Video Consultation as an Adequate Alternative to Face-to-Face Consultation in Continuous Positive Airway Pressure Use for Newly Diagnosed Patients With Obstructive Sleep Apnea: Randomized Controlled Trial.

BACKGROUND: The effectiveness of continuous positive airway pressure (CPAP) is dependent on the degree of use, so adherence is essential. Cognitive components (eg, self-efficacy) and support during treatment have been found to be important in CPAP use. Video consultation may be useful to support patients during treatment. So far, video consultation has rarely been evaluated in thorough controlled research, with only a limited number of outcomes assessed. OBJECTIVE: The aim of the study was to evaluate the superiority of video consultation over face-to-face consultation for patients with obstructive sleep apnea (OSA) on CPAP use (minutes per night), adherence, self-efficacy, risk outcomes, outcome expectancies, expectations and experiences with video consultation, and satisfaction of patients and nurses. METHODS: A randomized controlled trial was conducted with an intervention (video consultation) and a usual care group (face-to-face consultation). Patients with confirmed OSA (apnea-hypopnea index >15), requiring CPAP treatment, no history of CPAP treatment, having access to a tablet or smartphone, and proficient in the Dutch language were recruited from a large teaching hospital. CPAP use was monitored remotely, with short-term (weeks 1 to 4) and long-term (week 4, week 12, and week 24) assessments. Questionnaires were completed at baseline and after 4 weeks on self-efficacy, risk perception, outcome expectancies (Self-Efficacy Measure for Sleep Apnea), expectations and experiences with video consultation (covering constructs of the unified theory of acceptance and use of technology), and satisfaction. Nurse satisfaction was evaluated using questionnaires. RESULTS: A total of 140 patients were randomized (1:1 allocation). The use of video consultation for OSA patients does not lead to superior results on CPAP use and adherence compared with face-to-face consultation. A significant difference in change over time was found between groups for short-term (P-interaction=.008) but not long-term (P-interaction=.68) CPAP use. CPAP use decreased in the long term (P=.008), but no significant difference was found between groups (P=.09). Change over time for adherence was not significantly different in the short term (P-interaction=.17) or long term (P-interaction=.51). A relation was found between CPAP use and self-efficacy (P=.001), regardless of the intervention arm (P=.25). No significant difference between groups was found for outcome expectancies (P=.64), self-efficacy (P=.41), and risk perception (P=.30). The experiences were positive, and 95% (60/63) intended to keep using video consultation. Patients in both groups rated the consultations on average with an 8.4. Overall, nurses (n=3) were satisfied with the video consultation system. CONCLUSIONS: Support of OSA patients with video consultation does not lead to superior results on CPAP use and adherence compared with face-to-face consultation. The findings of this research suggest that self-efficacy is an important factor in improving CPAP use and that video consultation may be a feasible way to support patients starting CPAP. Future research should focus on blended care approaches in which self-efficacy receives greater emphasis. TRIAL REGISTRATION: Clinicaltrials.gov NCT04563169; https://clinicaltrials.gov/show/NCT04563169.

Effectiveness of a Mobile Health and Self-Management App for High-Risk Patients With Chronic Obstructive Pulmonary Disease in Daily Clinical Practice: Mixed Methods Evaluation Study.

