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ePoster Display

1516P - Core variables for managed entry agreements, regarding clinical outcomes and patient reported measures, in cancer

Date

16 Sep 2021

Session

ePoster Display

Topics

Clinical Research;  Translational Research

Tumour Site

Presenters

Ana Silva

Citation

Annals of Oncology (2021) 32 (suppl_5): S1102-S1110. 10.1016/annonc/annonc711

Authors

A. Silva1, F.R. Gonçalves2

Author affiliations

  • 1 Porto Pharmacovigilance Centre, FMUP - Faculdade de Medicina da Universidade do Porto, 4200-319 - Porto/PT
  • 2 Department Of Community Medicine, Information And Health Decision Sciences - Medcids, FMUP - Faculdade de Medicina da Universidade do Porto, 4200-319 - Porto/PT

Resources

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Abstract 1516P

Background

The aim was to define a core set of outcomes, the Cancer Standard Set, that would serve as a guide to innovative outcome measurement initiatives, such as in the application of managed entry agreements or risk-sharing agreements.

Methods

We present a literature search in MEDLINE (for the three most common cancers) to identify baseline characteristics, treatment patterns and outcomes to guide discussions of the working group composed by oncologists, pathologists, radiotherapy specialists, surgeons, pharmacists, nurses and hospital managers to review existing data and practices. The group has had structured meetings to share evidence and expert opinions. We explain which outcomes are essential, respecting the proposal of Porter's three-tiers of hierarchy (Health status achieved/retained, Process of recovery and Sustainability of health), in his value-based healthcare framework.

Results

We include baseline characteristics such as: birth date, death date, admission date, main diagnosis and respective date, ECOG performance status, comorbidities, sex, topographic location, behaviour, histological type, genetic markers/biomarkers and cancer stage. Treatments can be surgical, pharmacological and/or radiotherapy/brachytherapy. In all types of treatment, patient-reported QOL outcomes should be periodically applied, as per appropriate protocol. In the surgical treatment the outcomes include: surgery date, beginning and ending date of hospitalization, procedure, radicality of surgery, radicality of anatomy, need for unplanned reintervention, unwanted postoperative occurrence, relevant devices and their cost. Both in pharmacological treatment and in radiotherapy/brachytherapy the outcomes include: beginning and ending treatment date, cycles number of, name of the protocol/medication/procedure, toxicity and complications, evaluation of the response and its date. Regarding pharmacological treatment, the date of disease progression and the medicines cost should also be included.

Conclusions

We set forward a base for cancer-related research and management of entry agreements. The systematic collection of this set of outcomes will generate insights for future decisions and improve healthcare.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Francisco Rocha Gonçalves.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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