Baseline health status and setting impacted minimal clinically important differences in COPD: an exploratory study

Alma, Harma; Jong, Corina de; Jelusic, Danijel; Wittmann, Michael; Schüler, Michael; Kollen, Boudewijn J.; Sanderman, Robbert; Kocks, Janwillem; Schultz, Konrad; Molen, Thys van der

doi:10.1016/j.jclinepi.2019.07.015

Cited by 11 publications

(7 citation statements)

References 74 publications

(61 reference statements)

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“…Another potential weakness is suggested by a recent study, which found that MCID estimates of health status questionnaires can vary significantly depending on baseline patient characteristics/disease severity. 59…”

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confidence: 99%

Therapeutic Success of Tiotropium/Olodaterol, Measured Using the Clinical COPD Questionnaire (CCQ), in Routine Clinical Practice: A Multinational Non-Interventional Study

Valipour¹,

Avdeev²,

Barczyk³

et al. 2021

COPD

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Background The Clinical COPD Questionnaire (CCQ) is a simple patient-reported tool to measure clinical control of chronic obstructive pulmonary disease (COPD). Objective This open-label, single-arm, non-interventional study (NCT03663569) investigated changes in CCQ score during treatment with tiotropium/olodaterol in clinical practice. Methods Data were included from consenting COPD patients, enrolled in Bulgaria, Czech Republic, Hungary, Israel, Lithuania, Poland, Romania, Russia, Slovenia, Switzerland and Ukraine, who were receiving a new prescription for tiotropium/olodaterol according to the treating physician in a real-world environment. The primary endpoint was the occurrence of therapeutic success, defined as a 0.4-point decrease in CCQ score after treatment with tiotropium/olodaterol for approximately 6 weeks. Results Overall, 4819 patients were treated; baseline and Week 6 CCQ scores were available for 4700 patients, mostly classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) B (51.6%) or D (42.7%). After 6 weeks’ treatment, 81.4% (95% confidence interval [95% CI] 80.24–82.49) of patients achieved therapeutic success; mean improvement in overall CCQ score was 1.02 points (95% CI 1.00–1.05). Improved CCQ score was seen in 92.2% of patients (95% CI 91.43–92.98), 2.5% had no change and 5.3% showed a worsening. When stratified by prior treatment, the greatest benefit was seen in treatment-naïve patients, with 85.7% achieving therapeutic success, compared with 79.5% of those pretreated with long-acting β 2 -agonist (LABA)/inhaled corticosteroid (ICS) and 74.2% of those pretreated with LABA or long-acting muscarinic antagonist (LAMA) monotherapy. Overall, rescue medication decreased by 1.25 puffs/day (95% CI 1.19–1.31) versus baseline. In total, 29 patients (0.6%) reported drug-related adverse events and 7 patients reported serious adverse events (0.15%). Conclusion In 4700 COPD patients, 6 weeks’ treatment with tiotropium/olodaterol, as initial treatment or follow-up to LAMA or LABA monotherapy or LABA/ICS, improved CCQ and decreased rescue medication use. The adverse event profile was consistent with the known safety profile of tiotropium/olodaterol.

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confidence: 99%

Therapeutic Success of Tiotropium/Olodaterol, Measured Using the Clinical COPD Questionnaire (CCQ), in Routine Clinical Practice: A Multinational Non-Interventional Study

Valipour¹,

Avdeev²,

Barczyk³

et al. 2021

COPD

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“…Thereby, we designed this quality of life based study to investigate the clinical outcomes of using HFCWO as an adjunctive therapy for COPD as measured by using the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) which is a disease speci c instrument designed to measure the impact on overall health, daily life, and perceived well-being in patients with COPD 13 . This has been an extensively validated questionnaire and often used to evaluate the advantage of a new treatment for COPD 13,14 .…”

Section: Introductionmentioning

confidence: 99%

Effects of High Frequency Chest Wall Oscillation (HFCWO) on Clinical Symptoms in COPD

