Patient-Centered Outcomes

/Patient-Centered Outcomes
Patient-Centered Outcomes 2018-12-03T05:29:13+00:00
Patient-Centered Outcomes

Capturing the Patient Experience to Optimize PRO/COA Endpoints

Our Patient-Centered Outcomes team captures the patients’ voice and engages with patients – whether that is part of the development of patient-reported outcomes instruments, as part of global value dossiers to support payer submissions, or to describe the patient’s journey through diagnosis and treatment to understand patients’ and caregivers’ unmet needs.

We offer a full range of Patient-Reported Outcomes and Clinical Outcomes Assessments services including:

  • Concept elicitation interviews
  • Cognitive debriefing interviews
  • Hybrid interviews
  • Coding and analysis of interviews
  • Assessment of saturation
  • Item generation and reconciliation meetings
  • Descriptive Methods
    • Response Compliance
    • Response patterns
    • Floor/Ceiling effects
  • Classical Methods
    • Inter-item correlations
    • Internal Consistency
    • Test-retest Reliability
    • Concurrent/convergent/divergent validity
    • Known-groups validity
  • Modern Methods: Empirical Domain Specification, Item Performance, Scoring
    • Exploratory Factor Analysis
    • Confirmatory Factor Analysis
    • Item Response Theory
    • Item Bias: Differential Item/Test Functioning
    • Unit-weighted, reliability-weighted, and plausible-value scores
  • Responsiveness/Sensitivity to detect change:
    • Distribution-based
    • Anchor-based
    • Cumulative distribution functions
    • Empirical responder definitions
  • Assess/Optimize Treatment Efficacy
    • Disease-tailored endpoint timing
    • Mixed-effect, Survival, and Joint-process models for time-dependent outcomes
    • Causal inference models
  • Provide recommendations on which right instruments to include in clinical trials and write appropriate sections for inclusion in the trial protocol
  • Support the development and/or review of PRO/COA-related statistical analysis plans and reports for appropriateness
  • Conduct analysis of PRO/COA endpoints, whether pre-specified or post-hoc
  • Assessment of patient, caregiver, and societal preferences (including willingness to pay) through use of discrete choice experiments
  • Utility elicitation using time-tradeoff approaches
  • Implementation of utility and other PRO/COA assessments during a patient’s journey through treatment to assess the comparative value of treatments
  • Developing PRO evidence dossiers for submission to the Food and Drug Administration (FDA) and European Medicines Agency (EMA)
  • Support/Facilitate PRO/COA Dossier Discussion at Type-A, Type-B, and/or Type-C
  • Strategic support and expert consulting advice for FDA, EMA, and HTA submissions
  • Determine disease burden
  • Identify potentially relevant PRO instruments
  • Assess psychometric properties of relevant published PRO instruments to determine appropriateness for context of use
  • Inform the new design or adaptation of PRO instruments

With Pharmerit as your partner, you have access to a team of leading scientists who have developed innovative methods and instruments that have been rapidly adopted by the field.

Why Pharmerit?

  • High-quality deliverables meeting HTA requirements

  • Multidisciplinary, dedicated teams including senior team members and experienced clinicians working on value communication/dossier development

  • Experienced HEOR and clinical researchers with a strategic focus, who are able to combine and interpret burden of illness, treatment pathway, clinical and economic evidence in order to support a product’s value communication and reimbursement strategy

  • Partnering with clients on products and portfolios from clinical development, launch, and post-launch

  • Innovative solutions to present and communicate the value of your product by interactive tools to visualize and highlight findings

Resources

“We chose Pharmerit because of their modelling expertise, flexibility and direct contact during the project. The collaboration was very pleasant, fruitful with relevant advice, resulting in quality deliverables.”

Global Senior Project Leader, Bayer Pharma AG

Meet Our Patient-Centered Outcomes Team

Patient-Centered Outcomes Publications

A New Method for Valuing Health: Directly Eliciting Personal Utility Functions

Authors: NJ Devlin, KK Shah, BJ Mulhern, K Pantiri, B van Hout

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Patient-reported Treatment-related Symptom Burden for Patients with Advanced Melanoma in Canada

Authors: WY Cheung; MK White; MS Bayliss; A Stroupe; A Lovley; BL King-Kallimanis; K Lasch

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Qualitative development of a patient-reported outcome symptom measure in diarrhea-predominant irritable bowel syndrome

Authors: P Marquis, KE Lasch, L Delgado-Herrera, S Kothari, A Lembo, C Lademacher, G Spears, A Nishida, WL Tesler, E Piault, K Rosa, B Zeiher.

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Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus: the PROFHER randomized clinical trial

Authors: A Rangan; H Handoll; S Brealey; L Jefferson; A Keding; B C Martin; L Goodchild; L H Chuang; C Hewitt; D Torgerson; PROFHER Trial Collaborators.

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Cultural adaptation: translatability assessment and linguistic validation of the patient-reported outcome instrument for irritable bowel syndrome with diarrhea.

Authors: L Delgado-Herrera; K Lasch, A Popielnicki; A Nishida; R Arbuckle; B Banderas; S Zentner; I Gagainis; B Zeiher

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Partner with Pharmerit