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  • 1
    In: BMJ Open, BMJ, Vol. 13, No. 3 ( 2023-03), p. e070240-
    Abstract: Previous studies demonstrated that the implementation of the Kidney Disease Improving Global Outcomes (KDIGO) guideline-based bundle, consisting of different supportive measures in patients at high risk for acute kidney injury (AKI), might reduce rate and severity of AKI after surgery. However, the effects of the care bundle in broader population of patients undergoing surgery require confirmation. Methods and analysis The BigpAK-2 trial is an international, randomised, controlled, multicentre trial. The trial aims to enrol 1302 patients undergoing major surgery who are subsequently admitted to the intensive care or high dependency unit and are at high-risk for postoperative AKI as identified by urinary biomarkers (tissue inhibitor of metalloproteinases 2*insulin like growth factor binding protein 7 (TIMP-2)*IGFBP7)). Eligible patients will be randomised to receive either standard of care (control) or a KDIGO-based AKI care bundle (intervention). The primary endpoint is the incidence of moderate or severe AKI (stage 2 or 3) within 72 hours after surgery, according to the KDIGO 2012 criteria. Secondary endpoints include adherence to the KDIGO care bundle, occurrence and severity of any stage of AKI, change in biomarker values during 12 hours after initial measurement of (TIMP-2)*(IGFBP7), number of free days of mechanical ventilation and vasopressors, need for renal replacement therapy (RRT), duration of RRT, renal recovery, 30-day and 60-day mortality, intensive care unit length-of-stay and hospital length-of-stay and major adverse kidney events. An add-on study will investigate blood and urine samples from recruited patients for immunological functions and kidney damage. Ethics and dissemination The BigpAK-2 trial was approved by the Ethics Committee of the Medical Faculty of the University of Münster and subsequently by the corresponding Ethics Committee of the participating sites. A study amendment was approved subsequently. In the UK, the trial was adopted as an NIHR portfolio study. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research. Trial registration number NCT04647396 .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2599832-8
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  • 2
    In: Journal of Epidemiology and Community Health, BMJ, Vol. 70, No. 5 ( 2016-05), p. 493-499
    Type of Medium: Online Resource
    ISSN: 0143-005X , 1470-2738
    Language: English
    Publisher: BMJ
    Publication Date: 2016
    detail.hit.zdb_id: 2015405-7
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  • 3
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 81, No. Suppl 1 ( 2022-06), p. 1032.2-1033
    Abstract: Musculoskeletal Ultrasonography (US) is a suitable tool for the clinical assessment in juvenile idiopathic arthritis (JIA). Recently US definitions for normal components of pediatric joints and synovitis have been developed by the OMERACT US working group. Currently this group is working on development and validation of US definition for tenosynovitis as it is also an essential prerequisite for the reliable use of this technology in the pediatric age group. Objectives To produce consensus-based definitions for US tenosynovitis in JIA through a Delphi process. Methods We undertook a Delphi process on US-defined tenosynovitis in children that consisted of two steps. As a prior systematic literature review showed that US anatomy of the tendons is similar to adults, a Delphi questionnaire was written based on the consensual definitions developed for and used in adults with rheumatoid arthritis [1, 2]. The Delphi questionnaire was sent to rheumatologists and pediatricians who perform pediatric US examination, asking them to rate their level of agreement with each statement of US-defined tenosynovitis. Group agreement was considered if ≥80% of responders scored an item as either 4 or 5. In the second step, the definitions were validated on 88 standardized US images displaying various degrees of tenosynovitis obtained from JIA patients at various ages. Tendons often involved in JIA were selected (foot and ankle tendons, hand and wrist tendons, bicep tendon.). US images of both normal and tenosynovitis elementary lesions were collected by the 18 experts participating in the OMERACT US task force on pediatric tenosynovitis. An agreement ≥70% was considered mandatory for accepting the definition as applicable in the rated image. Results The response rate was 75% (28 out of 37) from the first Delphi questionnaire. Strong group agreement (≥86%) was obtained for the US definitions tested. The response rate was 88.9% (16 out of 18) from the Web-exercise after four rounds. The final definitions were validated on still images for all tendons, except for the biceps tenosynovitis in the age group 2-4 years (the definitions of elementary lesions and the global definition of tenosynovitis) as no image was available for this location and age group. Despite not reaching group agreement after the second and the third round for the US-defined normal finger pulley in children aged 8 years and younger (roughly 68% and 69% respectively), it reached a score of 99.8% after the fourth round. Conclusion US