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Study Response Missing Assessment Base Tool

Audit denominators for independently coded study responses, without defining response criteria.

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Description

Audit denominators for independently coded study responses, without defining response criteria.

Research lesion records distinguish measured dimensions, geometric size models, censoring conventions, assessment denominators, and follow-up timing. An axis product, percent change, or coverage measure describes only its stated inputs and model. Such arithmetic does not automatically implement a clinical response criterion or validate a study.

Audit denominators for independently coded study responses, without defining response criteria.

When to use this tool

Use Study Response Missing Assessment Base when you need this research measurement, assessment-base, source, or event-time calculation.

How to use the tool and how it works

  1. Enter enrolled, assessed, responseCount, includeMissing. Use the units and conventions below.
  2. Run the tool. Correct any format, range, or cross-field input error before interpreting the output.
  3. Read denominator, missing, fractionDefined, responseFraction. Inspect fractionDefined before interpreting the associated values.

For nonnegative integer enrolled, assessed<=enrolled, and responseCount<=assessed choose denominator=enrolled if includeMissing, otherwise assessed. Return missing=enrolled-assessed, responseFraction when positive or zero otherwise, and fractionDefined.1

Input fieldMeaning and unitsAccepted input
enrolledEnrolledRequired. Safe integer; minimum 0.
assessedAssessedRequired. Safe integer; minimum 0.
responseCountResponse CountRequired. Safe integer; minimum 0.
includeMissingInclude MissingRequired. Boolean.
Output fieldInterpretationReturned shape
denominatorDenominator or exact integer denominator text under the stated sign restriction.Required. Safe integer.
missingMissingRequired. Safe integer.
fractionDefinedWhether the selected assessed/enrolled denominator is positive.Required. Boolean.
responseFractionResponse FractionRequired. Finite number.
json
{
  "input": {
    "enrolled": 100,
    "assessed": 80,
    "responseCount": 40,
    "includeMissing": true
  },
  "output": {
    "denominator": 100,
    "missing": 20,
    "fractionDefined": true,
    "responseFraction": 0.4
  }
}

Limitations and assumptions

  • Including missing observations changes the reporting base without resolving their outcomes. The zero on an undefined denominator is a placeholder; response definitions, trial estimands, and clinical conclusions are not supplied.
  • Inputs must satisfy both the field types and the cross-field conditions above. Invalid input causes an error; a successful false flag or documented placeholder is a different result.
  • Numeric calculations use binary floating point unless exact decimal-integer arithmetic is explicitly stated. No hidden measurement tolerance or decimal rounding is added; nonfinite or out-of-contract results are rejected. Numeric signed-zero results are exported as zero.

Alternative or Complementary methods

Use the intended study protocol and a complete measurement or analysis model for a broader conclusion. Verify lesion definitions, censoring, measurement correspondence, time anchors, and missing-assessment policy.

References

  1. Calculation and input contract: oncology/study-response-missing-assessment-base — tool.io

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