Automatic categorization of self-acknowledged limitations in randomized controlled trial publications.

OBJECTIVE: Acknowledging study limitations in a scientific publication is a crucial element in scientific transparency and progress. However, limitation reporting is often inadequate. Natural language processing (NLP) methods could support automated reporting checks, improving research transparency. In this study, our objective was to develop a dataset and NLP methods to detect and categorize self-acknowledged limitations (e.g., sample size, blinding) reported in randomized controlled trial (RCT) publications. METHODS: We created a data model of limitation types in RCT studies and annotated a corpus of 200 full-text RCT publications using this data model. We fine-tuned BERT-based sentence classification models to recognize the limitation sentences and their types. To address the small size of the annotated corpus, we experimented with data augmentation approaches, including Easy Data Augmentation (EDA) and Prompt-Based Data Augmentation (PromDA). We applied the best-performing model to a set of about 12K RCT publications to characterize self-acknowledged limitations at larger scale. RESULTS: Our data model consists of 15 categories and 24 sub-categories (e.g., Population and its sub-category DiagnosticCriteria). We annotated 1090 instances of limitation types in 952 sentences (4.8 limitation sentences and 5.5 limitation types per article). A fine-tuned PubMedBERT model for limitation sentence classification improved upon our earlier model by about 1.5 absolute percentage points in F1 score (0.821 vs. 0.8) with statistical significance (p<.001). Our best-performing limitation type classification model, PubMedBERT fine-tuning with PromDA (Output View), achieved an F1 score of 0.7, improving upon the vanilla PubMedBERT model by 2.7 percentage points, with statistical significance (p<.001). CONCLUSION: The model could support automated screening tools which can be used by journals to draw the authors' attention to reporting issues. Automatic extraction of limitations from RCT publications could benefit peer review and evidence synthesis, and support advanced methods to search and aggregate the evidence from the clinical trial literature.

Effects of a transitional care programme on medication adherence in an older cardiac population: A randomized clinical trial.

AIMS: Medication non-adherence post-discharge is common among patients, especially those suffering from chronic medical conditions, and contributes to hospital admissions and mortality. This study aimed to evaluate the effect of the Cardiac Care Bridge (CCB) intervention on medication adherence post-discharge. METHODS: We performed a secondary analysis of the CCB randomized single-blind trial, a study in patients ≥70 years, at high risk of functional loss and admitted to cardiology departments in six hospitals. In this multi-component intervention study, community nurses performed medication reconciliation and observed medication-related problems (MRPs) during post-discharge home visits, and pharmacists provided recommendations to resolve MRPs. Adherence to high-risk medications was measured using the proportion of days covered (PDC), using pharmacy refill data. Furthermore, MRPs were assessed in the intervention group. RESULTS: For 198 (64.7%) of 306 CCB patients, data were available on adherence (mean age: 82 years; 58.9% of patients used a multidose drug dispensing [MDD] system). The mean PDC before admission was 92.3% in the intervention group (n = 99) and 88.5% in the control group (n = 99), decreasing to 85.2% and 84.1% post-discharge, respectively (unadjusted difference: -2.6% (95% CI -9.8 to 4.6, P = .473); adjusted difference -3.3 (95% CI -10.3 to 3.7, P = .353)). Post-hoc analysis indicated that a modest beneficial intervention effect may be restricted to MDD non-users (Pinteraction = .085). In total, 77.0% of the patients had at least one MRP post-discharge. CONCLUSIONS: Our findings indicate that a multi-component intervention, including several components targeting medication adherence in older cardiac patients discharged from hospital back home, did not benefit their medication adherence levels. A modest positive effect on adherence may potentially exist in those patients not using an MDD system. This finding needs replication.

Defining Core Competencies for Epidemiologists in Academic Settings to Tackle Tomorrow's Health Research Challenges: A Structured, Multinational Effort.

