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1.
Arthritis Rheumatol ; 72(1): 125-136, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31342624

RESUMO

OBJECTIVE: T cells play a key role in the pathogenesis of early systemic sclerosis. This study was undertaken to assess the safety and efficacy of abatacept in patients with diffuse cutaneous systemic sclerosis (dcSSc). METHODS: In this 12-month, randomized, double-blind, placebo-controlled trial, participants were randomized 1:1 to receive either subcutaneous abatacept 125 mg or matching placebo, stratified by duration of dcSSc. Escape therapy was allowed at 6 months for worsening disease. The coprimary end points were change in the modified Rodnan skin thickness score (MRSS) compared to baseline and safety over 12 months. Differences in longitudinal outcomes were assessed according to treatment using linear mixed models, with outcomes censored after initiation of escape therapy. Skin tissue obtained from participants at baseline was classified into intrinsic gene expression subsets. RESULTS: Among 88 participants, the adjusted mean change in the MRSS at 12 months was -6.24 units for those receiving abatacept and -4.49 units for those receiving placebo, with an adjusted mean treatment difference of -1.75 units (P = 0.28). Outcomes for 2 secondary measures (Health Assessment Questionnaire disability index and a composite measure) were clinically and statistically significantly better with abatacept. The proportion of subjects in whom escape therapy was needed was higher in the placebo group relative to the abatacept group (36% versus 16%). In the inflammatory and normal-like skin gene expression subsets, decline in the MRSS over 12 months was clinically and significantly greater in the abatacept group versus the placebo group (P < 0.001 and P = 0.03, respectively). In the abatacept group, adverse events occurred in 35 participants versus 40 participants in the placebo group, including 2 deaths and 1 death, respectively. CONCLUSION: In this phase II trial, abatacept was well-tolerated, but change in the MRSS was not statistically significant. Secondary outcome measures, including gene expression subsets, showed evidence in support of abatacept. These data should be confirmed in a phase III trial.

2.
Chem Commun (Camb) ; 55(100): 15129-15132, 2019 Dec 12.
Artigo em Inglês | MEDLINE | ID: mdl-31788680

RESUMO

Here, a reaction-based indicator displacement hydrogel assay (RIA) was developed for the detection of hydrogen peroxide (H2O2) via the oxidative release of the optical reporter Alizarin Red S (ARS). In the presence of H2O2, the RIA system displayed potent biofilm inhibition for Methicillin-resistant Staphylococcus aureus (MRSA), as shown through an in vitro assay quantifying antimicrobial efficacy. This work demonstrated the potential of H2O2-responsive hydrogels containing a covalently bound diol-based drug for controlled drug release.


Assuntos
Antraquinonas/química , Antibacterianos/farmacologia , Biofilmes/efeitos dos fármacos , Peróxido de Hidrogênio/química , Staphylococcus aureus Resistente à Meticilina/fisiologia , Antraquinonas/farmacologia , Antibacterianos/química , Escherichia coli/efeitos dos fármacos , Hidrogéis/química , Hidrogéis/farmacologia , Testes de Sensibilidade Microbiana , Pseudomonas aeruginosa/efeitos dos fármacos , Solubilidade
3.
BMJ Open ; 9(12): e033472, 2019 Dec 18.
Artigo em Inglês | MEDLINE | ID: mdl-31857316

RESUMO

INTRODUCTION: Burn care represents a healthcare and economic burden to patients internationally. Choice of the most clinically effective treatment strategies requires evidence which is best obtained through high-quality randomised controlled trials (RCT). The number of published RCTs of burn care is increasing. However, trial quality and reporting standards are unclear. This study will assess the risk of bias and adequacy of reporting in recent burn care RCTs using tools endorsed by the Cochrane Collaboration. METHODS AND ANALYSIS: A systematic literature review will be undertaken, assessing parallel group RCTs evaluating therapeutic interventions for patients with cutaneous burns. Literature searches will use Ovid Medline, Ovid Embase, Web of Science and the Cochrane Library. Separate searches for each database will include medical subject heading and free text terms including 'burn', 'scald', 'thermal injury' and 'RCT'. Two reviewers will independently assess each study for inclusion. Risk of bias (RoB) will be assessed with the revised tool (RoB 2) and reporting completeness with the CONsolidated Standards of Reporting Trials (CONSORT) 2010 guidelines. We will report a narrative synthesis of all studies, including domain specific, and overall risk of bias for the primary outcome of each trial. Inter-rater agreement for RoB 2 will be reported using Fleiss's Kappa. For adherence to the CONSORT guidelines, we will generate a completeness of reporting index for the five domains. ETHICS AND DISSEMINATION: No ethics approval is required because published documents will be used. Findings of the study will be disseminated in a peer-reviewed journal and presented at conferences. PROSPERO REGISTRATION NUMBER: CRD42018111020.

