Musculoskeletal diseases

Arthritis

Manuscript and analysis on an anti-inflammatory treatment for arthritis
PRO literature review for two different anti-inflammatory drugs for the treatment of arthritis

Ankylosing spondylitis

Interactive cost-effectiveness model for a selective inhibitor treatment used for ankylosing spondylitis
Manuscript cost-effectiveness analysis of a treatment for ankylosing spondylitis in Norway
Workshop and FAQ development in immunology in ankylosing spondylitis
Development of a payer value deck in immunology in ankylosing spondylitis
Competitor review deck in ankylosing spondylitis
Total Brand FAQ deck and Total Brand Workshop in ankylosing spondylitis
Global value dossier and budget impact model for a biosimilar in ankylosing spondylitis
Competitor value story slide deck in ankylosing spondylitis
Core value dossier in ankylosing spondylitis
Global value dossier update for the latest HEOR evidence in ankylosing spondylitis
Development of launch materials in ankylosing spondylitis
HTA strategy in ankylosing spondylitis
GI tolerability endpoint white paper including literature and instrument reviews on ankylosing spondylitis

Axial spondyloarthritis

Payer slide kit in non-radiographic axial spondyloarthritis
Structured literature review and value dossier updates in a biosimilar for axial spondyloarthiritis
Payer value deck for a biosimilar in axial spondyloarthiritis

Juvenile idiopathic arthritis

Workshop and FAQ development in immunology in juvenile idiopathic arthritis
Development of a payer value deck in immunology in juvenile idiopathic arthritis
Frequently asked questions deck in juvenile idiopathic arthritis
Structured literature review and value dossier updates in a biosimilar for juvenile idiopathic arthritis
Payer value deck for a biosimilar in juvenile idiopathic arthritis

Osteoarthritis

Global value dossier and budget impact model for a biosimilar in osteoarthritis
Literature review of PROs and endpoints of pain in osteoarthritis
Literature review to support the use of COA measures in osteoarthritis
Competitive assessment and burden of illness study in osteoarthritis
Review of endpoints for clinical trials in osteoarthritis
Instrument review and assessment strategy in osteoarthritis
Mixed treatment comparison of two treatments for osteoarthritis of the knee
Mode of administration validation study for an electronic diary in back pain for osteoarthritis patients
Development and cognitive debriefing on a patient global response to a treatment measure in osteoarthritis pain
Translation and validation of the revised Hopkins Verbal Learning Test for osteoarthritis
Translation and validation of an osteoarthritis diary
Development of a measure of disease flare in osteoarthritis patients
Patient interviews to capture disease burden and unmet treatment needs in hand osteoarthritis
Mode of administration equivalency and usability testing of COA instruments in osteoarthritis
GI tolerability endpoint white paper including literature and instrument reviews on osteoarthritis
Consulting on PRO analysis and study design of trials in osteoarthritis
Top up literature review of PROs in osteoarthritis
Gap analysis and review of PRO measures in osteoarthritis
Qualitative exit interviews to assess the patient experience of treatment and clinical trial participation among patients with osteoarthritis

Psoriatic arthritis

Payer dossier update in psoriatic arthritis
Support for a manuscript on a network meta-analysis in psoriatic arthritis
Systematic literature review and network analysis in psoriasis and psoriatic arthritis
Targeted literature review in psoriatic arthritis patients with concomitant moderate to severe psoriasis
Workshop and FAQ development in immunology in psoriatic arthritis
Development of a payer value deck in immunology in psoriatic arthritis
Competitor review decks in psoriatic arthritis
Competitor value story slide deck in psoriatic arthritis
Structured literature review and value dossier updates in a biosimilar for psoriatic arthritis
Data checks and DEF amendments in psoriatic arthritis
HTA support regarding psoriatic arthritis submissions in Canada, Spain and the UK
Regulatory support on SMC questions on psoriatic arthritis work
Payer interviews and message testing in psoriatic arthritis
Payer value deck for a biosimilar in psoriatic arthritis
Core value dossier on psoriatic arthritis
Global value dossier update for the latest HEOR evidence in psoriatic arthritis
Development of launch materials in psoriatic arthritis
HTA strategy in psoriatic arthritis
Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of psoriatic arthritis

