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  • 1
    Online-Ressource
    Online-Ressource
    Development of a core measurement set for research in degenerative cervical myelopathy: a study protocol (AO Spine RECODE-DCM CMS)
    BMJ ; 2022
    In:  BMJ Open Vol. 12, No. 6 ( 2022-06), p. e060436-
    Details
    In: BMJ Open, BMJ, Vol. 12, No. 6 ( 2022-06), p. e060436-
    Kurzfassung: Progress in degenerative cervical myelopathy (DCM) is hindered by inconsistent measurement and reporting. This impedes data aggregation and outcome comparison across studies. This limitation can be reversed by developing a core measurement set (CMS) for 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: the next step of this initiative is to determine ‘how’ to measure these features. This 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 and the Consensus-based Standards for the selection of health Measurement Instruments. The process involves five phases. In phase 1, the steering committee agreed on the constructs to be measured by sourcing consensus definitions from patients, professionals and the literature. In phases 2 and 3, systematic reviews were conducted to identify tools for each construct and aggregate their evidence. Constructs with and without tools were identified, and scoping reviews were conducted for constructs without tools. Evidence on measurement properties, as well as on timing of assessments, are currently being aggregated. These will be presented in phase 4: a consensus meeting where a multi-disciplinary panel of experts will select the instruments that will form the CMS. Following selection, guidance on the implementation of the CMS will be developed and disseminated (phase 5). A preliminary CMS review scheduled at 4 years from release. Ethics and dissemination Ethical approval was obtained from the University of Cambridge (HBREC2019.14). Dissemination strategies will 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.
    Materialart: Online-Ressource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2021-060436
    Sprache: Englisch
    Verlag: BMJ
    Publikationsdatum: 2022
    ZDB Id: 2599832-8
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 2
    Online-Ressource
    Online-Ressource
    Clinical outcome measures and their evidence base in degenerative cervical myelopathy: a systematic review to inform a core measurement set (AO Spine RECODE-DCM)
    BMJ ; 2022
    In:  BMJ Open Vol. 12, No. 1 ( 2022-01), p. e057650-
    Details
    In: BMJ Open, BMJ, Vol. 12, No. 1 ( 2022-01), p. e057650-
    Kurzfassung: To evaluate the measurement properties of outcome measures currently used in the assessment of degenerative cervical myelopathy (DCM) for clinical research. Design Systematic review Data sources MEDLINE and EMBASE were searched through 4 August 2020. Eligibility criteria Primary clinical research published in English and whose primary purpose was to evaluate the measurement properties or clinically important differences of instruments used in DCM. Data extraction and synthesis Psychometric properties and clinically important differences were both extracted from each study, assessed for risk of bias and presented in accordance with the Consensus-based Standards for the selection of health Measurement Instruments criteria. Results Twenty-nine outcome instruments were identified from 52 studies published between 1999 and 2020. They measured neuromuscular function (16 instruments), life impact (five instruments), pain (five instruments) and radiological scoring (five instruments). No instrument had evaluations for all 10 measurement properties and 〈 50% had assessments for all three domains (ie, reliability, validity and responsiveness). There was a paucity of high-quality evidence. Notably, there were no studies that reported on structural validity and no high-quality evidence that discussed content validity. In this context, we identified nine instruments that are interpretable by clinicians: the arm and neck pain scores; the 12-item and 36-item short form health surveys; the Japanese Orthopaedic Association (JOA) score, modified JOA and JOA Cervical Myelopathy Evaluation Questionnaire; the neck disability index; and the visual analogue scale for pain. These include six scores with barriers to application and one score with insufficient criterion and construct validity. Conclusions This review aggregates studies evaluating outcome measures used to assess patients with DCM. Overall, there is a need for a set of agreed tools to measure outcomes in DCM. These findings will be used to inform the development of a core measurement set as part of AO Spine RECODE-DCM.
