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. 2021 Jul 17;28(4):2708–2719. doi: 10.3390/curroncol28040236

Table 2.

Illustrative quotes for themes on sources of uncertainty identified in pCODR documents.

THEME (FREQUENCY) QUOTATION
TRIAL VALIDITY (50%)
  • SELECTION BIAS

  • REPORTING BIAS

  • PERFORMANCE BIAS

  • ATTRITION BIAS

“Uncertainties about the heavily pre-treated patient population”
“The open label nature of the trials might introduce the risk of reporting and performance biases, as the study participants and the investigators were aware of the treatment assignments.”
POPULATION (47%)
  • ECOG

“From a methodological perspective, the low number of Canadian patients in the study make it uncertain how generalizable results are to the broader Canadian population.”
COMPARATORS (40%)
  • NO COMPARATORS

  • INAPPROPRIATE COMPARATORS

“Substantial uncertainty due to non-comparative data”
“Uncertainty in results of indirect comparisons”
OUTCOMES (72%)
  • UNVALIDATED ENDPOINTS

  • MISSING DATA

“Progression-free survival may be a surrogate outcome for overall survival, but it has not been determined if benefits of PFS [progression-free disease] translates into overall survival benefits in patients with pancreatic neuroendocrine tumors.”
“Modest improvement in progression-free survival”
“There were uncertainties with regard to the magnitude of the progression-free survival benefit”
“Neither study reported quality of life data”
INTERVENTION (83%)
  • DURATION OF TREATMENT

  • ADOPTION FEASIBILITIES

  • BUDGET IMPACT

“pERC acknowledged a substantial uncertainty regarding duration of treatment”
“pERC noted that the administration of intravenous daratumumab is resource-intensive due to the duration, frequency, and changing pattern of dosing”
“[There is a] concern that implementation could lead to significantly increased resource utilization (e.g., nursing, pharmacy, clinic, and chemotherapy chair time”