RESUMEN
Avoiding excessive dialysis-associated volume depletion may help preserve residual kidney function (RKF). To establish whether knowledge of the estimated normally hydrated weight from bioimpedance measurements (BI-NHW) when setting the post-hemodialysis target weight (TW) might mitigate rate of loss of RKF, we undertook an open label, randomized controlled trial in incident patients receiving HD, with clinicians and patients blinded to bioimpedance readings in controls. A total of 439 patients with over 500 ml urine/day or residual GFR exceeding 3 ml/min/1.73m2 were recruited from 34 United Kingdom centers and randomized 1:1, stratified by center. Fluid assessments were made for up to 24 months using a standardized proforma in both groups, supplemented by availability of BI-NHW in the intervention group. Primary outcome was time to anuria, analyzed using competing-risk survival models adjusted for baseline characteristics, by intention to treat. Secondary outcomes included rate of RKF decline (mean urea and creatinine clearance), blood pressure and patient-reported outcomes. There were no group differences in cause-specific hazard rates of anuria (0.751; 95% confidence interval (0.459, 1.229)) or sub-distribution hazard rates (0.742 (0.453, 1.215)). RKF decline was markedly slower than anticipated, pooled linear rates in year 1: -0.178 (-0.196, -0.159)), year 2: -0.061 (-0.086, -0.036)) ml/min/1.73m2/month. Blood pressure and patient-reported outcomes did not differ by group. The mean difference agreement between TW and BI-NHW was similar for both groups, Bioimpedance: -0.04 kg; Control: -0.25 kg. Thus, use of a standardized clinical protocol for fluid assessment when setting TW is associated with excellent preservation of RKF. Hence, bioimpedance measurements are not necessary to achieve this.
Asunto(s)
Anuria , Fallo Renal Crónico , Humanos , Espectroscopía Dieléctrica/métodos , Diálisis Renal/efectos adversos , Diálisis Renal/métodos , Urea , Riñón , Fallo Renal Crónico/diagnóstico , Fallo Renal Crónico/terapia , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Systemic inflammation, measured as circulating Interleukin-6 (IL-6) levels, is associated with cardiovascular and all-cause mortality in chronic kidney disease. However, this has not been convincingly demonstrated in a systematic review or a meta-analysis in the dialysis population. We provide such evidence, including a re-analysis of the GLOBAL Fluid Study. METHODS: Mortality in the GLOBAL fluid study was re-analysed using Cox proportional hazards regression with IL-6 levels as a covariate using a continuous non-logarithmic scale. Literature searches of the association of IL-6 levels with mortality were conducted on MEDLINE, EMBASE, PyschINFO and CENTRAL. All studies were assessed for risk of bias using the QUIPS tool. To calculate a pooled effect size, studies were grouped by use of IL-6 scale and included in the meta-analysis if IL-6 was analysed as a continuous linear covariate, either per unit or per 10 pg/ml, in both unadjusted or adjusted for other patient characteristics (e.g. age, comorbidity) models. Funnel plot was used to identify potential publication bias. RESULTS: Of 1886 citations identified from the electronic search, 60 were included in the qualitative analyses, and 12 had sufficient information to proceed to meta-analysis after full paper screening. Random effects meta-analysis of 11 articles yielded a pooled hazard ratio (HR) per pg/ml of 1.03, (95% CI 1.01, 1.03), [Formula: see text]= 81%. When the analysis was confined to seven articles reporting a non-adjusted HR the result was similar: 1.03, per pg/ml (95% CI: 1.03, 1.06), [Formula: see text]=92%. Most of the heterogeneity could be attributed to three of the included studies. Publication bias could not be determined due to the limited number of studies. CONCLUSION: This systematic review confirms the adverse association between systemic IL-6 levels and survival in people treated with dialysis. The heterogeneity that we observed may reflect differences in study case mix. SYSTEMATIC REVIEW REGISTRATION: PROSPERO - CRD42020214198.
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Interleucina-6 , Diálisis Renal , Insuficiencia Renal Crónica , Humanos , Interleucina-6/sangre , Modelos de Riesgos Proporcionales , Diálisis Renal/mortalidad , Insuficiencia Renal Crónica/mortalidad , Insuficiencia Renal Crónica/terapiaRESUMEN
BACKGROUND: Mainstreaming of germline testing demands that all healthcare professionals have good communication skills, but few have genetic testing and counselling experience. We developed and evaluated educational workshops-Talking about Risk & UncertaintieS of Testing IN Genetics (TRUSTING). Contents included: presentations and exercises, an interview with a geneticist about BRCA testing, screening and prevention implications, filmed interactions between surgeons, a genetic counsellor and geneticists with a fictitious family (proband had a BRCA2 pathogenic variant with triple-negative breast cancer, her older sister-BRCA2 heterozygous, and cousin-negative for BRCA2 variant). METHODS: Twenty-one surgeons, 5 oncologists, 18 nurses and 9 genetic counsellors participated. Knowledge (18 item MCQ), communication skills (responses to 6 questions from proband and relatives) and self-confidence (discussing 9 genetic testing issues) were assessed pre- and post workshop. RESULTS: Knowledge scores improved significantly post workshop (mean change = 7.06; 95% confidence interval (CI) 6.37-7.74; P < 0.001), as did communication (mean change = 5.38; 95% CI 4.37-6.38; P < 0.001) and self-confidence (P < 0.001). DISCUSSION: Healthcare professionals' knowledge and self-confidence when discussing the risks and uncertainties in genetics are often poor. TRUSTING workshops significantly enhanced attendees' navigation of communication difficulties encountered and will be rolled out more widely.
