Introduction Routine collection of patient-reported outcome measures (PROMs) has the potential to inform and improve cancer care. It is now feasible for patients to complete PROMs electronically (ePROMs) providing information about their current levels of symptoms, side effects of treatment and other concerns. PROM scores can be tracked over time allowing more timely identification of problems and more appropriate intervention. Studies have reported clear benefits in patient–clinician communication when PROMs are used and trials in the USA and France found patients randomised to complete regular ePROMs reported better health-related quality of life, had fewer unplanned hospital visits and, importantly, significantly better survival than those randomised to usual care. However, information about the effects on health outcomes and, particularly, the cost-effectiveness of incorporating this information into practice is limited. Methods and analysis PROMISE (Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service Experience) is a multicentre, randomised hybrid effectiveness/implementation trial to evaluate the clinical and cost-effectiveness of using ePROMs in routine cancer care to improve patient outcomes. Participants (target sample=572; randomised 1:1 to intervention and control) are adults aged 18 years or older diagnosed with a solid cancer and starting treatment at one of the four study hospitals. The primary outcomes are unplanned hospital presentations and physical/functional well-being at 6 months. We hypothesise that, compared with usual care, patients randomised to use an ePROM tool will have fewer unplanned hospital presentations, report better health-related quality of life and greater satisfaction with their care and that the ePROM tool will be cost-effective. We will also assess implementation and process outcomes consistent with the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) Framework. Ethics and dissemination This trial has been approved by the Metro South Human Research Ethics Committee (HREC/2020/QMS/67441). Participants provide written informed consent, including consent for record linkage, prior to completing the baseline questionnaire. Study results will be disseminated via peer-reviewed journals and presentations at scientific conferences and clinical meetings. Trial registration number ACTRN12620001290987.
Background Gastroesophageal reflux is overrepresented in people with obstructive sleep apnea (OSA) and it has been suggested that OSA worsens gastroesophageal reflux symptoms. Aggravated reflux might lead to an increased risk of Barrett’s esophagus. Aim To assess the association between sleep apnea symptoms and Barrett’s esophagus. Methods Included in a case-control study in Brisbane, Australia were 237 patients with histologically confirmed Barrett’s esophagus and 247 population controls. The controls were randomly selected from the electoral roll and frequency-matched to the cases by age and sex. Information on OSA symptoms (excessive daytime sleepiness and sleep related apnea symptoms), gastroesophageal reflux symptoms and anthropometric measures were collected through interviews and written questionnaires. Multivariable logistic regression provided odds ratios (OR) and 95% confidence intervals (CI), adjusted for potential confounding by BMI and gastroesophageal reflux. Results The prevalence of Barrett’s esophagus was higher among people with excessive daytime sleepiness than those without (24% vs. 18%; p-value 0.1142) and in participants with sleep-related apnea symptoms (20% vs. 13%; p-value 0.1730). However, there were non-significantly increased ORs of Barrett’s esophagus among people with excessive daytime sleepiness (OR 1.42, 95% CI 0.90–2.34) and sleep related apnea symptoms (OR 1.32, 95% CI 0.74–2.36) when adjusting for age, sex and BMI. After further adjustment for gastroesophageal reflux symptoms, the point ORs were no longer increased (OR 1.02, 95% CI 0.61–1.70 for daytime sleepiness and OR 0.72, 95% CI 0.38–1.38 for sleep related apnea symptoms). Conclusions Symptoms of OSA are possibly associated with an increased risk of Barrett’s esophagus, an association that appears to be mediated entirely by gastroesophageal reflux.
Goal: The goal of this study was to determine if there is an association between the insulin–insulin-like growth factor axis, the metabolic syndrome (MetS), type 2 diabetes mellitus and risk of Barrett’s esophagus (BE), and if these associations are modified by sex. Background: BE is more common in males. Gastroesophageal reflux disease, the major risk factor for BE occurs at similar frequencies in both sexes, suggesting that sex-related factors such as the metabolic effects of abdominal obesity may be important in the causation of BE. Materials and Methods: A structured interview, anthropometric measures, and fasting blood were collected within a population-based case-control study. We recruited 227 BE cases (70% male) and 241 population controls, frequency matched by age and sex. We estimated odds ratios (ORs) and 95% confidence intervals (CIs) for association with BE using multivariable logistic regression models. Results: Hyperinsulinemia (highest vs. lowest tertile, OR=1.9; 95% CI: 1.2-3.1), Homeostatic Model Assessment of Insulin Resistance (OR=1.9; 95% CI: 1.2-3.1) and the MetS (OR=1.8; 95% CI: 1.2-2.6) were independently associated with an increased risk of BE. With each additional MetS criterion, there was a 20% increased risk of BE (OR=1.2; 95% CI: 1.0-1.4). When stratified by sex, these associations were found in males but not females. We found no association with serum measures of insulin-like growth factors or interleukin-6 and risk of BE. Conclusion: Hyperinsulinemia, insulin resistance, and the MetS are associated with the risk of BE in males but not females, suggesting these factors may contribute to the higher prevalence of BE in males.
