Clinical standards for diagnosis, treatment and prevention of post-COVID-19 lung disease.

BACKGROUND: The aim of these clinical standards is to provide guidance on 'best practice' care for the diagnosis, treatment and prevention of post-COVID-19 lung disease.METHODS: A panel of international experts representing scientific societies, associations and groups active in post-COVID-19 lung disease was identified; 45 completed a Delphi process. A 5-point Likert scale indicated level of agreement with the draft standards. The final version was approved by consensus (with 100% agreement).RESULTS: Four clinical standards were agreed for patients with a previous history of COVID-19: Standard 1, Patients with sequelae not explained by an alternative diagnosis should be evaluated for possible post-COVID-19 lung disease; Standard 2, Patients with lung function impairment, reduced exercise tolerance, reduced quality of life (QoL) or other relevant signs or ongoing symptoms ≥4 weeks after the onset of first symptoms should be evaluated for treatment and pulmonary rehabilitation (PR); Standard 3, The PR programme should be based on feasibility, effectiveness and cost-effectiveness criteria, organised according to local health services and tailored to an individual patient's needs; and Standard 4, Each patient undergoing and completing PR should be evaluated to determine its effectiveness and have access to a counselling/health education session.CONCLUSION: This is the first consensus-based set of clinical standards for the diagnosis, treatment and prevention of post-COVID-19 lung disease. Our aim is to improve patient care and QoL by guiding clinicians, programme managers and public health officers in planning and implementing a PR programme to manage post-COVID-19 lung disease.

Clusters of individuals recovering from an exacerbation of chronic obstructive pulmonary disease and response to in-hospital pulmonary rehabilitation.

INTRODUCTION AND OBJECTIVES: Due to the present low availability of pulmonary rehabilitation (PR) for individuals recovering from a COPD exacerbation (ECOPD), we need admission priority criteria. We tested the hypothesis that these individuals might be clustered according to baseline characteristics to identify subpopulations with different responses to PR. METHODS: Multicentric retrospective analysis of individuals undergone in-hospital PR. Baseline characteristics and outcome measures (six-minute walking test - 6MWT, Medical Research Council scale for dyspnoea -MRC, COPD assessment test -CAT) were used for clustering analysis. RESULTS: Data analysis of 1159 individuals showed that after program, the proportion of individuals reaching the minimal clinically important difference (MCID) was 85.0%, 86.3%, and 65.6% for CAT, MRC, and 6MWT respectively. Three clusters were found (C1-severe: 10.9%; C2-intermediate: 74.4%; C3-mild: 14.7% of cases respectively). Cluster C1-severe showed the worst conditions with the largest post PR improvements in outcome measures; C3-mild showed the least severe baseline conditions, but the smallest improvements. The proportion of participants reaching the MCID in ALL three outcome measures was significantly different among clusters, with C1-severe having the highest proportion of full success (69.0%) as compared to C2-intermediate (48.3%) and C3-mild (37.4%). Participants in C2-intermediate and C1-severe had 1.7- and 4.6-fold increases in the probability to reach the MCID in all three outcomes as compared to those in C3-mild (OR = 1.72, 95% confidence interval [95% CI] = 1.2 - 2.49, p = 0.0035 and OR = 4.57, 95% CI = 2.68 - 7.91, p < 0.0001 respectively). CONCLUSIONS: Clustering analysis can identify subpopulations of individuals recovering from ECOPD associated with different responses to PR. Our results may help in defining priority criteria based on the probability of success of PR.

Prevalence of exercise-induced oxygen desaturation after recovery from SARS-CoV-2 pneumonia and use of lung ultrasound to predict need for pulmonary rehabilitation.