Only a few efforts have been made to define core competencies for epidemiologists working in academic settings. Here we describe a multinational effort to define competencies for epidemiologists, who are increasingly facing emerging and potentially disruptive technological and societal health trends in academic research. During a 1.5-year period (2017-2019), we followed an iterative process that aimed to be inclusive and multinational to reflect the various perspectives of a diverse group of epidemiologists. Competencies were developed by a consortium in a consensus-oriented process that spanned 3 main activities: 2 in-person interactive meetings held in Amsterdam, the Netherlands, and Zurich, Switzerland, and an online survey. In total, 93 meeting participants from 16 countries and 173 respondents from 19 countries contributed to the development of 31 competencies. These 31 competencies included 14 on "developing a scientific question" and "study planning," 12 on "study conduct and analysis," 3 on "overarching competencies," and 2 on "communication and translation." The process described here provides a consensus-based framework for defining and adapting the field. It should initiate a continuous process of thinking about competencies and the implications for teaching epidemiology to ensure that epidemiologists working in academic settings are well prepared for today's and tomorrow's health research.

Noncollapsibility and its role in quantifying confounding bias in logistic regression.

BACKGROUND: Confounding bias is a common concern in epidemiological research. Its presence is often determined by comparing exposure effects between univariable- and multivariable regression models, using an arbitrary threshold of a 10% difference to indicate confounding bias. However, many clinical researchers are not aware that the use of this change-in-estimate criterion may lead to wrong conclusions when applied to logistic regression coefficients. This is due to a statistical phenomenon called noncollapsibility, which manifests itself in logistic regression models. This paper aims to clarify the role of noncollapsibility in logistic regression and to provide guidance in determining the presence of confounding bias. METHODS: A Monte Carlo simulation study was designed to uncover patterns of confounding bias and noncollapsibility effects in logistic regression. An empirical data example was used to illustrate the inability of the change-in-estimate criterion to distinguish confounding bias from noncollapsibility effects. RESULTS: The simulation study showed that, depending on the sign and magnitude of the confounding bias and the noncollapsibility effect, the difference between the effect estimates from univariable- and multivariable regression models may underestimate or overestimate the magnitude of the confounding bias. Because of the noncollapsibility effect, multivariable regression analysis and inverse probability weighting provided different but valid estimates of the confounder-adjusted exposure effect. In our data example, confounding bias was underestimated by the change in estimate due to the presence of a noncollapsibility effect. CONCLUSION: In logistic regression, the difference between the univariable- and multivariable effect estimate might not only reflect confounding bias but also a noncollapsibility effect. Ideally, the set of confounders is determined at the study design phase and based on subject matter knowledge. To quantify confounding bias, one could compare the unadjusted exposure effect estimate and the estimate from an inverse probability weighted model.

Toward assessing clinical trial publications for reporting transparency.

OBJECTIVE: To annotate a corpus of randomized controlled trial (RCT) publications with the checklist items of CONSORT reporting guidelines and using the corpus to develop text mining methods for RCT appraisal. METHODS: We annotated a corpus of 50 RCT articles at the sentence level using 37 fine-grained CONSORT checklist items. A subset (31 articles) was double-annotated and adjudicated, while 19 were annotated by a single annotator and reconciled by another. We calculated inter-annotator agreement at the article and section level using MASI (Measuring Agreement on Set-Valued Items) and at the CONSORT item level using Krippendorff's α. We experimented with two rule-based methods (phrase-based and section header-based) and two supervised learning approaches (support vector machine and BioBERT-based neural network classifiers), for recognizing 17 methodology-related items in the RCT Methods sections. RESULTS: We created CONSORT-TM consisting of 10,709 sentences, 4,845 (45%) of which were annotated with 5,246 labels. A median of 28 CONSORT items (out of possible 37) were annotated per article. Agreement was moderate at the article and section levels (average MASI: 0.60 and 0.64, respectively). Agreement varied considerably among individual checklist items (Krippendorff's α= 0.06-0.96). The model based on BioBERT performed best overall for recognizing methodology-related items (micro-precision: 0.82, micro-recall: 0.63, micro-F1: 0.71). Combining models using majority vote and label aggregation further improved precision and recall, respectively. CONCLUSION: Our annotated corpus, CONSORT-TM, contains more fine-grained information than earlier RCT corpora. Low frequency of some CONSORT items made it difficult to train effective text mining models to recognize them. For the items commonly reported, CONSORT-TM can serve as a testbed for text mining methods that assess RCT transparency, rigor, and reliability, and support methods for peer review and authoring assistance. Minor modifications to the annotation scheme and a larger corpus could facilitate improved text mining models. CONSORT-TM is publicly available at https://github.com/kilicogluh/CONSORT-TM.