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Proteína BRCA2 , Neoplasias de la Mama , Proteína BRCA1/genética , Proteína BRCA2/genética , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/genética , Atención a la Salud , Familia , Femenino , Predisposición Genética a la Enfermedad , Pruebas Genéticas , Personal de Salud , Heterocigoto , HumanosRESUMEN
BACKGROUND: There is limited information available on the impact that provision of an assisted peritoneal dialysis (PD) service has on the initiation of PD. The aim of this study was to assess this impact in a centre following initiation of assisted PD in 2011. METHODS: This retrospective, single-centre study analysed 1576 patients incident to renal replacement therapies (RRTs) between January 2002 and 2017. Adjusted Cox regression with a time-varying explanatory variable and a Fine and Gray model were used to examine the effect of assisted PD use on the rates and cumulative incidence of PD initiation, accounting for the non-linear impact of RRT starting time and the competing risks (transplant and death). RESULTS: Patients starting PD with assistance were older than those starting unassisted: median (interquartile range): 70.0 (61.5-78.3) versus 58.7 (43.8-69.2) years old, respectively. In the adjusted analysis assisted PD service availability was associated with an increased rate of PD initiation [cause-specific hazard ratio (cs-HR) 1.78, 95% confidence interval 1.21-2.61]. During the study period, the rate of starting PD fell before flattening out. Transplantation and death rates increased over time but this did not affect the fall in PD initiation [for each year in the study cs-HR of starting PD 0.95 (0.93-0.98), sub-distribution HR 0.95 (0.94-0.97)]. CONCLUSIONS: In a single-centre study, introducing an assisted PD service significantly increased the rate of PD initiation, benefitting older patients most. This offsets a fall in PD usage over time, which was not explained by changes in transplantation or death.
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Implementación de Plan de Salud , Servicios de Atención de Salud a Domicilio/organización & administración , Servicios de Atención de Salud a Domicilio/estadística & datos numéricos , Fallo Renal Crónico/terapia , Diálisis Peritoneal/métodos , Diálisis Peritoneal/enfermería , Sistema de Registros/estadística & datos numéricos , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
BACKGROUND: Risk of encapsulating peritoneal sclerosis (EPS) is strongly associated with the duration of peritoneal dialysis (PD), such that patients who have been on PD for some time may consider elective transfer to haemodialysis to mitigate the risk of EPS. There is a need to determine this risk to better inform clinical decision making, but previous studies have not allowed for the competing risk of death. METHODS: This study included new adult PD patients in Australia and New Zealand (ANZ; 1990-2010) or Scotland (2000-08) followed until 2012. Age, time on PD, primary renal disease, gender, data set and diabetic status were evaluated as predictors at the start of PD, then at 3 and 5 years after starting PD using flexible parametric competing risks models. RESULTS: In 17 396 patients (16 162 ANZ, 1234 Scotland), EPS was observed in 99 (0.57%) patients, less frequently in ANZ patients (n = 65; 0.4%) than in Scottish patients (n = 34; 2.8%). The estimated risk of EPS was much lower when the competing risk of death was taken into account (1 Kaplan-Meier = 0.0126, cumulative incidence function = 0.0054). Strong predictors of EPS included age, primary renal disease and time on PD. The risk of EPS was reasonably discriminated at the start of PD (C-statistic = 0.74-0.79) and this improved at 3 and 5 years after starting PD (C-statistic = 0.81-0.92). CONCLUSIONS: EPS risk estimates are lower when calculated using competing risk of death analyses. A patient's estimated risk of EPS is country-specific and can be predicted using age, primary renal disease and duration of PD.
