Title: Adherence – meaningful outcome measure or explanatory variable?
Lead Investigator: Gene Colice, Pulmonary, Critical Care and Respiratory Services, Washington Hospital Center, and The George Washington University School of Medicine.
- Cynthia Rand, USA
- David Price, UK
- Hilary Pinnock, UK
- Iain Small, UK
- Janet Holbrook, USA
- Randall Brown, USA
- Miguel Román Rodríguez, Spain
- Alex Dima, The Netherlands
- Michelle Eakin, USA
- Eric van Ganse, France
- Nemr Eid, USA
- Good medication adherence is typically encouraged to improve treatment outcomes. Thus, good adherence can commonly be assumed to be associated with good treatment-related outcomes.
- In clinical practice, adherence to ICS in excess of the label-defined dosing interval appears to be a marker of poorer asthma control.
- A medication possession ratio in excess of 100% (i.e. prescribing in excess of the label-defined dosing period) may be a simple tool to identify patients in need of more intensive evaluation – exploratory data (submitted to the 2013 ERS for consideration) show severe exacerbations are more common and asthma control attainment lower in patients with MPR >100% than in patients with MPR≤100%
Work is required to further investigate the true relationships between medication adherence, disease severity and treatment outcomes so that “drug consumption” can be meaningfully interpreted as either a treatment-related outcome, or as an explanatory variable.
Dataset: This study is its early planning phase and the dataset for use has yet to be decided. Options include:
- The ELEVATE dataset: ELEVATE were two parallel, multicenter, pragmatic trials to evaluate the real-world effectiveness of a leukotriene-receptor antagonist (LTRA) as compared with either an inhaled glucocorticoid for first-line asthma-controller therapy or a long-acting beta(2)-agonist (LABA) as add-on therapy in patients already receiving inhaled glucocorticoid therapy. The resultant dataset includes: demographic data (age, sex), comorbid chronic respiratory conditions, comorbid rhinitis and adherence to medication (evaluated vs questionnaire reported [RQLQ]), reversibility, smoking status, ACQ, MiniAQLQ, Royal College of Physicians’ 3 / 21 questions and patient-defined targets and symptom diary card, etc.
- The CYMPLA dataset: Mobile phone-based structured intervention to achieve asthma control in patients with uncontrolled persistent asthma: a pragmatic randomised controlled trial.
- Optimum Patient Care Research Database (OPCRD): The OPCRD is a UK respiratory dataset containing anonymized, longitudinal, research-quality clinical records and patient-reported outcome data from practices that subscribe to OPC for respiratory review services; the database includes in excess of 341,000 patients at 176 practices. It has Multicentre Research Ethics Committee (MREC) approval for medical research.
Sponsor: The study analysis is funded by the Respiratory Effectiveness Group. Co-funding may be provided by Research in Real Life Ltd (depending on the dataset selected to optimise the analysis)
- Study protocol approved and finalised by the Working group.
- Annonymised Data Ethics and Protocol Transparency (ADEPT) Committee approval secured for use of the OPCRD for the proposed study (ADEPT approval number 2.9)
- Study registered with the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance Research (ENCePP) – click here to access the ENCePP study record
- Study to commence February 2014.
Links (these links will become activated as the various study outputs become available):
- Abstracts (an abstract has been submitted to the European Respiratory Society for their September 2013 Conference)
- Final publications
- ELEVATE: Leukotriene antagonists as first-line or add-on asthma-controller therapy. Price D, Musgrave SD, Shepstone L, et al. N Engl J Med. 2011 May 5;364(18):1695-707
- ELEVATE: A pragmatic single-blind randomised controlled trial and economic evaluation of the use of leukotriene receptor antagonists in primary care at steps 2 and 3 of the national asthma guidelines (ELEVATE study). Price D, Musgrave S, Wilson E, et al. Health Technol Assess 2011;15(21):1–132
- The CYMPLA trial. Mobile phone-based structured intervention to achieve asthma control in patients with uncontrolled persistent asthma: a pragmatic randomised controlled trial. Ryan D, Pinnock H, Lee AJ, et al. Primary Care Respiratory Journal. 2009; 18: 343-345
- Optimum Patient Care Research Database (OPCRD)
- Contradictory literature
Low-Dose Inhaled Corticosteroids and the Prevention of Death from Asthma.
- Exploratory real-life research
- State of the Union – An assessment of current adult asthmatics, their demographics, treatment and outcomes in 210 practices across the UK. Price D, Ryan F, Mascarenhas L, et al. Presented at the British Thoracic Society Winter Congress, 5-7 December 2012
- Asthma outcomes and costs of therapy with extrafine beclomethasone and fluticasone. Colice G, Martin R, Israel E, et al. Journal of Allergy and Clinical Immunolgy (in press)
Contact us at firstname.lastname@example.org if you are interested in collaborating on this study, or would like to find out further information about the protocol.