Reporting of Sociodemographic Data in Cochlear Implant Clinical Trials: A Systematic Review

Author:

Meinhardt Gerek1,Sharrer Christine1,Perez Nicole1,Downes Alexandra2,Davidowitz Tess2,Schuh Marissa3,Robinson Lauren1,Lustig Lawrence R.2,Bush Matthew3

Affiliation:

1. College of Medicine, University of Kentucky, Lexington, KY

2. Department of Otolaryngology–Head and Neck Surgery, Vagelos College of Physicians and Surgeons, Columbia University New York, NY

3. Department of Otolaryngology–Head and Neck Surgery, University of Kentucky Medical Center, Lexington, KY

Abstract

Objective The purpose of this study was to systematically evaluate the literature on the frequency of reporting of sociodemographic data (gender, race, ethnicity, education status, health insurance status, geographic location of residence, and socioeconomic status) among interventional clinical trials involving cochlear implant patients. Databases Reviewed A systematic search was performed in PubMed, Cochrane Database of Systematic Reviews, Web of Science, and SCOPUS to identify peer reviewed research. Methods A systematic review was performed, which included original prospective clinical trial research studies involving cochlear implantation and/or interventional trials involving cochlear implant patients. Collected data included funding type, level of evidence, race reporting, ethnicity reporting, socioeconomic status reporting, education level reporting, type of insurance, geographic location, and gender of patients. Results A total of 644 articles were included for review. Gender was the most reported sociodemographic factor (70% of included studies). Reporting of other data among included studies was low: educational level (6%), socioeconomic status (2%), race (1%), ethnicity (1%), insurance status (0.3%), and geography (1%). The odds of reporting gender (odds ratio [OR] = 1.51), education (OR = 1.81), and geography (OR = 2.72) increased with each subsequent publication date decade; however, this trend was not seen for reporting of race, ethnicity, socioeconomic status, or insurance. The reporting of gender was less likely to be reported in studies with the pediatric participants (OR = 0.62), level II evidence (OR = 0.14), and device programming interventional studies (OR = 0.26). Conclusion Reporting of sociodemographic data, other than gender, is low among prospective clinical trials involving cochlear implant patients. The lack of reporting of this key data may limit research rigor and generalizability. Clinical researchers are advised to prospectively collect these data to promote equity in cochlear implant research and clinical care.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Neurology (clinical),Sensory Systems,Otorhinolaryngology

Reference31 articles.

1. Geographic and racial disparities in infant hearing loss;Otolaryngol Head Neck Surg,2018

2. Racial/ethnic and sex representation in US-based clinical trials of hearing loss management in adults: a systematic review;JAMA Otolaryngol Head Neck Surg,2021

3. Defining disparities in cochlear implantation through the social determinants of health;Semin Hear,2021

4. Neonatal abstinence syndrome and infant hearing assessment: a kid’s inpatient database review;Journal of Early Hearing Detection and Intervention,2020

5. Racial and insurance inequalities in access to early pediatric cochlear implantation;Otolaryngol Head Neck Surg,2021

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