications of day-case versus inpatient unilateral cochlear implantation in adults: a randomized controlled, equivalence trial.

OBJECTIVE: To investigate the hypothesis that day-case cochlear implantation is associated with equal quality of life, hearing benefits and complications rates, compared to inpatient cochlear implantation. STUDY DESIGN: A single-center, non-blinded, randomized controlled, equivalence trial in a tertiary referral center. METHODS: Thirty adult patients with post-lingual bilateral sensorineural hearing loss eligible for unilateral cochlear implantation surgery were randomly assigned to either the day-case or inpatient treatment group. The effect on general quality of life, patient satisfaction, (subjective) hearing improvement, postoperative complications and causes of crossover and/or readmission were assessed using questionnaires, auditory evaluations and patients' charts over a follow-up period of 1 year. RESULTS: Overall quality of life measured by the HUI3 was equal between the day-case (n = 14) and inpatient group (n = 14). The overall patients' satisfaction showed a slight favor towards an inpatient approach. There was no significant difference in the subjective and objective hearing improvement between both treatment groups. During the 1-year follow-up period no major complications occurred. Minor complications occurred intraoperatively in three day-case patients resulting in three out of nine admissions of day-case patients. Other causes of admission of day-case patients were nausea and vomiting (n = 1), drowsiness (n = 1), late scheduled surgery (n = 2), social reasons (n = 1), or due to an unclear reason (n = 1). No patients required readmission. CONCLUSION: We found equal outcomes of QoL, patient satisfaction, objective, and subjective hearing outcomes between day-case and inpatient unilateral cochlear implantation. Nine out of 14 day-case patients were admitted for at least one night postoperatively (crossover). No major complications occurred in both groups. A day-case approach seems feasible when using specific patient selection, surgical planning and the preoperative provision of patient information into account. Besides this, the familiarity with a day-case approach of both patient and the surgical team can increase the feasibility of day-case surgery.

Day-case stapes surgery: Day-case versus inpatient stapes surgery for otosclerosis: a randomized controlled trial.

BACKGROUND: Otosclerosis is characterized by bony deposits in the otic capsule, resulting in stapes fixation and progressive hearing loss. It can be treated effectively by surgically removing (part of) the stapes and replacing it with a prosthesis. Increasingly, stapes surgery is performed as a day-case procedure. The major drive towards day-case surgery has been out of economic considerations. However, it is also increasingly an explicit patient request and leads to shorter waiting times for surgery, a reduced risk of infection and most likely positively influences the patient's quality of life as a result of rapid discharge and rehabilitation. Even though stapes surgery seems well suited to a day-case approach, given the low complication rates and early recovery, evidence is scarce and of low quality. METHODS AND DESIGN: A single-center unblinded randomized controlled trial was designed to (primarily) investigate the effect of hearing outcomes of day-case stapes surgery compared to inpatient stapes surgery and (secondarily) investigate the effect of both methods on quality of life, tinnitus, vertigo and cost-effectiveness. One hundred and twelve adult otosclerosis patients who are eligible for stapes surgery will be randomly assigned to either the day-case or inpatient treatment group. The primary and secondary outcome measures will be assessed using pure-tone audiometry (at approximately 2 months and 1 year follow-up), questionnaires (at 3 months and 1 year follow-up) and costs diaries (weekly the first month after which once a month until 1 year follow-up). DISCUSSION/CONCLUSION: This trial allows for a comparison between day-case and inpatient stapes surgery to investigate the hypothesis that day-case stapes surgery is associated with a higher quality of life and higher cost-effectiveness, while maintaining equal hearing results, compared to inpatient stapes surgery. TRIAL REGISTRATION: Netherlands Trial Register (www.trialregister.nl): NTR4133, registration date 21(st) August 2013.

Hearing Results, Quality of Life, Patient Satisfaction, and Postoperative Complications of Day-case Versus Inpatient Stapes Surgery for Otosclerosis in Adults: A Randomized Controlled Trial.

