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Yvonne JG Korpershoek,1,2,* Joyce C Bruins Slot,1,* Tanja W Effing,3,4 Marieke J Schuurmans,1,2 Jaap CA Trappenburg1 1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 2Research Group Chronic Illnesses, University of Applied Sciences Utrecht, Utrecht, the Netherlands; 3Department of Respiratory Medicine, Southern Adelaide Local Health Network, 4School of Medicine, Flinders University, Adelaide, SA, Australia *These authors contributed equally to this work Background: Little is known about which self-management behaviors have the highest potential to influence exacerbation impact in COPD patients. We aimed to reach expert consensus on the most relevant set of self-management behaviors that can be targeted and influenced to maximize reduction of exacerbation impact.Materials and methods: A 2-round Delphi study was performed using online surveys to rate the relevance and feasibility of predetermined self-management behaviors identified by literature and expert opinion. Descriptive statistics and qualitative analyses were used.Results: An international expert panel reached consensus on 17 self-management behaviors focusing on: stable phase (n=5): pharmacotherapy, vaccination, physical activity, avoiding stimuli and smoking cessation; periods of symptom deterioration (n=1): early detection; during an exacerbation (n=5): early detection, health care contact, self-treatment, managing stress/anxiety and physical activity; during recovery (n=4): completing treatment, managing stress/anxiety, physical activity and exercise training; and after recovery (n=2): awareness for recurrent exacerbations and restart of pulmonary rehabilitation.Conclusion: This study has provided insight into expert opinion on the most relevant and feasible self-management behaviors that can be targeted and influenced before, during and after an exacerbation to exert the highest magnitude of influence on the impact of exacerbations. Future research should focus at developing more comprehensive patient-tailored interventions supporting patients in these exacerbation-related self-management behaviors. Keywords: COPD, self-management, exacerbation, Delphi study, self-care, Delphi technique and behavior

YJG Korpershoek,1,2 SCJM Vervoort,3 LIT Nijssen,2 JCA Trappenburg,2 MJ Schuurmans1,2 1Research Group Chronic Illnesses, Faculty of Health Care, University of Applied Sciences Utrecht, 2Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 3Cancer Center, University Medical Center Utrecht, Utrecht, the Netherlands Background: In patients with COPD, self-management skills are important to reduce the impact of exacerbations. However, both detection and adequate response to exacerbations appear to be difficult for some patients. Little is known about the underlying process of exacerbation-related self-management. Therefore, the objective of this study was to identify and explain the underlying process of exacerbation-related self-management behavior.Methods: A qualitative study using semi-structured in-depth interviews was performed according to the grounded theory approach, following a cyclic process in which data collection and data analysis alternated. Fifteen patients (male n=8; age range 59–88 years) with mild to very severe COPD were recruited from primary and secondary care settings in the Netherlands, in 2015.Results: Several patterns in exacerbation-related self-management behavior were identified, and a conceptual model describing factors influencing exacerbation-related self-management was developed. Acceptance, knowledge, experiences with exacerbations, perceived severity of symptoms and social support were important factors influencing exacerbation-related self-management. Specific factors influencing recognition of exacerbations were heterogeneity of exacerbations and habituation to symptoms. Feelings of fear, perceived influence on exacerbation course, patient beliefs, ambivalence toward treatment, trust in health care providers and self-empowerment were identified as specific factors influencing self-management actions.Conclusion: This study provided insight into factors influencing exacerbation-related self-management behavior in COPD patients. The conceptual model can be used as a framework for health care professionals providing self-management support. In the development of future self-management interventions, factors influencing the process of exacerbation-related self-management should be taken into account. Keywords: COPD, self-management, exacerbation, qualitative research, grounded theory

YJG Korpershoek,1–3 ID Bos-Touwen,2 JM de Man-van Ginkel,2,4 J-WJ Lammers,3 MJ Schuurmans,1,2 JCA Trappenburg2 1Research Group Chronic Illnesses, Faculty of Health Care, University of Applied Sciences Utrecht, 2Department of Rehabilitation, Nursing Science & Sports, University Medical Center Utrecht, 3Department of Respiratory Medicine, Division of Heart & Lungs, University Medical Center Utrecht, 4Nursing Science, Program in Clinical Health Science, University Medical Center Utrecht, Utrecht, the Netherlands Background: COPD self-management is a complex behavior influenced by many factors. Despite scientific evidence that better disease outcomes can be achieved by enhancing self-management, many COPD patients do not respond to self-management interventions. To move toward more effective self-management interventions, knowledge of characteristics associated with activation for self-management is needed. The purpose of this study was to identify key patient and disease characteristics of activation for self-management. Methods: An explorative cross-sectional study was conducted in primary and secondary care in patients with COPD. Data were collected through questionnaires and chart reviews. The main outcome was activation for self-management, measured with the 13-item Patient Activation Measure (PAM). Independent variables were sociodemographic variables, self-reported health status, depression, anxiety, illness perception, social support, disease severity, and comorbidities. Results: A total of 290 participants (age: 67.2±10.3; forced expiratory volume in 1 second predicted: 63.6±19.2) were eligible for analysis. While poor activation for self-management (PAM-1) was observed in 23% of the participants, only 15% was activated for self-management (PAM-4). Multiple linear regression analysis revealed six explanatory determinants of activation for self-management (P

