Evaluation of Exacerbation and Symptom-Free Time in Patients with COPD.

In clinical practice, clinicians mainly focus on Chronic Obstructive Pulmonary Disease (COPD) exacerbations and symptoms, while patients may prefer to evaluate periods free of COPD exacerbations and deteriorated symptoms. The latter would suit the positive health approach that centralizes people and their beliefs. We aimed to identify patient characteristics and health outcomes relating to: 1) COPD exacerbation-free days; 2) days with no more symptoms than usual; and 3) combined COPD exacerbation and comorbid flare-up-free days (i.e. chronic heart failure, anxiety, depression flare-ups) using negative binomial regression analyzes. Data were obtained from two self-management intervention trials including COPD patients with and without comorbidities. 313 patients (mean age 66.0 years, 63.6% male, 68.7% comorbidity) were included. Better baseline chronic respiratory questionnaire (CRQ) fatigue (incidence rate ratio (IRR) = 1.03 (95% CI 1.01-1.05), p = 0.02) and mastery scores (IRR = 1.03 (95% CI 1.00-1.06), p = 0.04) and fewer courses of antibiotics (IRR = 0.95 (95% CI 0.94-0.96), p < 0.01) were related to more COPD exacerbation-free days. Additionally, better baseline CRQ fatigue (IRR = 1.05 (95% CI 1.00-1.10), p = 0.04) and mastery scores (IRR = 1.06 (95% CI 1.00-1.12), p = 0.04), fewer courses of antibiotics (IRR = 0.94 (95% CI 0.91-0.96), p < 0.01), and improved CRQ dyspnea scores over 12 months of follow-up (IRR = 1.07 (95% CI 1.01-1.12), p < 0.01) were correlated to more days free of deteriorated symptoms. Less baseline dyspnea (modified Medical Research Council score) (IRR = 0.95 (95% CI 0.92-0.98), p < 0.01) and fewer courses of antibiotics (IRR = 0.94 (95% CI 0.93-0.95), p < 0.01) were associated with more combined COPD exacerbation and comorbid flare-up-free days. Healthcare professionals should be aware that less fatigue and better mastering of COPD relate to more exacerbation and symptom-free time in COPD patients.

Self-management interventions for people with chronic obstructive pulmonary disease.

