Respiratory diseases

Activated phosphoinositide 3-kinase delta syndrome (APDS)

Clinical trial exit interviews to characterise patients’ experience and treatment benefit in patients with activated phosphoinositide 3-kinase delta syndrome (APDS)

Allergic rhinitis

Structured review of medication adherence in allergic rhinitis compared with other treatments for chronic conditions
Communications and manuscript on a survey of the impact of allergic rhinitis on sleep
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
Value messaging and HE training support in 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

Interstitial lung disease

Consulting to help inform a PRO strategy for pulmonary hypertension in interstitial lung disease (PH-ILD)
Brief literature review to inform endpoint strategy recommendations for interstitial lung disease in systemic sclerosis (SSc-ILD)

Nasal polyps

Quantitative validation of symptom scores in nasal polyposis
Characterisation of symptoms and impacts of severe nasal polyps

Other respiratory experience

Literature search and slide deck for a lung surfactant treatment
Cost calculator model for lung surfactant
Assessment of the commercial and economic value for the development of new diagnostic tests for respiratory infections
Review of existing respiratory compromise safety data
Respiratory manuscript editing and submission
Reimbursement pathway review in respiratory disease
Literature review on the clinical outcome assessment (COA) landscape of bacterial respiratory infections
COA landscape review and literature review in a vaccine for respiratory bacterial infections
Budget impact model in chronic cough
Development and validation of a preference questionnaire in a respiratory disease

Respiratory syncytial virus

Core value dossier for a treatment for respiratory syncytial virus
Core value dossier update in respiratory syncytial virus prophylaxis to support the roll-out of a new liquid formation
Value dossier update on respiratory syncytial virus
Payer objection handlers to support treatment in secondary hyperparathyroidism (SHPT) and respiratory syncytial virus
Economic evaluation of a treatment for respiratory syncytial virus
Value communication support in acute otitis media associated with respiratory syncytial virus (RSV)
Observational study and claims analysis of respiratory distress in infants with respiratory syncytial virus
Development of an evidence package for a COA strategy for paediatric respiratory syncytial virus
Content validation of a COA strategy for paediatric respiratory syncytial virus
Exit interviews with caregivers and clinicians in a prospective study to assess the Paediatric Respiratory Syncytial Virus Electronic Severity and Outcome Rating System (PRESORS)
Content validation of a COA strategy for respiratory synctial virus in the elderly or in those with respiratory compromise

Rhinoconjunctivitis and rhinitis

Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Work Productivity and Activity Impairment (WPAI) questionnaire trial in Japan
Psychometric validation of the RQLQ in Japanese
Manuscript on the validation of the RQLQ
Development of a paediatric rhinitis symptom assessment tool
Review of PROs and development of a patient-reported screening tool in allergic rhinitis/rhinoconjunctivitis

Sinusitis

Symptom reporting in chronic sinusitis
Economic and PRO trial in chronic sinusitis