RESUMO
BACKGROUND: Continuous glucose monitoring (CGM) provides the most objective method of assessing glucose in daily life. Although there have been small, short-term physiologic studies of glucose metabolism in 'healthy' pregnant women a comprehensive, longitudinal description of changes in glucose over the course of pregnancy and how glucose dysregulation earlier in pregnancy relates to traditional third trimester screening for gestational diabetes, fetal growth and pregnancy outcomes is lacking. This study aims to characterise longitudinal changes in glycemia across gestation using CGM, in order to understand the evolution of dysglycemia and its relationship to fetal growth. METHOD/DESIGN: A multi-centre, prospective, observational, cohort study of 500 healthy pregnant women, recruited in the first trimester of pregnancy. Masked CGM will be performed for a 14-day period on five occasions across pregnancy at ~ 10-12, 18-20, 26-28, 34-36 weeks gestation and postnatally. Routinely collected anthropometric and sociodemographic information will be recorded at each visit including: weight, height, blood pressure, current medication. Age, parity, ethnicity, smoking will be recorded. Blood samples will be taken at each visit for HbA1c and a sample stored. Details on fetal growth from ultrasound scans and the OGTT results will be recorded. Maternal and neonatal outcomes will be collected. CGM glucose profiling is the exposure of interest, and will be performed using standard summary statistics, functional data analysis and glucotyping. The primary maternal outcome is clinical diagnosis of GDM. The primary neonatal outcome is large for gestational age (LGA) (> 90th centile defined by customised birthweight centile). The relationship of glucose to key secondary maternal and neonatal outcomes will be explored. DISCUSSION: This study will ascertain the relationship of maternal dysglycemia to fetal growth and outcomes. It will explore whether CGM glucose profiling can detect GDM before the OGTT; or indeed whether CGM glucose profiling may be more useful than the OGTT at detecting LGA and other perinatal outcomes. TRIAL REGISTRATION: ISRCTN 15,706,303 https://www.isrctn.com/ISRCTN15706303 Registration date: 13th March 2023.
Assuntos
Diabetes Gestacional , Glucose , Feminino , Humanos , Gravidez , Glicemia/análise , Automonitorização da Glicemia , Estudos de Coortes , Desenvolvimento Fetal , Estudos Observacionais como Assunto , Resultado da Gravidez , Estudos Prospectivos , Estudos Multicêntricos como AssuntoRESUMO
BACKGROUND: Annualized relapse rate (ARR) is used as an outcome measure in multiple sclerosis (MS) clinical trials. Previous studies demonstrated that ARR has reduced in placebo groups between 1990 and 2012. This study aimed to estimate real-world ARRs from contemporary MS clinics in the UK, in order to improve the feasibility estimations for clinical trials and facilitate MS service planning. METHODS: A multicentre observational, retrospective study of patients with MS from 5 tertiary neuroscience centres in the UK. We included all adult patients with a diagnosis of MS that had a relapse between 01/04/2020 and 30/06/2020. RESULTS: One hundred thirteen out of 8783 patients had a relapse during the 3-month study period. Seventy-nine percent of the patients with a relapse were female, the mean age was 39 years, and the median disease duration was 4.5 years; 36% of the patients that had a relapse were on disease-modifying treatment. The ARR from all study sites was estimated at 0.05. The ARR for relapsing remitting MS (RRMS) was estimated at 0.08, while the ARR for secondary progressive MS (SPMS) was 0.01. CONCLUSIONS: We report a lower ARR compared to previously reported rates in MS.
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Esclerose Múltipla Recidivante-Remitente , Esclerose Múltipla , Adulto , Humanos , Feminino , Masculino , Esclerose Múltipla/tratamento farmacológico , Esclerose Múltipla/epidemiologia , Estudos Retrospectivos , Estudos de Coortes , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Recidiva , Doença Crônica , Reino Unido/epidemiologiaRESUMO
BACKGROUND: Substantial numbers of medical students and doctors have specific learning difficulties (SpLDs) and failure to accommodate their needs can disadvantage them academically. Evidence about how SpLDs affect performance during postgraduate general practice (GP) specialty training across the different licencing assessments is lacking. We aimed to investigate the performance of doctors with SpLDs across the range of licencing assessments. METHODS: We adopted the social model of disability as a conceptual framework arguing that problems of disability are societal and that barriers that restrict life choices for people with disabilities need to be addressed. We used a longitudinal design linking Multi-Specialty Assessment (MSRA) records from 2016 and 2017 with their Applied Knowledge Test (AKT), Clinical Skills Assessment (CSA), Recorded Consultation Assessment (RCA) and Workplace Based Assessment (WPBA) outcomes up to 2021. Multivariable logistic regression models accounting for prior attainment and demographics were used to determine the SpLD doctors' likelihood of passing licencing assessments. RESULTS: The sample included 2070 doctors, with 214 (10.34%) declaring a SpLD. Candidates declaring a SpLD were significantly less likely to pass the CSA (OR 0.43, 95% CI 0.26, 0.71, p = 0.001) but not the AKT (OR 0.96, 95% CI 0.44, 2.09, p = 0.913) or RCA (OR 0.81, 95% CI 0.35, 1.85, p = 0.615). Importantly, they were significantly more likely to have difficulties with WPBA (OR 0.28, 95% CI 0.20, 0.40, p < 0.001). When looking at licencing tests subdomains, doctors with SpLD performed significantly less well on the CSA Interpersonal Skills (B = -0.70, 95% CI -1.2, -0.19, p = 0.007) and the RCA Clinical Management Skills (B = -1.68, 95% CI -3.24, -0.13, p = 0.034). CONCLUSIONS: Candidates with SpLDs encounter difficulties in multiple domains of the licencing tests and during their training. More adjustments tailored to their needs should be put in place for the applied clinical skills tests and during their training.