4.
BMC Med Inform Decis Mak ; 19(1): 211, 2019 11 06.
Artigo em Inglês | MEDLINE | ID: mdl-31694707

RESUMO

BACKGROUND: Diabetes and cardiovascular disease are two of the main causes of death in the United States. Identifying and predicting these diseases in patients is the first step towards stopping their progression. We evaluate the capabilities of machine learning models in detecting at-risk patients using survey data (and laboratory results), and identify key variables within the data contributing to these diseases among the patients. METHODS: Our research explores data-driven approaches which utilize supervised machine learning models to identify patients with such diseases. Using the National Health and Nutrition Examination Survey (NHANES) dataset, we conduct an exhaustive search of all available feature variables within the data to develop models for cardiovascular, prediabetes, and diabetes detection. Using different time-frames and feature sets for the data (based on laboratory data), multiple machine learning models (logistic regression, support vector machines, random forest, and gradient boosting) were evaluated on their classification performance. The models were then combined to develop a weighted ensemble model, capable of leveraging the performance of the disparate models to improve detection accuracy. Information gain of tree-based models was used to identify the key variables within the patient data that contributed to the detection of at-risk patients in each of the diseases classes by the data-learned models. RESULTS: The developed ensemble model for cardiovascular disease (based on 131 variables) achieved an Area Under - Receiver Operating Characteristics (AU-ROC) score of 83.1% using no laboratory results, and 83.9% accuracy with laboratory results. In diabetes classification (based on 123 variables), eXtreme Gradient Boost (XGBoost) model achieved an AU-ROC score of 86.2% (without laboratory data) and 95.7% (with laboratory data). For pre-diabetic patients, the ensemble model had the top AU-ROC score of 73.7% (without laboratory data), and for laboratory based data XGBoost performed the best at 84.4%. Top five predictors in diabetes patients were 1) waist size, 2) age, 3) self-reported weight, 4) leg length, and 5) sodium intake. For cardiovascular diseases the models identified 1) age, 2) systolic blood pressure, 3) self-reported weight, 4) occurrence of chest pain, and 5) diastolic blood pressure as key contributors. CONCLUSION: We conclude machine learned models based on survey questionnaire can provide an automated identification mechanism for patients at risk of diabetes and cardiovascular diseases. We also identify key contributors to the prediction, which can be further explored for their implications on electronic health records.

5.
Clin Exp Rheumatol ; 37 Suppl 119(4): 49-56, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31498073

RESUMO

OBJECTIVES: PROMIS-29 is a generic health-related quality of life instrument. Our objective was to assess the reliability, construct validity, and responsiveness to change of PROMIS-29 in systemic sclerosis-associated interstitial lung disease (SSc-ILD). METHODS: Seventy-three participants with SSc-ILD were administered patient reported outcomes (PROs) at baseline and follow-up visits which included PROMIS-29 and other measures of generic health, dyspnea, and cough instruments. We assessed internal consistency reliability using Cronbach's α, an alpha of ≥ 0.70 was considered satisfactory. We assessed the responsiveness to change using linear regression models. RESULTS: Mean age of the participants was 51.9 years and the mean disease duration was 7.9 years after first non-Raynaud's symptom. Of the 73 participants, 56.2% were classified as diffuse SSc and 26% limited SSc. The baseline (mean ± SD) FVC % predicted was 73.9±15.5 with a DLCO % predicted of 57.7±21.1; 95.9% had fibrotic NSIP pattern on HRCT. PROMIS-29 scores were 0.2 to 0.9 SD below the US population. Cronbach's α reliability was acceptable for all domains (ranged from 0.77 to 0.98). All scales showed statistically significant correlations with hypothesised PROMIS-29 domains (p≤0.05 for all comparisons). PROMIS-29 showed none-to-small discriminatory ability in comparison with physiologic measures (FVC and DLCO). There was no significant relationship between the change in FVC versus the change in PROMIS-29 measures over time. CONCLUSIONS: PROMIS-29 has adequate reliability and construct validity for evaluation in SSc-ILD. It has moderate-to-large correlations with other PROs. The PROMIS-29 domains were not found to change over time in this cohort, likely due to stable nature of the observational cohort.