The nurse-coordinated cardiac care bridge transitional care programme: a randomised clinical trial.

BACKGROUND: after hospitalisation for cardiac disease, older patients are at high risk of readmission and death. OBJECTIVE: the cardiac care bridge (CCB) transitional care programme evaluated the impact of combining case management, disease management and home-based cardiac rehabilitation (CR) on hospital readmission and mortality. DESIGN: single-blind, randomised clinical trial. SETTING: the trial was conducted in six hospitals in the Netherlands between June 2017 and March 2020. Community-based nurses and physical therapists continued care post-discharge. SUBJECTS: cardiac patients ≥ 70 years were eligible if they were at high risk of functional loss or if they had had an unplanned hospital admission in the previous 6 months. METHODS: the intervention group received a comprehensive geriatric assessment-based integrated care plan, a face-to-face handover with the community nurse before discharge and follow-up home visits. The community nurse collaborated with a pharmacist and participants received home-based CR from a physical therapist. The primary composite outcome was first all-cause unplanned readmission or mortality at 6 months. RESULTS: in total, 306 participants were included. Mean age was 82.4 (standard deviation 6.3), 58% had heart failure and 92% were acutely hospitalised. 67% of the intervention key-elements were delivered. The composite outcome incidence was 54.2% (83/153) in the intervention group and 47.7% (73/153) in the control group (risk differences 6.5% [95% confidence intervals, CI -4.7 to 18%], risk ratios 1.14 [95% CI 0.91-1.42], P = 0.253). The study was discontinued prematurely due to implementation activities in usual care. CONCLUSION: in high-risk older cardiac patients, the CCB programme did not reduce hospital readmission or mortality within 6 months. TRIAL REGISTRATION: Netherlands Trial Register 6,316, https://www.trialregister.nl/trial/6169.

The performance of the Dutch Safety Management System frailty tool to predict the risk of readmission or mortality in older hospitalised cardiac patients.

BACKGROUND: Early identification of older cardiac patients at high risk of readmission or mortality facilitates targeted deployment of preventive interventions. In the Netherlands, the frailty tool of the Dutch Safety Management System (DSMS-tool) consists of (the risk of) delirium, falling, functional impairment, and malnutrition and is currently used in all older hospitalised patients. However, its predictive performance in older cardiac patients is unknown. AIM: To estimate the performance of the DSMS-tool alone and combined with other predictors in predicting hospital readmission or mortality within 6 months in acutely hospitalised older cardiac patients. METHODS: An individual patient data meta-analysis was performed on 529 acutely hospitalised cardiac patients ≥70 years from four prospective cohorts. Missing values for predictor and outcome variables were multiply imputed. We explored discrimination and calibration of: (1) the DSMS-tool alone; (2) the four components of the DSMS-tool and adding easily obtainable clinical predictors; (3) the four components of the DSMS-tool and more difficult to obtain predictors. Predictors in model 2 and 3 were selected using backward selection using a threshold of p = 0.157. We used shrunk c-statistics, calibration plots, regression slopes and Hosmer-Lemeshow p-values (PHL) to describe predictive performance in terms of discrimination and calibration. RESULTS: The population mean age was 82 years, 52% were males and 51% were admitted for heart failure. DSMS-tool was positive in 45% for delirium, 41% for falling, 37% for functional impairments and 29% for malnutrition. The incidence of hospital readmission or mortality gradually increased from 37 to 60% with increasing DSMS scores. Overall, the DSMS-tool discriminated limited (c-statistic 0.61, 95% 0.56-0.66). The final model included the DSMS-tool, diagnosis at admission and Charlson Comorbidity Index and had a c-statistic of 0.69 (95% 0.63-0.73; PHL was 0.658). DISCUSSION: The DSMS-tool alone has limited capacity to accurately estimate the risk of readmission or mortality in hospitalised older cardiac patients. Adding disease-specific risk factor information to the DSMS-tool resulted in a moderately performing model. To optimise the early identification of older hospitalised cardiac patients at high risk, the combination of geriatric and disease-specific predictors should be further explored.