BACKGROUND: Mobile health and self-management interventions may positively affect behavioral change and reduce hospital admissions for patients with chronic obstructive pulmonary disease (COPD). However, not all patients qualify for these interventions, and systematic, comprehensive information on implementation- and compliance-related aspects of mobile self-management apps is lacking. Due to the tendency to target digital services to patients in stable phases of disease, it is especially relevant to focus on the use of these services in broad clinical practice for patients recently discharged from hospital. OBJECTIVE: This study aims to evaluate the effects of a mobile health and self-management app in clinical practice for recently discharged patients with COPD on use of the app, self-management, expectations, and experiences (technology acceptance); patients' and nurses' satisfaction; and hospital readmissions. METHODS: A prototype of the app was pilot tested with 6 patients with COPD. The COPD app consisted of an 8-week program including the Lung Attack Action Plan, education, medication overview, video consultation, and questionnaires (monitored by nurses). In the feasibility study, adult patients with physician-diagnosed COPD, access to a mobile device, and proficiency of the Dutch language were included from a large teaching hospital during hospital admission. Self-management (Partners in Health Scale), technology acceptance (Unified Theory Acceptance and Use of Technology model), and satisfaction were assessed using questionnaires at baseline, after 8 weeks, and 20 weeks. Use was assessed with log data, and readmission rates were extracted from the electronic medical record. RESULTS: A total of 39 patients were included; 76.4% (133/174) of patients had to be excluded from participation, and 48.9% of those patients (65/133) were excluded because of lack of digital skills, access to a mobile device, or access to the internet. The COPD app was opened most often in the first week (median 6.0; IQR 3.5-10.0), but its use decreased over time. The self-management element knowledge and coping increased significantly over time (P=.04). The COPD app was rated on a scale of 1-10, with an average score by patients of 7.7 (SD 1.7) and by nurses of 6.3 (SD 1.2). Preliminary evidence about the readmission rate showed that 13% (5/39) of patients were readmitted within 30 days; 31% (12/39) of patients were readmitted within 20 weeks, compared with 14.1% (48/340) and 21.8% (74/340) in a preresearch cohort, respectively. CONCLUSIONS: The use of a mobile self-management app after hospital discharge seems to be feasible only for a small number of patients with COPD. Patients were satisfied with the service; however, use decreased over time, and only knowledge and coping changed significantly over time. Therefore, future research on digital self-management interventions in clinical practice should focus on including more difficult subgroups of target populations, a multidisciplinary approach, technology-related aspects (such as acceptability), and fine-tuning its adoption in clinical pathways. TRIAL REGISTRATION: Clinicaltrials.gov NCT04540562; https://clinicaltrials.gov/ct2/show/NCT04540562.

Can AMP induce sputum eosinophils, even in subjects with complete asthma remission?

BACKGROUND: The definition of "clinical asthma remission" is based on absence of symptoms and use of medication. However, in the majority of these subjects airway inflammation is still present when measured. In the present study we investigated whether "complete asthma remission", additionally defined by the absence of bronchial hyperresponsiveness (BHR) and the presence of a normal lung function, is associated with the absence of airway inflammation. METHODS: Patients with a former diagnosis of asthma and a positive histamine provocation test were re-examined to identify subjects with complete asthma remission (no asthma symptoms or medication, PC20 histamine > 32 mg/ml, FEV1 > 90% predicted). Patients with PC20 histamine < or = 32 mg/ml were defined as current asthmatics and were divided in two groups, i.e. asthmatics with and without BHR to adenosine 5'monophoshate (AMP). Sputum induction was performed 1 week before and 1 hour after AMP provocation. Sputum induction and AMP provocation were previously shown to be sensitive markers of airway inflammation. RESULTS: Seven patients met criteria for complete asthma remission. Twenty-three were current asthmatics, including twelve without hyperresponsiveness to AMP. Subjects with complete asthma remission showed no AMP-induced sputum eosinophilia (median (range) 0.2 (0 - 4.6)% at baseline and 0.2 (0 - 2.6)% after AMP). After AMP, current asthmatics had a significant increase in sputum eosinophils (0.5 (0 - 26.0)% at baseline and 2.6 (0 - 32.0) % after AMP), as had the subgroup of current asthmatics without hyperresponsiveness to AMP (0.2 (0 - 1.8)% at baseline and 1.3 (0 - 6.3)% after AMP). CONCLUSIONS: Subjects with complete asthma remission, in contrast to subjects with current asthma, do not respond with eosinophilic inflammation in sputum after AMP provocations. These data lend support to the usefulness of the definition of complete asthma remission.

Expression of ADAMs ("a disintegrin and metalloprotease") in the human lung.

In view of the associations of "a disintegrin and metalloprotease" (ADAM) with respiratory diseases, we assessed the expression of various ADAMs in human lung tissue. Lung tissue was obtained from nine individuals who underwent surgery for lung cancer or underwent lung transplantation for emphysema. Also, 16HBE 14o- (human bronchial epithelial) and A549 (alveolar type II epithelium-like) cell lines were used. Immunohistochemistry was performed with antibodies recognizing different ADAM domains. The ADAMs were typically distributed over the bronchial epithelium. ADAM8 and ADAM10 were expressed diffusely in all layers of the epithelium. ADAM9, ADAM17, and ADAM19 were predominantly expressed in the apical part of the epithelium, and ADAM33 was predominantly and strongly expressed in basal epithelial cells. In smooth muscle, ADAM19 and ADAM17 were strongly expressed, as was ADAM33, though this expression was weaker. ADAM33 was strongly expressed in vascular endothelium. All ADAMs were generally expressed in inflammatory cells. The typical distribution of ADAMs in the lung, especially in the epithelium, is interesting and suggests a localized function. As most ADAMs are involved in release of (pro-) inflammatory mediators and growth factors, they may play an important role in the first line of defense and in initiation of repair events in the airways.