Assuntos
Doenças Pulmonares Intersticiais , Qualidade de Vida , Escleroderma Sistêmico , Inquéritos e Questionários/normas , Dispneia , Feminino , Humanos , Doenças Pulmonares Intersticiais/psicologia , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Escleroderma Sistêmico/psicologia
6.
J Clin Epidemiol ; 115: 14-24, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31276780

RESUMO

OBJECTIVES: Core outcome set (COS) development often begins with a systematic review to identify outcomes. Reviews frequently show heterogeneity in numbers of outcomes reported across trials. Contributing to this is a lack of a uniform definition for an outcome. This study proposes a first working definition for a unique trial outcome to support reporting a quantitative assessment of outcome reporting heterogeneity (ORH). STUDY DESIGN AND SETTING: Eligible COS literature (development papers, protocols, and reviews) were identified using the COMET database, Ovid MEDLINE, and PubMed. Outcome numbers, definitions, timing, and grouping methodology were examined. RESULTS: One hundred and thirty two studies were included. 82 (88.1%) studies (excluding protocols) reported a total number of unique outcomes (median, 82; range, 12-5776; IQR, 261). Timing of assessment was reported in 32 (31.4%) studies. Methods to group similar outcomes were reported in 8 (7.8%) articles. No study defined how outcomes were agreed as different and how final numbers of unique outcomes were determined. It is proposed that a unique outcome requires original meaning and context. Thus ORH is suggested to be the reporting of multiple unique outcomes across trials related to one health care condition. CONCLUSION: This review identified inconsistencies in how authors define, extract, group, and count trial outcomes. Further work is needed to refine our proposed definitions to optimize COS development and allow a quantifiable measure of ORH.

7.
Eur Respir J ; 54(2)2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31196948

RESUMO

INTRODUCTION: Pulmonary arterial hypertension (PAH) is one of the leading causes of mortality in systemic sclerosis (SSc). We explored the impact of the updated haemodynamic definition of pulmonary hypertension (PH), as proposed by the 6th World Symposium on Pulmonary Hypertension. METHODS: In this single-centre retrospective analysis, patients with SSc who had right heart catheterisation (RHC) were included. We compared the prior PH definition to the updated PH definition. The prior definition classified PH as mean pulmonary arterial pressure (mPAP) ≥25 mmHg and further divided into pre-capillary PH (PAH and PH due to lung disease and/or hypoxia), post-capillary PH, and combined pre- and post-capillary PH groups. For the updated definition, PH was classified as mPAP >20 mmHg and further divided into the different groups. We validated our findings in the DETECT cohort. RESULTS: Between 2005 and March 2019, 268 RHCs were performed in this single-centre cohort. Using the prior definition, 137 (51%) were diagnosed with PH, with 89 classified as pre-capillary PH (56 with PAH and 33 with PH due to lung disease and/or hypoxia), 29 as post-capillary PH, and 19 as combined pre- and post-capillary PH. When the updated definition was applied to the cohort, seven out of 131 (5%) with no PH were reclassified to pre-capillary PH (PAH (n=1), PH due to lung disease (n=3) and post-capillary PH (n=3)). In those with mPAP 21-24 mmHg, with no left heart or significant lung disease, one out of 28 (4%) in our cohort and four out of 36 (11%) in the DETECT cohort were reclassified as PAH. CONCLUSION: The updated PH definition does not appear to have a significant impact on the diagnosis of PH in two different screening cohorts.

8.
BMJ Open ; 9(5): e026056, 2019 05 14.
Artigo em Inglês | MEDLINE | ID: mdl-31092650

RESUMO

INTRODUCTION: Systematic 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. AIMS: The 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 DISSEMINATION: Participants 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 NUMBER: CRD42018096647.