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Medicina Geral , Proteínas Proto-Oncogênicas c-akt , Humanos , Medicina de Família e Comunidade/educação , Medicina Geral/educação , Educação de Pós-Graduação em Medicina , Avaliação Educacional , Competência ClínicaRESUMO
BACKGROUND: The Recorded Consultation Assessment (RCA) was developed rapidly during the COVID-19 pandemic to replace the Clinical Skills Assessment (CSA) for UK general practice licensing. Our aim was to evaluate examiner perceptions of the RCA. METHODS: We employed a cross-sectional design using a questionnaire survey of RCA examiners with attitudinal (relating to examiners thoughts and perceptions of the RCA) and free text response options. We conducted statistical descriptive and factor analysis of quantitative data with qualitative thematic analysis of free text responses. RESULTS: Overall, 182 of 260 (70%) examiners completed the questionnaire. Responders felt that consultations submitted were representative of the work of a typical GP during the pandemic and provided a good sample across the curriculum. They were also generally positive about the logistic, advisory and other support provided as well as the digital platform. Despite responders generally agreeing there was sufficient information available in video or audio consultations to judge candidates' data gathering, clinical management, and interpersonal skills, they were less confident about their ability to make judgments of candidates' performance compared with the CSA. The qualitative analysis of free text responses detailed the problems of case selection and content, explained examiners' difficulties when making judgments, and detailed the generally positive views about support, training and information technology. Responders also provided helpful recommendations for improving the assessment. CONCLUSION: The RCA was considered by examiners to be feasible and broadly acceptable, although they experienced challenges from candidate case selection, case content and judgments leading to suggested areas for improvement.
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COVID-19 , Medicina Geral , Humanos , Estudos Transversais , Pandemias , Avaliação Educacional , Educação de Pós-Graduação em Medicina , Medicina Geral/educação , Competência Clínica , Encaminhamento e ConsultaRESUMO
BACKGROUND: People with MS (pwMS) have had higher rates of anxiety and depression than the general population before the COVID-19 pandemic, placing them at higher risk of experiencing poor psychological wellbeing during the pandemic. OBJECTIVE: To assess mental health and its social/lifestyle determinants in pwMS during the first wave of the outbreak in the United Kingdom. METHODS: This is a community-based, prospective longitudinal cohort and cross-sectional case-control online questionnaire study. It includes 2010 pwMS from the UK MS Register and 380 people without MS. RESULTS: The Hospital Anxiety and Depression Scale scores of pwMS for anxiety and depression during the outbreak did not change from the previous year. PwMS were more likely to have anxiety (using General Anxiety Disorder-7) and/or depression (using Patient Health Questionnaire-9) than controls during the outbreak (OR: 2.14, 95% CI: 1.58-2.91). PwMS felt lonelier (OR: 1.37, 95% CI: 1.04-1.80) reported worse social support (OR: 1.90, 95% CI: 1.18-3.07) and reported worsened exercise habits (OR: 1.65, 95% CI: 1.18-2.32) during the outbreak than controls. CONCLUSION: Early in the pandemic, pwMS remained at higher risk of experiencing anxiety and depression than the general population. It is important that multidisciplinary teams improve their support for the wellbeing of pwMS, who are vulnerable to the negative effects of the pandemic on their lifestyle and social support.
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COVID-19 , Esclerose Múltipla , Ansiedade/epidemiologia , COVID-19/epidemiologia , Estudos de Casos e Controles , Estudos Transversais , Depressão/epidemiologia , Humanos , Saúde Mental , Esclerose Múltipla/epidemiologia , Pandemias , Estudos Prospectivos , SARS-CoV-2RESUMO
BACKGROUND: Hypoglycaemia is a potentially serious condition, characterised by lower-than-normal blood glucose levels, common in people with diabetes (PWD). It can be prevented and self-managed if expert support, such as education on lifestyle and treatment, is provided. Our aim was to conduct a process evaluation to investigate how ambulance staff and PWD perceived the "Hypos can strike twice" booklet-based ambulance clinician intervention, including acceptability, understandability, usefulness, positive or negative effects, and facilitators or barriers to implementation. METHODS: We used an explanatory sequential design with a self-administered questionnaire study followed by interviews of people with diabetes and ambulance staff. We followed the Medical Research Council framework for process evaluations of complex interventions to guide data collection and analysis. Following descriptive analysis (PWD and staff surveys), exploratory factor analysis was conducted to identify staff questionnaire subscales and multiple regression models were fitted to identify demographic predictors of overall and subscale scores. RESULTS: 113 ambulance staff members and 46 PWD completed the survey. We conducted interviews with four ambulance staff members and five PWD who had been attended by an ambulance for a hypoglycaemic event. Based on surveys and interviews, there were positive attitudes to the intervention from both ambulance staff and PWD. Although the intervention was not always implemented, most staff members and PWD found the booklet informative, easy to read and to use or explain. PWD who completed the survey reported that receiving the booklet reminded and/or encouraged them to test their blood glucose more often, adjust their diet, and have a discussion/check up with their diabetes consultant. Interviewed PWD felt that the booklet intervention would be more valuable to less experienced patients or those who cannot manage their diabetes well. Overall, participants felt that the intervention could be beneficial, but were uncertain about whether it might help prevent a second hypoglycaemic event and/or reduce the number of repeat ambulance attendances. CONCLUSIONS: The 'Hypos may strike twice' intervention, which had demonstrable reductions in repeat attendances, was found to be feasible, acceptable to PWD and staff, prompting reported behaviour change and help-seeking from primary care. TRIAL REGISTRATION: Registered with ClinicalTrials.gov: NCT04243200 on 27 January 2020.