    Materialart: Online-Ressource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2021-057650
    Sprache: Englisch
    Verlag: BMJ
    Publikationsdatum: 2022
    ZDB Id: 2599832-8
    Standort Signatur Einschränkungen Verfügbarkeit
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    Online-Ressource
  • 3
    Online-Ressource
    Online-Ressource
    Secondary analysis of a James Lind Alliance priority setting partnership to facilitate knowledge translation in degenerative cervical myelopathy (DCM): insights from AO Spine RECODE-DCM
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 7 ( 2023-07), p. e064296-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 7 ( 2023-07), p. e064296-
    Kurzfassung: To explore whether a James Lind Alliance Priority Setting Partnership could provide insights on knowledge translation within the field of degenerative cervical myelopathy (DCM). Design Secondary analysis of a James Lind Alliance Priority Setting Partnership process for DCM. Participants and setting DCM stake holders, including spinal surgeons, people with myelopathy and other healthcare professionals, were surveyed internationally. Research suggestions submitted by stakeholders but considered answered were identified. Sampling characteristics of respondents were compared with the overall cohort to identify subgroups underserved by current knowledge translation. Results The survey was completed by 423 individuals from 68 different countries. A total of 22% of participants submitted research suggestions that were considered ‘answered’. There was a significant difference between responses from different stakeholder groups (p 〈 0.005). Spinal surgeons were the group which was most likely to submit an ‘answered’ research question. Respondents from South America were also most likely to submit ‘answered’ questions, when compared with other regions. However, there was no significant difference between responses from different stakeholder regions (p=0.4). Conclusions Knowledge translation challenges exist within DCM. This practical approach to measuring knowledge translation may offer a more responsive assessment to guide interventions, complementing existing metrics.
    Materialart: Online-Ressource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2022-064296
    DOI: 10.1136/bmjopen-2022-064296.supp1
    Sprache: Englisch
    Verlag: BMJ
    Publikationsdatum: 2023
    ZDB Id: 2599832-8
    Standort Signatur Einschränkungen Verfügbarkeit
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    Online-Ressource
  • 4
    Online-Ressource
    Online-Ressource
    Recovery priorities in degenerative cervical myelopathy: a cross-sectional survey of an international, online community of patients
    BMJ ; 2019
    In:  BMJ Open Vol. 9, No. 10 ( 2019-10), p. e031486-
    Details
    In: BMJ Open, BMJ, Vol. 9, No. 10 ( 2019-10), p. e031486-
    Kurzfassung: To establish the recovery priorities of individuals suffering with degenerative cervical myelopathy (DCM). Design A cross-sectional, observational study. Setting Patients from across the world with a diagnosis of DCM accessed the survey over an 18-month period on Myelopathy.org, an international myelopathy charity. Participants 481 individuals suffering from DCM completed the online survey fully. Main outcome measures Functional recovery domains were established through qualitative interviews and a consensus process. Individuals were asked about their disease characteristics, including limb pain (Visual Analogue Scale) and functional disability (patient-derived version of the modified Japanese Orthopaedic Association score). Individuals ranked recovery domains (arm and hand function, walking, upper body/trunk function, sexual function, elimination of pain, sensation and bladder/bowel function) in order of priority. Priorities were analysed as the modal first priority and mean ranking. The influence of demographics on selection was analysed, with significance p 〈 0.05. Results Of 659 survey responses obtained, 481 were complete. Overall, pain was the most popular recovery priority (39.9%) of respondents, followed by walking (20.2%), sensation (11.9%) and arm and hand function (11.5%). Sexual function (5.7%), bladder and bowel (3.7%) and trunk function (3.5%) were chosen less frequently. When considering the average ranking of symptoms, while pain remained the priority (2.6±2.0), this was closely followed by walking (2.9±1.7) and arm/hand function (3.0±1.4). Sensation ranked lower (4.3±2.1). With respect to disease characteristics, overall pain remained the recovery priority, with the exception of patients with greater walking impairment ( p 〈 0.005) who prioritised walking, even among patients with lower pain scores. Conclusions This is the first study investigating patient priorities in DCM. The patient priorities reported provide an important framework for future research and will help to ensure that it is aligned with patient needs.
    Materialart: Online-Ressource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2019-031486
    Sprache: Englisch
    Verlag: BMJ
    Publikationsdatum: 2019
    ZDB Id: 2599832-8
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 5
    Online-Ressource
    Online-Ressource
    Recommendations for effective documentation in regional anesthesia: an expert panel Delphi consensus project
    BMJ ; 2022
    In:  Regional Anesthesia & Pain Medicine Vol. 47, No. 5 ( 2022-05), p. 301-308
    Details
    In: Regional Anesthesia & Pain Medicine, BMJ, Vol. 47, No. 5 ( 2022-05), p. 301-308
    Kurzfassung: Documentation is important for quality improvement, education, and research. There is currently a lack of recommendations regarding key aspects of documentation in regional anesthesia. The aim of this study was to establish recommendations for documentation in regional anesthesia. Methods Following the formation of the executive committee and a directed literature review, a long list of potential documentation components was created. A modified Delphi process was then employed to achieve consensus amongst a group of international experts in regional anesthesia. This consisted of 2 rounds of anonymous electronic voting and a final virtual round table discussion with live polling on items not yet excluded or accepted from previous rounds. Progression or exclusion of potential components through the rounds was based on the achievement of strong consensus. Strong consensus was defined as ≥75% agreement and weak consensus as 50%–74% agreement. Results Seventy-seven collaborators participated in both rounds 1 and 2, while 50 collaborators took part in round 3. In total, experts voted on 83 items and achieved a strong consensus on 51 items, weak consensus on 3 and rejected 29. Conclusion By means of a modified Delphi process, we have established expert consensus on documentation in regional anesthesia.