Nini H Jonkman,1 Heleen Westland,1 Jaap CA Trappenburg,1 Rolf HH Groenwold,2 Erik WMA Bischoff,3 Jean Bourbeau,4 Christine E Bucknall,5 David Coultas,6 Tanja W Effing,7 Michael J Epton,8 Frode Gallefoss,9 Judith Garcia-Aymerich,10–12 Suzanne M Lloyd,13 Evelyn M Monninkhof,2 Huong Q Nguyen,14 Job van der Palen,15,16 Kathryn L Rice,17 Maria Sedeno,4 Stephanie JC Taylor,18 Thierry Troosters,19 Nicholas A Zwar,20 Arno W Hoes,2 Marieke J Schuurmans1 1Department of Rehabilitation, Nursing Science and Sports, 2Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, 3Department of Primary and Community Care, Radboud University Medical Center, Nijmegen, the Netherlands; 4Respiratory Epidemiology and Clinical Research Unit, Department of Medicine, McGill University Health Center, McGill University, Montreal, QC, Canada; 5Department of Respiratory Medicine, Glasgow Royal Infirmary, Glasgow, UK; 6Veterans Administration Portland Health Care System and Oregon Health & Science University, Portland, OR, USA; 7Department of Respiratory Medicine, Repatriation General Hospital, Adelaide, SA, Australia; 8Canterbury District Health Board, Respiratory Services, Christchurch Hospital, Christchurch, New Zealand; 9Department of Pulmonary Medicine, Sorlandet Hospital, Kristiansand, Norway; 10Centre for Research in Environmental Epidemiology CREAL, 11Pompeu Fabra University, 12CIBER Epidemiología y Salud Pública CIBERESP, Barcelona, Spain; 13Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK; 14Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, USA; 15Department of Research Methodology, Measurement and Data Analysis, University of Twente, 16Department of Clinical Epidemiology, Medisch Spectrum Twente, Enschede, the Netherlands; 17Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Minneapolis Veterans Affairs Health Care Service and University of Minnesota, Minneapolis, MN, USA; 18Centre for Primary Care and Public Health, Queen Mary University of London, London, UK; 19Department of Rehabilitation Sciences, Catholic University of Leuven, Leuven, Belgium; 20School of Public Health and Community Medicine, UNSW Australia, Sydney, NSW, Australia Background: Self-management interventions are considered effective in patients with COPD, but trials have shown inconsistent results and it is unknown which patients benefit most. This study aimed to summarize the evidence on effectiveness of self-management interventions and identify subgroups of COPD patients who benefit most.Methods: Randomized trials of self-management interventions between 1985 and 2013 were identified through a systematic literature search. Individual patient data of selected studies were requested from principal investigators and analyzed in an individual patient data meta-analysis using generalized mixed effects models.Results: Fourteen trials representing 3,282 patients were included. Self-management interventions improved health-related quality of life at 12 months (standardized mean difference 0.08, 95% confidence interval [CI] 0.00–0.16) and time to first respiratory-related hospitalization (hazard ratio 0.79, 95% CI 0.66–0.94) and all-cause hospitalization (hazard ratio 0.80, 95% CI 0.69–0.90), but had no effect on mortality. Prespecified subgroup analyses showed that interventions were more effective in males (6-month COPD-related hospitalization: interaction P=0.006), patients with severe lung function (6-month all-cause hospitalization: interaction P=0.016), moderate self-efficacy (12-month COPD-related hospitalization: interaction P=0.036), and high body mass index (6-month COPD-related hospitalization: interaction P=0.028 and 6-month mortality: interaction P=0.026). In none of these subgroups, a consistent effect was shown on all relevant outcomes.Conclusion: Self-management interventions exert positive effects in patients with COPD on respiratory-related and all-cause hospitalizations and modest effects on 12-month health-related quality of life, supporting the implementation of self-management strategies in clinical practice. Benefits seem similar across the subgroups studied and limiting self-management interventions to specific patient subgroups cannot be recommended. Keywords: chronic obstructive pulmonary disease, individual patient data meta-analysis, self-management, subgroup analysis

Background: Early treatment of COPD exacerbations has shown to be important. Despite a non-negligible negative impact on health related quality of life, a large proportion of these episodes is not reported (no change in treatment). Little is known whether (low burden) strategies are able to capture these unreported exacerbations.Methods: The Clinical COPD Questionnaire (CCQ) is a short questionnaire with great evaluative properties in measuring health status. The current explorative study evaluates the discriminative properties of weekly CCQ assessment in detecting exacerbations.Results: In a multicentre prospective cohort study, 121 patients, age 67.4 ± 10.5 years, FEV1 47.7 ± 18.5% pred were followed for 6 weeks by daily diary card recording and weekly CCQ assessment. Weeks were retrospectively labeled as stable or exacerbation (onset) weeks using the Anthonisen symptom diary-card algorithm. Change in CCQ total scores are significantly higher in exacerbation-onset weeks, 0.35 ± 0.69 compared to -0.04 ± 0.37 in stable weeks (p < 0.001). Performance of the Δ CCQ total score discriminating between stable and exacerbation onset weeks was sufficient (area under the ROC curve 0.75). At a cut off point of 0.2, sensitivity was 62.5 (50.3-73.4), specificity 82.0 (79.3-84.4), and a positive and negative predictive value of 43.5 (35.0-51.0) and 90.8 (87.8-93.5), respectively. Using this cut off point, 22 (out of 38) unreported exacerbations were detected while 39 stable patients would have been false positively 'contacted'.Conclusions: Weekly CCQ assessment is a promising, low burden method to detect unreported exacerbations. Further research is needed to validate discriminative performance and practical implications of the CCQ in detecting exacerbations in daily care. [ABSTRACT FROM AUTHOR]

