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  • 1
    Online Resource
    Online Resource
    Change in cardiorespiratory parameters following surgical correction of pectus excavatum: protocol for the historical-prospective HeartSoar cohort
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 6 ( 2023-06), p. e070891-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 6 ( 2023-06), p. e070891-
    Abstract: How cardiorespiratory function changes following the surgical correction of pectus excavatum (PE) often gives mixed results, with meta-analyses demonstrating no benefit in terms of pulmonary function but improvement in cardiac function. Functional responses may depend on type of surgery, follow-up time and/or the patient’s presurgical functional status, and debate persists on the purely aesthetic nature of such surgery. The aim of this protocol is to analyse data describing lung function and incremental exercise testing before vs after the surgical correction of PE. Methods and analysis A historical-prospective before–after surgical correction of PE cohort will be constituted. Historical inclusions are recruited during follow-up visits at approximately 12, 24, 36 or 48 months following a prior surgery (with presurgical data mined from patient records). Prospective inclusions are recruited during presurgical work-ups and followed for 1 year following surgery. The data collected include spirometry, incremental exercise testing, body mass index, body composition, questionnaires targeting general health status, self-esteem and body image. Any complications due to surgery are also described. The primary outcome is oxygen pulse during incremental exercise testing, and 44 data points are required to demonstrate a moderate postsurgical change (ie, a Cohen’s effect of d=0.5). Wilcoxon signed-rank tests or t-tests for paired data will be used for before–after comparisons (with false discovery rate corrections for secondary analyses). Ethics and dissemination This study will be conducted according to the principles of the Declaration of Helsinki (as revised in 2013) and was approved by a randomly assigned, independent, ethics committee (Comité de Protection des Personnes Sud-Méditerranée II, reference number: 218 B21) as per French law on 6 July 2018. Informed, written consent for study participation is required of all study candidates prior to enrolment. Results will be published in an international peer-reviewed journal. Trial registration number NCT03770390 ; Clinicaltrials.gov.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2022-070891
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2599832-8
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  • 2
    Online Resource
    Online Resource
    Standard patient training versus Vik-Asthme chatbot-guided training: ‘AsthmaTrain’ – a protocol for a randomised controlled trial for patients with asthma
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 2 ( 2023-02), p. e067039-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 2 ( 2023-02), p. e067039-
    Abstract: Therapeutic education for patients with asthma has been shown to reduce asthma morbidity. The high availability of smart phones provides the opportunity to furnish patient training via specifically designed chatbot applications. The goal of this protocol is to perform a first pilot comparison of traditional face to face versus chatbot-guided patient therapeutic education programmes for patients with asthma. Methods and analysis Eighty adult patients with a physician-confirmed diagnosis of asthma will be enrolled in a two-parallel-arm, randomised (1:1) controlled pilot trial. A single-Zelen consent procedure is deployed to first enrol all participants in the comparator arm, that is, the standard patient therapeutic education programme at the University Hospitals of Montpellier, France. This means of patient therapeutic education is based on reoccurring interviews and discussion with qualified nursing staff as per usual care. Following baseline data acquisition, randomisation will be performed. Those patients randomised to the comparator arm will not be informed of the second arm. Those patients randomised to the experimental arm will be proposed access to a specifically designed chatbot (Vik-Asthme) as the second tested means of patient training (refusals continue with standard training, though analysed as intention to treat). The primary outcome is change in the total Asthma Quality of Life Questionnaire score at the end of follow-up (6 months). Secondary outcomes cover asthma control, spirometry, general health status, programme adherence and burden for medical staff, exacerbations and medical resource use (medications, consults, emergency visits, hospitalisation and intensive care). Ethics and dissemination This study (‘AsthmaTrain’ protocol version 4–20220330) has been approved by the Committee for the Protection of Persons Ile-de-France VII on 28 March 2022 (reference number 21.03617.000059). Enrolment began on 24 May 2022. Results will be published in international peer-reviewed journals. Trial registration number NCT05248126 .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2022-067039
    DOI: 10.1136/bmjopen-2022-067039.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2599832-8
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  • 3
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    Online Resource
    Complication and lung function impairment prediction using perfusion and computed tomography air trapping (CLIPPCAIR): protocol for the development and validation of a novel multivariable model for the prediction of post-resection lung function
    AME Publishing Company ; 2021
    In:  Annals of Translational Medicine Vol. 9, No. 13 ( 2021-7), p. 1092-1092
    Details
    In: Annals of Translational Medicine, AME Publishing Company, Vol. 9, No. 13 ( 2021-7), p. 1092-1092
    Type of Medium: Online Resource
    ISSN: 2305-5839 , 2305-5847
    URL: Journal
    URL: Article
    DOI: 10.21037/atm