BACKGROUND: Self-management interventions help people with chronic obstructive pulmonary disease (COPD) to acquire and practise the skills they need to carry out disease-specific medical regimens, guide changes in health behaviour and provide emotional support to enable them to control their disease. Since the 2014 update of this review, several studies have been published. OBJECTIVES: Primary objectives To evaluate the effectiveness of COPD self-management interventions compared to usual care in terms of health-related quality of life (HRQoL) and respiratory-related hospital admissions. To evaluate the safety of COPD self-management interventions compared to usual care in terms of respiratory-related mortality and all-cause mortality. Secondary objectives To evaluate the effectiveness of COPD self-management interventions compared to usual care in terms of other health outcomes and healthcare utilisation. To evaluate effective characteristics of COPD self-management interventions. SEARCH METHODS: We searched the Cochrane Airways Trials Register, CENTRAL, MEDLINE, EMBASE, trials registries and the reference lists of included studies up until January 2020. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cluster-randomised trials (CRTs) published since 1995. To be eligible for inclusion, self-management interventions had to include at least two intervention components and include an iterative process between participant and healthcare provider(s) in which goals were formulated and feedback was given on self-management actions by the participant. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, assessed trial quality and extracted data. We resolved disagreements by reaching consensus or by involving a third review author. We contacted study authors to obtain additional information and missing outcome data where possible. Primary outcomes were health-related quality of life (HRQoL), number of respiratory-related hospital admissions, respiratory-related mortality, and all-cause mortality. When appropriate, we pooled study results using random-effects modelling meta-analyses. MAIN RESULTS: We included 27 studies involving 6008 participants with COPD. The follow-up time ranged from two-and-a-half to 24 months and the content of the interventions was diverse. Participants' mean age ranged from 57 to 74 years, and the proportion of male participants ranged from 33% to 98%. The post-bronchodilator forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of participants ranged from 33.6% to 57.0%. The FEV1/FVC ratio is a measure used to diagnose COPD and to determine the severity of the disease. Studies were conducted on four different continents (Europe (n = 15), North America (n = 8), Asia (n = 1), and Oceania (n = 4); with one study conducted in both Europe and Oceania). Self-management interventions likely improve HRQoL, as measured by the St. George's Respiratory Questionnaire (SGRQ) total score (lower score represents better HRQoL) with a mean difference (MD) from usual care of -2.86 points (95% confidence interval (CI) -4.87 to -0.85; 14 studies, 2778 participants; low-quality evidence). The pooled MD of -2.86 did not reach the SGRQ minimal clinically important difference (MCID) of four points. Self-management intervention participants were also at a slightly lower risk for at least one respiratory-related hospital admission (odds ratio (OR) 0.75, 95% CI 0.57 to 0.98; 15 studies, 3263 participants; very low-quality evidence). The number needed to treat to prevent one respiratory-related hospital admission over a mean of 9.75 months' follow-up was 15 (95% CI 8 to 399) for participants with high baseline risk and 26 (95% CI 15 to 677) for participants with low baseline risk. No differences were observed in respiratory-related mortality (risk difference (RD) 0.01, 95% CI -0.02 to 0.04; 8 studies, 1572 participants ; low-quality evidence) and all-cause mortality (RD -0.01, 95% CI -0.03 to 0.01; 24 studies, 5719 participants; low-quality evidence). We graded the evidence to be of 'moderate' to 'very low' quality according to GRADE. All studies had a substantial risk of bias, because of lack of blinding of participants and personnel to the interventions, which is inherently impossible in a self-management intervention. In addition, risk of bias was noticeably increased because of insufficient information regarding a) non-protocol interventions, and b) analyses to estimate the effect of adhering to interventions. Consequently, the highest GRADE evidence score that could be obtained by studies was 'moderate'. AUTHORS' CONCLUSIONS: Self-management interventions for people with COPD are associated with improvements in HRQoL, as measured with the SGRQ, and a lower probability of respiratory-related hospital admissions. No excess respiratory-related and all-cause mortality risks were observed, which strengthens the view that COPD self-management interventions are unlikely to cause harm. By using stricter inclusion criteria, we decreased heterogeneity in studies, but also reduced the number of included studies and therefore our capacity to conduct subgroup analyses. Data were therefore still insufficient to reach clear conclusions about effective (intervention) characteristics of COPD self-management interventions. As tailoring of COPD self-management interventions to individuals is desirable, heterogeneity is and will likely remain present in self-management interventions. For future studies, we would urge using only COPD self-management interventions that include iterative interactions between participants and healthcare professionals who are competent using behavioural change techniques (BCTs) to elicit participants' motivation, confidence and competence to positively adapt their health behaviour(s) and develop skills to better manage their disease. In addition, to inform further subgroup and meta-regression analyses and to provide stronger conclusions regarding effective COPD self-management interventions, there is a need for more homogeneity in outcome measures. More attention should be paid to behavioural outcome measures and to providing more detailed, uniform and transparently reported data on self-management intervention components and BCTs. Assessment of outcomes over the long term is also recommended to capture changes in people's behaviour. Finally, information regarding non-protocol interventions as well as analyses to estimate the effect of adhering to interventions should be included to increase the quality of evidence.

The Effect of Telehealth on Hospital Services Use: Systematic Review and Meta-analysis.

BACKGROUND: Telehealth interventions, that is, health care provided over a distance using information and communication technology, are suggested as a solution to rising health care costs by reducing hospital service use. However, the extent to which this is possible is unclear. OBJECTIVE: The aim of this study is to evaluate the effect of telehealth on the use of hospital services, that is, (duration of) hospitalizations, and to compare the effects between telehealth types and health conditions. METHODS: We searched PubMed, Scopus, and the Cochrane Library from inception until April 2019. Peer-reviewed randomized controlled trials (RCTs) reporting the effect of telehealth interventions on hospital service use compared with usual care were included. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool and quality of evidence according to the Grading of Recommendations Assessment, Development and Evaluation guidelines. RESULTS: We included 127 RCTs in the meta-analysis. Of these RCTs, 82.7% (105/127) had a low risk of bias or some concerns overall. High-quality evidence shows that telehealth reduces the risk of all-cause or condition-related hospitalization by 18 (95% CI 0-30) and 37 (95% CI 20-60) per 1000 patients, respectively. We found high-quality evidence that telehealth leads to reductions in the mean all-cause and condition-related hospitalizations, with 50 and 110 fewer hospitalizations per 1000 patients, respectively. Overall, the all-cause hospital days decreased by 1.07 (95% CI -1.76 to -0.39) days per patient. For hospitalized patients, the mean hospital stay for condition-related hospitalizations decreased by 0.89 (95% CI -1.42 to -0.36) days. The effects were similar between telehealth types and health conditions. A trend was observed for studies with longer follow-up periods yielding larger effects. CONCLUSIONS: Small to moderate reductions in hospital service use can be achieved using telehealth. It should be noted that, despite the large number of included studies, uncertainties around the magnitude of effects remain, and not all effects are statistically significant.