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Diabetes Mellitus , Hipoglicemia , Ambulâncias , Glicemia , Diabetes Mellitus/terapia , Humanos , Hipoglicemia/prevenção & controle , Hipoglicemiantes , FolhetosRESUMO
The Recorded Consultation Assessment (RCA) was rapidly developed to replace the Clinical Skills Assessment (CSA) for UK general practice licencing during COVID-19. We aimed to evaluate candidate perceptions of the RCA and relationships with performance. We conducted a cross-sectional survey of RCA candidates with attitudinal, demographic, and free text response options, undertaking descriptive and factor analysis of quantitative data with qualitative thematic analysis of free text. Binomial regression was used to estimate associations between RCA pass, candidate characteristics and questionnaire responses.645 of 1551 (41.6%) candidates completed a questionnaire; 364 (56.4%) responders permitted linkage with performance and demographic data. Responders and non-responders were similar in exam performance, gender and declared disability but were significantly more likely to be UK graduates (UKG) or white compared with international medical (IMG) or ethnic minority graduates. Responders were positive about the digital platform and support resources. A small overall majority regarded the RCA as a fair assessment; a larger majority reported difficulty collecting, selecting, and submitting cases or felt rushed during recording.Logistic regression showed that ethnicity (white vs minority ethnic: odds ratio [OR] 2.99,95% confidence interval [CI] 1.23, 7.30, p = 0.016), training (UK vs IMG: OR 6.88, 95% CI 2.79, 16.95, p < 0.001), and English as first language (OR 5.11, 0% CI 2.08, 12.56, p < 0.001) were associated with exam success but questionnaire subscales, consultation type submitted, or extent of trainer review were not. The RCA was broadly acceptable but experiences were variable. Candidates experienced challenges and suggested areas for improvement.
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COVID-19 , Etnicidade , Competência Clínica , Estudos Transversais , Avaliação Educacional , Humanos , Armazenamento e Recuperação da Informação , Grupos Minoritários , Encaminhamento e Consulta , SARS-CoV-2 , Reino UnidoRESUMO
AIMS: We aimed to investigate the effect of an intervention in which ambulance personnel provided advice supported by a booklet-'Hypos can strike twice'-issued following a hypoglycaemic event to prevent future ambulance attendances. METHODS: We used a non-randomised stepped wedge-controlled design. The intervention was introduced at different times (steps) in different areas (clusters) of operation within East Midlands Ambulance Service NHS Trust (EMAS). During the first step (T0), no clusters were exposed to the intervention, and during the last step (T3), all clusters were exposed. Data were analysed using a general linear mixed model (GLMM) and an interrupted-time series analysis (ITSA). RESULTS: The study included 4825 patients (mean age 65.42 years, SD 19.42; 2,166 females) experiencing hypoglycaemic events attended by EMAS. GLMM indicated a reduction in the number of unsuccessful attendances (i.e., attendance followed by a repeat attendance) in the final step of the intervention when compared to the first (odds ratio OR: 0.50, 95%CI: 0.33-0.76, p = 0.001). ITSA indicated a significant decrease in repeat ambulance attendances for hypoglycaemia-relative to the pre-intervention trend (p = 0.008). Furthermore, the hypoglycaemia care bundle was delivered in 66% of attendances during the intervention period, demonstrating a significant level of practice change (p < 0.001). CONCLUSION: The 'Hypos can strike twice' intervention had a positive effect on reducing numbers of repeat attendances for hypoglycaemia and in achieving the care bundle. The study supports the use of information booklets by ambulance clinicians to prevent future attendances for recurrent hypoglycaemic events.
