scholarly journals Protocol for the development of a core indicator set for reporting burn wound infection in trials: ICon-B study

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e026056 ◽  
Author(s):  
Anna Davies ◽  
Louise Teare ◽  
Sian Falder ◽  
Karen Coy ◽  
Jo C Dumville ◽  
...  

IntroductionSystematic reviews of high-quality randomised controlled trials are necessary to identify effective interventions to impact burn wound infection (BWI) outcomes. Evidence synthesis requires that BWI is reported in a consistent manner. Cochrane reviews investigating interventions for burns report that the indicators used to diagnose BWI are variable or not described, indicating a need to standardise reporting. BWI is complex and diagnosed by clinician judgement, informed by patient-reported symptoms, clinical signs, serum markers of inflammation and bacteria in the wound. Indicators for reporting BWI should be important for diagnosis, frequently observed in patients with BWI and assessed as part of routine healthcare. A minimum (core) set of indicators of BWI, reported consistently, will facilitate evidence synthesis and support clinical decision-making.AimsThe Infection Consensus in Burns study aims to identify a core indicator set for reporting the diagnosis of BWI in research studies.Methods(1) Evidence review: a systematic review of indicators used in trials and observational studies reporting BWI outcomes to identify a long list of candidate indicators; (2) refinement of the long list into a smaller set of survey questions with an expert steering group; (3) a two-round Delphi survey with 100 multidisciplinary expert stakeholders, to achieve consensus on a short list of indicators; (4) a consensus meeting with expert stakeholders to agree on the BWI core indicator set.Ethics and disseminationParticipants will be recruited through professional bodies, such that ethical approval from the National Health Service (NHS) Health Research Authority (HRA) is not needed. The core indicator set will be disseminated through peer-reviewed publication, co-production with journal editors, research funders and professional bodies, and presentation at national conferences.PROSPERO registration numberCRD42018096647.

Author(s):  
Rikke Torenholt ◽  
Henriette Langstrup

In both popular and academic discussions of the use of algorithms in clinical practice, narratives often draw on the decisive potentialities of algorithms and come with the belief that algorithms will substantially transform healthcare. We suggest that this approach is associated with a logic of disruption. However, we argue that in clinical practice alongside this logic, another and less recognised logic exists, namely that of continuation: here the use of algorithms constitutes part of an established practice. Applying these logics as our analytical framing, we set out to explore how algorithms for clinical decision-making are enacted by political stakeholders, healthcare professionals, and patients, and in doing so, study how the legitimacy of delegating to an algorithm is negotiated and obtained. Empirically we draw on ethnographic fieldwork carried out in relation to attempts in Denmark to develop and implement Patient Reported Outcomes (PRO) tools – involving algorithmic sorting – in clinical practice. We follow the work within two disease areas: heart rehabilitation and breast cancer follow-up care. We show how at the political level, algorithms constitute tools for disrupting inefficient work and unsystematic patient involvement, whereas closer to the clinical practice, algorithms constitute a continuation of standardised and evidence-based diagnostic procedures and a continuation of the physicians’ expertise and authority. We argue that the co-existence of the two logics have implications as both provide a push towards the use of algorithms and how a logic of continuation may divert attention away from new issues introduced with automated digital decision-support systems.


2018 ◽  
Vol 38 (6) ◽  
pp. 935-947 ◽  
Author(s):  
Bruno Fautrel ◽  
Rieke Alten ◽  
Bruce Kirkham ◽  
Inmaculada de la Torre ◽  
Frederick Durand ◽  
...  

2013 ◽  
Vol 15 (4) ◽  
pp. 194-201 ◽  
Author(s):  
Robert J. Fox ◽  
Amber R. Salter ◽  
Tuula Tyry ◽  
Jennifer Sun ◽  
Xiaojun You ◽  
...  

Injectable first-line disease-modifying therapies (DMTs) for multiple sclerosis (MS) are generally prescribed for continuous use. Accordingly, the various factors that influence patient persistence with treatment and that can lead some patients to switch medications or discontinue treatment may affect clinical outcomes. Using data from the North American Research Committee on Multiple Sclerosis (NARCOMS) database, this study evaluated participants' reasons for discontinuation of injectable DMTs as well as the relationship between staying on therapy and sustained patient-reported disease progression and annualized relapse rates. Participants selected their reason(s) for discontinuation from among 16 possible options covering the categories of efficacy, safety, tolerability, and burden, with multiple responses permitted. Both unadjusted data and data adjusted for baseline age, disease duration, disability, and sex were evaluated. Discontinuation profiles varied among DMTs. Participants on intramuscular interferon beta-1a (IM IFNβ-1a) and glatiramer acetate (GA) reported the fewest discontinuations based on safety concerns, although GA was associated with reports of higher burden and lower efficacy than other therapies. Difficulties with tolerability were more often reported as a reason for discontinuing subcutaneous (SC) IFNβ-1a than as a reason for discontinuing IM IFNβ-1a, GA, or SC IFNβ-1b. In the persistent therapy cohort, less patient-reported disability progression was reported with IM IFNβ-1a treatment than with SC IFNβ-1a, IFNβ-1b, or GA. These findings have relevance to clinical decision making and medication compliance in MS patient care.


