Harma Alma

Inspiratory muscle training does not improve clinical outcomes in 3-week COPD rehabilitation: Results from a randomised controlled trial

The value of inspiratory muscle training (IMT) in pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD) is unclear. The RIMTCORE (Routine Inspiratory Muscle Training within COPD Rehabilitation) randomised controlled trial examined the effectiveness of IMT added to pulmonary rehabilitation. In total, 611 COPD patients (Global Initiative for Chronic Obstructive Lung Disease stage II–IV) received a 3-week inpatient pulmonary rehabilitation, of which 602 patients were included in the intention-to-treat analyses. The intervention group (n=300) received highly intensive IMT and the control group (n=302) received sham IMT. The primary outcome was maximal inspiratory pressure (PImax). The secondary outcomes were 6-min walk distance, dyspnoea, quality of life and lung function. Outcomes were assessed pre- and post-pulmonary rehabilitation. ANCOVA was used. The intervention group showed higher effects in PImax (p<0.001) and forced inspiratory volume in 1 s (p=0.013). All other outcomes in both study groups improved significantly, but without further between-group differences. Sex and pulmonary rehabilitation admission shortly after hospitalisation modified quality of life effects. IMT as an add-on to a 3-week pulmonary rehabilitation improves inspiratory muscle strength, but does not provide additional benefits in terms of exercise capacity, quality of life or dyspnoea. A general recommendation for COPD patients to add IMT to a 3-week pulmonary rehabilitation cannot be made. IMT added to a 3-week PR programme improved PImax and FIV1, but not exercise capacity, dyspnoea or QoL #COPD http://ow.ly/hPGK30gfqej

Health status instruments for patients with COPD in pulmonary rehabilitation : defining a minimal clinically important difference

The minimal clinically important difference (MCID) defines to what extent change on a health status instrument is clinically relevant, which aids scientists and physicians in measuring therapy effects. This is the first study that aimed to establish the MCID of the Clinical chronic obstructive pulmonary disease (COPD) Questionnaire (CCQ), the COPD Assessment Test (CAT) and the St George’s Respiratory Questionnaire (SGRQ) in the same pulmonary rehabilitation population using multiple approaches. In total, 451 COPD patients participated in a 3-week Pulmonary Rehabilitation (PR) programme (58 years, 65% male, 43 pack-years, GOLD stage II/III/IV 50/39/11%). Techniques used to assess the MCID were anchor-based approaches, including patient-referencing, criterion-referencing and questionnaire-referencing, and the distribution-based methods standard error of measurement (SEM), 1.96SEM and half standard deviation (0.5s.d.). Patient- and criterion-referencing led to MCID estimates of 0.56 and 0.62 (CCQ); 3.12 and 2.96 (CAT); and 8.40 and 9.28 (SGRQ). Questionnaire-referencing suggested MCID ranges of 0.28–0.61 (CCQ), 1.46–3.08 (CAT) and 6.86–9.47 (SGRQ). The SEM, 1.96SEM and 0.5s.d. were 0.29, 0.56 and 0.46 (CCQ); 3.28, 6.43 and 2.80 (CAT); 5.20, 10.19 and 6.06 (SGRQ). Pooled estimates were 0.52 (CCQ), 3.29 (CAT) and 7.91 (SGRQ) for improvement. MCID estimates differed depending on the method used. Pooled estimates suggest clinically relevant improvements needing to exceed 0.40 on the CCQ, 3.00 on the CAT and 7.00 on the SGRQ for moderate to very severe COPD patients. The MCIDs of the CAT and SGRQ in the literature might be too low, leading to overestimation of treatment effects for patients with COPD.

Investigating sensitivity, specificity, and area under the curve of the Clinical COPD Questionnaire, COPD Assessment Test, and Modified Medical Research Council scale according to GOLD using St George's Respiratory Questionnaire cutoff 25 (and 20) as reference

Background In the GOLD (Global initiative for chronic Obstructive Lung Disease) strategy document, the Clinical COPD Questionnaire (CCQ), COPD Assessment Test (CAT), or modified Medical Research Council (mMRC) scale are recommended for the assessment of symptoms using the cutoff points of CCQ ≥1, CAT ≥10, and mMRC scale ≥2 to indicate symptomatic patients. The current study investigates the criterion validity of the CCQ, CAT and mMRC scale based on a reference cutoff point of St George’s Respiratory Questionnaire (SGRQ) ≥25, as suggested by GOLD, following sensitivity and specificity analysis. In addition, areas under the curve (AUCs) of the CCQ, CAT, and mMRC scale were compared using two SGRQ cutoff points (≥25 and ≥20). Materials and methods Two data sets were used: study A, 238 patients from a pulmonary rehabilitation program; and study B, 101 patients from primary care. Receiver-operating characteristic (ROC) curves were used to assess the correspondence between the recommended cutoff points of the questionnaires. Results Sensitivity, specificity, and AUC scores for cutoff point SGRQ ≥25 were: study A, 0.99, 0.43, and 0.96 for CCQ ≥1, 0.92, 0.48, and 0.89 for CAT ≥10, and 0.68, 0.91, and 0.91 for mMRC ≥2; study B, 0.87, 0.77, and 0.9 for CCQ ≥1, 0.76, 0.73, and 0.82 for CAT ≥10, and 0.21, 1, and 0.81 for mMRC ≥2. Sensitivity, specificity, and AUC scores for cutoff point SGRQ ≥20 were: study A, 0.99, 0.73, and 0.99 for CCQ ≥1, 0.91, 0.73, and 0.94 for CAT ≥10, and 0.66, 0.95, and 0.94 for mMRC ≥2; study B, 0.8, 0.89, and 0.89 for CCQ ≥1, 0.69, 0.78, and 0.8 for CAT ≥10, and 0.18, 1, and 0.81 for mMRC ≥2. Conclusion Based on data from these two different samples, this study showed that the suggested cutoff point for the SGRQ (≥25) did not seem to correspond well with the established cutoff points of the CCQ or CAT scales, resulting in low specificity levels. The correspondence with the mMRC scale seemed satisfactory, though not optimal. The SGRQ threshold of ≥20 corresponded slightly better than SGRQ ≥25, recently suggested by GOLD 2015, with the established cutoff points for the CCQ, CAT, and mMRC scale.