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Ambulâncias/estatística & dados numéricos , Auxiliares de Emergência , Hipoglicemia/prevenção & controle , Armazenamento e Recuperação da Informação/métodos , Análise de Séries Temporais Interrompida , Pacotes de Assistência ao Paciente/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Prevenção Secundária , Adulto JovemRESUMO
Background: Clostridioides difficile infection (CDI) is a risk factor for bloodstream infection (BSI). Fecal microbiota transplantation (FMT) is more effective than antibiotics in treating recurrent CDI, but its efficacy in preventing CDI-related BSI is uncertain. Objective: To assess incidence of primary BSI in patients with recurrent CDI treated with FMT versus antibiotics. Design: Prospective cohort study. Patients treated with FMT and those treated with antibiotics were matched on propensity score. Setting: Single academic medical center. Patients: 290 inpatients with recurrent CDI (57 patients per treatment in matched cohort). Intervention: FMT or antibiotics. Measurements: The primary outcome was primary BSI within 90 days. Secondary outcomes were length of hospitalization and overall survival (OS) at 90 days. Results: Of the 290 patients, 109 were treated with FMT and 181 received antibiotics. Five patients in the FMT group and 40 in the antibiotic group developed BSI. Because of differences in the patients treated with FMT versus antibiotics in many baseline characteristics, including number of recurrences and CDI severity, comparative analyses were limited to the matched cohort. Risk for BSI was 23 percentage points (95% CI, 10 to 35 percentage points) lower in the FMT group; the FMT group also had 14 fewer days of hospitalization (CI, 9 to 20 fewer days) and a 32-percentage point increase in OS (CI, 16 to 47 percentage points) compared with the antibiotic group. Limitation: Nonrandomized study with potential for unmeasured or residual confounding; limited generalizability of the propensity score-matched cohort. Conclusion: In a propensity score-matched cohort, patients with recurrent CDI treated with FMT were less likely to develop primary BSI. Primary Funding Source: None.
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Antibacterianos/uso terapêutico , Bacteriemia/epidemiologia , Infecções por Clostridium/terapia , Transplante de Microbiota Fecal , Tempo de Internação , Idoso , Clostridioides difficile , Infecções por Clostridium/mortalidade , Estudos de Coortes , Feminino , Humanos , Incidência , Itália/epidemiologia , Masculino , Análise por Pareamento , RecidivaRESUMO
BACKGROUND: Aortic valve replacement (AVR) for aortic stenosis is timed primarily on the development of symptoms, but late surgery can result in irreversible myocardial dysfunction and additional risk. The aim of this study was to determine whether the presence of focal myocardial scar preoperatively was associated with long-term mortality. METHODS: In a longitudinal observational outcome study, survival analysis was performed in patients with severe aortic stenosis listed for valve intervention at 6 UK cardiothoracic centers. Patients underwent preprocedural echocardiography (for valve severity assessment) and cardiovascular magnetic resonance for ventricular volumes, function and scar quantification between January 2003 and May 2015. Myocardial scar was categorized into 3 patterns (none, infarct, or noninfarct patterns) and quantified with the full width at half-maximum method as percentage of the left ventricle. All-cause mortality and cardiovascular mortality were tracked for a minimum of 2 years. RESULTS: Six hundred seventy-four patients with severe aortic stenosis (age, 75±14 years; 63% male; aortic valve area, 0.38±0.14 cm2/m2; mean gradient, 46±18 mm Hg; left ventricular ejection fraction, 61.0±16.7%) were included. Scar was present in 51% (18% infarct pattern, 33% noninfarct). Management was surgical AVR (n=399) or transcatheter AVR (n=275). During follow-up (median, 3.6 years), 145 patients (21.5%) died (52 after surgical AVR, 93 after transcatheter AVR). In multivariable analysis, the factors independently associated with all-cause mortality were age (hazard ratio [HR], 1.50; 95% CI, 1.11-2.04; P=0.009, scaled by epochs of 10 years), Society of Thoracic Surgeons score (HR, 1.12; 95% CI, 1.03-1.22; P=0.007), and scar presence (HR, 2.39; 95% CI, 1.40-4.05; P=0.001). Scar independently predicted all-cause (26.4% versus 12.9%; P<0.001) and cardiovascular (15.0% versus 4.8%; P<0.001) mortality, regardless of intervention (transcatheter AVR, P=0.002; surgical AVR, P=0.026 [all-cause mortality]). Every 1% increase in left ventricular myocardial scar burden was associated with 11% higher all-cause mortality hazard (HR, 1.11; 95% CI, 1.05-1.17; P<0.001) and 8% higher cardiovascular mortality hazard (HR, 1.08; 95% CI, 1.01-1.17; P<0.001). CONCLUSIONS: In patients with severe aortic stenosis, late gadolinium enhancement on cardiovascular magnetic resonance was independently associated with mortality; its presence was associated with a 2-fold higher late mortality.