    Materialart: Online-Ressource
    ISSN: 1098-7339 , 1532-8651
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    DOI: 10.1136/rapm-2021-103136
    DOI: 10.1136/rapm-2021-103136.supp1
    DOI: 10.1136/rapm-2021-103136.supp2
    DOI: 10.1136/rapm-2021-103136.supp3
    Sprache: Englisch
    Verlag: BMJ
    Publikationsdatum: 2022
    ZDB Id: 2028901-7
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 6
    Online-Ressource
    Online-Ressource
    Safety and immunogenicity of novel 5T4 viral vectored vaccination regimens in early stage prostate cancer: a phase I clinical trial
    BMJ ; 2020
    In:  Journal for ImmunoTherapy of Cancer Vol. 8, No. 1 ( 2020-06), p. e000928-
    Details
    In: Journal for ImmunoTherapy of Cancer, BMJ, Vol. 8, No. 1 ( 2020-06), p. e000928-
    Kurzfassung: Prostate cancer (PCa) has been under investigation as a target for antigen-specific immunotherapies in metastatic disease settings for the last two decades leading to a licensure of the first therapeutic cancer vaccine, Sipuleucel-T, in 2010. However, neither Sipuleucel-T nor other experimental PCa vaccines that emerged later induce strong T-cell immunity. Methods In this first-in-man study, VANCE, we evaluated a novel vaccination platform based on two replication-deficient viruses, chimpanzee adenovirus (ChAd) and MVA (Modified Vaccinia Ankara), targeting the oncofetal self-antigen 5T4 in early stage PCa. Forty patients, either newly diagnosed with early-stage PCa and scheduled for radical prostatectomy or patients with stable disease on an active surveillance protocol, were recruited to the study to assess the vaccine safety and T-cell immunogenicity. Secondary and exploratory endpoints included immune infiltration into the prostate, prostate-specific antigen (PSA) change, and assessment of phenotype and functionality of antigen-specific T cells. Results The vaccine had an excellent safety profile. Vaccination-induced 5T4-specific T-cell responses were measured in blood by ex vivo IFN-γ ELISpot and were detected in the majority of patients with a mean level in responders of 198 spot-forming cells per million peripheral blood mononuclear cells. Flow cytometry analysis demonstrated the presence of both CD8+ and CD4+ polyfunctional 5T4-specific T cells in the circulation. 5T4-reactive tumor-infiltrating lymphocytes were isolated from post-treatment prostate tissue. Some of the patients had a transient PSA rise 2–8 weeks following vaccination, possibly indicating an inflammatory response in the target organ. Conclusions An excellent safety profile and T-cell responses elicited in the circulation and also detected in the prostate gland support the evaluation of the ChAdOx1-MVA 5T4 vaccine in efficacy trials. It remains to be seen if this vaccination strategy generates immune responses of sufficient magnitude to mediate clinical efficacy and whether it can be effective in late-stage PCa settings, as a monotherapy in advanced disease or as part of multi-modality PCa therapy. To address these questions, the phase I/II trial, ADVANCE, is currently recruiting patients with intermediate-risk PCa, and patients with advanced metastatic castration-resistant PCa, to receive this vaccine in combination with nivolumab. Trial registration The trial was registered with the U.S. National Institutes of Health (NIH) Clinical Trials Registry (ClinicalTrials.gov identifier NCT02390063 ).
    Materialart: Online-Ressource
    ISSN: 2051-1426
    URL: Article
    DOI: 10.1136/jitc-2020-000928
    Sprache: Englisch
    Verlag: BMJ
    Publikationsdatum: 2020
    ZDB Id: 2719863-7
    Standort Signatur Einschränkungen Verfügbarkeit
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