Experience

Adelphi Values has an experienced global team of qualitative researchers, health economists, statisticians, creative scientists, clinicians and strategists with industry experience, who truly understand the need to develop evidence and communicate value throughout the product lifecycle.

Below is a selection of our projects, presented according to therapeutic or strategic/methodological area. It is not exhaustive, and we would be happy to provide further information on request.

Mitochondrial disease

  • PRO questionnaire development in mitochondrial myopathy
  • Cognitive debriefing interviews for the Primary Mitochondrial Disease (PMD) Symptom Assessment Questionnaire

Stuttering

  • Development of a stuttering PRO
  • Gap analysis of PRO and clinician measures in stuttering

Anxiety

  • Validation of the SIS in anxiety
  • Manuscripts on the development and validation of the Sleep Impact Scale (SIS) in generalised anxiety disorder
  • PRO strategy in generalized anxiety disorder with functional digestive disorders / irritable bowel syndrome (IBS)

Bipolar disorder

  • Systematic literature review and manuscript on the burden of illness in bipolar disorder
  • Psychometric validation of the Sheehan Disability Scale in bipolar disorder
  • Support network study to improve compliance in a psychotropic medication used in bipolar disorder
  • FDA PRO dossier on bipolar depression
  • Development of an endpoint model, training and recommendations for endpoint support in bipolar disorder
  • Composition of a PASS report on bipolar disorder, including a review of local physician monitoring guidelines
  • Validation of the Caregiver Strain Questionnaire in paediatric bipolar disease

Schizophrenia

  • Core value dossier for treatment of schizophrenia to support local payer discussions
  • Update of a value dossier in schizophrenia
  • Identification and determination of the evidence base for a drug used to treat schizophrenia and the value drivers to support continued (and increased) patient access
  • Literature review on the burden of negative symptoms in schizophrenia
  • Content validation of the Readiness for Work questionnaire in schizophrenia
  • Literature review of ClinROs used to measure negative symptoms of schizophrenia
  • Database analysis for adherence and re-hospitalizations in schizophrenia patients
  • Literature research and review of the emotional components of schizophrenia
  • Review of the cognitive components of schizophrenia
  • Comprehensive literature review on cognitive impairment in schizophrenia
  • Development of a manuscript on the humanistic burden of cognitive impairment associated with schizophrenia
  • Translation and validation of the schizophrenia cognitive functioning scale into Japanese
  • Endpoint review and strategic recommendations on the application of the Zarit Burden Interview (ZBI) to assess caregiver burden in schizophrenia
  • Preparation of a conference abstract and poster on schizophrenia
  • Cognitive debriefing and usability testing of ePRO measures to be used in a schizophrenia registry study
  • Workshop moderator for roundtable discussions regarding the clinical relevance of negative symptoms in schizophrenia
  • Development and validation of a clinical decision-making tool in schizophrenia
  • Development of an endpoint model, training and recommendations for endpoint support in schizophrenia
  • Composition of a PASS report on schizophrenia, including a review of local physician monitoring guidelines
  • Validation of the Caregiver Strain Questionnaire in schizophrenia

Vertigo

  • Communication of the economic burden of vertigo based on the REVERT registry
  • Manuscript on clinical outcomes in vertigo

Restless leg syndrome

  • Development of a value slide set in restless leg syndrome (RLS)
  • Global value dossier and e-v@luate platform development in RLS
  • PRO and Health Economics (HE) consulting on global health outcomes in RLS
  • Development of a sleep measure for a labelling claim in RLS
  • Linguistic validation management of the Restless Leg Syndrome Next Day Impact (RLS-NDI)
  • Synopsis of conclusions for diagnosis of paediatric RLS
  • Regulatory consulting to support development of a structured diagnostic interview and severity scale in paediatric RLS, along with development of two manuscripts to document the development and validation process
  • Abstracts and presentations on the results from an independent study of RLS
  • Psychometric validation of a two-factor solution for RLS
  • Analysis of RLS sub-scales
  • Manuscript on RLS, sleep and cognition
  • Consultation on the development of questionnaires for RLS
  • Expert meeting on paediatric RLS
  • Development and validation of a diagnostic interview and severity scale for paediatric RLS
  • Validation of the Medical Outcomes Study (MOS) sleep questionnaire using pooled trial data from RLS trials
  • Validation of the Restless Leg Syndrome Rating Scale (RLS-RS) and Restless Leg Syndrome Quality of Life (RLS QoL) questionnaire

Artery diseases and high cholesterol

  • Literature review of burden of illness and cardiovascular risk group identification of symptomatic peripheral artery disease
  • Literature review and payer appraisals in peripheral artery disease
  • Budget impact and economic evaluation of a statin
  • Advisory board on arterial occlusive disease
  • Workshop communicating health economic data of an anticoagulant medication for deep vein thrombosis (DVT)
  • Development of a treatment satisfaction measure for an injectable low-density lipoprotein (LDL) cholesterol lowering medication
  • Costs for psychometric validation of the Injection-Treatment Acceptance Questionnaire (I-TAQ) in an independent observational study in hypercholesterolemia
  • Statistical consultancy to support use of the I-TAQ for a cholesterol-lowering medication
  • Production of a revised heart model for hypercholesterolaemia incorporating additional comments from country affiliates
  • Worldwide database analysis of statins and cholesterol levels
  • Probabilistic analysis of a statin model and advice on a pharmacoeconomic manuscript
  • Endpoint review for FDA-approved flushing claims in atherosclerosis