Objective: To explore how to build and maintain the resilience of frontline healthcare professionals exposed to COVID-19 outbreak working conditions., Design: Scoping review supplemented with expert interviews to validate the findings., Setting: Hospitals., Methods: We searched PubMed, Embase, PsycINFO, CINAHL, bioRxiv and medRxiv systematically and grey literature for articles focusing on the impact of COVID-19-like working conditions on the physical and/or mental health of healthcare professionals in a hospital setting. Articles using an empirical design about determinants or causes of physical and/or mental health and about interventions, measures and policies to preserve physical and/or mental health were included. Four experts were interviewed to reflect on the results from the scoping review., Results: In total, 4471 records were screened leading to an inclusion of 73 articles. Recommendations prior to the outbreak fostering resilience included optimal provision of education and training, resilience training and interventions to create a feeling of being prepared. Recommendations during the outbreak consisted of (1) enhancing resilience by proper provision of information, psychosocial support and treatment (eg, create enabling conditions such as forming a psychosocial support team), monitoring the health status of professionals and using various forms and content of psychosocial support (eg, encouraging peer support, sharing and celebrating successes), (2) tasks and responsibilities, in which attention should be paid to kind of tasks, task mix and responsibilities as well as the intensity and weight of these tasks and (3) work patterns and working conditions. Findings of the review were validated by experts., Conclusions: Recommendations were developed on how to build and maintain resilience of frontline healthcare professionals exposed to COVID-19 outbreak working conditions. These practical and easy to implement recommendations can be used by hospitals and other healthcare organisations to foster and preserve short-term and long-term physical and mental health and employability of their professionals., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: To understand better the success of self-management interventions and to enable tailoring of such interventions at specific subgroups of patients, the nurse-led Activate intervention is developed targeting one component of self-management (physical activity) in a heterogeneous subgroup (patients at risk of cardiovascular disease) in Dutch primary care., Aim: The aim of this study was to evaluate the effectiveness of the Activate intervention and identifying which patient-related characteristics modify the effect., Methods: A two-armed cluster-randomised controlled trial was conducted comparing the intervention with care as usual. The intervention consisted of four nurse-led behaviour change consultations within a 3-month period. Data were collected at baseline, 3 months and 6 months. Primary outcome was the daily amount of moderate to vigorous physical activity at 6 months. Secondary outcomes included sedentary behaviour, self-efficacy for physical activity, patient activation for self-management and health status. Prespecified effect modifiers were age, body mass index, level of education, social support, depression, patient provider relationship and baseline physical activity., Results: Thirty-one general practices ( n  = 195 patients) were included (intervention group n  = 93; control group n  = 102). No significant between-group difference was found for physical activity (mean difference 2.49 minutes; 95% confidence interval -2.1; 7.1; P  = 0.28) and secondary outcomes. Patients with low perceived social support ( P  = 0.01) and patients with a low baseline activity level ( P  = 0.02) benefitted more from the intervention., Conclusion: The Activate intervention did not improve patients' physical activity and secondary outcomes in primary care patients at risk of cardiovascular disease. To understand the results, the intervention fidelity and active components for effective self-management require further investigation.Trial registration: ClinicalTrials.gov NCT02725203.

Background: There is an emergence of mobile health (mHealth) interventions to support self-management in patients with chronic obstructive pulmonary disease (COPD). Recently, an evidence-driven mHealth intervention has been developed to support patients with COPD in exacerbation-related self-management: the Copilot app. Health care providers (HCPs) are important stakeholders as they are the ones who have to provide the app to patients, personalize the app, and review the app. It is, therefore, important to investigate at an early stage whether the app is feasible in the daily practice of the HCPs., Objective: The aim of this study is to evaluate the perceived feasibility of the Copilot app in the daily practice of HCPs., Methods: A multimethods design was used to investigate how HCPs experience working with the app and how they perceive the feasibility of the app in their daily practice. The feasibility areas described by Bowen et al were used for guidance. HCPs were observed while performing tasks in the app and asked to think aloud. The System Usability Scale was used to investigate the usability of the app, and semistructured interviews were conducted to explore the feasibility of the app. The study was conducted in primary, secondary, and tertiary care settings in the Netherlands from February 2019 to September 2019., Results: In total, 14 HCPs participated in this study-8 nurses, 5 physicians, and 1 physician assistant. The HCPs found the app acceptable to use. The expected key benefits of the app were an increased insight into patient symptoms, more structured patient conversations, and more tailored self-management support. The app especially fits within the available time and workflow of nurses. The use of the app will be influenced by the autonomy of the professional, the focus of the organization on eHealth, costs associated with the app, and compatibility with the current systems used. Most HCPs expressed that there are conditions that must be met to be able to use the app. The app can be integrated into the existing care paths of primary, secondary, and tertiary health care settings. Individual organizational factors must be taken into account when integrating the app into daily practice., Conclusions: This early-stage feasibility study shows that the Copilot app is feasible to use in the daily practice of HCPs and can be integrated into primary, secondary, and tertiary health care settings in the Netherlands. The app was considered to best fit the role of the nurses. The app will be less feasible for those organizations in which many conditions need to be met to use the app. This study provides a new approach to evaluate the perceived feasibility of mHealth interventions at an early stage and provides valuable insights for further feasibility testing., (©Yvonne JG Korpershoek, Tjitske Holtrop, Sigrid CJM Vervoort, Lisette Schoonhoven, Marieke J Schuurmans, Jaap CA Trappenburg. Originally published in JMIR Formative Research (http://formative.jmir.org), 19.11.2020.)

