scholarly journals Development of a core measurement set for research in degenerative cervical myelopathy: a study protocol (AO Spine RECODE-DCM CMS)

2021 ◽  
Author(s):  
Benjamin M Davies ◽  
Alvaro Yanez Touzet ◽  
Oliver D Mowforth ◽  
Keng S Lee ◽  
Danyal Khan ◽  
...  
Keyword(s):  
Cervical Myelopathy ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Measurement Instruments ◽  
Health Measurement ◽  
Common Data Elements ◽  
Potential Measurement ◽  
The Core ◽  
Data Elements ◽  
Degenerative Cervical Myelopathy

Introduction: Progress in degenerative cervical myelopathy (DCM) is hindered by inconsistent measurement and reporting of outcomes. This can, for example, impede the aggregation of data and comparison of outcomes between studies. This limitation can be reversed by developing a core measurement set (CMS) for use in DCM research. Previously, the AO Spine Research Objectives and Common Data Elements for DCM (AO Spine RECODE-DCM) defined what should be measured in DCM: specifically, the core data elements and core outcome set of the disease. The next step of this initiative is to determine how to measure these features. The current protocol outlines the steps necessary for the development of a CMS for DCM research and audit. Methods and analysis: The CMS will be developed in accordance with the guidance developed by the Core Outcome Measures in Effectiveness Trials (COMET) and the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN). The process will involve five phases: (1) agreement on the measurement constructs and approaches to their evaluation; (2) the formation of a long list of potential measurement instruments, by identifying existing instruments and assessing their psychometric properties; (3) the aggregation of evidence concerning when measurements should be taken; (4) consensus about which instruments to include in the CMS and (5) implementation. Ethics and dissemination: Ethical approval was obtained from the University of Cambridge. Dissemination strategies to promote awareness and adoption of the CMS include peer-reviewed scientific publications; conference presentations; podcasts; the identification of AO Spine RECODE-DCM ambassadors; and engagement with relevant journals, funders, and the DCM community.

scholarly journals Gathering Global Perspectives to Establish the Research Priorities and Minimum Data Sets for Degenerative Cervical Myelopathy: Sampling Strategy of the First Round Consensus Surveys of AO Spine RECODE-DCM

2021 ◽  
pp. 219256822110475
Author(s):  
Oliver D. Mowforth ◽  
Danyal Z Khan ◽  
Mei Yin Wong ◽  
George A. E. Pickering ◽  
Lydia Dean ◽  
...  
Keyword(s):  
Cervical Myelopathy ◽  
Healthcare Professionals ◽  
Core Outcome Set ◽  
Research Priorities ◽  
Core Outcome ◽  
Core Data ◽  
Minimum Data ◽  
Outcome Set ◽  
Data Elements ◽  
Degenerative Cervical Myelopathy

Study Design Survey. Introduction AO Spine Research Objectives and Common Data Elements for Degenerative Cervical Myelopathy (RECODE-DCM) is an international initiative that aims to accelerate knowledge discovery and improve outcomes by developing a consensus framework for research. This includes defining the top research priorities, an index term and a minimum data set (core outcome set and core data elements set – core outcome set (COS)/core data elements (CDE)). Objective To describe how perspectives were gathered and report the detailed sampling characteristics. Methods A two-stage, electronic survey was used to gather and seek initial consensus. Perspectives were sought from spinal surgeons, other healthcare professionals and people with degenerative cervical myelopathy (DCM). Participants were allocated to one of two parallel streams: (1) priority setting or (2) minimum dataset. An email campaign was developed to advertise the survey to relevant global stakeholder individuals and organisations. People with DCM were recruited using the international DCM charity Myelopathy.org and its social media channels. A network of global partners was recruited to act as project ambassadors. Data from Google Analytics, MailChimp and Calibrum helped optimise survey dissemination. Results Survey engagement was high amongst the three stakeholder groups: 208 people with DCM, 389 spinal surgeons and 157 other healthcare professionals. Individuals from 76 different countries participated; the United States, United Kingdom and Canada were the most common countries of participants. Conclusion AO Spine RECODE-DCM recruited a diverse and sufficient number of participants for an international PSP and COS/CDE process. Whilst PSP and COS/CDE have been undertaken in other fields, to our knowledge, this is the first time they have been combined in one process.

scholarly journals RE-CODE DCM (REsearch Objectives and Common Data Elements for Degenerative Cervical Myelopathy): A Consensus Process to Improve Research Efficiency in DCM, Through Establishment of a Standardized Dataset for Clinical Research and the Definition of the Research Priorities

