Author's response to reviews

Size: px
Start display at page:

Download "Author's response to reviews"

Transcription

1 Author's response to reviews Title:Does the 2013 GOLD classification improve the ability to predict lung function decline, exacerbations and mortality? A post-hoc analysis of the 4-year UPLIFT trial Authors: Lucas MA Goossens (goossens@bmg.eur.nl) Inge Leimer (inge.leimer@boehringer-ingelheim.com) Norbert Metzdorf (norbert.metzdorf@boehringer-ingelheim.com) Karin Becker (karin.becker@boehringer-ingelheim.com) Maureen PMH Rutten-van Mölken (m.rutten@bmg.eur.nl) Version:3Date:29 August 2014 Author's response to reviews: see over

2 Dear editor, We thank you and both reviewers for your very valuable comments. Below, I quote and discuss each comment, as well as the changes we made to our manuscript. Sincerely, Lucas Goossens Reviewer 1 1. In the methods the authors report including the tiotropium treated group when testing their classification scheme. Doesn't this alter the predictive value of the model since it has been demonstrated to reduce the rate of acute exacerbations? Can the authors repeat the classification scheme in the roughly 3000 subjects randomized to placebo to see if their results are similar? We repeated all analyses in the control group. The conclusions were similar. The results are presented in a new table in the Appendix. Patients in both groups were allowed to use all respiratory medications, except other inhaled anticholinergic drugs. This made the control treatment usual care rather than placebo, although tiotropium was replaced by placebo in the control group. We added the following text to the Methods section: Furthermore, the analyses with the SGRQ threshold 25 were repeated in the control group from the trial separately. We added this text to the Results section: When the analyses with the SGRQ threshold 25 were repeated on the control group separately, similar patterns were found (see table A5). For (severe) exacerbations, the best fit was achieved by models with the new classification system with substages. For mortality and lung function decline the best fit was achieved by models with the old classification system. 2. As the authors point out, the subjects for this investigation were drawn from the UPLIFT trial which will be a biased cohort. What were the inclusion and exclusion criteria for UPLIFT? Please provide more detail in the Methods so readers can better understand such potential bias. 1

3 The description on the sample was rewritten as follows: The UPLIFT trial was a multinational, randomized, double-blind, placebo-controlled trial, investigating the effect of tiotropium on the yearly rate of decline in FEV1 in 40 years old, currently or formerly smoking patients ( 10 packyears) with moderate to very severe COPD according to the old GOLD classification system (stages 2 to 4, post-bronchodilator FEV1 of 70% or less of the predicted value) {{189 Decramer,M. 2004; 196 Tashkin,D.P. 2008}}. Key exclusion criteria were a history of asthma, a COPD exacerbation or respiratory infection within 4 weeks before screening, a pulmonary resection, use of supplemental oxygen for more than 12 hours per day, and coexisting illnesses that could preclude participation in the study or interfere with the study results. Patients received either 18 μg of tiotropium or a matching placebo once daily. All respiratory medications, except other inhaled anticholinergic drugs, were permitted during the trial. Smoking cessation programs were offered to all patients before randomization. 3. The analysis of lung function decline started at 30 days post enrollment. What was the next time point? Was it 6 months? This 30 day lag was utilized to account for potential increase in postrandomization improvement in lung function in the tiotropium group. Did lung function continue to increase beyond that time point? If so, could the authors repeat the lung function decline analysis with data obtained from later time points? The improvement continued up to the next measurement, which took place after six months. In our manuscript, we took the same approach as the original pre-specified analyses of the UPLIFT trial, which were specified to start at day 30 (Tashkin et al., NEJM 2008). At the request of the reviewer, we repeated the lung function analysis with data starting from the six-month measurement (see table). These results lead to the same conclusion as the results in the manuscript. The best fit and largest spread was achieved by the old classification system. Annual rate of lung function decline in millilitres, per GOLD stage (starting point six months after randomisation) Old stages New stages Substages 2 50 A 46 C B 50 C C 41 C3 41 D 42 D1 38 D2 49 D3 41 AIC -26, , ,

4 4. There is mention of subgroups in the methods section, C1, C2, C3, etc yet there are no details in the text describing these subgroups. There is text in the subsequent tables but the tabular presentation is initially confusing without already having described how the groups were created. Please explain the subgroups in the text. The text on substages in the Method section was rewritten as follows: Patients were assigned to substages based on the reason for being considered high-risk: FEV1 % predicted < 50% but no history of frequent exacerbations (C1 and D1), history of frequent exacerbations but FEV1 % predicted 50% (C2 en D2), or FEV1 % predicted < 50% combined with a history of frequent exacerbations (C3 en D3). The Results section already contained some explanation on substages, but we added: While the exacerbation rate in C1 (no history of frequent exacerbations) was similar to the rate in B, patients in C3 (low lung function and history of frequent exacerbations) experienced more exacerbations than patients in D overall. 5. In the Results there is mention that almost all stage 3 and stage 4 patients were put into group D. Also, the majority of stage 2 were classified into B. Are these observations because of the enrolment criteria of UPLIFT? Were there requirements regarding symptoms? UPLIFT did not have any requirements regarding symptoms. As we write in our Discussion, the choice for a certain symptom score and threshold (CAT=10, mmrc=1, SGRQ=25, SGRP=39) has a substantial influence on the classification of patients into stages A or B and C or D. Nevertheless, this choice did not have an impact on our conclusion regarding the comparison of the old and new systems. Reviewer 2 Major Compulsory Revisions 1. Table 1 and 2: it is not clear to me why the number of patients differ in Table 1 and Table 2. Table one contains 5630 patients and Table 2 contains 5666 patients. The total number of patients analyzed should be clearly stated in the methods section. 3