Clinically relevant differences in COPD health status: systematic review and triangulation

The minimal clinically important difference (MCID) quantifies when measured differences can be considered clinically relevant. This study aims to review and triangulate MCIDs of chronic obstructive pulmonary disease (COPD) health status tools. A systematic search in PubMed, EMBASE and Cochrane Library was conducted (Prospero #CRD42015023221). Study details, patient characteristics, MCID methodology and estimates were assessed and extracted by two authors. A triangulated mean was obtained for each tools MCID, with two-thirds weighting for anchor-based and one-third for distribution-based results. This was then multiplied by a weighted factor based upon the study size and quality rating. Overall, 785 records were reviewed of which 21 studies were included for analysis. MCIDs of 12 tools were presented. General quality and risk of bias were average to good. Triangulated MCIDs for the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and St. Georges Respiratory Questionnaire (SGRQ) were −2.54, −0.43 and −7.43 for improvement. Too few and/or too diverse studies were present to triangulate MCIDs of other tools. Evidence for the MCID of the CAT and CCQ was strong and triangulation was valid. Currently used MCIDs in clinical practice for the SGRQ (4) and Chronic Respiratory Questionnaire (0.5) did not match the reviewed content, for which the MCIDs were much higher. Using too low MCIDs may lead to an overestimation of the interpretation of treatment effects. MCIDs for deterioration were scarce, which highlights the need for more research. Reviewed and triangulated thresholds for minimal clinically relevant improvements are −2.54 (CAT), −0.43 (CCQ) and −7.43 (SGRQ) http://ow.ly/1y4v30l1yVI

Klinisch relevant en statistisch significant

SamenvattingOp het spreekuur komt een COPD-patiënt die een longrevalidatieprogramma heeft gevolgd. Hierbij werd de Clinical COPD Questionnaire (CCQ) afgenomen om te bepalen of zijn gezondheidsstatus is verbeterd. Vergeleken met het begin van het traject toonde de CCQ een verbetering van de totaalscore met één punt. Hoe moeten we dit interpreteren? Was het revalidatieprogramma succesvol? Is hier sprake van klinisch relevante verbetering?

Die deutschsprachige Version des Clinical COPD Questionnaires (CCQ) als Outcome-Parameter der Rehabilitation bei COPD

Hintergrund: In den 2013 aktualisierten GOLD-Empfehlungen wurde der CCQ neben dem CAT (COPD Assessment Test) und der MMRC-Dyspnoe-Skala als Symptom-Parameter aufgenommen und ist damit Grundlage der Einteilung in die Gruppen A-D. Bisher liegen aber keine Daten aus Deutschland vor, in wie weit sich der CCQ-Score nach einer dreiwochigen stationaren pneumologischer Rehabilitation bei COPD-Patienten andert und wie anderungssensitiv der CCQ im Vergleich mit dem CAT und der MMRC-Dyspnoe-Skala ist. Methode: Bei 201 konsekutiven COPD-Rehabilitanden (63,5% ♂, GOLD-Schweregrad 2 41,1%, GOLD 3 36%, GOLD 4 22,8%, mittleres Alter 57,4J., FEV1 51%SW) wurden zu Reha-Beginn (T0) und zu Reha-Ende (T1) MMRC, CAT und CCQ erfasst. Zur Abschatzung der Veranderungssensitivitat wurden die Effektstarken (SRM) verglichen. Ergebnisse: Zu T1 finden sich signifikante Verbesserungen aller 3 Scores, wobei die SRM bzgl. CCQ und CAT als mittelgradiger, die bzgl. MMRC als schwacher Effekt zu werten sind. Diskussion: CCQ und CAT verbessern sich am Ende der Rehabilitation mit einer Effektstarke (SRM) von 0,67. Beide weisen somit eine vergleichbare Anderungssensitivitat bzgl. der Rehabilitation auf. Demgegenuber erscheint die Anderungssensitivitat der MMRC-Dyspnoe-Skala deutlich geringer.