Validation of multi-dimensional indices (ADO, DOSE) and GOLD categorisation in routine care patients with COPD

Global Obstructive Lung Disease (GOLD) categories for chronic obstructive pulmonary disease (COPD) are recommended for severity assessment in clinical care. There is a need to understand their value in routine clinical settings and compare them with other multidimensional assessment measures.

An observational cohort study using databases comprising 5486 primary care COPD patients from UK Sweden, and Holland.

The GOLD categories, DOSE and ADO indices, associations with (i) current health status measured by the CCQ and SGRQ; exacerbations and hospital admissions and (ii) future exacerbations, admissions and mortality. The distribution into GOLD categories and future risk associated with the categories.

Lead Investigator:
Dr Rupert Jones
Research Team:
David Price, Niels H. Chavannes, Amanda Lee, Björn Ställberg, Karin Lisspers, Josefin Sundh and Michael Hyland.
On behalf of the UNLOCK group of the IPCRG.

Status: Active Study
Support: Respiratory Effectiveness Group, UNLOCK Group of the IPCRG
Registration: 
Documents and Publications:
Protocol
Abstracts
Presentations
Final Publications:
Primary Care Respiratory Medicine
Additional Material

Validation of the Concept of Control of COPD in Clinical Practice

The primary aims of this multicenter, observational longitudinal study are to:

  • Identify the degree of control in an international cohort of unselected COPD patients
  • Compare the outcomes of controlled versus uncontrolled patients after one year follow-up

The study will also:

  • Compare the clinical variables with CAT and CCQ as tool to identify impact and stability in COPD
  • Identify differences in degree of control according to adequacy of treatment to current guidelines
  • Identify demographic and clinical characteristics associated with poor control of COPD

Lead Investigator:
Marc Miravitlles
Research Team:
Alison Chisholm Anjan Nibber

Status: Active Study
Support: Novartis
Registration: ENCEPP/SDPP/10697
Documents and Publications:
Protocol
Abstracts
Presentations
Final Publications
Additional Material

Validate outcome definitions and methodologies use in observational asthma research

The aim of this study is to validate a series of objective asthma control measures that have been used in published real-life respiratory research. The outcome measures will be compared and contrasted to patient-reported outcomes and/or gold-standard, validated asthma control tools and measures (as appropriate). Where possible, their validity, responsiveness and predictive value will also be assessed and a rank order of outcomes (and possibly hierarchical modelling) will be established to aid in appropriate outcome selection for future studies.

Lead Investigator:
Richard Martin
Research Team:
David Price, Alex Dima, Alan Kaplan, Gene Colice, Todor Popov, Janet Holbrook, Emilio Pizzichini, Nikos Papadopoulos, Guy Brusselle, Helen Reddel, Professor David Price, Julie von Ziegenweidt, Annie Burden, Vicky Thomas, Muzammil Ali, Liz Hillyer.

Status: Active Study
Support: Respiratory Effectiveness Group
Registration: ENCePP: ENCEPP/SDPP/4860
Documents and Publications:
Protocol
Abstracts
Presentations
Final Publications
Additional Material

Develop (implementable) tools to facilitate quality appraisal of published real-world evidence

Assess the quality of the asthma comparative effectiveness literature to identify evidence for consideration by future guideline developers

Evaluation and validation of oscillometry in terms of clinical value and reliability in routine patient care

The REG / EAACI Taskforce aims to conduct a systematic critical review of the real-life asthma literature between 2009–13 and write a report describing the current quality of real-life research in asthma; highlighting studies worthy of possible integration into asthma-related guidelines and policy decisions, and recommending quality targets for the future.