5 Table 2 stated the number of patients incorrectly. This was corrected, in line with Table 1. The number of patients in the analysis was added to the first paragraph of the Methods section: Data on 5630 patients were used in the analysis. - Minor Essential Revisions 1. Abstract: In the results, should add lung function decline since this was a major endpoint. Add CI or p-values for the data presented. Page 2, line 13, with GOLD stages at baseline as covariate should be covariates ; would add the word groups on line 15 before C and D. Line 16, decline was analyses should say analyzed. The abstract was revised in line with the comments. The following text was added to the abstract: Annual rates of lung function decline were: 47, 38 and 26 ml for stages 2-4 and 44, 48, 38 and 39 for stages A-D. With regards to model fit, the new system performed worse at predicting mortality and lung function decline, and better at predicting exacerbations. Distinguishing between the sub-stages of high-risk led to substantial improvements. Covariate was changed into covariates. The word stages was added before C and D. The word analyses was corrected: analysed. We consistently use the British spelling of English. 2. Background: should add references for mmrc and CAT (page 4, lines 13 and 14). I think you did an excellent job putting this study in context of previous work. We added the references. 3. Methods: Page 7, line 6, analyse should be analyze. We consistently use the British spelling of English. 4. Results: Page 12, line 5: For (severe) exacerbations (tables A1 and A2)... should not say severe as it is written since only table A2 is severe. The way it is written makes it look like both tables A1 and A2 are severe. Also, should comment on how results of SGRQ > 39 compare to >25 for each outcome (mortality, exacerbations, lung function decline). 4

6 We followed the recommendation and removed (severe) from page 12. The results from both SGRQ thresholds are now compared more explicitly. The text was rewritten as follows: The results of the sensitivity analyses are presented in the appendix. The same patterns in relative predictive power can be seen as in the base case analyses. Using the SGRQ 39 threshold, however, led to improvement of all AICs for the new classification system. Similarly as to what was found in the base case analysis, all three mortality models had very similar c-statistics (table A1). In contrast with the primary analysis, the best AIC was achieved by the mortality model with the new classification system with substages. The old and new classification models had the same fit. The predicted exacerbation rates in the new classification covered a broader range than the rates in the old classification (tables A2 and A3). The new classification system also had a much better AIC than the old system, and the AIC for the new classification with substages was even better. Predicted exacerbation rates were slightly higher when the SGRQ 39 threshold was used. With regard to lung function decline (table A4), annual decline rates covered a broader range for the old model, which also had the best AIC. Rates of lung function decline were not different for different SGRQ thresholds. When the analyses with the original threshold were repeated on the placebo group separately, similar patterns were found (see table A5). For severe exacerbations, the best fit was achieved by models with the new system with the new classification system with substages. For mortality and lung function the best fit was achieved by models with the old classification system. 5. Discussion: How do you explain the fact that your sensitivity analysis found the new model with subgroups had the best AIC but in your discussion you say the old model performed better in terms of fit? The results of the sensitivity analysis need to be addressed based on how they differ from the primary outcome, especially since using SGRQ instead of mmrc or CAT is a major limitation of the study. There is no difference in findings between the base case analysis and the sensitivity analysis varying the SGRQ threshold. The fit of the old model was better for mortality and lung function decline, while the new model with subgroups performed best for exacerbations. The specific text on the performance in terms of fit refers to mortality. The second to fourth paragraphs of the Discussion each cover one outcome measure. This has been clarified. 5

7 6. Tables: Table 1 Distribution of patients from grades should say stage 2-4. Table A1 and A2 say symptom threshold SGRQ<39 ; do you mean #39? The word grades was replaced by stage. The symbol < was replaced by. - Discretionary Revisions 1. Abstract: The background section could be shortened by removing the descriptions of the 4 groups and instead saying The new GOLD classification of COPD distinguishes four groups A-D based on symptoms and risk. Also on Line 6, Assessment of exacerbation risk... should say Assessment of risk is based on exacerbation history... If word count allows, could add rationale to the background section to explain why this study adds to the prior literature. The first appearance of the word exacerbation in line 6 was removed. Word count allowed for a longer abstract. The Background paragraph was rewritten to explain the addition of this study to prior literature. It was not necessary to shorten this part of the abstract. 2. Methods: Page 8, line 12: it would be helpful to add a figure showing the new classification system. Page 9, line 3, because of their low FEV1 it would be helpful to give a number such as because of their FEV1 less than... On line 5 a relatively good FEV1 should be defined. The suggested figure of the new classification system was added. The subgroups were defined more clearly. 3. Results: page 10, line 6-7, could simplify to say The adjusted survival curves for each GOLD stage are presented... Page 12, Sensitivity analyses: I would recommend presenting the data in the same order as the rest of the results mortality, exacerbation frequency, lung function decline (rather than exacerbation frequency, lung function decline, mortality as it is currently presented). We followed both suggestions. The newly ordered results of the sensitivity analyses were already shown in response to point 4 of this reviewer. 6

Surveillance report Published: 6 April 2016 nice.org.uk. NICE All rights reserved.

