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      Outcomes and outcomes measurements used in intervention studies of pelvic girdle pain and lumbopelvic pain: a systematic review

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          Abstract

          Background

          Pelvic girdle pain is a common problem during pregnancy and postpartum with significant personal and societal impact and costs. Studies examining the effectiveness of interventions for pelvic girdle pain measure different outcomes, making it difficult to pool data in meta-analysis in a meaningful and interpretable way to increase the certainty of effect measures. A consensus-based core outcome set for pelvic girdle pain can address this issue. As a first step in developing a core outcome set, it is essential to systematically examine the outcomes measured in existing studies.

          Objective

          The objective of this systematic review was to identify, examine and compare what outcomes are measured and reported, and how outcomes are measured, in intervention studies and systematic reviews of interventions for pelvic girdle pain and for lumbopelvic pain (which includes pelvic girdle pain).

          Methods

          We searched PubMed, Cochrane Library, PEDro and Embase from inception to the 11th May 2018. Two reviewers independently selected studies by title/abstract and by full text screening. Disagreement was resolved through discussion. Outcomes reported and their outcome measurement instruments were extracted and recorded by two reviewers independently. We assessed the quality of reporting with two independent reviewers. The outcomes were grouped into core domains using the OMERACT filter 2.0 framework.

          Results

          A total of 107 studies were included, including 33 studies on pelvic girdle pain and 74 studies on lumbopelvic pain. Forty-six outcomes were reported across all studies, with the highest amount (26/46) in the ‘life impact’ domain. ‘Pain’ was the most commonly reported outcome in both pelvic girdle pain and lumbopelvic pain studies. Studies used different instruments to measure the same outcomes, particularly for the outcomes pain, function, disability and quality of life.

          Conclusions

          A wide variety of outcomes and outcome measurements are used in studies on pelvic girdle pain and lumbopelvic pain. The findings of this review will be included in a Delphi survey to reach consensus on a pelvic girdle pain - core outcome set. This core outcome set will allow for more effective comparison between future studies on pelvic girdle pain, allowing for more effective translation of findings to clinical practice.

          Supplementary information

          Supplementary information accompanies this paper at 10.1186/s12998-019-0279-2.

          Resumen en Español

          Introducción

          El dolor de la cintura pélvica es un problema común durante el embarazo y el posparto con un impacto personal y social significativo. Los estudios que examinan la efectividad de intervenciones para el dolor de la cintura pélvica miden diferentes resultados, lo que dificulta el agrupamiento de los datos en un metanálisis para aumentar la certeza de las medidas del efecto. Un conjunto de resultados principales basado en un consenso puede abordar este problema. Primero, para desarrollar un conjunto de resultados principales, es esencial examinar sistemáticamente los resultados utilizados en los estudios existentes.

          Objetivo

          El objetivo de esta revisión sistemática fue identificar, examinar y comparar qué resultados se miden y reportan, y cómo se los miden, en estudios de intervención y revisiones sistemáticas de intervenciones para el dolor de la cintura pélvica y para el dolor lumbopélvico.

          Método

          Se realizaron búsquedas en PubMed, Cochrane Library, PEDro y Embase desde el inicio hasta el 11 mayo 2018. Dos revisores seleccionaron independientemente los estudios por título/resumen y texto completo. El desacuerdo se resolvió por discusión. Los resultados reportados y sus instrumentos de medición fueron extraídos por dos revisores independiente. Se evaluó la calidad de informe con dos revisores independientes. Los resultados se agruparon en dominios principales utilizando el filtro OMERACT 2.0.

          Resultados

          Se incluyeron 107 artículos: 33 artículos sobre el dolor de la cintura pélvica y 74 artículos sobre el dolor lumbopélvico. Se informaron 46 resultados, principalmente (26/46) en el dominio “Impacto en la vida”. “El Dolor” fue el resultado más frecuente. Los estudios utilizaron diferentes instrumentos para medir los mismos resultados, particularmente para los resultados dolor, función, discapacidad y calidad de vida.

          Conclusiones

          Se utiliza una amplia variedad de resultados y mediciones de resultados en estudios sobre el dolor de la cintura pélvica y el dolor lumbopélvico. Los resultados de esta revisión se incluirán en una encuesta Delphi, obtener para llegar a un consenso sobre un conjunto de resultados principales. Este conjunto de resultados principales permitirá una comparación más efectiva entre estudios sobre el dolor de la cintura pélvica, lo que permitirá un análisis más efectivo en la práctica clínica.