Objective: To investigate the effect of day-case stapes surgery on hearing results, quality of life, patient satisfaction, and complications rates, compared with inpatient stapes surgery. Study Design: A single-center, nonblinded, randomized controlled trial in a tertiary referral center. Methods: One hundred twelve adult patients planned for primary or revision stapes surgery were randomly assigned to either the day-case or inpatient treatment group. The effect on hearing outcomes (primarily), hearing benefits, quality of life, patient satisfaction, postoperative complications, and causes of crossover or readmission (secondarily) were assessed using auditory evaluations, questionnaires, and patients' charts over a follow-up period of 1 year. Results: Audiometric measurements and postoperative success rates were not different between the inpatient and day-case group. There were no statistically significant differences between both groups regarding the overall quality of life (QoL) (HUI3), disease-specific QoL (GHSI), change in postoperative health status (GBI), and postoperative complications rate. We found a high patient satisfaction toward the day-case approach. Six patients allocated to the inpatient group requested same-day discharge. Of the day-case patients, there was a crossover rate to inpatient care of 38% (20 patients), mainly due to postoperative nausea and vomiting (25%), vertigo (20%), or dizziness (40%). Conclusion: We found no significant differences in outcomes of audiometric measurements, QoL, patient satisfaction and postoperative complications following day-case, and inpatient stapes surgery. Therefore, stapes surgery in a day-case setting seems to be a feasible approach in terms of postoperative outcome, safety, and desirability when taking patient selection and surgical planning into account. Besides this, the familiarity with a day-case approach of both patient and the surgical team, will increase the acceptance and feasibility of day-case stapes surgery.

Admission Rates Following Day-Case Major Otologic Surgery: A Systematic Review.

OBJECTIVE: To assess whether day-case major otologic ear surgery is a safe and feasible alternative to inpatient surgery, while maintaining equal complication rates, and to identify causes of admission after day-case surgery. DATA SOURCES: PubMed, Embase, and Cochrane. REVIEW METHODS: A systematic search was conducted. Studies reporting original data on the effect of day-case ear surgery on admission rate, patient satisfaction, and/or postoperative complications were included. Risk of bias of the selected articles was assessed using criteria based on the Cochrane Collaboration's tool for assessing risk of bias. RESULTS: A total of 1,734 unique studies were retrieved of which 35 articles discussing 34 studies were eligible for data extraction. The admission rates ranged from 0% to 88% following day-case endaural surgery, 0% to 13% following day-case stapes surgery, 0% to 82% following day-case mastoid surgery, and 0% to 15% following day-case cochlear implant surgery. Patient and parent satisfaction regarding day-case surgery ranged from 67% to 99%. Five studies comparing day-case and inpatient otologic surgery showed no difference in hearing outcome, postoperative complications, or patient satisfaction. CONCLUSION: The highest pooled admission rate was seen following day-case mastoid surgery. Studies comparing day-case and inpatient care suggest hearing results and postoperative complication rates in day-case otologic surgery are similar to inpatient otologic surgery in both children and adults. Therefore, day-case major otologic surgery seems to be a safe and feasible alternative to inpatient surgery for both children and adults.

An internally validated prognostic model for success in revision stapes surgery for otosclerosis.