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Diálisis Peritoneal/efectos adversos , Enfermedades Peritoneales/etiología , Enfermedades Peritoneales/mortalidad , Medición de Riesgo/métodos , Esclerosis/etiología , Esclerosis/mortalidad , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Nueva Zelanda , Enfermedades Peritoneales/patología , Pronóstico , Factores de Riesgo , Esclerosis/patología , Escocia , Tasa de SupervivenciaRESUMEN
BACKGROUND: Optimally treated heart failure (HF) patients often have persisting symptoms and poor health-related quality of life. Comorbidities are common, but little is known about their impact on these factors, and guideline-driven HF care remains focused on cardiovascular status. The following hypotheses were tested: (i) comorbidities are associated with more severe symptoms and functional limitations and subsequently worse patient-rated health in HF, and (ii) these patterns of association differ among selected comorbidities. METHODS AND FINDINGS: The Swedish Heart Failure Registry (SHFR) is a national population-based register of HF patients admitted to >85% of hospitals in Sweden or attending outpatient clinics. This study included 10,575 HF patients with patient-rated health recorded during first registration in the SHFR (1 February 2008 to 1 November 2013). An a priori health model and sequences-of-regressions analysis were used to test associations among comorbidities and patient-reported symptoms, functional limitations, and patient-rated health. Patient-rated health measures included the EuroQol-5 dimension (EQ-5D) questionnaire and the EuroQol visual analogue scale (EQ-VAS). EQ-VAS score ranges from 0 (worst health) to 100 (best health). Patient-rated health declined progressively from patients with no comorbidities (mean EQ-VAS score, 66) to patients with cardiovascular comorbidities (mean EQ-VAS score, 62) to patients with non-cardiovascular comorbidities (mean EQ-VAS score, 59). The relationships among cardiovascular comorbidities and patient-rated health were explained by their associations with anxiety or depression (atrial fibrillation, odds ratio [OR] 1.16, 95% CI 1.06 to 1.27; ischemic heart disease [IHD], OR 1.20, 95% CI 1.09 to 1.32) and with pain (IHD, OR 1.25, 95% CI 1.14 to 1.38). Associations of non-cardiovascular comorbidities with patient-rated health were explained by their associations with shortness of breath (diabetes, OR 1.17, 95% CI 1.03 to 1.32; chronic kidney disease [CKD, OR 1.23, 95% CI 1.10 to 1.38; chronic obstructive pulmonary disease [COPD], OR 95% CI 1.84, 1.62 to 2.10) and with fatigue (diabetes, OR 1.27, 95% CI 1.13 to 1.42; CKD, OR 1.24, 95% CI 1.12 to 1.38; COPD, OR 1.69, 95% CI 1.50 to 1.91). There were direct associations between all symptoms and patient-rated health, and indirect associations via functional limitations. Anxiety or depression had the strongest association with functional limitations (OR 10.03, 95% CI 5.16 to 19.50) and patient-rated health (mean difference in EQ-VAS score, -18.68, 95% CI -23.22 to -14.14). HF optimizing therapies did not influence these associations. Key limitations of the study include the cross-sectional design and unclear generalisability to other populations. Further prospective HF studies are required to test the consistency of the relationships and their implications for health. CONCLUSIONS: Identification of distinct comorbidity health pathways in HF could provide the evidence for individualised person-centred care that targets specific comorbidities and associated symptoms.
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Comorbilidad , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/epidemiología , Anciano , Anciano de 80 o más Años , Ansiedad/complicaciones , Ansiedad/epidemiología , Estudios Transversales , Depresión/complicaciones , Depresión/epidemiología , Femenino , Estado de Salud , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Calidad de Vida , Sistema de Registros , Análisis de Regresión , Encuestas y Cuestionarios , Suecia/epidemiología , Resultado del TratamientoRESUMEN
Background We previously showed, in patients with diabetes, that >50% of monitoring tests for glycated haemoglobin (HbA1c) are outside recommended intervals and that this is linked to diabetes control. Here, we examined the effect of tests/year on achievement of commonly utilised HbA1c targets and on HbA1c changes over time. Methods Data on 20,690 adults with diabetes with a baseline HbA1c of >53 mmol/mol (7%) were extracted from Clinical Biochemistry Laboratory records at three UK hospitals. We examined the effect of HbA1c tests/year on (i) the probability of achieving targets of ≤53 mmol/mol (7%) and ≤48 mmol/mol (6.5%) in a year using multi-state modelling and (ii) the changes in mean HbA1c using a linear mixed-effects model. Results The probabilities of achieving ≤53 mmol/mol (7%) and ≤48 mmol/mol (6.5%) targets within 1 year were 0.20 (95% confidence interval: 0.19-0.21) and 0.10 (0.09-0.10), respectively. Compared with four tests/year, having one test or more than four tests/year were associated with lower likelihoods of achieving either target; two to three tests/year gave similar likelihoods to four tests/year. Mean HbA1c levels were higher in patients who had one test/year compared to those with four tests/year (mean difference: 2.64 mmol/mol [0.24%], p<0.001). Conclusions We showed that ≥80% of patients with suboptimal control are not achieving commonly recommended HbA1c targets within 1 year, highlighting the major challenge facing healthcare services. We also demonstrated that, although appropriate monitoring frequency is important, testing every 6 months is as effective as quarterly testing, supporting international recommendations. We suggest that the importance HbA1c monitoring frequency is being insufficiently recognised in diabetes management.
