Central nervous system and neurological diseases

Alzheimer’s disease

  • Advisory panel on Alzheimer’s disease
  • Critical analysis and report to support the widespread use of a combination therapy in Alzheimer’s disease
  • Analysis and report generation of widespread use of combination therapy in Europe for the treatment of Alzheimer’s disease
  • Summary report on EMA marketing organisation for a treatment in Alzheimer’s disease
  • Budget impact model in Alzheimer’s disease
  • Disutility study in Alzheimer’s disease
  • Disutility of caregiver burden associated with Alzheimer’s disease in Japan
  • Health state development for mild cognitive impairment in Alzheimer’s disease
  • Early payer value deck for Alzheimer’s disease
  • Development of additional caregiver burden items for the Resource Utilization in Dementia Questionnaire for Alzheimer’s disease
  • Literature research and analysis on the Alzheimer’s disease landscape in Japan
  • Conceptual framework for the Alzheimer’s Disease Caregiver Preference Questionnaire (ADCPQ)
  • Linguistic validation of the ADCPQ into Chinese
  • Validation of the Alzheimer’s disease caregiver preference questionnaire
  • Evaluation of quality of life in cognitively impaired Alzheimer’s disease patients
  • Review of the Alzheimer’s Disease Activity Scale-cognitive subscale (ADAS-Cog)
  • Development of a COA strategy for mild-moderate symptomatic Alzheimer’s disease
  • Development of a trial-specific caregiver satisfaction and preference questionnaire for a treatment for Alzheimer’s disease
  • PRO instrument development, qualification quantitative component of content validity stage and in-trial psychometric analysis stage in mild cognitive impairment
  • Review of the University of California San Diego Performance-based Skills Assessment (UPSA) in Alzheimer’s disease
  • Cognitive debriefing of the Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL) questionnaire
  • Analysis of an open label extension study in Alzheimer’s disease

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)

Autism

  • Equivalency testing of an eCOA version of the Vineland Adaptive Behavior Scales II (VABS-II) for use in autism spectrum disorder

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

Dementia

  • Linguistic validation of the Neuropsychiatric Inventory (NPI) in dementia
  • Structured literature review in lewy body dementia
  • Network meta-analysis in dementia with lewy bodies
  • Manuscript on dementia with lewy bodies
  • Clinical trial synopsis consulting for a phase III clinical program in dementia

Depression

  • Development of an online therapy tool for depression along with a landscape analysis, structured and grey literature review, local language literature review, gap analysis, local language payer interviews and clinician interviews
  • Literature review and advisor feedback on the burden of illness, clinical and economic outcomes in US patients receiving adjunctive treatment for major depressive disorder
  • Literature review of the burden of depression in haemodialysis patients (in chronic kidney disease)
  • Literature review and sourcing of UK unit costs in depression
  • KOL interviews and Delphi method to estimate the direct health care costs of treating patients with treatment-resistant depression
  • Manuscript and content validity of a PRO measure in major depressive disorder
  • Validation of the Children’s Depressions Rating Scale – Revised (CDRS-R) in Japan
  • Translation of the CDRS-R manual
  • PRO dossier on major depressive disorder for EMA submission
  • Development of an EMA technical document for PROs in depression
  • Instrument review and development of an EMA technical document to support patient-reported health-related quality of life labelling claims in depression
  • Communications on PRO clinical trial data and a literature review on depression
  • Development of a manuscript and presentation based on clinical trial PRO data in depression, primarily focused on interpretation of treatment
  • Validation and treatment effect analysis of the Sleep Impact Scale (SIS) in major depressive disorder
  • Review of PRO and CRO measures in severe depression
  • Selection of a PRO for depression in multiple sclerosis (MS)
  • Linguistic validation of a quality of life questionnaire on depression into UK English
  • Manuscript on validation and efficacy results in depression

Diabetic neuropathy

  • Linguistic validation of the Norfolk Quality of Life (QoL) questionnaire in diabetic neuropathy
  • Competitive analysis and burden of illness in diabetic peripheral neuropathy
  • Literature review of PROs and endpoints of pain in peripheral diabetic neuropathy
  • PRO assessment in diabetic peripheral neuropathy
  • Validation study of the modified version of the Brief Pain Inventory – Short Form (mBPI-SF), MOS-S and 3 single item questions in diabetic peripheral neuropathy
  • Gap analysis and strategic recommendation for PRO and market access studies in diabetic peripheral neuropathy
  • Consultancy on the validity of the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale for use in painful diabetic neuropathy patients
  • Interview study to understand the experience of walking pain among patients with diabetic peripheral neuropathy
  • Analysis of diabetic neuropathy

