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.

Multiple sclerosis

  • Global value dossier update in multiple sclerosis (MS)
  • Multiple technology appraisal in MS for NICE
  • Research into UK data sources for MS
  • Delphi study (with KOL and payer interviews) to inform market access strategy in MS
  • Utility elicitation study on patients with 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)

Muscle wasting

  • COA review and development for muscle wasting associated with chronic illness
  • Exit interviews to explore patient disease burden, treatment satisfaction and clinical trial participation in muscle wasting associated with chronic obstructive pulmonary disease (COPD)
  • Qualitative research to support the identification of key impacts on physical functioning and activities of daily living in patients with muscle wasting

Musculoskeletal pain

  • Conference abstract and poster for early decision modelling in acute pain
  • Strategic literature review of chronic pain
  • Competitive assessment and burden of illness in chronic low back pain
  • Content confirmation and testing of the Roland Morris Disability Questionnaire (RMDQ) and Pain NRS Personal Digital Assistant in chronic low back pain
  • Development of a responder index in low back pain
  • Manuscript on the chronic low back pain responder index
  • Development of a PRO measure of stiffness in acute low back pain
  • Focus group interviews with patients with chronic low back pain
  • Gap analysis and strategic recommendation for PRO and market access studies in chronic low back pain and diabetic peripheral neuropathy
  • Mode of Administration (MOA) equivalency study in lower back pain
  • Consulting on PRO analysis and study design of trials in chronic low back pain
  • Burden, economics, epidemiology and treatment patterns in chronic low back pain
  • Qualitative exit interviews to assess the patient experience of treatment and clinical trial participation among patients with chronic low back pain
  • Gap analysis and review of PRO measures in low back pain and neck pain
  • Development of a briefing document on the modified Brief Pain Inventory – Short Form (mBPI-SF) in acute musculoskeletal pain
  • Critical review of PRO instruments in fatigue and pain in rheumatic disease
  • PRO literature review in pelvic pain
  • Patient perspective literature review for chronic pelvic pain in both men and women

Myelodysplastic syndrome

  • Value dossier and e-v@luate platform in a treatment for low-risk myelodysplastic syndrome
  • Value dossier and e-v@luate platform in a treatment for high-risk myelodysplastic syndrome
  • Resource utilisation in myelodysplastic syndromes
  • Quality of life analysis for a treatment in myelodysplastic syndrome
  • Patient survey of the indirect costs and quality of life impacts in myelodysplastic syndromes
  • Qualitative interviews with patients with myelodysplastic syndrome
  • In-trial analyses of treatments in myelodysplastic syndrome (TASTE-PRO)
  • Manuscript support in myelodysplastic syndrome (TASTE-PRO)

Myelofibrosis

  • Global value dossier and e-v@luate platform for a treatment in myelofibrosis
  • Quality of life analysis, value proposition and value messages for a treatment in myelofibrosis
  • Modification of a web-based patient survey to assess QoL, economic impact and work productivity for patients with myeloproliferative neoplasms
  • Development and documentation of a PRO questionnaire for use among patients with myelofibrosis in second line treatment
  • Score interpretation guidance on the use of the Myelofibrosis Symptom Assessment Form (MF-SAF) diary in treatment resistant patients
  • Post-hoc analysis of PRO outcomes in a phase II clinical trial in myeloid metaplasia

Myocardial infarction

  • Literature review of the unmet need in patients with a history of myocardial infarction and high risk of developing atherothrombotic events
  • Literature review of coronary artery bypass grafting (CABG) treatment in acute myocardial infarction (AMI)
  • Validation of clinician and patient questionnaires for myocardial infarction imaging
  • Development and validation of patient and clinician tools for myocardial infarction imaging
  • Analysis and reporting of myocardial infarction imaging validation study data
  • Clinician and patient satisfaction in an observational study in myocardial infarction SPECT imaging

Nasal polyps

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

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

Neuroendocrine tumours

  • Payer value proposition, payer value dossier and cost-effectiveness model in neuroendocrine tumours (NETs)
  • Development of preference, tolerability and satisfaction PROs for patients with neuroendocrine tumours (NETs)