Exacerbation action plans for patients with COPD and comorbidities: a randomised controlled trial.

This international randomised controlled trial evaluated whether COPD patients with comorbidities, trained in using patient-tailored multidisease exacerbation action plans, had fewer COPD exacerbation days than usual care (UC).COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification II-IV) with ≥1 comorbidity (ischaemic heart disease, heart failure, diabetes, anxiety, depression) were randomised to a patient-tailored self-management intervention (n=102) or UC (n=99). Daily symptom diaries were completed for 12 months. The primary outcome "COPD exacerbation days per patient per year" was assessed using intention-to-treat analyses.No significant difference was observed in the number of COPD exacerbation days per patient per year (self-management: median 9.6 (interquartile range (IQR) 0.7-31.1); UC: median 15.6 (IQR 3.0-40.3); incidence rate ratio (IRR) 0.87 (95% CI 0.54; 1.39); p=0.546). There was a significantly shorter duration per COPD exacerbation for self-management (self-management: median 8.1 (IQR 4.8-10.1) days; UC: median 9.5 (IQR 7.0-15.1) days; p=0.021), with no between-group differences in the total number of respiratory hospitalisations (IRR 0.76 (95% CI 0.42; 1.35); p=0.348), but a lower probability of ≥1 for respiratory-related hospitalisation compared to UC (relative risk 0.55 (95% CI 0.35; 0.87); p=0.008). No between-group differences were observed in all-cause hospitalisations (IRR 1.07 (95% CI 0.66; 1.72)) or mortality (self-management: n=4 (3.9%); UC: n=7 (7.1%); relative risk 0.55 (95% CI 0.17; 1.84)).Patient-tailored exacerbation action plans for COPD patients with comorbidities did not significantly reduce exacerbation days, but reduced the duration per COPD exacerbation and the risk of having at least one respiratory-related hospitalisation during follow-up, without excess all-cause mortality.

Self-management interventions including action plans for exacerbations versus usual care in patients with chronic obstructive pulmonary disease.

BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) self-management interventions should be structured but personalised and often multi-component, with goals of motivating, engaging and supporting the patients to positively adapt their behaviour(s) and develop skills to better manage disease. Exacerbation action plans are considered to be a key component of COPD self-management interventions. Studies assessing these interventions show contradictory results. In this Cochrane Review, we compared the effectiveness of COPD self-management interventions that include action plans for acute exacerbations of COPD (AECOPD) with usual care. OBJECTIVES: To evaluate the efficacy of COPD-specific self-management interventions that include an action plan for exacerbations of COPD compared with usual care in terms of health-related quality of life, respiratory-related hospital admissions and other health outcomes. SEARCH METHODS: We searched the Cochrane Airways Group Specialised Register of trials, trials registries, and the reference lists of included studies to May 2016. SELECTION CRITERIA: We included randomised controlled trials evaluating a self-management intervention for people with COPD published since 1995. To be eligible for inclusion, the self-management intervention included a written action plan for AECOPD and an iterative process between participant and healthcare provider(s) in which feedback was provided. We excluded disease management programmes classified as pulmonary rehabilitation or exercise classes offered in a hospital, at a rehabilitation centre, or in a community-based setting to avoid overlap with pulmonary rehabilitation as much as possible. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. We resolved disagreements by reaching consensus or by involving a third review author. Study authors were contacted to obtain additional information and missing outcome data where possible. When appropriate, study results were pooled using a random-effects modelling meta-analysis. The primary outcomes of the review were health-related quality of life (HRQoL) and number of respiratory-related hospital admissions. MAIN RESULTS: We included 22 studies that involved 3,854 participants with COPD. The studies compared the effectiveness of COPD self-management interventions that included an action plan for AECOPD with usual care. The follow-up time ranged from two to 24 months and the content of the interventions was diverse.Over 12 months, there was a statistically significant beneficial effect of self-management interventions with action plans on HRQoL, as measured by the St. George's Respiratory Questionnaire (SGRQ) total score, where a lower score represents better HRQoL. We found a mean difference from usual care of -2.69 points (95% CI -4.49 to -0.90; 1,582 participants; 10 studies; high-quality evidence). Intervention participants were at a statistically significant lower risk for at least one respiratory-related hospital admission compared with participants who received usual care (OR 0.69, 95% CI 0.51 to 0.94; 3,157 participants; 14 studies; moderate-quality evidence). The number needed to treat to prevent one respiratory-related hospital admission over one year was 12 (95% CI 7 to 69) for participants with high baseline risk and 17 (95% CI 11 to 93) for participants with low baseline risk (based on the seven studies with the highest and lowest baseline risk respectively).There was no statistically significant difference in the probability of at least one all-cause hospital admission in the self-management intervention group compared to the usual care group (OR 0.74, 95% CI 0.54 to 1.03; 2467 participants; 14 studies; moderate-quality evidence). Furthermore, we observed no statistically significant difference in the number of all-cause hospitalisation days, emergency department visits, General Practitioner visits, and dyspnoea scores as measured by the (modified) Medical Research Council questionnaire for self-management intervention participants compared to usual care participants. There was no statistically significant effect observed from self-management on the number of COPD exacerbations and no difference in all-cause mortality observed (RD 0.0019, 95% CI -0.0225 to 0.0263; 3296 participants; 16 studies; moderate-quality evidence). Exploratory analysis showed a very small, but significantly higher respiratory-related mortality rate in the self-management intervention group compared to the usual care group (RD 0.028, 95% CI 0.0049 to 0.0511; 1219 participants; 7 studies; very low-quality evidence).Subgroup analyses showed significant improvements in HRQoL in self-management interventions with a smoking cessation programme (MD -4.98, 95% CI -7.17 to -2.78) compared to studies without a smoking cessation programme (MD -1.33, 95% CI -2.94 to 0.27, test for subgroup differences: Chi² = 6.89, df = 1, P = 0.009, I² = 85.5%). The number of behavioural change techniques clusters integrated in the self-management intervention, the duration of the intervention and adaptation of maintenance medication as part of the action plan did not affect HRQoL. Subgroup analyses did not detect any potential variables to explain differences in respiratory-related hospital admissions among studies. AUTHORS' CONCLUSIONS: Self-management interventions that include a COPD exacerbation action plan are associated with improvements in HRQoL, as measured with the SGRQ, and lower probability of respiratory-related hospital admissions. No excess all-cause mortality risk was observed, but exploratory analysis showed a small, but significantly higher respiratory-related mortality rate for self-management compared to usual care.For future studies, we would like to urge only using action plans together with self-management interventions that meet the requirements of the most recent COPD self-management intervention definition. To increase transparency, future study authors should provide more detailed information regarding interventions provided. This would help inform further subgroup analyses and increase the ability to provide stronger recommendations regarding effective self-management interventions that include action plans for AECOPD. For safety reasons, COPD self-management action plans should take into account comorbidities when used in the wider population of people with COPD who have comorbidities. Although we were unable to evaluate this strategy in this review, it can be expected to further increase the safety of self-management interventions. We also advise to involve Data and Safety Monitoring Boards for future COPD self-management studies.

Definition of a COPD self-management intervention: International Expert Group consensus.

There is an urgent need for consensus on what defines a chronic obstructive pulmonary disease (COPD) self-management intervention. We aimed to obtain consensus regarding the conceptual definition of a COPD self-management intervention by engaging an international panel of COPD self-management experts using Delphi technique features and an additional group meeting.In each consensus round the experts were asked to provide feedback on the proposed definition and to score their level of agreement (1=totally disagree; 5=totally agree). The information provided was used to modify the definition for the next consensus round. Thematic analysis was used for free text responses and descriptive statistics were used for agreement scores.In total, 28 experts participated. The consensus round response rate varied randomly over the five rounds (ranging from 48% (n=13) to 85% (n=23)), and mean definition agreement scores increased from 3.8 (round 1) to 4.8 (round 5) with an increasing percentage of experts allocating the highest score of 5 (round 1: 14% (n=3); round 5: 83% (n=19)).In this study we reached consensus regarding a conceptual definition of what should be a COPD self-management intervention, clarifying the requisites for such an intervention. Operationalisation of this conceptual definition in the near future will be an essential next step.

Lack of Evidence Regarding Markers Identifying Acute Heart Failure in Patients with COPD: An AI-Supported Systematic Review.