9.
Arthritis Rheumatol ; 71(8): 1339-1349, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30762947

RESUMO

OBJECTIVE: Systemic sclerosis (SSc) is associated with interstitial lung disease (ILD) and pulmonary hypertension (PH). This study was undertaken to determine the prevalence, characteristics, treatment, and outcomes of PH in a cohort of patients with SSc-associated ILD. METHODS: Patients with SSc-associated ILD on high-resolution computed tomography (HRCT) were included in a prospective observational cohort. Patients were screened for PH based on a standardized screening algorithm and underwent right-sided heart catheterization (RHC) if indicated. PH classification was based on hemodynamic findings and the extent of ILD on HRCT. Summary statistics and survival using the Kaplan-Meier method were calculated. RESULTS: Of the 93 patients with SSc-associated ILD included in the study, 76% were women and 65.6% had diffuse cutaneous SSc. The mean age was 54.9 years, and the mean SSc disease duration was 8 years. Twenty-nine patients (31.2%) had RHC-proven PH; of those 29 patients, 24.1% had PAH, 55.2% had World Health Organization (WHO) Group III PH, 34.5% had WHO Group III PH with pulmonary vascular resistance >3.0 Wood units, 48.3% had a PH diagnosis within 7 years of SSc onset, 82.8% received therapy for ILD, and 82.8% received therapy for PAH. The survival rate 3 years after SSc-associated ILD diagnosis for all patients was 97%. The survival rate 3 years after PH diagnosis for those with SSc-associated ILD and PH was 91%. CONCLUSION: In a large cohort of patients with SSc-associated ILD, a significant proportion of patients had coexisting PH, which often occurs early after SSc diagnosis. Most patients were treated with ILD and PAH therapies, and survival was good. Patients with SSc-associated ILD should be evaluated for coexisting PH.


Assuntos
Hipertensão Pulmonar/mortalidade , Doenças Pulmonares Intersticiais/mortalidade , Escleroderma Sistêmico/mortalidade , Adulto , Cateterismo Cardíaco , Comorbidade , Feminino , Humanos , Hipertensão Pulmonar/etiologia , Hipertensão Pulmonar/terapia , Estimativa de Kaplan-Meier , Doenças Pulmonares Intersticiais/etiologia , Doenças Pulmonares Intersticiais/terapia , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Prospectivos , Escleroderma Sistêmico/complicações , Taxa de Sobrevida , Tomografia Computadorizada por Raios X , Resultado do Tratamento
10.
BMJ Open ; 9(2): e025135, 2019 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-30772859

RESUMO

INTRODUCTION: Systematic reviews collate trial data to provide evidence to support clinical decision-making. For effective synthesis, there must be consistency in outcome reporting. There is no agreed set of outcomes for reporting the effect of burn care interventions. Issues with outcome reporting have been identified, although not systematically investigated. This study gathers empirical evidence on any variation in outcome reporting and assesses the need for a core outcome set for burn care research. METHODS: Electronic searches of four search engines were undertaken from January 2012 to December 2016 for randomised controlled trials (RCTs), using medical subject headings and free text terms including 'burn', 'scald' 'thermal injury' and 'RCT'. Two authors independently screened papers, extracted outcomes verbatim and recorded the timing of outcome measurement. Duplicate outcomes (exact wording ± different spelling), similar outcomes (albumin in blood, serum albumin) and identical outcomes measured at different times were removed. Variation in outcome reporting was determined by assessing the number of unique outcomes reported across all included trials. Outcomes were classified into domains. Bias was reduced using five researchers and a patient working independently and together. RESULTS: 147 trials were included, of which 127 (86.4%) were RCTs, 13 (8.8%) pilot studies and 7 (4.8%) RCT protocols. 1494 verbatim clinical outcomes were reported; 955 were unique. 76.8% of outcomes were measured within 6 months of injury. Commonly reported outcomes were defined differently. Numbers of unique outcomes per trial varied from one to 37 (median 9; IQR 5,13). No single outcome was reported across all studies demonstrating inconsistency of reporting. Outcomes were classified into 54 domains. Numbers of outcomes per domain ranged from 1 to 166 (median 11; IQR 3,24). CONCLUSIONS: This review has demonstrated heterogeneity in outcome reporting in burn care research which will hinder amalgamation of study data. We recommend the development of a Core Outcome Set. PROSPERO REGISTRATION NUMBER: CRD42017060908.