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

Insomnia and sleep disorders

  • Survey of the impact of allergy on sleep (including literature review and HCP interviews)
  • Advisory panel in insomnia
  • Review of PROs in insomnia
  • Cognitive debriefing of the daytime insomnia symptom scale and FDA support
  • Strategic consulting in insomnia
  • Validation of a primary insomnia functioning questionnaire
  • PRO strategy in insomnia
  • Manuscripts on the development and validation of the Sleep Impact Scale (SIS) in insomnia
  • Support on translation of the SIS in insomnia
  • Communications on the SIS in insomnia
  • Support on the adaptation of the SIS into three languages
  • Support on linguistic validation of the SIS in insomnia
  • Investigator meeting, review and presentation of slides on the Functional Outcomes of Sleep Questionnaire (FOSQ) and Work Limitation Questionnaire (WLQ)
  • Validation of the FOSQ in insomnia
  • Development of a conceptual framework and endpoint model in insomnia, plus qualitative patient interviews to confirm the validity of the conceptual framework and the psychometric validation of the final conceptual framework
  • Consultation on study design and interpretation of data on insomnia
  • Advisory panel in sleep disorders
  • Quality of life questionnaire in sleep disorders
  • Modification to the Sleep Impact Questionnaire following FDA review
  • Validation and linguistic adaptation of a sleep questionnaire
  • Linguistic validation of the Fatigue Impact Scale (FIS) into Argentinean Spanish, Austrian German, South African English, Norwegian and Afrikaans
  • Evaluation of the potential for a satisfaction claim for sleep disorders
  • Development of a PRO instrument for measuring mood swings and sleep problems resulting from vasomotor symptoms during the menopause
  • Evaluation of existing documentation and recommendations for psychometrically validating the modified Daytime Insomnia Symptom Scale (mDISS)
  • Scenario model in sleep disorders
  • Development of a sleep measure in different conditions
  • Report of sleep problems in fibromyalgia
  • Content validation of the modified Daytime Insomnia Symptom Scale (DISS) and the Sleep Impact Questionnaire event log
  • Manuscript on validation and efficacy results in insomnia

Metachromatic leukodystrophy

  • Understanding and documenting the disease burden of metachromatic leukodystrophy
  • Support of patient survey study development among patients with metachromatic leukodystrophy
  • Web-based survey implementation and analytic consulting support in metachromatic leukodystrophy
  • Clinical outcome assessment strategy development and validation in metachromatic leukodystrophy

Migraine

  • Literature review of cardiovascular disease in migraine patients
  • Systematic literature review in migraine
  • Development of a PRO measure in chronic adolescent migraine
  • Statistical analysis plan for in-trial psychometric validation of the assessment of chronic migraine symptoms and impacts measures
  • Gap analysis and assessment of PROs in migraine
  • Development of a PRO measure in postdrome migraine
  • Development of an FDA briefing document and regulatory support in chronic migraine
  • Qualitative interviews in chronic migraine headaches
  • Gap analysis of PRO measures in paediatric migraine
  • Generation of evidence for the content validity of instruments assessing motor weakness in hemiplegic migraine
  • Review of concussion PROs relating to migraine

Mitochondrial disease

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

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)

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

Other CNS and neurological experience

  • Socio-economic analysis and phase I of a cost effectiveness analysis model for human cord graft
  • Global value dossier and e-v@luate instance in attention deficit hyperactivity disorder (ADHD)
  • Validation of the amyotrophic lateral sclerosis functional rating scale (ALSFRS-R)
  • FDA consultancy and pre-NDA meeting in neurology
  • Literature review, conceptual models and mapping of generic utility instruments in neurology
  • Consultancy on an FDA submission for a central nervous system condition
  • Topline report on a side effect questionnaire in a central nervous system condition for submission

Pain (other)

  • Manuscript on Delphi panels in transdermal and intravenous patient-controlled analgesia (IV PCA) in pain patients
  • Literature research and value story update in pain
  • Global value dossier and e-v@luate platform development in pain
  • Competitor landscape review and model in pain
  • Review of documents for strategic recommendation on the validation of a questionnaire in opioids treatment for pain
  • Analysis of FDA and EMEA PRO claims in the areas of pain and inflammation
  • Literature review of functional scales in pain
  • Development and administration of a PRO to assess needle pain
  • Workshop for the development of a needle pain PRO questionnaire
  • Seminar on PROs in acute, chronic and acute recurring pain

Acute pain

  • Development of early cost utility and budget impact models for acute pain

Chronic pain

  • Core value dossier update in chronic pain
  • Manuscript on phase III quality of life data in severe chronic pain
  • Usability testing of ePRO devices ahead of their use in forthcoming clinical trials in chronic pain
  • PRO review in chronic pain

Trauma pain

  • Understanding the payer landscape and funding flows for trauma pain therapy in the emergency setting
  • Literature review and publication on trauma pain therapy in the emergency setting
  • Global value dossier and e-v@luate platform for a product in trauma pain
  • Global value dossier summary poster in trauma pain
  • Manuscript and structured literature review on product value in trauma pain

Parkinson’s disease

  • Global value dossier for a treatment in Parkinson’s disease
  • Cost effectiveness model on Parkinson’s disease in the USA
  • Pricing research for a new Parkinson’s disease treatment
  • Literature review, strategic consultancy, stakeholder interviews and outcomes assessment in Parkinson’s disease
  • Validation of the transfer of a patient diary for Parkinson’s disease from a paper version to an electronic diary
  • Psychometric validation of the IDQ in Parkinson’s disease
  • Consultation on linguistic validation of the IDQ in Parkinson’s disease
  • Naturalistic health outcomes trial in Parkinson’s disease
  • Development of a PRO strategy for a treatment in Parkinson’s disease
  • Development of an endpoint/measurement strategy for Parkinson’s disease
  • Literature review in Parkinson’s disease
  • Concept elicitation and cognitive debriefing interviews in GBA-Parkinson’s disease
  • Longitudinal quality of life and HE study in Parkinson’s disease patients with drug-induced dyskinesia
  • Abstract on a longitudinal quality of life and HE study in Parkinson’s disease patients with drug-induced dyskinesia
  • Conference poster on the results from a qualitative study of the impact of dyskinesia on Parkinson’s disease patients
  • Assessment of the impact of nocturnal syndrome on Parkinson’s disease patients