definitions of tenosynovitis and its elementary components covering a wide pediatric age range were successfully developed through a Delphi questionnaire and validated in a web-based still images exercise. These results provide the basis for the standardized US assessment of tenosynovitis in clinical practice. References [1]Ultrasound in the assessment of tenosynovitis in juvenile idiopathic arthritis: systematic literature review. Collado P on behalf of the OMERACT Ultrasound Task Force. DOI: 10.1136/annrheumdis-2019-eular.3493 [2]Reliability of a consensus-based ultrasound score for tenosynovitis in rheumatoid arthritis. Naredo E on behalf of the OMERACT Ultrasound Task Force. Ann Rheum Dis 2013;72:1328 Acknowledgements AG Bruyn, L Terslev, S Jousse-Joulin, A Rodriguez, M Steiner, E Inarejos, P Bøyesen, K Misaki, A Iagnocco, B Marston, T Cazenave, P Mandl, A Bruns. Disclosure of Interests None declared
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    RVK:
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 1481557-6
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  • 4
    In: BMJ Global Health, BMJ, Vol. 8, No. 1 ( 2023-01), p. e009495-
    Abstract: Despite a growing body of research on the risks of SARS-CoV-2 infection during pregnancy, there is continued controversy given heterogeneity in the quality and design of published studies. Methods We screened ongoing studies in our sequential, prospective meta-analysis. We pooled individual participant data to estimate the absolute and relative risk (RR) of adverse outcomes among pregnant women with SARS-CoV-2 infection, compared with confirmed negative pregnancies. We evaluated the risk of bias using a modified Newcastle-Ottawa Scale. Results We screened 137 studies and included 12 studies in 12 countries involving 13 136 pregnant women. Pregnant women with SARS-CoV-2 infection—as compared with uninfected pregnant women—were at significantly increased risk of maternal mortality (10 studies; n=1490; RR 7.68, 95% CI 1.70 to 34.61); admission to intensive care unit (8 studies; n=6660; RR 3.81, 95% CI 2.03 to 7.17); receiving mechanical ventilation (7 studies; n=4887; RR 15.23, 95% CI 4.32 to 53.71); receiving any critical care (7 studies; n=4735; RR 5.48, 95% CI 2.57 to 11.72); and being diagnosed with pneumonia (6 studies; n=4573; RR 23.46, 95% CI 3.03 to 181.39) and thromboembolic disease (8 studies; n=5146; RR 5.50, 95% CI 1.12 to 27.12). Neonates born to women with SARS-CoV-2 infection were more likely to be admitted to a neonatal care unit after birth (7 studies; n=7637; RR 1.86, 95% CI 1.12 to 3.08); be born preterm (7 studies; n=6233; RR 1.71, 95% CI 1.28 to 2.29) or moderately preterm (7 studies; n=6071; RR 2.92, 95% CI 1.88 to 4.54); and to be born low birth weight (12 studies; n=11 930; RR 1.19, 95% CI 1.02 to 1.40). Infection was not linked to stillbirth. Studies were generally at low or moderate risk of bias. Conclusions This analysis indicates that SARS-CoV-2 infection at any time during pregnancy increases the risk of maternal death, severe maternal morbidities and neonatal morbidity, but not stillbirth or intrauterine growth restriction. As more data become available, we will update these findings per the published protocol.
    Type of Medium: Online Resource
    ISSN: 2059-7908
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2851843-3
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  • 5
    In: BMJ Open, BMJ, Vol. 11, No. 12 ( 2021-12), p. e050165-
    Abstract: To explore care experiences in multidisciplinary primary healthcare centres from the patients, carers and healthcare professionals perspectives. Design This qualitative study used face-to-face, in-depth interviews and focus groups. Patients with multimorbidity monitored by a General Practitioner (GP) and another professional from the health centre were recruited through purposive sampling and included with their carer. They were interviewed together while professionals were interviewed separately. Verbatims were coded with subsequent blind analysis, using an inductive approach, to find aspects and features. The constant comparative method highlighted data consistencies and variations. Participants Twenty-six patients, 23 family carers and 57 healthcare professionals. Setting Five multidisciplinary primary healthcare centres, in France, between March 2017 and December 2018. Results This unique study grouped perspectives into nine core quality of primary care aspects: having accessible, available, and varied care; feeling welcome and enjoying comfortable, well-equipped, and clean premises; having quality medicotechnical care (medical knowledge and technical skills); having a reliable GP; receiving appropriate care from healthcare professionals other than the GP; maintaining an efficient relationship with healthcare professionals; benefiting from organised and coordinated care; being an informed, supported and involved patient; having an informed, supported and involved carer. New areas of interest include the multidisciplinary nature of the centres, appreciation of other professionals within the centre, medicotechnical dimensions of care and the carer’s role in maintaining patient autonomy. Conclusions This is the first study to interview patients and carers alongside healthcare professionals. This enhanced knowledge improves understanding of these aspects and can guide implementation of evaluation tools that truly reflect patient and carer needs and enable an efficient experience in terms of quality. To address deficiencies in existing questionnaires, the new perspectives found will be added to former aspects to create a comprehensive quality of primary care evaluation tool. Trial registration number NCT02934711 , Results.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2599832-8
