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.

Glucose transporter type 1 deficiency syndrome

  • Qualitative research to explore and support the assessment of the patient experience and impact of functioning of movement disorders in glucose transporter type 1 deficiency syndrome, and literature review in absence seizures

Fragile X syndrome

  • Consultancy support for clinical trials in Fragile X syndrome
  • Literature review to develop a conceptual model for individuals with Fragile X syndrome (aged 5-12 years old)

Barth syndrome

  • Concept elicitation interviews in Barth syndrome patients
  • Concept selection meeting for a PRO in Barth syndrome
  • Cognitive debriefing for Barth syndrome PROs
  • Qualitative concept elicitation and case studies documenting the disease progression of Barth Syndrome

Influenza vaccines

  • Economic value dossiers for influenza vaccines in a) an unprimed paediatric population and b) a primed school age population (intranasal delivery) including literature review, gap analysis and recommendations
  • Communications package for an influenza vaccine
  • Communication of the economics of an influenza vaccine
  • Two manuscripts on an influenza vaccine for patients at risk and patients over 65 years old in France
  • Review of influenza vaccine uptake data
  • Updating an economic model of influenza vaccination (phase 1) – update of a model in patients aged over 65 years in France and the UK
  • Economic evaluation of a workplace influenza vaccination in Russia
  • Cost-effectiveness analysis of an influenza vaccine
  • Adaptation of a cost effectiveness model for an influenza vaccine for Germany, Austria and Mexico
  • Conference poster on the cost effectiveness of adjuvant influenza vaccination in France
  • Adaptation of an influenza vaccine model to Belgium
  • Regulatory support for the validation of a questionnaire for influenza vaccination

Diptheria

  • Burden of disease literature review on diptheria in the UK and Ireland

Clostridium difficile

  • Pre-budget impact analysis and economic advice for personalized medicine: approaches to diagnose and control clostridium difficile infections

Animal health

Canines

  • Qualitative activities to support validity and feasibility of the canine quality of life and treatment satisfaction measure administered via a cell phone application
  • Development of a user manual for canine dermatitis quality of life and treatment satisfaction
  • Psychometric evaluation of a revised canine dermatitis quality of life questionnaire
  • Clinical trial analysis and ad-hoc consultancy for a canine quality of life questionnaire
  • Exploration of canine-owner burden in various conditions and provision of recommendations for measurement
  • Psychometric evaluation and analysis of a revised canine dermatitis quality of life questionnaire

Felines

  • Building of a feline QoL tool for cats with GI lymphoma
  • Development and validation of an instrument to measure quality of life in cats
  • Development of a user manual for a feline quality of life tool

Cancer-related pain, fatigue and side effects

Cancer-related pain and fatigue

  • Initial consultation to design a study in order to generate health utilities values associated with different levels of cancer-related pain
  • Utility study in breakthrough cancer pain
  • Update of report for utility elicitation in breakthrough cancer pain
  • Abstract, manuscript and budget impact model on breakthrough cancer pain
  • Training in pilot budget impact model for a treatment for patients with breakthrough cancer pain
  • SMC submission in breakthrough cancer pain
  • Development of a breakthrough cancer pain submission to the All Wales Medicines Strategy Group (AWMSG)
  • Attendance at an AWMSG meeting with regards to strategic consultancy in breakthrough cancer pain
  • Expert interviews and amendment project to heath economic model for a treatment for breakthrough cancer pain
  • Economic evaluation of a treatment for breakthrough cancer pain in Canada
  • Budget impact tool for a treatment for patients with breakthrough cancer pain in the UK
  • Consulting support and development of a briefing document to support fatigue symptom claims in cancer pain
  • Recommendation of a measure of chronic cancer pain
  • Assessment of a pain communication tool for advanced cancer patients: a cross-sectional survey
  • Qualitative research for the Cancer-Related Fatigue Consortium
  • Phase II cognitive interviews on Patient-Reported Outcomes of Fatigue – Cancer (PROOF-C)
  • Cancer-related fatigue consortium: qualitative research in the experience of fatigue among cancer patients
  • Qualitative research on the experience of fatigue among cancer patients
  • PRO development, abstracts and posters on cancer-related fatigue

Cancer-related anaemia

  • Linking a cost utility assessment model with a budget impact model for treatment for anaemia in cancer
  • NICE consultancy for a treatment for chemotherapy-induced anaemia
  • Statistical pharmacoeconomic analysis of patient level data for a treatment for anaemia following chemotherapy
  • Phase II cognitive interviews and regulatory support in inflammatory anaemia in cancer
  • Evaluation of the PRO landscape using a systematic literature review on chemo-induced anaemia in oncology

