Voice and Vocal Fold Condition Following Short-Term General Anesthesia: A Prospective Study.

BACKGROUND: Dysphonia, with or without laryngeal changes, has been reported as a complication following prolonged intubation. In contrast, it is unknown if laryngeal changes also occur following short-term airway instrumentation. The objectives of this study were to determine the prevalence of laryngeal changes in patients undergoing short-term routine general anesthesia using an endotracheal tube (ETT) or supraglottic airway (SGA), and to identify predictors to these changes. METHODS: Standardized voice assessments were performed preoperatively, postoperatively, and at follow-up on adults undergoing general anesthesia for an elective procedure of less than three hours requiring an ETT or a SGA. The standardized voice assessment protocol comprised a rigid videolaryngostroboscopy, the Voice Handicap Index (VHI), and acoustic voice analysis. The effects of demographic and anesthetic characteristics and type of airway instrumentation on the videolaryngostroboscopic variables were studied using multilevel logistic regression. Multilevel linear regression was used to reveal preoperative versus postoperative changes in VHI and acoustic voice scores. RESULTS: Overall, the prevalence of postoperative laryngeal changes was low. Significant postoperative laryngeal changes were found for the variables right-sided vocal fold redness in the ETT group (P = 0.048) and right-sided vocal fold blood vessels in both groups (ETT versus SGA). However, after adjustment for all demographic and anesthetic characteristics in the regression model, the effect of the type of airway instrumentation (ETT versus SGA) on the variable right-sided vocal fold redness was no longer significant. CONCLUSIONS: ETT and SGA short-term airway instrumentation are vocal fold function sparing techniques with negligible laryngeal changes.

A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System-A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology.

Background: It is hypothesized that, for patients with hearing loss, surgically placing an implant/abutment combination whilst leaving the subcutaneous tissues intact will improve cosmetic and clinical results, increase quality of life (QoL) for the patient, and reduce medical costs. Here, incremental costs and consequences associated with soft tissue preservation surgery with a hydroxyapatite (HA)-coated abutment (test) were compared with the conventional approach, soft tissue reduction surgery with an all-titanium abutment (control). Methods: A cost-consequence analysis was performed based on data gathered over a period of 3 years in an open randomized (1:1) controlled trial (RCT) running in four European countries (The Netherlands, Spain, France, and Sweden). Subjects with conductive or mixed hearing loss or single-sided sensorineural deafness were included. Results: During the first year, in the Netherlands (NL), France (FR), and Spain (ES) a net cost saving was achieved in favor of the test intervention because of a lower cost associated with surgery time and adverse event treatments [NL €86 (CI -50.33; 219.20), FR €134 (CI -3.63; 261.30), ES €178 (CI 34.12; 97.48)]. In Sweden (SE), the HA-coated abutment was more expensive than the conventional abutment, which neutralized the cost savings and led to a negative cost (SE €-29 CI -160.27; 97.48) of the new treatment modality. After 3 years, the mean cost saving reduced to €17 (CI -191.80; 213.30) in the Netherlands, in Spain to €84.50 (CI -117.90; 289.50), and in France to €80 (CI -99.40; 248.50). The mean additional cost in Sweden increased to €-116 (CI -326.90; 68.10). The consequences in terms of the subjective audiological benefit and Health-related quality of life (HRQoL) were comparable between treatments. A trend was identified for favorable results in the test group for some consequences and statistical significance is achieved for the cosmetic outcome as assessed by the clinician. Conclusions: From this multinational cost-consequence analysis it can be discerned that health care systems can achieve a cost saving during the first year that regresses after 3 years, by implementing soft tissue preservation surgery with a HA-coated abutment in comparison to the conventional treatment. The cosmetic results are better. (sponsored by Cochlear Bone Anchored Solutions AB; Clinical and health economic evaluation with a new Baha® abutment design combined with a minimally invasive surgical technique, ClinicalTrials.gov NCT01796236).

Minimally Invasive Ponto Surgery Versus the Linear Incision Technique With Soft Tissue Preservation for Bone Conduction Hearing Implants: A Multicenter Randomized Controlled Trial.