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Diabetes Mellitus Tipo 2/sangre , Hemoglobina Glucada/análisis , Adulto , Glucemia/análisis , Femenino , Humanos , Masculino , ProbabilidadRESUMEN
BACKGROUND: Relatively little is known about dietary changes and their relationships with weight change during behavioural weight loss interventions. In a secondary analysis of data from a multicentre RCT, we investigated whether greater improvements in diet would be achieved by overweight adults following a 12 month group-based commercial weight loss programme (CP) than those receiving standard care (SC) in primary practice, and if these dietary changes were associated with greater weight loss. METHODS: Adults with a BMI 27-35 kg/m2 and >1 risk factor for obesity-related disorders were recruited in study centres in Australia and the UK during 2007-2008. Dietary intake and body weight were measured at baseline, 6 and 12 months. Linear mixed effects models compared mean changes in dietary macronutrient intake, fibre density and energy density over time between groups, and their relationships with weight loss. RESULTS: The CP group demonstrated greater mean weight loss than the SC group at 6 months (3.3 kg, 95% CI: 2.2, 4.4) and 12 months (3.3 kg, 95% CI: 2.1, 4.5). Diet quality improved in both intervention groups at 6 and 12 months. However, the CP group (n = 228) achieved significantly greater mean reductions in energy intake (mean difference; 95% CI: - 503 kJ/d; - 913, - 93), dietary energy density (- 0.48 MJ/g; - 0.81, - 0.16), total fat (- 6.9 g/d; - 11.9, - 1.8), saturated fat (- 3.3 g/d; - 5.4, - 1.1), and significantly greater mean increases in fibre density (0.30 g/MJ; 0.15, 0.44) at 6 months than the SC group (n = 239). Similar differences persisted at 12 months and the CP group showed greater mean increases in protein density (0.65 g/MJ). In both groups, weight loss was associated with increased fibre density (0.68 kg per g/MJ, 95% CI: 0.08, 1.27) and protein density (0.26 kg per g/MJ, 95% CI: 0.10, 0.41). CONCLUSIONS: Following a group-based commercial program led to greater improvements in diet quality than standard care. Increases in dietary protein and fibre density were independently associated with weight loss in both behavioural weight loss interventions. Greater increases in protein and fibre density in the commercial program likely contributed to their greater weight loss. TRIAL REGISTRATION: ISRCTN: ISRCTN85485463 Registered 03/08/2007 Retrospectively Registered.
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Sobrepeso/terapia , Atención Primaria de Salud , Programas de Reducción de Peso , Adulto , Australia , Terapia Conductista , Índice de Masa Corporal , Dieta Reductora , Fibras de la Dieta/administración & dosificación , Proteínas en la Dieta/administración & dosificación , Ingestión de Energía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reino Unido , Pérdida de PesoRESUMEN
BACKGROUND: To examine the impact of multimodal (MMS) and ultrasound (USS) screening on the sexual activity and functioning of 22 966 women in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) RCT. METHODS: Fallowfield's Sexual Activity Questionnaire (FSAQ) was completed prior to randomisation, then annually in a random sample (RS) of women from MMS, USS and control groups. Any women in the study who required repeat screening due to unsatisfactory results formed an Events Sample (ES); they completed questionnaires following an event and annually thereafter. RESULTS: Over time in the RS (n=1339) there was no difference between the MMS and USS groups in sexual activity compared with controls. In the ES there were significant differences between the USS group (n=10 156) and the MMS group (n=12 810). The USS group had lower pleasure scores (mean difference=-0.14, P=0.046). For both groups women who had ⩾2 repeat screens, showed a decrease in mean pleasure scores compared with their annual scores (mean difference=-0.16, P=0.005). Similarly mean pleasure scores decreased following more intensive screens compared with annual screening (mean difference=-0.09, P=0.046). CONCLUSIONS: Ovarian cancer screening did not affect sexual activity and functioning unless a woman had abnormal results and underwent repeated or higher level screening.
