Cardiovascular diseases

Angina

  • Gap analysis of PRO measures to substantiate labelling claims in angina trials of a drug-eluting stent (DES)
  • Cognitive debriefing interviews and item finalization for a PRO for microvascular angina (MVA)

Artery diseases and high cholesterol

  • Literature review of burden of illness and cardiovascular risk group identification of symptomatic peripheral artery disease
  • Literature review and payer appraisals in peripheral artery disease
  • Budget impact and economic evaluation of a statin
  • Advisory board on arterial occlusive disease
  • Workshop communicating health economic data of an anticoagulant medication for deep vein thrombosis (DVT)
  • Development of a treatment satisfaction measure for an injectable low-density lipoprotein (LDL) cholesterol lowering medication
  • Costs for psychometric validation of the Injection-Treatment Acceptance Questionnaire (I-TAQ) in an independent observational study in hypercholesterolemia
  • Statistical consultancy to support use of the I-TAQ for a cholesterol-lowering medication
  • Production of a revised heart model for hypercholesterolaemia incorporating additional comments from country affiliates
  • Worldwide database analysis of statins and cholesterol levels
  • Probabilistic analysis of a statin model and advice on a pharmacoeconomic manuscript
  • Endpoint review for FDA-approved flushing claims in atherosclerosis

Atrial fibrillation

  • Payer digital value communication testing in stroke prevention in patients with atrial fibrillation (SPAF)
  • Analysis of atrial fibrillation in the UK
  • Qualitative research on PROs in atrial fibrillation
  • Development of PRO instrument modules and validation research in atrial fibrillation
  • Manuscript on the development of a symptoms questionnaire in atrial fibrillation
  • Decentralised framework for real life data generation in stroke prevention in atrial fibrillation (SPAF)
  • Reporting of development work in atrial fibrillation
  • Indirect comparison of two drugs used in the prevention of thromboembolic events due to atrial fibrillation
  • Analysis of the Anti-Clot Treatment Scale (ACTS), Treatment Satisfaction Questionnaire for Medication (TSQM) and healthcare resource utilization in a clinical trial in atrial fibrillation
  • Manuscript development on the ACTS/TSQM data
  • Manuscript support for statistical results in an observational study measuring outcomes in atrial fibrillation
  • Measurement of resource use, satisfaction, productivity and HRQoL in atrial fibrillation
  • Translation and validation of the ACTS and TSQM in atrial fibrillation in Japan

Dyslipidaemia

  • Development of a manuscript from an existing report detailing an analysis already performed using an existing economic model in dyslipidemia

Heart disease

  • Global value dossier on cardiovascular disease and dyslipidaemia
  • Literature review of cardiovascular disease in migraine patients
  • Update of a report on the impact of changing total cholesterol targets in the General Medical Services (GMS) contract for heart disease
  • NHS and public health impact of revising General Medical Services (GMS) targets for cholesterol in coronary heart disease
  • Manuscript on the cost-effectiveness and budget impact of a statin treatment for coronary heart disease
  • Targeted literature review and value messages for cardiovascular disease
  • Investigator training and analysis of QoL data in heart disease
  • Analysis of the prevalence of bradycardia and co-morbidities in coronary artery disease
  • Data management and reporting of an outcomes project on a statin drug for the treatment of heart disease
  • Analysis of the SF-ESTQ in the JEWEL studies in heart disease
  • PRO questionnaire development for statin intolerance
  • Demonstrating the value of a transcatheter heart valve in aortic stenosis
  • Report on the cost of diagnosing vascular diseases with an MRA as the primary imaging modality
  • Consultation on an epidemiological quality of life study in cardiovascular disease
  • Development of a PRO best practices document in cardiovascular diseases – interactions with international regulatory and HTA agencies

Heart failure and transthyretin amyloid cardiomyopathy (ATTR-CM)