Background: Due to shared symptoms, acute heart failure (AHF) is difficult to differentiate from an acute exacerbation of COPD (AECOPD). This systematic review aimed to identify markers that can diagnose AHF underlying acute dyspnea in patients with COPD presenting at the hospital. Methods: All types of observational studies and clinical trials that investigated any marker's ability to diagnose AHF in acutely dyspneic COPD patients were considered eligible for inclusion. An AI tool (ASReview) supported the title and abstract screening of the articles obtained from PubMed, Scopus, Web of Science, the Cochrane Library, Embase, and CINAHL until April 2023. Full text screening was independently performed by two reviewers. Twenty percent of the data extraction was checked by a second reviewer and the risk of bias was assessed in duplicate using the QUADAS-2 tool. Markers' discriminative abilities were evaluated in terms of sensitivity, specificity, positive and negative predictive values, and the area under the curve when available. Results: The search identified 10,366 articles. After deduplication, title and abstract screening was performed on 5,386 articles, leaving 153 relevant, of which 82 could be screened full text. Ten distinct studies (reported in 16 articles) were included, of which 9 had a high risk of bias. Overall, these studies evaluated 12 distinct laboratory and 7 non-laboratory markers. BNP, NT-proBNP, MR-proANP, and inspiratory inferior vena cava diameter showed the highest diagnostic discrimination. Conclusion: There is not much evidence for the use of markers to diagnose AHF in acutely dyspneic COPD patients in the hospital setting. BNPs seem most promising, but should be interpreted alongside imaging and clinical signs, as this may lead to improved diagnostic accuracy. Future validation studies are urgently needed before any AHF marker can be incorporated into treatment decision-making algorithms for patients with COPD. Protocol Registration: CRD42022283952.

Artificial intelligence in systematic reviews: promising when appropriately used.

BACKGROUND: Systematic reviews provide a structured overview of the available evidence in medical-scientific research. However, due to the increasing medical-scientific research output, it is a time-consuming task to conduct systematic reviews. To accelerate this process, artificial intelligence (AI) can be used in the review process. In this communication paper, we suggest how to conduct a transparent and reliable systematic review using the AI tool 'ASReview' in the title and abstract screening. METHODS: Use of the AI tool consisted of several steps. First, the tool required training of its algorithm with several prelabelled articles prior to screening. Next, using a researcher-in-the-loop algorithm, the AI tool proposed the article with the highest probability of being relevant. The reviewer then decided on relevancy of each article proposed. This process was continued until the stopping criterion was reached. All articles labelled relevant by the reviewer were screened on full text. RESULTS: Considerations to ensure methodological quality when using AI in systematic reviews included: the choice of whether to use AI, the need of both deduplication and checking for inter-reviewer agreement, how to choose a stopping criterion and the quality of reporting. Using the tool in our review resulted in much time saved: only 23% of the articles were assessed by the reviewer. CONCLUSION: The AI tool is a promising innovation for the current systematic reviewing practice, as long as it is appropriately used and methodological quality can be assured. PROSPERO REGISTRATION NUMBER: CRD42022283952.

Exploring Patterns of COPD Exacerbations and Comorbid Flare-Ups.

Background: Comorbidities are known to complicate disease management in patients with Chronic Obstructive Pulmonary Disease (COPD). This is partly due to lack of insight into the interplay of acute exacerbations of COPD (AECOPD) and comorbid flare-ups. This study aimed to explore patterns of AECOPDs and comorbid flare-ups. Methods: Data of increased symptoms were extracted from a 12-month daily symptom follow-up database including patients with COPD and comorbidities (chronic heart failure (CHF), anxiety, depression) and transformed to visualizations of AECOPDs and comorbid flare-up patterns over time. Patterns were subsequently categorized using an inductive approach, based on both predominance (ie, which occurs most often) of AECOPDs or comorbid flare-ups, and their simultaneous (ie, simultaneous start in ≥ 50%) occurrence. Results: We included 48 COPD patients (68 ± 9 years; comorbid CHF: 52%, anxiety: 40%, depression: 38%). In 25 patients with AECOPDs and CHF flare-ups, the following patterns were identified: AECOPDs predominant (n = 14), CHF flare-ups predominant (n = 5), AECOPDs nor CHF flare-ups predominant (n = 6). Of the 24 patients with AECOPDs and anxiety and/or depression flare-ups, anxiety and depression flare-ups occurred simultaneously in 15 patients. In 9 of these 24 patients, anxiety or depression flare-ups were observed independently from each other. In 31 of the included 48 patients, AECOPDs and comorbid flare-ups occurred mostly simultaneously. Conclusion: Patients with COPD and common comorbidities show a variety of patterns of AECOPDs and comorbid flare-ups. Some patients, however, show repetitive patterns that could potentially be used to improve personalized disease management, if recognized.

An Embodied Conversational Agent in an eHealth Self-management Intervention for Chronic Obstructive Pulmonary Disease and Chronic Heart Failure: Exploratory Study in a Real-life Setting.

