Power of Outcome Measurements to Detect Clinically Significant Changes in Pulmonary Rehabilitation of Patients With COPD

doi:10.1378/chest.121.4.1092

Chest

Volume 121, Issue 4, April 2002, Pages 1092-1098

https://doi.org/10.1378/chest.121.4.1092 Get rights and content

Study objectives

Several validated instruments are used to measure outcomes, such as exercise performance, dyspnea, and health-related quality of life after pulmonary rehabilitation (PR) in patients with COPD. However, no study has simultaneously compared the responsiveness of the most frequently used outcome measurements after PR. We designed this study to investigate the capacity of several of the most frequently used outcome measurements to detect changes after PR in a population of patients with severe COPD who qualified for lung volume reduction surgery.

Design, patients, and interventions

We evaluated 37 patients with severe COPD (FEV₁ < 40%) before and after 6 to 8 weeks of outpatient PR. The following frequently used tools were evaluated: the 6-min walk distance (6MWD); functional dyspnea with the Medical Research Council (MRC) scale; baseline and transitional dyspnea index (BDI/TDI); resting and 6MWD visual analog scale (VAS); quality of life with a generic tool (the Short Form-36 [SF-36]); and two disease-specific tools, the Chronic Respiratory Disease Questionnaire (CRQ) and the St. George's Respiratory Questionnaire (SGRQ).

Results

After PR, mean ± SD 6MWD increased in 33 of 37 patients (89%), from 285 ± 97 to 343 ± 92 m (p = 0.009). Improvements were seen also in the MRC scale in 23 of 37 patients (62%; from 2.27 ± 0.8 to 1.86 ± 0.6; p = 0.01); in CRQ dyspnea in 25 of 37 patients (67%; from 3.25 ± 0.9 to 3.90 ± 1.4; p = 0.02); in CRQ mastery in 22 of 37 patients (60%; from 4.37 ± 1.4 to 5.14 ± 1.3; p = 0.01); and in BDI/TDI functional in 24 of 37 patients (64%; from 1.4 ± 0.8 to 0.7 ± 1.1; p = 0.002). There were smaller improvements in the SGRQ in 18 of 37 patients (48%) and in the SF-36 in 19 of 37 patients (51%), but they were not statistically significant. There were good correlations between the dyspnea components of all the tools. The 6MWD change did not correlate with the changes in the other outcomes. Clinically significant changes in the values for those outcome tools were detected in > 50% of patients for the BDI/TDI, 29% of patients for the MRC scale, in 37% of patients for the 6MWD, in 48% of patients for the VAS at peak exercise, in > 50% of patients for the CRQ, and in 40% of patients for the SGRQ.

Conclusions

We conclude that the VAS peak exercise, BDI/TDI, and CRQ adequately reflect the beneficial effects of PR. The 6MWD evaluates a unique domain not related to quality of life. Due to their simplicity and sensitivity, VAS at peak exercise, 6MWD, and CRQ may be the best practical tools to evaluate responsiveness to PR.

Section snippets

Study Population

The population consisted of the first 37 consecutive patients with severe COPD selected for LVRS at seven hospitals in Massachusetts as part of the Overholt/Blue Cross/Blue Shield Emphysema Surgical Trial. The human research committee at all institutions approved the study. All patients signed the informed consent. In summary, the study population consists of all the patients participating in an ongoing trial comparing LVRS and standard medical treatment. All patients completed 6 to 8 weeks of

Results

All 37 patients enrolled completed the 8 weeks of PR. Their demographic and physiologic characteristics are shown in Table 1. Both genders were represented. The patients had severe COPD and were severely hyperinflated.

The pre-PR and post-PR values for the tools are shown in Table 2. There were statistical significant improvements in MRC scale (p = 0.018), 6MWD (p = 0.0096), VAS at peak exercise (p < 0.0001), CRQ dyspnea (p = 0.02), CRQ mastery (p = 0.016), BDI/TDI magnitude of effort (p =

Discussion

This prospective study was designed to evaluate the responsiveness of the most commonly used outcome measurement tools for PR in patients with COPD, and had two major findings: (1) the clinically significant improvements in BDI/TDI, VAS at peak exercise, and the CRQ capture the beneficial effects of PR in most of the patients; and (2) the 6MWD in a unique way evaluates exercise capacity, and its change is not adequately reflected by the others tools.

