Developing a core outcome set for traumatic brachial plexus injuries: a systematic review of outcomes.
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ABSTRACT: Objective
To identify what outcomes have been assessed in traumatic brachial plexus injury (TBPI) research to inform the development of a core outcome set for TBPI.Design
Systematic review.Method
Medline (OVID), EMBASE, CINAHL and AMED were systematically searched for studies evaluating the clinical effectiveness of interventions in adult TBPIs from January 2013 to September 2018 updated in May 2021. Two authors independently screened papers. Outcome reporting bias was assessed. All outcomes were extracted verbatim from studies. Patient-reported outcomes or performance outcome measures were extracted directly from the instrument. Variation in outcome reporting was determined by assessing the number of unique outcomes reported across all included studies. Outcomes were categorised into domains using a prespecified taxonomy.Results
Verbatim outcomes (n=1491) were extracted from 138 studies including 32 questionnaires. Unique outcomes (n=157) were structured into 4 core areas and 11 domains. Outcomes within the musculoskeletal domain were measured in 86% of studies, physical functioning in 25%, emotional functioning in 25% and adverse events in 33%. We identified 63 different methods for measuring muscle strength, 16 studies for range of movement and 63 studies did not define how they measured movement. More than two-thirds of the outcomes were incompletely reported in prospective studies.Conclusion
This review of outcome reporting in TBPI research demonstrated an impairment focus and heterogeneity. A core outcome set would ensure standardised and relevant outcomes are reported to facilitate future systematic review and meta-analysis.Prospero registration number
CRD42018109843.
SUBMITTER: Miller C
PROVIDER: S-EPMC8327802 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionTraumatic 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 analysisThis 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 disseminationThe 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 numbersCRD42018109843.
| S-EPMC6575635 | biostudies-literature
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.
| S-EPMC7406142 | biostudies-literature
Project description:BackgroundCombined injuries to the spinal cord and brachial plexus present challenges in the detection of both injuries as well as to subsequent treatment. The purpose of this study is to describe the epidemiology and clinical factors of concomitant spinal cord injuries in patients with a known brachial plexus injury.MethodsA retrospective review was performed on all patients who were evaluated for a brachial plexus injury in a tertiary, multidisciplinary brachial plexus clinic from January 2000 to December 2008. Patients with clinical and/or imaging findings for a coexistent spinal cord injury were identified and underwent further analysis.ResultsA total of 255 adult patients were evaluated for a traumatic traction injury to the brachial plexus. We identified thirty-one patients with a combined brachial plexus and spinal cord injury, for a prevalence of 12.2%. A preganglionic brachial plexus injury had been sustained in all cases. The combined injury group had a statistically greater likelihood of having a supraclavicular vascular injury (odds ratio [OR] = 22.5; 95% confidence interval [CI] = 1.9, 271.9) and a cervical spine fracture (OR = 3.44; 95% CI = 1.6, 7.5). These patients were also more likely to exhibit a Horner sign (OR = 3.2; 95% CI = 1.5, 7.2) and phrenic nerve dysfunction (OR = 2.5; 95% CI = 1.0, 5.8) compared with the group with only a brachial plexus injury.ConclusionHeightened awareness for a combined spinal cord and brachial plexus injury and the presence of various associated clinical and imaging findings may aid in the early recognition of these relatively uncommon injuries.
| S-EPMC3234346 | biostudies-literature
Project description:BackgroundCaesarean section (CS) is widely perceived as protective against obstetric brachial plexus injury (BPI), but few studies acknowledge the factors associated with such injury. The objectives of this study were therefore to aggregate cases of BPI after CS, and to illuminate risk factors for BPI.MethodsPubmed Central, EMBASE and MEDLINE databases were searched using free text: ("brachial plexus injury" or "brachial plexus injuries" or "brachial plexus palsy" or "brachial plexus palsies" or "Erb's palsy" or "Erb's palsies" or "brachial plexus birth injury" or "brachial plexus birth palsy") and ("caesarean" or "cesarean" or "Zavanelli" or "cesarian" or "caesarian" or "shoulder dystocia"). Studies with clinical details of BPI after CS were included. Studies were assessed using the National Institutes for Healthy Study Quality Assessment Tool for Case Series, Cohort and Case-Control Studies.Main results39 studies were eligible. 299 infants sustained BPI after CS. 53% of cases with BPI after CS had risk factors for likely challenging handling/manipulation of the fetus prior to delivery, in the presence of considerable maternal or fetal concerns, and/or in the presence of poor access due to obesity or adhesions.ConclusionsIn the presence of factors that would predispose to a challenging delivery, it is difficult to justify that BPI could occur due to in-utero, antepartum events alone. Surgeons should exercise care when operating on women with these risk factors.
| S-EPMC10190031 | biostudies-literature
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.
| S-EPMC9127148 | biostudies-literature
Project description:Adult traumatic brachial plexus injuries can have devastating effects on upper extremity function. Although neurolysis, nerve repair, and nerve grafting have been used to treat injuries to the plexus, nerve transfer makes use of an undamaged nerve to supply motor input over a relatively short distance to reinnervate a denervated muscle. A review of several recent innovations in nerve transfer surgery for brachial plexus injuries is illustrated with surgical cases performed at this institution.
