Description of the Protocol Investigating Whether Remote Care Can Reduce Clinic Attendance in Lung Transplantation.

Home monitoring for patients with ILD and the COVID-19 pandemic

Complications often occur during the early phase after lung transplantation, and rapid diagnosis is vital. Home spirometry is used to detect early changes in graft function. Bluetooth-equipped cell phones are easy to use and facilitate data transfer from home spirometry. To explore use of home spirometry with Bluetooth data transfer in outpatient lung transplant recipients. Single-center prospective randomized controlled trial. Intervention-Fifty-six patients were randomized either to home spirometry with data transfer via Bluetooth-equipped cell phones or to home spirometry alone before discharge after lung transplantation. In the Bluetooth group, results were transferred to a database capable of generating alarm messages. Time from onset of symptoms to physician consultation during the first 6 months after lung transplantation was the primary end point. Adherence to home spirometry was 97.2% in the Bluetooth group and 95.3% in the home spirometry alone group (P = .73). Median time to first consultation (P = .60) and frequency of consultation (P = .06) did not differ significantly in the 2 groups. Mean scores on the Hospital Anxiety and Depression Scale were lower in patients in the Bluetooth group (1.5; range, 0.0-4.0) than in the home spirometry alone group (4.0; range, 2.0-6.0; P = .04). Home spirometry with data transfer is feasible and safe in lung transplant recipients. Compared with home spirometry alone, additional data transfer was equally effective regarding the time interval from symptom onset to consultation. Patients in the Bluetooth group reported less anxiety, which may improve emotional well-being.

Complications often occur during the early phase after lung transplantation, and rapid diagnosis is vital. Home spirometry is used to detect early changes in graft function. Bluetooth-equipped cell phones are easy to use and facilitate data transfer from home spirometry. To explore use of home spirometry with Bluetooth data transfer in outpatient lung transplant recipients. Single-center prospective randomized controlled trial. Intervention-Fifty-six patients were randomized either to home spirometry with data transfer via Bluetooth-equipped cell phones or to home spirometry alone before discharge after lung transplantation. In the Bluetooth group, results were transferred to a database capable of generating alarm messages. Time from onset of symptoms to physician consultation during the first 6 months after lung transplantation was the primary end point. Adherence to home spirometry was 97.2% in the Bluetooth group and 95.3% in the home spirometry alone group (P = .73). Median time to first consultation (P = .60) and frequency of consultation (P = .06) did not differ significantly in the 2 groups. Mean scores on the Hospital Anxiety and Depression Scale were lower in patients in the Bluetooth group (1.5; range, 0.0-4.0) than in the home spirometry alone group (4.0; range, 2.0-6.0; P = .04). Home spirometry with data transfer is feasible and safe in lung transplant recipients. Compared with home spirometry alone, additional data transfer was equally effective regarding the time interval from symptom onset to consultation. Patients in the Bluetooth group reported less anxiety, which may improve emotional well-being.

We previously reported national 30-d readmission rates of 27% in patients with decompensated cirrhosis (DC). To study prospective interventions to reduce early readmissions in DC at our tertiary center. Adults with DC admitted July 2019 to December 2020 were enrolled and randomized into the intervention (INT) or standard of care (SOC) arms. Weekly phone calls for a month were completed. In the INT arm, case managers ensured outpatient follow-up, paracentesis, and medication compliance. Thirty-day readmission rates and reasons were compared. Calculated sample size was not achieved due to coronavirus disease 2019; 240 patients were randomized into INT and SOC arms. 30-d readmission rate was 33.75%, 35.83% in the INT vs 31.67% in the SOC arm (P = 0.59). The top reason for 30-d readmission was hepatic encephalopathy (HE, 32.10%). There was a lower rate of 30-d readmissions for HE in the INT (21%) vs SOC arm (45%, P = 0.03). There were fewer 30-d readmissions in patients who attended early outpatient follow-up (n = 17, 23.61% vs n = 55, 76.39%, P = 0.04). Our 30-d readmission rate was higher than the national rate but reduced by interventions in patients with DC with HE and early outpatient follow-up. Development of interventions to reduce early readmission in patients with DC is needed.

Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: a double-blind, randomised, placebo-controlled, phase 2 trial

INTRODUCTION The TB-PRACTECAL study trialed a shorter, more tolerable regimen of oral drugs than standard of care (SoC) – which can last for up to 20 months and involve both injectables and up to 20 tablets a day. In this sub-study, PRACTECAL-PRO, we measured and explored trial participant quality of life, experiences, and perspectives on treatment, to understand outcomes more fully. Both studies were conducted in Uzbekistan, South Africa, and Belarus. METHODS We conducted a mixed-methods evaluation using quality of life (QoL) surveys and in-depth interviews. Participants in investigational and SoC arms completed the Short Form 12 (SF-12) and St George’s Respiratory Questionnaire (SGRQ) at four timepoints (baseline, 12, 24, and 48 weeks). Healthy age- and sex-matched volunteers were surveyed at a single timepoint to establish locally relevant controls. Participants from investigational arms were purposively sampled for in-depth interviews to describe qualitatively patient satisfaction and experience with the investigational arm trial, including factors enabling toleration or rejection of a novel treatment by patients. ETHICS This study was approved by the MSF Ethics Review Board and by the ethics review committees of the Ministry of Health of the Republic of Uzbekistan; the Republican Scientific and Practical Centre for Pulmonology and Tuberculosis, Belarus; the regulatory authority of the Ministry of Health of the Republic of Belarus and Pharma Ethics Independent Ethics Committee, South Africa. RESULTS Overall, of 137 trial participants 28.5% (39) and 71.5% (98) were randomised to the SoC arm and one of three investigational arms, respectively. Statistically significant univariate scores by arm were observed at week 48 for SGRQ Impact domain (median -3.8, 95% confidence interval (CI), -5.7 to 0.0) and at week 24 for SF-12 physical component score (median 3.1, 95%CI 0.2 to 6.7). Longitudinal analysis showed that the proportional reduction in SGRQ scores per month was higher in the investigational group compared to the SoC for all domains and the total score. For both the SGRQ and SF-12, baseline scores indicated worse quality of life for the trial participant group (that is, investigational arms and SoC together) than for the healthy control group. Qualitative analysis showed early treatment satisfaction was a useful predictor of better adherence. Treatment acceptability was linked to participants’ support networks and their experience of counselling and clinical advice. Tolerability of the regimen helped reassure patients and household members on efficacy and value of the treatment. Participants reported that early improvement helped them return to productive lives sooner, with the potential to address social determinants with financial protection schemes for a shorter investment period. Patient perspectives around residual burden of disease can help inform clinicians about ongoing care. CONCLUSION All PRACTECAL-PRO participants reported worse generic and disease-specific QoL at baseline, compared to an age and sex-matched healthy control group. Participants taking a novel shortened oral regimens demonstrated both a quicker improvement in their respiratory disease-specific QoL over 48 weeks than those receiving SoC, and an improvement that exceeded the SGRQ’s minimum clinically important difference. In-depth interviews give insights suggesting investment toward patient-sensitive and socially responsive treatment and care. For interviewees, the supportive care experienced was as important as their satisfaction and tolerability of the novel drug regimen. Patient perspectives are an essential component of assessing clinical trial outcomes. CONFLCITS OF INTEREST None declared.