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          Most cited references74

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          Core outcome domains for clinical trials in non-specific low back pain.

          Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP.
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            MOMENT – Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

            Background Cleft palate (CP) has an incidence of approximately 1 in 700. Children with CP are also susceptible to otitis media with effusion (OME), with approximately 90% experiencing nontrivial OME. There are several approaches to the management of OME in children with CP. The Management of Otitis Media with Effusion in Children with Cleft Palate (MOMENT) study is a feasibility study that includes the development of a core outcome set for use in future trials of the management of OME in children with CP. Methods/Design The MOMENT study will include a systematic review of the literature to identify a list of outcomes that have previously been reported. This list of outcomes will be used in a Delphi study with cleft clinicians. The Delphi study is anticipated to include three rounds. The first round will ask clinicians to score the outcome list and to add any outcomes they think are relevant. The second round involves presentation of scores according to stakeholder group and the opportunity for participants to rescore outcomes. To ensure that the opinion of parents and children are sought, qualitative interviews will be completed with a purposive sample in parallel. In the final round of the Delphi process, participants will be shown the distribution of scores, for each outcome, for all stakeholder groups separately as well as a summary of the results concerning outcomes from the qualitative interviews with parents. A final consensus meeting will be held with all stakeholders, including parents and children, to review outcomes. Discussion A core outcome set represents the minimum that should be measured in a clinical trial for a particular condition. The MOMENT study will aim to identify a core outcome set that can be used in future trials of the management of OME, improving the consistency of research in this clinical area.
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              Prognosis in four syndromes of pregnancy-related pelvic pain.

              The aim of the present study was to describe, on the basis of specific classification criteria and for a period of two years after delivery, the prognosis for women suffering from pregnancy-related pelvic joint pain, and to describe the characteristics influencing the prognosis. One thousand seven hundred and eighty-nine pregnant women who were booked for delivery at Odense University Hospital formed a cohort to investigate the prognosis. Women whose reported daily pain from pelvic joints could be objectively confirmed were divided, according to symptoms, into five subgroups (n=405) - four classification groups (pelvic girdle syndrome, symphysiolysis, one-sided sacroiliac syndrome and double-sided sacroiliac syndrome) and one miscellaneous. The women in the five subgroups were re-examined at regular intervals for two years after delivery or until disappearance of symptoms (whichever was less). Thre hundred and forty-one women from the 5 subgroups participated in the postpartum follow-up. The majority (62.5%) of women in the four classification groups experienced disappearance of pain within a month after delivery. Two years after parturition 8.6% were still suffering from pelvic joint pain (determined subjectively and objectively). Persistence of pain was found to vary significantly from one classification group to another. None of those initially classified as suffering from symphysiolysis had pain 6 months after delivery in comparison to the 21 percent of those with pelvic girdle syndrome who continued to have pain at the two-year mark. This study shows that pregnancy-related pelvic joint pain had an excellent postpartum prognosis (in general) in three out of four classification groups. The women with pelvic girdle syndrome (pain in all 3 pelvic joints) had a markedly worse prognosis than the women in the other three classification groups. High number of positive test and a low mobility index were identified as giving the highest relative risk for long term pain.
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                Author and article information

                Contributors
                +35318963200 , wuytacf@tcd.ie
                odonovm4@tcd.ie
                Journal
                Chiropr Man Therap
                Chiropr Man Therap
                Chiropractic & Manual Therapies
                BioMed Central (London )
                2045-709X
                5 November 2019
                5 November 2019
                2019
                : 27
                : 62
                Affiliations
                [1 ]ISNI 0000 0004 1936 9705, GRID grid.8217.c, School of Nursing & Midwifery, , Trinity College Dublin, ; 24 D’Olier Street, Dublin 2, Ireland
                [2 ]School of Medicine, Discipline of Physiotherapy, Trinity College Dublin, Trinity Centre for Health Sciences, St James’s Hospital, Dublin 8, Ireland
                Author information
                http://orcid.org/0000-0001-7720-1722
                Article
                279
                10.1186/s12998-019-0279-2
                6829811
                8b726b0d-74c4-4f6b-8541-e87b72c4a0bb
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 7 May 2019
                : 3 September 2019
                Funding
                Funded by: Health Research Board Trials Methodology Research Network
                Award ID: Summer Student Scholarship
                Categories
                Systematic Review
                Custom metadata
                © The Author(s) 2019

                Complementary & Alternative medicine
                pelvic girdle pain,lumbopelvic pain,outcomes,outcome measurement,systematic review

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