    DOI: 10.21037/atm-21-214
    Language: Unknown
    Publisher: AME Publishing Company
    Publication Date: 2021
    detail.hit.zdb_id: 2893931-1
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  • 4
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    Management of sleep apnoea syndrome (SAS) in patients with vasovagal syncope (VVS): a protocol for the VVS-SAS cohort study
    BMJ ; 2020
    In:  BMJ Open Vol. 10, No. 9 ( 2020-09), p. e038791-
    Details
    In: BMJ Open, BMJ, Vol. 10, No. 9 ( 2020-09), p. e038791-
    Abstract: Recurrent vasovagal syncope (VVS) is associated with decreased quality-of-life and frequent use of emergency services. The evidence base for causality, diagnostic procedures and potential VVS treatments is poor. Scattered observations in the literature suggest a link between respiratory disturbances during sleep and VVS. Empirical observations lead us to further hypothesise that the appropriate management of sleep apnoea syndrome (SAS) may help resolve comorbid recurrent VVS in certain patients. We therefore designed this pilot study to provide a framework for the observation of changes in outcomes accompanying the deployment of SAS treatments in patients with VVS. Methods and analysis This is a multicentre, registry-based study whose primary objective is to evaluate the effect of SAS management on the number of syncope/presyncope episodes in a population suffering from both VVS and SAS. To this effect, syncope rates prior to the treatment of SAS will be compared with those occurring after the initiation of the latter. In addition, yearly assessments will collect data for echocardiography, polysomnography, Holter monitoring, table tilt tests, multiple sleep latency tests, SAS management parameters and questionnaires describing fatigue, depression and quality-of-life. Sixty patients will be included with a minimum follow-up period of 12 months. The primary analysis will use comparisons of centrality for paired data to describe the changes in syncope rates before versus after the initiation of SAS management. Longitudinal data will be analysed using mixed models with patients set as a random effect. Subgroup analyses will be performed for SAS-treatment adherence and efficacy. Ethics and dissemination The VVS-SAS registry was approved by an ethics committee (Comité pour la Protection des Personnes Ile-de-France VI, Reference number CPP/2-18) in accordance with French law. The princeps publication will present before–after SAS management results and longitudinal analyses. Trial registration number NCT04294524 . Pre-results.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2020-038791
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 2599832-8
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  • 5
    Online Resource
    Online Resource
    Randomised controlled trials in severe asthma: selection by phenotype or stereotype
    European Respiratory Society (ERS) ; 2019
    In:  European Respiratory Journal Vol. 53, No. 2 ( 2019-02), p. 1802187-
    Details
    In: European Respiratory Journal, European Respiratory Society (ERS), Vol. 53, No. 2 ( 2019-02), p. 1802187-
    Type of Medium: Online Resource
    ISSN: 0903-1936 , 1399-3003
    URL: Article
    DOI: 10.1183/13993003.02187-2018
    Language: English
    Publisher: European Respiratory Society (ERS)
    Publication Date: 2019
    detail.hit.zdb_id: 2834928-3
    detail.hit.zdb_id: 1499101-9
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  • 6
    Online Resource
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    Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials?
    Springer Science and Business Media LLC ; 2020
    In:  BMC Medical Ethics Vol. 21, No. 1 ( 2020-12)
    Details
    In: BMC Medical Ethics, Springer Science and Business Media LLC, Vol. 21, No. 1 ( 2020-12)
    Abstract: Patient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research. The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in clinical research. Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results. Methods This prospective, multicenter survey consisted in the administration of a self-questionnaire to patients during a pulmonology consultation. The 1025 questionnaires distributed collected demographics, socio-professional and basic health literacy characteristics. Patients were asked to rank their level of trust for pharmaceutical companies and indicate their willingness to participate in different categories of research (pre or post marketing, sponsored by an academic institution or pharmaceutical company). Logistic regression was used to determine factors contributing to “trust” versus “distrust” group membership and willingness to participate in each category of research. Results One thousand patients completed the survey, corresponding to a response rate of 97.5%. Data from 838 patients were analyzed in this study. 48.3% of respondents declared that they trusted pharmaceutical companies, while 35.5% declared distrust. Being female ( p  = 0.042), inactive in the employment market( p  = 0.007), and not-knowing the name of one’s disease( p  = 0.010) are factors related to declared distrust. Distrust-group membership is associated with unwillingness to participate in certain categories of trials such as pre-marketing and industry-sponsored trials. Conclusion Distrust in pharmaceutical companies is associated with a specific patient profile and with refusal to participate in certain subcategories of trials. This potential recruitment bias may explain the under-representation of certain categories of patients such as women in pre-marketing drug trials.
    Type of Medium: Online Resource
    ISSN: 1472-6939
    URL: Article
    DOI: 10.1186/s12910-020-00509-y
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2041552-7
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  • 7
    Online Resource
    Online Resource
    The evolutionary potential of invasive Carpobrotus (Aizoaceae) taxa: are pollen-mediated gene flow potential and hybrid vigor levels connected?