Influence of nursing staff characteristics on seclusion in acute mental health care-A prospective two-year follow-up study.

INTRODUCTION: Seclusion still occurs on mental health wards, despite absence of therapeutic efficacy and high risks of adverse patient effects. Literature on the effect of nursing teams, and the role of psychological characteristics in particular, on frequency of seclusion is scarce. AIM: To explore the influence of demographic, professional or psychological, nursing team-level, and shift characteristics on the frequency of use of seclusion. METHODS: Prospective two-year follow-up study. RESULTS: We found that the probability of seclusion was lower when nursing teams with at least 75% males were on duty, compared to female only teams, odds ratio (OR = 0.283; 95% CrI 0.046-0.811). We observed a trend indicating that teams scoring higher on the openness personality dimension secluded less, (OR = 0.636; 95% CrI 0.292-1.156). DISCUSSION: Higher proportions of male nurses in teams on duty were associated with lower likelihood of seclusion. We found an indication that teams with a higher mean openness personality trait tended to seclude less. These findings, if causal, could serve as an incentive to reflect on staff mix if circumstances demand better prevention of seclusion.

Effectiveness of sensor monitoring in a rehabilitation programme for older patients after hip fracture: a three-arm stepped wedge randomised trial.

OBJECTIVES: to test the effects of an intervention involving sensor monitoring-informed occupational therapy on top of a cognitive behavioural treatment (CBT)-based coaching therapy on daily functioning in older patients after hip fracture. DESIGN, SETTING AND PATIENTS: three-armed randomised stepped wedge trial in six skilled nursing facilities, with assessments at baseline (during admission) and after 1, 4 and 6 months (at home). Eligible participants were hip fracture patients ≥ 65 years old. INTERVENTIONS: patients received care as usual, CBT-based occupational therapy or CBT-based occupational therapy with sensor monitoring. Interventions comprised a weekly session during institutionalisation, followed by four home visits and four telephone consultations over three months. MAIN OUTCOMES AND MEASURES: the primary outcome was patient-reported daily functioning at 6 months, assessed with the Canadian Occupational Performance Measure. RESULTS: a total of 240 patients (mean[SD] age, 83.8[6.9] years were enrolled. At baseline, the mean Canadian Occupational Performance Measure scores (range 1-10) were 2.92 (SE 0.20) and 3.09 (SE 0.21) for the care as usual and CBT-based occupational therapy with sensor monitoring groups, respectively. At six months, these values were 6.42 (SE 0.47) and 7.59 (SE 0.50). The mean patient-reported daily functioning in the CBT-based occupational therapy with sensor monitoring group was larger than that in the care as usual group (difference 1.17 [95% CI (0.47-1.87) P = 0.001]. We found no significant differences in daily functioning between CBT-based occupational therapy and care as usual. CONCLUSIONS AND RELEVANCE: among older patients recovering from hip fracture, a rehabilitation programme of sensor monitoring-informed occupational therapy was more effective in improving patient-reported daily functioning at six months than to care as usual. TRIAL REGISTRATION: Dutch National Trial Register, NTR 5716.

Effects of Postacute Multidisciplinary Rehabilitation Including Exercise in Out-of-Hospital Settings in the Aged: Systematic Review and Meta-analysis.

OBJECTIVE: Many older individuals receive rehabilitation in an out-of-hospital setting (OOHS) after acute hospitalization; however, its effect on mobility and unplanned hospital readmission is unclear. Therefore, a systematic review and meta-analysis were conducted on this topic. DATA SOURCES: Medline OVID, Embase OVID, and CINAHL were searched from their inception until February 22, 2018. STUDY SELECTION: OOHS (ie, skilled nursing facilities, outpatient clinics, or community-based at home) randomized trials studying the effect of multidisciplinary rehabilitation were selected, including those assessing exercise in older patients (mean age ≥65y) after discharge from hospital after an acute illness. DATA EXTRACTION: Two reviewers independently selected the studies, performed independent data extraction, and assessed the risk of bias. Outcomes were pooled using fixed- or random-effect models as appropriate. The main outcomes were mobility at and unplanned hospital readmission within 3 months of discharge. DATA SYNTHESIS: A total of 15 studies (1255 patients) were included in the systematic review and 12 were included in the meta-analysis (7 assessing mobility using the 6-minute walk distance [6MWD] test and 7 assessing unplanned hospital readmission). Based on the 6MWD, patients receiving rehabilitation walked an average of 23 m more than controls (95% confidence interval [CI]=: -1.34 to 48.32; I2: 51%). Rehabilitation did not lower the 3-month risk of unplanned hospital readmission (risk ratio: 0.93; 95% CI: 0.73-1.19; I2: 34%). The risk of bias was present, mainly due to the nonblinded outcome assessment in 3 studies, and 7 studies scored this unclearly. CONCLUSION: OOHS-based multidisciplinary rehabilitation leads to improved mobility in older patients 3 months after they are discharged from hospital following an acute illness and is not associated with a lower risk of unplanned hospital readmission within 3 months of discharge. However, the wide 95% CIs indicate that the evidence is not robust.