2019 ◽  
Vol 9 (1_suppl) ◽  
pp. 65S-76S ◽  
Author(s):  
Benjamin M. Davies ◽  
Danyal Z. Khan ◽  
Oliver D. Mowforth ◽  
Angus G. K. McNair ◽  
Toto Gronlund ◽  
...  
Keyword(s):  
Cervical Myelopathy ◽  
Research Priorities ◽  
Measurement Instruments ◽  
Consensus Process ◽  
Common Data Elements ◽  
Definition Of ◽  
Data Elements ◽  
Multi Stakeholder ◽  
Minimum Dataset ◽  
Degenerative Cervical Myelopathy

Study Design: Mixed-method consensus process. Objectives: Degenerative cervical myelopathy (DCM) is a common and disabling condition that arises when mechanical stress damages the spinal cord as a result of degenerative changes in the surrounding spinal structures. RECODE-DCM ( REsearch Objectives and Common Data Elements for Degenerative Cervical Myelopathy) aims to improve efficient use of health care resources within the field of DCM by using a multi-stakeholder partnership to define the DCM research priorities, to develop a minimum dataset for DCM clinical studies, and confirm a definition of DCM. Methods: This requires a multi-stakeholder partnership and multiple parallel consensus development processes. It will be conducted via 4 phases, adhering to the guidance set out by the COMET (Core Outcomes in Effectiveness Trials) and JLA (James Lind Alliance) initiatives. Phase 1 will consist of preliminary work to inform online Delphi processes (Phase 2) and a consensus meeting (Phase 3). Following the findings of the consensus meeting, a synthesis of relevant measurement instruments will be compiled and assessed as per the COSMIN (Consensus-based Standards for the Selection of Health Measurement Instruments) criteria, to allow recommendations to be made on how to measure agreed data points. Phase 4 will monitor and promote the use of eventual recommendations. Conclusions: RECODE-DCM sets out to establish for the first time an index term, minimum dataset, and research priorities together. Our aim is to reduce waste of health care resources in the future by using patient priorities to inform the scope of future DCM research activities. The consistent use of a standard dataset in DCM clinical studies, audit, and clinical surveillance will facilitate pooled analysis of future data and, ultimately, a deeper understanding of DCM.

scholarly journals Patient, sufferer, victim, casualty or person with cervical myelopathy: let us decide our identifier

2020 ◽  
Vol 2 (1) ◽  
pp. e000023 ◽  
Author(s):  
Timothy F Boerger ◽  
Benjamin M Davies ◽  
Iwan Sadler ◽  
Ellen Sarewitz ◽  
Mark R N Kotter
Keyword(s):  
Cervical Myelopathy ◽  
First Language ◽  
Steering Committee ◽  
Consensus Process ◽  
Common Data Elements ◽  
Medical Diagnoses ◽  
Link Type ◽  
Biomedical Journals ◽  
Data Elements ◽  
Degenerative Cervical Myelopathy

Among biomedical journals, person-first language is considered preferable to identity person-first language. However, not all populations of people with certain medical diagnoses, such as deafness, prefer person-first language. Moreover, adherence to person-first language is poor among the literature on some neurological diagnoses. Therefore, it is most appropriate to consult with people with a given diagnosis regarding their preferred identifier. Here, we describe a consensus process undertaken by the REsearch objectives and COmmon Data Elements for Degenerative Cervical Myelopathy (RECODE-DCM, recode-dcm.com) steering committee members with cervical myelopathy to determine our preferred identifier.

scholarly journals Outcomes of Degenerative Cervical Myelopathy From The Perspective of Persons Living With the Condition: Findings of a Semistructured Interview Process With Partnered Internet Survey

2020 ◽  
pp. 219256822095381
Author(s):  
Benjamin M. Davies ◽  
Colin Munro ◽  
Danyal Z. Khan ◽  
Siobhan M. Fitzpatrick ◽  
Bryn Hilton ◽  
...  
Keyword(s):  
Focus Group ◽  
Cervical Myelopathy ◽  
Core Outcome Set ◽  
Internet Survey ◽  
Core Outcome ◽  
Semistructured Interview ◽  
Cross Sectional ◽  
Outcome Set ◽  
Degenerative Cervical Myelopathy ◽  
The Impact