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Detección Precoz del Cáncer/métodos , Neoplasias Ováricas/diagnóstico , Conducta Sexual , Disfunciones Sexuales Psicológicas/epidemiología , Estrés Psicológico , Estudios de Casos y Controles , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Imagen Multimodal/métodos , Estadificación de Neoplasias , Neoplasias Ováricas/diagnóstico por imagen , Neoplasias Ováricas/psicología , Pronóstico , Encuestas y Cuestionarios , Ultrasonografía/métodos , Reino Unido/epidemiologíaRESUMEN
BACKGROUND: Preserved residual kidney function (RKF) and normal fluid status are associated with better patient outcomes in incident haemodialysis patients. The objective of this trial is to determine whether using bioimpedance technology in prescribing the optimal post-dialysis weight can reduce the rate of decline of RKF and potentially improve patient outcomes. METHODS/DESIGN: 516 pateints commencing haemodialysis, aged >18 with RKF of > 3 ml/min/1.73 m2 or a urine volume >500 ml per day or per the shorter inter-dialytic period will be consented and enrolled into a pragmatic, open-label, randomized controlled trial. The intervention is incorporation of bioimpedance spectroscopy (BI) determination of normally hydrated weight to set a post-dialysis target weight that limits volume depletion, compared to current standard practice. Clinicians and participants will be blinded to BI measures in the control group and a standardized record capturing management of fluid status will be used in all participants. Primary outcome is preservation of residual kidney function assessed as time to anuria (≤100 ml/day or ≤200 ml urine volume in the short inter-dialytic period). A sample size of 516 was based upon a cumulative incidence of 30% anuria in the control group and 20% in the treatment group and 11% competing risks (death, transplantation) over 10 months, with up to 2 years follow-up. Secondary outcomes include rate of decline in small solute clearance, significant adverse events, hospitalization, loss of vascular access, cardiovascular events and interventions, dialysis efficacy and safety, dialysis-related symptoms and quality of life. Economic evaluation will be carried out to determine the cost-effectiveness of the intervention. Analyses will be adjusted for patient characteristics and dialysis unit practice patterns relevant to fluid management. DISCUSSION: This trial will establish the added value of undertaking BI measures to support clinical management of fluid status and establish the relationship between fluid status and preservation of residual kidney function in incident haemodialysis patients. TRIAL REGISTRATION: ISCCTN Number: 11342007 , completed 26/04/2016; NIHR Portfolio number: CPMS31766; Sponsor: Keele University.
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Espectroscopía Dieléctrica/métodos , Fluidoterapia/métodos , Diálisis Renal/métodos , Insuficiencia Renal/diagnóstico , Insuficiencia Renal/terapia , Desequilibrio Hidroelectrolítico/diagnóstico , Desequilibrio Hidroelectrolítico/terapia , Adulto , Anciano , Anciano de 80 o más Años , Terapia Combinada/métodos , Femenino , Humanos , Pruebas de Función Renal/métodos , Masculino , Persona de Mediana Edad , Calidad de Vida , Insuficiencia Renal/complicaciones , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Resultado del Tratamiento , Desequilibrio Hidroelectrolítico/complicaciones , Adulto JovenRESUMEN
Exposure to large portion sizes is a risk factor for obesity. Specifically designed tableware may modulate how much is eaten and help with portion control. We examined the experience of using a guided crockery set (CS) and a calibrated serving spoon set (SS) by individuals trying to manage their weight. Twenty-nine obese adults who had completed 7-12 weeks of a community weight-loss programme were invited to use both tools for 2 weeks each, in a crossover design, with minimal health professional contact. A paper-based questionnaire was used to collect data on acceptance, perceived changes in portion size, frequency, and type of meal when the tool was used. Scores describing acceptance, ease of use and perceived effectiveness were derived from five-point Likert scales from which binary indicators (high/low) were analysed using logistic regression. Mean acceptance, ease of use and perceived effectiveness were moderate to high (3·7-4·4 points). Tool type did not have an impact on indicators of acceptance, ease of use and perceived effectiveness (P>0·32 for all comparisons); 55 % of participants used the CS on most days v. 21 % for the SS. The CS was used for all meals, whereas the SS was mostly used for evening meals. Self-selected portion sizes increased for vegetables and decreased for chips and potatoes with both tools. Participants rated both tools as equally acceptable, easy to use and with similar perceived effectiveness. Formal trials to evaluate the impact of such tools on weight control are warranted.
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Comportamiento del Consumidor , Utensilios de Comida y Culinaria , Dieta Reductora/métodos , Obesidad/dietoterapia , Aceptación de la Atención de Salud , Cooperación del Paciente , Tamaño de la Porción/normas , Adulto , Índice de Masa Corporal , Calibración , Comportamiento del Consumidor/economía , Utensilios de Comida y Culinaria/economía , Estudios Cruzados , Dieta Saludable/economía , Dieta Saludable/psicología , Dieta Saludable/normas , Dieta Reductora/economía , Dieta Reductora/psicología , Dieta Reductora/normas , Conducta Alimentaria/psicología , Femenino , Humanos , Masculino , Comidas/psicología , Persona de Mediana Edad , Obesidad/economía , Obesidad/psicología , Aceptación de la Atención de Salud/psicología , Cooperación del Paciente/psicología , Educación del Paciente como Asunto/economía , Tamaño de la Porción/efectos adversos , Tamaño de la Porción/economía , Autoinforme , Reino Unido , Programas de Reducción de PesoRESUMEN
BACKGROUND: Within-person variation in dietary records can lead to biased estimates of the distribution of food intake. Quantile estimation is especially relevant in the case of skewed distributions and in the estimation of under- or over-consumption. The analysis of the intake distributions of occasionally-consumed foods presents further challenges due to the high frequency of zero records. Two-part mixed-effects models account for excess-zeros, daily variation and correlation arising from repeated individual dietary records. In practice, the application of the two-part model with random effects involves Monte Carlo (MC) simulations. However, these can be time-consuming and the precision of MC estimates depends on the size of the simulated data which can hinder reproducibility of results. METHODS: We propose a new approach based on numerical integration as an alternative to MC simulations to estimate the distribution of occasionally-consumed foods in sub-populations. The proposed approach and MC methods are compared by analysing the alcohol intake distribution in a sub-population of individuals at risk of developing metabolic syndrome. RESULTS: The rate of convergence of the results of MC simulations to the results of our proposed method is model-specific, depends on the number of draws from the target distribution, and is relatively slower at the tails of the distribution. Our data analyses also show that model misspecification can lead to incorrect model parameter estimates. For example, under the wrong model assumption of zero correlation between the components, one of the predictors turned out as non-significant at 5 % significance level (p-value 0.062) but it was estimated as significant in the correctly specified model (p-value 0.016). CONCLUSIONS: The proposed approach for the analysis of the intake distributions of occasionally-consumed foods provides a quicker and more precise alternative to MC simulation methods, particularly in the estimation of under- or over-consumption. The method is readily available to non-technical users in contrast to MC methods whereby the simulation error may be substantial and difficult to evaluate.