External Validation and Recalculation of the CODEX Index in COPD Patients. A 3CIAplus Cohort Study.

The CODEX index was developed and validated in patients hospitalized for COPD exacerbation to predict the risk of death and readmission within one year after discharge. Our study aimed to validate the CODEX index in a large external population of COPD patients with variable durations of follow-up. Additionally, we aimed to recalculate the thresholds of the CODEX index using the cutoffs of variables previously suggested in the 3CIA study (mCODEX). Individual data on 2,755 patients included in the COPD Cohorts Collaborative International Assessment Plus (3CIA+) were explored. A further two cohorts (ESMI AND EGARPOC-2) were added. To validate the CODEX index, the relationship between mortality and the CODEX index was assessed using cumulative/dynamic ROC curves at different follow-up periods, ranging from 3 months up to 10 years. Calibration was performed using univariate and multivariate Cox proportional hazard models and Hosmer-Lemeshow test. A total of 3,321 (87.8% males) patients were included with a mean ± SD age of 66.9 ± 10.5 years, and a median follow-up of 1,064 days (IQR 25-75% 426-1643), totaling 11,190 person-years. The CODEX index was statistically associated with mortality in the short- (≤3 months), medium- (≤1 year) and long-term (10 years), with an area under the curve of 0.72, 0.70 and 0.76, respectively. The mCODEX index performed better in the medium-term (<1 year) than the original CODEX, and similarly in the long-term. In conclusion, CODEX and mCODEX index are good predictors of mortality in patients with COPD, regardless of disease severity or duration of follow-up.

Effects of the "Living well with COPD" intervention in primary care: a comparative study.

The pivotal objective of chronic obstructive pulmonary disease (COPD) self-management programmes is behaviour change to avoid moderate and severe exacerbations and improve health related quality of life.In a prospectively planned, controlled study, COPD patients who participated in the "Living well with COPD" (LWWCOPD) self-management intervention were compared with usual care patients from the primary care COPD Cohort ICE COLD ERIC, who did not receive self-management intervention (NCT00706602) The primary outcome was behaviour change and disease-specific health related quality of life after 1 year. Secondary end-points included exacerbation rates. We calculated mixed linear, zero-inflated negative binomial and logistic regression models and used propensity scores to counteract confounding.467 patients, 71 from the LWWCOPD and 396 from the usual care cohort, were included. The differences between intervention and control were 0.54 (95% CI 0.13-0.94) on the Chronic Respiratory Questionnaire domain "mastery", 0.55 (95% CI 0.11-0.99) on "fatigue", 0.54 (0.14-0.93) on "emotional function" and 0.64 (95% CI 0.14-1.14) on "dyspnoea". The intervention considerably reduced the risk of moderate and severe exacerbations (incidence rate ratio 0.36, 95% CI 0.25-0.52).Self-management coaching in primary care improves health-related quality of life and lowers exacerbation rates and health care use.

The dyspnoea-inactivity vicious circle in COPD: development and external validation of a conceptual model.

