Experience in Therapeutic Areas

Oncology

Breast cancer

Review of treatment patterns for breast cancer screening, diagnosis and treatment
International economic modeling and submissions of hormonal therapy in postmenopausal advanced breast cancer (UK, Spain, Belgium and the Netherlands)
Development of analysis plan for patient-reported outcome data in breast cancer
Literature review of patient-reported outcome instruments for breast cancer
Development of symptom and health-related quality of life measures for metastatic breast cancer
Systematic review of adjuvant and neoadjuvant treatments in breast cancer
Analysis of patient-reported outcome data from clinical trial in breast cancer
Modeling of treatment adherence in hormonal treatment of advanced breast cancer
Development of perceived tolerability questionnaire in 1st line treatment of advanced breast cancer
Strategic consulting for PRO labeling and publication in breast cancer
Submission to Scottish Medicines Consortium for treatment for breast cancer
Preparation of submission to National Institute for Health and Clinical Excellence for treatment for breast cancer
PRO instrument review for chemotherapy side effects in breast cancer
Development of a budget impact model for primary prophylactic granulocyte-colony stimulating factor in patients receiving adjuvant treatment for breast cancer
Treatment cost comparison and costs of treating adverse events in breast cancer
Manuscript on quality of life data from a clinical trial in metastatic breast cancer
Willingness to pay study in breast cancer in Thailand
Literature review on economic burden of triple negative breast cancer
Development of a budget impact model for treatment of advanced breast cancer
Development and adaptation to various countries of a cost effectiveness model for treatment of advanced breast cancer
Resuming the Quality of Life AVADO manuscript in metastatic breast cancer
Mixed treatment comparison of adverse events in breast cancer
Systematic review in breast cancer
Literature review and patient interviews in triple negative breast cancer
Value dossier for treatment in breast cancer
Patient interviews to investigate side effects of breast cancer treatment
PRO Knowledge Base Instruments & Methods Library for metastatic breast cancer

Cervical cancer

Markov model in cervical cancer screening
Markov model in human papillomavirus vaccination(HPV)to prevent cervical cancer
Budget impact model in HPV to prevent cervical cancer
Value pack preparation in HPV to prevent cervical cancer
Submission to Joint Committee on Vaccination and Immunisation for HPV
Development of PRO strategy in HPV to prevent cervical cancer
Literature review of PRO instruments for use in cervical cancer
Analysis and communication for psychosocial impact of HPV-related diseases among women
HPV burden of disease study
Health economic evaluation for an HPV vaccine
Analysis to support reimbursement for HPV vaccine in patient sub-groups
Value dossier for an HPV vaccine
HPV vaccine cost-effectiveness analysis for Spain
Manuscript on a German cost effectiveness analysis of an HPV vaccine
Manuscript of the Spanish cost effectiveness model in HPV vaccine
Analysis of the psychosocial impact of HPV in the UK
Review of economic models of HPV vaccine in adolescent females and young women
Literature review on resource use in cervical intraepithelial neoplasia
Development of cost model for cervical intraepithelial neoplasia

Colorectal cancer

International development and validation of patient satisfaction questionnaire in colorectal cancer
Literature review and recommendations for patient-reported outcome assessment in clinical trial of advanced metastatic colorectal cancer
Analysis of patient-reported outcome assessment of treatment for advanced colorectal cancer
Patient and clinician interviews to establish patient-reported outcome issues in colorectal cancer
Conjoint analysis to ascertain patient preferences in colorectal cancer treatment
Publication on the economic impact of a new treatment for metastatic colorectal cancer
Development of cost arguments and brochure for continuous infusion pump for colorectal cancer treatment
Communications, including manuscript, on the economic impact of denutrition in colorectal cancer
Meta-analysis for treatment in metastatic colorectal cancer

Head and neck cancer

International Markov model in head and neck cancer
Development of cost-effectiveness model in head and neck cancer and adaptation to various countries
Submission to Scottish Medicines Consortium for treatment for head and neck cancer
Budget impact model for head and neck cancer
Mapping of utilities in head and neck cancer

Leukemia

Assessment of leukemia patients satisfaction with chemotherapy
Utility assessment in elderly acute myelogenous leukemia patients
Position paper on health-related quality of life in elderly acute myelogenous leukemia patients
Value dossier for monoclonal antibody treatment for chronic lymphocytic leukemia (CLL)
Strategic consulting on PRO analysis from clinical trials in CLL
Mixed treatment comparison in CLL
Health state preference study mapping the change over the course of the CLL disease process, including poster development
Linking response to utilities in chronic myeloid leukemia
Exploring physicians’ perceptions of adherence in leukemia patients
Consultancy in PRO measures for CLL
Critical review of an economic model for CLL
Utility study in advanced CLL
PRO consulting in chronic myeloid leukaemia(CML)
Development of a manuscript for utility results in CLL
Literature review and manuscript on factors associated with adherence in CML
Post hoc analysis of PRO outcomes in a phase II clinical trial in myeloid metaplasia
PRO strategy for an open-label trial in acute myelogenous leukemia

Lung cancer

International economic evaluation of new treatment for non small cell lung cancer (NSCLC) in the UK, the Netherlands and Germany and preparation of submission for the Netherlands
Meta-analysis of published data in stage IIIb and IV NSCLC
Publication on meta-analysis in NSCLC
Poster comparing new treatment with best supportive care in NSCLC
Literature review of outcomes and costs during treatment for advanced NSCLC
Markov model for monotherapy in NSCLC
Selection of patient-reported outcome instrument for use in SCLC trials
Analysis of health-related quality of life data from clinical trial in NSCLC
Literature review to identify utility measure for use in lung cancer patients
Recommendations on assessing health-related quality of life in lung cancer
Budget impact model in NSCLC
Submission to Scottish Medicines Consortium for treatment for NSCLC
Mapping of utilities in lung cancer
Economic modeling in NSCLC
Development of abstracts on cost-effectiveness of treatment in lung cancer
Review of economic models in NSCLC
Value dossier for a drug in metastatic NSCLC
Development of technical documentation for an economic model in NSCLC
Development of a manuscript on an economic model in NSCLC
Communications on cost and cost effectiveness of first-line treatment for NSCLC – maunuscript and presentations at clinical and technical conferences
Quality assessment and critical appraisal of an economic model evaluating a breast cancer drug as a first-line treatment for NSCLC
Qualitative study on advanced NSCLC patients’ needs and preferences for maintenance therapy
Systematic review and mixed treatment comparison in advanced NSCLC
Comparative effectiveness (mixed treatment comparison) for the treatment of non-small-cell lung cancer
Mixed treatment comparison for treatment in NSCLC in Spain
Development of guidance documents in treatment for NSCLC
Situational analysis report of epidermal growth factor receptor predictive testing in NSCLC
Development of a questionnaire to assess the impact of NSCLC
Value slide deck for treatment in NSCLC

Myeloma

Analysis and reporting of patient-reported outcome data from a number of studies and clinical trials in multiple myeloma
Publication on health-related quality of life in myeloma
Presentation on PRO in multiple myeloma
Validation study for patient utilities in multiple myeloma
Meta-analysis, mixed treatment comparison & multiparameter evidence synthesis in multiple myeloma
Re-analysis of PRO data in order to differentiate first-line treatment of multiple myeloma
European survey quantifying the impact of novel treatments on quality of life in multiple myeloma
Mixed treatment comparison in multiple myeloma
Statistical analyses and publication on multiple myeloma using data from five clinical trials
Publication of mixed treatment comparison in multiple myeloma
Value dossier for treatment in multiple myeloma
Systematic literature review in multiple myeloma

Prostate cancer

Development of symptom and health-related quality of life measures in prostate cancer
Strategy and selection of health-related quality of life module in prostate cancer
Development of health-related quality of life module for prostate cancer
Building an interactive model for treatment of late stage prostate cancer
Analysis of health-related quality of life data from clinical trial in prostate cancer
Literature review of health-related quality of life in prostate cancer
PRO dossier for Functional Assessment of Cancer Therapy – Prostate (FACT-P)
Strategy to support an evidence dossier in pain due to hormone refractory prostate cancer and bone metastases
Statistical analysis plan and analyses of the Brief Pain Index, using phase II prostate cancer trial data
Consulting for castration resistant prostate cancer PRO strategy - scenario development for data interpretation
Critical review of a HTA package for a treatment for hormone resistant prostate cancer
Investigation and interpretation of PRO results for phase III clinical trial in castration resistant prostate cancer
Post-hoc analysis of a phase III clinical trial in castrate-resistant prostate cancer

Gastric cancer

Submission to Scottish Medicines Consortium for treatment for advanced gastric cancer
Literature review and development of PRO strategy for gastric cancer
Systematic literature review and indirect comparison in gastric cancer
Analysis of systematic literature review and indirect comparison in gastric cancer
Systematic review in gastric cancer
Global value dossier for treatment in gastric cancer

Ovarian cancer

Analysis and reporting of health-related quality of life data in clinical trial in ovarian cancer
Strategic consulting for PRO labeling and publication for a clinical development program in ovarian cancer
Costing of treatment in ovarian cancer
Adapting a UK model for treatment in ovarian cancer for the Netherlands
Adding a comparator to an economic model in ovarian cancer
Development of cost effectiveness model for a treatment in ovarian cancer for the Netherlands
PRO Knowledge Base and Library in ovarian cancer

Supportive treatment for cancer, and pathologies associated with cancer treatment