Electronics ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. 1253
Author(s):  
Muhammad Afzal ◽  
Beom Joo Park ◽  
Maqbool Hussain ◽  
Sungyoung Lee

A major blockade to support the evidence-based clinical decision-making is accurately and efficiently recognizing appropriate and scientifically rigorous studies in the biomedical literature. We trained a multi-layer perceptron (MLP) model on a dataset with two textual features, title and abstract. The dataset consisting of 7958 PubMed citations classified in two classes: scientific rigor and non-rigor, is used to train the proposed model. We compare our model with other promising machine learning models such as Support Vector Machine (SVM), Decision Tree, Random Forest, and Gradient Boosted Tree (GBT) approaches. Based on the higher cumulative score, deep learning was chosen and was tested on test datasets obtained by running a set of domain-specific queries. On the training dataset, the proposed deep learning model obtained significantly higher accuracy and AUC of 97.3% and 0.993, respectively, than the competitors, but was slightly lower in the recall of 95.1% as compared to GBT. The trained model sustained the performance of testing datasets. Unlike previous approaches, the proposed model does not require a human expert to create fresh annotated data; instead, we used studies cited in Cochrane reviews as a surrogate for quality studies in a clinical topic. We learn that deep learning methods are beneficial to use for biomedical literature classification. Not only do such methods minimize the workload in feature engineering, but they also show better performance on large and noisy data.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S056-S057
Author(s):  
P Golovics ◽  
L Gonczi ◽  
J Reinglas ◽  
C Verdon ◽  
S Pundir ◽  
...  

Abstract Background Optimal management of patients with ulcerative colitis (UC) requires the accurate assessment of disease activity. Endoscopic evaluation is considered the gold standard approach, but it is invasive. We aimed to determine the operating characteristics of the Ulcerative Colitis Endoscopic Index of Severity (UCEIS), to quantify the cut off most closely correlated with clinical remission or activity and determine agreement with the Mayo endoscopic subscore (MES), Baron score, clinical scores and biomarkers. Methods 171 patients were included prospectively and consecutively (age: 49 (IQR: 38–61) years, duration 12 (4–19)years, 79 females (46.2%), 57.3% extensive disease, 42.7% on biologicals) at the time of the colonoscopy. Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Mayo endoscopic subscore (MES), Baron scores were calculated, as well as the 2 item patient reported outcome (PRO), partial MAYO, Simple Clinical Colitis Activity Index (SCCAI). C reactive Protein (CRP) and fecal calprotectin (FCAL) was available in 83 and 45.6% of patients. 17.0% had clinical flare, treatment was escalated in 14.6% of patients. Sensitivity, specificity, PPV and NPV values were calculated, ROC analysis and K-statistics were performed. Results UCEIS was strongly associated to PRO2 SF (AUC:0.863), RBS (AUC:0.924), PRO2 combined (AUC:0.898), partial MAYO (AUC:0.945) and SCCAI (AUC:0.901) remission in a ROC analysis. A UCEIS of ≤3 was identified as the best cut-off to identify RBS subscore of 0, or total PRO2 remission (RBS 0 and SF ≤1), partial MAYO (≤2) and SCCAI (≤2.5) remission, while a UCEIS≥4 identified active disease frequently needing change in medical therapy. A moderate agreement was found between UCEIS <4 and MES 0 (K=0.471) or Baron 0 (K=0.414)/Baron 0–1 (K=0.353). Correlation between FCAL and UCEIS (coeff:0.701, p<0.0001) was strong, while modest only with CRP (coeff:0.248, p=0.01). Conclusion UCEIS was strongly associated with clinical remission defined as PRO2, SF, RBS, partial Mayo or SCCAI with best agreement with RBS and partial Mayo remission. A UCEIS of ≤3 was identified as a cut-off for quiescent disease, while a UCEIS≥4 identified active disease, which can support clinical decision-making based on endoscopic findings. Agreement between UCEIS and FCAL was strong, while agreement with UCEIS and MES/Baron scores was moderate.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4860-4860 ◽  
Author(s):  
Pushpendra Goswami ◽  
Esther Natalie Oliva ◽  
Tatyana Ionova ◽  
Sam Salek