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Estenose da Valva Aórtica/patologia , Miocárdio/patologia , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/cirurgia , Cicatriz , Meios de Contraste/química , Ecocardiografia , Feminino , Gadolínio/química , Humanos , Estimativa de Kaplan-Meier , Estudos Longitudinais , Imagem Cinética por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter , Resultado do TratamentoRESUMO
BACKGROUND: In patients with type 1 diabetes who are not pregnant, closed-loop (automated) insulin delivery can provide better glycemic control than sensor-augmented pump therapy, but data are lacking on the efficacy, safety, and feasibility of closed-loop therapy during pregnancy. METHODS: We performed an open-label, randomized, crossover study comparing overnight closed-loop therapy with sensor-augmented pump therapy, followed by a continuation phase in which the closed-loop system was used day and night. Sixteen pregnant women with type 1 diabetes completed 4 weeks of closed-loop pump therapy (intervention) and sensor-augmented pump therapy (control) in random order. During the continuation phase, 14 of the participants used the closed-loop system day and night until delivery. The primary outcome was the percentage of time that overnight glucose levels were within the target range (63 to 140 mg per deciliter [3.5 to 7.8 mmol per liter]). RESULTS: The percentage of time that overnight glucose levels were in the target range was higher during closed-loop therapy than during control therapy (74.7% vs. 59.5%; absolute difference, 15.2 percentage points; 95% confidence interval, 6.1 to 24.2; P=0.002). The overnight mean glucose level was lower during closed-loop therapy than during control therapy (119 vs. 133 mg per deciliter [6.6 vs. 7.4 mmol per liter], P=0.009). There were no significant differences between closed-loop and control therapy in the percentage of time in which glucose levels were below the target range (1.3% and 1.9%, respectively; P=0.28), in insulin doses, or in adverse-event rates. During the continuation phase (up to 14.6 additional weeks, including antenatal hospitalizations, labor, and delivery), glucose levels were in the target range 68.7% of the time; the mean glucose level was 126 mg per deciliter (7.0 mmol per liter). No episodes of severe hypoglycemia requiring third-party assistance occurred during either phase. CONCLUSIONS: Overnight closed-loop therapy resulted in better glucose control than sensor-augmented pump therapy in pregnant women with type 1 diabetes. Women receiving day-and-night closed-loop therapy maintained glycemic control during a high proportion of the time in a period that encompassed antenatal hospital admission, labor, and delivery. (Funded by the National Institute for Health Research and others; Current Controlled Trials number, ISRCTN71510001.).
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Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Gravidez em Diabéticas/tratamento farmacológico , Adulto , Glicemia/metabolismo , Estudos Cross-Over , Diabetes Mellitus Tipo 1/sangue , Feminino , Humanos , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , GravidezRESUMO
BACKGROUND: Health and socioeconomic status (SES) are linked in studies worldwide. Measures of SES exist for many countries, however not for Saudi Arabia (SA). We describe two indices of area-based SES for SA. METHODS: Routine census data has been used to construct two indices of SES at the geographically-delimited administrative region of Governorates in SA (n = 118). The data used included indicators of educational status, employment status, car and material ownership. A continuous measure of SES was constructed using exploratory factor analysis (EFA) and a categorical measure of SES using latent class analysis (LCA). Both indices were mapped by Governorates. RESULTS: The EFA identified three factors: The first explained 51.58% of the common variance within the interrelated factors, the second 15.14%, and the third 14.26%. These proportions were used in the formulation of the standard index. The scores were fixed to range from 100 for the affluent Governorate and 0 for the deprived. The LCA found a 4 class model as the best model fit. Class 1 was termed "affluent" and included 11.01% of Governorates, class 2 "upper middle class" (44.91%), class 3 "lower middle class" (33.05%) and class 4 "deprived" (11.01%). The populated urbanised Governorates were found to be the most affluent whereas the smaller rural Governorates were the most deprived. CONCLUSION: This is the first description of measures of SES in SA at a geographical level. Two measures have been successfully constructed and mapped. The maps show similar patterns suggesting validity. Both indices support the common perception of SES in SA.
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Indicadores Básicos de Saúde , População Rural/estatística & dados numéricos , Classe Social , População Urbana/estatística & dados numéricos , Análise Fatorial , Humanos , Propriedade/estatística & dados numéricos , Arábia SauditaRESUMO
AIMS/HYPOTHESIS: This study aimed to examine the relationship between average glucose levels, assessed by continuous glucose monitoring (CGM), and HbA1c levels in pregnant women with diabetes to determine whether calculations of standard estimated average glucose (eAG) levels from HbA1c measurements are applicable to pregnant women with diabetes. METHODS: CGM data from 117 pregnant women (89 women with type 1 diabetes; 28 women with type 2 diabetes) were analysed. Average glucose levels were calculated from 5-7 day CGM profiles (mean 1275 glucose values per profile) and paired with a corresponding (±1 week) HbA1c measure. In total, 688 average glucose-HbA1c pairs were obtained across pregnancy (mean six pairs per participant). Average glucose level was used as the dependent variable in a regression model. Covariates were gestational week, study centre and HbA1c. RESULTS: There was a strong association between HbA1c and average glucose values in pregnancy (coefficient 0.67 [95% CI 0.57, 0.78]), i.e. a 1% (11 mmol/mol) difference in HbA1c corresponded to a 0.67 mmol/l difference in average glucose. The random effects model that included gestational week as a curvilinear (quadratic) covariate fitted best, allowing calculation of a pregnancy-specific eAG (PeAG). This showed that an HbA1c of 8.0% (64 mmol/mol) gave a PeAG of 7.4-7.7 mmol/l (depending on gestational week), compared with a standard eAG of 10.2 mmol/l. The PeAG associated with maintaining an HbA1c level of 6.0% (42 mmol/mol) during pregnancy was between 6.4 and 6.7 mmol/l, depending on gestational week. CONCLUSIONS/INTERPRETATION: The HbA1c-average glucose relationship is altered by pregnancy. Routinely generated standard eAG values do not account for this difference between pregnant and non-pregnant individuals and, thus, should not be used during pregnancy. Instead, the PeAG values deduced in the current study are recommended for antenatal clinical care.
