Dataset Information

Development of a core outcome set for traumatic brachial plexus injuries (COMBINE): study protocol.

ABSTRACT:

Introduction

Traumatic brachial plexus injury (TBPI) involves major trauma to the large nerves of the arm which control the movement and sensation. Fifty per cent of injuries result in complete paralysis of the arm with many other individuals having little movement, sensation loss and unremitting pain. The injury often causes severe and permanent disability affecting work and social life, with an estimated cost to the National Health Service and the economy of £35?million per annum. Advances in microsurgery have resulted in an increase in interventions aimed at reconstructing these injuries. However, data to guide evidence-based decisions is lacking. Different outcomes are used across studies to assess the effectiveness of treatments. This has impeded our ability to synthesise results to determine which treatments work best. Studies frequently report short-term clinical outcomes but rarely report longer term outcomes and those focused on quality of life. This project aims to produce a core outcome set (COS) for surgical and conservative management of TBPI. The TBPI COS will contain a minimum set of outcomes to be reported and measured in effectiveness studies and collected through routine clinical care.

Methods and analysis

This mixed-methods project will be conducted in two phases. In phase 1 a long list of patient-reported and clinical outcomes will be identified through a systematic review. Interviews will then explore outcomes important to patients. In phase 2, the outcomes identified across the systematic review, and the interviews will be included in a three-round online Delphi exercise aiming to reach consensus on the COS. The Delphi process will include patient and healthcare participants. A consensus meeting will be held to achieve the final COS.

Ethics and dissemination

The use of a COS in TBPI will increase the relevance of research and clinical care to all stakeholders, facilitate evidence synthesis and evidence-based decision making. The study has ethical approval.

Trial registration numbers

CRD42018109843.

SUBMITTER: Miller C

PROVIDER: S-EPMC6575635 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Publications

Development of a core outcome set for traumatic brachial plexus injuries (COMBINE): study protocol.

Miller Caroline C Cross Jane J Power Dominic M DM Kyte Derek D Jerosch-Herold Christina C

BMJ open 20190614 6

<h4>Introduction</h4>Traumatic brachial plexus injury (TBPI) involves major trauma to the large nerves of the arm which control the movement and sensation. Fifty per cent of injuries result in complete paralysis of the arm with many other individuals having little movement, sensation loss and unremitting pain. The injury often causes severe and permanent disability affecting work and social life, with an estimated cost to the National Health Service and the economy of £35 million per annum. Adva ...[more]

PMID: 31201195

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Project description:BackgroundTraumatic brachial plexus injuries (BPIs) disproportionately affect young, able-bodied individuals. Beyond direct costs associated with medical treatment, there are far-reaching indirect costs related to disability and lost productivity. Our objective was to estimate per-patient indirect cost associated with BPI.MethodsWe estimated indirect costs as the sum of (1) short-term wage loss, (2) long-term wage loss, and (3) disability payments. Short-term (6-month) wage loss was the product of missed work days and the average earnings per day. The probability of return to work was derived from a systematic review of the literature, and long-term wage loss and disability payments were estimated. Monte Carlo simulation was used to perform a sensitivity analysis of long-term wage loss by varying age, sex, and return to work simultaneously. Disability benefits were estimated from U.S. Social Security Administration data. All cost estimates are in 2018 U.S. dollars.ResultsA systematic review of the literature demonstrated that the patients with BPI had a mean age of 26.4 years, 90.5% were male, and manual labor was the most represented occupation. On the basis on these demographics, our base case was a 26-year-old American man working as a manual laborer prior to BPI, with an annual wage of $36,590. Monte Carlo simulation estimated a short-term wage loss of $22,740, a long-term wage loss of $737,551, and disability benefits of $353,671. The mean total indirect cost of traumatic BPI in the Monte Carlo simulations was $1,113,962 per patient over the post-injury lifetime (median: $801,723, interquartile range: $22,740 to $2,350,979). If the probability of the patient returning to work at a different, lower-paying job was doubled, the per-patient total indirect cost was $867,987.ConclusionsBPI can have a far-reaching economic impact on both individuals and society. If surgical reconstruction enables patients with a BPI to return to work, the indirect cost of this injury decreases.Level of evidenceEconomic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Project description:IntroductionBrachial plexus injury (BPI) can result in complete loss of neurological function and reduces the quality of life. Nerve transfer, nerve grafting, external neurolysis, and free functional muscle transfer are several management options that determine the eventual outcomes. Despite various methods of treatment, hardly any literature compares directly the result of these treatment options. This study aimed to analyze differences in clinical and functional outcomes after a reconstructive surgery.MethodsA cohort retrospective study was conducted on traumatic brachial plexus injured patients aged from 17 to 65 years at one hospital in Surabaya, Indonesia, from January 2009 to December 2019. All patients were divided into 4 groups depending on the types of surgery. The clinical outcomes were measured using elbow and shoulder muscle strength, elbow and shoulder range of motion (ROM), and pain level (measured using Visual Analog Scale/VAS); the functional outcomes were measured using the overall quality of life using the DASH (disabilities of the arms, shoulder, and hand) score.ResultsThis study included 316 patients comprising of 256 males with an average age of 27.53 ± 11.37, an average time from injury to surgery of 17.74 ± 35.82 months, and average follow-up duration of 59.89 ± 37.68 months. Most cases were caused by road traffic accidents (77.22%) and most were total arm type of BPI injury (70.7%). There was no significant difference in the mean values of study parameters except in VAS (p = 0.042) as nerve grafting resulted in less pain than external neurolysis (2.27 ± 1.03 vs. 3.68 ± 1.93, respectively; p = 0.017). Besides, nerve transfer procedure also resulted in less pain compared to external neurolysis (2.99 ± 1.84 vs. 3.68 ± 1.93, respectively; p = 0.036).ConclusionWe found no significant difference between types of surgery and the postsurgical outcome. A wider multicenter study was required to define the clinical and functional outcomes clearly.

Dataset Information

Development of a core outcome set for traumatic brachial plexus injuries (COMBINE): study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration numbers

Publications

Development of a core outcome set for traumatic brachial plexus injuries (COMBINE): study protocol.

Similar Datasets

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