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

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

Opioids in patients with COPD and refractory dyspnea:literature review and design of a multicenter double blind study of low dosed morphine and fentanyl (MoreFoRCOPD)

BACKGROUND: Refractory dyspnea or breathlessness is a common symptom in patients with advanced chronic obstructive pulmonary disease (COPD), with a high negative impact on quality of life (QoL). Low dosed opioids have been investigated for refractory dyspnea in COPD and other life-limiting conditions, and some positive effects were demonstrated. However, upon first assessment of the literature, the quality of evidence in COPD seemed low or inconclusive, and focused mainly on morphine which may have more side effects than other opioids such as fentanyl. For the current publication we performed a systematic literature search. We searched for placebo-controlled randomized clinical trials investigating opioids for refractory dyspnea caused by COPD. We included trials reporting on dyspnea, health status and/or QoL. Three of fifteen trials demonstrated a significant positive effect of opioids on dyspnea. Only one of four trials reporting on QoL or health status, demonstrated a significant positive effect. Two-thirds of included trials investigated morphine. We found no placebo-controlled RCT on transdermal fentanyl. Subsequently, we hypothesized that both fentanyl and morphine provide a greater reduction of dyspnea than placebo, and that fentanyl has less side effects than morphine.METHODS: We describe the design of a robust, multi-center, double blind, double-dummy, cross-over, randomized, placebo-controlled clinical trial with three study arms investigating transdermal fentanyl 12 mcg/h and morphine sustained-release 10 mg b.i.d. The primary endpoint is change in daily mean dyspnea sensation measured on a numeric rating scale. Secondary endpoints are change in daily worst dyspnea, QoL, anxiety, sleep quality, hypercapnia, side effects, patient preference, and continued opioid use. Sixty patients with severe stable COPD and refractory dyspnea (FEV1 &lt; 50%, mMRC ≥ 3, on optimal standard therapy) will be included.DISCUSSION: Evidence for opioids for refractory dyspnea in COPD is not as robust as usually appreciated. We designed a study comparing both the more commonly used opioid morphine, and transdermal fentanyl to placebo. The cross-over design will help to get a better impression of patient preferences. We believe our study design to investigate both sustained-release morphine and transdermal fentanyl for refractory dyspnea will provide valuable information for better treatment of refractory dyspnea in COPD. Trial registration NCT03834363 (ClinicalTrials.gov), registred at 7 Feb 2019, https://clinicaltrials.gov/ct2/show/NCT03834363 .</p

Opioids in patients with COPD and refractory dyspnea:literature review and design of a multicenter double blind study of low dosed morphine and fentanyl (MoreFoRCOPD)

Abstract Background Refractory dyspnea or breathlessness is a common symptom in patients with advanced chronic obstructive pulmonary disease (COPD), with a high negative impact on quality of life (QoL). Low dosed opioids have been investigated for refractory dyspnea in COPD and other life-limiting conditions, and some positive effects were demonstrated. However, upon first assessment of the literature, the quality of evidence in COPD seemed low or inconclusive, and focused mainly on morphine which may have more side effects than other opioids such as fentanyl. For the current publication we performed a systematic literature search. We searched for placebo-controlled randomized clinical trials investigating opioids for refractory dyspnea caused by COPD. We included trials reporting on dyspnea, health status and/or QoL. Three of fifteen trials demonstrated a significant positive effect of opioids on dyspnea. Only one of four trials reporting on QoL or health status, demonstrated a significant positive effect. Two-thirds of included trials investigated morphine. We found no placebo-controlled RCT on transdermal fentanyl. Subsequently, we hypothesized that both fentanyl and morphine provide a greater reduction of dyspnea than placebo, and that fentanyl has less side effects than morphine. Methods We describe the design of a robust, multi-center, double blind, double-dummy, cross-over, randomized, placebo-controlled clinical trial with three study arms investigating transdermal fentanyl 12 mcg/h and morphine sustained-release 10 mg b.i.d. The primary endpoint is change in daily mean dyspnea sensation measured on a numeric rating scale. Secondary endpoints are change in daily worst dyspnea, QoL, anxiety, sleep quality, hypercapnia, side effects, patient preference, and continued opioid use. Sixty patients with severe stable COPD and refractory dyspnea (FEV1 < 50%, mMRC ≥ 3, on optimal standard therapy) will be included. Discussion Evidence for opioids for refractory dyspnea in COPD is not as robust as usually appreciated. We designed a study comparing both the more commonly used opioid morphine, and transdermal fentanyl to placebo. The cross-over design will help to get a better impression of patient preferences. We believe our study design to investigate both sustained-release morphine and transdermal fentanyl for refractory dyspnea will provide valuable information for better treatment of refractory dyspnea in COPD. Trial registration NCT03834363 (ClinicalTrials.gov), registred at 7 Feb 2019, https://clinicaltrials.gov/ct2/show/NCT03834363