Background Improving health-related quality of life (HRQL) is an important goal of lung transplantation, and St. George's Respiratory Questionnaire (SGRQ) is frequently used for assessing HRQL in patients waitlisted for lung transplantation. We hypothesized that chronic respiratory failure (CRF)-specific HRQL measures would be more suitable than the SGRQ, considering the underlying disease and its severity in these patients. Methods We prospectively collected physiological and patient-reported data (HRQL, dyspnea, and psychological status) of 199 patients newly registered in the waiting list of lung transplantation. CRF-specific HRQL measures of the Maugeri Respiratory Failure Questionnaire (MRF) and Severe Respiratory Insufficiency Questionnaire (SRI) were assessed in addition to the SGRQ. Results Compared to the MRF-26 and SRI, the score distribution of the SGRQ was skewed toward the worse ends of the scale. All domains of the MRF-26 and SRI were significantly correlated with the SGRQ. Multiple regression analyses to investigate factors predicting each HRQL score indicated that dyspnea and psychological status accounted for 12% to 28% of the variance more significantly than physiological measures did. The MRF-26 Total and SRI Summary significantly worsened from the baseline to 1 year (p < 0.001 and p < 0.001 and p < 0.001 and Conclusions The MRF-26 and SRI are valid, discriminative, and responsive in patients waitlisted for lung transplantation. In terms of the score distribution and responsiveness, CRF-specific measures may function better in their HRQL assessment than the currently used measures do.

Background and Objectives:The purpose of this study was to evaluate the feasibility of a customized, culturally sensitive pregnancy wheel given to pregnant women to improve gestational age dating accuracy at the time of delivery and to improve antenatal care attendance.Methods:This was a pilot randomized trial involving pregnant women presenting to a regional hospital in Lilongwe, Malawi. The primary outcome was accuracy of gestational age at the time of presentation to the hospital in labor. The secondary outcome was the number of antenatal visits.Results:At final analysis, 14 subjects were included in the pregnancy wheel (intervention) arm and 11 in the standard care arm. Fifty percent (n=7) of women in the intervention arm were accurately dated at the time of presentation for delivery, compared to only 9% (n=1) in the standard antenatal care arm (p=0.04). There was not a significant difference in the number of antenatal visits between the two study arms. No patients met the World Health Organization’s recommended eight antenatal care visits for prenatal care.Conclusion and Global Health Implications:The customized pregnancy wheel given to patients could improve gestational age dating accuracy, and as a result, clinical decision making. However, the barriers to greater antenatal care access are more complex and likely require a more complex solution. Significant attrition in this pilot trial limited statistical power, suggesting the need for future larger interventions. Accurate gestational dating requires access to ultrasonography and early antenatal care initiation, both of which are inadequate in Malawi. Although the customized pregnancy wheel did not improve antenatal care attendance, it improved gestational age dating accuracy in a pilot study at a central hospital in Lilongwe, Malawi.

Home spirometry after lung transplantation is common practice, to monitor graft function. However, there is little experience with online home monitoring applications with direct data transfer to the hospital. We evaluated the feasibility and patient experiences with a new online home monitoring application, integrated with a Bluetooth-enabled spirometer and real-time data transfer. Consecutive lung transplant recipients were asked to evaluate this home monitoring application for three months in a pilot study. Home spirometry measurements were compared with in-hospital lung function tests (the forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC)) at the end of the study. Ten patients participated. The home and hospital spirometry measurements showed a high correlation, for both the FEV1 (r = 0.99, p < 0.01) and FVC (r = 0.99, p < 0.01). The adherence and patient satisfaction were high, and the patients preferred the home monitoring application over the current home spirometer, with a difference of 1.4 ± 1.5 points on a scale from 0 to 10 (p = 0.02). Online home monitoring with direct data transfer is feasible and reliable after lung transplantation and results in high patient satisfaction. Whether the implementation of online home monitoring enables the earlier detection of lung function decline and improves patient and graft outcomes will be the subject of future research.