Background: Self-management interventions are considered effective in patients with chronic disease, but trials have shown inconsistent results, and it is unknown which patients benefit most. Adequate self-management requires behaviour change in both patients and health care providers. Therefore, the Activate intervention was developed with a focus on behaviour change in both patients and nurses. The intervention aims for change in a single self-management behaviour, namely physical activity, in primary care patients at risk for cardiovascular disease. The aim of this study is to evaluate the effectiveness of the Activate intervention., Methods/design: A two-arm cluster randomised controlled trial will be conducted to compare the Activate intervention with care as usual at 31 general practices in the Netherlands. Approximately 279 patients at risk for cardiovascular disease will participate. The Activate intervention is developed using the Behaviour Change Wheel and consists of 4 nurse-led consultations in a 3-month period, integrating 17 behaviour change techniques. The Behaviour Change Wheel was also applied to analyse what behaviour change is needed in nurses to deliver the intervention adequately. This resulted in 1-day training and coaching sessions (including 21 behaviour change techniques). The primary outcome is physical activity, measured as the number of minutes of moderate to vigorous physical activity using an accelerometer. Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline number of minutes of physical activity. Data will be collected at baseline and at 3 months and 6 months of follow-up. A process evaluation will be conducted to evaluate the training of nurses, treatment fidelity, and to identify barriers to and facilitators of implementation as well as to assess participants' satisfaction., Discussion: To increase physical activity in patients and to support nurses in delivering the intervention, behaviour change techniques are applied to change behaviours of the patients and nurses. Evaluation of the effectiveness of the intervention, exploration of which patients benefit most, and evaluation of our theory-based training for primary care nurses will enhance understanding of what works and for whom, which is essential for further implementation of self-management in clinical practice., Trial Registration: ClinicalTrials.gov identifier: NCT02725203 . Registered on 25 March 2016.

Background and Aim: Self-management support is an integral part of current chronic care guidelines. The success of self-management interventions varies between individual patients, suggesting a need for tailored self-management support. Understanding the role of patient factors in the current decision making of health professionals can support future tailoring of self-management interventions. The aim of this study is to identify the relative importance of patient factors in health professionals' decision making regarding self-management support., Method: A factorial survey was presented to primary care physicians and nurses. The survey consisted of clinical vignettes (case descriptions), in which 11 patient factors were systematically varied. Each care provider received a set of 12 vignettes. For each vignette, they decided whether they would give this patient self-management support and whether they expected this support to be successful. The associations between respondent decisions and patient factors were explored using ordered logit regression., Results: The survey was completed by 60 general practitioners and 80 nurses. Self-management support was unlikely to be provided in a third of the vignettes. The most important patient factor in the decision to provide self-management support as well as in the expectation that self-management support would be successful was motivation, followed by patient-provider relationship and illness perception. Other factors, such as depression or anxiety, education level, self-efficacy and social support, had a small impact on decisions. Disease, disease severity, knowledge of disease, and age were relatively unimportant factors., Conclusion: This is the first study to explore the relative importance of patient factors in decision making and the expectations regarding the provision of self-management support to chronic disease patients. By far, the most important factor considered was patient's motivation; unmotivated patients were less likely to receive self-management support. Future tailored interventions should incorporate strategies to enhance motivation in unmotivated patients. Furthermore, care providers should be better equipped to promote motivational change in their patients., Competing Interests: The authors have declared that no competing interests exist.

