Pharmaceutical company funding of cancer patient advocacy organizations in the Netherlands.

BACKGROUND: Financial conflicts of interest (FCOI) of medical professionals and associated organizations with pharmaceutical companies (pharma) might contribute to the use of low value oncological treatments. Value criteria for oncological drug approvals in the Netherlands have recently become more stringent leading to objections by cancer patient advocacy organizations (cPAOs). Considering the importance of cPAOs input in cancer patient care we analyzed whether pharma funding of cPAOs occurs in the Netherlands. METHODS: The cPAO websites and available annual reports were evaluated for disclosure of pharma funding for the years 2021 and 2022. Also, data from the Dutch Healthcare Transparency Registry (DHTR) were extracted. RESULTS: Twenty-one of 34 (61.8 %) cPAOs received pharma funding (with 20 registered in the DHTR), and for 13 (29.4 %) cPAOs no reporting of pharma funding could be found. Three of the cPAOs disclosed pharma funding directly on their main website. Online educational material was available from 22 cPAOs on their websites with pharma funding disclosed on the educational material in 5. The total registered amount of pharmaceutical funding was €667,232.00 in 2021 and €536,098.00 in 2022. The median (and interquartile ranges) DHTR registered amount of support per cPAO that received funding in the studied period was €23,799.50 (14,823.75-84,663.30). The most common funding category as defined in the DHTR was project sponsorship. CONCLUSIONS: Financial support by the pharmaceutical industry is common for Dutch cPAOs. Given the importance of cPAOs and their objective input in the societal debate on the availability of cancer drugs, the potential influence of pharma sponsoring should be critically evaluated.

The Assessment of Burden of ColoRectal Cancer (ABCRC)-tool; a validity and reliability study.

INTRODUCTION: Follow-up care after treatment for colorectal cancer (CRC) is increasingly focused on health-related quality of life (HRQoL) and functional outcomes. The Assessment of Burden of ColoRectal Cancer (ABCRC)-tool is developed to measure these outcomes and support patient-oriented care. The tool comprises items assessing burden of disease and lifestyle parameters. It consists of a generic module combined with one of the three CRC specific modules. The objective of this study is to assess the construct validity and reliability of the items of the ABCRC-tool. METHODS: Patients who were receiving follow-up care after surgical CRC treatment were invited to complete the ABCRC-tool together with other validated patient-reported outcome measures (PROMs). Construct validity was assessed by testing expected correlations between items of the ABCRC-tool and domains of other PROMs and by examining predefined hypotheses regarding differences in subgroups of patients. Patients completed the ABCRC-tool twice, with 8 days apart, to evaluate its reliability. RESULTS: In total, 177 patients participated (64% male) with a mean age of 67 years (range 33-88). The colon, rectum and stoma module were completed by subsequently 89, 53 and 35 patients. Most items correlated as expected with anticipated domains of the EORTC QLQ-C30 or EORTC QLQ-CR29 (all p-values <0.05). Furthermore, the ABCRC-tool could discriminate between subgroups of patients. The intraclass correlation coefficient (ICC) was good (>0.70) for most items, indicating good reliability. CONCLUSION: The ABCRC-tool is a valid and reliable instrument that is ready for use in a clinical setting to support personalized follow-up care after CRC treatment.

Development and content validation of the Assessment of Burden of ColoRectal Cancer (ABCRC)-tool.

BACKGROUND: It is essential to include patient-reported outcomes (PROs), such as health-related quality of life and symptom burden, in follow-up care of colorectal cancer (CRC) survivors. These outcomes are most valuable when they are discussed with patients and used to guide follow-up care. The purpose of this study was to develop and validate the Assessment of Burden of Colorectal cancer (ABCRC)-tool: a tool that includes a patient-reported questionnaire covering the experienced burden of colorectal cancer, assessment of lifestyle parameters, visualisation of the results, and treatment advice. METHODS: A 5-step method was used to develop the ABCRC-tool: (1) definition of the experienced burden of CRC, (2) determination of the components of experienced burden, (3) formulation of the instrument preconditions, (4) literature study on existing instruments, (5) development of an integrated instrument. Content validity was evaluated by think-aloud interviews with 11 patients and 22 healthcare professionals (HCPs). RESULTS: The ABCRC-tool consists of a generic module and three CRC specific modules with items related to experienced disease burden, and lifestyle. The CRC specific modules are available for both colon and rectal cancer patients with anastomosis, and patients with a stoma. An algorithm with cut-off points was developed to visualise outcomes and offer treatment advice based on (inter)national guidelines. The evaluation of content led to a few minor amendments. CONCLUSION: The ABCRC-tool is a product of close cooperation between patients and HCPs and has good face and content validity. It is aimed to incorporate PROs in treatment decisions in oncological care.