OBJECTIVE: To compare the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with those of the linear incision technique with soft-tissue preservation for bone-anchored hearing systems (BAHS). DESIGN: Sponsor-initiated multicenter, open, randomized, controlled clinical trial. SETTING: Maastricht University Medical Centre, Ziekenhuisgroep Twente and Medisch Centrum Leeuwarden, all situated in The Netherlands. PARTICIPANTS: Sixty-four adult patients eligible for unilateral BAHS surgery.Interventions Single-stage BAHS surgery with 1:1 randomization to the linear incision technique with soft-tissue preservation (control) or the MIPS (test) group. PRIMARY AND SECONDARY OUTCOME MEASUREMENTS: Primary objective: compare the incidence of inflammation (Holgers Index ≥ 2) during 12 weeks' follow-up after surgery. Secondary objectives: skin dehiscence, pain scores, loss of sensibility around the implant, soft-tissue overgrowth, skin sagging, implant extrusion, cosmetic results, surgical time, wound healing and Implant Stability Quotient measurements. RESULTS: Sixty-three subjects were analyzed in the intention-to-treat population. No significant difference was found for the incidence of inflammation between groups. Loss of skin sensibility, cosmetic outcomes, skin sagging, and surgical time were significantly better in the test group. No statistically significant differences were found for dehiscence, pain, and soft-tissue overgrowth. A nonsignificant difference in extrusion was found for the test group. The Implant Stability Quotient was statistically influenced by the surgical technique, abutment length, and time. CONCLUSION: No significant differences between the MIPS and the linear incision techniques were observed regarding skin inflammation. MIPS results in a statistically significant reduction in the loss of skin sensibility, less skin sagging, improved cosmetic results, and reduced surgical time. Although nonsignificant, the implant extrusion rate warrants further research.

Observer Agreement for Measurements in Videolaryngostroboscopy.

OBJECTIVE: This study evaluated the levels of intraobserver and interobserver agreement for measurements of visuoperceptual variables in videolaryngostroboscopic examinations and compared the observers' behavior during independent versus consensus panel rating. STUDY DESIGN: This is a retrospective study. SETTING: This study was conducted in a single-center tertiary care facility. PARTICIPANTS: Sixty-four patients with dysphonia of heterogeneous etiology were included. EXPOSURE: All subjects underwent a standardized videolaryngostroboscopic examination. MAIN OUTCOME AND MEASURES: Two experienced and trained observers scored exactly the same examinations, first independently and then on a consensus panel. Specific visuoperceptual variables and the clinical diagnosis (as recommended by the Committee on Phoniatrics and the Phonosurgery Committee of the European Laryngological Society and advised by the American Speech-Language-Hearing Association) were scored. Descriptive and kappa statistics were used. RESULTS: In general, intraobserver agreement was better than agreement between observers for measurements of several variables. The intrapanel observer agreement levels were slightly higher than the intraobserver agreement levels on the independent rating task. When rating on the consensus panel, the observers deviated considerably from the scores they had previously given on the independent rating task. CONCLUSION AND RELEVANCE: Observer agreement in videolaryngostroboscopic assessment has important implications not only for the diagnosis and treatment of dysphonic patients but also for the interpretation of the results of scientific studies using videolaryngostroboscopic outcome parameters. The identification of factors that can influence the levels of observer agreement can provide a better understanding of the rating process and its limitations. The results of this study suggest that future research could achieve better agreement levels by rating the visuoperceptual variables in a panel setting.

Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial.

BACKGROUND: Over the last years, less invasive surgical techniques with soft tissue preservation for bone conduction hearing implants (BCHI) have been introduced such as the linear incision technique combined with a punch. Results using this technique seem favorable in terms of rate of peri-abutment dermatitis (PAD), esthetics, and preservation of skin sensibility. Recently, a new standardized surgical technique for BCHI placement, the Minimally Invasive Ponto Surgery (MIPS) technique has been developed by Oticon Medical AB (Askim, Sweden). This technique aims to standardize surgery by using a novel surgical instrumentation kit and minimize soft tissue trauma. METHODS: A multicenter randomized controlled trial is designed to compare the MIPS technique to the linear incision technique with soft tissue preservation. The primary investigation center is Maastricht University Medical Center. Sixty-two participants will be included with a 2-year follow-up period. Parameters are introduced to quantify factors such as loss of skin sensibility, dehiscence of the skin next to the abutment, skin overgrowth, and cosmetic results. A new type of sampling method is incorporated to aid in the estimation of complications. To gain further understanding of PAD, swabs and skin biopsies are collected during follow-up visits for evaluation of the bacterial profile and inflammatory cytokine expression. The primary objective of the study is to compare the incidence of PAD during the first 3 months after BCHI placement. Secondary objectives include the assessment of parameters related to surgery, wound healing, pain, loss of sensibility of the skin around the implant, implant extrusion rate, implant stability measurements, dehiscence of the skin next to the abutment, and esthetic appeal. Tertiary objectives include assessment of other factors related to PAD and a health economic evaluation. DISCUSSION: This is the first trial to compare the recently developed MIPS technique to the linear incision technique with soft tissue preservation for BCHI surgery. Newly introduced parameters and sampling method will aid in the prediction of results and complications after BCHI placement. TRIAL REGISTRATION: Registered at the CCMO register in the Netherlands on 24 November 2014: NL50072.068.14 . Retrospectively registered on 21 April 2015 at ClinicalTrials.gov: NCT02438618 . This trial is sponsored by Oticon Medical AB.