PR in patients with COPD provides benefits in

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Cited by (197)

Predicting Response to In-Hospital Pulmonary Rehabilitation in Individuals Recovering From Exacerbations of Chronic Obstructive Pulmonary Disease
2024, Archivos de Bronconeumologia
Predicting the response to pulmonary rehabilitation (PR) could be valuable in defining admission priorities. We aimed to investigate whether the response of individuals recovering from a COPD exacerbation (ECOPD) could be forecasted using machine learning approaches.
This multicenter, retrospective study recorded data on anthropometrics, demographics, physiological characteristics, post-PR changes in six-minute walking distance test (6MWT), Medical Research Council scale for dyspnea (MRC), Barthel Index dyspnea (BId), COPD assessment test (CAT) and proportion of participants reaching the minimal clinically important difference (MCID). The ability of multivariate approaches (linear regression, quantile regression, regression trees, and conditional inference trees) in predicting changes in each outcome measure has been assessed.
Individuals with lower baseline 6MWT, as well as those with less severe airway obstruction or admitted from acute care hospitals, exhibited greater improvements in 6MWT, whereas older as well as more dyspnoeic individuals had a lower forecasted improvement. Individuals with more severe CAT and dyspnea, and lower 6MWT had a greater potential improvement in CAT. More dyspnoeic individuals were also more likely to show improvement in BId and MRC. The Mean Absolute Error estimates of change prediction were 44.70 m, 3.22 points, 5.35 points, and 0.32 points for 6MWT, CAT, BId, and MRC respectively. Sensitivity and specificity in discriminating individuals reaching the MCID of outcomes ranged from 61.78% to 98.99% and from 14.00% to 71.20%, respectively.
While the assessed models were not entirely satisfactory, predictive equations derived from clinical practice data might help in forecasting the response to PR in individuals recovering from an ECOPD. Future larger studies will be essential to confirm the methodology, variables, and utility.
Dyspnea-induced Limitation (DYSLIM), a new self-administered concise questionnaire to evaluate dyspnea-related activity limitation in chronic respiratory diseases
2023, Respiratory Medicine
Few questionnaires are available for routine assessment of dyspnea. The study aimed to design a self-administered questionnaire assessing the impact of chronic dyspnea on daily activities, named DYSLIM (Dyspnea-induced Limitation).
The development followed 4 steps: 1: selection of relevant activities and related questions (focus groups); 2: clinical study: internal and concurrent validity vs. modified Medical Research Council (mMRC), Baseline Dyspnea Index (BDI) and Saint George Respiratory Questionnaire (SGRQ); 3: item reduction; 4: responsiveness.
Eighteen activities (from eating to climbing stairs) were considered with 5 modalities for each: doing the task slowly, taking breaks, seeking assistance, changing habits, and activity avoidance. Each modality was graded from 5 (never) to 1 (very often). Validation study included 194 patients: COPD (FEV1 ≥ 50% pred: n = 40; FEV1 < 50% pred: n = 65); cystic fibrosis (n = 30), interstitial lung disease (n = 30), pulmonary hypertension (n = 29). Responsiveness was evaluated by post-pulmonary rehabilitation data in 52 COPD patients.
Acceptability was high and short term (7 days) reproducibility was satisfactory (Kappa mostly above 0.7). Concurrent validity was high vs. mMRC (Spearman correlation coefficient, r = 0.71), BDI (r = - 0.75) and SGRQ (r = - 0.79). The reduced questionnaire with 8 activities (from cleaning to climbing stairs) and 3 modalities (slowly, seeking help, changing habits) showed a comparable validity and was chosen as the final short version. Effect size of rehabilitation was good for both the full (0.57) and short (0.51) versions. A significant correlation was also found between changes of SGRQ and DYSLIM post rehabilitation: r = - 0.68 and r = - 0.60 for full and reduced questionnaires, respectively.
The DYSLIM questionnaire appears promising for the evaluation of dyspnea-induced limitations in chronic respiratory diseases and seems suitable for use in various contexts.
Clusters of individuals recovering from an exacerbation of chronic obstructive pulmonary disease and response to in-hospital pulmonary rehabilitation
2023, Pulmonology
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.
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.
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).
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.
The role of the physiotherapist in the assessment and management of dyspnea
2023, Revue des Maladies Respiratoires
La dyspnée est le symptôme le plus commun dans les pathologies cardio-respiratoires. Les avancées récentes dans les connaissances sur les mécanismes de la dyspnée ont démontré la nécessité d’une évaluation selon 3 domaines. Ces 3 domaines sont également retrouvés dans le modèle clinique « breathing, thinking, functioning » qui propose une approche multidimensionnelle de la dyspnée comprenant un domaine respiratoire, un domaine émotionnel et un domaine fonctionnel. Avant de mettre en place un traitement pour diminuer la dyspnée des patients, il est bien évidemment indispensable d’évaluer la dyspnée pour plusieurs raisons : faire un état des lieux du type de dyspnée ressentie par le patient, de l’impact de cet essoufflement et pouvoir estimer l’efficacité du traitement mis en place. Le kinésithérapeute a une place importante dans la prise en soins des patients dyspnéiques, tout d’abord dans l’évaluation, puis le traitement et enfin, il est un interlocuteur majeur au sein d’une équipe pluridisciplinaire, notamment en réadaptation respiratoire. L’objectif de cette revue est de faire un état des lieux des outils d’évaluation de la dyspnée et des différents traitements kinésithérapiques possibles en utilisant l’approche holistique afin de faciliter le choix des techniques et d’améliorer la qualité des soins en répondant mieux aux besoins du patient.
The role of the physiotherapist in the assessment and management of dyspnea. Dyspnea is the most common symptom in cardio-respiratory diseases. Recently improved comprehension of dyspnea mechanisms have underlined the need for three-faceted assessment. The three key aspects correspond to the “breathing, thinking, functioning” clinical model, which proposes a multidimensional – respiratory, emotional and functional – approach. Before initiating treatment, it is essential for several reasons to assess each specific case, determining the type of dyspnea affecting the patient, appraising the impact of shortness of breath, and estimating the effectiveness of the treatment applied. The physiotherapist has a major role to assume in the care of dyspneic patients, not only in assessment followed by treatment but also as a major collaborator in a multidisciplinary team, especially with regard to pulmonary rehabilitation. The aim of this review is to inventory the existing assessment tools and the possible physiotherapies for dyspnea, using a holistic approach designed to facilitate the choice of techniques and to improve quality of care by fully addressing the patient's needs.
The presence of extra-pulmonary treatable traits increases the likelihood of responding to pulmonary rehabilitation
2023, Respiratory Medicine
Studies suggest that people with chronic obstructive pulmonary disease (COPD) who are worse at baseline respond better to pulmonary rehabilitation (PR). Identifying treatable traits (TTs) may help to distinguish responders from non-responders. We explored the impact of PR on extra-pulmonary traits of people with COPD and whether the presence of TT influences the type of response to PR.
A comprehensive assessment of 9 TT including symptoms (dyspnoea, fatigue, anxiety and depression), functional capacity, deconditioning, balance, impact of the disease and health-related quality of life was conducted before and after a 12-week community-based PR programme. Pre-post differences between people with or without each TT at baseline were compared with independent samples t-tests or Mann-Whitney U tests. Proportion of responders between groups were explored with chi-square tests and odds ratio.
102 people with COPD were included (70 [65; 75] years old, 78% male, FEV₁ 47 [36; 60] %predicted). They had a median of 3 (out of 9) TTs per person and each patient responded on average to 5 (out of 9) outcomes of PR. People with TT were more responsive than those without them in all outcomes (p < 0.05) except for the 1-min sit-to-stand test. The presence of TT increased 4 to 20 times the likelihood of being a good responder.
Identification of baseline extra-pulmonary TT in people with COPD showed the potential to inform on PR responsiveness and might therefore be an important strategy for patient prioritization, treatment personalisation (i.e., activation of the most suitable components) and optimisation.
Airflow grades, outcome measures and response to pulmonary rehabilitation in individuals after an exacerbation of severe chronic obstructive pulmonary disease
2023, European Journal of Internal Medicine
Individuals with COPD may be staged according to symptoms and exacerbation history (GOLD groups: A-D) and on airflow obstruction (GOLD grades: 1–4). Guidelines recommend pulmonary rehabilitation (PR) for these individuals, including those recovering from an exacerbation (ECOPD)
To evaluate whether in individuals with clinically severe COPD, recovering from an ECOPD, the effect size of an in-hospital PR program would be affected by airflow severity grades and assessed outcome measures.
Retrospective, multicentre study. Participants were compared according to different GOLD airflow grades. In addition to the MRC dyspnoea scale, six-minute walking distance test and COPD assessment test (CAT), Barthel dyspnoea index (Bid), and Short Physical Performance Battery (SPPB) were assessed, evaluating the proportion of individuals reaching the minimum clinically important difference (MCID) (responders).
Data of 479 individuals, completing the program were evaluated. Most of the participants were allocated in GOLD grades 4, (57.6%) and 3 (22.1%). All outcome measures significantly improved after PR (p < 0.05), without any significant difference in the proportion of responders in any measure.
in individuals with severe COPD, recovering from ECOPD the success rate of PR does not depend on airflow severity, or outcome measure assessed. In addition to the most used outcome measures, also Bid and SPPB are sensitive to PR.