Rheumatoid arthritis

Literature search, data extraction and report on rheumatoid arthritis
Cost-consequences manuscript on rheumatoid arthritis
Generating evidence to support the unmet need in rheumatoid arthritis
Measuring indirect and societal costs of morning stiffness in patients with rheumatoid arthritis
Manuscript on a treatment in rheumatoid arthritis
Review of an economic model to assess utility requirements for a treatment in rheumatoid arthritis
Utility study and economic model in rheumatoid arthritis
Review of European HTA requirements for treatment in rheumatoid arthritis
Adaptation of an economic model on treatment of rheumatoid arthritis for the USA
Value message testing for a biosimilar in rheumatoid arthritis
Objection handler in rheumatoid arthritis
Economic model on a treatment for rheumatoid arthritis
Budget impact model for a biosimilar in rheumatoid arthritis
Competitor review in rheumatoid arthritis
Competitor review of two JAK inhibitors in rheumatoid arthritis
Payer focused value communication on rheumatoid arthritis
Payer value proposition in rheumatoid arthritis
Frequently asked questions on an immunology biosimilar for rheumatoid arthritis
Literature review of unmet need in rheumatoid arthritis
Literature review and recommendations for rheumatoid arthritis
Utility study in rheumatoid arthritis
Competitor value story in rheumatoid arthritis
Competitor value stories for two treatments of rheumatoid arthritis
Manuscript on a budget impact model for a cross-indication biosimilar in conditions including rheumatoid arthritis
Core value dossier, value deck and objection handler in rheumatoid arthritis
Update to an AMCP dossier for a rheumatoid arthritis biosimilar
Global value dossier and budget impact model for a biosimilar in rheumatoid arthritis
Workshop and FAQ development in immunology in rheumatoid arthritis
Development of a payer value deck in immunology in rheumatoid arthritis
Total Brand FAQ deck and Total Brand Workshop in rheumatoid arthritis
Structured literature review and value dossier updates in a biosimilar for rheumatoid arthritis
Review of PROs and preparation and writing of a PRO briefing document for the FDA on the treatment of rheumatoid arthritis
Generation of evidence to support the unmet need in rheumatoid arthritis
Modified Delphi Panel to gain consensus in rheumatology (rheumatoid arthritis)
Update to payer materials in rheumatoid arthritis
Payer value deck for a biosimilar in rheumatoid arthritis
Development of a PRO strategy in rheumatoid arthritis
Qualitative research in rheumatoid arthritis
Poster and manuscript on an indirect comparison of biologic treatments for TNF-IR rheumatoid arthritis patients
Systematic review to explore minimal important differences in PROs for rheumatoid arthritis
Meta-analysis of joint structural deterioration over time in minimally treated rheumatoid arthritis patients with inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR)
Mixed treatment comparison of efficacy and safety of an immunosuppressant drug versus a TNF inhibitor drug in rheumatoid arthritis patients with DMARD-IR
Mixed treatment comparison of an oral drug used in the treatment of rheumatoid arthritis
Characterising and predicting treatment response to rheumatoid arthritis biologic therapy
Literature review of unmet need in rheumatoid arthritis
Mixed treatment comparison of a treatment for rheumatoid arthritis populations – DMARD-IR and MTX-naive patients
Q&A and mixed treatment comparison on a treatment for rheumatoid arthritis
Indirect comparison of a monotherapy treatment for rheumatoid arthritis patients with DMARD-IR
Face and content validity testing of a tiredness item in a sample of rheumatoid arthritis patients
Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of rheumatoid arthritis
Psychometric evaluation of a PRO in rheumatoid arthritis
Evaluation of fatigue in rheumatoid arthritis using a PRO instrument
Patient interviews on rheumatoid arthritis
Patient interviews to capture disease burden and unmet treatment needs in rheumatoid arthritis
Support in development and analyses of a patient support programme in indications including rheumatoid arthritis
GI tolerability endpoint white paper including literature and instrument reviews on rheumatoid arthritis
Top up literature review of PROs in rheumatoid arthritis
Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of rheumatoid arthritis