Surveillance report Published: 6 April 2016 nice.org.uk. NICE All rights reserved. Surveillance report 2016 Chronic obstructive pulmonary disease in over 16s: diagnosis and management (2010) NICE guideline CG101 Surveillance report Published: 6 April 2016 nice.org.uk NICE 2016. All rights

More information

Treatment Responses. Ronald Dahl, Aarhus University Hospital, Denmark

Treatment Responses. Ronald Dahl, Aarhus University Hospital, Denmark Asthma and COPD: Are They a Spectrum Treatment Responses Ronald Dahl, Aarhus University Hospital, Denmark Pharmacological Treatments Bronchodilators Inhaled short-acting β -Agonist (rescue) Inhaled short-acting

More information

Lead team presentation: Roflumilast for treating chronic obstructive pulmonary disease [ID984]

Lead team presentation: Roflumilast for treating chronic obstructive pulmonary disease [ID984] Lead team presentation: Roflumilast for treating chronic obstructive pulmonary disease [ID984] 1 st Appraisal Committee meeting Background & Clinical Effectiveness John McMurray 11 th January 2016 For

More information

Disease progression in COPD:

Disease progression in COPD: Disease progression in COPD: What is it? How should it be measured? Can it be modified? Professor Paul Jones MD, PhD, FERS Emeritus Professor of Respiratory Medicine; St George s, University of London

More information

Author's response to reviews

Author's response to reviews Author's response to reviews Title:Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo-controlled, crossover trial Authors:

More information

Title: Identifying work ability promoting factors for home care aides and assistant nurses

Title: Identifying work ability promoting factors for home care aides and assistant nurses Author's response to reviews Title: Identifying work ability promoting factors for home care aides and assistant nurses Authors: Agneta Larsson (agneta.larsson@ltu.se) Lena Karlqvist (lena.karlqvist@ltu.se)

More information

Title:Continuity of GP care is associated with lower use of complementary and alternative medical providers A population-based cross-sectional survey

Title:Continuity of GP care is associated with lower use of complementary and alternative medical providers A population-based cross-sectional survey Author's response to reviews Title:Continuity of GP care is associated with lower use of complementary and alternative medical providers A population-based cross-sectional survey Authors: Anne Helen Hansen

More information

Title:The role of BRCA1 and BRCA2 mutations in prostate, pancreatic and stomach cancers.

Title:The role of BRCA1 and BRCA2 mutations in prostate, pancreatic and stomach cancers. Author's response to reviews Title:The role of BRCA1 and BRCA2 mutations in prostate, pancreatic and stomach cancers. Authors: Helen Cavanagh (helen21987@hotmail.com) Katherine MA Rogers (k.rogers@qub.ac.uk)

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

Supplementary appendix

Supplementary appendix Supplementary appendix This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Calverley P M A, Anzueto A R, Carter K, et

More information

Long-term efficacy of tiotropium in relation to smoking status in the UPLIFT trial

Long-term efficacy of tiotropium in relation to smoking status in the UPLIFT trial Eur Respir J 2010; 35: 287 294 DOI: 10.1183/09031936.00082909 CopyrightßERS Journals Ltd 2010 Long-term efficacy of tiotropium in relation to smoking status in the UPLIFT trial D.P. Tashkin*, B. Celli

More information

Title: Systematic review of lung function and COPD with peripheral blood DNA methylation in population based studies

Title: Systematic review of lung function and COPD with peripheral blood DNA methylation in population based studies Author s response to reviews Title: Systematic review of lung function and COPD with peripheral blood DNA methylation in population based studies Authors: Matthew Machin (matthew.machin12@imperial.ac.uk)

More information

umeclidinium, 55 micrograms, powder for inhalation (Incruse ) SMC No. (1004/14) GlaxoSmithKline

umeclidinium, 55 micrograms, powder for inhalation (Incruse ) SMC No. (1004/14) GlaxoSmithKline umeclidinium, 55 micrograms, powder for inhalation (Incruse ) SMC No. (1004/14) GlaxoSmithKline 07 November 2014 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product

More information

Title:Association of resting heart rate with cardiovascular function: a cross-sectional study in 522 Finnish subjects

Title:Association of resting heart rate with cardiovascular function: a cross-sectional study in 522 Finnish subjects Author's response to reviews Title:Association of resting heart rate with cardiovascular function: a cross-sectional study in 522 Finnish subjects Authors: Jenni K Koskela (jenni.k.koskela@uta.fi) Anna

More information

รศ. นพ. ว ชรา บ ญสว สด M.D., Ph.D. ภาคว ชาอาย รศาสตร คณะแพทยศาสตร มหาว ทยาล ยขอนแก น

รศ. นพ. ว ชรา บ ญสว สด M.D., Ph.D. ภาคว ชาอาย รศาสตร คณะแพทยศาสตร มหาว ทยาล ยขอนแก น รศ. นพ. ว ชรา บ ญสว สด M.D., Ph.D. ภาคว ชาอาย รศาสตร คณะแพทยศาสตร มหาว ทยาล ยขอนแก น COPD Guideline Changing concept in COPD management Evidences that we can offer COPD patients better life COPD Guidelines

More information

SGRQ Questionnaire assessing respiratory disease-specific quality of life. Questionnaire assessing general quality of life

SGRQ Questionnaire assessing respiratory disease-specific quality of life. Questionnaire assessing general quality of life SUPPLEMENTARY MATERIAL e-table 1: Outcomes studied in present analysis. Outcome Abbreviation Definition Nature of data, direction indicating adverse effect (continuous only) Clinical outcomes- subjective

More information

COPD is a syndrome of chronic limitation in expiratory airflow encompassing emphysema or chronic bronchitis.

COPD is a syndrome of chronic limitation in expiratory airflow encompassing emphysema or chronic bronchitis. 1 Definition of COPD: COPD is a syndrome of chronic limitation in expiratory airflow encompassing emphysema or chronic bronchitis. Airflow obstruction may be accompanied by airway hyper-responsiveness

More information

Title:The role of BRCA1 and BRCA2 mutations in prostate, pancreatic and stomach cancers.

Title:The role of BRCA1 and BRCA2 mutations in prostate, pancreatic and stomach cancers. Author's response to reviews Title:The role of BRCA1 and BRCA2 mutations in prostate, pancreatic and Authors: Helen Cavanagh (helen21987@hotmail.com) Katherine MA Rogers (k.rogers@qub.ac.uk) Version:3Date:1

More information

Pulmonary and Critical Care Year in Review

Pulmonary and Critical Care Year in Review Pulmonary and Critical Care Year in Review Heath E Latham, MD Assistant Professor University of Kansas Dept of Internal Medicine Division of Pulmonary and Critical Care None Disclosure Lung Cancer Screening

More information

Title: Survival endpoints in colorectal cancer. The effect of second primary other cancer on disease free survival.