Heart failure

  • Payer value proposition and communication for a new remote patient monitoring platform in congestive heart failure
  • Disease area review, burden of illness and unmet needs in heart failure (and associated renal dysfunction)
  • Development of a PRO dossier for the Minnesota Living with Heart Failure Questionnaire and selection of a validated dyspnoea questionnaire
  • Content validity of a symptom endpoint and dossier in heart failure with preserved ejection fraction
  • Consultation on the validation of a primary clinical endpoint in heart failure
  • Chart review of heart failure in China
  • Meetings for a heart failure study
  • Heart failure chart review in China
  • Caregiver burden in patients with chronic heart failure
  • Psychometric validation of the chronic heart failure (CHF) caregiver burden questionnaire
  • Support for additional translations of the Heart Failure Compliance Questionnaire (HFCQ) for chronic heart failure
  • Network meta-analysis of pharmacological treatment of heart failure
  • Selection of a caregiver burden questionnaire for acute decompensated heart failure

Heart disease

  • Global value dossier on cardiovascular disease and dyslipidaemia
  • Literature review of cardiovascular disease in migraine patients
  • Update of a report on the impact of changing total cholesterol targets in the General Medical Services (GMS) contract for heart disease
  • NHS and public health impact of revising General Medical Services (GMS) targets for cholesterol in coronary heart disease
  • Manuscript on the cost-effectiveness and budget impact of a statin treatment for coronary heart disease
  • Investigator training and analysis of QoL data in heart disease
  • Analysis of the prevalence of bradycardia and co-morbidities in coronary artery disease
  • Data management and reporting of an outcomes project on a statin drug for the treatment of heart disease
  • Analysis of the SF-ESTQ in the JEWEL studies in heart disease
  • PRO questionnaire development for statin intolerance
  • Demonstrating the value of a transcatheter heart valve in aortic stenosis
  • Report on the cost of diagnosing vascular diseases with an MRA as the primary imaging modality
  • Consultation on an epidemiological quality of life study in cardiovascular disease
  • Development of a PRO best practices document in cardiovascular diseases – interactions with international regulatory and HTA agencies

Atrial fibrillation

  • Analysis of atrial fibrillation in the UK
  • Qualitative research on PROs in atrial fibrillation
  • Development of PRO instrument modules and validation research in atrial fibrillation
  • Manuscript on the development of a symptoms questionnaire in atrial fibrillation
  • Decentralised framework for real life data generation in stroke prevention in atrial fibrillation (SPAF)
  • Reporting of development work in atrial fibrillation
  • Indirect comparison of two drugs used in the prevention of thromboembolic events due to atrial fibrillation
  • Analysis of the Anti-Clot Treatment Scale (ACTS), Treatment Satisfaction Questionnaire for Medication (TSQM) and healthcare resource utilization in a clinical trial in atrial fibrillation
  • Manuscript development on the ACTS/TSQM data
  • Manuscript support for statistical results in an observational study measuring outcomes in atrial fibrillation
  • Measurement of resource use, satisfaction, productivity and HRQoL in atrial fibrillation
  • Translation and validation of the ACTS and TSQM in atrial fibrillation in Japan

Stroke

  • Literature review and payer appraisals in stroke
  • Landscaping of acute ischaemic stroke care in the USA
  • Concept confirmation and cognitive debriefing of spasticity PRO measures in post-stroke spasticity patients, and development of spasticity screener
  • Mechanism of Action (MOA) Equivalency Testing of the SIA and SSA in post-stroke spasticity patients
  • Consolidation of post-stroke spasticity development reports for FDA submission
  • Refinement of a checklist on ischemic stroke
  • Content confirmation and cognitive interviews of the post-stroke rehabilitation checklist
  • Data analysis of the Singapore post-stroke checklist pilot study
  • Data analysis of a follow-up patient survey in the Singapore post-stroke checklist study
  • Analysis of 50 patients of the Singapore post-stroke checklist pilot study and provision of medical writing assistance for conference posters
  • Development of conference abstracts and manuscripts from the UK post-stroke checklist pilot study
  • Medical writing assistance for the development of communications on strokes
  • Manuscript on a Delphi panel to develop a post-stroke referral checklist
  • Support for development of study documents for validation of the Post Stroke Checklist
  • Mixed treatment comparison of a treatment for secondary prevention of stroke
  • Meta-analysis of secondary stroke prevention with two comparative treatments
  • Consulting on the Anticoagulant Treatment Satisfaction (ACTS) scale as an endpoint for FDA claims in stroke