Background: Abdominal obesity is strongly associated with the risk of Barrett's oesophagus (BO). Hip obesity appears to protect against the cardiovascular and metabolic consequences of abdominal obesity. A recent study in men has suggested hip obesity may similarly be protective against the effects of abdominal obesity on risk of BOAim: To conduct a case-control study to assess the effects of hip obesity on the risk of BO associated with abdominal obesity.Methods: We undertook a structured interview, clinical and anthropometric measures within a case-control study conducted in Brisbane, Australia. We recruited 237 cases (70% Males, Mean age 62.1 yrs) with histologically confirmed BO diagnosed 2003–6 and 247 controls from the electoral roll, frequency matched by age and sex to cases. Odds ratios (OR) and 95% confidence intervals (CI) were estimated using multivariable logistic regression analysis. Sex adjusted tertile cut points in the control population were used for classification of anthropometric variables with the lowest tertile being used as the reference category.Results: Hip circumference (Cases 106.4 cm, Controls 105.0 cm; p = 0.05) and waist circumference (Cases 101.8 cm, Controls 97.4 cm; p = 0.002) were higher in cases than controls. Both hip circumference (OR 1.76; 1.12–2.76) and waist circumference (OR 2.18; 1.37–3.45) were associated with the risk of BO. When adjusted for each other, the association with waist circumference (OR 2.31; 1.17–4.57) strengthened but the association with hip circumference was abolished (OR 0.94; 0.48–1.84). These effects were greater in men than women, with an inverse association between high hip circumference and risk of BO when adjusted for waist circumference in men (OR 0.57;0.25–1.31, per 5 cm increments OR 0.79; 0.64–0.98).Conclusions: As with risk of cardiovascular and metabolic disease, the risk of BO associated with abdominal obesity appears to be attenuated by hip obesity, particular in men. The mechanism for this is uncertain but factors including the metabolic “sink” effect of hip obesity warrant further study.
Introduction Provision of palliative care is inequitable with wide variations across conditions and settings in the UK. Lack of a standard way to classify by case complexity is one of the principle obstacles to addressing this. We aim to develop and validate a casemix classification to support the prediction of costs of specialist palliative care provision. Methods and analysis Phase I: A cohort study to determine the variables and potential classes to be included in a casemix classification. Data are collected from clinicians in palliative care services across inpatient hospice, hospital and community settings on: patient demographics, potential complexity/casemix criteria and patient-level resource use. Cost predictors are derived using multivariate regression and then incorporated into a classification using classification and regression trees. Internal validation will be conducted by bootstrapping to quantify any optimism in the predictive performance (calibration and discrimination) of the developed classification. Phase II: A mixed-methods cohort study across settings for external validation of the classification developed in phase I. Patient and family caregiver data will be collected longitudinally on demographics, potential complexity/casemix criteria and patient-level resource use. This will be triangulated with data collected from clinicians on potential complexity/casemix criteria and patient-level resource use, and with qualitative interviews with patients and caregivers about care provision across difference settings. The classification will be refined on the basis of its performance in the validation data set. Ethics and dissemination The study has been approved by the National Health Service Health Research Authority Research Ethics Committee. The results are expected to be disseminated in 2018 through papers for publication in major palliative care journals; policy briefs for clinicians, commissioning leads and policy makers; and lay summaries for patients and public. Trial registration number ISRCTN90752212 .
ContextEnd-of-life care (EoLC) communication skills training for generalist palliative care providers is recommended in policy guidance globally. Although many training programs now exist, there has been no comprehensive evidence synthesis to inform future training delivery and evaluation.ObjectivesTo identify and appraise how EoLC communication skills training interventions for generalist palliative care providers are developed, delivered, evaluated, and reported.MethodsSystematic review. Ten electronic databases (inception to December 2015) and five relevant journals (January 2004 to December 2015) were searched. Studies testing the effectiveness of EoLC communication skills training for generalists were included. Two independent authors assessed study quality. Descriptive statistics and narrative synthesis are used to summarize the findings.ResultsFrom 11,441 unique records, 170 reports were identified (157 published, 13 unpublished), representing 160 evaluation studies of 153 training interventions. Of published papers, eight were of low quality, 108 medium, and 41 high. Few interventions were developed with service user involvement (n = 7), and most were taught using a mixture of didactics (n = 123), reflection and discussion (n = 105), and role play (n = 86). Evaluation designs were weak: <30% were controlled, <15% randomized participants. Over half (n = 85) relied on staff self-reported outcomes to assess effectiveness, and 49% did not cite psychometrically validated measures. Key information (e.g., training duration, participant flow) was poorly reported.ConclusionsDespite a proliferation of EoLC communication skills training interventions in the literature, evidence is limited by poor reporting and weak methodology. Based on our findings, we present a CONSORT statement supplement to improve future reporting and encourage more rigorous testing.
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