scholarly journals International development and implementation of a core measurement set for research and audit studies in implant-based breast reconstruction: a study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e035505
Author(s):  
Shelley Potter ◽  
Charlotte Davies ◽  
Christopher Holcombe ◽  
Eva Weiler-Mithoff ◽  
Joanna Skillman ◽  
...  

IntroductionOutcome reporting in research studies of breast reconstruction is inconsistent and lacks standardisation. The results of individual studies therefore cannot be meaningfully compared or combined limiting their value. A core outcome set (COS) has been developed to address these issues and identified 11 key outcomes to be measured and reported in all future research and audit studies in reconstructive breast surgery (RBS). A COS represents what key outcomes should be measured. The next step is to determine how and when this should be done. The aim of this study is to develop a core measurement set (CMS) for use in research and audit studies in implant-based breast reconstruction.Methods and analysisThe CMS will be developed in accordance with the guidance developed by the Core Outcome Measures in Effectiveness Trials initiative (COMET) and COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) group for the selection of outcome measurement instruments (OMIs) for relevant outcome domains included in the RBS COS. This will involve three phases with strategies to promote implementation as a final additional phase. The phases are (1) conceptual considerations in which the target population, procedures and settings are defined; (2) systematic reviews to identify existing clinical, patient-reported and cosmetic OMIs and, if appropriate, assess their quality using COSMIN methodology; (3) a modified Delphi process including sequential Delphi surveys involving approximately 100 healthcare professionals and a face to face consensus meeting to agree and ratify which outcome definitions and OMIs should be used and standardised time points for assessment; (4) strategies to promote dissemination and adoption of the CMS.Ethics and disseminationEthical approval has been granted by University of Bristol Faculty Research Ethics Committee FREC ID 60221. Dissemination strategies will include scientific meeting presentations and peer-reviewed journal publications. Implementation activities will include engagement with journal editors and funders to promote uptake and use of the CMS.

2021 ◽  
Vol 12 (2) ◽  
pp. 225-237
Author(s):  
Jane Fletcher ◽  
Sheldon C. Cooper ◽  
Amelia Swift

The measurement of outcomes is key in evaluating healthcare or research interventions in inflammatory bowel disease (IBD). In patient-centred care, patient-reported outcome measures (PROMs) are central to this evaluation. In this review, we provide an overview of validated, adult disease-specific PROMs developed for use in IBD. Our aim is to assist clinicians and researchers in selection of PROMs to measure outcomes in their patient cohort. The Consensus-based Standards for the Selection of Health Measurement Instruments database of systematic reviews was the primary resource used to identify PROMs used in IBD. Search terms were ‘Crohn’s disease’, ‘ulcerative colitis’, and ‘IBD’. Seven systematic reviews were identified from this search. In addition, the publication by the IBD Core Outcome Set Working Group was used to identify further PROMs. Three systematic reviews were excluded as they did not meet the inclusion criteria. From the five included systematic reviews, we identified 21 PROMs and their shortened versions. In conclusion, it does not appear that any one PROM is entirely suitable for both research and clinical practice. Overall, the IBDQ-32 is most widely used in research but has the limitation of cost, whereas the IBD-Control has been recommended in the clinical core outcome set.


2018 ◽  
Vol 26 (4) ◽  
Author(s):  
Maria Elena Echevarría-Guanilo ◽  
Natália Gonçalves ◽  
Priscila Juceli Romanoski

RESUMO Objetivo: apresentar e discutir bases conceituais e métodos de avaliações que fundamentam importantes propriedades de instrumentos de medidas. Método: estudo teórico embasado na literatura internacional e nacional e nos instrumentos Consensus-based Standards for the selection of health Measurement Instruments e Evaluating the Measurement of Patient-Reported Outcomes que contemplam conceitos de avaliação de instrumentos para apreciação de resultados relatados pelo paciente. Inicialmente são apresentados e discutidos os conceitos de confiabilidade, responsividade e interpretabilidade, citados exemplos das principais formas de avaliação dessas propriedades. Resultados: pode-se perceber que ainda há divergências em algumas descrições conceituais. Entretanto, os autores ressaltam a importância da confiabilidade para avaliar o instrumento de medida. Destaca-se a importância do conhecimento do Modelo Conceitual, das propriedades de medidas e dos diferentes métodos de avaliação para garantir, principalmente em estudo de validação de instrumentos, resultados confiáveis e válidos. Conclusões: a discussão apresentada sobre a confiabilidade, responsividade e interpretabilidade contribui para os profissionais de saúde no conhecimento teórico e senso crítico na escolha de instrumentos e na condução de análises sobre essas propriedades de medida.


