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Anxiety and depression in cardiac rehabilitation (CR) are associated with greater morbidity, mortality, and increased healthcare costs. Current psychological interventions within CR have small effects based on low-quality studies of clinic-based interventions with limited access to home-based psychological support. We tested the effectiveness of adding self-help metacognitive therapy (Home-MCT) to CR in reducing anxiety and depression in a randomised controlled trial (RCT). We ran a single-blind, multi-centre, two-arm RCT. A total of 240 CR patients were recruited from 5 NHS-Trusts across North West England between April 20, 2017 and April 6, 2020. Patients were randomly allocated to Home-MCT+CR (n = 118, 49.2%) or usual CR alone (n = 122, 50.8%). Randomisation was 1:1 via randomised blocks within hospital site, balancing arms on sex and baseline Hospital Anxiety and Depression Scale (HADS) scores. The primary outcome was the HADS total score at posttreatment (4-month follow-up). Follow-up data collection occurred between August 7, 2017 and July 20, 2020. Analysis was by intention to treat. The 4-month outcome favoured the MCT intervention group demonstrating significantly lower end of treatment scores (HADS total: adjusted mean difference = -2.64 [-4.49 to -0.78], p = 0.005, standardised mean difference (SMD) = 0.38). Sensitivity analysis using multiple imputation (MI) of missing values supported these findings. Most secondary outcomes also favoured Home-MCT+CR, especially in reduction of post-traumatic stress symptoms (SMD = 0.51). There were 23 participants (19%) lost to follow-up in Home-MCT+CR and 4 participants (3%) lost to follow-up in CR alone. No serious adverse events were reported. The main limitation is the absence of longer term (e.g., 12-month) follow-up data. Self-help home-based MCT was effective in reducing total anxiety/depression in patients undergoing CR. Improvement occurred across most psychological measures. Home-MCT was a promising addition to cardiac rehabilitation and may offer improved access to effective psychological treatment in cardiovascular disease (CVD) patients. NCT03999359.

Electronic patient-reported outcomes (ePROs) are commonly used in oncology clinical practice and have shown benefits for patients and health resource use. The aim of this study was to compare the isolated effect of administering ePROs to patients with cancer versus a control condition. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Randomized controlled trials evaluating ePRO interventions that aimed to improve health-related outcomes among patients with cancer were included. The primary outcome was health-related quality of life (HRQOL), and the secondary outcomes were symptoms, hospital admissions, unplanned visits, chemotherapy completion, survival, and satisfaction with care. The effect sizes of ePROs on health-related outcomes were analyzed as standardized mean differences (SMDs) with 95% CIs using a random effects model. The search identified 10,965 papers, of which 19 (0.17%) from 15 studies were included. The meta-analysis showed an improvement in HRQOL at 3 months, measured by the Functional Assessment of Cancer Therapy–General (SMD 0.29, 95% CI 0.19 to 0.39), and at 6 months, assessed using various HRQOL measures (SMD 0.21, 95% CI 0.11 to 0.30). Of the 15 studies, 9 (60%) reported a positive signal on HRQOL, with two-thirds of the studies (n=6, 67%) including tailored patient advice and two-thirds (n=6, 67%) using clinician alert systems. The meta-analysis showed an improvement in HRQOL at 6 months and in Functional Assessment of Cancer Therapy–General scores at 3 months for studies that included tailored advice and clinician alerts, suggesting that these elements may improve ePRO effectiveness. The findings will provide guidance for future use and help health care professionals choose the most suitable ePRO features for their patients. PROSPERO CRD42020175007; https://tinyurl.com/5cwmy3j6.