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Consumo de Bebidas Alcohólicas , Encuestas sobre Dietas/métodos , Dieta , Ingestión de Alimentos , Algoritmos , Simulación por Computador , Humanos , Modelos Teóricos , Método de Montecarlo , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: There is increasing recognition of complex interrelations between the endocrine functions of bone and fat tissues or organs. OBJECTIVE: The objective was to describe nonmechanical and mechanical links between metabolic factors, body composition, and bone with the use of graphical Markov models. METHODS: Seventy postmenopausal women with a mean ± SD age of 62.3 ± 3.7 y and body mass index (in kg/m2) of 24.9 ± 3.8 were recruited. Bone outcomes were peripheral quantitative computed tomography measures of the distal and diaphyseal tibia, cross-sectional area (CSA), volumetric bone mineral density (vBMD), and cortical CSA. Biomarkers of osteoblast and adipocyte function were plasma concentrations of leptin, adiponectin, osteocalcin, undercarboxylated osteocalcin (UCOC), and phylloquinone. Body composition measurements were lean and percent fat mass, which were derived with the use of a 4-compartment model. Sequences of Regressions, a subclass of graphical Markov models, were used to describe the direct (nonmechanical) and indirect (mechanical) interrelations between metabolic factors and bone by simultaneously modeling multiple bone outcomes and their relation with biomarker outcomes with lean mass, percent fat mass, and height as intermediate explanatory variables. RESULTS: The graphical Markov models showed both direct and indirect associations linking plasma leptin and adiponectin concentrations with CSA and vBMD. At the distal tibia, lean mass, height, and adiponectin-UCOC interaction were directly explanatory of CSA (R2 = 0.45); at the diaphysis, lean mass, percent fat mass, leptin, osteocalcin, and age-adiponectin interaction were directly explanatory of CSA (R2 = 0.49). The regression models exploring direct associations for vBMD were much weaker, with R2 = 0.15 and 0.18 at the distal and diaphyseal sites, respectively. Lean mass and UCOC were associated, and the global Markov property of the graph indicated that this association was explained by osteocalcin. CONCLUSIONS: This study, to our knowledge, offers a novel approach to the description of the complex physiological interrelations between adiponectin, leptin, and osteocalcin and the musculoskeletal system. There may be benefits to jointly targeting both systems to improve bone health.
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BACKGROUND: Disparities in home dialysis uptake across England suggest inequity and unexplained variation in access. We surveyed staff at all English kidney centres to identify patterns in service organisation/delivery and explore correlations with home therapy uptake, as part of a larger study ('Inter-CEPt'), which aims to identify potentially modifiable factors to address observed variations. METHODS: Between June and September 2022, staff working at English kidney centres were surveyed and individual responses combined into one centre-level response per question using predetermined data aggregation rules. Descriptive analysis described centre practices and their correlation with home dialysis uptake (proportion of new home dialysis starters) using 2019 UK Renal Registry 12-month home dialysis incidence data. RESULTS: In total, 180 responses were received (50/51 centres, 98.0%). Despite varied organisation of home dialysis services, most components of service delivery and practice had minimal or weak correlations with home dialysis uptake apart from offering assisted peritoneal dialysis and 'promoting flexible decision-making about dialysis modality'. Moderate to strong correlations were identified between home dialysis uptake and centres reporting supportive clinical leadership (correlation 0.32, 95% Confidence Interval (CI): 0.05-0.55), an organisational culture that values trying new initiatives (0.57, 95% CI: 0.34-0.73); support for reflective practice (0.38, 95% CI: 0.11-0.60), facilitating research engagement (0.39, 95% CI: 0.13-0.61) and promoting continuous quality improvement (0.29, 95% CI: 0.01-0.53). CONCLUSIONS: Uptake of home dialysis is likely to be driven by organisational culture, leadership and staff attitudes, which provide a supportive clinical environment within which specific components of service organisation and delivery can be effective.