Thromboembolism and pulmonary embolism

  • Utility elicitation in thromboembolism in the UK
  • HTA assessment of therapeutic interventions and treatments for venous thromboembolism
  • Manuscript on the incidence of venous thromboembolism following major abdominal surgery
  • Abdominal surgery cohort study to evaluate the risk of venous thromboembolism
  • In-trial cost-consequences analysis of a drug used in venous thromboembolism
  • Matched cohort pulmonary embolism evaluation in orthopaedic surgery in Japan
  • Consulting on the Anticoagulant Treatment Satisfaction (ACTS) scale as an endpoint for FDA claims in venous thromboembolism and thromboembolism prophylaxis
  • Decentralised framework for real life data generation in venous thromboembolism

Post-operative ileus

  • Literature review of the management of post-operative ileus in Europe
  • Analysis of the burden of illness of post-operative ileus in 4 European countries
  • Analysis of post-operative ileus in a complicated population using country-specific databases

Eosinophilic esophagitis

  • Development and validation of a PRO measure in paediatric patients with eosinophilic esophagitis
  • Qualitative interviews to develop a symptom measure in adult patients with eosinophilic esophagitis
  • Re-analysis of qualitative data and cognitive debriefing interviews to create a symptom measure in esonophilic esophagitis
  • Analysis of a field trial on eosinophilic esophagitis
  • Cognitive debriefing and modification of the Eosinophilic Esophagitis Activity Index (EEsAI)
  • Modification of the Eosinophilic Esophagitis Activity Index (EEsAI)

Sjögren’s syndrome

  • Literature review and consultancy on symptom questionnaires for use as a primary endpoint and consultancy on inclusion of a PRO questionnaire as a secondary endpoint in Sjögren’s syndrome
  • Measurement strategy for ichthyosis in Sjögren’s syndrome

Lupus and systemic lupus erythematosus

  • Manuscript on the understanding of payers and pricing in lupus nephritis
  • PRO consulting in lupus for labelling claims
  • Assessing utility for flares in systemic lupus erythematosus in the UK, France, Spain, Australia and Canada, including training and managing local interviewing agencies and providing support to local teams
  • Key opinion leader contracting and additional interviews for assessing utility in various severities of flares in systemic lupus erythematosus
  • Study on the treatment of systemic lupus erythematosus in Japan
  • Update of a literature search in systemic lupus erythematosus and lupus nephritis
  • Strategic literature review and gap analysis in systemic lupus erythematosus and lupus nephritis
  • Communication of a literature review on systemic lupus erythematosus and lupus nephritis
  • Manuscript on the health-related quality of life benefits of a treatment for systemic lupus erythematosus
  • A study of the value of simple disease activity tools to rheumatologists who treat systemic lupus erythematosus
  • Target product profile development in systemic lupus erythematosus
  • Analysis of a PRO and resource utilisation in systemic lupus erythematosus
  • Development of posters on the analysis of a PRO and resource utilisation in systemic lupus erythematosus
  • Critical review of PRO instruments in systemic lupus erythematosus and fatigue and pain in rheumatic disease

Hidradenitis suppurativa

  • Core value dossier to support new treatment in hidradenitis suppurativa
  • Update to a value proposition deck with adolescent data in hidradentis suppurativa
  • Core value dossier, payer value proposition and objection handler update in hidradenitis suppurativa
  • Development and validation of a PRO tool in hidradenitis suppurativa
  • Measurement of pain in hidradenitis suppurativa
  • Development of a PRO in hidradenitis suppurativa
  • Development of an investigator training manual in hidradenitis suppurativa
  • Development of FDA response on phase II hidradenitis suppurativa study protocol
  • Poster for a PRO in hidradenitis suppurativa
  • Mechanism of Action (MOA) Equivalency Testing in hidradenitis suppurativa
  • Clinical endpoint guidance and observational study in hidradenitis suppurativa
  • ClinRO inter-rater reliability study in hidradenitis suppurtiva
  • Design, placement and placement of outcomes in registry for hidradenitis suppurativa
  • HEOR strategic consulting in hidradenitis suppurativa
  • Pre- and post-surgery research study in hidradenitis suppurativa
  • Development of three measurement dossiers in hidradenitis suppurativa to support regulatory submissions
  • Psychometric testing of the Hidradenitis Suppurativa Impact Assessment (HSIA) and Hidradenitis Suppurativa Symptom Assessment (HSSA)
  • Summary report and publications for hidradenitis suppurativa pain and relevant tools
  • Evaluating the clinical meaning of defining treatment response based on the Hidradenitis Suppurativa Clinical Response (HiSCR)
  • Statistical analyses of registry data (UNITE) in hidradenitis suppurativa
  • Literature review on hidradenitis suppurativa

X-linked hypophosphatemia (XLH)

  • Development of an FDA dossier in X-Linked Hypophosphatemia (XLH)
  • Validation activities of an FDA dossier in XLH
  • Psychometric validation of the Brief Pain Inventory (BPI) and Western Ontario and McMaster osteoarthritis index (WOMAC) in XLH using online survey data
  • Exploration of content validity of PROMIS items for use in children with XLH
  • Psychometric evaluation of the BPI-SF and WOMAC in XLH using phase III trial data