Objectives: Systematic reviews on complex interventions like self-management interventions often do not explicitly state an operational definition of the intervention studied, which may impact the review's conclusions. This study aimed to propose an operational definition of self-management interventions and determine its discriminative performance compared with other operational definitions., Study Design and Setting: Systematic review of definitions of self-management interventions and consensus meetings with self-management research experts and practitioners., Results: Self-management interventions were defined as interventions that aim to equip patients with skills to actively participate and take responsibility in the management of their chronic condition in order to function optimally through at least knowledge acquisition and a combination of at least two of the following: stimulation of independent sign/symptom monitoring, medication management, enhancing problem-solving and decision-making skills for medical treatment management, and changing their physical activity, dietary, and/or smoking behavior. This definition substantially reduced the number of selected studies (255 of 750). In two preliminary expert meetings (n = 6), the proposed definition was identifiable for self-management research experts and practitioners (80% and 60% agreement, respectively)., Conclusion: Future systematic reviews must carefully consider the operational definition of the intervention studied because the definition influences the selection of studies on which conclusions and recommendations for clinical practice are based., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: To identify those characteristics of self-management interventions in patients with heart failure (HF) that are effective in influencing health-related quality of life, mortality, and hospitalizations., Methods and Results: Randomized trials on self-management interventions conducted between January 1985 and June 2013 were identified and individual patient data were requested for meta-analysis. Generalized mixed effects models and Cox proportional hazard models including frailty terms were used to assess the relation between characteristics of interventions and health-related outcomes. Twenty randomized trials (5624 patients) were included. Longer intervention duration reduced mortality risk (hazard ratio 0.99, 95% confidence interval [CI] 0.97-0.999 per month increase in duration), risk of HF-related hospitalization (hazard ratio 0.98, 95% CI 0.96-0.99), and HF-related hospitalization at 6 months (risk ratio 0.96, 95% CI 0.92-0.995). Although results were not consistent across outcomes, interventions comprising standardized training of interventionists, peer contact, log keeping, or goal-setting skills appeared less effective than interventions without these characteristics., Conclusion: No specific program characteristics were consistently associated with better effects of self-management interventions, but longer duration seemed to improve the effect of self-management interventions on several outcomes. Future research using factorial trial designs and process evaluations is needed to understand the working mechanism of specific program characteristics of self-management interventions in HF patients., Competing Interests: The authors declare the following interests: this work was supported by a grant from The Netherlands Organisation for Health Research and Development, ZonMw (grant number 520001002). DAD reports grants from NIH during the conduct of the study, outside the submitted work. MH reports grants from MDRTC during the conduct of the study, outside the submitted work. RTT reports investigator-initiated grants from Merck Canada Inc., AstraZeneca Canada, and personal fees from Merck Canada Inc., all outside the submitted work. The other authors declare no conflict of interest., (Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.)

It is unknown whether heterogeneity in effects of self-management interventions in patients with chronic obstructive pulmonary disease (COPD) can be explained by differences in programme characteristics. This study aimed to identify which characteristics of COPD self-management interventions are most effective.Systematic search in electronic databases identified randomised trials on self-management interventions conducted between 1985 and 2013. Individual patient data were requested for meta-analysis by generalised mixed effects models.14 randomised trials were included (67% of eligible), representing 3282 patients (75% of eligible). Univariable analyses showed favourable effects on some outcomes for more planned contacts and longer duration of interventions, interventions with peer contact, without log keeping, without problem solving, and without support allocation. After adjusting for other programme characteristics in multivariable analyses, only the effects of duration on all-cause hospitalisation remained. Each month increase in intervention duration reduced risk of all-cause hospitalisation (time to event hazard ratios 0.98, 95% CI 0.97-0.99; risk ratio (RR) after 6 months follow-up 0.96, 95% CI 0.92-0.99; RR after 12 months follow-up 0.98, 95% CI 0.96-1.00).Our results showed that longer duration of self-management interventions conferred a reduction in all-cause hospitalisations in COPD patients. Other characteristics are not consistently associated with differential effects of self-management interventions across clinically relevant outcomes., (The content of this work is not subject to copyright. Design and branding are copyright ©ERS 2016.)

Background: Self-management interventions are widely implemented in the care for patients with heart failure (HF). However, trials show inconsistent results, and whether specific patient groups respond differently is unknown. This individual patient data meta-analysis assessed the effectiveness of self-management interventions in patients with HF and whether subgroups of patients respond differently., Methods and Results: A systematic literature search identified randomized trials of self-management interventions. Data from 20 studies, representing 5624 patients, were included and analyzed with the use of mixed-effects models and Cox proportional-hazard models, including interaction terms. Self-management interventions reduced the risk of time to the combined end point of HF-related hospitalization or all-cause death (hazard ratio, 0.80; 95% confidence interval [CI], 0.71-0.89), time to HF-related hospitalization (hazard ratio, 0.80; 95% CI, 0.69-0.92), and improved 12-month HF-related quality of life (standardized mean difference, 0.15; 95% CI, 0.00-0.30). Subgroup analysis revealed a protective effect of self-management on the number of HF-related hospital days in patients <65 years of age (mean, 0.70 versus 5.35 days; interaction P=0.03). Patients without depression did not show an effect of self-management on survival (hazard ratio for all-cause mortality, 0.86; 95% CI, 0.69-1.06), whereas in patients with moderate/severe depression, self-management reduced survival (hazard ratio, 1.39; 95% CI, 1.06-1.83, interaction P=0.01)., Conclusions: This study shows that self-management interventions had a beneficial effect on time to HF-related hospitalization or all-cause death and HF-related hospitalization alone and elicited a small increase in HF-related quality of life. The findings do not endorse limiting self-management interventions to subgroups of patients with HF, but increased mortality in depressed patients warrants caution in applying self-management strategies in these patients., Competing Interests: Disclosures: The other authors have no conflict of interest to declare., (© 2016 American Heart Association, Inc.)