BACKGROUND: Embodied conversational agents (ECAs) have the potential to stimulate actual use of eHealth apps. An ECA's design influences the user's perception during short interactions, but daily life evaluations of ECAs in health care are scarce. OBJECTIVE: This is an exploratory, long-term study on the design of ECAs for eHealth. The study investigates how patients perceive the design of the ECA over time with regard to the ECA's characteristics (friendliness, trustworthiness, involvement, expertise, and authority), small talk interaction, and likeliness of following the agent's advice. METHODS: We developed an ECA within an eHealth self-management intervention for patients with both chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF), which we offered for 4 months. Patients rated 5 agent characteristics and likeliness of following the agent's advice before use and after 3 and 9 weeks of use. The amount of patients' small talk interaction was assessed by log data. Lastly, individual semistructured interviews were used to triangulate results. RESULTS: Eleven patients (7 male and 4 female) with COPD and CHF participated (median age 70 years). Patients' perceptions of the agent characteristics did not change over time (P>.05 for all characteristics) and only 1 participant finished all small talk dialogues. After 3 weeks of use, the patients were less likely to follow the agent's advice (P=.01). The agent's messages were perceived as nonpersonalized and the feedback as inappropriate, affecting the agent's perceived reliability. CONCLUSIONS: This exploratory study provides first insights into ECA design for eHealth. The first impression of an ECA's design seems to remain during long-term use. To investigate future added value of ECAs in eHealth, perceived reliability should be improved by managing users' expectations of the ECA's capabilities and creating ECA designs fitting individual needs. TRIAL REGISTRATION: Netherlands Trial Register NL6480; https://www.trialregister.nl/trial/6480.

Predictors of patient adherence to COPD self-management exacerbation action plans.

OBJECTIVE: Identifying patient characteristics predicting categories of patient adherence to Chronic Obstructive Pulmonary Disease (COPD) exacerbation action plans. METHODS: Data were obtained from self-treatment intervention groups of two COPD self-management trials. Patients with ≥1 exacerbation and/or ≥1 self-initiated prednisolone course during one-year follow-up were included. Optimal treatment was defined as 'self-initiating prednisolone treatment ≤2 days from the onset of a COPD exacerbation'. Predictors of adherence categories were identified by multinomial logistic regression analysis using patient characteristics. RESULTS: 145 COPD patients were included and allocated to four adherence categories: 'optimal treatment' (26.2 %), 'sub optimal treatment' (11.7 %), 'significant delay or no treatment' (31.7 %), or 'treatment outside the actual exacerbation period' (30.3 %). One unit increase in baseline dyspnoea score (mMRC scale 0-4) increased the risk of 'significant delay or no treatment' (OR 1.64 (95 % CI 1.07-2.50)). Cardiac comorbidity showed a borderline significant increased risk of 'treatment outside the actual exacerbation period' (OR 2.40 (95 % CI 0.98-5.85)). CONCLUSION: More severe dyspnoea and cardiac comorbidity may lower adherence to COPD exacerbation action plans. PRACTICE IMPLICATIONS: Tailored self-management support with more focus on dyspnoea and cardiac disease symptoms may help patients to better act upon increased exacerbation symptoms and improve adherence to COPD exacerbation action plans.

Adherence to an eHealth Self-Management Intervention for Patients with Both COPD and Heart Failure: Results of a Pilot Study.

Background: Chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) often coexist and share periods of symptom deterioration. Electronic health (eHealth) might play an important role in adherence to interventions for the self-management of COPD and CHF symptoms by facilitating and supporting home-based care. Methods: In this pilot study, an eHealth self-management intervention was developed based on paper versions of multi-morbid exacerbation action plans and evaluated in patients with both COPD and CHF. Self-reporting of increased symptoms in diaries was linked to an automated decision support system that generated self-management actions, which was communicated via an eHealth application on a tablet. After participating in self-management training sessions, patients used the intervention for a maximum of four months. Adherence to daily symptom diary completion and follow-up of actions were analyzed. An add-on sensorized (Respiro®) inhaler was used to analyze inhaled medication adherence and inhalation technique. Results: In total, 1148 (91%) of the daily diaries were completed on the same day by 11 participating patients (mean age 66.8 ± 2.9 years; moderate (55%) to severe (45%) COPD; 46% midrange left ventricular function (LVF) and 27% reduced LVF). Seven patients received a total of 24 advised actions because of increased symptoms of which 11 (46%) were followed-up. Of the 13 (54%) unperformed advised actions, six were "call the case manager". Adherence to inhaled medication was 98.4%, but 51.9% of inhalations were performed incorrectly, with "inhaling too shortly" (<1.25 s) being the most frequent error (79.6%). Discussion: Whereas adherence to completing daily diaries was high, advised actions were inadequately followed-up, particularly the action "call the case manager". Inhaled medication adherence was high, but inhalations were poorly performed. Future research is needed to identify adherence barriers, further tailor the intervention to the individual patient and analyse the intervention effects on health outcomes.

