Pharmacologic and surgical therapies for patients with Meniere’s disease: a protocol for a systematic review and meta-analysis

Abstract

BackgroundHearing loss is one of the leading causes of disability in Canada and worldwide, with more than one million Canadians enduring a hearing-related disability. Meniere’s disease (MD) is a chronic condition of the inner ear, manifesting as a triad of disabling symptoms, including attacks of vertigo, fluctuating sensorineural hearing loss (SNHL), and tinnitus. Impacts on quality of life are severe, particularly with respect to restrictions in social participation and physical activity, fatigue, and reduced capacity to work. Anxiety and other psychological disorders may result from the restrictions imposed on life, the constant uncertainty of vertigo attacks, and fluctuating SNHL, with neuroses and depression affecting 40 to 60% of sufferers of intractable MD. There is a need to establish the benefits of previously studied interventions with greater certainty. The planned systematic review and meta-analyses/network meta-analyses (NMAs) will assess the relative effects of competing pharmacologic and surgical interventions for management of MD in adults.MethodsAn experienced medical information specialist in consultation with the review team will develop the electronic search strategies. We will search various databases including MEDLINE, Embase, and the Cochrane Library with no date or language restrictions for published literature, and key clinical trial registries for in-progress and completed trials. Screening of the literature will be performed by two reviewers independently using pre-specified eligibility criteria, and quality of the included studies will be assessed using the Cochrane Risk of Bias tool. We will resolve disagreements through consensus or third-party adjudication. When applicable, meta-analyses and NMAs will be pursued to compare interventions in terms of their effects on outcomes, including frequency and severity of vertigo, occurrence and intensity of tinnitus, changes in hearing and speech recognition, quality of life, and harms. Separate analyses exploring the effects of pharmacologic and surgical approaches will be performed.DiscussionOur planned systematic review will provide informative evaluations of existing treatments for management of Meniere’s disease. The findings will inform practitioners as to the relative benefits and harms of the existing competing interventions for MD, offer optimal clinical treatment strategies, identify evidence gaps, and determine promising therapies for evaluation in future trials.Systematic review registrationPROSPERO CRD42019119129

Pharmacologic and surgical therapies for patients with Meniere’s disease: A systematic review and network meta-analysis

“…Our review adhered to methods recommended by the Cochrane Collaboration for the conduct of systematic reviews of interventions [12], and conformed to reporting standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Network Meta-Analyses (PRISMA-NMA) [13]. We registered the review with the International Prospective Register of Systematic Reviews (PROSPERO; registration #CRD42019119129) [14] and published the review protocol [15]. Minor deviations from the planned protocol were encountered during the review and are detailed in S1 Text.…”

“…The study’s research question and eligibility criteria with regard to the PICOTS (Population, Intervention, Comparator, Outcomes, Timing, Study design) framework were established a prior and reported in the published protocol [ 15 ], and are also detailed in SA1 Table in S3 Text . In brief, a RCT or quasi-RCT was to be included if it compared pharmacological or surgical interventions of interest to placebo or other active arms for treatment of patients with MD defined as per the established criteria (i.e., American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) 1985, AAO-HNS 1995, and American Academy of Ophthalmology and Otolaryngology (AAOO) 1972) [ 9 , 22 ], and reported a minimum follow-up time of six months post-treatment.…”

“…cited trial design, number of sites, duration of follow-up, funding source, and authors' conflicts of interest). A complete listing of data extraction items is presented in the published protocol [15]. Data extraction was piloted on a set of five studies prior to proceeding with extraction of all included studies.…”

Salvage therapy for progressive, treatment-refractory or recurrent pediatric medulloblastoma: a systematic review protocol

“…Reviewers will develop a comprehensive data extraction form on Microsoft Excel, as guided by Covidence's piloting forms, and data collection forms for RCTs by Cochrane Training, in addition to several peer-reviewed systematic reviews and protocols [36][37][38][39][40][41]. An initial calibration test will be conducted (AAA, SKS) on a set of 5 randomly selected articles and 5 randomly selected clinical trials to ensure high inter-rater agreement; the latter will compare manual and automatic data extraction methods (using Extracting Accurate efficacy and safety information from ClinicalTrials.gov, EXACT) [42].…”