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  • 6
    In: Journal of Medical Genetics, BMJ, Vol. 58, No. 8 ( 2021-08), p. 570-578
    Abstract: Inherited retinal disorders are a clinically and genetically heterogeneous group of conditions and a major cause of visual impairment. Common disease subtypes include vitelliform macular dystrophy (VMD) and retinitis pigmentosa (RP). Despite the identification of over 90 genes associated with RP, conventional genetic testing fails to detect a molecular diagnosis in about one third of patients with RP. Methods Exome sequencing was carried out for identifying the disease-causing gene in a family with autosomal dominant RP. Gene panel testing and exome sequencing were performed in 596 RP and VMD families to identified additional IMPG1 variants. In vivo analysis in the medaka fish system by knockdown assays was performed to screen IMPG1 possible pathogenic role. Results Exome sequencing of a family with RP revealed a splice variant in IMPG1 . Subsequently, the same variant was identified in individuals from two families with either RP or VMD. A retrospective study of patients with RP or VMD revealed eight additional families with different missense or nonsense variants in IMPG1 . In addition, the clinical diagnosis of the IMPG1 retinopathy-associated variant, originally described as benign concentric annular macular dystrophy, was also revised to RP with early macular involvement. Using morpholino-mediated ablation of Impg1 and its paralog Impg2 in medaka fish, we confirmed a phenotype consistent with that observed in the families, including a decreased length of rod and cone photoreceptor outer segments. Conclusion This study discusses a previously unreported association between monoallelic or biallelic IMPG1 variants and RP. Notably, similar observations have been reported for IMPG2 .
    Type of Medium: Online Resource
    ISSN: 0022-2593 , 1468-6244
    RVK:
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2009590-9
    SSG: 12
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  • 7
    In: Emergency Medicine Journal, BMJ, Vol. 39, No. 5 ( 2022-05), p. 347-352
    Abstract: Emergency physicians can use a manual or an automated defibrillator to provide defibrillation of patients who had out-of-hospital cardiac arrest (OHCA). Performance of emergency physicians in identifying shockable rhythm with a manual defibrillator has been poorly explored whereas that of automated defibrillators is well known (sensitivity 0.91–1.00, specificity 0.96–0.99). We conducted this study to estimate the sensitivity/specificity and speed of shock/no-shock decision-making by prehospital emergency physicians for shockable or non-shockable rhythm, and their preference for manual versus automated defibrillation. Methods We developed a web application that simulates a manual defibrillator ( https://simul-shock.firebaseapp.com/ ). In 2019, all (262) emergency physicians of six French emergency medical services were invited to participate in a study in which 60 ECG rhythms from real OHCA recordings were successively presented to the physicians for determination of whether they would or would not administer a shock. Time to decision was recorded. Answers were compared with a gold standard (concordant answers of three experts). We report sensitivity for shockable rhythms (decision to shock) and specificity for non-shockable rhythms (decision not to shock). Physicians were also asked whether they preferred manual or automated defibrillation. Results Among 215 respondents, we were able to analyse results for 190 physicians. 57% of emergency physicians preferred manual defibrillation. Median (IQR) sensitivity for a shock delivery for shockable rhythm was 0.91 (0.81–1.00); median specificity for no-shock delivery for non-shockable rhythms was 0.91 (0.80–0.96). More precisely, sensitivities for shock delivery for ventricular tachycardia (VT) and coarse ventricular fibrillation (VF) were both 1.0 (1.0–1.0); sensitivity for fine VF was 0.6 (0.2–1). Specificity for not shocking a pulseless electrical activity (PEA) was 0.83 (0.72–0.86), and for asystole, specificity was 0.93 (0.86–1). Median speed of decision-making (in seconds) were: VT 2.0 (1.6–2.7), coarse VF 2.1 (1.7–2.9), asystole 2.4 (1.8–3.5), PEA 2.8 (2.0–4.2) and fine VF 2.8 (2.1–4.3). Conclusions Global sensitivity and specificity were comparable with published automated external defibrillator studies. Shockable rhythms with the best clinical prognoses (VT and coarse VF) were very rapidly recognised with very good sensitivity. The decision-making for fine VF or asystole and PEA was less accurate.
    Type of Medium: Online Resource
    ISSN: 1472-0205 , 1472-0213
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2027092-6
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