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.

Short bowel syndrome

  • Initial market access evidence assessment for a new orphan drug for short bowel syndrome
  • UK patient disease journey in short bowel syndrome

Short stature

  • Gap analysis of the Quality of Life in Short Stature Youth (QOLISSY) questionnaire in small for gestational age patients

Sickle cell disease

  • Development of a PRO questionnaire in sickle cell disease
  • Exit interviews in sickle cell disease

Sinusitis

  • Symptom reporting in chronic sinusitis
  • Economic and PRO trial in chronic sinusitis

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

Smoking

  • Psychometric validation of a cohort study on adherence to lifestyle changes in weight loss and smoking cessation
  • Development and validation of a questionnaire to assess well-being changes in people who would like to lose weight and quit smoking
  • Focus groups assessing patient experience with smoking
  • Development of a readiness to quit smoking tool for use in clinical practice
  • Gap analysis of the Questionnaire of Smoking Urges (QSU) to support labelling claims in smoking cessation
  • Literature review of PROs in smoking cessation
  • Regulatory consulting for smoking cessation
  • Briefing document in smoking cessation
  • Confirmatory psychometric analyses of the Leicester Cough Questionnaire (LCQ) in smokers
  • Linguistic validation of the Brief Questionnaire of Smoking Urges (BQSU), Minnesota Nicotine Withdrawal Scale (MNWS) and Smoking Effects Inventory (SEI) into UK English

Spasticity

  • Conference abstract on spasticity
  • Top up literature review in paediatric lower limb spasticity
  • Development and validation of a physician-administered diagnostic tool for spasticity
  • Validation of a screening/consensus tool in spasticity
  • Concept confirmation and cognitive debriefing of spasticity PRO measures in post-stroke spasticity (PSS) patients, and development of spasticity screener
  • Mechanism of Action (MOA) Equivalency Testing of the SIA and SSA in post-stroke spasticity patients
  • Poster for Post-Stroke Spasticity (PSS) PRO
  • Consolidation of Post-Stroke Spasticity (PSS) development reports for FDA submission

Spinal cord injury

  • Advisory panel in spinal cord injury
  • Development of a PRO on spinal cord injury
  • Development of work on incomplete spinal cord injuries into French and US Spanish
  • Psychometric validation of the treatment of incomplete spinal cord injury
  • Psychometric validation of the treatment of incomplete spinal cord injury in patients with ASIA C and D levels of injury
  • Economic impact on incomplete spinal cord injury patients with ASIA C and D levels of injury
  • PRO instrument reviews in relapsing MS and spinal cord injury
  • Analysis of clinical trial data and clinical assessments in incomplete spinal cord injuries
  • Management of a translation in Swedish and Gujarati on incomplete spinal cord injuries
  • FDA meeting and preparation on a PRO in spinal cord injury

Spinal muscular atrophy

  • Qualitative research to support development of a conceptual model and COA strategy in spinal muscular atrophy

Streptococcus

  • Literature review in group B streptococcus
  • Manuscript on the burden of group B streptococcus in the EU5

Stroke

  • Literature review and payer appraisals in stroke
  • Payer digital value communication testing in stroke prevention in patients with atrial fibrillation (SPAF)
  • 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

Study endpoint reviews

  • Bone healing
  • Chronic pain in malignant cancer
  • Epilepsy
  • Fatigue and functioning in fibromyalgia
  • Female hypoactive sexual desire disorder
  • Fibromyalgia
  • Heart failure with preserved ejection fraction
  • Goitre
  • Inhaled insulin in type 2 diabetes
  • Opioid addiction
  • Rheumatoid arthritis
  • Review of a protocol and protocol amendment for a Phase II gastroparesis study which includes the CGSI as a primary endpoint

Stuttering

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

Subcutaneous fat

  • Development of PRO instruments for anterior and posterior peri-axillary fat
  • Content validity testing of the lower facial shape questionnaire and regulatory support
  • End of phase II regulatory support for PRO endpoints in submental fat
  • Analytic and strategic support in cosmetic/submental fat
  • Non-parametric statistics PRO endpoints on cosmetic surgery on the chin
  • Revisions of a photonumeric scale in centralized abdominal bulging
  • Content validity of PROs in submental subcutaneous fat

Surgery

  • Identification of data inputs for a Canadian budget impact model in surgery
  • Research into resource utilisation for post-operative pain for HE modelling
  • Development of an economic model for treatment in post-liver transplant in paediatric patients
  • Value dossier on a treatment for post liver transplant in paediatric patients
  • AMCP dossiers for several surgical products
  • Value slide deck for bariatric surgery
  • Training in a manual compression device for surgery
  • Strategic review of European market access potential for a surgical device
  • General consultancy on economics, quality of life and reimbursement in lung volume reduction surgery in emphysema
  • Kidney transplant pricing research
  • Pricing research on kidney transplant in emerging markets
  • Cost-effectiveness model for cytomegalovirus (CMV) prophylaxis in kidney transplant recipients
  • Peripheral parenteral nutrition landscape review and manuscript for a medical device for surgical recovery
  • Healthcare resource use and statistical analysis consulting on a clinical trial for kidney transplantation
  • Development of a PRO questionnaire in abdominoplasty (tummy tuck)
  • Consulting on PRO claims and an FDA dossier on abdominoplasty (tummy tuck)
  • Publications on the tummy tuck development and validation project
  • Phase III analysis of a tummy tuck clinical trial
  • Pre- and post-surgery research study in hidradenitis suppurativa
  • Protocol review, case report form and analysis plan for a treatment to prevent complications of vascular surgery
  • Matched cohort pulmonary embolism evaluation in orthopaedic surgery in Japan
  • Manuscript on the incidence of venous thromboembolism following major abdominal surgery
  • Abdominal surgery cohort study to evaluate the risk of venous thromboembolism
  • Non-parametric statistics PRO endpoints on cosmetic surgery on the chin
  • Development of a photonumeric guide and PRO measure of surgical scarring
  • Support for a value dossier submission for a treatment for moderate surgical bleeding in Asia-Pacific
  • Training work on post-operative nausea and vomiting
  • Delphi panel to estimate nursing time in post-operative pain management

Surgical infections

  • Development of an interactive model for skin and nasal antiseptic for infection prevention, allowing users to tailor settings to stakeholders’ specific circumstances at a regional or local level or within hospital departments
  • Scientific communication of a budget impact model for prevention of surgical skin infections

Systemic mastocytosis

  • Statistical analysis of a clinical trial PRO and ClinRO data in advanced systemic mastocytosis
  • Conference abstract and poster for a PRO analysis in advanced systemic mastocytosis
  • PRO questionnaire development for symptoms of aggressive and indolent systemic mastocytosis
  • Development of a PRO questionnaire in indolent systemic mastocytosis – Longitudinal data collection
  • Psychometric evaluation and regulatory dossier on indolent systemic mastocytosis (ISM-SAF)
  • Observational study to inform the use of the ISM-SAF as a clinical trial screening tool in indolent systemic mastocytosis
  • Longitudinal data analyses and development of a PRO questionnaire in indolent systemic mastocytosis

Systemic sclerosis

  • Executive summary slide deck based on an early value evidence dossier in systemic sclerosis
  • Early value dossier with value message proposition in systemic sclerosis

Systemic sclerosis / Scleroderma

  • Review of PROs in systemic sclerosis/scleroderma
  • Brief literature review to inform endpoint strategy recommendations for interstitial lung disease in systemic sclerosis (SSc-ILD)

Tetanus

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