Minimally important differences in the Mahler's Transition Dyspnoea Index in a large randomized controlled trial--results from the Scleroderma Lung Study

Khanna, Dinesh; Tseng, Chi Hong; Fürst, Daniel E.; Clements, Philip J.; Elashoff, Robert M.; Roth, Michael D.; Elashoff, David; Tashkin, Donald P.

doi:10.1093/rheumatology/kep284

Cited by 45 publications

(34 citation statements)

References 14 publications

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“…With an overall increase of 0.8 ± 1.7 points after an 8-week outpatient PR, these studies failed to show a significant or clinically relevant improvement in dyspnea, except for IPF patients categorized as MRC grade 2. These patients were able to improve their TDI by 1.6 points (95% CI 1.0-2.3), which is closely above the discussed MID of 1.5 points in patients with ILD [37]. Rammaert et al [20] assessed breathlessness using a visual analog scale (0-10 points) and found a significant reduction (5.8 ± 1.8 vs. 5.1 ± 2.4; p < 0.025) in dyspnea in IPF patients following an 8-week home-based PR.…”

Section: Dyspneamentioning

confidence: 61%

Pulmonary Rehabilitation in Patients with Idiopathic Pulmonary Fibrosis - A Review

Kenn

Gloeckl

Behr³

2013

Respiration

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Among the various types of interstitial lung diseases, idiopathic pulmonary fibrosis (IPF) is the most common disorder and has a poor prognosis and a limited response to pharmacological treatment. In patients with IPF, functional exercise tolerance and quality of life have been shown to be significantly decreased. Current IPF guidelines suggest only a weak recommendation for pulmonary rehabilitation (PR). However, PR is regarded as a reasonable choice for the majority of patients with IPF. This review will summarize all of the available studies that have investigated the effects of PR in patients with IPF so far. Although only a small number of studies have been published to date, most studies have found significant short-term improvements in functional exercise capacity, quality of life, and level of perceived dyspnea. Long-term improvements or maintenance strategies of PR in IPF patients have not been adequately investigated yet. Up to now there is still no sufficient evidence for the recommendation of PR in IPF. However, physical training seems to be the major component of all PR programs. The current review will discuss potential exercise training regimens for patients with IPF and suggest additional useful modalities of a specific multidisciplinary PR program for IPF patients. Based on the current literature and our own experience, this article will try to highlight the importance of PR as an additional, beneficial therapeutic option for patients with IPF.

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Section: Dyspneamentioning

confidence: 61%

Pulmonary Rehabilitation in Patients with Idiopathic Pulmonary Fibrosis - A Review

Kenn

Gloeckl

Behr³

2013

Respiration

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“…The BDI was predictive of response to cyclophosphamide therapy for SSc-ILD patients in one large, randomized trial (with important implications for SSc-ILD cohort enrichment). TDI was able to distinguish between patients with improved lung function in response to cyclophosphamide versus worsening in those receiving placebo [9,10] with calculation of a minimal clinically important difference [29]. Largely due to feasibility issues, TDI was required to undergo further research in SSc-ILD before recommendation as a major endpoint in future trials [12].…”

Section: Dyspnea As An Outcome Measurementioning

confidence: 99%

“…They found a 2.53% difference in FVC change, which was statistically significant. In an analysis of the placebo group in the SLS, the mean decline in FVC over a one year period was 4.2 ± 12.8% of predicted [29]. In this same study, <15% of patients experienced a ≥10% decrease from baseline in percent predicted FVC [99].…”

Section: Lung Physiology and Functionmentioning

confidence: 99%

Outcome Measures for Clinical Trials in Interstitial Lung Diseases

Lammi

Baughman

Birring

et al. 2015

CRMR

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The chronic fibrosing idiopathic interstitial pneumonias (IIPs) are a group of heterogeneous pulmonary parenchymal disorders described by radiologic and histological patterns termed usual interstitial pneumonia (UIP) and non-specific interstitial pneumonia (NSIP). These include idiopathic pulmonary fibrosis (IPF) and those related to connective tissue disease (CTD) and are associated with substantial morbidity and mortality. Beyond the importance of establishing an appropriate diagnosis, designing optimal clinical trials for IIPs has been fraught with difficulties in consistency of clinical endpoints making power analyses, and the establishment of efficacy and interpretation of results across trials challenging. Preliminary recommendations, developed by rigorous consensus methods, proposed a minimum set of outcome measures, a ‘core set’, to be incorporated into future clinical trials (Saketkoo et al, THORAX. 2014.). This paper sets out to examine the candidate instruments for each domain (Dyspnea, Cough, Health Related Quality of Life, Imaging, Lung Physiology and Function, Mortality). Candidate measures that were not selected as well as measures that were not available for examination at the time of the consensus process will also be discussed.

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“…No significant differences were detected between the sham acupuncture group and waiting list group (Table 4). Although the clinically significant minimal change of the TDI was estimated as a total of 1 point in chronic obstructive pulmonary disease (19,20) and 1.5 points in scleroderma interstitial lung disease (21), no such study has been conducted for asthma. Thus, we cannot directly conclude whether the change seen in the acupuncture or sham acupuncture group from baseline was clinically significant.…”

Section: Discussionmentioning

confidence: 99%

A Randomized Pilot Study of Acupuncture as an Adjunct Therapy in Adult Asthmatic Patients

et al. 2010

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Acupuncture as an adjunct therapy to conventional medical care does not seem to affect pulmonary function in asthmatic patients. However, 12 sessions of acupuncture treatment during 4 weeks showed a favorable effect on the quality of life in adult asthmatic patients. Further large trials assessing the effectiveness of acupuncture on the quality of life and symptoms in asthmatic patients are needed.

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Minimally important differences in the Mahler's Transition Dyspnoea Index in a large randomized controlled trial--results from the Scleroderma Lung Study

Abstract: A change (improvement/worsening) of 1.5 U in the TDI is the MID for SSc-related interstitial lung disease (SSc-ILD). This can aid in interpreting clinically important changes in breathlessness in SSc-ILD.

Cited by 45 publications

References 14 publications

Pulmonary Rehabilitation in Patients with Idiopathic Pulmonary Fibrosis - A Review

Pulmonary Rehabilitation in Patients with Idiopathic Pulmonary Fibrosis - A Review

Outcome Measures for Clinical Trials in Interstitial Lung Diseases

A Randomized Pilot Study of Acupuncture as an Adjunct Therapy in Adult Asthmatic Patients

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