Cervical dystonia

Validation and reliability of the Pictorial Spasmodic Torticollis Rating Scale (P-STRS) in cervical dystonia
Development of a screening tool in cervical dystonia (Delphi panel) and validate using registry
Validation of a screening tool in cervical dystonia
Measurement strategy in cervical dystonia
Content validity of global questionnaires in cervical dystonia

Duchenne muscular dystrophy

Gap analysis of clinical outcome assessments and natural history of duchenne muscular dystrophy
Qualitative interviews with patients, caregivers and clinicians to define a clinician global impression of change item for duchenne muscular dystrophy

Fibromyalgia

Literature review of PROs and endpoints of pain in fibromyalgia
Competitive assessment and burden of illness in fibromyalgia
Assessment of the feasibility of achieving claims for cognitive functioning in fibromyalgia
Gap analysis and endpoint review in fibromyalgia
Validation of the fatigue Visual Analogue Scale (VAS) and Jenkins Sleep Scale for fibromyalgia
Development of a manuscript on fatigue and sleep triangulation results in fibromyalgia
Development of a manuscript on the use of the Jenkins Sleep Scale on patients with fibromyalgia
Focus groups to determine the best questionnaire to assess fibromyalgia and recommendations for clinical trials
Assessment of PROs in fibromyalgia
Development of a manuscript in fibromyalgia (reporting results from focus groups and Delphi panel phases)
Endpoint review of fatigue and functioning in fibromyalgia
Development of a conceptual framework for the measurement of fatigue in patients with fibromyalgia
Pilot testing interviews on fibromyalgia fatigue
Consultancy relating to the psychometric validation of the daily diary of fatigue symptoms in fibromyalgia (DFS-Fibro)
Manuscript reporting the results from the validation of the DFS-Fibro
PRO assessment in fibromyalgia and diabetic peripheral neuropathy
Development of a dossier on the Daily Diary of Fatigue Symptoms – Fibromyalgia (DFS-Fibro) and regulatory consultancy for fibromyalgia
Consultancy for fibromyalgia fatigue study
Post-hoc Rasch analysis of existing data from the DFS-Fibro
Validation study of the modified version of the Brief Pain Inventory – Short Form (mBPI-SF), MOS-S and 3 single item questions in fibromyalgia and diabetic peripheral neuropathy
Report of sleep problems in fibromyalgia
Burden, economics, epidemiology and treatment patterns in fibromyalgia

GNE myopathy

Review and support for the development of a FDA dossier in patients with GNE Myopathy
Development of a manuscript describing the GNE Myopathy Functional Activity Scale (GNEM-FAS) validation
Development of a user manual for the GNEM-FAS validation
Analysis of the GNEM-FAS validation
Support for translations of the GNEM-FAS
Post-hoc analyses to aid interpretation of change in GNE Myopathy endpoints including the primary endpoint of the strength composite score

Gout

Patient interviews to inform the development of a PRO strategy to support labelling claims in gout
Manuscript on patient interviews to inform the development of a PRO strategy to support labelling claims in gout

Masseter muscle

Development and validation of a PRO for masseter muscle hypertrophy
In-trial validation of a PRO for masseter muscle prominence in Canada and Taiwan
Development and psychometric evaluation of severity measures in masseter prominence
Conceptual equivalency and psychometric evaluation of PRO and ClinRo measures of masseter muscle prominence
Interim psychometric evaluation of the lower facial shape questionnaire in masseter muscle hypertrophy

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

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 musculoskeletal experience

Economic analysis and trial design in hip replacement
Payer value slide deck in muscle relaxation management
Manuscript on a budget impact model for a biosimilar in rheumatology
General consultancy on economic and quality of life endpoints in planned trials in several musculoskeletal disease indications
Measurement strategy to demonstrate efficacy of medical devices in patients with pigmented villonodular synovitis (PVNS) or tenosynovial giant cell tumour (dTGCT)
Review adherence questionnaire in a musculoskeletal disease

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