View all citing articles on Scopus

: Supported in part by the Overholt/Blue Cross/Blue Shield Emphysema Surgical Trial, The Thoracic Foundation, and Biovascular, Inc.

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Chest

Clinical InvestigationsREHABILITATIONPower of Outcome Measurements to Detect Clinically Significant Changes in Pulmonary Rehabilitation of Patients With COPD

Study objectives

Design, patients, and interventions

Results

Conclusions

Section snippets

Study Population

Results

Discussion

Chest

Lancet

Chest

Chest

Respir Med

Lancet

Lancet

Chest

Chest

Exercise training in chronic obstructive lung disease

Effects of pulmonary rehabilitation on physiologic and psychosocial outcomes in patients with chronic obstructive pulmonary disease

Ann Intern Med

Randomized controlled trial of rehabilitation in chronic respiratory disability

Thorax

Controlled trial of supervised exercise training in chronic bronchitis

Br Med J

Older patients with COPD: benefits of exercise training

Geriatrics

Weight training and backpacking in chronic obstructive pulmonary disease

Respir Care

Effects of home rehabilitation on physical performance in patients with chronic obstructive pulmonary disease (COPD)

Eur Respir J

Health status measurement instruments in chronic obstructive pulmonary disease

Can Respir J

Clinical Investigations
REHABILITATION
Power of Outcome Measurements to Detect Clinically Significant Changes in Pulmonary Rehabilitation of Patients With COPD