Protocol for the development of a patient-reported outcome measure for patients with hypospadias

Introduction

Existing patient-reported outcome measures (PROMs) do not meet accepted international criteria for measuring health outcomes of hypospadias treatment. This protocol describes the qualitative development (phase I) of a novel PROM to evaluate outcomes of hypospadias treatments.

Methods and analysis

Participants aged 7 years and older with hypospadias and caregivers of children under 8 years seeking treatment at Boston Children’s Hospital, Children’s Hospital of Eastern Ontario (CHEO), Children’s Hospital of Philadelphia (CHOP) and McMaster Children’s Hospital), will be invited to participate in concept elicitation and cognitive interviews. Concept elicitation interviews will be in-depth and semi-structured to understand concepts important to patients seeking treatment for hypospadias. Cognitive interviews will be performed concurrently to ensure that the scale items, instructions and response options are relevant, understandable and comprehensive. Cognitive interviews will be complemented by expert input. Concept elicitation and cognitive interview transcripts will be coded line-by-line. Participant quotes will be categorised into top-level domains, themes and subthemes. The primary outcome of this research will be to develop a conceptual model representing the patient experience of hypospadias and a novel PROM.

Ethics and dissemination

Ethics approval was obtained from Boston Children’s Hospital’s Institutional Review Board (HHS Registration: IRB00000352; Protocol number IRB-P00042425). CHOP, McMaster and CHEO have reliance agreements with Boston Children’s Hospital. Findings from this research will be disseminated at national and international conferences and published in relevant peer-reviewed journals for the target audience.

Bridging the gap: A systematic review of intraoperative electrocochleography during cochlear implantation and preservation of residual hearing

by Jaimee Cooper, Jeenu Mittal, Max Zalta, Nicholas DiStefano, Delany L. Klassen, Keelin McKenna, Dimitri A. Godur, Andrea Monterrubio, Moeed Moosa, Rahul Mittal, Adrien A. Eshraghi

Cochlear implantation is a surgical intervention to provide auditory rehabilitation to individuals with severe to profound hearing loss. Intraoperative electrocochleography (ECochG) has emerged as a promising tool for monitoring cochlear health during cochlear implant (CI) surgery. This systematic review aims to synthesize current evidence regarding the effectiveness of intraoperative ECochG in predicting postoperative residual hearing levels in CI recipients. A comprehensive literature search was conducted across major databases including PubMed, Embase, Web of Science, and SCOPUS. The protocol for this systematic review was registered in the PROSPERO database (registration number: CRD42023476617). The key outcomes assessed were the correlation between intraoperative ECochG patterns and postoperative residual hearing levels, as well as the influence of surgical techniques and electrode design on ECochG responses and hearing preservation. The Risk of Bias analysis was conducted using the Joanna Briggs Institute Critical Appraisal Tool. The review included a total of eighteen studies that met the inclusion and exclusion criteria. A significant correlation was reported between specific intraoperative ECochG response patterns and the preservation of residual hearing post-surgery. Studies highlighted that robust ECochG responses typically indicated a higher likelihood of postoperative hearing preservation. The review also identified factors influencing ECochG responses, including electrode design and insertion techniques. Several studies reported improved preservation of residual hearing with modifications in surgical approaches guided by ECochG feedback. Intraoperative ECochG monitoring emerges as a crucial tool in predicting and potentially enhancing postoperative residual hearing outcomes in implanted individuals. The review underscores the value of ECochG in guiding surgical technique adjustments, thereby maximizing hearing preservation. However, the heterogeneity in study designs and ECochG protocols suggests a need for standardization in this field. Future research should focus on large-scale, multicenter trials to establish definitive guidelines for integrating ECochG in CI surgeries, with an emphasis on long-term hearing outcomes.

Further psychometric validation and test–retest reproducibility of the WOUND‐Q

Abstract

WOUND-Q is a condition-specific patient-reported outcome measure developed for all types of chronic wounds, located anywhere on the body. To establish reliability and validity of a patient-reported outcome measure, multiple pieces of evidence are required. The purpose of this study was to examine the measurement properties of 9 of the 13 WOUND-Q scales and perform a test–retest reproducibility study in an international sample. In August 2022, we invited members of an international online community (Prolific.com) with any type of chronic wound to complete a survey containing the WOUND-Q scales, the Wound-QoL and EQ-5D. A test–retest survey was performed 7 days after the first survey. It was possible to examine the reliability and validity of eight of the nine WOUND-Q scales by Rasch Measurement Theory (RMT). To examine test–retest reproducibility intraclass correlation coefficients (ICCs), the standard error of the measurement and the smallest detectable change were calculated. In total, 421 patients from 22 different countries with 11 different types of chronic wounds took part in this study. Our analyses provided further evidence of the reliability and validity of the scales measuring wound characteristics (assessment, drainage, smell), health-related quality of life (life impact, psychological, sleep, social) and wound treatment (dressing).