A self-rating scale for patient-perceived side effects of inhaled corticosteroids.

BACKGROUND: Patient-reported side effect questionnaires offer a simple method for the systematic measurement of drug-related side effects. In order to measure patients' inhaled corticosteroids (ICS) related side effect perceptions the 14-day retrospective Inhaled Corticosteroid Questionnaire (ICQ) was developed. In this research we aim to assess the construct validity and reliability of the ICQ and test its responsiveness to dose changes in adult asthma patients. METHODS: In a cross-sectional study, current inhaler users with asthma completed the ICQ (27 with non ICS inhaler; 61 BDP equivalent daily ICS low dose < or =400 microg; 62 mid dose 401-800 microg; and 105 with high dose >800 microg). We generated 3 construct validity hypotheses: 1) a hierarchical dose-response pattern for scoring of the individual items on the ICQ, and statistically significant differences in the scores of each of the 15 ICQ domains by ICS dose group 2) an association between ICS dose and ICQ scoring after adjusting for appropriate confounders in multiple regression; 3) greater convergence between local side effect domains than between systemic and local domains of the scale. Test-retest reliability was assessed on a randomly selected subgroup of patients (n = 73) who also completed the ICQ a second time after 7 days. In a separate longitudinal study, 61 patients with asthma completed the ICQ at baseline and after changing their daily ICS dose, at 2- and 6- months, in order to test the ICQ's responsiveness. RESULTS: All three construct validity hypotheses were well supported: 1) a statistically significant difference existed in scores for 14 domains, the high ICS dose group scoring highest; 2) ICS dose independently predicted ICQ scoring after adjusting for confounders; 3) greater convergence existed between local ICQ domains than between local and systemic domains. The ICQ had good reproducibility: test-retest intraclass correlation coefficients were > or =0.69 for all but the 'Facial Oedema' domain. In the longitudinal study, ICQ scores for 'Voice Problems' changed significantly at 2- and 6-months from baseline and other ICQ domains displayed trends in scoring change accordant with dose modulation at 6-months. CONCLUSION: The ICQ has good dose-related discriminative properties, is valid, reliable, and shows potential responsiveness to ICS dose change.

Estrogen receptor 1 polymorphisms are associated with airway hyperresponsiveness and lung function decline, particularly in female subjects with asthma.

BACKGROUND: Sex hormones may contribute to the higher prevalence and severity of adult asthma in women compared with men. OBJECTIVE: Sequence variants in the estrogen receptor alpha gene (ESR1) may alter estrogen action in asthma. METHODS: Two hundred asthma probands and their families (n=1249) were genotyped for 5 single nucleotide polymorphisms (SNPs) in the ESR1 gene (intervening sequence 1 [IVS1]-1505A/G, IVS1-1415T/C, IVS1-397C/T, IVS1-351G/A and exon1+30T/C). Association with asthma and bronchial hyperresponsiveness (BHR) were tested. In the asthma probands, association of SNPs with BHR severity and annual FEV1 decline were determined. RESULTS: No SNP was associated with asthma. IVS1-397 was significantly associated with the presence of BHR (P=.02) and interacted with sex; female subjects with the CT or TT genotype were at risk (P=.01). In asthma probands, all SNPs were associated with FEV1 decline. Exon1+30 CT and TT group had an excess decline of 11.6 mL/y (P=.03) and 15.7 mL/y (P=.01), respectively, compared with the CC group. Of the IVS1 polymorphisms, IVS1-351G/A showed the strongest association, with the AA group having excess decline of 16.1 mL/y (P=.01) compared with the GG group. In subanalyses by sex, these associations were significant only in female subjects. CONCLUSION: ESR1 gene variants may affect development of BHR, particularly in female subjects. They may also lead to a more rapid lung function loss in patients with asthma, and in female subjects specifically. This may result from altered estrogen action, which affects lung development and/or airway remodeling. Further studies on ESR1 gene variations are important to understand better the origin of sex differences in asthma. CLINICAL IMPLICATIONS: Variations in the gene encoding estrogen receptor alpha are associated with BHR and a more rapid annual lung function decline, especially in female subjects. Even though this has no diagnostic or clinical implication, it may open avenues for future sex-specific treatment in asthma.