Assessment of cancer patients’ satisfaction with anemia treatment and management
Generation of economic evidence for erythropoietin use in cancer
Development of economic model for erythropoietin use in cancer
Linking of cost-utility model with a budget impact model for erythropoietin use in cancer
Value dossier for treatment for chemotherapy-induced neutropenia
Pilot study of questionnaire administration to patients with chemotherapy-induced neutropenia
Review of questionnaires available to assess the impact of cancer pain
Economic evaluation of prevention of skeletal related events in bone metastasis patients suffering of advanced breast cancer
Value dossier for treatment for cancer breakthrough pain
Mixed treatment comparison in cancer breakthrough pain, and related manuscript
Development of, and communication for, a cost-effectiveness model for treatment for cancer breakthrough pain
Utility elicitation in cancer breakthrough pain
Selection of PRO endpoints for clinical trial in cancer breakthrough pain
Economic analysis and submission to Scottish Medicines Consortium for treatment for anthracycline extravasation
Value dossier for treatment for chemotherapy-induced anemia
Development and analysis of, and training and communication for, a budget impact tool in patients with breakthrough cancer pain
Scottish Medicines Consortium submission in breakthrough cancer pain
Psychometric validation of a satisfaction questionnaire on the use of delivery device for treatment for chemotherapy-induced anemia
Communication on validation of satisfaction questionnaire for delivery device in chemotherapy-induced anemia
Support for interpretation of PRO data from observational study of delivery device for treatment for chemotherapy-induced anemia
Literature review and reccomendations for PROs in chemotherapy-induced peripheral neuropathy
Economic evaluation of treatment in cancer breakthrough pain for Canada

General consultancy in oncology

Advise on selection and implementation of PRO assessment in clinical development of new compounds in oncology
Advise on the assessment of PRO in non-hormonal biological treatments: establishing a marketing strategy
Numerous consulting projects on the assessment of PRO in cancer

Other

Consortium project: qualitative research in the experience of fatigue among cancer patients
Development and validation of patient satisfaction questionnaire in chemotherapy treatment
Publication on development and validation of chemotherapy satisfaction questionnaire
Literature review on resource use in basal cell carcinoma
Development of cost model for basal cell carcinoma
Development and validation of measure of impact of symptomatic malignant ascites
Strategic PRO endpoint support in non-Hodgkin’s lymphoma
Willingness to Pay study for oncology medications
Health state preference, mapping the change over the course of the Chronic Lymphatic Lymphoma disease process: CLL Poster Production
Reimbursement submission to CVZ of orphan drug for treatment of metastatic soft-tissue sarcoma
Indirect comparison of 2nd line treatments for glioblastoma
Research into experiences and preferences of cancer patients and their families
Development of a PRO dossier for the Cancer Therapy Satisfaction Questionnaire (CTSQ) for the FDA
PRO dossiers for Brief Pain Inventory (BPI) in cancer pain
PRO dossiers for EuroQoL 5 Dimension questionnaire (EQ-5D)
Development of a PRO measure in metastatic renal cell cancer
Review of PRO measures for a Phase II trial in renal cell carcinoma
Literature review evaluating the association between objective and PRO endpoints in metastatic cancer
Consultancy in PRO measures to support labeling claims with the FDA and EMEA in renal cell carcinoma
Development of a measure comparing the therapeutic value of treatments in a number of cancer types
Statistical analysis plan and analyses of the BPI using data from a phase II prostate cancer clinical trial
Comparative effectiveness of systemic therapies for unresectable stage IIIc and stage IV melanoma
Review and adaptation of economic models for the treatment of unresectable melanoma
Qualitative research on symptoms and impact in hepatocellular carcinoma
Qualitative research on symptoms and impact in brain metastasis
Development and validation of a PRO measure in brain metastases
Oncology EU/USA payer Advisory Board meeting
Analysis of EORTC data from clinical trial in malignant ascites
Research resource use of intravenous and subcutaneous drug administration in metastatic bone disease
Interviews for resource use for intravenous and subcutaneous drug administration in metastic bone disease
Clinical investigator training for patient-reported outcomes administration in chemotherapy clinical trials
Economic model for treatment of medullary thyroid cancer
Meta-analysis for the efficacy of first line treatment for unresectable stage IIIC/IV in melanoma
Literature review, indirect comparison, comparative effectiveness, and critical appraisal of survival analysis methodology in oncology, with recommendations
Literature review and conceptual mapping in non-Hodgkins lymphoma
Linguistic validation of brain metastases assessment
Model refinement and survival analyses for medullary thyroid cancer in the UK
Publication on literature review on the analysis of PRO data in metastatic cancer
PRO strategy for an open-label trial in myelodysplastic syndrome

Cardiovascular Disease

Angina

US piggyback study in unstable angina: strategic consulting, design, bill extraction and analysis plan
Longitudinal follow-up of angina pectoris cohort in France: questionnaire choice, data management, analysis, report and manuscript
Psychometric validation of angina PRO questionnaire
Gap analysis of PRO measures to substantiate a labeling claim in angina trials of a drug-eluting stent
Qualitative research on treatment side effects
Qualitative research in the benefits/drawbacks of treatment in angina pectoris
Communication for treatment in angina pectoris

Atrial fibrillation

Economic model in atrial fibrillation
Development and validation of a specific PRO questionnaire in atrial fibrillation
Analysis of PRO data from three clinical trials in atrial fibrillation
Measuring resource use, satisfaction, productivity and health-related quality of life in atrial fibrillation
An abstract on treatment effect and satisfaction analyses performed on pooled data from an atrial fibrillation study
Advisory board meeting for Implantable Cardioverter Defibrillator population
Translation and validation of the Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medications (TSQM) in atrial fibrillation in Japan

Dislipidemia

Competitor analysis and literature review of pharmacoeconomic and patient-reported endpoints in statins
Development of an interactive model in statins
Prospective longitudinal outcomes study comparing statins in a managed care environment and in a Medicaid population: protocol, CRF, IRB approval, data management and reporting
Development and validation of a patient satisfaction instrument in dyslipedemia Worldwide database analysis of statins and cholesterol levels
Publication of evaluation of statins in routine practice in the UK
Value dossier for cardiovascular disease and dyslipidemia
Mixed treatment comparison to estimate the efficacy of a drug relative to other treatments for patients with elevated triglycerides
Review of HTA submissions & economic literature in lipid modification

Heart failure

Selection of a caregiver burden questionnaire for acute decompensated heart failure
Burden of illness and unmet need in heart failure
Effects of anti-anginal treatment on cardiovascular events in patients with moderate to severe chronic heart failure
Development of a PRO dossier for Minnesota Living with Heart Failure questionnaire
Content validity of a symptom endpoint and dossier in heart failure with preserved ejection fraction
Literature review and questionnaire development for caregiver burden in patients with chronic heart failure
Value dossier and strategic consulting for treatment in chronic heart failure

Hypertension

US drug utilization review in: formulary data analysis, report
Development and validation of a patient satisfaction instrument in hypertension
Consultancy on preference claim for antihypertensive combination therapy
Literature review of pulmonary hypertension secondary to COPD
Development of a compliance and persistence screener in hypertensive patients
Budget impact model for anti-hypertensive
Economic modeling of hypertension for Japan and Korea
PRO claims for pulmonary arterial hypertension: Endpoint review, qualitative patient interviews and regulatory support
Statistical analysis plan for the validation of the modified Living with Pulmonary Hypertension questionnaire
Validation utilizing administrative data of an adherence questionnaire for hypertension patients
Utility assessment in pulmonary arterial hypertension
Cost-effectiveness model for exercise training in patients with pulmonary hypertension
Value Dossier in hypertension
Strategic treatment pathways for treatment in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Manuscript on an economic model in patients with pulmonary arterial hypertension
Consulting on a PRO strategy for pulmonary hypertension
Psychometric validation of the Living with Pulmonary Hypertension (LPH) Questionnaire

Myocardial infarction

US piggyback study in acute myocardial infarction: strategic consulting, design, bill extraction and analysis plan
European (Big 5 + Sweden) piggyback study in acute myocardial infarction: expert interviews and costing
Development and validation of patient and clinician tools for myocardial infarction imaging
Systematic review and evidence synthesis for the treatment of patients with ST elevation myocardial infarction intended for primary percutaneous coronary intervention

Thromboembolism / Pulmonary embolism

HTA assessment of therapeutic interventions and treatments for venous thromboembolism
Value dossier for anti-thrombotic
Development and validation of a specific PRO questionnaire in venous thromboembolism
Analysis of PRO data from three clinical trials in venous thromboembolism
Matched cohort pharmacoeconomic evaluation of pulmonary embolism following orthopaedic surgery in Japan
Incidence of venous thromboemolism following major abdominal surgery
An abstract on treatment effect and satisfaction analyses performed on pooled data from deep venous thromboembolism and pulmonary embolism study
Piggyback study in peripheral arterial disease: protocol and CRF
International psychometric validation of a quality of life questionnaire in chronic venous insufficiency
Abdominal surgery cohort study to evaluate the risk of venous thromboembolism
Consulting on the Anticoagulant Treatment Satisfaction scale as an endpoint for FDA claims
Development of a clinical tool to identify patients at risk of stent thrombosis

Other

Cost of illness model for development of a disease management program
US and European cross sectional compliance study: questionnaire design, data collection, analysis and report
Budget impact model for treatment for weight loss and metabolic syndrome – considering cardiovascular sequelae
Effects of anti-anginal treatment on cardiovascular events in patients with left ventricular systolic dysfunction
Economic evaluation of fixed combination product to treat high blood pressure and high cholesterol
Value dossier for treatment for hemostasis and sealing in surgery
Validation of the flushing severity questionnaire in patients with niacin induced flushing
Consulting on an epidemiological health-related quality of life study
Psychometric validation of two PRO questionnaires in hyponatremia
PRO review and gap analysis in pain in advanced pancreatic cancer in support of labeling claim
Selection and recommendations of a battery of PRO instruments in ventricular arrhythmia