White Paper: Open Digital Health – accelerating transparent and scalable health promotion and treatment

In this White Paper, we outline recommendations from the perspective of health psychology and behavioural science, addressing three research gaps: (1) What methods in the health psychology research toolkit can be best used for developing and evaluating digital health tools? (2) What are the most feasible strategies to reuse digital health tools across populations and settings? (3) What are the main advantages and challenges of sharing (openly publishing) data, code, intervention content and design features of digital health tools? We provide actionable suggestions for researchers joining the continuously growing Open Digital Health movement, poised to revolutionise health psychology research and practice in the coming years. This White Paper is positioned in the current context of the COVID-19 pandemic, exploring how digital health tools have rapidly gained popularity in 2020-2022, when world-wide health promotion and treatment efforts rapidly shifted from face-to-face to remote delivery. This statement is written by the Directors of the not-for-profit Open Digital Health initiative (n = 6), Experts attending the European Health Psychology Society Synergy Expert Meeting (n = 17), and the initiative consultant, following a two-day meeting (19-20th August 2021).Peer reviewe

Exhaled hydrogen peroxide in chronic obstructive pulmonary disease : an analysis of its applicability as a non-invasive biomarker

Contains fulltext : 19369.pdf (publisher's version ) (Open Access)Several non-invasive biomarkers have been used to investigate the pathophysiology, treatment and prognosis of COPD. However, for most markers there is no standardized procedure and few randomised studies have been performed with COPD patients. We have developed an efficient, sensitive and reproducible procedure for measuring hydrogen peroxide (H2O2) in exhaled breath condensate (EBC) and have shown that it is important to have a low detection limit. We also found that the H2O2 concentration increases significantly over the day in both COPD patients and healthy controls. It is possible that exhaled H2O2 levels are influenced by the intake of food and drinks or exercise and it is therefore very important to perform H2O2 measurements in follow-up studies at the same time of day in the same conditions. In contrast to other investigators, we did not find significant higher exhaled H2O2 concentrations in stable COPD patients compared with healthy controls, possibly because our control group was matched with the patient group for age and smoking status. The number and activation of inflammatory cells seem to be increased in COPD patients compared with healthy persons, we showed that peripheral neutrophils are more easily activated by certain stimuli to release superoxide. No changes were observed in exhaled H2O2 levels during a COPD exacerbation and subsequent treatment. In contrast, serum inflammatory markers such as ESR, CRP and MPO concentration did show a reduction during treatment. This means that these parameters are more appropriate to evaluate the effect of treatment during exacerbation than exhaled H2O2 levels. Finally, we used exhaled H2O2 levels to evaluate the effect of two different ICS in stable COPD patients. The exhaled H2O2 levels decreased in both treatment groups after four weeks and the effect lasted for several weeks after discontinuation. We found no difference in effect between both ICS. This study shows that ICS do influence the concentration of exhaled H2O2.161 p

Patient and Health Care Provider Perspectives on Potential Preventability of Hospital Admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Qualitative Study