Title: Survival endpoints in colorectal cancer. The effect of second primary other cancer on disease free survival. Author's response to reviews Title: Survival endpoints in colorectal cancer. The effect of second primary other cancer on disease free survival. Authors: Helgi Birgisson (helgi.birgisson@surgsci.uu.se)

More information

DATE: 09 December 2009 CONTEXT AND POLICY ISSUES:

DATE: 09 December 2009 CONTEXT AND POLICY ISSUES: TITLE: Tiotropium Compared with Ipratropium for Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease: A Review of the Clinical Effectiveness DATE: 09 December 2009 CONTEXT AND POLICY

More information

TORCH: Salmeterol and Fluticasone Propionate and Survival in COPD

TORCH: Salmeterol and Fluticasone Propionate and Survival in COPD TORCH: and Propionate and Survival in COPD April 19, 2007 Justin Lee Pharmacy Resident University Health Network Outline Overview of COPD Pathophysiology Pharmacological Treatment Overview of the TORCH

More information

roflumilast 500 microgram tablets (Daxas ) SMC No. (635/10) Nycomed Ltd

roflumilast 500 microgram tablets (Daxas ) SMC No. (635/10) Nycomed Ltd roflumilast 500 microgram tablets (Daxas ) SMC No. (635/10) Nycomed Ltd 06 August 2010 (Issued 10 September 2010) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product

More information

Title: Home Exposure to Arabian Incense (Bakhour) and Asthma Symptoms in Children: A Community Survey in Two Regions in Oman

Title: Home Exposure to Arabian Incense (Bakhour) and Asthma Symptoms in Children: A Community Survey in Two Regions in Oman Author's response to reviews Title: Home Exposure to Arabian Incense (Bakhour) and Asthma Symptoms in Children: A Community Survey in Two Regions in Oman Authors: Omar A Al-Rawas (orawas@squ.edu.om) Abdullah

More information

Title:Video-confidence: a qualitative exploration of videoconferencing for psychiatric emergencies

Title:Video-confidence: a qualitative exploration of videoconferencing for psychiatric emergencies Author's response to reviews Title:Video-confidence: a qualitative exploration of videoconferencing for psychiatric emergencies Authors: Marianne V Trondsen (marianne.trondsen@telemed.no) Stein Roald Bolle

More information

Turning Science into Real Life Roflumilast in Clinical Practice. Roland Buhl Pulmonary Department Mainz University Hospital

Turning Science into Real Life Roflumilast in Clinical Practice. Roland Buhl Pulmonary Department Mainz University Hospital Turning Science into Real Life Roflumilast in Clinical Practice Roland Buhl Pulmonary Department Mainz University Hospital Therapy at each stage of COPD I: Mild II: Moderate III: Severe IV: Very severe

More information

Author's response to reviews

Author's response to reviews Author's response to reviews Title:Mental health problems in the 10th grade and non-completion of upper secondary school: the mediating role of grades in a population-based longitudinal study Authors:

More information

Dear Reader, What was the study about? Why was the research needed? BI NCT

Dear Reader, What was the study about? Why was the research needed? BI NCT Dear Reader, Sponsors of clinical studies create study reports. A study report describes how the study was done and what the results of the study were. This is a summary of such a report. It is meant for

More information

Direct and indirect CV effects of current drugs and those in development

Direct and indirect CV effects of current drugs and those in development Direct and indirect CV effects of current drugs and those in development Heribert Staudinger CSRC MARCH 201 Cardiac Manifestations of COPD Cardiovascular Disease is probably the most frequent and most

More information

Supplementary Online Content

Supplementary Online Content Supplementary Online Content Regan EA, Lynch DA, Curran-Everett D, et al; Genetic Epidemiology of COPD (COPDGene) Investigators. Clinical and radiologic disease in smokers with normal spirometry. Published

More information

2/4/2019. GOLD Objectives. GOLD 2019 Report: Chapters

2/4/2019. GOLD Objectives. GOLD 2019 Report: Chapters GOLD Objectives To provide a non biased review of the current evidence for the assessment, diagnosis and treatment of patients with COPD. To highlight short term and long term treatment objectives organized

More information

Author's response to reviews

Author's response to reviews Author's response to reviews Title:How differently do physicians and patients evaluate the current status of primary care in Korea?: A qualitative study using focus group discussion Authors: Minsu Ock

More information

COPD, Asthma, Or Something In Between? Sharon R. Rosenberg Assistant Professor of Medicine Northwestern University December 4, 2013

COPD, Asthma, Or Something In Between? Sharon R. Rosenberg Assistant Professor of Medicine Northwestern University December 4, 2013 COPD, Asthma, Or Something In Between? Sharon R. Rosenberg Assistant Professor of Medicine Northwestern University December 4, 2013 None Disclosures Definitions Asthma Asthma is a chronic inflammatory

More information

News on Evidence-Based Care Fourth Quarter 2013 Volume 5 Issue 4

News on Evidence-Based Care Fourth Quarter 2013 Volume 5 Issue 4 SPECIAL EDITION: COPD CME AVAILABLE! News on Evidence-Based Care Fourth Quarter 2013 Volume 5 Issue 4 Update on Chronic Obstructive Lung Disease (COPD) 2013 During 2013, the Institute for Evidence-Based

More information

Decline In lung-function Among Patients with chronic obstructive Lung disease On maintenance therapy (DIAPLO)

Decline In lung-function Among Patients with chronic obstructive Lung disease On maintenance therapy (DIAPLO) Version V1.4 Decline In lung-function Among Patients with chronic obstructive Lung disease On maintenance therapy (DIAPLO) An observational study evaluating the benefits of early intervention with maintenance

More information

aclidinium 322 micrograms inhalation powder (Eklira Genuair ) SMC No. (810/12) Almirall S.A.

aclidinium 322 micrograms inhalation powder (Eklira Genuair ) SMC No. (810/12) Almirall S.A. aclidinium 322 micrograms inhalation powder (Eklira Genuair ) SMC No. (810/12) Almirall S.A. 05 October 2012 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and

More information

CARE OF THE ADULT COPD PATIENT

CARE OF THE ADULT COPD PATIENT CARE OF THE ADULT COPD PATIENT Target Audience: The target audience for this clinical guideline is all MultiCare providers and staff including those associated with our Clinically Integrated Network. The

More information

Title: Tiotropium's cost-effectiveness for the treatment of COPD: a cost-utility analysis under real-world conditions.