Central Nervous System and Neurological Disease

Alzheimer’s disease

Piggyback study in Alzheimer’s disease: strategic consulting, design, analysis plan, costing of resource utilization questionnaire, economic analysis, reporting
Database and literature review
Decision analytic / Markov model Go / No Go
Development and cognitive debriefing of a caregiver questionnaire
Development of a trial-specific caregiver satisfaction and preference questionnaire
Development of caregiver burden items for the Resource Utilization in Dementia Questionnaire
Comprehension tests of a questionnaire to assess clinician satisfaction with diagnosis using positron emission tomography imaging
Critical analysis of a mixed treatment comparison in Alzheimer disease
Critical analysis and a report to support the widespread use of combination therapy in Alzheimer's Disease
Linguistic validation of the Alzheimer’s Disease Caregiver Preference Questionnaire into Chinese
Validation of an existing exploratory cost-effectiveness model for the diagnosis and therapy of dementia including Alzheimer's disease

Depression

Development of a symptom scale in depression
Psychometric validation of a symptom scale in depression in five European countries
Development of a manuscript and presentation based on clinical trial PRO data in depression (primarily focused on interpretation of treatment results)
Managed care database analysis: comparative study and treatment failure analysis (US)
Managed care database analysis: cost of care (US)
Use of data from the Disease Specific Program (depression database) for an analysis of an SSRI (UK)
Markov model in depression: programming, costing, report, publication (France)
Piggyback study with quality of life for an atypical antidepressant
Decision analytic model of new anti-depressant versus TCAs and SSRIs in Canada, France, UK, Austria and Hungary
Saskatchewan database analysis
Participation in the ACNP taskforce for reading articles in the field of CNS (depression and psychosis)
Benefit of early response to treatment: hypothesis generation & definition of PRO strategy
Validation of the Children's Depressions Rating Scale-Revised (CDRS-R) in Japan
Consultancy on obtaining a PRO claim in MDD
Development and validation of primary endpoints in MDD
Gap analysis of PRO strategy document in MDD
Literature search on MDD and fatigue or psychomotor retardation
Repositioning of treatment in MDD using an observational study: synopsis and advisory board preparation
Evaluation of somatic and emotional symptoms of MDD with pulmonary co-morbidities
Manuscript and content validity of PRO measure in MDD
PRO dossier for EMA submission in MDD

Epilepsy

US clinical trial: analysis plan for PRO data, psychometric validation, analysis, report
Anti-epileptic unmet need analysis / manuscript
Instrument development / assessment strategy: literature review, patient interviews, development of battery instrument, psychometric validation, report
Submission to Scottish Medicines Consortium for treatment for partial epilepsy
Development of cost-effectiveness model and budget impact model for treatment in epilepsy
Value dossier for treatment in epilepsy
Evidence synthesis and modeling for treatment in epilepsy
Development of a US value dossier meeting AMCP and WellPoint guidelines and an expanded budget impact model
Consultancy for and attendance at an SMC meeting on an anti-epilepsy drug
Consultancy on cost-effectiveness model for an anti-epileptic drug for Italy
Mixed treatment comparison for treatment in epilepsy

Multiple Sclerosis

PRO endpoint review, preparation of FDA briefing document, advisory board, in multiple sclerosis
Assessment of the psychometric properties of PRO questionnaires in multiple sclerosis
Treatment effect analysis on PRO scores in multiple sclerosis
Analysis of the responsiveness of PRO measures in multiple sclerosis (interim analysis)
Endpoint review for orphan drug in multiple sclerosis
Advisory Board for a clinical screening tool for overactive bladder in multiple sclerosis
Identification of available PRO questionnaires in multiple sclerosis
Development and validation of a screening tool for overactive bladder in multiple sclerosis patients
Identification of available PRO questionnaires in multiple sclerosis
Development and content confirmation and validation of a fatigue measure in relapsing remitting multipl sclerosis
Development of a PRO measurement strategy in relapsing multiple sclerosis
Development of a PRO dossier for Multiple Sclerosis Impact Scale - 29 in relapsing-remitting multiple sclerosis
Value dossier for a multiple sclerosis treatment in the Netherlands
Development and content confirmation and validation of a fatigue measure in relapsing remitting multiple sclerosis

Parkinson’s disease

Development of a pharmacoeconomic / budget impact model for add on therapy on Parkinson’s disease
Economic evaluation in Parkinson's disease
Meta-analysis of treatment for Parkinson's disease
Submission to Scottish Medicines Consortium for treatment for Parkinson’s disease
Mixed treatment comparisons in Parkinson's disease
Cross sectional QoL / cost study in Parkinson's disease patients with levodopa induced dyskinesia
Longitudinal QoL and HE study in Parkinson's disease patients with levodopa induced dyskinesias
Results from a qualitative study of the impact of dyskinesia on Parkinson's disease patients
The assessment of the impact of nocturnal syndrome on Parkinson's disease patients
Naturalistic health outcomes trial in Parkinson’s disease
Cost effectiveness model in Parkinson's disease in the US
Value dossier for treatment for Parkinson's disease
Preparation of a statistical analysis plan for PRO data from a trial in Parkinson’s disease
Analysis of PRO and utility data from clinical trials in Parkinson's disease
Consultancy for the optimization of a PRO strategy for FDA/EMA/payers in Parkinson's disease

Schizophrenia

US clinical trial in schizophrenia: analysis plan for PRO data, data management, psychometric validation, report, publication
Value dossier for schizophrenia treatment
Development and adaptation to other countries of budget impact model in schizophrenia
Validation of the Cognitive Functioning Scale in Japan
Review of emotional and cognitive components of schizophrenia
Literature review on cognitive impairment in schizophrenia
Communication on cognitive impairment for the American Neurological Association
Content validation of the Readiness for Work Questionnaire in schizophrenia
Systematic literature review and evidence synthesis for adherence issues in schizophernia and psychosis
Manuscript for humanistic burden of cognitive impairment associated with schizophrenia
PRO endpoint strategy in acute schizophrenia
Application of the Zarit Burden Interview (ZBI) to assess caregiver burden in schizophrenia

Sleep disorders

Literature survey, patient interviews, burden of illness model in narcolepsy
Literature survey, pricing model in sleep disorders
Review of PRO measures in insomnia
Sleep Impact Scale communication plan
Development and validation of conceptual framework and endpoint model in insomnia
Participation in advisory panels in insomnia/sleep disorders
Analysis of the psychometric properties of the MOS–Sleep Scale
Content validation of modified Daytime Insomnia Symptom Scale and the Sleep Impact Questionnaire event log

Stroke

Piggyback study for a neuro-protective versus placebo in acute ischemic stroke: CRF design, analysis plan, reporting
Piggyback and extension study in ischemic stroke: project management and analysis plan
Decision analytic model in acute ischemic stroke
Cost determinants and database review for stroke treatment for the US
Health economic plan for ischemic stroke treatment
Development of a PRO instrument to assess post-stroke spacticity
Review of PRO in two Phase III clinical trial protocols in ischemic stroke
Mixed treatment comparison in secondary prevention of stroke
Meta-analysis in secondary prevention of stroke
PRO and productivity evaluation in stroke and transient ischemic attack in Japan
Manuscript on a Delphi panel to develop a post-stroke referral checklist
Cognitive interview of the post-stroke rehabilitation checklist
Literature review and payer appraisals in peripheral artery disease and stroke

Other

Development of a structured diagnostic interview and severity scale in pediatric restless leg syndrome
Price justification for a new drug dependency compound (heroin)
Validation of the Panic and Agoraphobic Scale (PAS) and Anti-Depressant Discontinuation Scale (ADDS) in Japan
PRO questionnaire review for smoking cessation
Regulatory consulting in smoking cessation
Development of a sleep measure for a labeling claim in restless leg syndrome
Review and input in questionnaire design and analysis of data for a cost of illness analysis in Friedrichs ataxia
Communication of the economic burden of vertigo based on the REVERT registry
Gap analysis of PROs in juvenile cerebal palsy
Refinement of a stroke checklist
Manuscript of clinical outcomes in vertigo
Development of a PRO for patients with stuttering
Development and validation of screening tool in cervical dystonia
PRO measurement strategy in Rett syndrome

Pain

Cancer-related pain

Value dossier for treatment for cancer breakthrough pain
Mixed treatment comparison in cancer breakthrough pain
Economic modeling for treatment for cancer breakthrough pain
Utility elicitation in cancer breakthrough pain
Selection of PRO endpoints for clinical trial in cancer breakthrough pain
Consultancy on intended PRO claim in pain related to bone metastases in hormone-refractory prostate cancer
Preparation of an FDA briefing document to support symptom claims in cancer pain
Review and recommendation of a PRO measure of chronic cancer pain
Strategy to support an evidence dossier in pain due to hormone refractory prostate cancer and bone metastases
Statistical analysis plan and analyses of the Brief Pain Index, using phase II prostate cancer trial data
Development and analysis of, and training and communication for, a budget impact tool in patients with breakthrough cancer pain
Scottish Medicines Consortium submission in breakthrough cancer pain
PRO dossiers for Brief Pain Inventory (BPI) in cancer pain
PRO review and gap analysis in pain in advanced pancreatic cancer in support of labeling claim