Other cancer-related side effects

  • Value dossier on a drug used to treat febrile neutropenia
  • Plan, execute and follow up a Train-the-Trainer meeting on chemotherapy-induced febrile neutropenia
  • Development of a PRO measure in muscle wasting (cancer cachexia) in prostate cancer, sarcopenia, gastric cancer and colorectal cancer
  • Debriefing of the cancer associated fibroblasts (CaF) PRO
  • SMC re-submission and economic analysis for a treatment for anthracycline extravasation
  • Case control study of costs associated with a treatment for oral mucositis in transplant patients
  • Literature review and recommendations on PROs for peripheral neuropathy due to chemotherapy in cancer patients
  • Review of PRO instruments for use in uveal melanoma and biliary tract cancer

Epilepsy

  • Mapping the health economic evidence landscape for anti-epileptic treatments
  • Systematic literature review and mixed treatment comparison for a treatment in epilepsy
  • Abstract review for the systematic literature review and mixed treatment comparison investigating treatments in epilepsy
  • Value dossier for an anticonvulsant medication for use in epilepsy
  • Evidence synthesis and modelling for an anticonvulsant medication in epilepsy
  • SMC submission for an anticonvulsant treatment for epilepsy
  • Brief literature review in epilepsy and search of FDA and EMA websites
  • Payer meeting and consultancy on an anti-epilepsy drug
  • Consultancy on an Italian model adaptation in epilepsy
  • Development of a US value dossier (meeting AMCP and WellPoint guidelines) and an expanded budget impact model on epilepsy
  • Cost-effectiveness analysis of two different anticonvulsant medications as adjunctive therapy for adults with partial refractory epilepsy in the US
  • Mixed treatment comparison summary for epilepsy

Dravet syndrome

  • Development of a composite trial endpoint for Dravet syndrome
  • Interviews on the development of a composite trial endpoint for Dravet syndrome
  • Manuscript on the development of a composite trial endpoint for Dravet syndrome
  • Publication support to disseminate findings from interviews with caregivers of children with Dravet syndrome, and independent qualitative analysis of findings

Lennox-Gastaut syndrome

  • Cost utility analysis model for Lennox-Gastaut Syndrome
  • Training with the client to discuss the Lennox-Gastaut Syndrome economic model/report and payer submission
  • Eliciting utilities in Lennox-Gastaut Syndrome
  • Assistance with responding to questions from the AWMSG and SMC on Lennox-Gastaut syndrome

Hypertension and Hypotension

Hypertension

  • Strategic treatment pathways for treatment in pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH)
  • Update to payer value decks in PAH and CTEPH
  • Framework for real world evidence generation in PAH and CTEPH
  • Strategic plan and real-world evidence toolkit in PAH and CTEPH
  • Consultancy on interpretation of phase III trial endpoints in PAH and CTEPH
  • Meta-analysis, systematic literature review, data extraction and report on an oral combination treatment of PAH
  • Systematic literature review, data extraction & report on sensitivity analyses and a meta-analysis of an oral combination treatment of PAH
  • Meta-analysis of an oral combination treatment of PAH
  • Meta-analysis of an oral treatment of PAH – exploratory analyses on the effect of administering additional PAH-specific therapy upon two additional endpoints
  • Utility assessment in PAH
  • Literature review of PAH secondary to chronic obstructive pulmonary disease (COPD)
  • Interpretation of clinical trial results in PAH
  • Cognitive debriefing interviews with patients with PAH
  • Network meta-analysis of combination therapies in PAH
  • Psychometric validation of the Living with Pulmonary Hypertension (LPH) questionnaire in PAH
  • PRO claims for PAH – endpoint review and regulatory support for the FDA and EMEA
  • PRO claims for PAH: endpoint review, regulatory support and qualitative patient interviews
  • Qualitative research to explore patient preference for modes of administration in PAH treatments
  • Budget impact model for an anti-hypertensive treatment
  • UK cost offset model of two treatments for hypertension
  • Preparation of an interactive report on a cost-offset model for a treatment for hypertension
  • Asian value dossier for hypertension
  • Heart study economic model in hypertension
  • Advisory board on hypertension
  • Cost model for a direct renin inhibitor medication for the treatment of hypertension
  • Validation of an adherence questionnaire for hypertension patients utilizing administrative data
  • Hypertension database analysis in Japan
  • Data management and reporting on a cardiovascular health outcomes project switching study in hypertension
  • Development of a compliance and persistence screener in hypertensive patients at risk for cardiovascular events
  • Validation of data analysis with an FDA response in orthostatic hypertension
  • Adaptation of a heart study economic model in hypertension to Korea
  • Validation of the hypertension / dyslipidaemia treatment satisfaction survey

Hypotension

  • Defence of the use of the Orthostatic Hypotension Questionnaire (OHQ) to demonstrate treatment benefit and labelling claim in neurogenic orthostatic hypotension
  • Validation of the OHQ in neurogenic orthostatic hypotension using clinical trial data
  • Key opinion leader interviews on neurogenic orthostatic hypotension
  • Evaluation of the current measurement strategy in neurogenic orthostatic hypotension