BACKGROUND: Persistence of breathlessness after recovery from SARS-CoV-2 pneumonia is frequent. Recovery from acute respiratory failure (ARF) is usually determined by normalized arterial blood gases (ABGs), but the prevalence of persistent exercise-induced desaturation (EID) and dyspnea is still unknown. METHODS: We investigated the prevalence of EID in 70 patients with normal arterial oxygen at rest after recovery from ARF due to COVID-19 pneumonia. Patients underwent a 6-min walking test (6MWT) before discharge from hospital. We recorded dyspnea score and heart rate during 6MWT. We also investigated the possible role of lung ultrasound (LU) in predicting EID. Patients underwent a LU scan and scores for each explored area were summed to give a total LU score. RESULTS: In 30 patients (43%), oxygen desaturation was >4% during 6MWT. These patients had significantly higher dyspnea and heart rate compared to non-desaturators. LU score >8.5 was significantly able to discriminate patients with EID. CONCLUSION: In SARS-CoV-2 pneumonia, ABGs at discharge cannot predict the persistence of EID, which is frequent. LU may be useful to identify patients at risk who could benefit from a rehabilitation program.

Inhaler technique knowledge and skills before and after an educational program in obstructive respiratory disease patients: A real-life pilot study.

INTRODUCTION AND OBJECTIVE: Patients present poor knowledge and skills about their respiratory disease and inhaler device. We aimed to: (1) evaluate COPD and asthmatic patients... ability to manage inhaled drugs (2) identify differences among devices and (3) correlate clinical data with patient ability. MATERIAL AND METHODS: Patients (n=134) admitted for pulmonary rehabilitation (PR) were given an ad-hoc questionnaire covering 0% as the worst and 100% the best value of global ability (indicating the sum of knowledge and skills in managing inhaled drugs) at baseline (T0) and discharge (T1). Educational program was provided during PR. Setting of rehabilitation, age, sex, diagnosis, spirometry, CIRS score, level of autonomy to use medications, if na..ve about PR, educational level, and number/type of prescribed inhaled drugs were recorded. RESULTS: Most patients used 1 drug while 37% used 2 drugs. DPIs were the main device prescribed. At baseline, patients... mean level of knowledge and skills were 73% and 58%, respectively. There was a significant difference in level of skills (p=0.046) among device families, DPIs resulting worst and pMDIs best. Global ability, skills and knowledge improved after educational support (p<0.001) but did not reach the optimal level, 88%, 87% and 89%, respectively. Baseline global ability was positively correlated to female gender, younger age, previous PR access, outpatient status, higher education level and GOLD D class. CONCLUSIONS: At hospital admission, global ability was not optimal. Education may improve this, irrespective of the type of device used, in particular in male, elderly, na..ve to PR, low educational level patients.

Does timing of initiation influence acceptance and adherence to NIV in patients with ALS?

BACKGROUND: The role of nocturnal non invasive ventilation (NIV) to prolong tracheostomy-free survival, is still controversial in amyotrophic lateral sclerosis (ALS) patients and the best timing to initiate NIV is unclear. OBJECTIVE: As NIV acceptance and adherence can be influenced by many factors, we aimed to compare immediate acceptance and short-term NIV adherence between NIV initiated very early and NIV initiated later. METHODS: This is a post hoc analysis of our previous cohort retrospective study of 88 ALS patients: 53 under later NIV (late group - LG) (forced vital capacity [FVC]<80% pred. at NIV prescription) and 35 under very early NIV (very early group - VEG) (FVC>80%). We compared hours of NIV use as immediate acceptance of NIV (use ≥4h/night) and dherence at 4 months post-initiation (defined as use ≥4h/night or 120h/month). RESULTS: No differences were found between VEG and LG in use of NIV (>5h/night in both groups), immediate acceptance (85.7% vs. 85.0%, p=0.927) and short-term adherence (81.3% vs. 87.2%, p=0.469); 39.7% of patients increased their NIV use (35% by >60min/night). A decline in adherence was observed in 12.5% of patients irrespective of group affiliation. CONCLUSIONS: In ALS patients, initiation of very early NIV does not reduce its immediate acceptance or the short-term adherence. However, at least 1 in 10 patients may be at risk of reducing their adherence irrespective of early or late NIV prescription. As still under debate and not conclusive, further literature on early NIV benefit is welcomed.

Effectiveness of manual therapy in COPD: A systematic review of randomised controlled trials.