Chronic low back pain

Gap analysis of epidemiology, economics and PRO data in chronic low back pain
Development and validation of a responder index in chronic low back pain
Mode of administration validation study for an electronic diary in back pain
Gap analysis and strategic recommendation for PRO and market access studies in chronic low back pain
Burden of illness
Gap analysis and review of PRO measures
Development of a PRO measurement strategy and a value demonstration strategy
Content validation of the Roland Morris Disability Questionnaire and testing of a personal digital assistant-administered version of a pain rating scale in chronic low back pain
Development of a PRO measure of stiffness in acute low back pain

Fibromyalgia

Gap analysis of epidemiology, economics and PRO data in fibromyalgia
Endpoint review of fatigue and functioning in fibromyalgia
Development of a conceptual framework for the measurement of fatigue in patients with fibromyalgia
Patient assessment of the relevance of fibromyalgia questionnaires
Development of multi-lingual versions of a questionnaire to assess the burden of fibromyalgia
Development of a screening tool in fibromyalgia to raise awareness of the disease
Literature review of PROs and endpoints in fibromyalgia
Competitive assessment and burden of illness in fibromyalgia
Pilot testing interviews in fibromyalgia fatigue
Communication on the development of fibromyalgia screening tool
Prepare article on development in 4 languages of a questionnaire to assess the burden of fibromyalgia on patient daily activities
Consultancy relating to the psychometric validation of the daily diary of fatigue symptoms
Validation of the fatigue VAS and Jenkins Sleep Scale for fibromyalgia
Manuscript on the use of the Jenkins Sleep Scale for fibromyalgia
Manuscript on the validation of a PRO instrument for fibromyalgia fatigue

Migraine

Focus group on patient functioning in migraine pain
Gap analysis and assessment of PROs in migraine
Development of an FDA briefing document and regulatory support in chronic migraine
Qualitative interviews in chronic migraine to confirm the content of the HIT-6 and other measures
Development of a measure of postdrome migraine (migraine hangover)
Qualitative interviews in chronic migraine
Gap analysis of PRO measures in pediatric migraine
Development of a PRO measure in chronic adolescent migraine

Neuropathic pain

Burden, epidemiology, competitor claims, and PROs in painful diabetic neuropathy
Costing study in neuropathic pain
Literature review and comprehensive PRO assessment strategy in neuropathic pain
Validation of the Brief Pain Inventory, the Work Productivity and Activities Impact Measure, and the MOS Sleep Scale in a neuropathic pain population
Validation of a PRO questionnaire in neuropathic pain
Consultancy on validity of a pain scale for use in painful neuropathy
Consulting on the finalisation of a screener in neuropathic pain
Analysis of PRO endpoints in neuropathic pain
Literature review and recommendation for PRO measurement strategy in neuropathic pain
Consultancy on the validation of a screener in neuropathic pain
Patient focus groups to validate a conceptual model in neuropathic pain
Development of a prediction tool to identify patients that respond to treatment in neuropathic pain

Opioid Therapy

Delphi panel of nursing time for iv PCA versus transdermal fentanyl PCA
Selection of PRO endpoints for a clinical trial of a long-acting local anesthetic for the treatment of post surgical pain
Preparation of FDA briefing document to support the use of an opioid symptom distress scale in clinical trials to support labeling claims
Strategic recommendations on validation of PRO questionnaires in opioid treatment
Burden of illness literature review in opioid-related bowel dysfunction

Rheumatoid and osteoarthritis

Rheumatoid arthritis clinical trial in 13 European countries, USA, Canada, Australia and New Zealand: PRO analysis plan, PRO analysis, report, FDA submission, manuscripts
Literature review in osteoarthritis and rheumatoid arthritis
Development of patient satisfaction measure for pain in osteoarthritis
Development and validation of a side effects module in rheumatoid arthritis
Cost-utility analysis in rheumatoid arthritis
Economic analysis in rheumatoid arthritis
Combination therapy analysis in rheumatoid arthritis
Methodological research in rheumatoid arthritis: evaluation of placebo effects in PRO measures; derivation of pooled indices for defining response to treatment; cross-walk of SF 36 to utilities
Validation of a patient osteoarthritis diary
Indirect comparison of DMARDs in treatment of rheumatoid arthritis
Mixed treatment comparison, of cox-1 and cox-2 inhibitors for rheumatoid and osteoarthritis
Mode of administration validation study for an electronic diary in back pain
Translation and validation of an osteoarthritis diary
Development and cognitive debriefing on a patient global response to treatment measure in osteoarthritis pain
Literature review, meta-analysis, development of core economic model and budget impact model for treatment of juvenile idiopathic arthritis
Mixed treatment comparison of products for the treatment of osteoarthritis of the knee
Literature review of PROs and endpoints in osteoarthritis
Development of an economic model in juvenile idiopathic arthritis
Competitive assessment and burden of illness study in osteoarthritis
Development of an FDA PRO briefing document for treatment in rheumatoid arthritis
Systematic review and indirect comparison in treatment of rheumatoid arthritis
Meta-analysis of joint structural deterioration in DMARD-IR rheumatoid arthritis patients
Mixed treatment comparison of efficacy and safety in rheumatoid arthritis
Gap analysis and review of PRO measures in osteoarthritis
NICE submission in rheumatoid arthritis
Consulting on PROs in an observational study in rheumatoid arthritis
Face and content validation of a tiredness item in rheumatoid arthritis
PRO instrument review and assessment strategy in osteoarthritis
Cost effectiveness analysis and budget impact model adaptation to Portugal for treatment in rheumatoid arthritis
Utility study in rheumatoid arthritis
Literature search, data extraction and report for rheumatoid arthritis
Manuscript for treatment in rheumatoid arthritis
NICE submission on treatment in rheumatoid arthritis
Endpoint review in osteoarthritis
Review of an economic model to assess utility requirements for treatment in rheumatoid arthritis
Literature review and recommendations for treatment in rheumatoid arthritis
Communications, including manuscript, on a mixed treatment comparison for treatment in rheumatoid arthritis
Measuring indirect/societal costs of morning stiffness in patients with rheumatoid arthritis
Review of European HTA requirements for treatment in rheumatoid arthritis
Indirect comparison for treatment in patients with rheumatoid arthritis
Meta-analysis in rheumatoid arthritis

Other

Literature review and comprehensive PRO assessment strategy in non-neuropathic pain
Environmental scan / marketing study in acute and chronic pain
Development of a budget impact model for a long-acting pain medication
Meta-analysis of the safety and efficacy of a cox-2 pain medication
Review of pain studies in a rare genetic disorder with pain as a primary outcome and the development of value arguments for payers in Europe and Australia
Consulting on collection of cost data in pain
Preparation of an FDA briefing document to support the use of the Brief Pain Inventory (and modifications) in clinical trials to support labeling claims
Analysis of FDA and EMEA PRO claims in pain and inflammation
Patient satisfaction instrument development / assessment strategy in acute and chronic pain
Literature review and assessment strategy on functional scales in pain
Literature review on PRO measures in pelvic pain and recommendations for measures in clinical trials
Communication planning on PROs in ocular pain and quality of life in glaucoma
Literature review of patient satisfaction assessments in acute and chronic pain
Review of ad hoc PRO assessment strategies in pain treatment
Literature review on PRO measures in fatigue and pain in rheumatic disease
Literature review on PRO measures in chronic pain
Cognitive debriefing of patient diary for use in clinical trial of long-acting pain medication
Development and validation of a diagnostic tool for patient management in ophthalmic pain
Development of a structural equation model linking demographic characteristics, prior resource use, satisfaction, and expectations to pain relief and intention to comply in chronic pain patients
Patient interviews and exploratory analysis of minimal clinically important difference on a pain visual analog scale
Consulting on study design and PRO analysis in clinical trials in pain
Gap analysis and review of PRO measures in neck pain
Systemic literature review in pain chronification
Participation in chronic pain advisory board
Validation of a pain diary data for an opioid analgesic
A mode of administration validation study for an electronic diary in back pain

Respiratory System Disease

Allergic rhinitis

Focus groups assessing patient experience with nasal spray in allergic rhinitis
Regulatory support for the Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
Validation of the preference module of the EARNS-Q in allergic rhinitis
Communication on the development of the EARNS-Q in allergic rhinitis
Demonstrating value of sublingual treatment of allergic rhino-conjunctivitis

Asthma

Development of a conceptual model and conceptual framework for the measurement of asthma control
Literature review and communications on treatment satisfaction questionnaires in asthma and other chronic respiratory diseases
Consultancy on obtaining FDA approval of a treatment satisfaction claim for a new asthma treatment
PRO consulting on an asthma clinical program for labeling
Submission to National Institute for Health and Clinical Excellence for treatment for adult and pediatric asthma
Validation of the Childhood Asthma Control Test (CACT)
Complementary analyses on the CACT
Validity assessment of the CACT faces in Japanese and Hong Kong Chinese children
Critical review of PRO instruments and strategic recommendations
Cognitive debriefing of the Asthma Symptom and Control Diary (ASCD)
Cognitive debriefing to confirm the face and content validity of Asthma Secondary Endpoint Questions for a consortium
Development of a symptom-based PRO instrument for adults and adolescents with asthma