The critical appraisal of the evidence will involve the following core components:

Based on a review of published quality standards (e.g. extended CONSORT, STROBE, REG quality standards, etc), quality checklists and scoring tools for pragmatic trials and observational studies will be developed.
Identification of real-life asthma studies published in peer review journals during the last 5 years (2009–13), and of the main research question(s) addressed in these studies.
Categorization of published studies using the proposed REG framework (in press with the Lancet Respiratory Medicine), i.e., in terms of the extent to which their (a) study population and (b) management approach reflect real-life. Based on their position within the REG framework, identification of the relevant quality appraisal tools to assess the quality of the categorized studies.
Application of the relevant assessment tools and taskforce’s quality scoring tool, resulting in up- or down-grading of the level of evidence provided by these studies on the considered research question(s).
Comparison of populations, settings, characteristics of care and results between selected high-quality real-life studies and RCTs addressing the same research question(s).
Identification of areas where real-life asthma research could add to RCTs’ results.
Synthesis and publication of the findings, with special interest on where and how the evidence retrieved from real-life research complements evidence from RCTs and could, therefore, be considered when developing guidelines.
Lead Investigator:
Nicolas Roche.
Research Team:
David Price, Nikos Papadopoulos, Leif Bjermer, Dermot Ryan, Helen Reddel, Maarten van den Berge, Guy Brusselle, John Haughney, Mike Thomas, Marc MIravitlles, Eric van Ganse, Jerry Krishnan
Status: Active Study
Support: EAACI
Registration:
Documents and Publications:
Protocol
Abstracts
Presentations
Final Publications
Additional Material

Assess the quality of the asthma comparative effectiveness literature to identify evidence for consideration by future guideline developers

The REG / EAACI  Taskforce aims to conduct a systematic critical review of the real-life asthma literature between 2009–13 and write a report describing the current quality of real-life research in asthma; highlighting studies worthy of possible integration into asthma-related guidelines and policy decisions, and recommending quality targets for the future.

The critical appraisal of the evidence will involve the following core components:

  • Based on a review of published quality standards (e.g. extended CONSORT, STROBE, REG quality standards, etc), quality checklists and scoring tools for pragmatic trials and observational studies will be developed.
  • Identification of real-life asthma studies published in peer review journals during the last 5 years (2009–13), and of the main research question(s) addressed in these studies.
  • Categorization of published studies using the proposed REG framework (in press with the Lancet Respiratory Medicine), i.e., in terms of the extent to which their (a) study population and (b) management approach reflect real-life. Based on their position within the REG framework, identification of the relevant quality appraisal tools to assess the quality of the categorized studies.
  • Application of the relevant assessment tools and taskforce’s quality scoring tool, resulting in up- or down-grading of the level of evidence provided by these studies on the considered research question(s).
  • Comparison of populations, settings, characteristics of care and results between selected high-quality real-life studies and RCTs addressing the same research question(s).
  • Identification of areas where real-life asthma research could add to RCTs’ results.
  • Synthesis and publication of the findings, with special interest on where and how the evidence retrieved from real-life research complements evidence from RCTs and could, therefore, be considered when developing guidelines.

Lead Investigator:
Nicolas Roche.
Research Team:
David Price, Nikos Papadopoulos, Leif Bjermer, Dermot Ryan, Helen Reddel, Maarten van den Berge, Guy Brusselle, John Haughney, Mike Thomas, Marc MIravitlles, Eric van Ganse, Jerry Krishnan
Status: Active Study
Support: EAACI
Registration: 
Documents and Publications:
Protocol
Abstracts
Presentations
Final Publications
Additional Material

Development of a technology-based solution to support optimised patient medication implementation (inhaler technique, timely delivery) tailored to patients’ attitudinal-control profiles

 

The proposed project is to build an app and integrated digital platform to improve asthma-patient care. Combining respiratory expertise with ground-breaking practical technology, the app would aim to integrate multi-dimensional assessment – patient attitudinal profiling; control assessment; inhaler technique assessment – and training in a more holistic and effective way.