Background/aims: This study examines the feasibility of a preoperative exercise program to improve the physical fitness of a patient before gastrointestinal surgery., Methods: An outpatient exercise program was developed to increase preoperative aerobic capacity, peripheral muscle endurance and respiratory muscle function in patients with pancreatic, liver, intestinal, gastric or esophageal cancer. During a consult at the outpatient clinic, patients were invited to participate in the exercise program when their surgery was not scheduled within 2 weeks., Results: The 115 participants followed on average 5.7 (3.5) training sessions. Adherence to the exercise program was high: 82% of the planned training sessions were attended, and no adverse events occurred. Mixed model analyses showed a significant increase of maximal inspiratory muscle strength (84.1-104.7 cm H2O; p = 0.00) and inspiratory muscle endurance (35.0-39.5 cm H2O; p = 0.00). No significant changes were found in aerobic capacity and peripheral muscle strength., Conclusion: This exercise program in patients awaiting oncological surgery is feasible in terms of participation and adherence. Inspiratory muscle function improved significantly as a result of inspiratory muscle training. The exercise program however failed to result in improved aerobic capacity and peripheral muscle strength, probably due to the limited number of training sessions as a result of the restricted time interval between screening and surgery., (© 2016 S. Karger AG, Basel.)

In this paper, we aim to emphasise the need for a more comprehensive and tailored approach to manage the broad nature of non-adherence, to personalise current asthma management. Although currently several methods are available to measure the extent of asthma patients' adherence, the vast majority do not incorporate confirmation of the actual inhalation, dose and inhalation technique. Moreover, most current measures lack detailed information on the individual consequences of non-adherence and on when and how to take action if non-adherence is identified. Notably, one has to realise there are several forms of non-adherence (erratic non-adherence, intelligent non-adherence and unwitting non-adherence), each requiring a different approach. To improve asthma management, more accurate methods are needed that integrate measures of non-adherence, asthma disease control and patient preferences. Integrating information from the latest inhaler devices and patient-reported outcomes using mobile monitoring- and feedback systems ('mHealth') is considered a promising strategy, but requires careful implementation. Key issues to be considered before large-scale implementation include patient preferences, large heterogeneity in patient and disease characteristics, economic consequences, and long-term persistence with new digital technologies.

Introduction: Self-management interventions in patients with chronic conditions have received increasing attention over the past few years, yet the meta-analyses encountered considerable heterogeneity in results. This suggests that the effectiveness of self-management interventions must be assessed in the context of which components are responsible for eliciting the effect and in which subgroups of patients the intervention works best. The aim of the present study is to identify condition-transcending determinants of success of self-management interventions in two parallel individual patient data meta-analyses of self-management trials in patients with congestive heart failure (CHF) and in patients with chronic obstructive pulmonary disease (COPD)., Methods and Analysis: Investigators of 53 randomised trials (32 in CHF and 21 in COPD) will be requested to share their de-identified individual patient data. Data will be analysed using random effects models, taking clustering within studies into account. Effect modification by age, sex, disease severity, symptom status, comorbid conditions and level of education will be assessed. Sensitivity analyses will be conducted to assess the robustness of the findings., Ethics and Dissemination: The de-identified individual patient data are used only for the purpose for which they were originally collected and for which ethical approval has been obtained by the original investigators. Knowledge on the effective ingredients of self-management programmes and identification of subgroups of patients in which those interventions are most effective will guide the development of evidence-based personalised self-management interventions for patients with CHF and COPD as well as with other chronic diseases., Trial Registration Number Prospero: CRD42013004698., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: Esophageal resection is associated with a high incidence of postoperative pneumonia. Respiratory complications account for almost half of the readmissions to the critical care unit. Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs. In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay. While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection, the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical populations other than cardiac surgery in a randomized and controlled study design., Methods/design: The effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter randomized controlled trial (the PREPARE study). In total 248 patients (age >18 years) undergoing esophageal resection for esophageal cancer will be included in this study. They are randomized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device. Patients have to complete 30 dynamic inspiratory efforts twice daily for 7 days a week until surgery with a minimum of 2 weeks. The starting training load will be aimed to be 60% of maximal inspiratory pressure and will be increased based on the rate of perceived exertion.The main study endpoint is the incidence of postoperative pneumonia. Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay, duration of mechanical ventilation, incidence of other postoperative (pulmonary) complications, quality of life, and on postoperative respiratory muscle function and lung function., Discussion: The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection., Trial Registration: NCT01893008.

Background: Inspiratory muscle training (IMT) before cardiac surgery has proved to be a promising intervention to reduce postoperative pneumonia in a randomized controlled trial setting. Effects of IMT in routine care have not been reported., Objective: The purpose of this study was to investigate the effect of IMT before cardiac surgery on postoperative pneumonia in routine care at a Dutch university medical center using propensity scoring., Design: This was an observational cohort study., Methods: All candidates for cardiac surgery were preoperatively stratified by a physical therapist for low risk or high risk for postoperative pulmonary complications. Patients at high risk either engaged in an unsupervised IMT program (20 minutes a day) at home for at least 2 weeks before surgery (group 1) or received usual care (no IMT) (group 2). Results in terms of outcome measures were adjusted with propensity scores to reduce bias caused by nonrandom treatment assignment., Results: The results showed that of the 94 patients at high risk in group 1, 1 patient (1.1%) developed a postoperative pneumonia. In group 2, 8 out of the 252 patients at high risk (3.2%) developed this pulmonary complication (adjusted odds ratio=0.34, 95% confidence interval=0.04-3.38). No significant differences were found regarding median (25th-75th percentile) ventilation time (7 [5-9] hours versus 7 [5-10] hours), length of stay in the intensive care unit (23 [21-24] hours versus 23 [21-25] hours), or total postoperative length of stay (7 [6-11] days versus 7 [5-9] days)., Limitations: The most important limitations of this study were confounding, incomplete data collection, and a low incidence of the primary outcome., Conclusions: Propensity scoring is believed to be a valuable tool of great potential interest to researchers in the field of observational studies. Whether IMT in routine care resulted in less postoperative pneumonia cannot be concluded.