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Glicemia/metabolismo , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/metabolismo , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/metabolismo , Hemoglobinas Glicadas/metabolismo , Adolescente , Adulto , Automonitorização da Glicemia , Feminino , Humanos , Pessoa de Meia-Idade , Assistência Perinatal , Gravidez , Adulto JovemRESUMO
BACKGROUND: Regional contractile dysfunction is a frequent finding in hypertrophic cardiomyopathy (HCM). We aimed to investigate the contribution of different tissue characteristics in HCM to regional contractile dysfunction. METHODS: We prospectively recruited 50 patients with HCM who underwent cardiovascular magnetic resonance (CMR) studies at 3.0 T including cine imaging, T1 mapping and late gadolinium enhancement (LGE) imaging. For each segment of the American Heart Association model segment thickness, native T1, extracellular volume (ECV), presence of LGE and regional strain (by feature tracking and tissue tagging) were assessed. The relationship of segmental function, hypertrophy and tissue characteristics were determined using a mixed effects model, with random intercept for each patient. RESULTS: Individually segment thickness, native T1, ECV and the presence of LGE all had significant associations with regional strain. The first multivariable model (segment thickness, LGE and ECV) demonstrated that all strain parameters were associated with segment thickness (P < 0.001 for all) but not ECV. LGE (Beta 2.603, P = 0.024) had a significant association with circumferential strain measured by tissue tagging. In a second multivariable model (segment thickness, LGE and native T1) all strain parameters were associated with both segment thickness (P < 0.001 for all) and native T1 (P < 0.001 for all) but not LGE. CONCLUSION: Impairment of contractile function in HCM is predominantly associated with the degree of hypertrophy and native T1 but not markers of extracellular fibrosis (ECV or LGE). These findings suggest that impairment of contractility in HCM is mediated by mechanisms other than extracellular expansion that include cellular changes in structure and function. The cellular mechanisms leading to increased native T1 and its prognostic significance remain to be established.
Assuntos
Cardiomiopatia Hipertrófica/diagnóstico por imagem , Interpretação de Imagem Assistida por Computador/métodos , Imagem Cinética por Ressonância Magnética/métodos , Contração Miocárdica , Miocárdio/patologia , Função Ventricular Esquerda , Adulto , Fenômenos Biomecânicos , Cardiomiopatia Hipertrófica/patologia , Cardiomiopatia Hipertrófica/fisiopatologia , Estudos de Casos e Controles , Meios de Contraste/administração & dosagem , Feminino , Fibrose , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Compostos Organometálicos/administração & dosagem , Valor Preditivo dos Testes , Estudos Prospectivos , Estresse Mecânico , Volume Sistólico , Remodelação VentricularRESUMO
OBJECTIVES: Symptom-based criteria to diagnose irritable bowel syndrome (IBS) positively perform only modestly. Our aim was to assess whether including other items from the clinical history and limited diagnostic evaluation improves their performance. METHODS: We collected complete symptom, colonoscopy, and histology data from 318 consecutive, unselected adult patients with lower gastrointestinal (GI) symptoms in secondary care. All participants underwent colonoscopy, with relevant organic findings recorded. The reference standard used to define the presence of true IBS was patient-reported lower abdominal pain or discomfort associated with a change in bowel habit, in the absence of organic GI disease. Sensitivity, specificity, and positive and negative likelihood ratios (LRs), with 95% confidence intervals, were calculated for Rome III criteria, as well as for modifications, incorporating nocturnal stools, results of simple blood tests (hemoglobin and C-reactive protein (CRP)), measures of somatization, and/or affective disorders (hospital anxiety or depression scale (HADS) score). RESULTS: The sensitivity and specificity of the Rome III criteria for identifying IBS was 69.6%, and 82.0%, respectively, with positive and negative LRs of 3.87 and 0.37, respectively. Clinically useful enhancements in positive LRs were provided by combining Rome III criteria with: (a) high level of somatization (7.27); (b) normal hemoglobin and CRP with HADS score of ≥8 (5.04); (c) normal hemoglobin and CRP with a high level of somatization (7.56); or (d) no nocturnal passage of stool with a high level of somatization (17.3). Specificity was ≥95% with each of these modifications. CONCLUSIONS: Incorporating nocturnal stools, somatization, and affective disorders from the clinical history, and hemoglobin and CRP measurements, enhances the positive LR and specificity of symptom-based Rome III criteria for IBS.