    Springer Science and Business Media LLC ; 2006
    In:  Evolutionary Ecology Vol. 20, No. 5 ( 2006-09), p. 447-463
    Details
    In: Evolutionary Ecology, Springer Science and Business Media LLC, Vol. 20, No. 5 ( 2006-09), p. 447-463
    Type of Medium: Online Resource
    ISSN: 0269-7653 , 1573-8477
    URL: Article
    DOI: 10.1007/s10682-006-0013-0
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2006
    detail.hit.zdb_id: 1497820-9
    SSG: 12
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  • 8
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    Apnoea–hypopnoea indices determined via continuous positive airway pressure (AHI-CPAP flow ) versus those determined by polysomnography (AHI-PSG gold ): a protocol for a systematic review and meta-analysis
    BMJ ; 2021
    In:  BMJ Open Vol. 11, No. 5 ( 2021-05), p. e044499-
    Details
    In: BMJ Open, BMJ, Vol. 11, No. 5 ( 2021-05), p. e044499-
    Abstract: To date, continuous positive airway pressure (CPAP) remains the cornerstone of obstructive sleep apnoea treatment. CPAP data describing residual sleep-disordered breathing events (ie, the CPAP-measured apnoea–hypopnoea indices (AHI-CPAP flow )) is difficult to interpret because it is an entirely different metric than the polysomnography (PSG) measured AHI gold standard (AHI-PSG gold ). Moreover, manufacturer definitions for apnoea and hypopnoea are not only different from those recommended for PSG scoring, but also different between manufacturers. In the context of CPAP initiation and widespread telemedicine at home to facilitate sleep apnoea care, there is a need for concrete evidence that AHI-CPAP flow can be used as a surrogate for AHI-PSG gold . Methods and analysis No published systematic review and meta-analysis (SRMA) has compared the accuracy of AHI-CPAP flow against AHI-PSG gold and the primary objective of this study is therefore to do so using published data. The secondary objectives are to similarly evaluate other sleep disordered breathing indices and to perform subgroup analyses focusing on the inclusion/exclusion of central apnoea patients, body mass index levels, CPAP device brands, pressure titration modes, use of a predetermined and fixed pressure level or not, and the impact of a 4% PSG desaturation criteria versus 3% PSG on accuracy. The Preferred Reporting Items for SRMA protocols statement guided study design. Randomised controlled trials and observational studies of adult patients (≥18 years old) treated by a CPAP device will be included. The CPAP intervention and PSG comparator must be performed synchronously. PSGs must be scored manually and follow the American Academy of Sleep Medicine guidelines (2007 AASM criteria or more recent). To assess the risk of bias in each study, the Quality Assessment of Diagnostic Accuracy Studies 2 tool will be used. Ethics and dissemination This protocol received ethics committee approval on 16 July 2020 (IRB_MTP_2020_07_2020000404) and results will be disseminated via peer-reviewed publications. PROSPERO/Trial registration numbers CRD42020159914/ NCT04526366 ; Pre-results
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2020-044499
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2599832-8
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  • 9
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    Prioritising outcomes for evaluating eosinophil-guided corticosteroid therapy among patients with acute COPD exacerbations requiring hospitalisation: a Delphi consensus study
    BMJ ; 2020
    In:  BMJ Open Vol. 10, No. 7 ( 2020-07), p. e035811-
    Details
    In: BMJ Open, BMJ, Vol. 10, No. 7 ( 2020-07), p. e035811-
    Abstract: Presently, those outcomes that should be prioritised for chronic obstructive pulmonary disease (COPD) exacerbation studies remain unclear. In order to coordinate multicentre studies on eosinophilia-driven corticosteroid therapy for patients hospitalised for acute exacerbation of COPD (AECOPD), we aimed to find consensus among experts in the domain regarding the prioritisation of outcomes. Design A modified Delphi study was proposed to recognised COPD experts. Two brainstorming questionnaires were used to collect potential outcomes. Four subsequent rounds of questionnaires were used to rank items according to a six-point Likert scale for their importance in the protocol, as well as for being the primary outcome. Priority outcome criteria were predefined as those for which ≥70% of experts indicated that the outcome was essential for interpreting study results. Setting COPD exacerbation management in France. Participants 34 experts recommended by the French Language Pulmonology Society were invited to participate. Of the latter, 21 experts participated in brainstorming, and 19 participated in all four ranking rounds. Results 105 outcomes were ranked. Two achieved consensus as candidate primary outcomes: (1) treatment failure defined as death from any cause or the need for intubation and mechanical ventilation, readmission because of COPD or intensification of pharmacologic therapy, and (2) the time required to meet predefined discharge criteria. The 10 secondary priority outcomes included survival, time with no sign of improvement, episodes of hospitalisation, exacerbation, pneumonia, mechanical or non-invasive ventilation and oxygen use, as well as comorbidities during the initial hospitalisation. Conclusions This Delphi consensus project generated and prioritised a great many outcomes, documenting current expert views concerning a diversity of COPD endpoints. Among the latter, 12 reached consensus as priority outcomes for evaluating the efficacy of eosinophil-driven corticosteroid therapy in AECOPD inpatients. Study registration The eo-Delphi project/protocol was registered on 23 January 2018 at https://osf.io/4ahqw/ .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2019-035811
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 2599832-8
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