Effect of tele-health care on quality of life in patients with severe COPD: a randomized clinical trial.

Background and objective: Telemonitoring (TM) of patients with COPD has gained much interest, but studies have produced conflicting results. We aimed to investigate the effect of TM with the option of video consultations on quality of life (QoL) in patients with severe COPD. Patients and methods: COPD patients at high risk of exacerbations were eligible for the 6-month study and a total of 281 patients were equally randomized to either TM (n=141) or usual care (n=140). TM comprised recording of symptoms, oxygen saturation, spirometry, and video consultations. Algorithms generated alerts if readings breached thresholds. Both groups filled in a health-related QoL questionnaire (15D©) and the COPD Assessment Test (CAT) at baseline and at 6 months. Within-group differences were analyzed by paired t-test. Results: Most of the enrolled patients had severe COPD (86% with Global Initiative for Chronic Obstructive Lung Disease stage 3 or 4 and 45% with admission for COPD within the last year, respectively). No difference in drop-out rate and mortality was found between the groups, and likewise there was no difference in 15D or CAT at baseline. At 6 months, a significant improvement of 0.016 in 15D score (p=0.03; minimal clinically important difference 0.015) was observed in the TM group (compared to baseline), while there was no improvement in the control group -0.003 (p=0.68). After stratifying 15D score at baseline to <0.75 or ≥0.75, respectively, there was a significant difference in the <0.75 TM group of 0.037 (p=0.001), which is a substantial improvement. No statistically significant changes were found in CAT score. Conclusion: Compared to the nonintervention group, TM as an add-on to usual care over a 6-month period improved QoL, as assessed by the 15D questionnaire, in patients with severe COPD, whereas no difference between groups was observed in CAT score.

Barriers for recruitment of patients with chronic obstructive pulmonary disease to a controlled telemedicine trial.

The aim of this analysis is to investigate reasons why patients with chronic obstructive pulmonary disease decline to participate in a controlled trial of telemedicine. Patients with previous chronic obstructive pulmonary disease exacerbations were invited to participate in a 6-month randomized telemedicine trial. For eligible patients, reasons for refusal were registered. Of 560 eligible patients, 279 (50%) declined to participate in the trial, 257 (92%) reported a reason: 53 (20.6%) technical concerns, 164 (63.8%) personal reasons, 17 (6.6%) preferred outpatient clinic visits, and 23 (8.9%) did not want to participate in clinical research. Compared to consenting patients, subjects declining participation were significantly older, more often female, had higher lung function (%predicted), lower body mass index, higher admission-rate for chronic obstructive pulmonary disease in the previous year, and were more often diagnosed with osteoporosis. Many eligible patients decline participating in a controlled tele-healthcare trial and, furthermore, a tailored approach for recruiting females and elderly patients appears appropriate.

Do telemedical interventions improve quality of life in patients with COPD? A systematic review.

OBJECTIVE: Telehealth is an approach to disease management, which may hold the potential of improving some of the features associated with COPD, including positive impact on disease progression, and thus possibly limiting further reduction in quality of life (QoL). Our objective was, therefore, to summarize studies addressing the impact of telehealth on QoL in patients with COPD. DESIGN: Systematic review. METHODS: A series of systematic searches were carried out using the following databases: PubMed, EMBASE, Cochrane Controlled Trials Register, and ClinicalTrials.gov (last updated November 2015). A predefined search algorithm was utilized with the intention to capture all results related to COPD, QoL, and telehealth published since year 2000. OUTCOME MEASURES: Primary outcome was QoL, assessed by validated measures. RESULTS: Out of the 18 studies fulfilling the criteria for inclusion in this review, three studies found statistically significant improvements in QoL for patients allocated to telemedical interventions. However, all of the other included studies found no statistically significant differences between control and telemedical intervention groups in terms of QoL. CONCLUSION: Telehealth does not make a strong case for itself when exclusively looking at QoL as an outcome, since statistically significant improvements relative to control groups have been observed only in few of the available studies. Nonetheless, this does not only rule out the possibility that telehealth is superior to standard care with regard to other outcomes but also seems to call for more research, not least in large-scale controlled trials.

Safety of bronchodilators and corticosteroids for asthma during pregnancy: what we know and what we need to do better.

Asthma is a common medical condition complicating pregnancy with potentially serious effects on pregnancy outcome. The aim of this review is to provide an update on efficacy and safety of asthma medications, primarily bronchodilators and corticosteroids, used during pregnancy with focus on pregnancy outcome, and, furthermore, to discuss limitations of available studies and point to possible improvements in future studies. A planned series of systematic searches was conducted using the PubMed database. Use of short-acting ß2-agonists has generally been established as safe, and the few studies stating otherwise appear to have, perhaps critical, methodological limitations. The safety of long-acting ß2-agonists remains to be further investigated, and the few available studies have methodological limitations and, therefore, provide no definite answers, although a very recent study supports the safety of add-on long-acting ß2-agonists to inhaled corticosteroids. Inhaled corticosteroids are generally found to be safe, although further research is needed to investigate both the efficacy and safety of high dose therapy with inhaled corticosteroids. Studies have reported associations between the use of systemic corticosteroids and adverse perinatal outcomes, such as preterm birth, low birth weight, and pre-eclampsia. This must, however, be weighed against the potential serious impact of severe, uncontrolled asthma itself on pregnancy outcome. The main obstacle to a valid interpretation of several of the available studies is the inadequate stratification for asthma severity and control. Overall, asthma in itself and not just poor asthma control poses a greater risk to pregnancy outcomes than asthma medication. Nonetheless, more studies focusing on disentangling the effects of asthma alone and asthma medications are needed. Increased use of stratified risk assessments, taking the concept of asthma severity into greater consideration, is much warranted in future studies.