Chronic obstructive pulmonary disease

PRO strategy support for combination treatment in COPD
FDA support for the Cough and Sputum Assessment Questionnaire (CASA-Q) in COPD, including review of PRO dossier
Communications and protocol support for the CASA-Q
Development of a user manual for the CASA-Q
Support at investigator meetings for the CASA-Q
Scientific Committee on the development of a questionnaire evaluating the handicap of COPD patients
Validation of a questionnaire to assess handicap in COPD
Consultancy on health economic and outcomes research to maximize the value of COPD treatment
Validation of a patient diary to assess symptoms of COPD
Develop and validate e-PRO for "well-controlled" days in COPD
Support for submission to FDA on e-PRO for "well-controlled" days in COPD
Systematic literature review on the concept of COPD stability or control
Literature review and recommendations on activities of daily living in COPD
Indirect comparison for COPD treatments
Value Dossier for vaccine to prevent COPD exacerbations
Consultancy on optimal design and analysis of health economic outcomes in clinical trials in COPD
Analyses to build the evidence base of beneficial effects of a treatment of COPD exacerbations and other outcomes
Literature review and analysis of definitions of acute exacerbation in COPD
Development of a manuscript for treatment in COPD
Communications in COPD
Mixed treatment comparison in COPD
Validation of the Lung Function Questionnaire for COPD
Meta-analysis for treatment in COPD

Cystic Fibrosis

Gap analysis and strategic recommendations for the Cystic Fibrosis Questionnaire-Revised
Evidence synthesis for antibiotics in cystic fibrosis
Literature review on the relationships between satisfaction and adherence in cystic fibrosis
Support on the communication of the Treatment Satisfaction Questionnaire for Medication results in cystic fibrosis
Consultancy and preparation at the European Cystic Fibrosis Society congress

Other

Validation study of a questionnaire assessing the impact on parents of a child's hospitalisation due to bronchiolitis
Economic and PRO trial in chronic sinusitis
Descriptive study of the impact of a child's bronchiolitis hospitalization on parents in UK, Italy, Spain, Netherlands and Germany (including a linguistic validation of the questionnaire developed in French)
Literature review in cough and cold over the counter medications
Demonstrating value of sublingual treatment of allergic rhino-conjunctivitis
Analysis of costs of infection by respiratory syncytial virus
Selection of a validated dyspnea questionnaire
Congnitive interviewing about cold symptom PRO questions in pediatric patients
Value dossier for treatment for respiratory syncytial virus
Consulting on the linguistic validation into US English of the Impact Bronchiolitis Hospitalisation Questionnaire
Development of a user manual for Impact of Bronchiolitis Hospitalization Questionnaire in Respiratory Syncitial Virus
The impact of the affective dimension of dyspnea on quality of life using the Multidimensional Dyspnea Profile

Gastrointestinal Disease

Constipation

Development and validation of a multiattribute system for patients’ assessment of constipation
Instrument development / assessment strategy in chronic idiopathic constipation
Instrument development / assessment strategy in functional constipation
Validation of the Diarrhea Symptom Assessment Measure
Budget impact model in opioid-induced constipation (OIC)
Review of patient diaries and PRO questionnaires for evaluating OIC
Patient interviews, endpoint model, conceptual framework in OIC
Instrument development in OIC
Cognitive debriefing of quality of life questionnaire and patient assessment of symptoms in OIC
Development of a PRO strategy for pediatric chronic constipation
Development of a manuscript on the PAC-QoL results (Quality of Life in Constipation)
Development of a manuscript on PRO in pediatric constipation
Development of symptom and HRQL PRO instruments for pediatric patients with chronic constipation
Advisory Board on the PRO strategy for phase III program for treatment in OIC
Cognitive debriefing of a PRO measure of pediatric CC and IBS-C
Interviews of patients completing clinical trial in chronic constipation and IBS-C to understand their experiences

Inflammatory disease

Literature review of quality of life in Crohn’s Disease
Literature review of pharmacoeconomics in Crohn’s Disease
Database analysis in Crohn’s Disease and ulcerative colitis
Early phase Markov model in Crohn’s Disease (pricing simulation)
Psychometric validation of a quality of life questionnaire in Crohn’s Disease
Submission to Scottish Medicines Consortium for treatment for ulcerative colitis
Development and validation of satisfaction with biological treatment questionnaire in Crohn's
Manuscript on the development of a questionnaire on satisfaction with biological treatment in Crohn's disease
PRO gap analysis and PRO dossier development in ulcerative colitis and Crohn's disease
Consultancy on SPACE questionnaire in Crohn's disease
Psychometric validation of a questionnaire in Crohn's disease in Canada, Portugal and Greece
Study concept for an observational study in severe Crohn's disease using a patient satisfaction questionnaire
Literature review and recommendations for treatment in Crohn's Disease
PRO review for Crohn's Disease

Irritable bowel syndrome

Review of FDA correspondence and recommendations for PRO measurement strategy in IBS D
Instrument development / assessment strategy in IBS
Prospective, naturalistic trial in IBS: literature review, protocol, CRA / investigator training, analysis plan, analysis
Development and validation of a primary endpoint to support an indication in IBS D
Literature review of PROs and endpoints in IBS
Design, conduct and analysis of focus groups in IBS
Analysis and a report for IBS-C interviews (to include evidence of saturation)
Development of a PRO strategy for pediatric IBS with constipation
Development of a manuscript on PRO in pediatric IBS
Consulting for PRO for treatment in patients with IBS
Development of symptom and HRQL PRO instruments for pediatric patients with IBS-C
Development of a PRO questionnaire to assess symptoms and burden of IBS in different languages (France, UK and Spain)
Development of a PRO Dossier in IBS-C
Communications in pediatric IBS-C
Psychometric validation for newly developed PRO in IBS-D
Cognitive debriefing of a PRO measure of pediatric chronic constipation and IBS-C
Interviews of patients completing clinical trial in chronic constipation and IBS-C to understand their experiences
Psychometric validation for a newly-developed PRO instrument in IBS-D
Development of PRO questionnaire in 3 languages in IBS

Upper GI disorders

Instrument development / assessment strategy in upper gastrointestinal disorders
Development and validation of a symptom checklist and diagnostic tool for patient management in upper GI disorders
Development of a symptom checklist in upper GI disorders
Development of a short form questionnaire in gastro-esophageal reflux disease
Development of a PRO questionnaire to assess symptoms and burden of dyspepsia in different languages (France, UK and Spain)
Consultancy on PRO questionnaire in dyspepsia

Other

Observational study of colostomy patients: study design, data collection, observational study, report
Foundation research in digestive problems
Development of a briefing packet for an FDA Type C meeting for a primary endpoint in functional dyspepsia
Clinical trial endpoint review, recommendations, and FDA PRO submission package in hereditary angioedema
Hereditary angioedema ad hoc strategic consulting
Interviews for language validation of the Ascites Impact Questionnaire
Market access evidence assessment for a new orphan drug for short bowel syndrome
Review of a protocol and protocol amendment for a phase II gastroparesis study which includes the CGSI as a primary endpoint
Burden of illness literature review in opioid-related bowel dysfunction
Literature review of the management of post-operative ileus in Europe
Burden of illness study of post-operative ileus in Europe
Development and validation of a PRO measure in pediatric patients with eosinophilic esophagitis
Qualitative interviews to develop a symptom measure in adult patients with eosinophilic esophagitis
Endpoint review and recommendations in hereditary angioedema
Update to FDA submission package in hereditary angiodema
Cognitive debriefing of a PRO questionnaire in hereditary angioedema
Analysis of qualitative data to create a symptom measure esonophilic esophagitis and cognitive debriefing interviews
Cognitive debriefing of a symptom measure of gastroparesis in diabetics
Conceptual model of the impact in the elderly of community-acquired Clostridium Difficile diarrheoa

Endocrinology / Metabolic Disorders

Diabetes

Exploratory focus groups in patients with type 2 diabetes in the US
PRO instrument review in diabetes
Focus groups in lower extremity edema in type 2 diabetes
International Diabetes Quality Of Life and Economic Study (IDQOLES)
Development of symptom and quality of life questionnaires for diabetic neuropathy
Development of quality of life questionnaires for diabetic foot ulcers
Assessment of cost and quality of life impact of diabetic foot ulcers
Assessment of quality of life impact on non-insulin dependent diabetes mellitus patients
Assessment of the impact of quality of life and attitudes toward the addition of insulin in the treatment regimen of non-insulin dependent diabetes mellitus patients
Development and validation of a patient satisfaction questionnaire in diabetes management
Development of a health outcomes value pack
Focus groups in patients with type 2 diabetes
Gap analysis, endpoint model and conceptual framework and claims language for patients with type 2 diabetes
Meta-analysis on self management of types 1 and 2 diabetes
Review of an FDA submission package for satisfaction claims for diabetes
FDA claim strategy and endpoint review in diabetes-related ophthalmological disorder
Submissions to Scottish Medicines Consortium for treatment for type 2 diabetes
Cognitive debriefing for Perceptions About Medications-Diabetes questionnaire (PAM-D)
Critical review of existing economic models, development of economic and budget impact models in type 2 diabetes
Competitive analysis and burden of illness in peripheral diabetic neuropathy
Analysis of cost of current treatments in type 2 diabetes
Literature review of PROs and endpoints in peripheral diabetic neuropathy
Submission to the National Institute for Health and Clinical for treatment in type 2 diabetes
Assessment of suitability of a patient diary for type 2 diabetes symptoms for European Phase II clinical trials
Costing pre-diabetes care in the USA
Gap analysis to identify the most responsive diabetes PRO measure for clinical trials
Gap analysis and strategic recommendation for PRO and market access studies in diabetic peripheral neuropathy
Consulting on a market research study on patient perceptions of pre-filled insulin pens
Indirect comparison in type 2 diabetes
Identification of PRO instruments to assess irritability, energy, sexual dysfunction, and overall perceived control in patients with type II diabetes
Review of PRO measures in diabetic macular edema
Educational program evaluation in type II diabetes
Validation of a hypoglycemia questionnaire in type II diabetes
Payor strategy analysis of type II diabetes literature search results
Systematic review of two treatments in type II diabetes
Development of a PRO measure of hypoglycemia, weight gain, tolerability and compliance in type II diabetes
Demonstrating the burden of hypoglycemia and weight gain via Quality of Life data from a clinical trial in diabetes
Analysis of PRO data from type II diabetes clinical trials, including dose ranging study
Presentation of cost-effectiveness model in type II diabetes to client team
Manuscript for patient perceptions of prefilled insulin delivery devices
Literature review for a HTA submission in diabetes mellitus II
Interview study of walking pain among patients with diabetic peripheral neuropathy
Cognitive debriefing of a symptom measure of gastroparesis in diabetics
Publications for two treatments in type II diabetes