Assuntos
Ansiedade/psicologia , Colonoscopia , Depressão/psicologia , Síndrome do Intestino Irritável/diagnóstico , Transtornos Somatoformes/psicologia , Dor Abdominal , Adulto , Idoso , Proteína C-Reativa/metabolismo , Ritmo Circadiano , Colo/patologia , Defecação , Feminino , Hemoglobinas/metabolismo , Humanos , Síndrome do Intestino Irritável/metabolismo , Síndrome do Intestino Irritável/patologia , Síndrome do Intestino Irritável/psicologia , Masculino , Anamnese , Pessoa de Meia-Idade , Sensibilidade e Especificidade , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: Many patients with diarrhoea undergo colonoscopy. If this is macroscopically normal, random biopsies are obtained to rule out microscopic colitis (MC), but most patients have functional disease. Accurate predictors of MC could avoid the need to take biopsies in a substantial proportion of patients, saving money for the health service. We validated a previously described diagnostic scoring system for MC, and incorporated further variables to assess whether this improved performance. MATERIAL AND METHODS: Consecutive adults with loose stools undergoing colonoscopy in Leeds, UK were included. Demographic and symptom data were collected prospectively. The diagnostic scoring system described previously was applied. In addition, the incorporation of further variables, including drugs associated with MC, number of stools, nocturnal passage of stools, and duration of loose stools, into the scoring system was assessed. Sensitivities, specificities, and positive and negative predictive values were calculated. RESULTS: Among 242 patients (mean age 51.0 years, 163 (67.4%) female), 26 (10.7%) of whom had MC, a cut off of ≥4 on the original scoring system had a sensitivity of 92.3% and specificity of 35.2%. Nocturnal passage of stools and duration of loose stools <6 months were significant predictors of MC. Incorporating these variables in a new scoring system with a cut off of ≥6 identified MC with 95.7% sensitivity and 46.0% specificity. CONCLUSIONS: Incorporating nocturnal passage of stools and duration of loose stools into the scoring system may improve ability to predict MC, and avoid random colonic biopsies in a greater proportion of patients with loose stools.
Assuntos
Colite Microscópica/diagnóstico , Colo/patologia , Colonoscopia/métodos , Índice de Gravidade de Doença , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Biópsia , Colite Microscópica/classificação , Colite Microscópica/patologia , Diarreia/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Curva ROC , Análise de Regressão , Sensibilidade e Especificidade , Reino Unido , Adulto JovemRESUMO
Treatable gastrointestinal disorders in patients with symptoms typical for irritable bowel syndrome (IBS) may be overlooked. The prevalence of five gastrointestinal conditions-bile acid diarrhoea (BAD), carbohydrate malabsorption (CM), microscopic colitis (MC), pancreatic exocrine insufficiency (PEI) and small intestinal bacterial overgrowth (SIBO) was systematically assessed from studies including consecutive patients meeting diagnostic criteria for IBS. 4 databases were searched from 1978 to 2020. Studies were included if they evaluated the prevalence of these conditions in secondary healthcare setting. Estimated pooled rates were calculated and statistical heterogeneity between studies was evaluated using Q and I2 statistics. Seven studies (n = 597) estimated the pooled prevalence for BAD as 41% (95% CI 29-54). 17 studies (n = 5068) estimated that of MC as 3% (95% CI 2-4%). Two studies (n = 478) suggested a rate of 4.6% (range: 1.8-6.1%) for PEI. Using breath testing, 26 studies (n = 6700) and 13 studies (n = 3415) estimated the prevalence of lactose and fructose malabsorption as 54% (95% CI 44-64%) and 43% (95% CI 23-62%); 36 studies (n = 4630) and 22 studies (n = 2149) estimated that of SIBO as 49% (95% CI 40-57%) with lactulose and 19% (95% CI 13-27%) with glucose. Rates of all conditions were significantly higher than in healthy controls. A significant proportion of patients presenting to secondary care with IBS have an organic condition which may account for their symptoms. Failure to exclude such conditions will deny patients effective treatment.