| S-EPMC2504085 | biostudies-other
Project description:BackgroundAdult brachial plexus injuries (BPI) are becoming more common. The reconstruction and prognosis of pre-ganglionic injuries (root avulsions) are different to other types of BPI injury. Preoperative magnetic resonance imaging (MRI) is being used to identify root avulsions, but the evidence from studies of its diagnostic accuracy are conflicting. Therefore, a systematic review is needed to address uncertainty about the accuracy of MRI and to guide future research.MethodsWe will conduct a systematic search of electronic databases alongside reference tracking. We will include studies of adults with traumatic BPI which report the accuracy of preoperative MRI (index test) against surgical exploration of the roots of the brachial plexus (reference standard) for detecting either of the two target conditions (any root avulsion or any pseudomeningocoele as a surrogate marker of root avulsion). We will exclude case reports, articles considering bilateral injuries and studies where the number of true positives, false positives, false negatives and true negatives cannot be derived. The methodological quality of the included studies will be assessed using a tailored version of the QUADAS-2 tool. Where possible, a bivariate model will be used for meta-analysis to obtain summary sensitivities and specificities for both target conditions. We will investigate heterogeneity in the performance of MRI according to field strength and the risk of bias if data permits.DiscussionThis review will summarise the current diagnostic accuracy of MRI for adult BPI, identify shortcomings and gaps in the literature and so help to guide future research.Systematic review registrationPROSPERO CRD42016049702 .
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Project description:Synthesis of effects of infant feeding interventions to prevent childhood obesity is limited by outcome measurement and reporting heterogeneity. Core outcome sets (COSs) represent standardised approaches to outcome selection and reporting. The aim of this review is to identify feeding outcomes used in infant feeding studies to inform an infant feeding COS for obesity prevention interventions. The databases EMBASE, Medline, CINAHL, CENTRAL, and PsycINFO searched from inception to February 2017. Studies eligible for inclusion must examine any infant feeding outcome in children ?1 year. Feeding outcomes include those measured using self-report and/or observational methods and include dietary intake, parent-child interaction, and parental beliefs, among others. Data were extracted using a standardised data extraction form. Outcomes were assigned to outcome domains using an inductive, iterative process with a multidisciplinary team. We identified 82 unique outcomes, representing nine outcome domains. Outcome domains were "breast and formula feeding," "introduction of solids," "parent feeding practices and styles," "parent knowledge and beliefs," "practical feeding," "food environment," "dietary intake," "perceptions of infant behaviour and preferences," and "child weight outcomes." Heterogeneity in definition and frequency of outcomes was noted in reviewed studies. "Introduction of solids" (59.5%) and "breastfeeding duration" (55.5%) were the most frequently reported outcomes. Infant feeding studies focus predominantly on consumption of milks and solids and infant weight. Less focus is given to modifiable parental and environmental factors. An infant feeding COS can minimise heterogeneity in selection and reporting of infant feeding outcomes for childhood obesity prevention interventions.
| S-EPMC7199036 | biostudies-literature
Project description:BackgroundThere is no agreement which outcomes should be measured when investigating interventions for periodontal diseases. It is difficult to compare or combine studies with different outcomes; resulting in research wastage and uncertainty for patients and healthcare professionals.ObjectiveDevelop a core outcome set (COS) relevant to key stakeholders for use in effectiveness trials investigating prevention and management of periodontal diseases.MethodsMixed method study involving literature review; online Delphi Study; and face-to-face consensus meeting.ParticipantsKey stakeholders: patients, dentists, hygienist/therapists, periodontists, researchers.ResultsThe literature review identified 37 unique outcomes. Delphi round 1: 20 patients and 51 dental professional and researchers prioritised 25 and suggested an additional 11 outcomes. Delphi round 2: from the resulting 36 outcomes, 13 patients and 39 dental professionals and researchers prioritised 22 outcomes. A face-to-face consensus meeting was hosted in Dundee, Scotland by an independent chair. Eight patients and six dental professional and researchers participated. The final COS contains: Probing depths, Quality of life, Quantified levels of gingivitis, Quantified levels of plaque, Tooth loss.ConclusionsImplementation of this COS will ensure the results of future effectiveness trials for periodontal diseases are more relevant to patients and dental professionals, reducing research wastage. This could reduce uncertainty for patients and dental professionals by ensuring the evidence used to inform their choices is meaningful to them. It could also strengthen the quality and certainty of the evidence about the relative effectiveness of interventions.RegistrationCOMET Database: http://www.comet-initiative.org/studies/details/265?result=true.
| S-EPMC8297801 | biostudies-literature
Project description:Cellular therapy is being actively pursued as a therapeutic modality in many of the neurological diseases. A variety of stem cells from diverse sources have been studied in detail and have been shown to exhibit angiogenetic and immunomodulatory properties in addition to other neuroprotective effects. Published clinical data have shown bone marrow mononuclear cell (BMMNC) injection in neurological disorders is safe and possesses regenerative potential. We illustrate a case of 27-year-old male with traumatic brachial plexus injury, administered with autologous BMMNCs intrathecally and intramuscularly, followed by multidisciplinary rehabilitation. At the follow-up assessment of 3 and 7 months after first cell transplantation, improvements were recorded in muscle strength and movements. Electromyography (EMG) performed after the intervention showed a response in biceps and deltoid muscles suggesting the process of reinnervation at the site of injury. In view of the improvements observed after the treatment, the patient underwent second cell transplantation 8 months after the first transplantation. Muscle wasting had completely stopped with an increase in the muscle girth. No adverse effects were noted. Improvements were maintained for 4 years. A comprehensive randomized study for this type of injury is needed to establish the therapeutic benefits of cellular therapy.
| S-EPMC5887704 | biostudies-literature