The evolving history of the small intestinal biopsy and its interpretation—and misinterpretations—are described in this paper. Certain interpretative errors in the technical approaches to histological assessment are highlighted—even though we may never be rid of them. For example, mucosal “flattening” does not reduce individual villi to their cores, as still seems to be widely believed. Neither is the mucosa undergoing an atrophic process—since it can recover structurally. Rather, the intestinal mucosa manifests a vast hypertrophic response resulting in the formation of large plateaus formed from partially reduced villi and their amalgamation with the now increased height and width of the inter‐villous ridges: this is associated with considerable increases in crypt volumes. Sections through mosaic plateaus gives an erroneous impression of the presence of stunted, flat‐topped villi which continues to encourage both the continued use of irrelevant “atrophy” terminologies and a marked failure to perceive what random sections through mosaic plateaus actually look like. While reviewing the extensive 40+ year literature on mucosal analysis, we extracted data on intraepithelial lymphocytes (IEL) counts from 607 biopsies, and applied receiver‐operating characteristic (ROC)‐curve analysis. From that perspective, it appears that counting IEL/100 enterocyte nuclei in routine haematoxylin and eosin (H&E) sections provides the most useful discriminator of celiac mucosae at histological level, with an effective cut‐off of 27 IEL, and offering a very high sensitivity with few false negatives. ROC‐curve analysis also revealed the somewhat lesser accuracies of either CD3+ or γδ+ IEL counts. Current official guidelines seem to be somewhat inadequate in clearly defining the spectrum of gluten‐induced mucosal pathologies and how they could be optimally interpreted, as well as in promoting the ideal manner for physicians and pathologists to interact in interpreting intestinal mucosae submitted for analysis. Future trends should incorporate 3‐D printing and computerised modelling in order to exemplify the subtle micro‐anatomical features associated with the crypt‐villus interzone. The latter needs precise delineation with use of mRNA in‐section assays for brush border enzymes such as alkaline phosphate and esterase. Other additional approaches are needed to facilitate recognition and interpretation of the features of this important inter‐zone, such as wells, basins and hypertrophic alterations in the size of inter‐villous ridges. The 3‐D computerised models could considerably expand our understandings of the microvasculature and its changes—in relation both to crypt hypertrophy, in addition to the partial attrition and subsequent regrowth of villi from the inter‐villous ridges during the flattening and recovery processes, respectively.

[This corrects the article DOI: 10.2196/49089.].

ObjectivesThe burden of cardiovascular disease (CVD) is increasing. Cardiac rehabilitation (CR) is a complex intervention offered to patients with CVD, following a heart event, diagnosis or intervention, and it aims to reduce mortality and morbidity. The objective of this within-trial economic evaluation was to compare the cost-effectiveness of metacognitive therapy (MCT) plus usual care (UC) to UC, from a health and social care perspective in the UK.MethodsA multicentre, single-blind, randomised controlled trial (ISRCTN74643496) was conducted in the UK involving 332 patients with CR with elevated symptoms of anxiety and/or depression and compared group-based MCT with UC. The primary outcome of the cost-effectiveness analysis was quality-adjusted life-years (QALYs). The time horizon of the primary analysis was a 12-month follow-up. Missing data were imputed using multiple imputation. Uncertainty was explored by probabilistic bootstrapping. Sensitivity analyses tested the impact of the study design and assumptions on the incremental cost-effectiveness ratio.ResultsIn the primary cost-effectiveness analysis, MCT intervention was dominant, with a cost-saving (net cost −£219; 95% CI −£1446, £1007) and QALY gains (net QALY 0.015; 95% CI −0.015, 0.045). However, there is a high level of uncertainty in the estimates. At a threshold of £30 000 per QALY, MCT intervention of around 76% was likely to be cost-effective.ConclusionsResults suggest that intervention may be cost-saving and health-increasing; however, findings are uncertain and subject to limitations. Further research should aim to reduce the uncertainty in the findings (eg, with larger sample sizes) and explore potential longer-term economic benefits associated with MCT in this setting.

Objective The variation in reported prevalence of growth hormone deficiency (GHD) post subarachnoid haemorrhage (SAH) is mainly due to methodological heterogeneity. We report on the prevalence of GHD in a large cohort of patients following SAH, when dynamic and confirmatory pituitary hormone testing methods are systematically employed. Design In this cross-sectional study, pituitary function was assessed in 100 patients following SAH. Baseline pituitary hormonal profile measurement and glucagon stimulation testing (GST) was carried out in all patients. Isolated GHD was confirmed with an Arginine stimulation test and ACTH deficiency was confirmed with a short synacthen test. Results The prevalence of hypopituitarism in our cohort was 19% and the prevalence of GHD was 14%. There was no association between GHD and the clinical or radiological severity of SAH at presentation, treatment modality, age, or occurrence of vasospasm. There were statistically significant differences in terms of Glasgow Outcome Scale (GOS; p = 0.03) between patients diagnosed with GHD and those without. Significant inverse correlations between GH peak on GST with body mass index (BMI) and waist hip ratio (WHR) was also noted (p < 0.0001 and p < 0.0001 respectively). Conclusion Using the current testing protocol, the prevalence of GHD detected in our cohort was 14%. It is unclear if the BMI and WHR difference observed is truly due to GHD or confounded by the endocrine tests used in this protocol. There is possibly an association between the development of GHD and worse GOS score. Routine endocrine screening of all SAH survivors with dynamic tests is time consuming and may subject many patients to unnecessary side-effects. Furthermore the degree of clinical benefit derived from growth hormone replacement in this patient group, remains unclear. Increased understanding of the most appropriate testing methodology in this patient group and more importantly which SAH survivors would derive most benefit from GHD screening is required.