Study Design: Mixed-methods cross-sectional study. Objectives: Degenerative cervical myelopathy (DCM) is a common and disabling condition. While classically, assessment and diagnosis has focused on neuromuscular symptoms, many other disabilities have been linked. The aim of this study was to explore the consequences of DCM for those with lived experience, producing a long list to inform the development of a core outcome set for DCM research. Methods: A 2-stage process was used: a focus group session of people with DCM (PwCM) and their supporters (n = 8) discussed the impact of DCM. This was used to develop a preliminary list of consequences, which were then placed into a survey of an online community of DCM sufferers (n = 224). Survey participants were asked to tick the consequences that they had experienced and given the opportunity to submit additional. Additional consequences were reviewed by a group of healthcare professionals and PwCM and included if not already represented. Demographic information including disease severity, age, and sex were captured for sampling comparison. Results: A total of 52 outcomes were identified from the focus group and nominally divided into 2 categories; symptoms (36 outcomes) and handicaps (18 outcomes), and further evaluated using a survey. All outcomes were recognized by at least 5% of respondents. A further 16 outcomes were added following the survey. Conclusions: A list of DCM consequences has been defined from the perspective of PwCM. This will now be evaluated as part of AO Spine RECODE-DCM, an international multistakeholder collaboration to establish a core outcome set for research.

scholarly journals ERS Statement: A core outcome set for clinical trials evaluating the management of chronic obstructive pulmonary disease (COPD) exacerbations

2021 ◽  
pp. 2102006
Author(s):  
Alexander G. Mathioudakis ◽  
Fekri Abroug ◽  
Alvar Agusti ◽  
Sachin Ananth ◽  
Per Bakke ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Systematic Reviews ◽  
Health Professionals ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Measurement Instruments ◽  
Copd Exacerbations ◽  
The Core ◽  
Arterial Blood ◽  
Outcome Set

Clinical trials evaluating the management of acute exacerbations of COPD assess heterogeneous outcomes, often omitting those that are clinically relevant or more important to patients. We have developed a core outcome set, a consensus-based minimum set of important outcomes that we recommend are evaluated in all future clinical trials on exacerbations management, to improve their quality and comparability. COPD exacerbations outcomes were identified through methodological systematic reviews and qualitative interviews with 86 patients from 11 countries globally. The most critical outcomes were prioritized for inclusion in the core outcome set through a two-round Delphi survey that was completed by 1,063 participants (256 patients, 488 health professionals and 319 clinical academics) from 88 countries in 5 continents. Two global, multi-stakeholder, virtual consensus meetings were conducted to (i) finalize the core outcome set and (ii) prioritize a single measurement instrument to be used for evaluating each of the prioritized outcomes. Consensus was informed by rigorous methodological systematic reviews. The views of patients with COPD were accounted for in all stages of the project. Survival, treatment success, breathlessness, quality of life, activities of daily living, need for higher level of care, arterial blood gases, disease progression, future exacerbations and hospital admissions, treatment safety and adherence were all included in the core outcome set. Focused methodological research was recommended to further validate and optimize some of the selected measurement instruments. The panel did not consider the prioritized set of outcomes and associated measurement instruments burdensome for patients and health professionals to use.

scholarly journals Prevailing outcome themes reported by people with degenerative cervical myelopathy: findings from a semi-structured interview (Preprint)

2020 ◽  
Author(s):  
Danyal Zaman Khan ◽  
Siobhan Mairead Fitzpatrick ◽  
Bryn Hilton ◽  
Angus G.K. McNair ◽  
Ellen Sarewitz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cervical Myelopathy ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Consensus Process ◽  
Outcome Set ◽  
Patient Reported ◽  
Degenerative Cervical Myelopathy ◽  
The Impact

BACKGROUND Degenerative cervical myelopathy (DCM) arises when arthritic changes of the cervical spine cause compression and a progressive injury to the spinal cord. It is common and potentially disabling. People with DCM (PwCM) to have amongst the lowest quality of life scores (SF-36) of chronic disease, although the drivers for this are not entirely understood. DCM research faces a number of challenges, including the heterogenous reporting of study data. The AO Spine RECODE-DCM project is an international consensus process that aims improve research efficiency through formation of a core outcome set (COS). A key part of COS development process is organizing outcomes into domains which represent key aspects of the disease. OBJECTIVE To facilitate this, we sought to qualitatively explore the context and impact of patient reported outcomes in DCM on people with DCM (PwCM) and their supporters. The aim was to improve understanding of patient perspective and assist the organisation of outcomes into domains for the consensus process. METHODS A single focus group was hosted by Myelopathy.org, a charity and support group for PwCM. The 40 minute session was audio-recorded and transcribed verbatim. Data was familiarized and 2 authors performed data coding independently. Codes were grouped into themes and a thematic analysis was performed guided by Braun & Clarke’s six-phase approach. The themes were subsequently reviewed with an independent PwCM stakeholder (ES), assisting in the process of capturing the true context and importance of themes. RESULTS Five PwCM (three men and two women) and three supporters (all women) participated. The average PwCM age was 53 and the median mJOA was 11 (±IQR 2), indicating these PwCM had moderate to severe DCM. 54 codes were grouped into 10 themes that captured the impact of DCM on PwCM and their supporters. These themes included: acceptance of symptoms, anticipatory anxiety, coping mechanisms/resilience, feelings of helplessness, financial consequences, lack of recognition, mental health impact, loss of life control, social reclusiveness/isolation and social stigma CONCLUSIONS This is the first study to undertake qualitative analysis of PwCM perspectives. It has highlighted a number of prevailing themes currently unmeasured in clinical research or care. The determinants of low quality of life in DCM are currently unknown, and these findings provide a novel and so far, unique perspective. These perspectives will be used to inform the development of a core outcome set for DCM which is inclusive of all relevant stakeholders, including PwCM.