The tool would aim to improve physician-patient interaction and communications by providing additional training and feedback / follow-up data for clinicians. The functionality of the app will:

  • Provide inhaler education around 7 key steps and common errors to support more successful administration of medication;
  • Use “augmented reality”, i.e. blend information over digital reality to provide educational tools;
  • Utilise the ubiquity and capacity of smartphones to provide immediate corrective measures.

The app would not only support both clinicians and patients with education across all devices, but would also show which device fails across patients and the need for new inhalers

Lead Investigators:
Status: Active Study
Support: Mundipharma Pte / Asia
Registration:
Documents and Publications:
Protocol
Abstracts
Presentations
Final Publications
Additional Material

 

Pool expertise to generate clinical management recommendations tailored to different attitudinal patient profiles with a view to optimising adherence to prescribed therapies

The aim of this study is to use the Delphi process to improve understanding of attitudes to asthma and its management within the attitudinal control clusters of REALISETM Asia, and to use these learnings to generate a number of asthma care recommendations with a view to improving asthma outcomes within the region.

Lead Investigators:
Professor David Price and Alison Chisholm
Research Team:
Professor Dahn-Warng Perng
Professor Sang-Heong Cho
Professor Camilo Roa
Professor David-Wang
Professor Liam Chong Kin

Status: Active Study
Support: Mundipharma Pte / Asia
Registration:
Documents and Publications:
Protocol
Abstracts: APSR 2015 Poster Presentation
Presentations
Final Publication 
Additional Material

Improve understanding of the bi-directional causality relationship between asthma outcomes and adherence

This study intends to explore:

  • To what extent and in what context adherence may be considered an asthma outcome, or/and a predictor of asthma outcomes by conducting an observational study designed to investigate the bi-directional relationship between database markers of asthma treatment adherence and asthma control (i.e. What is the impact of adherence, and change in adherence, on asthma outcomes, and vice versa?).
  • Clinically meaningful adherence and outcomes thresholds will be explored by treating them as continuous variables and estimating linear/nonlinear relationships and meaningful cut-off points.

Lead Investigator:
Gene Colice
Research Team:
David Price
Alexandra Dima
Hilary Pinnock
Iain Small
Cynthia Rand
Michelle Eakin
Janet Holbrook
Miguel Román Rodríguez
Eric van Ganse
Nemr Eid
Randy Brown
Alison Chisholm
Status: Active Study
Support: Respiratory Effectiveness Group
Registration: ENCEPP/SDPP/489
Documents and Publications:
Protocol
Abstracts
Presentations
Final Publications
Additional Material

Comparative effectiveness of spacers for the delivery of extrafine veruss non-extrafine particle ICS in asthma

The objective of this study is to investigate the real life effectiveness of ICS delivery of Fluticasone Propionate (FP) and Qvar® (beclomethasone dipropionate HFA) by pMDI with spacer compared to pMDI alone.

Lead Investigator:
Professor David Price
Research Team:
Catherine Hutton
Victoria Carter
Annie Burden
Vicky Thomas
Kathryn Richardson
Muzammil Ali
Julie von Ziegenweidt
Alice Durieux
Status: Active Study
Support: Teva
Registration:
Documents and Publications:
Protocol
Abstracts
Presentations
Final Publications
Additional Material

Implications of ICS particle size on potential long-term asthma treatment-related side effects (e.g. metabolic and musculoskeletal comorbidities, pneumonia)

The aim of the study was to assess metabolic and other adverse consequences of small particle inhaled corticosteroids (ICS) and large particle ICS in patients with obstructive lung disease. Specifically to examine worsening control of pre-existing diabetes, risk of developing new-onset diabetes, change in BMI  and incidence of pneumonia; determining absolute rates and any dose-response relationships.

Lead Investigator:
Professor David Price
Research Team: Annie Burden, RiRL
Status: Active Study
Support: Teva
Registration:
Documents and Publications:
Protocol
Abstracts
Presentations
Final Publications
Additional Material