PURPOSE: Manual therapy (MT) has been proposed in pulmonary rehabilitation programmes for patients with chronic obstructive pulmonary disease (COPD), but an updated systematic review of the evidence is lacking. We aimed to systematically review the effectiveness of MT interventions, alone or added to exercise, on lung function, exercise capacity and quality of life in COPD patients, compared to other therapies (e.g. exercise alone) or no treatment. MATERIALS AND METHODS: We searched MEDLINE, EMBASE, Physiotherapy Evidence Database, and Cochrane Central Register of Controlled Trials databases, using the terms: COPD, manual therapy, manipulation, joint mobilisation, osteopathic manipulation. Only randomised controlled trials (RCT) were considered. RESULTS: Out of 555 articles screened, 6 fulfilled the inclusion criteria. The study designs were heterogeneous (with different intervention schedules) and there was a high risk of bias. No effect on lung function was found, while results on exercise capacity were contrasting. MT had no effect on quality of life, although valid measures were available only in one study. Only mild adverse events were reported. CONCLUSIONS: Few RCTs of poor methodological quality are available on the effects of MT in COPD. More and better quality RCTs are needed before this technique can be included in rehabilitation programmes for these patients.

Impact of an early respiratory care programme with non-invasive ventilation adaptation in patients with amyotrophic lateral sclerosis.

BACKGROUND AND PURPOSE: Forced vital capacity (FVC) <80% is one of the key indications for starting non-invasive ventilation (NIV) in amyotrophic lateral sclerosis (ALS). It was hypothesized that a very early start of NIV could lengthen the free interval before death compared to later-start NIV; as a secondary outcome, the survival rate of patients on NIV without tracheotomy was also evaluated. METHODS: This retrospective study was conducted on 194 ALS patients, divided into a later group (LG) with FVC <80% at NIV prescription (n = 129) and a very early group (VEG) with FVC ≥80% at NIV prescription (n = 65). Clinical and respiratory functional data and time free to death between groups over a 3-year follow-up were compared. RESULT: At 36 months from diagnosis, mortality was 35% for the VEG versus 52.7% for the LG (P = 0.022). Kaplan-Meier survival curves adjusted for tracheotomy showed a lower probability of death (P = 0.001) for the VEG as a whole (P = 0.001) and for the non-bulbar (NB) subgroup (P = 0.007). Very early NIV was protective of survival for all patients [hazard ratio (HR) 0.45; 95% confidence interval (CI) 0.28-0.74; P = 0.001] and for the NB subgroup (HR 0.43; 95% CI 0.23-0.79; P = 0.007), whilst a tracheotomy was protective for all patients (HR 0.27; 95% CI 0.15-0.50; P = 0.000) and both NB (HR 0.26; 95% CI 0.12-0.56; P = 0.001) and bulbar subgroups (HR 0.29; 95% CI 0.11-0.77; P = 0.013). Survival in VEG patients on NIV without tracheotomy was three times that for the LG (43.1% vs. 14.7%). CONCLUSION: Very early NIV prescription prolongs the free time from diagnosis to death in NB ALS patients whilst tracheotomy reduces the mortality risk in all patients.

Decision Making Concepts for the Remote, Personalized Evaluation of COPD Patients' Health Status.

INTRODUCTION: This article is part of the Focus Theme of Methods of Information in Medicine on "Biosignal Interpretation: Advanced Methods for Neural Signals and Images". OBJECTIVES: This paper presents the main concepts of a decision making approach for the remote management of COPD patients based on the early detection of disease exacerbation episodes. METHODS: An e-diary card is defined to evaluate a number of physiological variables and clinical parameters acquired remotely by means of wearable and environmental sensors deployed in patients' long-stay settings. The automatic evaluation of the card results in a so-called Chronic Status Index (CSI) whose computation is tailored to patients' specific manifestation of the disease (i.e., patient's phenotype). The decision support method relies on a parameterized analysis of CSI variations so as to early detect worsening changes, identify exacerbation severity and track the patterns of recovery. RESULTS: A preliminary study, carried out in real settings with 30 COPD patients monitored at home, has shown the validity and sensitivity of the method proposed, which was effectively able to timely and correctly identify patients' critical situation. CONCLUSION: The preliminary results showed that the proposed e-diary card, which presents several novel features with respect to other solutions presented in the literature, can be practically used to remotely monitor COPD patients.

Place of death in patients with amyotrophic lateral sclerosis.

