Urology and urogenital diseases

Hypogonadism

Utility evaluation for administration frequency for a drug for hypogonadism
Targeted literature review, value proposition and budget impact model in hypogonadism
Consultation on an FDA submission hypogonadism
Development of a hypogonadism questionnaire
Psychometric validation of the hypogonadism questionnaire
Consultancy on FDA-related issues on a hypogonadism questionnaire

Interstitial cystitis

Literature review on interstitial cystitis
Development of a PRO for interstitial cystitis
Identification of cut-points to allow a newly developed interstitial cystitis symptom PRO to be used to screen patients entering a clinical trial and to assess the psychometric properties of the interstitial cystitis
Development of a manuscript on the Painful Bladder/Interstitial Cystitis Symptom Score (PBIC-SS) questionnaire
Revision of a manuscript on the PBIC-SS questionnaire and submission to a peer-reviewed journal

Lower urinary tract symptoms

Cognitive debriefing interviews on the symptom assessment goal achievement questionnaire on lower urinary tract symptoms in the UK, Germany and Spain
Data analysis and communication activities on Self-Assessment Goal Achievement (SAGA) in lower urinary tract symptoms

Nocturia and paediatric enuresis

Stand-alone quantitative evaluation of the Impact of Nocturia End of Day Questionnaire
Creation of CDFs for the Impact of Nocturia End of Day Questionnaire
Consulting in a PRO strategy for use in paediatric enuresis (bed wetting)

Other urology and urogenital experience

Worldwide advisory board on a treatment for lower urinary tract symptoms (LUTS)
Content validation of a neurogenic detrusor overactivity (NDO) diary in paediatric spina bifida patients
Analysis of urology and gynaecology in patient waiting lists
Systematic review of lithotripters for ureterolithiasis
Presentation of a PRO in urology
PRO training in urology

Overactive bladder and urinary incontinence

Value dossier for a treatment in stress urinary incontinence
HTA review and analysis for urinary incontinence
Abstracts, posters and a manuscript on the content validity of a patient bladder diary and the incontinence quality of life questionnaire
Further qualitative development of the incontinence quality of life questionnaire
Development of a PRO report on quality of life in urinary incontinence
Development of a regulatory dossier and claims assistance in idiopathic overactive bladder (OAB) with urinary urge incontinence
Recommendations for obtaining EMEA claims on the Incontinence Quality of Life Questionnaire (I-QOL) and the King’s Health Questionnaire (KHQ)
Content validation and psychometric validation of the Kings Health Questionnaire in incontinent OAB patients
Development of a PRO dossier for the FDA to support the King’s Health Questionnaire on OAB
Content validation and psychometric validation of an incontinence questionnaire for patients
Content validation of the patient bladder diary for OAB with urinary urge incontinence
Health outcomes appendices for phase III neurogenic OAB studies
Development and validation of a clinical screening tool for OAB in multiple sclerosis
Advisory board for a clinical screening tool for OAB in multiple sclerosis
Publications from the tool development and validation projects of OAB in multiple sclerosis
Development of health outcomes appendices in idiopathic OAB
Preference evaluation to compare treatments for OAB
Mode of administration study in an OAB population
Economic dossier on an antispasmodic, anticholinergic agent for OAB
Review of screening tools in OAB
Item pooling for OAB
Development of a screener for OAB based on a pragmatic approach and item pooling
SAP, analysis, report and manuscript on the OAB-S questionnaire
Standalone validation study in treatment-naive OAB patients
Development of a tool for ranking the importance of OAB symptoms and the achievement of treatment goals
Review of data and promotional claim strategy in OAB
Cognitive debriefing of an OAB questionnaire
Linguistic validation of a natural remedy for OAB
Phase I disease progression study of OAB in Sweden
Development of a patient satisfaction questionnaire in OAB
Validation of the Overactive Bladder Satisfaction (OAB-S) Questionnaire
Support activity on the OAB-S questionnaire
Development of a briefing package in relation to the concept of urinary urgency
FDA meeting attendance on the development of a briefing package in relation to the concept of urinary urgency
Cognitive debriefing of a new PRO assessment for urinary urgency
Worldwide advisory board on a treatment for OAB

Prostatic hyperplasia

Early economic model in benign prostatic hyperplasia
PRO literature review in benign prostatic hyperplasia