(366) - Internet-Based Telemonitoring System of Daily Home Spirometry in Lung Transplant Recipients

&lt;p&gt;&lt;strong&gt;Background:&lt;/strong&gt; Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality and leads to frequent hospital admissions and emergency department (ED) visits. COPD exacerbations are an important patient outcome, and reducing their frequency would result in significant cost savings. Remote monitoring and self-monitoring could both help patients manage their symptoms and reduce the frequency of exacerbations, but they have different resource implications and have not been directly compared.&lt;/p&gt; &lt;p&gt;&lt;strong&gt;Objective:&lt;/strong&gt; This study aims to compare the effectiveness of implementing a technology-enabled self-monitoring program versus a technology-enabled remote monitoring program in patients with COPD compared with a standard care group.&lt;/p&gt; &lt;p&gt;&lt;strong&gt;Methods:&lt;/strong&gt; We conducted a 3-arm randomized controlled trial evaluating the effectiveness of a remote monitoring and a self-monitoring program relative to standard care. Patients with COPD were recruited from outpatient clinics and a pulmonary rehabilitation program. Patients in both interventions used a Bluetooth-enabled device kit to monitor oxygen saturation, blood pressure, temperature, weight, and symptoms, but only patients in the remote monitoring group were monitored by a respiratory therapist. All patients were assessed at baseline and at 3 and 6 months after program initiation. Outcomes included self-management skills, as measured by the Partners in Health (PIH) Scale; patient symptoms measured with the St George's Respiratory Questionnaire (SGRQ); and the Bristol COPD Knowledge Questionnaire (BCKQ). Patients were also asked to self-report on health system use, and data on health use were collected from the hospital.&lt;/p&gt; &lt;p&gt;&lt;strong&gt;Results:&lt;/strong&gt; A total of 122 patients participated in the study: 40 in the standard care, 41 in the self-monitoring, and 41 in the remote monitoring groups. Although all 3 groups improved in PIH scores, BCKQ scores, and SGRQ impact scores, there were no significant differences among any of the groups. No effects were observed on the SGRQ activity or symptom scores or on hospitalizations, ED visits, or clinic visits.&lt;/p&gt; &lt;p&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Despite regular use of the technology, patients with COPD assigned to remote monitoring or self-monitoring did not have any improvement in patient outcomes such as self-management skills, knowledge, or symptoms, or in health care use compared with each other or with a standard care group. This may be owing to low health care use at baseline, the lack of structured educational components in the intervention groups, and the lack of integration of the action plan with the technology.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Background:&lt;/strong&gt; Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality and leads to frequent hospital admissions and emergency department (ED) visits. COPD exacerbations are an important patient outcome, and reducing their frequency would result in significant cost savings. Remote monitoring and self-monitoring could both help patients manage their symptoms and reduce the frequency of exacerbations, but they have different resource implications and have not been directly compared.&lt;/p&gt; &lt;p&gt;&lt;strong&gt;Objective:&lt;/strong&gt; This study aims to compare the effectiveness of implementing a technology-enabled self-monitoring program versus a technology-enabled remote monitoring program in patients with COPD compared with a standard care group.&lt;/p&gt; &lt;p&gt;&lt;strong&gt;Methods:&lt;/strong&gt; We conducted a 3-arm randomized controlled trial evaluating the effectiveness of a remote monitoring and a self-monitoring program relative to standard care. Patients with COPD were recruited from outpatient clinics and a pulmonary rehabilitation program. Patients in both interventions used a Bluetooth-enabled device kit to monitor oxygen saturation, blood pressure, temperature, weight, and symptoms, but only patients in the remote monitoring group were monitored by a respiratory therapist. All patients were assessed at baseline and at 3 and 6 months after program initiation. Outcomes included self-management skills, as measured by the Partners in Health (PIH) Scale; patient symptoms measured with the St George's Respiratory Questionnaire (SGRQ); and the Bristol COPD Knowledge Questionnaire (BCKQ). Patients were also asked to self-report on health system use, and data on health use were collected from the hospital.&lt;/p&gt; &lt;p&gt;&lt;strong&gt;Results:&lt;/strong&gt; A total of 122 patients participated in the study: 40 in the standard care, 41 in the self-monitoring, and 41 in the remote monitoring groups. Although all 3 groups improved in PIH scores, BCKQ scores, and SGRQ impact scores, there were no significant differences among any of the groups. No effects were observed on the SGRQ activity or symptom scores or on hospitalizations, ED visits, or clinic visits.&lt;/p&gt; &lt;p&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Despite regular use of the technology, patients with COPD assigned to remote monitoring or self-monitoring did not have any improvement in patient outcomes such as self-management skills, knowledge, or symptoms, or in health care use compared with each other or with a standard care group. This may be owing to low health care use at baseline, the lack of structured educational components in the intervention groups, and the lack of integration of the action plan with the technology.&lt;/p&gt;