Title: Tiotropium's cost-effectiveness for the treatment of COPD: a cost-utility analysis under real-world conditions. Author's response to reviews Title: Tiotropium's cost-effectiveness for the treatment of COPD: a cost-utility analysis under real-world conditions. Authors: Mattias Neyt (mattias.neyt@kce.fgov.be) Stephan

More information

COPD: A Renewed Focus. Disclosures

COPD: A Renewed Focus. Disclosures COPD: A Renewed Focus Heath Latham, MD Assistant Professor Division of Pulmonary and Critical Care Medicine Disclosures No Business Interests No Consulting No Speakers Bureau No Off Label Use to Discuss

More information

APSR RESPIRATORY UPDATES

APSR RESPIRATORY UPDATES APSR RESPIRATORY UPDATES Volume 6, Issue 12 Newsletter Date: December 2014 APSR EDUCATION PUBLICATION Inside this issue: COPD Simvastatin for the prevention of exacerbations in moderate-to severe COPD

More information

THE BEST I HAVE READ THIS YEAR (IN PULMONARY AND CRITICAL CARE)

THE BEST I HAVE READ THIS YEAR (IN PULMONARY AND CRITICAL CARE) 23 March 2018 Boca Raton, Florida THE BEST I HAVE READ THIS YEAR (IN PULMONARY AND Johnson.margaret2@mayo.edu No disclosures or off label uses CRITICAL CARE) Margaret M. Johnson, MD Chair, Division of

More information

Dr Stephen Child. General Physician Auckland. 14:20-14:40 Secondary Care Perspective

Dr Stephen Child. General Physician Auckland. 14:20-14:40 Secondary Care Perspective Dr Stephen Child General Physician Auckland 14:20-14:40 Secondary Care Perspective Wheeze Witchery Stephen Child MD, FRACP, FRCPC General Physician Respiratory Interest Director of Clinical Training Auckland

More information

Controversies in Clinical Trials

Controversies in Clinical Trials Controversies in Clinical Trials Christopher B Cooper, MD Professor of Medicine and Physiology David Geffen School of Medicine Medical Director, UCLA COPD Center Methodological issues discussed Pitfalls

More information

Journal of the COPD Foundation

Journal of the COPD Foundation 132 Predictors of Change in SGRQ Score Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation Original Research Baseline Severity as Predictor of Change in St George s Respiratory Questionnaire

More information

Disclosure and Conflict of Interest 8/15/2017. Pharmacist Objectives. At the conclusion of this program, the pharmacist will be able to:

Disclosure and Conflict of Interest 8/15/2017. Pharmacist Objectives. At the conclusion of this program, the pharmacist will be able to: Digging for GOLD Rebecca Young, PharmD, BCACP, Roosevelt University College of Pharmacy Assistant Professor of Clinical Sciences Practice Site Advocate Medical Group-Nesset Pavilion Disclosure and Conflict

More information

Author's response to reviews

Author's response to reviews Author's response to reviews Title: Diabetes duration and health-related quality of life in individuals with onset of diabetes in the age group 15-34 years - a Swedish population-based study using EQ-5D

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

Study No.: Title: Rationale: Phase: Study Period Study Design: Centres: Indication: Treatment: Objectives : Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period Study Design: Centres: Indication: Treatment: Objectives : Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Study population The study population comprised a hypothetical cohort of poorly reversible COPD patients with a history of exacerbations.

Study population The study population comprised a hypothetical cohort of poorly reversible COPD patients with a history of exacerbations. Development of an economic model to assess the cost-effectiveness of treatment interventions for chronic obstructive pulmonary disease Spencer M, Briggs A H, Grossman R F, Rance L Record Status This is

More information

Decramer 2014 a &b [21]

Decramer 2014 a &b [21] Buhl 2015 [19] Celli 2014 [20] Decramer 2014 a &b [21] D Urzo 2014 [22] Maleki-Yazdi 2014 [23] Inclusion criteria: Diagnosis of chronic obstructive pulmonary disease; 40 years of age or older; Relatively

More information

Screening for chronic obstructive pulmonary disease (COPD) in the general adult population

Screening for chronic obstructive pulmonary disease (COPD) in the general adult population Screening for chronic obstructive pulmonary disease (COPD) in the general adult population External review against programme appraisal criteria for the UK National Screening Committee Version: FINAL Author:

More information

Title:Pemetrexed for advanced non-small cell lung cancer patients with interstitial lung disease

Title:Pemetrexed for advanced non-small cell lung cancer patients with interstitial lung disease Author's response to reviews Title:Pemetrexed for advanced non-small cell lung cancer patients with interstitial lung disease Authors: Motoyasu Kato (mtkatou@juntendo.ac.jp) Takehito Shukuya (tshukuya@juntendo.ac.jp)

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

What s new in COPD? Apichart Khanichap MD. Department of Medicine, Faculty of Medicine, Thammasat university

What s new in COPD? Apichart Khanichap MD. Department of Medicine, Faculty of Medicine, Thammasat university What s new in COPD? Apichart Khanichap MD. Department of Medicine, Faculty of Medicine, Thammasat university Management stable COPD Relieve symptoms Improve exercise tolerance Improve health status Prevent

More information

This is the publisher s version. This version is defined in the NISO recommended practice RP

This is the publisher s version. This version is defined in the NISO recommended practice RP Journal Article Version This is the publisher s version. This version is defined in the NISO recommended practice RP-8-2008 http://www.niso.org/publications/rp/ Suggested Reference Chong, J., Karner, C.,

More information

Tiotropium: Do the findings of a CV safety signal in the meta-analyses have implications for all drugs to treat COPD?