UNLABELLED: Amyotrophic lateral sclerosis (ALS) is a degenerative neurological disorder that affects motor neurons. Involvement of respiratory muscles causes the failure of the ventilator pump with more or less significant bulbar troubles. ALS course is highly variable but, in most cases, this disease entails a very significant burden for patients and caregivers, especially in the end-of-life period. In order to analyze the characteristics of ALS patients who die at home (DH) and in hospital (DHosp) and to study the variability of clinical practice, a retrospective medical records analysis was performed (n=77 from five hospitals). VARIABLES: time elapsed since the onset of symptoms and the beginning of ventilation, characteristics of ventilation (device, mask and hours/day), and support devices and procedures. RESULTS: In all, 14% of patients were ventilated by tracheotomy. From the analysis, 57% of patients were of DH. Mean time since the onset of symptoms was 35.93±25.89 months, significantly shorter in patients who DHosp (29.28±19.69 months) than DH (41.12±29.04) (p=0.044). The percentage of patients with facial ventilation is higher in DHosp (11.4% vs 39.4%, p<0.005). DH or not is related to a set of elements in which health resources, physician attitudes and support resources in the community play a role in the decision-making process. There is great variability between countries and between hospitals in the same country. Given the variability of circumstances in each territory, the place of death in ALS might not be the most important element; more important are the conditions under which the process unfolds.

Pilot study for home monitoring of cough capacity in amyotrophic lateral sclerosis: A case series.

BACKGROUND: Cough capacity derangement is associated with a high risk of pulmonary complications in amyotrophic lateral sclerosis patients when cough assistance is not routinely performed at home. The primary aim of this study was to evaluate the feasibility of a long-term home based daily self-monitoring cough capacity. METHODS: Eighteen subjects were enrolled in a 9-month study at home. Changes in peak cough expiratory flow, oxygen saturation, respiratory discomfort and incidence of respiratory deterioration events were evaluated. In subjects presenting respiratory deterioration events, decline in the abovementioned respiratory variables was evaluated (#NCT00613899). RESULTS: During an average follow-up of 125±102 days, a total of 1175 measures were performed on 12 subjects. Mean compliance to proposed evaluations was 37±32% which worsened over time. Peak cough expiratory flow decreased by 15.08±32.43L/min monthly. Five subjects reported 6 episodes of respiratory deterioration events, after a mean period of 136±108 days. They had poor respiratory function and more years of disease. There was no difference in peak cough expiratory flow and its decline whether subjects presented respiratory deterioration events or not. In 4 subjects the respiratory discomfort score significantly worsened after respiratory deterioration events from 3.0±1.41 to 4.25±1.71. CONCLUSION: Daily self-monitoring of peak cough expiratory flow, oxygen saturation and respiratory discomfort seems difficult to obtain because of poor adherence to measures; this protocol does not seem to add anything to current practice of advising on clinical derangements. Confirmatory larger studies are necessary.

Advanced COPD patients under home mechanical ventilation and/or long term oxygen therapy: Italian healthcare costs.

BACKGROUND AND AIM: Little information is available on healthcare costs for patients with very severe chronic obstructive pulmonary disease. The aim of the current work was to evaluate Italian healthcare costs in these patients. METHODS: Prospective 1-year analysis was assessed in three subgroups of patients; non-invasively ventilated (n=30); invasively-ventilated (n=12) and on long-term oxygen therapy (n=41). Acute costs for care were a sum of fees for doctor's consultations, admissions to hospital (ward and intensive care units) and emergency drugs. Chronic costs were the sum of costs for pharmacotherapy and home ventilation and/or oxygen care. RESULTS: Mean cost/day/patient was 96 +/- 112 Euro (range 9-526 Euro), with acute costs accounting for 72% and chronic costs for 28% of the total cost burden, with no significant differences in costs associated with the three subgroups. Acute costs had a non-normal distribution (range 0 to 510 Euro) being cost for hospitalisation the highest cost burden with more than 30% of acute care costs attributed to only a small segment of patients. Chronic care costs were also unevenly distributed among the various groups (ANOVA p = 0.006), being home oxygen supply the highest cost burden. CONCLUSIONS: The current Health Care System is in urgent need for a reassessment of the high cost burden associated with hospitalisations and home oxygen supply.