Purpose: Chronic obstructive pulmonary disease (COPD) is a highly prevalent chronic disease partly characterised by the occurrence of acute exacerbations (AECOPD). The need for hospital admissions for COPD exacerbations could theoretically be decreased through timely and appropriate outpatient care or self-management. The aim of this study is to explore and compare patients’ and health care providers’ (HCP) perspectives on the potential preventability of COPD hospitalisations and to identify strategies to prevent unnecessary hospitalisations. Patients and Methods: Semi-structured interviews were conducted with patients admitted for an AECOPD (N = 11), HCPs on the respiratory ward (N = 11), and treating pulmonologists (N = 10). Interviews were transcribed verbatim and analysed using thematic content analysis. Results: Patient and HCP perspectives on the potential preventability of hospital admissions for AECOPD often conflict. The kappa coefficients were −0.18 [95% CI: −0.46–0.11] for patients and pulmonologists and −0.28 [95% CI: −0.80–0.21] for patients and HCPs, which indicates poor agreement. The kappa coefficient for pulmonologists and HCPs was 0.14 [95% CI: −0.13–0.41], which indicates slight agreement. Patient and HCP factors that could potentially prevent hospitalisation for AECOPD were identified, including timely calling for help, recognizing and acting on symptoms, and receiving instruction about COPD, including treatment and action plans. Conclusion: Patients and their HCPs have different beliefs about the potential preventability of AECOPD hospitalisations. Most patients and HCPs mentioned factors that potentially could have led to a different outcome for the current AECOPD or that could impact the patient’s health status and treatment of AECOPDs in the future. The factors identified in this study indicate that shared decision making is crucial to center the patient’s perspective and individual needs and to provide timely treatment or prevention of AECOPD, thereby potentially decreasing hospital admission rates

Construct validity of the Dutch version of the 12-item Partners in Health scale : measuring self-management behaviour and knowledge in COPD patients

The 12-item Partner in Health (PIH) scale was developed in Australia to measure self-management behaviour and knowledge in patients with chronic diseases. The scale has undergone several changes since first published. Our study aim was to validate the latest PIH in Dutch COPD patients.The 12 items of the PIH are scored on a self-rated 9-point Likert scale (range: 0-8; higher scores indicate better self-management), providing total and subscale scores (knowledge, coping, recognition and management of functions, adherence to treatment).We used forward-backward translation of the latest version of the Australian PIH. Dimensionality and reliability analyses were performed to investigate the psychometric properties, and to determine whether the Dutch PIH replicated the same four subscales of self-management as the original PIH.Reanalysis of the original PIH validation study (186 Australian patients with chronic diseases) showed a single scale. Two scales (1. knowledge and coping; 2. recognition and management of symptoms, adherence to treatment) were found for the Dutch PIH (118 Dutch COPD patients). The correlation between the two Dutch scales was 0.43. The lower-bound of the reliability of the total scale was 0.81 (Australian PIH) and 0.84 (Dutch PIH).Different scale structures were found for the original Australian and the Dutch PIH. Our results did not support the 4-scale structure reported previously. To increase comparability and generalisability of our findings, the scale structure of the revised Australian PIH needs to be investigated further. Meanwhile, we advise using the PIH total score or two subscale scores when assessing COPD patients

Validation of the 12-item Partners in Health scale to measure patient self-management behaviour and knowledge in Dutch patients with COPD

The 12-item Partner in Health (PIH) scale was developed in Australia to measure self-management behaviour and knowledge in patients with chronic diseases. The scale has undergone several changes since first published. Our study aim was to validate the latest PIH in Dutch COPD patients.The 12 items of the PIH are scored on a self-rated 9-point Likert scale (range: 0-8; higher scores indicate better self-management), providing total and subscale scores (knowledge, coping, recognition and management of functions, adherence to treatment).We used forward-backward translation of the latest version of the Australian PIH. Dimensionality and reliability analyses were performed to investigate the psychometric properties, and to determine whether the Dutch PIH replicated the same four subscales of self-management as the original PIH.Reanalysis of the original PIH validation study (186 Australian patients with chronic diseases) showed a single scale. Two scales (1. knowledge and coping; 2. recognition and management of symptoms, adherence to treatment) were found for the Dutch PIH (118 Dutch COPD patients). The correlation between the two Dutch scales was 0.43. The lower-bound of the reliability of the total scale was 0.81 (Australian PIH) and 0.84 (Dutch PIH).Different scale structures were found for the original Australian and the Dutch PIH. Our results did not support the 4-scale structure reported previously. To increase comparability and generalisability of our findings, the scale structure of the revised Australian PIH needs to be investigated further. Meanwhile, we advise using the PIH total score or two subscale scores when assessing COPD patients