Neurogenic orthostatic 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

Neuromuscular block

  • Local market adaptations of economic models in anaesthesia (for neuromuscular block)
  • Payer value deck in neuromuscular block
  • Development of a conceptual framework and SAP for a treatment for neuromuscular block
  • Treatment effect analyses based on a Quality of Recovery questionnaire (QoR-40) and Reversal Agent Satisfaction Questionnaire (RASQ) in neuromuscular block

Neuropathic/neurological pain

  • Core value dossier update in chronic/neuropathic pain
  • Update of core value dossier and value story in chronic neurological pain
  • Manuscript based on burden of illness study in neuropathic pain for submission to peer-reviewed journal
  • Rapid payer research to support investment decisions in neuropathic pain
  • Payer interviews in neuropathic pain
  • Mapping out and costing of care pathways for neuropathic pain
  • Use of focus groups for the assessment of PROs in neuropathic pain
  • Assessment of PROs in neuropathic pain
  • Consultation on an observational study in neuropathic pain: review of protocol and SAP to ensure that an appropriate PRO strategy can be developed for phase III studies
  • PRO analyses in neuropathic pain
  • Patient focus groups to validate a conceptual model in neuropathic pain
  • Translation of the Neuropathic Pain Symptom Inventory (NPSI)
  • Manuscript on the NPSI

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)

Opioid addiction

  • Development of a screening tool for opioid dependence
  • Endpoint review and qualitative research in opioid addiction
  • Interviews and Rasch analysis in opioid addiction
  • Psychometric validation of the clinical opiate withdrawal scale (COWS), subjective opiate withdrawal scale (SOWS) and craving visual analog scale (VAS) in opioid withdrawal symptoms

Osteoporosis

  • Manuscript support for a screening model in osteoporosis in Japan
  • Cost-effectiveness model in osteoporosis
  • Cost-effectiveness analysis of a medicine used for the treatment of osteoporosis
  • Assessing the clinical gap by incorporating bone mineral density (BMD) screening into the annual health check-ups for osteoporosis in Japan
  • Indirect comparison of two treatments for non-vertebral fractures in osteoporosis

Other antibiotic / bacterial infection experience

  • Cost-effectiveness model of a treatment for bacterial infections
  • Cost-effectiveness analysis model for Portugal on a treatment for bacterial infections
  • Cost-effectiveness analysis of a treatment of intra-abdominal infections in the USA
  • Assessment of the commercial and economic value for the development of new diagnostic tests for respiratory infections
  • HEOR team capabilities audit and training plan in infectious diseases
  • Literature review and development of a suite of dossiers in anti-infectives (antibacterial resistance)
  • Literature review of antibiotic resistance
  • Global value dossier, slide deck and FAQs on antibiotic resistance in gram-negative infections
  • Update to an anti-infectives dossier in gram negative bacterial infections
  • Systematic literature review on competitor real word evidence in antibiotic resistance
  • Demonstrating the value of antibiotic resistance testing software
  • Development of a manuscript and consulting on economic evaluations alongside a clinical trial in intra-abdominal infections
  • Pharmacoeconomic and PRO design and analysis for an immunoglobulin product
  • Analysis in an EU study in primary immunodeficiency

Other cardiovascular diseases

  • Value proposition development for three Integrated Delivery Networks (IDNs) within the cardiovascular system
  • Review of the HTA submissions & economic literature in lipid modification
  • Development of a clinical tool to identify patients at risk of stent thrombosis
  • Update of a budget impact model for an anorectic antiobesity drug for cardiometabolic risk
  • Service impact model on cardiovascular complications in obesity
  • Development of a value proposition for amyloid cardiomyopathy
  • Mixed treatment comparison to estimate the efficacy of a drug relative to other treatments for patients with elevated triglycerides
  • General consulting on a new stent device
  • Validation of the Flushing Severity Questionnaire (FSQ) in patients with niacin induced flushing (NIF)
  • Manuscript on a heart model and statins
  • Strategic review of a treatment for atherothrombosis to prevent blood clots following a heart attack or stroke
  • Analysis of the risk of cardiovascular events with an antiplatelet medicine and proton pump inhibitors (PPI) in Japan
  • Protocol review, case report form and analysis plan for a treatment to prevent complications of vascular surgery