  • Payer value proposition and communication for a new remote patient monitoring platform in congestive heart failure
  • Objection handlers in transthyretin amyloid cardiomyopathy (ATTR-CM)
  • Disease area review, burden of illness and unmet needs in heart failure (and associated renal dysfunction)
  • Development of a PRO dossier for the Minnesota Living with Heart Failure Questionnaire and selection of a validated dyspnoea questionnaire
  • Content validity of a symptom endpoint and dossier in heart failure with preserved ejection fraction
  • Consultation on the validation of a primary clinical endpoint in heart failure
  • Chart review of heart failure in China
  • Meetings for a heart failure study
  • Heart failure chart review in China
  • Caregiver burden in patients with chronic heart failure
  • Psychometric validation of the chronic heart failure (CHF) caregiver burden questionnaire
  • Support for additional translations of the Heart Failure Compliance Questionnaire (HFCQ) for chronic heart failure
  • Network meta-analysis of pharmacological treatment of heart failure
  • Selection of a caregiver burden questionnaire for acute decompensated heart failure

Hypertension and Hypotension

Hypertension

  • Strategic treatment pathways for treatment in pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH)
  • Update to payer value decks in PAH and CTEPH
  • Framework for real world evidence generation in PAH and CTEPH
  • Strategic plan and real-world evidence toolkit in PAH and CTEPH
  • Consultancy on interpretation of phase III trial endpoints in PAH and CTEPH
  • Meta-analysis, systematic literature review, data extraction and report on an oral combination treatment of PAH
  • Systematic literature review, data extraction & report on sensitivity analyses and a meta-analysis of an oral combination treatment of PAH
  • Meta-analysis of an oral combination treatment of PAH
  • Meta-analysis of an oral treatment of PAH – exploratory analyses on the effect of administering additional PAH-specific therapy upon two additional endpoints
  • Literature review of pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD)
  • Utility assessment in PAH
  • Literature review of PAH secondary to chronic obstructive pulmonary disease (COPD)
  • Interpretation of clinical trial results in PAH
  • Cognitive debriefing interviews with patients with PAH
  • Network meta-analysis of combination therapies in PAH
  • Psychometric validation of the Living with Pulmonary Hypertension (LPH) questionnaire in PAH
  • PRO claims for PAH – endpoint review and regulatory support for the FDA and EMEA
  • PRO claims for PAH: endpoint review, regulatory support and qualitative patient interviews
  • Qualitative research to explore patient preference for modes of administration in PAH treatments
  • Budget impact model for an anti-hypertensive treatment
  • UK cost offset model of two treatments for hypertension
  • Preparation of an interactive report on a cost-offset model for a treatment for hypertension
  • Asian value dossier for hypertension
  • Heart study economic model in hypertension
  • Advisory board on hypertension
  • Cost model for a direct renin inhibitor medication for the treatment of hypertension
  • Validation of an adherence questionnaire for hypertension patients utilizing administrative data
  • Hypertension database analysis in Japan
  • Data management and reporting on a cardiovascular health outcomes project switching study in hypertension
  • Development of a compliance and persistence screener in hypertensive patients at risk for cardiovascular events
  • Validation of data analysis with an FDA response in orthostatic hypertension
  • Adaptation of a heart study economic model in hypertension to Korea
  • Validation of the hypertension / dyslipidaemia treatment satisfaction survey

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

Hyponatremia

  • Qualitative study to support the content validity of the trail making test and MOS-Cognition in patients with hyponatremia
  • Psychometric validation study of the TMT-B and MOS-Cognition tests in patients with hyponatremia
  • Regulatory support for cognition endpoints of a treatment for hyponatremia
  • FDA advisory committee meeting support for HRQoL endpoints in hyponatraemia

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

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

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

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

Thromboembolism and pulmonary embolism

  • Utility elicitation in thromboembolism in the UK
  • HTA assessment of therapeutic interventions and treatments for venous thromboembolism
  • Manuscript on the incidence of venous thromboembolism following major abdominal surgery
  • Abdominal surgery cohort study to evaluate the risk of venous thromboembolism
  • In-trial cost-consequences analysis of a drug used in venous thromboembolism
  • Matched cohort pulmonary embolism evaluation in orthopaedic surgery in Japan
  • Consulting on the Anticoagulant Treatment Satisfaction (ACTS) scale as an endpoint for FDA claims in venous thromboembolism and thromboembolism prophylaxis
  • Decentralised framework for real life data generation in venous thromboembolism