11.
Semin Arthritis Rheum ; 48(6): 1059-1067, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30415942

RESUMO

OBJECTIVE: Pulmonary arterial hypertension (PAH) has high morbidity and mortality in connective tissue diseases (CTDs), especially systemic sclerosis (SSc). In this systematic review, we provide an update on screening measures for early detection of PAH in CTD. METHODS: Manuscripts published between July 2012 and October 2017, which incorporated screening measures to identify patients with PAH by right heart catheterization, were identified. Risk of bias was assessed using the QUADAS-2 tool. RESULTS: The systematic review resulted in 1514 unique citations and 22 manuscripts were included for final review; the majority of manuscripts had a lower risk of bias based on the QUADAS-2 tool. There were 16 SSc cohort studies and 6 case-control studies (SSc 4, SLE 2). Four SSc cohort studies evaluated transthoracic echocardiography (TTE) only. Eight SSc cohort studies evaluated composite measures including ASIG, DETECT, and a combination of tricuspid regurgitation velocity (TRV) and PFT variables. DETECT and ASIG had greater sensitivity and negative predictive value (NPV) compared to the 2009 ESC/ERS guidelines in different cohorts. The addition of PFT variables, such as DLCO or FVC/ DLCO ratio, to TRV, resulted in greater sensitivity and NPV compared to TRV alone. CONCLUSION: Current screening for PAH in CTDs is centered on SSc. Data continues to support the use of TTE and provides additional evidence for use of composite measures.

12.
Autism ; 23(5): 1143-1151, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30288988

RESUMO

Based in participatory action research, this project had the aim of building capacity in treatment and support for individuals and families impacted by autism spectrum disorder in remote and rural communities of Canada. Communities were selected based on their rurality and willingness to engage in change efforts for enhanced service delivery within their region. Fifteen discussion groups with key stakeholders were convened in seven communities with ~200 community stakeholders. Based on analyses of these data from the stakeholders, themes were distilled through interpretive description, which in turn were presented to community stakeholders for reflection and collective action. Findings indicate broad thematic domains consisting of: insufficient services, protective factors in community, change efforts via collectivity within community, limitations and benefits of residing in rural communities relative to care associated with autism spectrum disorder, a sense of "community" in rural contexts, and engaging in focused dialogue as a pathway to advancement. Opportunities for building capacity for support in autism spectrum disorder emerged within intersecting layers of leadership, contextual factors, and community collaboration. Consistent with participatory action research principles, emerging local knowledge was supported with strategies for improved autism spectrum disorder service development.

13.
Arch Dis Child ; 104(3): 280-285, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30262511

RESUMO

BACKGROUND: Optimal fluid resuscitation in children with major burns is crucial to prevent or minimise burn shock and prevent complications of over-resuscitation. OBJECTIVES: To identify studies using endpoints to guide fluid resuscitation in children with burns, review the range of reported endpoint targets and assess whether there is evidence that targeted endpoints impact on outcome. DESIGN: Systematic review. METHODS: Medline, Embase, Cinahl and the Cochrane Central Register of Controlled Trials databases were searched with no restrictions on study design or date. Search terms combined burns, fluid resuscitation, endpoints, goal-directed therapy and related synonyms. Studies reporting primary data regarding children with burns (<16 years) and targeting fluid resuscitation endpoints were included. Data were extracted using a proforma and the results were narratively reviewed. RESULTS: Following screening of 777 unique references, 7 studies fulfilled the inclusion criteria. Four studies were exclusively paediatric. Six studies used urine output (UO) as the primary endpoint. Of these, one set a minimum UO threshold, while the remainder targeted a range from 0.5-1.0 mL/kg/hour to 2-3 mL/kg/hour. No studies compared different UO targets. Heterogeneous study protocols and outcomes precluded comparison between the UO targets. One study targeted invasive haemodynamic variables, but this did not significantly affect patient outcome. CONCLUSIONS: Few studies have researched resuscitation endpoints for children with burns. Those that have done so have investigated heterogeneous endpoints and endpoint targets. There is a need for future randomised controlled trials to identify optimal endpoints with which to target fluid resuscitation in children with burns.