Background: Although timely treatment of COPD exacerbations seems clinically important, nearly half of these exacerbations remain unreported and subsequently untreated. Recent studies have investigated incidence and impact of failure to seek medical treatment during exacerbations. Yet, little is known about type and timing of other self-management actions in periods of symptom deterioration. The current prospective study aims at determining the relative incidence, timing and determinants of three types of patient responses., Methods: In a multicentre observational study, 121 patients (age 67 ± 11 years, FEV1pred. 48 ± 19) were followed for 6 weeks by daily diary symptom recording. Three types of action were assessed daily: planning periods of rest, breathing techniques and/or sputum clearing (type-A), increased bronchodilator use (type-B) and contacting a healthcare provider (type-C)., Results: Type-A action was taken in 70.7%, type-B in 62.7% and type C in 17.3% of exacerbations (n = 75). Smokers were less likely to take type-A and B actions. Type-C actions were associated with more severe airflow limitation and increased number of hospital admissions in the last year., Conclusions: Our study shows that most patients are willing to take timely self-management actions during exacerbations. Future research is needed to determine whether the low incidence of contacting a healthcare provider is due to a lack of self-management or healthcare accessibility.

Not all exacerbations are captured by reliance on healthcare contacts. Symptom-based exacerbation definitions have shown to provide more adequate measures of exacerbation rates, severity and duration. However, no consensus has been reached on what is the most useful method and algorithm to identify these events. This article provides an overview of the existing symptom-based definitions and tests the hypothesis that differences in exacerbation characteristics depend on the algorithms used. We systematically reviewed symptom-based methods and algorithms used in the literature, and quantified the impact of the four most referenced algorithms on exacerbation-related outcome using an existing chronic obstructive pulmonary disease (COPD) cohort (n = 137). We identified 51 studies meeting our criteria using 14 widely varying symptom algorithms to define onset, severity and recovery. The most (71%) frequently referenced algorithm (modified Anthonisen) identified an incidence rate of 1.7 episodes·patient-yr⁻¹ (95% CI 1.4-2.1), while for requiring only one major or two major symptoms this was 1.9 episodes·patient-yr⁻¹ (95% CI 1.6-2.3) and 1.5 episodes·patient-yr⁻¹ (95% CI 0.6-1.0), respectively. Studies were generally lacking methods to enhance validity and accuracy of symptom recording. This review revealed large inconsistencies in definitions, methods and accuracy to define symptom-based COPD exacerbations. We demonstrated that minor changes in symptom criteria substantially affect incidence rates, clustering type and classification of exacerbations.

Background: Early detection of exacerbations by COPD patients initiating prompt interventions has shown to be clinically relevant. Until now, research failed to identify the effectiveness of a written individualized Action Plan (AP) to achieve this., Methods/design: The current multicenter, single-blind RCT with a follow-up period of 6 months, evaluates the hypothesis that individualized AP's reduce exacerbation recovery time. Patients are included from regular respiratory nurse clinics and allocated to either usual care or the AP intervention. The AP provides individualized treatment prescriptions (pharmaceutical and non-pharmaceutical) related to a color coded symptom status (reinforcement at 1 and 4 months). Although usually not possible in self-management trials, we ensured blinding of patients, using a modified informed consent procedure in which patients give consent to postponed information. Exacerbations in both study arms are defined using the Anthonisen symptom diary-card algorithm. The Clinical COPD Questionnaire (CCQ) is assessed every 3-days. CCQ-recovery time of an exacerbation is the primary study outcome. Additionally, healthcare utilization, anxiety, depression, treatment delay, and self-efficacy are assessed at baseline and 6 months. We aim at including 245 COPD patients from 7 hospitals and 5 general practices to capture the a-priori sample size of at least 73 exacerbations per study arm., Discussion: This RCT identifies if an AP is an effective component of self-management in patients with COPD and clearly differentiates from existing studies in its design, outcome measures and generalizability of the results considering that the study is carried out in multiple sites including general practices.

Background: Since available studies have provided conflicting results, this study investigated respiratory muscle function and its relationship with exercise capacity, degree of dyspnoea and leg discomfort, and quality of life in patients with Cystic Fibrosis (CF)., Methods: Using a cross-sectional design, 27 clinically stable adolescent and adult patients (f/m: 14/13, age: 26+/-7 years) were included. Data of respiratory muscle strength (P(i)max and P(e)max), lung function (spirometry), peripheral muscle strength (peak isometric quadriceps and hand-grip strength), symptom-limited exercise capacity (modified shuttle test, MST), post-exercise dyspnoea and leg discomfort (Borg scores), and quality of life (CFQ-14+, MRC) were obtained for further analysis., Results: P(i)max of the total patient group was significantly higher than reference values (P(i)max=124+/-32% predicted), and correlated positively with the walk/run distance of the MST (r(s)=0.59, p=0.00). Female patients showed more dyspnoea and a more impaired lung function than male patients. However, P(i)max and P(e)max (% predicted) showed a tendency to be higher in female than in male patients., Conclusion: Increased work of breathing will have a conditioning effect on the respiratory muscles, suggesting that training-related inspiratory muscle strength can play a positive role in the limited exercise capacity of CF patients.