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Hemodiálisis en el Domicilio , Humanos , Hemodiálisis en el Domicilio/estadística & datos numéricos , Inglaterra , Fallo Renal Crónico/terapia , Encuestas y CuestionariosRESUMEN
BACKGROUND: Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, issues to be considered before the decision to use HSD for outcome data in a clinical trial is finalised, a methodological question prioritised by the clinical trials community. METHODS: The PRIMORANT study had three phases. First, an initial workshop was held to scope the issues faced by trialists when considering whether to use HSDs for trial outcomes. Second, a consultation exercise was undertaken with clinical trials unit (CTU) staff, trialists, methodologists, clinicians, funding panels and data providers. Third, a final discussion workshop was held, at which the results of the consultation were fed back, case studies presented, and issues considered in small breakout groups. RESULTS: Key topics included in the consultation process were the validity of outcome data, timeliness of data capture, internal pilots, data-sharing, practical issues, and decision-making. A majority of consultation respondents (n = 78, 95%) considered the development of guidance for trialists to be feasible. Guidance was developed following the discussion workshop, for the five broad areas of terminology, feasibility, internal pilots, onward data sharing, and data archiving. CONCLUSIONS: We provide guidance to inform decisions about whether or not to use HSDs for outcomes, and if so, to assist trialists in working with registries and other HSD providers to improve the design and delivery of trials.
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Atención a la Salud , Difusión de la Información , Humanos , Sistema de RegistrosRESUMEN
Estimating how much is appropriate to consume can be difficult, especially for foods presented in multiple units, those with ambiguous energy content and for snacks. This study tested the hypothesis that the number of units (single vs. multi-unit), meal type and food energy density disrupts accurate estimates of portion size. Thirty-two healthy weight men and women attended the laboratory on 3 separate occasions to assess the number of portions contained in 33 foods or beverages of varying energy density (1.7-26.8 kJ/g). Items included 12 multi-unit and 21 single unit foods; 13 were labelled "meal", 4 "drink" and 16 "snack". Departures in portion estimates from reference amounts were analysed with negative binomial regression. Overall participants tended to underestimate the number of portions displayed. Males showed greater errors in estimation than females (p=0.01). Single unit foods and those labelled as 'meal' or 'beverage' were estimated with greater error than multi-unit and 'snack' foods (p=0.02 and p<0.001 respectively). The number of portions of high energy density foods was overestimated while the number of portions of beverages and medium energy density foods were underestimated by 30-46%. In conclusion, participants tended to underestimate the reference portion size for a range of food and beverages, especially single unit foods and foods of low energy density and, unexpectedly, overestimated the reference portion of high energy density items. There is a need for better consumer education of appropriate portion sizes to aid adherence to a healthy diet.
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Ingestión de Energía , Comidas/psicología , Tamaño de la Porción de Referencia/psicología , Adolescente , Adulto , Apetito/fisiología , Bebidas , Índice de Masa Corporal , Peso Corporal , Dieta/psicología , Grasas de la Dieta/administración & dosificación , Grasas de la Dieta/análisis , Femenino , Alimentos , Alimentos Orgánicos , Humanos , Modelos Lineales , Masculino , Persona de Mediana Edad , Percepción del Tamaño , Encuestas y Cuestionarios , Adulto JovenRESUMEN
Introduction: How patient, center, and insertion technique factors interact needs to be understood when designing peritoneal dialysis (PD) catheter insertion pathways. Methods: We undertook a prospective cohort study in 44 UK centers enrolling participants planned for first catheter insertion. Sequences of regressions were used to describe the associations linking patient and dialysis unit-level characteristics with catheter insertion technique and their impact on the occurrence of catheter-related events in the first year (catheter-related infection, hospitalization, and removal). Factors associated with catheter events were incorporated into a multistate model comparing the rates of catheter events between medical and surgical insertion alongside treatment modality transitions and mortality. Results: Of 784 first catheter insertions, 466 (59%) had a catheter event in the first year and 61.2% of transitions onto hemodialysis (HD) were immediately preceded by a catheter event. Catheter malfunction was less but infection was more common with surgical compared with medical insertions. Participants at centers with fewer late presenters and more new dialysis patients starting PD, had a lower probability of a catheter event. Adjusting for these factors, the hazard ratio for a catheter event following insertion (medical vs. surgical) was 0.70 (95% confidence interval [CI] 0.43 to 1.13), and once established on PD 0.77 (0.62 to 0.96). Conclusion: Offering both medical and surgical techniques is associated with lower catheter event rates and keeps people on PD for longer.