Assuntos
Queimaduras/terapia , Hidratação/métodos , Ressuscitação/métodos , Adolescente , Criança , Pré-Escolar , Medicina Baseada em Evidências , Feminino , Hidratação/normas , Humanos , Lactente , Recém-Nascido , Masculino , Ressuscitação/normas , Resultado do Tratamento
14.
BMC Microbiol ; 19(1): 310, 2019 Dec 30.
Artigo em Inglês | MEDLINE | ID: mdl-31888471

RESUMO

BACKGROUND: The majority of in vitro studies of medically relevant biofilms involve the development of biofilm on an inanimate solid surface. However, infection in vivo consists of biofilm growth on, or suspended within, the semi-solid matrix of the tissue, whereby current models do not effectively simulate the nature of the in vivo environment. This paper describes development of an in vitro method for culturing wound associated microorganisms in a system that combines a semi-solid collagen gel matrix with continuous flow of simulated wound fluid. This enables culture of wound associated reproducible steady state biofilms under conditions that more closely simulate the dynamic wound environment. To demonstrate the use of this model the antimicrobial kinetics of ceftazidime, against both mature and developing Pseudomonas aeruginosa biofilms, was assessed. In addition, we have shown the potential application of this model system for investigating microbial metabolomics by employing selected ion flow tube mass spectrometry (SIFT-MS) to monitor ammonia and hydrogen cyanide production by Pseudomonas aeruginosa biofilms in real-time. RESULTS: The collagen wound biofilm model facilitates growth of steady-state reproducible Pseudomonas aeruginosa biofilms under wound like conditions. A maximum biofilm density of 1010 cfu slide- 1 was achieved by 30 h of continuous culture and maintained throughout the remainder of the experiment. Treatment with ceftazidime at a clinically relevant dose resulted in a 1.2-1.6 log reduction in biofilm density at 72 h compared to untreated controls. Treatment resulted in loss of complex biofilm architecture and morphological changes to bacterial cells, visualised using confocal microscopy. When monitoring the biofilms using SIFT-MS, ammonia and hydrogen cyanide levels peaked at 12 h at 2273 ppb (±826.4) and 138 ppb (±49.1) respectively and were detectable throughout experimentation. CONCLUSIONS: The collagen wound biofilm model has been developed to facilitate growth of reproducible biofilms under wound-like conditions. We have successfully used this method to: (1) evaluate antimicrobial efficacy and kinetics, clearly demonstrating the development of antimicrobial tolerance in biofilm cultures; (2) characterise volatile metabolite production by P. aeruginosa biofilms, demonstrating the potential use of this method in metabolomics studies.

15.
J Clin Rheumatol ; 2018 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-30585996

RESUMO

BACKGROUND/OBJECTIVE: The criterion standard for anti-topoisomerase I antibody (anti-topo I antibody) testing in systemic sclerosis (SSc) uses immunodiffusion (ID) techniques, but enzyme-linked immunosorbent assay (ELISA) and multiple-bead technology are often used in current settings to save time and cost. Our aim was to assess the performance of the multiple-bead assay, ELISA, and ID testing methods. METHODS: We conducted a retrospective study of patients at the University of Michigan whose extractable nuclear antigen 10 autoantibody panel tested positive for the anti-topo I antibody by multiple-bead technology during a 1-year period. All samples positive by multiple-bead assay were sent to the RDL Laboratories and reflexed for ELISA, and all anti-topo I antibodies positive by ELISA were further tested by ID. Clinical data were reviewed by a rheumatologist and assessed for presence of SSc. Data were analyzed via frequency tables. RESULTS: Approximately 9500 extractable nuclear antigen 10 panels were ordered by physicians at the University of Michigan. Of these, 129 patients were positive for the anti-topo I antibody by multiple-bead assay, 51 were positive by multiple-bead assay and ELISA, and 21 were positive by multiple-bead assay, ELISA, and ID. We found that 26.4% of patients positive by multiple-bead assay, 47.1% positive by multiple-bead assay and ELISA, and 95.2% positive by multiple-bead assay, ELISA, and ID had SSc. CONCLUSIONS: Multiple-bead assays have a high rate of false-positive results for the anti-topo I antibody in patients without clinical evidence of SSc. A stepwise approach of confirmation of positive multiple-bead assay results using both ELISA and ID improves the predictive value of antibody testing for the diagnosis of SSc.