Phenylketonuria

Development and validation of questionnaires assessing impact of phenylketonuria on a child's quality of life and burden on caregiver
Review and refinement of a cost-effectiveness model for an orphan drug in phenylketonuria
Value dossier update for treatment in phenylketonuria
Update of a manuscript on the cost of managing phenylketonuria
Communications on questionnaires in phenylketonuria
Financial impact of living with phenylketonuria

Other

Development and validation of a PRO instrument for pediatric patients with growth hormone deficiency (PGHD)
Collecting normative data in France for the Quality of Life in Adult Growth Hormone Deficiency Assessment(QoL-AGHDA) questionnaire
PRO endpoint review in multinodal goiter
Qualitative data analysis and FDA support for multinodal goiter
Systematic review and evidence synthesis for treatment for Fabry's disease
Submission to Scottish Medicines Consortium for treatment for secondary hyperparathyroidism in end stage renal disease
Pricing and reimbursement dossier for product in Niemann-Pick disease type-C
Gap analysis of PRO questionnaires for obesity trials
Psychometric validation of the Pictorial Spasmodic Torticollis Rating Scale (P-STRS)
Development of an instrument to assess subject perception of gastric bands in obesity
Strategic literature review to select PRO for pediatric growth hormone deficiency trial
Pilot utility elicitation study in end stage renal disease
Global value dossier for the treatment of Fabry disease
Development of a PRO questionnaire on well-being for use in the general population

Musculoskeletal Disease

Ankylosing spondylitis

Indirect / mixed treatment comparison and cost effectiveness analysis of two treatments for ankylosing spondylitis
Manuscript on the cost-effectiveness analysis of treatment of ankylosing spondylitis in Norway
Interactive cost-effectiveness model for the treatment of ankylosing spondylitis
Survey to document management of work disability in polyarthritis and ankylosing spondylitis

Fibromyalgia

Gap analysis of epidemiology, economics and PRO data in fibromyalgia
Endpoint review of fatigue and functioning in fibromyalgia
Development of a conceptual framework for the measurement of fatigue in patients with fibromyalgia
Patient assessment of the relevance of fibromyalgia questionnaires
Development of multi-lingual versions of a questionnaire to assess the burden of fibromyalgia
Development of a screening tool in fibromyalgia to raise awareness of the disease
Literature review of PROs and endpoints in fibromyalgia
Competitive assessment and burden of illness in fibromyalgia
Pilot testing interviews in fibromyalgia fatigue
Communication on the development of fibromyalgia screening tool
Prepare article on development in 4 languages of a questionnaire to assess the burden of fibromyalgia on patient daily activities
Validation of the fatigue VAS and Jenkins Sleep Scale for fibromyalgia
Manuscript on the use of the Jenkins Sleep Scale for fibromyalgia
Manuscript on the validation of a PRO instrument for fibromyalgia fatigue

Osteoporosis

Development and validation of screening tool to detect / predict non-adherence to osteoporosis treatment in postmenopausal women - the ADEOS questionnaire(ADhErence to OSteoporosis treatment)
Meta-analysis and update of economic model in osteoporosis
Indirect comparison of bisphosphonates in the treatment of post-menopausal osteoporosis
Patient focus group for osteoporosis
Exploring patient compliance to support osteoporosis treatment use in the face of competition
Communication on the validation of the ADEOS questionnaire to various clinical and outcomes congresses
Analysis of longitudinal data from the ADEOS questionnaire
Linguistic validation of the ADEOS questionnaire
Patient interviews in medication persistence
Abstract on patients’ medication experiences for submission to ISPOR and clinical congresses
Cost-effectiveness analysis for treatment of osteoporosis
Development of study concept on adherence to osteoporosis treatment
Evaluation of the ADEOS questionnaire in clinical practice
Communication on osteoporosis for the ECCEO congress
Indirect comparison of treatment on non-vertebral fractures

Rheumatoid and osteoarthritis

Rheumatoid arthritis clinical trial in 13 European countries, USA, Canada, Australia and New Zealand: PRO analysis plan, PRO analysis, report, FDA submission, manuscripts
Literature review in osteoarthritis and rheumatoid arthritis
Development of patient satisfaction measure for pain in osteoarthritis
Development and validation of a side effects module in rheumatoid arthritis
Cost-utility analysis in rheumatoid arthritis
Economic analysis in rheumatoid arthritis
Combination therapy analysis in rheumatoid arthritis
Methodological research in rheumatoid arthritis: evaluation of placebo effects in PRO measures; derivation of pooled indices for defining response to treatment; cross-walk of SF 36 to utilities
Validation of a patient osteoarthritis diary
Indirect comparison of DMARDs in treatment of rheumatoid arthritis
Mixed treatment comparison of cox-1 and cox-2 inhibitors for rheumatoid and osteoarthritis
Mode of administration validation study for an electronic diary in back pain
Translation and validation of an osteoarthritis diary
Development and cognitive debriefing on a patient global response to treatment measure in osteoarthritis pain
Literature review, meta-analysis, development of core economic model and budget impact model for treatment of juvenile idiopathic arthritis
Mixed treatment comparison of products for the treatment of osteoarthritis of the knee
Literature review of PROs and endpoints in osteoarthritis
Development of an economic model in juvenile idiopathic arthritis
Competitive assessment and burden of illness study in osteoarthritis
Development of an FDA PRO briefing document for treatment in rheumatoid arthritis
Systematic review and indirect comparison in treatment of rheumatoid arthritis
Meta-analysis of joint structural deterioration in DMARD-IR rheumatoid arthritis patients
Mixed treatment comparison of efficacy and safety in rheumatoid arthritis
Gap analysis and review of PRO measures in osteoarthritis
NICE submission in rheumatoid arthritis
Consulting on PROs in an observational study in rheumatoid arthritis
Face and content validation of a tiredness item in rheumatoid arthritis
PRO instrument review and assessment strategy in osteoarthritis
Cost effectiveness analysis and budget impact model adaptation to Portugal for treatment in rheumatoid arthritis
Utility study in rheumatoid arthritis
Literature search, data extraction and report for rheumatoid arthritis
Manuscript for treatment in rheumatoid arthritis
NICE submission on treatment in rheumatoid arthritis
Endpoint review in osteoarthritis
Review of an economic model to assess utility requirements for treatment in rheumatoid arthritis
Literature review and recommendations for treatment in rheumatoid arthritis
Communications, including manuscript, on a mixed treatment comparison for treatment in rheumatoid arthritis
Measuring indirect/societal costs of morning stiffness in patients with rheumatoid arthritis
Review of European HTA requirements for treatment in rheumatoid arthritis
Indirect comparison for treatment in patients with rheumatoid arthritis
Meta-analysis in rheumatoid arthritis
PRO review of two clinical trial protocols in knee osteoarthritis and microfractures

Chronic low back pain

Gap analysis of epidemiology, economics and PRO data
Development and validation of a responder index
Mode of administration validation study for an electronic diary
Gap analysis and strategic recommendation for PRO and market access studies
Burden of illness
Gap analysis and review of PRO measures
Development of a PRO measurement strategy and a value demonstration strategy
Content validation of the Roland Morris Disability Questionnaire and testing of a personal digital assistant-administered version of a pain rating scale in chronic low back pain
Development of a PRO measure of stiffness in acute low back pain

Other

Endpoint review and gap analysis in bone healing
PRO and costs literature review in systemic lupus erythematosus
Recommendation for PRO and HE endpoints for a phase III trial in systemic lupus erythematosus
Strategic assessment of the reimbursement, HTA and market access potential for a treatment in systemic lupus erythematosus

Ophthamology

Cataract

Consulting in the development of a satisfaction questionnaire for cataract surgery
Interviews with patients receiving ocular implants
Communication on the health-related quality of life of patients after cataract surgery
Consulting and publication on the development of the Freedom from Glasses Value Scale (FGVS)
Scoring and validation of the FGVS questionnaire in an observational study of intraocular lenses in cataract and presbyopia surgery
Recommendations for PRO measures to assess perceived benefit of multifocal intraocular lenses
Literature review and manuscript on PRO instruments for cataract surgery
Etiology and meta-analysis in treatment for posterior cacular opacification
Meta-analysis of cataract treatment procedures in Asia

Dry eye

Choice of a PRO measure to assess symptom relief in dry eye
Literature review and manuscript on PRO instruments in dry eye
Development of a health-related quality of life instrument for dry eye – the Impact of Dry Eye in Everyday Life (IDEEL)
Development of a user manual for the IDEEL
Manuscript describing the development of the IDEEL
Development and validation of a PRO instrument for dry eye
Consulting on composite endpoint in dry eye
Communication on the development of impact of dry eye for IDEEL