The vicious circle of dyspnoea-inactivity has been proposed, but never validated empirically, to explain the clinical course of chronic obstructive pulmonary disease (COPD). We aimed to develop and validate externally a comprehensive vicious circle model.We utilised two methods. 1) Identification and validation of all published vicious circle models by a systematic literature search and fitting structural equation models to longitudinal data from the Spanish PAC-COPD (Phenotype and Course of COPD) cohort (n=210, mean age 68 years, mean forced expiratory volume in 1 s (FEV1) 54% predicted), testing both the hypothesised relationships between variables in the model ("paths") and model fit. 2) Development of a new model and external validation using longitudinal data from the Swiss and Dutch ICE COLD ERIC (International Collaborative Effort on Chronic Obstructive Lung Disease: Exacerbation Risk Index Cohorts) cohort (n=226, mean age 66 years, mean FEV1 57% predicted).We identified nine vicious circle models for which structural equation models confirmed most hypothesised paths but showed inappropriate fit. In the new model, airflow limitation, hyperinflation, dyspnoea, physical activity, exercise capacity and COPD exacerbations remained related to other variables and model fit was appropriate. Fitting it to ICE COLD ERIC, all paths were replicated and model fit was appropriate.Previously published vicious circle models do not fully explain the vicious circle concept. We developed and externally validated a new comprehensive model that gives a more relevant role to exercise capacity and COPD exacerbations.

Large-scale external validation and comparison of prognostic models: an application to chronic obstructive pulmonary disease.

BACKGROUND: External validations and comparisons of prognostic models or scores are a prerequisite for their use in routine clinical care but are lacking in most medical fields including chronic obstructive pulmonary disease (COPD). Our aim was to externally validate and concurrently compare prognostic scores for 3-year all-cause mortality in mostly multimorbid patients with COPD. METHODS: We relied on 24 cohort studies of the COPD Cohorts Collaborative International Assessment consortium, corresponding to primary, secondary, and tertiary care in Europe, the Americas, and Japan. These studies include globally 15,762 patients with COPD (1871 deaths and 42,203 person years of follow-up). We used network meta-analysis adapted to multiple score comparison (MSC), following a frequentist two-stage approach; thus, we were able to compare all scores in a single analytical framework accounting for correlations among scores within cohorts. We assessed transitivity, heterogeneity, and inconsistency and provided a performance ranking of the prognostic scores. RESULTS: Depending on data availability, between two and nine prognostic scores could be calculated for each cohort. The BODE score (body mass index, airflow obstruction, dyspnea, and exercise capacity) had a median area under the curve (AUC) of 0.679 [1st quartile-3rd quartile = 0.655-0.733] across cohorts. The ADO score (age, dyspnea, and airflow obstruction) showed the best performance for predicting mortality (difference AUCADO - AUCBODE = 0.015 [95% confidence interval (CI) = -0.002 to 0.032]; p = 0.08) followed by the updated BODE (AUCBODE updated - AUCBODE = 0.008 [95% CI = -0.005 to +0.022]; p = 0.23). The assumption of transitivity was not violated. Heterogeneity across direct comparisons was small, and we did not identify any local or global inconsistency. CONCLUSIONS: Our analyses showed best discriminatory performance for the ADO and updated BODE scores in patients with COPD. A limitation to be addressed in future studies is the extension of MSC network meta-analysis to measures of calibration. MSC network meta-analysis can be applied to prognostic scores in any medical field to identify the best scores, possibly paving the way for stratified medicine, public health, and research.

The prognostic value of heart rate recovery in patients with coronary artery disease: A systematic review and meta-analysis.

BACKGROUND: Routine outpatient care of patients with coronary artery disease (CAD) lacks a simple measure of physical fitness and risk of mortality. Heart rate recovery (HRR) is noninvasive and easily obtainable in outpatient settings. Prior studies have suggested that delayed postexercise HRR in the first minutes is associated with mortality in several types of populations. However, a comprehensive overview of the prognostic value of delayed HRR for time to mortality specifically in CAD patients is not available. The purpose of the current meta-analysis is to evaluate the prognostic value of delayed HRR in CAD patients. METHODS: We conducted a systematic search in OVID MEDLINE and OVID EMBASE to identify studies reporting on HRR and risk of incident cardiovascular events or mortality in CAD patients. Hazard ratios for delayed versus nondelayed HRR were pooled using random-effects meta-analysis. RESULTS: Four studies were included, comprising 2,428 CAD patients. The study quality of the included studies was rated moderate (n = 2) to high (n = 2). Delayed HRR was defined by ≤12 to ≤21 beat/min in the recovery period. During follow-up (range 2.0-9.8 years), 151 patients died (6.2% [range 2.5%-19.5%]). Only data on mortality could be pooled. Heterogeneity was limited (I2 = 32%; P = .23); pooled unadjusted hazard ratio for mortality, based on 3 studies, was 5.8 (95% CI 3.2-10.4). CONCLUSIONS: In CAD patients, delayed HRR is significantly associated with all-cause mortality. As exercise testing is performed routinely in CAD patients, HRR can be considered in monitoring exercise; still, further research must investigate the addition of HRR in current risk scores.