Experiences and preferences of patients visiting an otorhinolaryngology outpatient clinic: a qualitative study.

BACKGROUND: Patient-centred care has received considerable attention in the last few decades, but the patients' perspective remains underexposed. This study reports on an in-depth evaluation of patients' experiences and preferences at an otorhinolaryngology outpatient department. METHODS: Qualitative research was conducted on patients' experiences and preferences at an otorhinolaryngology outpatient department in an academic hospital. The study comprised two phases. First, semi-structured interviews were held with 22 patients. Second, results from the interviews were verified and deepened in a focus group (N = 7). RESULTS: Overall, experience with patient-centred care was positive at the outpatient department. Three of the six dimensions of patient-centred care predominated in the interviews and the focus group: information, communication and education; coordination and integration of care; and respect for patients' values, preferences and expressed needs. The negative experiences were mostly in these dimensions. The dimensions physical comfort and involvement of family and friends were of lesser significance. Opinion on emotional support--relieving fear and anxiety differed as to whether this was the responsibility of the doctor or the patient. CONCLUSION: Qualitative research provided a deeper understanding of patients' experiences and preferences at an otorhinolaryngology outpatient department. Such an in-depth evaluation can be useful in the transition towards patient-centred care.

Using Lean Thinking at an otorhinolaryngology outpatient clinic to improve quality of care.

OBJECTIVES/HYPOTHESIS: Although Lean Thinking has led to considerable improvement in a variety of healthcare settings, its effects on otorhinolaryngology remain underexposed. This study reports on how the implementation of Lean Thinking at an otorhinolaryngology outpatient clinic has affected patient and provider satisfaction, waste reduction, and organizational culture. STUDY DESIGN: Prospective before-and-after design. METHODS: The 18-month prospective before-and-after design used mixed methods for data collection and analysis. A survey was conducted to measure satisfaction among patients and providers. Semistructured interviews were conducted to evaluate the effect of Lean Thinking on waste and organizational culture. RESULTS: During the project, 69 issues were posted on the Lean board. Improvements were made on 36 inefficiency issues, not all concerning a specific type of waste. Employees reported considerable improvement in transportation, motion, and waiting. Patient satisfaction was high both at baseline and follow-up and did not change significantly. The effects on provider satisfaction were slight; satisfaction with autonomy and participation decreased significantly, but satisfaction with communication increased significantly. CONCLUSIONS: The implementation of Lean Thinking at an otorhinolaryngology outpatient clinic reduced waste and increased provider satisfaction with communication. Although patient satisfaction did not change significantly, it cannot be concluded that the intervention had no effect on perceived quality of care. Other approaches to measure patients' perceptions should be considered. LEVEL OF EVIDENCE: NA.

Reliability and validity of student peer assessment in medical education: a systematic review.

BACKGROUND: Peer assessment has been demonstrated to be an effective educational intervention for health science students. AIMS: This study aims to give an overview of all instruments or questionnaires for peer assessments used in medical and allied health professional educational settings and their psychometric characteristics as described in literature. METHODS: A systematic literature search was carried out using the electronic databases Pubmed, Embase, ERIC, PsycINFO and Web of Science, including all available inclusion dates up to May 2010. RESULTS: Out of 2899 hits, 28 studies were included, describing 22 different instruments for peer assessment in mainly medical educational settings. Although most studies considered professional behaviour as a main subject of assessment and described peer assessment usually as an assessment tool, great diversity was found in educational settings and application of peer assessment, dimensions or constructs as well as number of items and scoring system per questionnaire, and in psychometric characteristics. CONCLUSIONS: Although quite a few instruments of peer assessment have been identified, many questionnaires did not provide sufficient psychometric data. Still, the final choice of an instrument for educational purposes can only be justified by its sufficient reliability and validity as well as the discriminative and evaluative purposes of the assessment.