Tiotropium: Do the findings of a CV safety signal in the meta-analyses have implications for all drugs to treat COPD? Tiotropium: Do the findings of a CV safety signal in the meta-analyses have implications for all drugs to treat COPD? Lorcan McGarvey MD FRCP Queen s University Belfast CSRC Outcomes Think Tank meeting:

More information

Please revise your paper to respond to all of the comments by the reviewers. Their reports are available at the end of this letter, below.

Please revise your paper to respond to all of the comments by the reviewers. Their reports are available at the end of this letter, below. Dear editor and dear reviewers Thank you very much for the additional comments and suggestions. We have modified the manuscript according to the comments below. We have also updated the literature search

More information

Center for Respiratory and Sleep Medicine COPD Chronic Disease Management Program

Center for Respiratory and Sleep Medicine COPD Chronic Disease Management Program Center for Respiratory and Sleep Medicine COPD Chronic Disease Management Program Cristina Ashworth, NP Khalil Diab,MD Center for Respiratory and Sleep Medicine Subgroup of Indiana Internal Medicine Consultants

More information

Title: Socioeconomic conditions and number of pain sites in women

Title: Socioeconomic conditions and number of pain sites in women Author's response to reviews Title: Socioeconomic conditions and number of pain sites in women Authors: Finn E Skjeldestad (fisk@fhi.no) Toril Rannestad (Toril.Rannestad@hist.no) Version: 2 Date: 17 January

More information

AECOPD: Management and Prevention

AECOPD: Management and Prevention Neil MacIntyre MD Duke University Medical Center Durham NC Professor P.J. Barnes, MD, National Heart and Lung Institute, London UK Professor Peter J. Barnes, MD National Heart and Lung Institute, London

More information

Aclidinium bromide/ formoterol Benefit assessment according to 35a Social Code Book V 1

Aclidinium bromide/ formoterol Benefit assessment according to 35a Social Code Book V 1 IQWiG Reports Commission No. A15-06 Aclidinium bromide/ formoterol Benefit assessment according to 35a Social Code Book V 1 Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Aclidiniumbromid/Formoterol

More information

Respiratory Subcommittee of PTAC Meeting held 4 March 2015

Respiratory Subcommittee of PTAC Meeting held 4 March 2015 Respiratory Subcommittee of PTAC Meeting held 4 March 2015 (minutes for web publishing) Respiratory Subcommittee minutes are published in accordance with the Terms of Reference for the Pharmacology and

More information

Making comparisons. Previous sessions looked at how to describe a single group of subjects However, we are often interested in comparing two groups

Making comparisons. Previous sessions looked at how to describe a single group of subjects However, we are often interested in comparing two groups Making comparisons Previous sessions looked at how to describe a single group of subjects However, we are often interested in comparing two groups Data can be interpreted using the following fundamental

More information

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 15 December 2010

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 15 December 2010 The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 15 December 2010 HIROBRIZ BREEZHALER 150 micrograms, inhalation powder, hard capsules B/10 with inhaler (CIP code:

More information

Outcomes: Initially, our primary definitions of pneumonia was severe pneumonia, where the subject was hospitalized

Outcomes: Initially, our primary definitions of pneumonia was severe pneumonia, where the subject was hospitalized The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

CEDAC FINAL RECOMMENDATION

CEDAC FINAL RECOMMENDATION CEDAC FINAL RECOMMENDATION ROFLUMILAST (Daxas Nycomed Canada Inc.) Indication: Chronic Obstructive Pulmonary Disease Recommendation: The Canadian Expert Drug Advisory Committee (CEDAC) recommends that

More information

Title:Emergency ambulance service involvement with residential care homes in the support of older people with dementia: an observational study

Title:Emergency ambulance service involvement with residential care homes in the support of older people with dementia: an observational study Author's response to reviews Title:Emergency ambulance service involvement with residential care homes in the support of older people with dementia: an observational study Authors: Sarah Amador (s.amador@herts.ac.uk)

More information

Relevant Papers: eight relevant articles were found, but four were reviewed because they were most directly related to the topic

Relevant Papers: eight relevant articles were found, but four were reviewed because they were most directly related to the topic Topic: Prehospital use of bromide paired with salbutamol as treatment for shortness of breath. Author: Lisa Henderson Clinical Scenario: Two primary care paramedics respond code 4 for a 55 year old male

More information

Potential risks of ICS use

Potential risks of ICS use Potential risks of ICS use Randomised controlled trial Observational study Systematic review Pneumonia Tuberculosis Bone fracture Skin thinning/easy bruising Cataract Diabetes No effect on fracture risk

More information

Chronic Obstructive Pulmonary Disease (COPD).