OBJECTIVES/HYPOTHESIS: To develop a prediction model that can accurately predict the chance of success following revision stapes surgery in patients with recurrent or persistent otosclerosis at 2- to 6-months follow-up and to validate this model internally. STUDY DESIGN: A retrospective cohort study of prospectively gathered data in a tertiary referral center. METHODS: The associations of 11 prognostic factors with treatment success were tested in 705 cases using multivariable logistic regression analysis with backward selection. Success was defined as a mean air-bone gap closure to 10 dB or less. The most relevant predictors were used to derive a clinical prediction rule to determine the probability of success. Internal validation by means of bootstrapping was performed. Model performance indices, including the Hosmer-Lemeshow test, the area under the receiver operating characteristics curve (AUC), and the explained variance were calculated. RESULTS: Success was achieved in 57.7% of cases at 2- to 6-months follow-up. Certain previous surgical techniques, primary causes of failure leading up to revision stapes surgery, and positions of the prosthesis placed during revision surgery were associated with higher success percentages. The clinical prediction rule performed moderately well in the original dataset (Hosmer-Lemeshow P = .78; AUC = 0.73; explained variance = 22%), which slightly decreased following internal validation by means of bootstrapping (AUC = 0.69; explained variance = 13%). CONCLUSIONS: Our study established the importance of previous surgical technique, primary cause of failure, and type of the prosthesis placed during the revision surgery in predicting the probability of success following stapes surgery at 2- to 6-months follow-up. LEVEL OF EVIDENCE: 2b. Laryngoscope, 128:2390-2396, 2018.

Congenital oval or round window malformations in children: Surgical findings and results in 17 cases.

OBJECTIVES/HYPOTHESIS: To prospectively evaluate surgical findings and hearing results in children undergoing surgery for congenital oval or round window malformations (class IV malformations). STUDY DESIGN: A nonrandomized, nonblinded, case series of prospectively collected data. METHODS: Fourteen consecutive pediatric patients who underwent 17 surgical procedures for congenital oval or round window malformations in a tertiary referral center were included. Postoperative pure-tone audiometry was available in 15 cases. The surgical technique for repair of the ossicular chain was dictated by the surgical findings at the time of surgery. The majority of the cases underwent ossiculoplasty using a Teflon piston, bucket-handle prosthesis, or total ossicular replacement prosthesis. Associated surgical techniques included malleus relocation and oval window drill-out procedure. The main outcome measures were preoperative and postoperative hearing status using four-frequency (0.5, 1, 2, and 4 kHz) audiometry. Air-conduction thresholds, bone-conduction thresholds, and air-bone gap were measured. Postoperative audiometry was performed at 3, 6, 9, 12, 18, and 24 months after surgery and at a yearly interval thereafter. RESULTS: Postoperative air-bone gap closure to 10 dB or less was achieved in 47%. A postoperative air-bone gap closure to within 20 dB or less was achieved in 60%. Postoperative sensorineural hearing loss did not occur in this series. CONCLUSIONS: Middle ear surgery for class IV abnormalities is feasible, but success percentages are much lower compared to other types of congenital ossicular malformations. Surgeons should be particularly careful in case of facial nerve abnormalities on computed tomography or during middle ear exploration. LEVEL OF EVIDENCE: 4 Laryngoscope, 126:2552-2558, 2016.

Congenital ossicular chain malformations with mobile stapes in children: Results in 17 cases.

OBJECTIVES/HYPOTHESIS: To prospectively evaluate surgical findings and hearing results in children undergoing surgery for congenital malformations of the ossicular chain with a mobile stapes footplate (Teunissen and Cremers class III malformations). STUDY DESIGN: A nonrandomized, nonblinded, prospective case series. METHODS: Fifteen consecutive pediatric patients who underwent 17 surgical procedures for congenital ossicular malformations with a mobile stapes at a tertiary referral center were included. In 16 cases, postoperative pure-tone audiometry was available. The surgical technique for repair of the ossicular chain was dictated by the surgical findings at the time of surgery. The majority of the cases underwent ossiculoplasty. A Teflon piston, partial ossicular replacement prosthesis, or total ossicular replacement prosthesis was used in these cases. Associated surgical techniques included malleus relocation, Silastic banding, drilling out of a bony bridge, and a combination of these techniques. Hearing loss was evaluated using preoperative and postoperative four-frequency (0.5, 1, 2, and 4 kHz) audiometry. Air-conduction thresholds, bone-conduction thresholds, and air-bone gaps were measured. Postoperative audiometry was performed at 3, 6, 9, 12, 18, and 24 months after surgery and at a yearly interval thereafter. RESULTS: Overall, a postoperative air-bone gap closure to 10 dB or less was achieved in 63% of the included cases. A postoperative air-bone gap closure to 20 dB or less was achieved in 75%. Postoperative sensorineural hearing loss did not occur in any of the cases. CONCLUSIONS: Ossicular reconstruction is a feasible treatment option in children with congenital malformations of the ossicular chain with a mobile stapes footplate. LEVEL OF EVIDENCE: 4. Laryngoscope, 126:682-688, 2016.