Assuntos
Gastroenteropatias/epidemiologia , Síndrome do Intestino Irritável/epidemiologia , Ácidos e Sais Biliares/metabolismo , Síndrome da Alça Cega/diagnóstico , Síndrome da Alça Cega/epidemiologia , Colite Microscópica/diagnóstico , Colite Microscópica/epidemiologia , Erros de Diagnóstico , Diarreia/diagnóstico , Diarreia/epidemiologia , Diarreia/metabolismo , Carboidratos da Dieta/metabolismo , Insuficiência Pancreática Exócrina/diagnóstico , Insuficiência Pancreática Exócrina/epidemiologia , Gastroenteropatias/diagnóstico , Gastroenteropatias/metabolismo , Humanos , Síndrome do Intestino Irritável/diagnóstico , Síndromes de Malabsorção/diagnóstico , Síndromes de Malabsorção/epidemiologia , Síndromes de Malabsorção/metabolismo , Valor Preditivo dos Testes , Prevalência , Avaliação de SintomasRESUMO
BACKGROUND: Contradicting assumptions have been made about the effectiveness of SARS-CoV-2 vaccines in patients with multiple sclerosis (MS) receiving immunomodulatory disease-modifying therapies (DMTs) based on the quantification of humoral and cellular immune responses. This study aimed to understand changes in the risk of SARS-CoV-2 infection among the total population of patients receiving MS DMTs in England following mass vaccination. METHODS: This is a retrospective analysis of national data collected prospectively and longitudinally. National Health Service (NHS) England and NHS Improvement (NHSE/I) hold prescribing data on all commissioned MS DMTs in England. United Kingdom Health Security Agency (UKHSA) has been collecting data on all registered SARS-CoV-2 test results, including polymerase chain reaction and rapid antigen tests. All patients receiving MS DMTs were identified using NHSE/I datasets. All patients receiving MS DMTs with SARS-CoV-2 infection (i.e., positive test) from March 2020 to August 2021 were identified by merging NHSE/I and UKHSA datasets. Similar data for the general population were captured using publicly available datasets of the United Kingdom government. The incidence rate ratios (IRR) of SARS-CoV-2 infection among patients receiving MS DMTs compared to the general population during the pre-vaccination (November 2020 to January 2021) and post-vaccination (June to August 2021) periods were calculated. RESULTS: A mean (standard deviation) of 41,208 (4,301) patients received an MS DMT in England during each month from March 2020 to August 2021. The IRR (95% confidence interval) of infection in patients taking ocrelizumab versus the general population increased from 1.13 (0.97-1.31) during the pre-vaccination period to 1.79 (1.57-2.03) during the post-vaccination period. For patients on fingolimod, it increased from 0.87 (0.73-1.02) to 1.40 (1.20-1.63) during the same periods. There were no significant changes for patients on other MS DMTs. CONCLUSION: SARS-CoV-2 vaccines offer less protection against infection to patients taking ocrelizumab or fingolimod, who have an impaired immune response to vaccines, than the general population. These findings will have implications for vaccination policies.
Assuntos
COVID-19 , Esclerose Múltipla , Vacinas contra COVID-19 , Humanos , Vacinação em Massa , Esclerose Múltipla/tratamento farmacológico , Esclerose Múltipla/epidemiologia , Estudos Retrospectivos , SARS-CoV-2 , Medicina EstatalRESUMO
Poor glycaemic control is found in diabetes, one of the most common, serious, non-communicable diseases worldwide. Trials suggest a relationship between glycaemic control and measures of sleep including duration and quality of sleep. Currently, the relationship between specific sleep stages (including slow-wave sleep (SWS), a sleep stage mainly found early in the night and linked to restorative functioning) and glycaemic control remains unclear. This systematic review aimed to synthesise the evidence of the effectiveness of specific sleep stage manipulation on measures of glycaemic control (insulin resistance, fasting and post-prandial glucose and insulin). Public databases (eg psychINFO, MEDLINE, Academic Search Complete, psychARTICLES, OpenDissertations, Scopus and Cochrane library) were searched for randomised controlled trials. Trials were included if they involved direct manipulation of SWS and/or rapid eye-movement sleep to explore the impact on measures of glycaemic control (insulin resistance, fasting and post-prandial glucose and insulin). Eight trials met the eligibility criteria, with four providing data for inclusion in one of the three meta-analyses. Insulin resistance was significantly higher in the SWS disruption when compared to the normal sleep condition, (p = 0.02). No significant differences were found for measures of fasting or post-prandial glucose or insulin. Risk of bias was considered low for performance bias, detection bias and incomplete outcome data, with unclear selection bias. This is an emerging area of research and this review provides preliminary findings and recommendations for future research around optimising sleep stage disruption (to further explore mechanisms) and sleep stage enhancement techniques (to explore potential interventions).
Assuntos
Diabetes Mellitus Tipo 2 , Hiperglicemia , Resistência à Insulina , Sono de Ondas Lentas , Glicemia , Humanos , Insulina , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVE: To determine gestational weekly changes in continuous glucose monitoring (CGM) metrics and 24-h glucose profiles and their relationship to infant birth weight in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS: An analysis of >10.5 million CGM glucose measures from 386 pregnant women with type 1 diabetes from two international multicenter studies was performed. CGM glucose metrics and 24-h glucose profiles were calculated for each gestational week, and the relationship to normal (10-90th percentile) and large (>90th percentile) for gestational age (LGA) birth weight infants was determined. RESULTS: Mean CGM glucose concentration fell and percentage of time spent in the pregnancy target range of 3.5-7.8 mmol/L (63-140 mg/dL) increased in the first 10 weeks of pregnancy and plateaued until 28 weeks of gestation, before further improvement in mean glucose and percentage of time in range until delivery. Maternal CGM glucose metrics diverged at 10 weeks of gestation, with significantly lower mean CGM glucose concentration (7.1 mmol/L; 95% CI 7.05-7.15 [127.8 mg/dL; 95% CI 126.9-128.7] vs. 7.5 mmol/L; 95% CI 7.45-7.55 [135 mg/dL; 95% CI 134.1-135.9]) and higher percentage of time in range (55%; 95% CI 54-56 vs. 50%; 95% CI 49-51) in women who had normal versus LGA. The 24-h glucose profiles were significantly higher across the day from 10 weeks of gestation in LGA. CONCLUSIONS: Normal birth weight is associated with achieving significantly lower mean CGM glucose concentration across the 24-h day and higher CGM time in range from before the end of the first trimester, emphasizing the need for a shift in clinical management, with increased focus on using weekly CGM glucose targets for optimizing maternal glycemia from early pregnancy.