Abstract Introduction: Patient-reported outcome (PRO) measures not only have been widely used in clinical research but also increasingly employed in daily clinical practice to understand the health outcomes of medical interventions. A novel hematological malignancy (HM) specific PRO tool, HM-PRO, has been recently developed for use in daily clinical practice. The HM-PRO is a composite measure consisting of two scales: Part A - measuring the 'impact on patients' quality of life (QoL); and Part B-measuring the effect of 'signs and symptoms' experienced by the patients. Both scales have linear scoring system ranging from 0 to 100, with higher scores representing greater impact on QoL and symptom burden. The assessment of the "meaningfulness" of HM-PRO scores is essential if clinicians are to be able to use the instrument to understand patient health outcomes to aid their clinical decision-making and encourage better patient engagement. One way of enhancing the clinical utility of scores on multi-item questionnaires is by investigating the importance (to patients and clinicians) of cross-sectional differences by anchoring those differences and changes to clinically familiar events that are related to patient well-being. The aims of the present study were to determine the relationship between the HM-PRO scores and a Global Question (GQ) measuring the impact on a patient's life from patients' perspective and to identify bands of HM-PRO scores equivalent to each GQ descriptor, reflecting patients' global rating of PROs. Methods: In this multicenter cross-sectional study, 905 patients: male 486; mean age 64.3 (±12.4, years; mean time since diagnosis 4.6 (±5.2) years; with different HM's ( acute lymphoblastic leukemia n=29, acute myeloid leukemia n=67, aggressive non Hodgkin lymphoma n=54, chronic lymphocytic leukemia n=64, chronic myeloid leukemia n=45, Hodgkin lymphoma n=37, indolent non Hodgkin lymphoma n=41, myelodysplastic syndrome n=158, multiple myeloma n=296, and myeloproliferative neoplasm n=114); in different disease states (stable-399, remission-277, and progressing - 229) were recruited from seven secondary hospitals and five patient organizations in the UK. All patients were asked to complete the HM-PRO and answer the global question as an anchor. Anchor-based differences were determined cross-sectionally (differences between clinically-defined groups at one time point) to determine clinically important differences in scores. The data analysis was carried out using IBM SPSS 23, a statistical software. Results: The mean HM-PRO score for Part A was 31.7 (±21.6) with median of 28.3 (IQR 13.6-46.6), for Part B was 20.9 (±14.2) with median of 17.6 (IQR 8.8 - 29.4), and the mean GQ score was 3.2 (±1.19) with range 1-5. The mean, mode, and median of the GQ scores for each HM-PRO score for both scales of HM-PRO were used to devise the bands (Figure 1) and intra-class correlation coefficient (ICC) was calculated for level of agreement. The set of scores proposed for adoption included: for Part A HM-PRO scores 0-7 = 'no impact' on patients' QoL (GQ=1, n=64), scores 8-25 = 'a small impact' on patients' QoL (GQ=2, n=133), scores 26-41 = 'moderate impact' on patients' QoL (GQ=3, n=97), scores 42-74 = 'very large impact' on patients' QoL (GQ=4, n=111), and scores 75-100 = 'extremely large impact' on patients' QoL (GQ=5, n=18), with ICC =0.80 (95% CI-0.77 - 0.83); for Part B HM-PRO scores 0-3 = 'no effect' of signs and symptoms on patient's life (GQ=1, n=56), scores 4-16 = 'a small effect' of signs and symptoms on patient's life (GQ=2, n=133), scores 17-29 = 'a moderate effect' of signs and symptoms on patient's life (GQ=3, n=122), scores 30-65 = 'very large effect' of signs and symptoms on patient's life (GQ=4, n=104), and scores 66-100 = 'extremely large effect' of signs and symptoms on patient's life (GQ=5, n=3), with ICC =0.75 (95% CI- 0.71-0.78), respectively (Table 1). Conclusion: This study employed the anchor-based approach for devising a set of score banding for both Part A and Part B of HM-PRO. The proposed bands (Part A=0-7, 8-25, 26-41, 42-74, 75-100; Part B=0-3, 4-16, 17-29, 30-65, 66-100) had the highest agreement and number of patients in the individual bands. The proposed bands could be applied independent of gender and different age groups. The findings of this study will help the clinician and the care team to interpret the HM-PRO scores to aid their clinical decision-making process in daily routine practice. Disclosures Oliva: Sanofi: Consultancy, Speakers Bureau; Celgene: Consultancy, Other: Royalties, Speakers Bureau; La Jolla: Consultancy; Amgen: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau. Ionova:Takeda: Research Funding; BMS: Research Funding.


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