Glaucoma

Patient interviews of glaucoma treatment characteristics and outcomes: unmet patient needs and value drivers
Psychometric validation of the Eye Drop Satisfaction Questionnaire (EDSQ) in glaucoma
Manuscript on compliance and the EDSQ in glaucoma
Communication planning on PROs in ocular pain and quality of life in glaucoma
Obtaining and formatting two PRO questionnaires for inclusion in a marketing study in patients with glaucoma
PRO measurement strategy for a device in glaucoma

Macular degeneration

Literature review to support the use of the NEI-VFQ-25 PRO instrument in age-related macular degeneration
Assessment of validation status of the NEI-VFQ25 in age-related macular degeneration
FDA claim strategy and endpoint review of NEI-VFQ in age-related macular degeneration
Development and validation of a screener and health-related quality of life module in macular degeneration
Literature review, reanalysis of health-related quality of life data from a clinical trial, and recommendation for further PRO assessment in age-related macular degeneration
Meta-analysis of risk factors for the development of late, age-related macular degeneration
Cross-sectional burden of illness study for age-related macular degeneration

Other

Development and validation of a diagnostic tool for patient management in ophthalmic pain
Development of a PRO questionnaire to assess (dis)comfort after micro incision vitrectomy surgery
FDA claim strategy and endpoint review of NEI-VFQ in diabetic macular edema and retinal vein occlusion
Development of briefing document for NEI-VFQ in retinal vein occlusion
Content validation of the NEI-VFQ25 in diabetic macular edema and retinal vein occlusion
Evaluation of focus groups, item generation, cognitive debriefing and analysis plan in atopic keratoconjunctivitis
Development and validation of a diagnostic tool for patient management in ocular surface disease
Review of the subjective eyelid swelling scale
Analysis and reporting on completed interviews in eyelid swelling
Content validation of the NEI VFQ25 with retinal vein occlusion patients
Psychometric validation of the Vision-Quality of Life questionnaire in uveitis patients
Development and validation of a PRO instrument for pterygium
Review of PRO measures in diabetic macular edema
Literature review on burden of astigmatism
Manuscript on NEI VFQ in retinal vein occlusion
Exploratory interviews in retinitis pigmentosis to confirm treatment benefits
Assessment of the burden of astigmatism in a French observational study
Manuscript and poster on qualitative research to support PRO instrument development in atopic keratoconjunctivitis
Meibomian gland dysfunction gap analysis and consultancy

Urology

Overactive bladder / Urinary incontinence

Review of screening tools in overactive bladder (OAB)
Review of EMEA-approved claims in urinary incontinence and strategic consulting for a claim
Development of a briefing package relation to the concept of urinary urgency
Prepare for and attend FDA meeting related to claim for urinary urgency treatment
HTA review and analysis for urinary incontinence
Review of data and promotional claim strategy in overactive bladder
Cognitive debriefing and psychometric validation PRO questionnaires for urinary urgency
Development of a tool for ranking the importance of OAB symptoms and the achievement of treatment goals (Self-Assessment Goal Attainment - SAGA)
Worldwide advisory board on the use of SAGA in OAB
Development of a regulatory dossier and claims assistance in idiopathic overactive bladder with urinary urge incontinence
Demonstrating the importance of treatment for nocturia: support development and review of evidence for a dossier for submission to SEALD (FDA)
Recommendations for obtaining EMEA claims on the Incontinence Quality of Life Questionnaire (I-QOL) and the Kings Health Questionnaire
Manuscript and other communications on the content validity of a patient bladder diary and questionnaire
Health outcomes appendices for phase III neurogenic overactive bladder studies
Value dossier for a treatment in stress urinary incontinence
Disease progression study of OAB in Sweden
Manuscript on the symptom score questionnaire in painful bladder/interstitial cystitis
Manuscript on psychometric validity of I-QOL in idiopathic OAB
Advisory Board for a clinical screening tool for overactive bladder in multiple sclerosis
Regulatory consulting for PRO strategy for Type A FDA meeting in nocturia
Development of a report on the content validity and psychometric properties of the I-QOL for use in EMA submissions
Development and validation of a screening tool for overactive bladder in multiple sclerosis patients
Development of health outcomes appendices in idiopathic overactive bladder

Other

Literature review in interstitial cystitis
Development and validation of a PRO questionnaire in interstitial cystitis
Cognitive debriefing interviews in Europe for SAGA questionnaire in lower urinary tract symptoms
PRO literature review in benign prostatic hyperplasia
Development and validation of a sexual dysfunction symptom scale in benign prostatic hyperplasia
Systematic review of treatment in ureterolithiasis

Women's Health

Female sexual desire

PRO endpoint review for treatment for hypoactive sexual desire disorder
Validation of the Decreased Sexual Desire Screener (DSDS) in hypoactive sexual desire disorder (HSDD) in Japan
Literature review and recommendations on PRO instruments in female sexual desire to assess loss of sexual desire after hysterectomy

Menopausal symptoms

Development of a PRO instrument for measuring mood swings and sleep problems resulting from vasomotor symptoms of menopause
Validation of the Hot Flash Instrument in three modes of administration
Pilot testing of a paper hot flash diary and questionnaire
Development of a briefing document for measuring impact of menopausal hot flashes

Other

PRO endpoint review in contraceptives
Review and research on premenstrual dysphoric disorder (PMDD)
Support of PRO endpoint dossier for regulatory submission in PMDD
Communications on symptoms and impact of PMDD
Design and pilot testing of an ePRO in uterine fibroids
Regulatory and statistical support for FDA claim for treatment for uterine fibroids
Meta-analysis of a drug for recurrent miscarriage
Regulatory consulting on dysmenorrhoea for FDA Type C meeting
Visual aid and communication for a drug in pelvic organ prolapse
Consultancy on endpoint assessment in dysmenorrheal
Endpoint review and regulatory support on the suitability of two PRO instruments to support labeling claims in endometriosis
Validation of an ePRO endpoint and regulatory dossier to support claims in endometriosis
Development and validation of satisfaction and tolerability instrument to compare intrauterine device versus oral contraceptives
Development of a PRO for breast pain/pressure and vaginal bleeding/spotting for patients on hormone replacement therapy
Development of an ePRO for adult and adolescent dysmenorrhea
Development of a PRO strategy in oral contraceptives and gynecological therapies
Validation of ePRO endpoints to support product labeling claims in endometriosis
Development of a PRO for breast pain and pressure for patients on hormone replacement therapy
Development of a PRO for vaginal bleeding and spotting for patients on hormone replacement therapy
Development of a PRO for breast pain/pressure and vaginal bleeding/spotting for patients on HRT

Hematology

Anemia

Value dossier for treatment for chemotherapy-induced anemia
Assessment of cancer patients’ satisfaction with anemia treatment and management
Value dossier for treatment for chemotherapy-induced anemia
Psychometric validation of a satisfaction questionnaire on the use of delivery device for treatment for chemotherapy-induced anemia
Support for interpretation of PRO data from observational study of delivery device for treatment for chemotherapy-induced anemia
Generation of economic evidence for erythropoietin use in cancer
Development of economic model for erythropoietin use in cancer
Psychometric validation of a satisfaction questionnaire to assess use of pen system for administration of erythropoietin
Linking of cost-utility model with a budget impact model for erythropoietin use in cancer
Value dossier for treatment for anemia in patients with chronic kidney disease
Consulting on PROs in anemia in patients with chronic kidney disease
Consulting for iron treatment in anemia
Literature review and recommendations on PRO strategy for the clinical development of a therapeutic agent in anemia in patients with chronic kidney disease

Hemophilia

Validation and reduction of QUAL HEMO questionnaire for teenagers with hemophilia
Psychometric validation of hemophilia PRO questionnaire
Exploring the potential cost and HRQL benefits of products in hemophilia: literature reviews, models and recommendations
Development of a compliance questionnaire in hemophilia
Literature review in hemophilia A
Literature review in hemophilia B
Analysis of PRO data from a phase III clinical trial in hemophilia A

Iron overload

PRO strategy for reimbursement in Europe for iron overload
Development of a PRO augmentation in iron overload
Utility elicitation in iron overload
Submission to Scottish Medicines Consortium for treatment for iron overload
Submission to AWMSG for treatment for iron overload
Analysis and communication of PRO data from a clinical trial in iron overload patients receiving iron chelation therapy
Consultancy on assessing satisfaction with phlebotomy
Modification of satisfaction questionnaire for patients receiving phlebotomy or oral therapy
Consulting on a manuscript on PRO and market research in hereditary hemochromatosis and phlebotomy

Other

Value dossier for treatment for chemotherapy-induced neutropenia
Burden of illness research in immune thrombocytopenic purpura in Europe
Publications describing validation of PRO instruments for use in end-stage renal disease patients undergoing chronic hemodialysis
Development of the HEMO model: Hemophilia Economic Model of Outcomes in Thailand, Mexico, and the Philippines
Qualitative literature and instrument review in atypical Hemolytic Uremic Syndrome
Development and validation of a PRO measure in von Willebrand's disease
PRO endpoint model for pre-dialysis population for the treatment of hyperphosphatemia
Systematic literature review to inform clinical trial validation activities for a new PRO in von Willebrand's disease