The Chronic Respiratory Questionnaire (CRQ) and the St George's Respiratory Questionnaire (SGRQ) are the two most widely used quality of life questionnaires in chronic obstructive pulmonary disease (COPD). A study was undertaken to compare directly the self-administered version of the CRQ and the SGRQ with respect to feasibility, internal consistency, validity, and sensitivity to changes resulting from bronchodilator therapy. One hundred and forty four patients with moderate or severe COPD were randomly assigned to receive three months of treatment with either salmeterol, salmeterol + ipratropium bromide, or placebo. Quality of life was measured at baseline and after 12 weeks of treatment. The proportions of missing values per patient were low for both questionnaires (0.54% for the CRQ and 2% for the SGRQ). The internal consistency was good for both questionnaires (Cronbach's alpha coefficients >/= 0.84 for the CRQ and >/= 0.76 for the SGRQ). Factor analysis confirmed the original domain structure of the CRQ but not of the SGRQ. Correlations with forced expiratory volume in one second (FEV(1)) % predicted and peak expiratory flow rate (PEFR) were low for both questionnaires but better for the SGRQ than for the CRQ. The ability to discriminate between subjects with different levels of FEV(1) was somewhat better for the SGRQ. The correlations with symptom scores were comparable for both questionnaires. Cross sectionally, the scores of the two questionnaires were moderately to highly correlated (coefficients ranged from 0.35 to 0.72). Longitudinally, these correlations were lower (coefficients ranged from 0.17 to 0.54) but were still significant. The CRQ total and emotions score and the SGRQ symptoms score were the most responsive to change. The SGRQ symptoms domain was the only domain where the improvement in patients receiving combination treatment crossed the threshold for clinical relevance. Since this analysis of reliability, validity, and responsiveness to change did not clearly favour one instrument above the other, the choice between the CRQ and the SGRQ can be based on other considerations such as the required sample size or the availability of reference values.

Changing Landscape and Disease-specific Considerations of Therapeutic Bronchoscopy in Clinical Trials

Pulmonary rehabilitation (PR) is advocated in the pre- and post-lung transplantation (LTx) periods. However, there is limited literature on the benefit of PR post-LTx. The aim of this study was to investigate the efficacy of an outpatient, multidisciplinary, comprehensive PR program in bilateral LTx recipients in the early period after LTx. Twenty-three LTx recipients were referred to the PR center. Change in incremental and endurance shuttle walk tests, hand and quadriceps strength, respiratory muscle strength (maximum inspiratory/expiratory pressure), dyspnea (Medical Research Council score), quality of life (St George's Respiratory Questionnaire, Chronic Respiratory Questionnaire), and psychological status (Hospital Anxiety Depression Scale) were compared pre- and post-PR. Seventeen of 23 (74%) recipients completed PR, comprising 15 male and 2 female patients whose median age was 51 yr. The initiation of the program was 75 ± 15 d after LTx. The incremental shuttle walk test distance was predicted as 23% before PR and it increased to 36% after PR (P < .001); the endurance shuttle walk test distance also increased (P < .01). Significant improvement was seen in upper and lower extremity strength, and St George's Respiratory Questionnaire and Chronic Respiratory Questionnaire scores and Hospital Anxiety Depression Scale scores reflected less anxiety and depressive symptoms. Furthermore, body mass and fat-free mass indices, maximum inspiratory pressure, and maximum expiratory pressure improved significantly. There was no significant change in forced expiratory volume in the first second of expiration, forced vital capacity, or Medical Research Council scores. This study demonstrated that patients who attended PR within 3 mo of bilateral LTx showed improvements in exercise capacity, respiratory muscle strength, quality of life, body composition, and psychological status.