Respiratory diseases

Allergic rhinitis

  • Structured review of medication adherence in allergic rhinitis compared with other treatments for chronic conditions
  • Review of PROs and development of a patient-reported screening tool in allergic rhinitis
  • Preference questionnaire on allergic rhinitis spray devices
  • Comparative preference trial with an experience questionnaire in allergic rhinitis
  • Focus groups assessing patient experience with nasal spray in allergic rhinitis, analysis of results and development of a report on concept elicitation and cognitive debriefing
  • Literature research and communications on the burden of nasal blockage in allergic rhinitis
  • Validation of the preference module of the Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q), with revisions to an FDA briefing document on the development and validation of the EARNS-Q experience and preference modules
  • Manuscript on the development of the EARNS-Q
  • Regulatory support for the EARNS-Q

Asthma

  • Systematic literature review on treatment patterns and burden of illness in asthma
  • Literature review, analysis and communications for asthma costs
  • Literature review of critical handling errors in asthma
  • Real-world evidence literature review in asthma
  • Landscape analysis in asthma and model assessment to support positioning paper
  • Structured literature reviews for paediatric wheeze detection
  • Rapid structured literature review of nebulisation inhalation efficiency in paediatric asthma and other respiratory conditions
  • Competitor literature review for real world evidence in asthma
  • Advisory board meeting on a literature review in asthma
  • Simple cost-utility model and targeted literature review for the treatment of asthma
  • Budget impact model and manuscript on asthma
  • Consultancy on exploratory economic modelling in severe asthma
  • Update to the pilot inference model for an inhaler used in the treatment of asthma
  • Health economic model in asthma
  • Economic model of asthma therapies for NICE
  • Economic model of combination asthma therapies for NICE
  • Resource use costing in asthma and communicating product value to a local payer audience
  • Global value dossier update on paediatric asthma
  • Global value dossier update and e-v@luate upload for an asthma device
  • Development of a mini global value dossier for an asthma device
  • e-v@luate platform development for paediatric asthma
  • Updates to critical handling error manuscript in asthma
  • Development of a manuscript in mild persistent asthma in specific geographies
  • Update to a critical handling errors manuscript in asthma
  • Preparation of a submission dossier for NICE on paediatric inhaled corticosteroid (ICS) drug use in asthma
  • Several conference posters on asthma, an asthma model, and economic analysis for the treatment of asthma
  • Advisory panel in asthma
  • Regulatory strategy consultancy in asthma
  • Consultancy on obtaining FDA approval of a treatment satisfaction claim for a new asthma treatment
  • Confirmation of an endpoint model for patients with asthma currently receiving treatment
  • PRO consulting on an asthma program for labelling
  • Cognitive debriefing to confirm the face and content validity of secondary endpoint questions in asthma
  • Database analysis and manuscript assessing death rate and hospitalisation rate in asthmatics
  • Development of a conceptual model and conceptual framework for the measurement of asthma control
  • Testing of a conceptual model of asthma in adolescents
  • Development of a symptom-based PRO instrument for adults and adolescents with asthma
  • Exit interviews to provide additional evidence of content validity for a quantitative study in asthma
  • Exit interviews on a connected inhaler system for asthma
  • Cognitive debriefing interviews in asthma
  • Validation of the Asthma Control Questionnaire (ACQ) using trial data
  • Manuscript on the psychometric validation of the ACQ report
  • Analyses of the ACQ
  • Conference poster reporting a ROC analysis performed to define cutpoints for the ACQ
  • Development of a questionnaire to assess control in children with paediatric asthma
  • Longitudinal validation of the Childhood Asthma Control Test (C-ACT)
  • Analysis and abstract on the longitudinal validation of the C-ACT
  • Validity assessment of the C-ACT in Japanese children
  • Validity assessment of the C-ACT in Hong Kong Chinese children
  • Complementary analyses on the C-ACT
  • Minimal clinically important differences for the C-ACT and symptom-free days/rescue medication–free days in paediatric asthma populations
  • Consulting on the linguistic validation of the C-ACT
  • Translation of the C-ACT
  • Equivalency testing of the modified Childhood Asthma Control Test (C-ACT) in children with mild to severe asthma
  • Cognitive debriefing of the Asthma Symptom and Control Diary (ASCD)
  • Linguistic validation of the Inhaled Corticosteroid Questionnaire (ICQ) into US English
  • Exit interviews and evaluation of the psychometric properties of the Asthma Daily Symptom Diary (ADSD) in severe asthma
  • Quantitative study to confirm the content validity of the ADSD
  • Development of a preference-based instrument specific to asthma

Asthma COPD overlap syndrome

  • Slide deck and manuscript in Asthma COPD Overlap Syndrome (ACOS)
  • Structured literature review on ACOS
  • Adequacy of COPD PROs for patients with ACOS