Bruner,

Bazan,

Liu

et al. 2024

Preprint

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Background: Mucociliary clearance plays a critical role in pulmonary host defense. Abnormal mucociliary clearance contributes to the pathogenesis of pulmonary disorders, including COPD. In bronchiectasis, treatments targeting mucus obstruction in the airways include the use of high frequency chest wall oscillation (HFCWO) therapy. This prospective outcome based study was designed to investigate the changes in symptoms and quality of life (QOL) to measure the effect of adjunctive HFCWO therapy to standard of care therapy for patients with COPD. Research Question: When HFCWO is indicated and used as intended, will the quality of life for those patients with COPD improve and sustain improvement. Study Design and Methods: We conducted a prospective, openl-label, observational study in COPD patients without concomitant bronchiectasis. Participants had assessments of QOL at baseline (day 0) and then at 30 and 90 days after initiation of HFCWO therapy. The St. George’s Respiratory Questionnaire for COPD Patients (SGRQ-C) was employed and longitudinally followed at each timepoint. Paired t-tests were used to compare means between each time points adjusted for multiple comparisons. A linear mixed model for the analysis of longitudinal data was then constructed to determine the simultaneous contribution of race, gender, ethnicity, time, and selected interactions in the primary outcome of change in SGRQ-C across 0, 30, and 90 days . Results: The cohort of patients (n=102) demonstrated a significant reduction in the SGRQ-C at 30 and sustained at 90 days compared to baseline. In addition, two component scores of the SGRQ-C questionnaire (“Symptoms” and Impacts”) were significantly reduced at 30 and 90 days. Interpretation: This prospective, observational study demonstrates statistically significant and clinically favorable responses to HFCWO as an adjunctive therapy for patients with a primary diagnosis of COPD without concomitant bronchiectasis. Results of this study inform the design of additional additional studies of HFCWO to prove efficacy inCOPD patients.

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“…Given that clinical outcomes can vary from one patient to another, the MCID has garnered attention as a clinically meaningful threshold value above which the outcome is deemed relevant by the patient. While many studies have examined the MCID, there has been a notable absence of research evaluating the MCID after post-stroke acute care programs [ 12 , 13 , 14 ]. Enhancing our understanding of the MCID and identifying factors that predict deterioration in the MCID can significantly impact the definition of worse outcomes and the development of shared decision-making methods.…”

Section: Introductionmentioning

confidence: 99%

Minimal Clinically Important Difference (MCID) in the Functional Status Measures in Patients with Stroke: Inverse Probability Treatment Weighting

Chang,

Lin,

Chen

et al. 2023

JCM

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This study proposed to evaluate the temporal trend, define the minimal clinically important difference (MCID) for five functional status measures, and identify risk factors for reaching deterioration in the MCID. This prospective cohort study analyzed 680 patients with ischemic stroke and 151 patients with hemorrhagic stroke at six hospitals between April 2015 and October 2021. All patients completed the functional status measures before rehabilitation (baseline), and at the 12th week and 2nd year after rehabilitation. Patients in the post-acute care (PAC) group exhibited significantly larger improvements for the functional status measures compared to those in the non-PAC group (p < 0.05). Patients with hemorrhagic stroke also displayed larger improvements in the functional status measures when compared to patients with ischemic stroke. Furthermore, the improvement in MCID ranged from 0.01 to 16.18 points when comparing baseline and the 12th week after rehabilitation, but the deterioration in MCID ranged from 0.38 to 16.12 points. Simultaneously, assessing the baseline and the second year after rehabilitation, the improvement in MCID ranged from 0.01 to 18.43 points, but the deterioration in MCID ranged from 0.68 to 17.26 points. Additionally, the PAC program, age, education level, body mass index, smoking, readmission within 30 days, baseline functional status score, use of Foley catheter and nasogastric tube, as well as a history of previous stroke are significantly associated with achieving deterioration in MCID (p < 0.05). These findings suggest that if the mean change scores of the functional status measures have reached the thresholds, the change scores can be perceived by patients as clinically important.

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Baseline health status and setting impacted minimal clinically important differences in COPD: an exploratory study

Cited by 11 publications

References 74 publications

Therapeutic Success of Tiotropium/Olodaterol, Measured Using the Clinical COPD Questionnaire (CCQ), in Routine Clinical Practice: A Multinational Non-Interventional Study

Therapeutic Success of Tiotropium/Olodaterol, Measured Using the Clinical COPD Questionnaire (CCQ), in Routine Clinical Practice: A Multinational Non-Interventional Study

Effects of High Frequency Chest Wall Oscillation (HFCWO) on Clinical Symptoms in COPD

Minimal Clinically Important Difference (MCID) in the Functional Status Measures in Patients with Stroke: Inverse Probability Treatment Weighting

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