The objective of this study was to determine the effects of a homebased telemonitoring device, The Health Buddy (HB), on health consumption and health-related quality of life (HRQoL) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). The HB provides daily symptom-surveillance by a case manager and education to enhance disease knowledge and self-management. A nonrandomized controlled multicenter study was established comparing the effectiveness of telemonitoring as an add-on to care as usual with a follow-up of 6 months. Four hospitals took part in the experimental group and 2 hospitals formed an equivalent control group with 59 and 56 patients, respectively. HRQoL was measured by the Clinical COPD Questionnaire. Healthcare consumption was assessed using medical records in the 6 months preceding study entry and during the study. Compared with the control group, the HB group showed a significant decrease in hospital admission rates (HB -0.11 +/- 1.16 vs. control +0.27 +/- 1.0, p = 0.02) and in the total number of exacerbations (HB -0.35 +/- 1.4 vs. control +0.32 +/- 1.2, p = 0.004). There was a tendency toward decreased hospital days and outpatient visits. No significant changes in HRQoL were observed at follow-up between both study groups. Despite inherent limitations of the study, these findings suggest that adopting telemonitoring in everyday clinical practice is feasible and can substantially improve care and decrease healthcare utilization of patients with moderate to severe COPD.

Introduction: Chronic disease management for patients with chronic obstructive pulmonary disease (COPD) may improve quality, outcomes and access to care., Objective: To investigate effectiveness of chronic disease management programmes on the quality-of-life of people with COPD., Methods: Medline and Embase (1995-2005) were searched for relevant articles, and reference lists and abstracts were searched for controlled trials of chronic disease management programmes for patients with COPD. Quality-of-life was assessed as an outcome parameter. Two reviewers independently reviewed each paper for methodological quality and extracted the data., Results: We found 10 randomized-controlled trials comparing chronic disease management with routine care. Patient populations, health-care professionals, intensity, and content of the intervention were heterogeneous. Different instruments were used to assess quality of life. Five out of 10 studies showed statistically significant positive outcomes on one or more domains of the quality of life instruments. Three studies, partly located in primary care, showed positive results., Conclusions: All chronic disease management projects for people with COPD involving primary care improved quality of life. In most of the studies, aspects of chronic disease management were applied to a limited extent. Quality of randomized-controlled trials was not optimal. More research is needed on chronic disease management programmes in patients with COPD across primary and secondary care.

Objectives: To characterize patients referred for pulmonary rehabilitation on a large number of psychologic and sociodemographic variables and to determine the contribution of these variables on the response to rehabilitation., Design: Cross-sectional, explorative., Setting: University hospital and outpatient clinic., Participants: Eighty-one consecutive patients with chronic obstructive pulmonary disease (forced expiratory volume in 1 second, 40%+/-16% of predicted) were included in outpatient pulmonary rehabilitation., Intervention: Multidisciplinary rehabilitation program., Main Outcome Measures: Pulmonary function, exercise capacity (Wmax, 6-minute walk test [6MWT]), Chronic Respiratory Disease Questionnaire (CRDQ), Modified Pulmonary Functional Status and Dyspnea Questionnaire (PFSDQ-M), anxiety and depression (Hospital Anxiety and Depression Scale [HADS]) were assessed before and after 3 months rehabilitation. In addition, psychosocial adjustment, social support, marital status, mode of transportation, education, employment, and smoking status were assessed at the start of the rehabilitation., Results: Rehabilitation improved exercise performance (Wmax, 6+/-12W; P<.01; 6MWT, 41+/-72 m; P<.001), quality of life (CRDQ score, 12+/-13 points; P<.001), functional status (PFSDQ-M activity score, -8+/-11 points; PFSDQ-M dyspnea score, -6+/-12 points; PFSDQ-M fatigue score, -4+/-8 points; all P<.01), HADS anxiety score (-2+/-3 points, P<.01), and HADS depression score (-3+/-3 points, P<.001). In single regression analysis, only baseline depression was weakly negatively correlated with the change in maximal workload. No other relations of initial psychologic or sociodemographic variables with outcome were observed., Conclusions: The effects of rehabilitation are not affected by baseline psychosocial factors. Patients with less favorable psychologic or sociodemographic conditions can also benefit from pulmonary rehabilitation. The multidisciplinary approach of the rehabilitation program might have contributed to this improvement.

Patients with chronic obstructive pulmonary disease (COPD) suffer frequently from physiologic and psychological impairments, such as dyspnea, peripheral muscle weakness, exercise intolerance, decreased health-related quality of life (HRQOL) and emotional distress. Rehabilitation programmes have shown to result in significant changes in perceived dyspnea and fatigue, utilisation of healthcare resources, exercise performance and HRQOL. Exercise training, which consists of whole-body exercise training and local resistance training, is the cornerstone of these programmes. Regrettably, the positive effects of respiratory rehabilitation deteriorate over time, especially after short programmes. Hence, attention should be given to the aftercare of these patients to prevent them to revert again to a sedentary lifestyle. On empirical basis three possibilities seem to be clinically feasible: (1) continuous outpatient exercise training; (2) exercise training in a home-based or community-based setting; or (3) exercise training sessions in a group of asthma and COPD patients.