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BACKGROUND: Discussing early-phase cancer trials is challenging; most offer little personal benefit to patients with life-limiting illnesses who frequently have a poor understanding of and misconceptions about the therapeutic aims. We evaluated an evidence-based training program aimed at enhancing communication. METHODS: Prior to and after the intervention, 47 health care professionals (HCPs) experienced in early-phase trial recruitment were audio taped discussing trials with patient simulators who completed postinterview evaluations. Coders rated the interviews for the presence of information areas required to elicit ethical consent. HCPs reported their self-confidence on 15 different aspects of trial discussion. RESULTS: Significant objective and subjective improvements in communication were found after the workshop. Analyses of audio tapes showed positive shifts in: establishing the patient's knowledge of their prognosis (odds ratio [OR], 2.7; p = .002), discussing symptomatic care (OR, 3.8; p < .001), the aims of the trial (OR, 2.6; p =.002), and the unlikelihood of medical benefit (OR, 3.0; p = .021). Patient simulator ratings showed improvements in: the awareness of palliative care and symptom control (OR, 2.1; p = .004), the voluntariness of participation (OR, 3.7; p = .015), the opportunity to ask questions (OR, 2.9; p = .044), and the time to consider participation (OR, 6.1; p = .009). HCPs' self-confidence increased significantly for all 15 items (OR range, 1.5-2.9; p ≤ .001). CONCLUSION: This short, intensive workshop changed communication skills competency and self-efficacy in ways likely to promote valid, ethically informed consent from patients contemplating trial entry.
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Ensayos Clínicos como Asunto , Educación del Paciente como Asunto , Ensayos Clínicos como Asunto/ética , Humanos , Educación del Paciente como Asunto/ética , Participación del Paciente/psicologíaRESUMEN
BACKGROUND: Protracted bacterial bronchitis (PBB) is an endobronchial infection and a the most common cause of chronic wet cough in young children. It is treated with antibiotics, which can only be targeted if the causative organism is known. As most affected children do not expectorate sputum, lower airway samples can only be obtained by bronchoalveolar lavage (BAL) samples taken during flexible bronchoscopy (FB-BAL). This is invasive and is therefore reserved for children with severe or relapsing cases. Most children with PBB are treated empirically with broad spectrum antibiotics. CLASSIC PBB will compare the pathogen yield from two less invasive strategies with that from FB-BAL to see if they are comparable. METHODS: 131 children with PBB from four UK centres referred FB-BAL will be recruited. When attending for FB-BAL, they will have a cough swab and an induced sputum sample obtained. The primary outcome will be the discordance of the pathogen yield from the cough swab and the induced sputum when compared with FB-BAL. Secondary outcomes will be the sensitivity of each sampling strategy, the success rate of the induced sputum in producing a usable sample and the tolerability of each of the three sampling strategies. DISCUSSION: If either or both of the two less invasive airway sampling strategies are shown to be a useful alternative to FB-BAL, this will lead to more children with PBB having lower airway samples enabling targeted antibiotic prescribing. It would also reduce the need for FB, which is known to be burdensome for children and their families. TRIAL REGISTRATION NUMBER: ISRCTN79883982.
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Infecciones Bacterianas , Bronquitis Crónica , Humanos , Niño , Preescolar , Tos/diagnóstico , Tos/tratamiento farmacológico , Tos/complicaciones , Líquido del Lavado Bronquioalveolar/microbiología , Recurrencia Local de Neoplasia/complicaciones , Bronquitis Crónica/tratamiento farmacológico , Bronquitis Crónica/complicaciones , Bronquitis Crónica/microbiología , Enfermedad Crónica , Infección Persistente , Antibacterianos/uso terapéuticoRESUMEN
INTRODUCTION: Use of home dialysis by centres in the UK varies considerably and is decreasing despite attempts to encourage greater use. Knowing what drives this unwarranted variation requires in-depth understanding of centre cultural and organisational factors and how these relate to quantifiable centre performance, accounting for competing treatment options. This knowledge will be used to identify components of a practical and feasible intervention bundle ensuring this is realistic and cost-effective. METHODS AND ANALYSIS: Underpinned by the non-adoption, abandonment, scale-up, spread and sustainability framework, our research will use an exploratory sequential mixed-methods approach. Insights from multisited focused team ethnographic and qualitative research at four case study sites will inform development of a national survey of 52 centres. Survey results, linked to patient-level data from the UK Renal Registry, will populate a causal graph describing patient and centre-level factors, leading to uptake of home dialysis and multistate models incorporating patient-level treatment modality history and mortality. This will inform a contemporary economic evaluation of modality cost-effectiveness that will quantify how modification of factors facilitating home dialysis, identified from the ethnography and survey, might yield the greatest improvements in costs, quality of life and numbers on home therapies. Selected from these factors, using the capability, opportunity and motivation for behaviour change framework (COM-B) for intervention design, the optimal intervention bundle will be developed through workshops with patients and healthcare professionals to ensure acceptability and feasibility. Patient and public engagement and involvement is embedded throughout the project. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Health Research Authority reference 20-WA-0249. The intervention bundle will comprise components for all stake holder groups: commissioners, provider units, recipients of dialysis, their caregivers and families. To reache all these groups, a variety of knowledge exchange methods will be used: short guides, infographics, case studies, National Institute for Health and Care Excellence guidelines, patient conferences, 'Getting it Right First Time' initiative, Clinical Reference Group (dialysis).