Surgery versus endoscopic cauterization in patients with third or fourth branchial pouch sinuses: A systematic review.

OBJECTIVES: To systematically review the current literature on treatment of third and fourth branchial pouch sinuses with endoscopic cauterization, including chemocauterization and electrocauterization, in comparison to surgical treatment. DATA SOURCES: PubMed, Embase, and the Cochrane Library. REVIEW METHODS: We conducted a systematic search. Studies reporting original study data were included. After assessing the directness of evidence and risk of bias, studies with a low directness of evidence or a high risk of bias were excluded from analysis. Cumulative success rates after initial and recurrent treatments were calculated for both methods. A meta-analysis was conducted comparing the success rate of electrocauterization and surgery. RESULTS: A total of 2,263 articles were retrieved, of which seven retrospective and one prospective article were eligible for analysis. The cumulative success rate after primary treatment with cauterization ranged from 66.7% to 100%, and ranged from 77.8% to 100% after a second cauterization. The cumulative success rate after the first surgical treatment ranged from 50% to 100% and was 100% after the second surgical attempt. Meta-analysis on electrocauterization showed a nonsignificant risk ratio of 1.35 (95% confidence interval: 0.78-2.33). CONCLUSIONS: The effectiveness of cauterization in preventing recurrence seems to be comparable to surgical treatment. However, we suggest endoscopic cauterization as the treatment of choice for third and fourth branchial pouch sinuses because of the lower morbidity rate.

Effect of day-case unilateral cochlear implantation in adults on general and disease-specific quality of life, postoperative complications and hearing results, tinnitus, vertigo and cost-effectiveness: protocol for a randomised controlled trial.

INTRODUCTION: Cochlear implantation is an increasingly common procedure in the treatment of severe to profound sensorineural hearing loss (SNHL) in children and adults. It is often performed as a day-case procedure. The major drive towards day-case surgery has been from a logistical, economical and societal perspective, but we also speculate that the patient's quality of life (QoL) is at least equal to inpatient surgery if not increased as a result of rapid discharge and rehabilitation. Even though cochlear implantation seems well suited to a day-case approach and this even seems to be common practice in some countries, evidence is scarce and of low quality to guide us towards the preferred treatment option. METHODS AND ANALYSIS: A single-centre, non-blinded, randomised, controlled trial was designed to (primarily) investigate the effect on general QoL of day-case cochlear implantation compared to inpatient cochlear implantation and (secondarily) the effect of both methods on (subjective) hearing improvement, disease-specific QoL, tinnitus, vertigo and cost-effectiveness. 30 adult patients with severe to profound bilateral postlingual SNHL who are eligible for unilateral cochlear implantation will be randomly assigned to either the day-case or inpatient treatment group. The outcome measures will be assessed using auditory evaluations, questionnaires (preoperatively, at 1-week, 3-week, 3-month and 1-year follow-up) and costs diaries (weekly during the first month postoperatively, after which once in a month until 1-year follow-up). Preoperative and postoperative outcomes will be compared. The difference in costs and benefit will be represented using the incremental cost utility/effectiveness ratio. The analyses will be carried out on an intention-to-treat basis. ETHICS AND DISSEMINATION: This research protocol was approved by the Institutional Review Board of the UMC Utrecht (NL45590.041.13; V.5, November 2015). The trial results will be disseminated through peer-reviewed medical journals and presented at scientific conferences. TRIAL REGISTRATION NUMBER: NTR4464; Pre-results.