Does immediate smart feedback on therapy adherence and inhalation technique improve asthma control in children with uncontrolled asthma? A study protocol of the IMAGINE I study.

BACKGROUND: Many asthmatic children suffer from uncontrolled asthma with frequent exacerbations, despite an optimal treatment plan using inhalation medication. Studies have shown that therapy adherence and inhalation technique are often suboptimal in asthmatic children, but these have traditionally been hard to measure. A novel device functioning as an add-on to the inhaler has been developed to measure both aspects by recording vibration patterns during inhalation. This data can be converted to smart feedback and provided to patients immediately via a mobile application. The aim of this study is to improve asthma control in children between 6 and 18 years old by providing immediate smart feedback on the intake of inhalation medication. Asthma control will be measured by forced expiratory volume in 1 s, (Childhood) Asthma Control Test ((c-)ACT) score, and lung function variability and reversibility. METHODS: The study will be performed in Medisch Spectrum Twente (Enschede, The Netherlands). The goal is to include 68 uncontrolled moderate to severe asthmatic children between 6 and 18 years old who receive controller inhalation medication through the Nexthaler®, Ellipta®, or Spiromax®. The study consists of three phases. Phase 1 is observational and will last 4 weeks to observe the baseline adherence and inhalation technique as monitored by the add-on device. A randomised controlled trial lasting 6 weeks will be performed in phase 2. Patients in the intervention group will receive immediate smart feedback about the performed inhalations via a mobile application. In the control group, adherence and inhalation technique will be monitored, but patients will not receive feedback. In phase 3, also lasting 6 weeks, the feedback will be ceased for all children and revision of current therapy may occur, depending on the findings in phase 2. Asthma control can be assessed by means of spirometry (both at home and in the hospital) and (c-)ACT questionnaires. DISCUSSION: Immediate smart feedback may improve therapy adherence and inhalation technique, and thus asthma control in children and prevent unnecessary switches to targeted biologics. Performing this study in children is desired, since they are known to react differently to feedback and medication than adults. TRIAL REGISTRATION: Dutch Trial Register NL7705 . Registered on 29 April 2019.

Improving physical activity, sedentary behaviour and sleep in COPD: perspectives of people with COPD and experts via a Delphi approach.

BACKGROUND: Little is known about how to achieve enduring improvements in physical activity (PA), sedentary behaviour (SB) and sleep for people with chronic obstructive pulmonary disease (COPD). This study aimed to: (1) identify what people with COPD from South Australia and the Netherlands, and experts from COPD- and non-COPD-specific backgrounds considered important to improve behaviours; and (2) identify areas of dissonance between these different participant groups. METHODS: A four-round Delphi study was conducted, analysed separately for each group. Free-text responses (Round 1) were collated into items within themes and rated for importance on a 9-point Likert scale (Rounds 2-3). Items meeting a priori criteria from each group were retained for rating by all groups in Round 4. Items and themes achieving a median Likert score of ≥7 and an interquartile range of ≤2 across all groups at Round 4 were judged important. Analysis of variance with Tukey's post-hoc tested for statistical differences between groups for importance ratings. RESULTS: Seventy-three participants consented to participate in this study, of which 62 (85%) completed Round 4. In Round 4, 81 items (PA n = 54; SB n = 24; sleep n = 3) and 18 themes (PA n = 9; SB n = 7; sleep n = 2) were considered important across all groups concerning: (1) symptom/disease management, (2) targeting behavioural factors, and (3) less commonly, adapting the social/physical environments. There were few areas of dissonance between groups. CONCLUSION: Our Delphi participants considered a multifactorial approach to be important to improve PA, SB and sleep. Recognising and addressing factors considered important to recipients and providers of health care may provide a basis for developing behaviour-specific interventions leading to long-term behaviour change in people with COPD.

Construct Validity of the Dutch Version of the 12-Item Partners in Health Scale: Measuring Patient Self-Management Behaviour and Knowledge in Patients with Chronic Obstructive Pulmonary Disease.