Introduction Focal segmental glomerulosclerosis (FSGS) is one of the leading causes of nephrotic syndrome in adults. This epidemiological study describes a renal centre’s 20-year experience of primary FSGS. Methods Patients were identified with a diagnosis of primary FSGS after exclusion of known secondary causes. In this retrospective observational study, data was collected for baseline demographics, immunosuppression and outcomes. A two-step cluster analysis was used to identify natural groupings within the dataset. Results The total cohort was made up of 87 patients. Those who received immunosuppression had lower median serum albumin than those who did not- 23g/L vs 40g/L ( p <0.001) and higher median urine protein creatinine ratios (uPCR)- 795mg/mmol vs 318mg/mmol ( p <0.001). They were more likely to achieve complete remission (62% vs 40%, p =0.041), but relapsed more 48.6% vs 22% ( p =0.027). Overall 5 year mortality was 10.3% and 5 year progression to RRT was seen in 17.2%. Complete remission was observed in 49.4%. The 2-step cluster analysis separated the cohort into 3 clusters: cluster 1 ( n =26) with ‘nephrotic-range proteinuria’; cluster 2 ( n =43) with ‘non-nephrotic-range proteinuria’; and cluster 3 ( n =18) with nephrotic syndrome. Immunosuppression use was comparable in clusters 1 and 3, but lower in cluster 2 (77.8% and 69.2% vs 11.6%, p <0.001). Rates of complete remission were greatest in clusters 1 and 3 vs cluster 2: 57.7% and 66.7% vs 37.2%. Conclusion People who received immunosuppression had lower serum albumin and achieved remission more frequently, but were also prone to relapse. Our cluster analysis highlighted 3 FSGS phenotypes: a nephrotic cluster that clearly require immunosuppression; a cohort with preserved serum albumin and non-nephrotic range proteinuria who will benefit from supportive care; and lastly a cluster with heavy proteinuria but serum albumin > 30g/L. This group may still have immune mediated disease and thus could potentially benefit from immunosuppression. Trial registration This study protocol was reviewed and approved by the ‘Research and Innovation committee of the Northern Care Alliance NHS Group’, study approval number (Ref: ID 22HIP54).

Background Arthritis (or compression) gloves are widely prescribed to people with rheumatoid arthritis and other forms of hand arthritis. They are prescribed for daytime wear to reduce hand pain and improve hand function, and/or night-time wear to reduce pain, improve sleep and reduce morning stiffness. However, evidence for their effectiveness is limited. The aims of this study were to investigate the clinical and cost effectiveness of arthritis gloves compared to placebo gloves on hand pain, stiffness and function in people with rheumatoid arthritis and persistent hand pain. Methods A parallel randomised controlled trial, in adults (≥ 18 years) with rheumatoid or undifferentiated inflammatory arthritis at 16 National Health Service sites in the UK. Patients with persistent hand pain affecting function and/or sleep were eligible. Randomisation (1:1) was stratified by recent change (or not) in medication, using permuted blocks of random sizes. Three-quarter-finger length arthritis gloves (Isotoner®: applying 23-32 mmHg pressure) (intervention) were compared to loose-fitting placebo gloves (Jobskin® classic: providing no/minimal pressure) (control). Both gloves (considered to have similar thermal qualities) were provided by occupational therapists. Patients and outcome assessors were blinded; clinicians were not. The primary outcome was dominant hand pain on activity (0–10) at 12 weeks, analysed using linear regression and intention to treat principles. Results Two hundred six participants were randomly assigned (103 per arm) and 163 (84 intervention: 79 control) completed 12-week follow-up. Hand pain improved by 1.0 (intervention) and 1.2 (control), an adjusted mean difference of 0.10 (95% CI: − 0.47 to 0.67; p = 0.72). Adverse events were reported by 51% of intervention and 36% of control group participants; with 6 and 7% respectively, discontinuing glove wear. Provision of arthritis gloves cost £129, with no additional benefit. Conclusion The trial provides evidence of no clinically important effect of arthritis gloves on any of the trial outcomes (hand pain, function and stiffness) and arthritis gloves are not cost-effective. The clinical and cost-effectiveness results support ceasing provision of arthritis gloves in routine clinical practice. Funding: National Institute for Health Research. Trial registration ISRCTN, ISRCTN25892131 ; Registered 05/09/2016: retrospectively registered.