Author(s):  
Maria Elena Echevarría-Guanilo ◽  
Natália Gonçalves ◽  
Priscila Juceli Romanoski

ABSTRACT Objective: to present and discuss conceptual bases and methods for evaluating the content, construct and criterion validity of self-reported measuring instruments. Method: theoretical study based on the concepts of the Consensus-based Standards for the Selection of Health Measurement Instruments and those evaluated in the Evaluating the Measurement of Patient-Reported Outcomes, which includes concepts of instrument assessment to assess patient-reported outcomes. Results: validity is significant for the methodological quality of an instrument; however, it is a relative criterion, since it depends on the adequacy of the instrument to be measured. There are three different validity measurement properties described in the literature: content, construct and criterion validity. Conclusions: as validity is an important property, it is recommended that it be verified in studies that aimed to develop new scales and in those that adapted and validated for another culture or population.


Author(s):  
Renly Lim ◽  
Lisa Kalisch Ellett ◽  
Elizabeth E. Roughead ◽  
Phaik Yeong Cheah ◽  
Nashwa Masnoon

Background: This systematic review aims to summarise available patient-reported questionnaires to detect adverse drug reactions (ADRs) that can be utilised by healthcare professionals in clinical practice and to summarise the psychometric properties (validity, reliability, and responsiveness) of the questionnaires. Methods: A systematic literature search was conducted using Medline, Pubmed, Embase, and Emcare databases to screen for articles published between January 2000 and July 2020. Data items regarding validity, reliability, and responsiveness were extracted independently by two authors. The methodological quality was assessed using the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) checklist. Results: A total of 1563 unique article titles were identified after removing duplicates. Following shortlisting of relevant articles, 19 patient-reported ADR questionnaires were identified. Questionnaires most commonly focused on mental health medications (42.1%, n = 8), followed by general questionnaires applicable to any medication (21.1%, n = 4). Many questionnaires did not report assessing the validity and reliability of the measurement tool. For example, only 11 questionnaires (58%) mentioned assessing content validity, in addition to criterion or construct testing. Conclusion: This systematic review summarised the available patient-reported questionnaires that can be used in research and clinical practice to identify ADRs. Results of this systematic review highlight the need for more robust validity and reliability testing when developing patient-reported ADR questionnaires.


2016 ◽  
Vol 20 (2) ◽  
pp. 105-113 ◽  
Author(s):  
Lidwine B. Mokkink ◽  
Cecilia A. C. Prinsen ◽  
Lex M. Bouter ◽  
Henrica C. W. de Vet ◽  
Caroline B. Terwee

Dermatology ◽  
2020 ◽  
pp. 1-17
Author(s):  
M. Ingmar van Raath ◽  
Sandeep Chohan ◽  
Albert Wolkerstorfer ◽  
Chantal M.A.M. van der Horst ◽  
Jacqueline Limpens ◽  
...  

<b><i>Background:</i></b> A plethora of outcome measurement instruments (OMIs) are being used in port wine stain (PWS) studies. It is currently unclear how valid, responsive, and reliable these are. <b><i>Objectives:</i></b> The aim of this systematic review was to appraise the content validity and other measurement properties of OMIs for PWS treatment to identify the most appropriate instruments and future research priorities. <b><i>Methods:</i></b> This study was performed using the updated Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology and adhered to PRISMA guidelines. Comprehensive searches in Medline and Embase were performed. Studies in which an OMI for PWS patients was developed or its measurement properties were evaluated were included. Two investigators independently extracted data and assessed the quality of included studies and instruments to perform qualitative synthesis of the evidence. <b><i>Results:</i></b> In total, 1,034 articles were screened, and 77 full-text articles were reviewed. A total of 8 studies were included that reported on 6 physician-reported OMIs of clinical improvement and 6 parent- or patient-reported OMIs of life impact, of which 3 for health-related quality of life and 1 for perceived stigmatization. Overall, the quality of OMI development was inadequate (63%) or doubtful (37%). Each instrument has undergone a very limited evaluation in PWS patients. No content validity studies were performed. The quality of evidence for content validity was very low (78%), low (15%), or moderate (7%), with sufficient comprehensibility, mostly sufficient comprehensiveness, and mixed relevance. No studies on responsiveness, minimal important change, and cross-cultural validity were retrieved. There was moderate- to very low-quality evidence for sufficient inter-rater reliability for some clinical PWS OMIs. Internal consistency and measurement error were indeterminate in all studies. <b><i>Conclusions:</i></b> There was insufficient evidence to properly guide outcome selection. Additional assessment of the measurement properties of OMIs is needed, preferentially guided by a core domain set tailored to PWS.


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