OBJECTIVE: The 12-item Partners in Health scale (PIH) was developed in Australia to measure self-management behaviour and knowledge in patients with chronic diseases, and has undergone several changes. Our aim was to assess the construct validity and reliability of the latest PIH version in Dutch COPD patients. METHODS: The 12 items of the PIH, scored on a self-rated 9-point Likert scale, are used to calculate total and subscale scores (knowledge; coping; recognition and management of symptoms; and adherence to treatment). We used forward-backward translation of the latest version of the Australian PIH to define a Dutch PIH (PIH(Du)). Mokken Scale Analysis and common Factor Analysis were performed on data from a Dutch COPD sample to investigate the psychometric properties of the Dutch PIH; and to determine whether the four-subscale solution previously found for the original Australian PIH could be replicated for the Dutch PIH. RESULTS: Two subscales were found for the Dutch PIH data (n = 118); 1) knowledge and coping; 2) recognition and management of symptoms, adherence to treatment. The correlation between the two Dutch subscales was 0.43. The lower-bound of the reliability of the total scale equalled 0.84. Factor analysis indicated that the first two factors explained a larger percentage of common variance (39.4% and 19.9%) than could be expected when using random data (17.5% and 15.1%). CONCLUSION: We recommend using two PIH subscale scores when assessing self-management in Dutch COPD patients. Our results did not support the four-subscale structure as previously reported for the original Australian PIH.

Development of a self-treatment approach for patients with COPD and comorbidities: an ongoing learning process.

BACKGROUND: Patient-initiated action plans are an important component of COPD self-management (SM) interventions. When integrated into SM interventions, these action plans have proven to be effective in reducing exacerbation severity, hospitalisations, and costs and in improving health status in patients with COPD without severe comorbidities. Because of overlap in symptoms, a self-treatment (ST) approach that focuses solely on traditional symptoms of COPD is inadequate for patients with COPD and comorbidities. The COPE-III SM intervention combines (I) patient-initiated action plans that are tailored to the individual's co-morbid disease(s), and (II) ongoing nurse support. In this paper we provide information regarding the integration of information from two previous COPD SM studies (COPE I and II) in the development of the current COPE-III ST approach. MATERIALS AND METHODS: COPE-III ST materials include daily symptom diaries and action plans that take patient's common comorbidities [chronic heart failure (CHF), anxiety, depression, ischaemic heart disease (IHD), and diabetes] into account. The comorbid diary and action plans components were developed in collaboration with multiple disease-experts. RESULTS: Previous SM studies have highlighted some essential topics that need to be considered when developing a SM or ST approach: 'when to initiate ST', 'how to optimize materials and safety', and 'how to achieve behavioural change'. In the COPE-III study, ST is initiated after a significant change in symptoms. This is consistent with the COPE-II approach and was implemented because disease symptoms are often present even when patients are stable. We have tried to ensure patient safety by providing an easily accessible case-manager to patients throughout their involvement in the study. Furthermore, a psychologist has ensured the use of behavioural change techniques throughout the intervention. CONCLUSIONS: We should continue to learn from our experiences with SM interventions to further optimize future SM and ST interventions. The use of materials that are suitable for different levels of patient literacy and the training of health care providers are other points of improvement.

A self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease (COPD) and comorbidities: the COPE-III study protocol.

BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) frequently coexists with other diseases. Whereas COPD action plans are currently part of usual care, they are less suitable and potentially unsafe for use in the presence of comorbidities. This study evaluates whether an innovative treatment approach directed towards COPD and frequently existing comorbidities can reduce COPD exacerbation days. We hypothesise that this approach, which combines self-initiated action plans and nurse support, will accelerate proper treatment actions and lead to better control of deteriorating symptoms. METHODS: In this multicenter randomised controlled trial we aim to include 300 patients with COPD (GOLD II-IV), and with at least one comorbidity (cardiovascular disease, diabetes, anxiety and/or depression). Patients will be recruited from hospitals in the Netherlands (n = 150) and Australia (n = 150) and will be assigned to an intervention or control group. All patients will learn to complete daily symptom diaries for 12-months. Intervention group patients will participate in self-management training sessions to learn the use of individualised action plans for COPD and comorbidities, linked to the diary. The primary outcome is the number of COPD exacerbation days. Secondary outcomes include hospitalisations, quality of life, self-efficacy, adherence, patient's satisfaction and confidence, health care use and cost data. ANALYSES: Intention-to-treat analyses (random effect negative binomial regression and random effect mixed models) and cost-effectiveness analyses will be performed. DISCUSSION: Prudence should be employed before extrapolating the use of COPD specific action plans in patients with comorbidities. This study evaluates the efficacy of tailored action plans for both COPD and common comorbidities.