Chronic Obstructive Pulmonary Disease (COPD). Chronic Obstructive Pulmonary Disease (COPD). Linde: Living healthcare 02 03 Chronic Obstructive Pulmonary Disease (COPD). A pocket guide for healthcare professionals. COPD the facts Moderate to severe

More information

Conference Report. Chronic Obstructive Pulmonary Disease From a Payer and Provider Lens. Managed Care & Healthcare Communications, LLC

Conference Report. Chronic Obstructive Pulmonary Disease From a Payer and Provider Lens. Managed Care & Healthcare Communications, LLC AUTHOR Joseph Johnson, MD Chief Medical Officer Arizona Integrated Physicians PUBLISHING STAFF Senior Vice President, Clinical and Scientific Affairs Jeff Prescott, PharmD, RPh Clinical Projects Managers

More information

Disclosures. Chronic Obstructive Pulmonary Disease. Chronic Obstructive Pulmonary Disease (COPD)

Disclosures. Chronic Obstructive Pulmonary Disease. Chronic Obstructive Pulmonary Disease (COPD) Chronic Obstructive Pulmonary Disease May 14, 2016 Orlando, FL COPD (Chronic obstructive pulmonary disease) is a major cause of mortality and morbidity in the United States. Alarmingly, COPD recently became

More information

Advances in the management of chronic obstructive lung diseases (COPD) David CL Lam Department of Medicine University of Hong Kong October, 2015

Advances in the management of chronic obstructive lung diseases (COPD) David CL Lam Department of Medicine University of Hong Kong October, 2015 Advances in the management of chronic obstructive lung diseases (COPD) David CL Lam Department of Medicine University of Hong Kong October, 2015 Chronic obstructive pulmonary disease (COPD) COPD in Hong

More information

OPTIMIZING MANAGEMENT OF COPD IN THE PRACTICE SETTING 10/16/2018 DISCLOSURES I have no financial or other disclosures

OPTIMIZING MANAGEMENT OF COPD IN THE PRACTICE SETTING 10/16/2018 DISCLOSURES I have no financial or other disclosures OPTIMIZING MANAGEMENT OF COPD IN THE PRACTICE SETTING J. Michael Fuller, MD, MEd, FACP, FCCP Associate Professor of Medicine University of South Carolina Greenville DISCLOSURES I have no financial or other

More information

2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY. MEASURE TYPE: Process

2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY. MEASURE TYPE: Process Quality ID #52 (NQF 0102): Chronic Obstructive Pulmonary Disease (COPD): Long-Acting Inhaled Bronchodilator Therapy National Quality Strategy Domain: Effective Clinical Care 2018 OPTIONS FOR INDIVIDUAL

More information

Three s Company - The role of triple therapy in chronic obstructive pulmonary disease (COPD)

Three s Company - The role of triple therapy in chronic obstructive pulmonary disease (COPD) Three s Company - The role of triple therapy in chronic obstructive pulmonary disease (COPD) Zahava Picado, PharmD PGY1 Pharmacy Practice Resident Central Texas Veterans Healthcare System Temple, TX October

More information

Cost-Effectiveness of Therapy with Combinations of Long-Acting Bronchodilators and Inhaled Steroids for Treatment of COPD

Cost-Effectiveness of Therapy with Combinations of Long-Acting Bronchodilators and Inhaled Steroids for Treatment of COPD Collaboration for Outcomes Research and Evaluation University of British Columbia Cost-Effectiveness of Therapy with Combinations of Long-Acting Bronchodilators and Inhaled Steroids for Treatment of COPD

More information

What s New in Acute COPD? Dr Nick Scriven Consultant AIM President SAM

What s New in Acute COPD? Dr Nick Scriven Consultant AIM President SAM What s New in Acute COPD? Dr Nick Scriven Consultant AIM President SAM Covering: Basic Definition New assessment criteria Some newer treatments BiPAP Not Covering: Definitions: Chronic Obstructive Pulmonary

More information

Author's response to reviews

Author's response to reviews Author's response to reviews Title: Boussignac continuous positive airway pressure for the management of acute cardiogenic pulmonary edema: prospective study with a retrospective control group Authors:

More information

Roflumilast (Daxas) for chronic obstructive pulmonary disease

Roflumilast (Daxas) for chronic obstructive pulmonary disease Roflumilast (Daxas) for chronic obstructive pulmonary disease August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended

More information

Title: The impact of the UK 'Act FAST' stroke awareness campaign: content analysis of patients, witness and primary care clinicians' perceptions

Title: The impact of the UK 'Act FAST' stroke awareness campaign: content analysis of patients, witness and primary care clinicians' perceptions Author's response to reviews Title: The impact of the UK 'Act FAST' stroke awareness campaign: content analysis of patients, witness and primary care clinicians' perceptions Authors: Stephan U Dombrowski

More information

Title: Evaluation of the Housing First Program in patients with severe mental disorders in France: study protocol for a randomised controlled trial

Title: Evaluation of the Housing First Program in patients with severe mental disorders in France: study protocol for a randomised controlled trial Author's response to reviews Title: Evaluation of the Housing First Program in patients with severe mental disorders in France: study protocol for a randomised controlled trial : Aurelie Tinland (laurent.boyer@ap-hm.fr)

More information

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 25 May 2011

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 25 May 2011 The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 25 May 2011 Examination of the file for the proprietary medicinal product included for a period of 5 years by the

More information

DRAFT (Final) Concept Paper On choosing appropriate estimands and defining sensitivity analyses in confirmatory clinical trials

DRAFT (Final) Concept Paper On choosing appropriate estimands and defining sensitivity analyses in confirmatory clinical trials DRAFT (Final) Concept Paper On choosing appropriate estimands and defining sensitivity analyses in confirmatory clinical trials EFSPI Comments Page General Priority (H/M/L) Comment The concept to develop

More information

Title: Use of food labels by adolescents to make healthier choices on snacks: a cross sectional study from Sri Lanka

Title: Use of food labels by adolescents to make healthier choices on snacks: a cross sectional study from Sri Lanka Author s response to reviews Title: Use of food labels by adolescents to make healthier choices on snacks: a cross sectional study from Sri Lanka Authors: Ishanka Talagala (drmaheshkeerthi@gmail.com;drishanka@gmail.com)

More information

Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: Secondary Outcome/Efficacy Variable(s): Statistical Methods:

Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: Secondary Outcome/Efficacy Variable(s): Statistical Methods: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Bronchodilator responsiveness in patients with COPD

Bronchodilator responsiveness in patients with COPD Eur Respir J 28; 31: 742 75 DOI: 1.1183/931936.12967 CopyrightßERS Journals Ltd 28 Bronchodilator responsiveness in patients with COPD D.P. Tashkin*, B. Celli #, M. Decramer ", D. Liu +, D. Burkhart +,

More information

COPD: Current Medical Therapy

COPD: Current Medical Therapy COPD: Current Medical Therapy Angela Golden, DNP, FNP-C, FAANP Owner, NP from Home, LLC Outcomes As a result of this activity, learners will be able to: 1. List the appropriate classes of medications for

More information

Title: Exposure of bakery and pastry apprentices to airborne flour dust using PM2.5 and PM10 personal samplers

Title: Exposure of bakery and pastry apprentices to airborne flour dust using PM2.5 and PM10 personal samplers Author's response to reviews Title: Exposure of bakery and pastry apprentices to airborne flour dust using PM2.5 and PM10 personal samplers Authors: Estelle Mounier-Geyssant (estellemounier@yahoo.fr) Jean-Francois

More information

Blood Pressure and Complications in Individuals with Type 2 Diabetes and No Previous Cardiovascular Disease. ID BMJ

Blood Pressure and Complications in Individuals with Type 2 Diabetes and No Previous Cardiovascular Disease. ID BMJ 1 Blood Pressure and Complications in Individuals with Type 2 Diabetes and No Previous Cardiovascular Disease. ID BMJ 2016.033440 Dear Editor, Editorial Committee and Reviewers Thank you for your appreciation

More information

Chronic Obstructive Pulmonary Disease (COPD) KAREN ALLEN MD PULMONARY & CRITICAL CARE MEDICINE VA HOSPITAL OKC / OUHSC

Chronic Obstructive Pulmonary Disease (COPD) KAREN ALLEN MD PULMONARY & CRITICAL CARE MEDICINE VA HOSPITAL OKC / OUHSC Chronic Obstructive Pulmonary Disease (COPD) KAREN ALLEN MD PULMONARY & CRITICAL CARE MEDICINE VA HOSPITAL OKC / OUHSC I have no financial disclosures Definition COPD is a preventable and treatable disease

More information

Blood Eosinophils and Response to Maintenance COPD Treatment: Data from the FLAME Trial. Online Data Supplement

Blood Eosinophils and Response to Maintenance COPD Treatment: Data from the FLAME Trial. Online Data Supplement Blood Eosinophils and Response to Maintenance COPD Treatment: Data from the FLAME Trial Nicolas Roche, Kenneth R. Chapman, Claus F. Vogelmeier, Felix JF Herth, Chau Thach, Robert Fogel, Petter Olsson,

More information

Global Strategy for the Diagnosis, Management and Prevention of COPD 2016 Clinical Practice Guideline. MedStar Health

Global Strategy for the Diagnosis, Management and Prevention of COPD 2016 Clinical Practice Guideline. MedStar Health Global Strategy for the Diagnosis, Management and Prevention of COPD 2016 Clinical Practice Guideline MedStar Health These guidelines are provided to assist physicians and other clinicians in making decisions

More information

Pharmacotherapy for COPD

Pharmacotherapy for COPD 10/3/2017 Topics to be covered Pharmacotherapy for chronic treatment Pharmacotherapy for COPD Dr. W C Yu 3rd September 2017 Commonly used drugs Guidelines for their use Inhaled corticosteroids (ICS) in

More information

Author's response to reviews

Author's response to reviews Author's response to reviews Title: Pneumococcal vaccination and otitis media in Australian Aboriginal infants: comparison of two birth cohorts before and after introduction of vaccination Authors: Grant

More information

Changing Landscapes in COPD New Zealand Respiratory Conference

Changing Landscapes in COPD New Zealand Respiratory Conference Changing Landscapes in COPD New Zealand Respiratory Conference Dr Robert Young BMedSc MBChB DPhil (Oxon) FRACP FRCP Associate Professor Consultant Physician Changing Landscapes in COPD: Summary 1. Overview

More information

Title:Hypertension after preeclampsia and relation to the C1114G polymorphism (rs4606) in RGS2: data from the Norwegian HUNT2 study

Title:Hypertension after preeclampsia and relation to the C1114G polymorphism (rs4606) in RGS2: data from the Norwegian HUNT2 study Author's response to reviews Title:Hypertension after preeclampsia and relation to the C1114G polymorphism (rs4606) in RGS2: data from the Norwegian HUNT2 study Authors: Anne Stine Kvehaugen (akvehaugen@yahoo.no)

More information

Global Initiative for Asthma (GINA) What s new in GINA 2017?

Global Initiative for Asthma (GINA) What s new in GINA 2017? Global Initiative for Asthma (GINA) GINA Global Strategy for Asthma Management and Prevention Asthma-COPD overlap The word syndrome has been removed from the previous term asthma-copd overlap syndrome

More information

Aclidinium bromide/formoterol Endpoint category. RR Endpoint. [95% CI 2 ] Study. with event

Aclidinium bromide/formoterol Endpoint category. RR Endpoint. [95% CI 2 ] Study. with event Resolution by the Federal Joint Committee on an amendment to the Pharmaceutical Directive (AM-RL): Appendix XII Resolutions on the benefit assessment of pharmaceuticals with new active ingredients, in

More information

Roflumilast for Management of Chronic Obstructive Pulmonary Disease

Roflumilast for Management of Chronic Obstructive Pulmonary Disease Roflumilast for Management of Chronic Obstructive Pulmonary Disease Submission to National Institute for Health and Clinical Excellence Single Technology Appraisal (STA) May 2011 Manufacturer MSD Ltd 1

More information