ObjectiveTo determine the prevalence, nature and predictors of patients having medication administration omissions in hospitals.MethodsAll medication administration omissions data collected using the standardised methodology of the Medication Safety Thermometer in January 2015 were examined. Hospital inpatients prescribed at least one medication were included in the analysis. Multilevel logistic regression models ascertained the effects of patients’ gender, age, number of prescribed medicines, ward specialty and medicines reconciliation initiation status on the likelihood of having omissions. Valid clinical reasons (VCRs) were excluded from regression models. A sensitivity analysis, excluding patient refusal (PR) omissions, was also conducted.ResultsThe final study sample included 5708 patients from 320 wards in 37 hospitals. Excluding VCRs, 30% of patients had medication administration omissions (95% CI 29 to 30). Approximately half of patients with omissions had refused medicines (51%, 95% CI 49 to 53). Univariable analysis suggested that all variables were significantly associated with omissions. However, in the multivariable model, significant differences were only observed regarding the numbers of medicines patients were prescribed and their ward specialty. Patients prescribed more than 20 medications were approximately five times more likely to have had omissions than patients prescribed one to four medications (OR 4.99, 95% CI 3.22 to 7.73). Patients on surgical wards were also more likely to have had omissions than those on medical wards (OR 1.58, 95% CI 1.14 to 2.18, p=0.006), but there was no significant difference when PRs were excluded (OR 0.5, 95% CI 0.27 to 1.22, p=0.473).ConclusionMedication administration omissions are a substantial problem that affect many hospital patients, and certain patient groups are at higher risk. Specific interventions are required targeting the underlying reasons for medication omissions for different patient subgroups.

ObjectivesTo devise an assessment tool to aid discharge and admission decision-making in relation to children and young people in hospital urgent and emergency care facilities, and thereby improve the quality of care that patients receive, using a clinical prediction modelling approach.DesignObservational cohort study with internal and external validation of a predictive tool.SettingTwo general emergency departments (EDs) and an urgent care centre in the North of England.ParticipantsThe eligibility criteria were children and young people 0–16 years of age who attended one of the three hospital sites within one National Health Service (NHS) organisation. Children were excluded if they opted out of the study, were brought to the ED following their death in the community or arrived in cardiac arrest when the heart rate and respiratory rate would be unmeasurable.Main outcome measuresAdmission or discharge. A participant was defined as being admitted to hospital if they left the ED to enter the hospital for further assessment, (including being admitted to an observation and assessment unit or hospital ward), either on first presentation or with the same complaint within 7 days. Those who were not admitted were defined as having been discharged.ResultsThe study collected data on 36 365 participants. 15 328 participants were included in the final analysis cohort (21 045 observations) and 17 710 participants were included in the validation cohort (23 262 observations). There were 14 variables entered into the regression analysis. Of the 13 that remained in the final model, 10 were present in all 500 bootstraps. The resulting Paediatric Admission Guidance in the Emergency Department (PAGE) score demonstrated good internal validity. The C-index (area under the ROC) was 0.779 (95% CI 0.772 to 0.786).ConclusionsFor units without the immediate availability of paediatricians the PAGE score can assist staff to determine risk of admission. Cut-off values will need to be adjusted to local circumstance.Study protocolThe study protocol has been published in an open access journal: Riaz et al Refining and testing the diagnostic accuracy of an assessment tool (Pennine Acute Hospitals NHS Trust-Paediatric Observation Priority Score) to predict admission and discharge of children and young people who attend an ED: protocol for an observational study. BMC Pediatr 18, 303 (2018). https://doi.org/10.1186/s12887-018-1268-7.Trial registration numberThe protocol has been published and the study registered (NIHR RfPB Grant: PB-PG-0815–20034; ClinicalTrials.gov:213469).