scholarly journals Improving Assessment of Disease Severity and Strategies for Monitoring Progression in Degenerative Cervical Myelopathy [AO Spine RECODE DCM Research Priority Number 4]

2021 ◽  
pp. 219256822110638
Author(s):  
Lindsay Tetreault ◽  
Philip Garwood ◽  
Aref-Ali Gharooni ◽  
Alvaro Yanez Touzet ◽  
Laura Nanna-Lohkamp ◽  
...  
Keyword(s):  
Disease Progression ◽  
Cervical Myelopathy ◽  
Assessment Tool ◽  
Cervical Spinal Cord ◽  
Research Priorities ◽  
Assessment Tools ◽  
Common Data Elements ◽  
Age Related ◽  
Data Elements ◽  
Degenerative Cervical Myelopathy

Study design Narrative Review. Objective To (i) discuss why assessment and monitoring of disease progression is critical in Degenerative cervical myelopathy (DCM); (ii) outline the important features of an ideal assessment tool and (iii) discuss current and novel strategies for detecting subtle deterioration in DCM. Methods Literature review Results Degenerative cervical myelopathy is an overarching term used to describe progressive injury to the cervical spinal cord by age-related changes of the spinal axis. Based on a study by Smith et al (2020), the prevalence of DCM is approximately 2.3% and is expected to rise as the global population ages. Given the global impact of this disease, it is essential to address important knowledge gaps and prioritize areas for future investigation. As part of the AO Spine RECODE-DCM (Research Objectives and Common Data Elements for Degenerative Cervical Myelopathy) project, a priority setting partnership was initiated to increase research efficiency by identifying the top ten research priorities for DCM. One of the top ten priorities for future DCM research was: What assessment tools can be used to evaluate functional impairment, disability and quality of life in people with DCM? What instruments, tools or methods can be used or developed to monitor people with DCM for disease progression or improvement either before or after surgical treatment? Conclusions With the increasing prevalence of DCM, effective surveillance of this population will require both the implementation of a monitoring framework as well as the development of new assessment tools.

scholarly journals Increasing awareness of degenerative cervical myelopathy: a preventative cause of non-traumatic spinal cord injury

Spinal Cord ◽  
2021 ◽  
Author(s):  
Carl M. Zipser ◽  
Konstantinos Margetis ◽  
Karlo M. Pedro ◽  
Armin Curt ◽  
Michael Fehlings ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Cervical Myelopathy ◽  
Cervical Spinal Cord ◽  
Neurological Impairment ◽  
Common Data Elements ◽  
Cord Injury ◽  
Data Elements ◽  
Degenerative Cervical Myelopathy ◽  
Work Up

AbstractDegenerative cervical myelopathy (DCM) is a common non-traumatic spinal cord disorder and characterized by progressive neurological impairment. Generally, it is still underdiagnosed and referral to spine specialists is often late, when patients already present with incomplete cervical spinal cord injury (SCI). To improve early diagnosis and accelerate referral, diagnostic criteria for DCM are required. Recently, AO Spine RECODE- DCM (REsearch Objectives and Common Data Elements for Degenerative Cervical Myelopathy) (aospine.org/recode), an international, interdisciplinary and interprofessional initiative, including patients with DCM, was funded with the aim to accelerate knowledge discovery that can change outcomes. In this perspective we advocate for the participation of SCI specialists in this process, where the expertise and perspective on this disorder and requirements for the diagnostic and therapeutic work up is well developed.

scholarly journals Patient-Reported Outcomes in Inflammatory Bowel Disease: A Measurement of Effect in Research and Clinical Care

2021 ◽  
Vol 12 (2) ◽  
pp. 225-237
Author(s):  
Jane Fletcher ◽  
Sheldon C. Cooper ◽  
Amelia Swift
Keyword(s):  
Inflammatory Bowel Disease ◽  
Systematic Reviews ◽  
Bowel Disease ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Health Measurement ◽  
Outcome Set ◽  
Patient Reported ◽  
Inflammatory Bowel ◽  
Selection Of

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.

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