16.
BMJ Open ; 8(6): e021886, 2018 06 14.
Artigo em Inglês | MEDLINE | ID: mdl-29903799

RESUMO

OBJECTIVES: To evaluate the impact of low-friction (LF) bedding on graft loss in an acute burn care setting, and to examine the feasibility and costs of using LF bedding compared with standard care. DESIGN: Proof of concept before and after study with feasibility of delivering the intervention. SETTING: Three burns services within two UK hospital trusts. PARTICIPANTS: Inclusion criteria were patients older than 4 weeks, who received a skin graft after burn injury and were admitted overnight. The comparator cohort were eligible patients admitted in a 12-month period before the intervention. INTERVENTION: Introduction of LF sheets and pillowcases during a 15-month period. OUTCOME MEASURES: For proof of concept, the LF and comparator cohorts were compared in terms of number of regrafting operations (primary), percentage graft loss, hospital length of stay (LoS) and LoS cost (secondary). Feasibility outcomes were practicality and safety of using LF bedding. RESULTS: 131 patients were eligible for the LF cohort and 90 patients for the comparator cohort. Although the primary outcome of the proportion needing regrafting was halved in the LF cohort, the confidence interval (CI) crossed 1 (OR (95% CI): 0.56 (0.16 to 1.88)). Partial graft loss (any loss) was significantly reduced in the LF cohort (OR (95% CI): 0.27 (0.14, 0.51)). Inpatient LoS was no different between the two cohorts (difference in median days (95% CI): 0 (-2 to 1)), and the estimated difference in LoS cost was £-1139 (-4829 to 2551). Practical issues were easily resolved, and no safety incidents occurred while patients were nursed on LF bedding. CONCLUSIONS: LF bedding is safe to use in burned patients with skin grafts and we have shown proof of concept for the intervention. Further economic modelling is required to see if an appropriately powered randomised control trial would be worthwhile or if roll out across the National Health Service is justified. TRIAL REGISTRATION NUMBER: ISRCTN82599687.


Assuntos
Roupas de Cama, Mesa e Banho , Queimaduras/cirurgia , Fricção , Tempo de Internação/economia , Transplante de Pele , Adolescente , Adulto , Análise Custo-Benefício , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recursos Humanos de Enfermagem no Hospital , Aceitação pelo Paciente de Cuidados de Saúde , Estudo de Prova de Conceito , Carga de Trabalho , Adulto Jovem
17.
Int J Clin Pharm ; 40(3): 676-685, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29675683

RESUMO

Background Providing verbal medicines information to patients may be insufficient. Providing medicine information leaflets could support verbal information, however New Zealand health professionals' opinions or use of leaflets is unknown. Objective To examine self-reported provision and health professionals' views about medicine information leaflets and to determine their support for tailoring patient leaflets. Setting A cross sectional survey of general practitioners (GPs) and community pharmacists in New Zealand primary care. Method GPs and pharmacists completed validated questionnaires. Data was collected using SurveyMonkey® and where applicable, Chi squared analysis was carried out. Main outcome measures Frequency of leaflet provision, how leaflets are used in practice and why, likes and dislikes of available leaflets, and opinions on providing tailored information. Results 143 GPs and 126 pharmacists responded. For new medicines, significantly more pharmacists than GPs reported providing leaflets all or most of the time. For repeat medicines, leaflets were more likely to be given only on request. Leaflets were given to ensure patients are well-informed. Most GPs and pharmacists report discussing sections of leaflets with patients. The likes and dislikes of leaflets were mostly about design and content. Both professions support tailoring leaflets to meet individual's requirements. Conclusions Provision of medicines information needs to be re-evaluated. Relying on verbal communication is inadequate and leaflet provision appears to be suboptimal. Making leaflets more patient-centred and accessible could improve health professionals' perceptions and use of them. Automated creation and provision of tailored summary leaflets would be beneficial. Further advantage could be gained by digital patient access.


Assuntos
Atitude do Pessoal de Saúde , Clínicos Gerais/psicologia , Folhetos , Farmacêuticos/psicologia , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nova Zelândia , Adulto Jovem
18.
Qual Life Res ; 27(3): 755-764, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28983738