Impact of Stressful Life Events on Patients with Chronic Obstructive Pulmonary Disease.

BACKGROUND: There is a general notion that stressful life events may cause mental and physical health problems. OBJECTIVES: We aimed to describe stressful life events reported by patients with chronic obstructive pulmonary disease (COPD) and to assess their impact on health outcomes and behaviors. METHODS: Two hundred and sixty-six primary care patients who participated in the ICE COLD ERIC cohort study were asked to document any stressful life events in the past 3 years. We assessed the before-after (the event) changes for symptoms of depression and anxiety, health status, dyspnea-related quality of life, exacerbations, cigarette use, and physical activity. We used linear regression analysis to estimate the crude and adjusted magnitude of the before-after changes. RESULTS: About 41% (110/266) of patients reported the experience of any stressful life events and "death of relatives/important persons" was most common (31%). After accounting for age, sex, living status, lung function, and anxiety/depression status at baseline, experiencing any stressful life events was associated with a 0.9-point increase on the depression scale (95% CI 0.3 to 1.4), a 0.8-point increase on the anxiety scale (95% CI 0.3 to 1.3), and a 0.8-point decrease in the physical activity score (95% CI -1.6 to 0). CONCLUSIONS: Experiencing stressful life events was associated with a small to moderate increase in symptoms of depression and anxiety in COPD, but no discernable effect was found for other physical outcomes. However, confirmation of these results in other COPD cohorts and identification of patients particularly vulnerable to stressful life events are needed.

Development and evaluation of a blended educational programme for general practitioners' trainers to stimulate proactive HIV testing.

BACKGROUND: In the Netherlands, a substantial proportion of newly diagnosed HIV patients present late for care, therefore, we investigated the effectiveness of a blended educational programme for trainers of GPs designed to stimulate proactive HIV testing. METHODS: GP trainers at the Academic Medical Center in Amsterdam were invited to participate in a two days training programme incorporating evidence-based practice guidelines and multiple teaching strategies, including interactive lectures, discussion groups, e-learning and quality improvement targets. The GP trainers completed questionnaires before and after the programme to evaluate the effect of the programme. We also used six-monthly cumulative laboratory data from 2010 to 2015 to compare the participating GPs' HIV tests to the general trend in testing among non-participating GPs. RESULTS: 150 GP trainers attended the first session, and 74 completed the questionnaires for both sessions. GPs median score on achieving their quality improvement targets was high and the quality of the programme highly appreciated. Between 2010 and 2013, the mean annual number of laboratory-documented HIV tests decreased by 9.1% in the 624 GPs in the control group, and by 13.0% for 11 GPs in the intervention group. After the programme, the annual decreases were 2.3% and 1.8%, respectively. Before the programme, the GPs in the intervention group had 50% more laboratory-documented HIV tests than GPs in the control group. After the programme, GPs in the intervention group had twice as many laboratory-documented HIV tests as the controls. CONCLUSIONS: We provided a detailed description of a programme based on educational and clinical evidence. We could not retrieve laboratory-documented HIV testing data for the majority of GPs in both the intervention and control groups. Therefore, the limited results should be interpreted with caution as our findings may not be representative of all participants. The blended educational programme appears to have stabilized - at a higher level - the initially stronger downward trend in testing for 11 GPs undergoing the intervention, indicating that the programme may have had an impact on their HIV testing behaviour.

A simple algorithm for the identification of clinical COPD phenotypes.

