Central nervous system and neurological diseases

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

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

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

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

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

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

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

Spinal muscular atrophy

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

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

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)

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

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