Bronchitis

  • Development of a cough and sputum questionnaire in chronic bronchitis in 7 languages
  • Validation of a cough and sputum questionnaire in chronic bronchitis
  • Development and validation of a patient diary for evaluating acute exacerbation of chronic bronchitis
  • Conducting European focus group sessions for acute exacerbation of chronic bronchitis
  • Validation of a patient diary for evaluating acute exacerbation of chronic bronchitis (AECB)

Chronic obstructive pulmonary disease (COPD)

  • Value proposition for a new metered dose inhaler to treat chronic obstructive pulmonary disease (COPD)
  • External expert assessment of a drug for COPD
  • Development of a global market access value pack to support regional/local access teams and HTA submissions in COPD
  • Value pack (objection handler and budget impact/cost minimisation model) in COPD
  • Conference abstract and poster development on COPD
  • Manuscript on the budget impact of a new treatment in COPD
  • Updates to critical handling error manuscript in chronic obstructive pulmonary disease (COPD)
  • Structured literature review and qualitative interviews with payers/HCPs on a device for COPD
  • Protocol development support for a conjoint patient preference study in COPD
  • PRO strategy support for an inhaler treatment for COPD
  • Literature review, FDA briefing document and FDA meeting related to the development of an ePRO for well controlled days in COPD
  • Targeted literature review of PRO measures in frequently exacerbating COPD patients
  • Literature review and research around treatment experiences of patients with COPD
  • Exit interviews to explore patient disease burden, treatment satisfaction and clinical trial participation in muscle wasting associated with COPD
  • Development and delivery of a manuscript on the results from a trial in COPD
  • Translation and validation of the chronic obstructive pulmonary disease population screener (COPD-PS) in Japan
  • Poster presentation on the validation of the COPD-PS in Japan
  • Manuscript on the validation of the COPD-PS in Japan
  • Poster on the development of the Cough and Sputum Assessment Questionnaire (CASA-Q) in COPD
  • Development of a user manual for the cough and sputum assessment questionnaire
  • Validation of the CASA-Q trial
  • Cross-team review of a CASA-Q PRO dossier in COPD for submission to the FDA
  • FDA support for the CASA-Q in COPD
  • Support at investigator meetings for the CASA-Q
  • Psychometric validation of the Shortness of Breath Questionnaire in COPD
  • Validation of a questionnaire for assessing control status of patients with COPD
  • Development of a dyspnoea scale in COPD
  • Development and validation of a satisfaction questionnaire in COPD
  • Development of a symptom diary in COPD
  • Validation of a patient diary to assess symptoms of COPD
  • Development of a poster and validation of a questionnaire in COPD
  • Development and validation of an ePRO in COPD
  • Mixed treatment comparison between competing interventions for COPD
  • Association between exacerbations, a respiratory questionnaire and the use of rescue medication in COPD
  • Network meta-analysis of two treatments for COPD
  • Network meta-analysis of one drug versus fixed dose combinations in COPD
  • Network meta-analysis of competing interventions in the management of COPD
  • Conference presentation on a network meta-analysis of a treatment for COPD
  • Development of a preference-based instrument specific to COPD
  • Validation of a patient diary for evaluating acute exacerbation of chronic obstructive pulmonary disease (AECOPD)

Cough and cold

  • Literature review on cough and cold over-the-counter medications
  • Strategy meeting on colds and coughs with the Consumer Healthcare Products Association
  • Communication support to develop a PRO instrument to measure multiple cold symptoms in children
  • Research to support the development of a PRO strategy for use in paediatric cough and cold
  • Development and validation of an ePRO instrument to assess symptoms associated with paediatric cold
  • Validation of a 3 item composite measure to assess the symptoms of chronic rhinisitus
  • Consulting for an FDA meeting and requirements regarding the Total Sinus Symptom Score (TSSS) as a primary endpoint in chronic rhinisitus
  • Cognitive debrief of cold symptom PRO questions in paediatric patients
  • Development and content validity testing of PRO questions developed to measure additional paediatric cold symptoms
  • Pilot testing and validation of a PRO instrument to measure multiple cold symptoms in children

Cystic fibrosis

  • FDA PRO consulting for cystic fibrosis
  • Gap analysis and strategic recommendations for the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
  • Model of cystic fibrosis disease progression

Emphysema

  • General consultancy on economics, quality of life and reimbursement in lung volume reduction surgery in emphysema

Idiopathic pulmonary fibrosis

  • Landscape economic outcomes data analysis in idiopathic pulmonary fibrosis
  • Assistance with a Delphi panel and consensus statement on idiopathic pulmonary fibrosis