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      Which is best for osteoporotic vertebral compression fractures: balloon kyphoplasty, percutaneous vertebroplasty or non-surgical treatment? A study protocol for a Bayesian network meta-analysis

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          Abstract

          Introduction

          Osteoporotic vertebral compression fractures (OVCFs) commonly cause both acute and chronic back pain, substantial spinal deformity, functional disability and decreased quality of life and increase the risk of future vertebral fractures and mortality. Percutaneous vertebroplasty (PVP), balloon kyphoplasty (BK) and non-surgical treatment (NST) are mostly used for the treatment of OVCFs. However, which treatment is preferred is unknown. The purpose of this study is to comprehensively review the literature and ascertain the relative efficacy and safety of BK, PVP and NST for patients with OVCFs using a Bayesian network meta-analysis.

          Methods and analysis

          We will comprehensively search PubMed, EMBASE and the Cochrane Central Register of Controlled Trials, to include randomided controlled trials that compare BK, PVP or NST for treating OVCFs. The risk of bias for individual studies will be assessed according to the Cochrane Handbook. Bayesian network meta-analysis will be performed to compare the efficacy and safety of BK, PVP and NST. The quality of evidence will be evaluated by GRADE.

          Ethics and dissemination

          Ethical approval and patient consent are not required since this study is a meta-analysis based on published studies. The results of this network meta-analysis will be submitted to a peer-reviewed journal for publication.

          PROSPERO registration number

          CRD42016039452; Pre-results.

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          Most cited references19

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          Evidence Synthesis for Decision Making 4

          Sofia Dias, Nicky Welton, Alex J Sutton … (2013)
          Inconsistency can be thought of as a conflict between “direct” evidence on a comparison between treatments B and C and “indirect” evidence gained from AC and AB trials. Like heterogeneity, inconsistency is caused by effect modifiers and specifically by an imbalance in the distribution of effect modifiers in the direct and indirect evidence. Defining inconsistency as a property of loops of evidence, the relation between inconsistency and heterogeneity and the difficulties created by multiarm trials are described. We set out an approach to assessing consistency in 3-treatment triangular networks and in larger circuit structures, its extension to certain special structures in which independent tests for inconsistencies can be created, and describe methods suitable for more complex networks. Sample WinBUGS code is given in an appendix. Steps that can be taken to minimize the risk of drawing incorrect conclusions from indirect comparisons and network meta-analysis are the same steps that will minimize heterogeneity in pairwise meta-analysis. Empirical indicators that can provide reassurance and the question of how to respond to inconsistency are also discussed.
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            [Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty].

            P Galibert, H Deramond, P Rosat … (1987)
            Findings in several cases are used to demonstrate that certain vertebral angiomas may not be congenital and can ultimately provoke medullary or radicular neurologic complications. Radiotherapy is the usual treatment but is not always accepted unconditionally close to spinal cord. Destruction of angioma and consolidation of vertebral column can be obtained by percutaneous intrasomatic injection of acrylic cement. The preoperative radiologic examination includes direct phlebography with insertion of trocar, the vertebroplasty being performed under television screen surveillance. Results in seven patients treated are very encouraging but the current 2-year follow up requires extension. However, the method appears to be able to be included amongst treatment for an affection of sometimes seriously questioned benign nature.
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              Evidence synthesis for decision making 3: heterogeneity--subgroups, meta-regression, bias, and bias-adjustment.

              Philip Ades, Nicky Welton, Sofia Dias … (2013)
              In meta-analysis, between-study heterogeneity indicates the presence of effect-modifiers and has implications for the interpretation of results in cost-effectiveness analysis and decision making. A distinction is usually made between true variability in treatment effects due to variation in patient populations or settings and biases related to the way in which trials were conducted. Variability in relative treatment effects threatens the external validity of trial evidence and limits the ability to generalize from the results; imperfections in trial conduct represent threats to internal validity. We provide guidance on methods for meta-regression and bias-adjustment, in pairwise and network meta-analysis (including indirect comparisons), using illustrative examples. We argue that the predictive distribution of a treatment effect in a "new" trial may, in many cases, be more relevant to decision making than the distribution of the mean effect. Investigators should consider the relative contribution of true variability and random variation due to biases when considering their response to heterogeneity. In network meta-analyses, various types of meta-regression models are possible when trial-level effect-modifying covariates are present or suspected. We argue that a model with a single interaction term is the one most likely to be useful in a decision-making context. Illustrative examples of Bayesian meta-regression against a continuous covariate and meta-regression against "baseline" risk are provided. Annotated WinBUGS code is set out in an appendix.
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2017
                Publication date (Electronic): 16 January 2017
                Volume: 7
                Issue: 1
                Electronic Location Identifier: e012937
                Affiliations
                [1 ]Department of Orthopaedics, Tianjin Medical University General Hospital , Tianjin, China
                [2 ]School of Nursing, Tianjin Medical University , Tianjin, China
                Author notes
                [Correspondence to ] Dr Shi-Qing Feng; sqfeng@tmu.edu.cn and Dr Guang-Zhi Ning; ninggz_tmu@foxmail.com

                S-LK and Z-FY are first co-authors.

                Article
                Publisher ID: bmjopen-2016-012937
                DOI: 10.1136/bmjopen-2016-012937
                PMC ID: 5253565
                PubMed ID: 28093431
                SO-VID: 2a7e0d5b-1faa-494b-b863-93709250388c
                Copyright © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
                License:

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

                History
                Date received : 3 June 2016
                Date revision received : 28 October 2016
                Date accepted : 19 December 2016
                Categories
                Subject: Surgery
                Subject: Protocol
                Subject: 1506
                Subject: 1737
                Subject: 1694

                ScienceOpen disciplines: Medicine
                Keywords: percutaneous vertebroplasty,balloon kyphoplasty,non-surgical treatment,osteoporotic vertebral compression fractures,network meta-analysis
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: percutaneous vertebroplasty, balloon kyphoplasty, non-surgical treatment, osteoporotic vertebral compression fractures, network meta-analysis

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