Multiple sclerosis

  • Global value dossier update in multiple sclerosis (MS)
  • Multiple technology appraisal in MS for NICE
  • Research into UK data sources for MS
  • Negotiation of a licensing agreement for the Multiple Sclerosis Impact Scale (MSIS-29)
  • Review and formatting of patient reported resource use, work productivity and caregiver burden in MS
  • Qualitative research to validate a screening tool for secondary progressive MS
  • PRO endpoint review in MS
  • Briefing document, advisory board and labelling strategy for the FDA on a treatment for MS
  • Cognitive debriefing UK study on walking impairment in MS
  • Psychometric testing of walking impairment in MS
  • Manuscript for the development and psychometric assessment of the Early Mobility Impairment Questionnaire (EMIQ) in MS
  • Rasch analysis of the cognitive debriefing survey data collected in a qualitative phase for MS
  • Rasch analysis and report of DSP data collected on the Full Scale Intelligence Quotient (FSIQ) measure in MS
  • PRO instrument reviews in relapsing MS and spinal cord injury
  • PRO review on MS
  • PRO statistical analysis plan for a clarity trial in MS
  • Selection of a PRO for depression in MS
  • Endpoint review of a treatment for MS
  • Concept confirmation and cognitive debriefing of spasticity PRO measures in MS patients, and development of spasticity screener
  • Development and validation of a clinical screening tool for overactive bladder in MS
  • Advisory board for a clinical screening tool for overactive bladder in MS
  • Development of a predictive calculator for a clinician-completed screening tool in secondary progressive multiple sclerosis (SPMS)
  • Psychometric validation of a clinician completed screening tool in SPMS
  • Exploratory analysis of phase II clinical trial data for acute optic neuritis

Relapsed-remitting multiple sclerosis

  • Development, content confirmation and validation of a fatigue measure in relapsing-remitting multiple sclerosis (RRMS)
  • Work on the equivalency of an e-PRO on the FSIQ in RRMS
  • Qualitative work in subgroups with RRMS
  • Development of a PRO measurement strategy in relapsing MS
  • Mode of administration equivalency and usability testing of the MSIS-29 in patients with relapsing MS
  • Development of a PRO dossier for the MSIS-29 in RRMS
  • Psychometric validation of a newly developed PRO for patients with RRMS
  • Poster development on the Fatigue Symptom and Impact Questionnaire for Relapsing Multiple Sclerosis (FSIQ-RMS)

Adenomyosis

  • Development of disease-specific modules for adenomyosis

Endometriosis

  • Validation of ePRO endpoints and a regulatory dossier to support claims in endometriosis
  • Qualitative research in Europe and validation of ePRO endpoints to support product labelling claims in endometriosis
  • Development and validation of ePRO endpoints for use in endometriosis
  • Psychometric validation and communications for newly developed PROs in endometriosis
  • PRO instrument development in endometriosis
  • Manuscript on PRO development and validation in endometriosis
  • Endpoint validation and finalisation in endometriosis
  • Review of a revision of a psychometric validation report on endometriosis and in-person attendance at FDA meeting
  • Endometriosis symptom diary and impact scale communications strategy
  • Exploration of instrument scoring (following EMA CHMP advice), psychometric evaluation using data from clinical studies and development of instrument user manuals in endometriosis
  • Consultancy services for linguistic validation of an endometriosis symptom diary and endometriosis impact scale
  • Endpoint review and regulatory support regarding the suitability of the Biberoglu & Behrman Scale (B&B) and Endometriosis Health Profile-30 (EHP-30) for supporting US product labelling claims in endometriosis
  • FDA PRO dossier updates and the development of Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS) user manuals
  • Review of a briefing book concerning a compound in development for the treatment of pain and other symptoms arising from endometriosis
  • Face and content validity of a new measure to assess symptoms associated with endometriosis
  • Development and face and content validation of a diary to assess symptoms associated with endometriosis
  • Development of disease-specific modules for endometriosis

Uterine fibroids

  • Consultation on the development of a diary to assess uterine fibroids
  • Assessment of a minimal clinically important difference in a uterine fibroid symptom and quality of life questionnaire
  • Design and pilot testing of an ePRO in uterine fibroids
  • Regulatory and statistical support for an FDA claim in women with uterine fibroids
  • Development of disease-specific modules for fibroids

Neural tube defects

  • Manuscripts, abstracts and posters on neural tube defects
  • Top-up literature review and communications on the burden of neural tube defects to patients, carers and society
  • Review on the burden of neural tube defects to healthcare systems, patients, care-givers and society
  • Content validation of a neurogenic detrusor overactivity (NDO) diary in paediatric spina bifida patients

Overactive bladder and urinary incontinence

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

Nocturia and paediatric enuresis

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