This study aimed to identify simple rules for allocating chronic obstructive pulmonary disease (COPD) patients to clinical phenotypes identified by cluster analyses.Data from 2409 COPD patients of French/Belgian COPD cohorts were analysed using cluster analysis resulting in the identification of subgroups, for which clinical relevance was determined by comparing 3-year all-cause mortality. Classification and regression trees (CARTs) were used to develop an algorithm for allocating patients to these subgroups. This algorithm was tested in 3651 patients from the COPD Cohorts Collaborative International Assessment (3CIA) initiative.Cluster analysis identified five subgroups of COPD patients with different clinical characteristics (especially regarding severity of respiratory disease and the presence of cardiovascular comorbidities and diabetes). The CART-based algorithm indicated that the variables relevant for patient grouping differed markedly between patients with isolated respiratory disease (FEV1, dyspnoea grade) and those with multi-morbidity (dyspnoea grade, age, FEV1 and body mass index). Application of this algorithm to the 3CIA cohorts confirmed that it identified subgroups of patients with different clinical characteristics, mortality rates (median, from 4% to 27%) and age at death (median, from 68 to 76 years).A simple algorithm, integrating respiratory characteristics and comorbidities, allowed the identification of clinically relevant COPD phenotypes.

Prediction of long-term clinical outcomes using simple functional exercise performance tests in patients with COPD: a 5-year prospective cohort study.

The 1-min sit-to-stand (1-min STS) test and handgrip strength test have been proposed as simple tests of functional exercise performance in chronic obstructive pulmonary disease (COPD) patients. We assessed the long-term (5-year) predictive performance of the 1-min sit-to-stand and handgrip strength tests for mortality, health-related quality of life (HRQoL) and exacerbations in COPD patients. In 409 primary care patients, we found the 1-min STS test to be strongly associated with long-term morality (hazard ratio per 3 more repetitions: 0.81, 95% CI 0.65 to 0.86) and moderately associated with long-term HRQoL. Neither test was associated with exacerbations. Our results suggest that the 1-min STS test may be useful for assessing the health status and long-term prognosis of COPD patients. This study was registered at http://www.clinicaltrials.gov/ (NCT00706602, 25 June 2008).

Effectiveness of sensor monitoring in an occupational therapy rehabilitation program for older individuals after hip fracture, the SO-HIP trial: study protocol of a three-arm stepped wedge cluster randomized trial.

BACKGROUND: The performance of activities of daily living (ADL) at home is important for the recovery of older individuals after hip fracture. However, 20-90% of these individuals lose ADL function and never fully recover. It is currently unknown to what extent occupational therapy (OT) with coaching based on cognitive behavioral treatment (CBT) improves recovery. The same holds for sensor monitoring-based coaching in addition to OT. Here, we describe the design of a study investigating the effect of sensor monitoring embedded in an OT rehabilitation program on the recovery of ADL among older individuals after hip fracture. METHODS/ DESIGN: Six nursing homes will be randomized in a three-arm stepped wedge cluster randomized trial. All nursing homes will initially provide standard care. At designated time points, nursing homes, successively and in random order, will cross over to the provision of OT and at the next time point, to sensor monitoring-enhanced OT. A total of 288 older individuals, previously living alone in the community, who after a hip fracture were admitted to a geriatric rehabilitation ward for a short-term rehabilitation, will be enrolled. Individuals in the first intervention group (OTc) will participate in an OT rehabilitation program with coaching based on cognitive behavioral therapy (CBT) principles. In the sensor monitoring group, sensor monitoring is added to the OT intervention (OTcsm). Participants will receive a sensor monitoring system consisting of (i) an activity monitor during nursing home stay, (ii) a sensor monitoring system at home and a (iii) a web-based feedback application. These components will be embedded in the OT. The OT consists of a weekly session with an occupational therapist during the nursing home stay followed by four home visits and four telephone consultations. The primary outcome is patient-perceived daily functioning at 6 months, assessed using the Canadian Occupational Performance Measure (COPM). DISCUSSION: As far as we know, this study is the first large-scale stepped wedge trial, studying the effect of sensor monitoring embedded in an OT coaching program. The study will provide new knowledge on the combined intervention of sensor monitoring and coaching in OT as a part of a rehabilitation program to enable older individuals to perform everyday activities and to remain living independently after hip fracture. TRIAL REGISTRATION NUMBER: Netherlands National Trial Register, NTR 5716 Date registered: April 1 2016.