Nephrology

Kidney Disease

Meta-analysis of clinical trial data and PRO endpoints for treatment for anemia in patients with chronic kidney disease
Value dossier for treatment for anemia in patients with chronic kidney disease
Consulting on PROs in anemia in patients with chronic kidney disease
Meta analysis of epoietin alfa in chronic kidney disease
Submission to Scottish Medicines Consortium for treatment for secondary hyperparathyroidism in end stage renal disease
Publications describing validation of PRO instruments for use in end-stage renal disease patients undergoing chronic hemodialysis
Meta-analysis of clinical trial data and PRO endpoints for treatment for anemia in patients with chronic kidney disease
Value dossier for treatment for stages III, IV, V renal disease
Qualitative literature and instrument review in atypical hemolytic uremic syndrome
Development of a PRO measure in metastatic renal cell cancer
Value dossier for a treatment for post-liver transplant pediatric patients
Qualitative interviews, conceptual model and strategic consulting on autosomal dominant polycystic kidney disease
PRO endpoint model for pre-dialysis population for the treatment of hyperphosphatemia
Logistical costs of changing treatment in chronic kidney disease
Literature review and recommendations on PRO strategy for the clinical development of a therapeutic agent in anemia in patients with chronic kidney disease

Infectious Disease

Chronic Hepatitis

Systematic literature review of the clinical literature for hepatitis B
Submission to National Institute for Health and Clinical Excellence for treatment for hepatitis B
Submission to Scottish Medicines Consortium for treatment for hepatitis B
Conceptual model for PROs in patients with hepatitis C
Literature research in chronic hepatitis C
Biomarkers for treatment of hepatitis C

Fungal infections

Development of core economic model with adaptations for treatment of invasive aspergillosis (US, UK, NL)
Cost-effectiveness and hospital budget impact analysis of treatment of invasive aspergillosis in Germany
Economic evaluation of empiric treatment of fungal infections in the UK and Italy
Economic evaluation of prophylaxis of fungal infections in neutropenic patients and allergenic HSCT patients in the UK and Netherlands
Value message slide deck and value dossier for treatment for fungal infections

Herpes Zoster

Literature review and recommendations on patient reported outcome measures for patients with herpes zoster and / or post-herpetic neuralgia
Systematic literature review of herpes zoster vaccine
Economic evaluation of a varicella-zoster vaccine in the Netherlands
Impact on Quality of Life research study for patients with herpes zoster
PRO literature review, instrumentation, gap analysis and recommendations for patients with herpes zoster and post-herpetic neuralgia
Communications for ISPOR/ISOQOL conferences on PRO research in zoster vaccine
Communications for British Pain Society Annual Scientific meeting in herpes zoster
Advisory Board related to the cost-effectiveness analysis of a herpes zoster vaccine

Human Immunodeficiency Virus / Acquired immune deficiency syndrome

Development of a value-based budget impact tool for HIV treatment
General consultancy on PRO endpoints in HIV / AIDS trials
Development and validation of a PRO instrument of tolerability in HIV treatment
Consulting on study documents and development of statistical analysis plan for psychometric validation of a PRO instrument assessing tolerability in HIV treatment
Development of an expert report and attendance at FDA meeting on tolerability in HIV treatment
Concept definitions for translation of HIV treatment tolerability index
Review of economic model and submission to Scottish Medicines Consortium for HIV treatment
Value dossier for HIV treatment
Identification of PRO questionnaires for two phase 2B clinical trials in HIV
Analysis of PRO data from a clinical trial in HIV-1
Consultancy and preparation of a manuscript on the development of the HIV Patient Symptom Profile (HIV/PSP)
Budget impact tool of a drug for naïve HIV patients
Literature review of the epidemiology and burden of illness in HIV-related neuropathy
Manuscript on meta-analysis for treatment in HIV
Consulting on a multinational case-control study on the impact of side effects on HIV patients' quality of life
Preliminary psychometric validation of the HIV PSP questionnaire using the UK SWITCH study data
Pilot testing study of PRO questionnaire in HIV

Human papillomavirus

HPV burden of disease study
Health economic evaluation for an HPV vaccine
Analysis to support reimbursement for HPV vaccine in patient sub-groups
Value dossier for an HPV vaccine
HPV vaccine cost-effectiveness analysis for Spain
Submission to Joint Committee on Vaccination and Immunisation for HPV vaccine
Manuscript on a German cost effectiveness analysis of an HPV vaccine
Manuscript of the Spanish cost effectiveness model in HPV vaccine
Analysis of the psychosocial impact of HPV in the UK
Review of economic models of HPV vaccine in adolescent females and young women
Analysis and communication for psychosocial impact of HPV-related diseases among women

Influenza

Impact of influenza vaccination on absenteeism in an occupational setting in Malaysia (cost effectiveness and cost benefit analysis)
Cost effectiveness interactive model of an adjuvanted vaccine in influenza in an elderly population and adults at risk in France
Adaptation of the adjuvanted economic model for influenza vaccine to Belgium
Adaptation of the adjuvanted influenza vaccine cost effectiveness model for Germany, Austria, Italy and Mexico
Update of a value dossier for an influenza vaccine
Modeling influenza coverage rates
Development of a specific acceptability questionnaire for influenza vaccination
Analysis of the Vaccines Perception Injection Questionnaire in a phase III clinical trial in influenza vaccination
Value dossiers for influenza vaccines in unprimed paediatric population and primed school age population (intranasal delivery).
Systematic literature review and gap analysis for intranasal influenza vaccines for product economic positioning in pediatric populations
Value dossiers for intranasal influenza vaccines in pediatric populations
Prepare epidemiology sections for influenza product economic positioning reports for pediatric and school age patients
Prepare value pack slide set for pediatric and school-age influenza review
Cost-effectiveness analysis of treatment for influenza
Research into epidemiology and economic burden of influenza B in Japan
Systematic literature review and gap analysis for quadrivalent influenza vaccine for product economic positioning
Health economic dossier for quadrivalent influenza vaccine
Development and content validity testing of patient-reported outcome questions developed to measure pediatric cold symptoms

Measles / mumps / rubella / varicella vaccine

Dynamic transmission model for measles / mumps / rubella / varicella vaccine
Value dossier for measles / mumps / rubella / varicella vaccine
Expert meeting on measles / mumps / rubella / varicella vaccine
Adaptation of dynamic transmission model for measles / mumps / rubella / varicella vaccine to other countries
Preparation of an abstract on dynamic transmission model for measles / mumps / rubella / varicella vaccine
Manuscript and posters on MMRV vaccine outcomes

Other

Communication on the Vaccination Comfort Questionnaire development and psychometric validation process
Cost-effectiveness of treatment of infections of diabetic foot ulcers
Pharmacoeconomic and PRO design and analysis for an immunoglobulin product for primary immunodeficiency
Update of the pharmacoeconomic dossier and economic model for a vaccine to prevent shingles
Economic literature review for product positioning in staphylococcus infection
Advisory board meetings on dynamic model development for epidemiological and economic impact of malaria and malaria vaccination in sub-Saharan Africa
Cost-effectiveness analysis for antifungal treatment in Sweden
Economic literature and HTA review, and gap analysis for a product economic positioning for a tuberculosis vaccine
Data collection for a health economic model in meningitis B
International cost-effectiveness model for treatment of intra-abdominal and diabetic foot ulcer infections taking into account local antimicrobial resistance

Dermatology

Psoriasis

Systematic literature review in psoriasis
Value dossier for monoclonal antibody in psoriasis
Strategic PRO reviews in psoriasis
Development of endpoint model in psoriasis
Patient focus groups in psoriasis
Mixed treatment comparison and manuscript for topical steroids in psoriasis
Cost-effectiveness analysis and model adaptations for treatment of moderate to severe psoriasis
Review of briefing document prepared for submission to FDA in support of labeling claims in psoriasis
NICE submissions for a new biologic for the treatment of moderate to severe psoriasis
Participation at dermatology advisory board for psoriasis
Development of a questionnaire to evaluate patient and clinician perception of the severity of psoriasis symptoms and treatment goal attainment
Development of an FDA PRO briefing document for treatment in psoriasis
Mixed treatment comparison for SMC submission for treatment in psoriasis
Protocol for the psychometric validation of a questionnaire assessing the severity of psoriasis
Psychometric validation of a psoriasis tool
Consulting on the evaluation of quality of life in a clinical study for the treatment of psoriasis
Development of a PRO to assess sexual dysfunction in psoriasis

Other

Development and validation of an excess sebum PRO instrument in adults and adolescents
Reimbursement support for treatment for atopic dermatitis
Impact of chronic hand dermatitis among health care workers in the US and UK
Consulting on patient qualitative insight into wound scar healing using blogs and follow-up interviews
Validation plan and FDA regulatory support, including development of a PRO briefing document, for the facial wrinkling scale
Content validation of the facial wrinkling scale
Development of a manuscript to report the results of a PRO measure in facial wrinkling
Gap analysis of PROs for the use of treatment to grow hair on the scalp
PRO gap analysis and review in acne vulgaris
Exploratory focus groups in acne vulgaris
Qualitative interviews to support the concept of psychological impact as assessed by the Facial Line Outcomes questionnaire
PRO development in acne vulgaris
Development and validation of a hydronitis superativa PRO tool
Development and validation of a photographic assessment and symptom measure in alopecia
Development of a Symptom and Impact PRO in alopecia
Development of PRO in hidradenitis suppurativa
Development of a treatment satisfaction module for alopecia
Development of a PRO dossier for the Subject Self-Assessment of Erythema Scale for erythematous rosacea
Meta-analysis of treatment efficacy and safety in atopic dermatitis