RESUMO

PURPOSE: Different patient-reported outcome (PRO) measures are used for rheumatic diseases (RD). The aims of this study are-(1) Identify PROMIS® domains most relevant to care of patients with RD, (2) Collect T-Score metrics in patients with RD, and (3) Identify clinically meaningful cut-points for these domains. METHODS: A convenience sample of RD patients was recruited consecutively during clinic visits, and asked to complete computer-adaptive tests on thirteen Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments. Based on discussion with clinical providers, four measures were chosen to be relevant and actionable (from rheumatologists' perspective) in RD patients. Data from RD patients were used to develop clinical vignettes across a range of symptom severity. Vignettes were created based on most likely item responses at different levels on the T-score metric (mean = 50; SD = 10) and anchored at 5-point intervals (0.5 SDs). Patients with RD (N = 9) and clinical providers (N = 10) participated as expert panelists in separate one-day meetings using a modified educational standard setting method. RESULTS: Four domains (physical function, pain interferences, sleep disturbance, depression) that are actionable at the point-of-care were selected. For all domains, patients endorsed cut-points at lower levels of impairment than providers by 0.5 to 1 SD (e.g., severe impairment in physical function was defined as a T-score of 35 by patients and 25 by providers). CONCLUSIONS: We used a modified educational method to estimate clinically relevant cut-points to classify severity for PROMIS measures This allows for meaningful interpretation of PROMIS® measures in a clinical setting of RD population.


Assuntos
Qualidade de Vida/psicologia , Doenças Reumáticas/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Doenças Reumáticas/patologia
19.
Res Social Adm Pharm ; 14(2): 196-202, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-28285793

RESUMO

The design of medicine information leaflets can determine whether a leaflet will be read or discarded by patients. It may also influence patients' ability to understand the information about their medicines within the leaflet. Researchers compared regulatory agencies' recommendations for medicine information leaflet design from New Zealand, the United Kingdom, the European Union, and the United States against recommended good design principles to determine the appropriateness, comprehensiveness, and consistency of their recommendations. Recommendations for medicine information leaflets varied between the regulatory agencies. There were some inconsistencies between the recommendations and some gaps were identified. There was little regulatory guidance given to creators of medicine information leaflets in New Zealand compared to other countries, and this could lead to manufacturer-produced information leaflets of a poorer quality. Up-to-date and enforceable guidance for creators of medicine information leaflets should be provided in all countries to ensure they are of an appropriate standard.


Assuntos
Rotulagem de Medicamentos/normas , Órgãos Governamentais , Folhetos , União Europeia , Nova Zelândia , Reino Unido , Estados Unidos
20.
BMJ Open ; 7(6): e017267, 2017 07 02.
Artigo em Inglês | MEDLINE | ID: mdl-28669969

RESUMO

INTRODUCTION: In 2004, nearly 11 million severely burn-injured patients required medical care worldwide. Burns cause prolonged hospitalisation and long-term disability. Although mortality has been reduced, morbidity remains significant.Burn care is costly and decision-making is challenging. A range of procedures are performed at different times after injury; new technology is emerging and alternate care pathways are regularly introduced. Data to guide evidence-based decision-making are lacking. Researchers use different outcomes to assess recovery, so it is not possible to combine trial information to draw meaningful conclusions. Early recovery measures include length of hospital stay, healing time and treatment complications. Longer-term outcomes include issues with function, cosmesis and psychological health. Reporting an agreed set of the most important outcomes (core outcome set (COS)) in randomised controlled trials (RCTs) will allow effective evidence synthesis to support clinical decisions. Patient input will ensure relevance. METHODS AND ANALYSIS: The aim is to produce a burn COS for RCT reporting. A long list of outcomes will be identified through systematic reviews of clinical and patient-reported outcomes. Additional outcomes will be identified from interviews with patients over 10 years, parents of children of any age and multidisciplinary professionals. A two-stage modified Delphi exercise will be undertaken to prioritise and condense the list, with patients (n=150) at different stages of recovery. We will also include nursing, therapy (n=100) and medical staff (n=100). A reduced list will be taken to consensus meetings with families and clinical staff to achieve a final COS. ETHICS AND DISSEMINATION: A COS will reduce outcome reporting heterogeneity in burn care research, allowing more effective use of research funding and facilitating evidence synthesis and evidence-based clinical decision-making. Stakeholders will include journal editors, health commissioners, researchers, patients and professionals. The study has ethical approval and is registered with Core Outcome Measures in Effectiveness Trials Initiative (http://www.comet-initiative.org/studies/details/798?result=true).


Assuntos
Queimaduras/terapia , Tomada de Decisão Clínica/métodos , Consenso , Medicina Baseada em Evidências , Técnica Delfos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Resultado do Tratamento
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