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. 2020 Jan 13;2020(1):CD012643. doi: 10.1002/14651858.CD012643.pub3

Hutchings 2014.

Study characteristics
Methods Secondary citation(s)
  • NA


Language of publication
  • English


Study design
  • Prospective, multi‐centre study


Study centre(s)
  • Not reported


Countries
  • USA, Italy, Poland, Denmark


Median follow‐up time (range)
  • 29 months

Participants Number of included participants
  • 126*


*Potential overlap of Danish participants with those included in Hutchings 2006
Inclusion criteria
  • Newly diagnosed classic HL


Exclusion criteria
  • None


Consent
  • Yes; written


Recruitment period
  • Not reported


Age (range, in years)
  • 34.1 (median, 16.8‐76.7)


Ethnic group(s)
  • Not reported


Stages of disease
  • All stages


Comorbidities
  • Not reported


Therapy regimen
  • Early‐stage disease: 2‐4 cycles ABVD followed by radiotherapy, or 6 cycles ABVD

  • Advanced‐stage disease: 6‐8 cycles ABVD with or without consolidation radiotherapy, with exceptions (5 Danish participants treated with BEACOPPesc)

Prognostic factor(s) Prognostic factor(s)
  • Interim PET


Definition of prognostic factor(s)
  • Whole‐body PET scan


Timing of prognostic factor measurement
  • Within the last 5 days of cycle 1 (PET1) and cycle 2 (PET2) (US and Italian participants had PET2 only if PET1 was positive)


Method for measurement (use of specific scale and cut‐off)
  • Deauville 5‐point scoring system

  • Scores of 1‐3 considered negative, scores of 4‐5 considered positive

  • Baseline interpretation by an expert with access to clinical information, second interpretation by an independent expert from another country blinded to clinical information


Was the same definition and method for measurement used in all participants?
  • No; not all participants received PET2


Were prognostic factor(s) assessed blinded for outcome(s), and for each other (if relevant)?
  • Yes; experts in both stages blinded to clinical outcome, baseline experts also blinded to clinical information

Outcome(s) Primary outcome(s) and definition(s)
  • Progression‐free survival (PFS), not defined

  • Overall survival (OS), not defined


Secondary outcome(s) and definition(s)
  • None


Timing of outcome measurement
  • At 2 and 3 years


Was the same definition and method for measurement used in all participants?
  • Not reported; unclear due to multi‐national study design


Was/were outcome(s) assessed blinded for prognostic factor(s), and for each other (if relevant)?
  • Not reported

Missing data Participants with any missing value?
  • No


If yes, how were missing data handled?
  • Not applicable

Analysis Univariable analysis: Yes
Total number of participants included in univariate analysis for each outcome
  • PFS: all

  • OS: all


Statistical method
  • Kaplan‐Meier (survival analysis)

  • Log‐rank (differences between groups)


How was the prognostic factor treated?
  • Binary


Multivariable analysis: Yes
Total number of participants included in multivariable analysis for each outcome
  • PFS: all

  • OS: none


Statistical method
  • Kaplan‐Meier (survival analysis)

  • Log‐rank (differences between groups)


How was the prognostic factor treated?
  • Binary


Number of candidate covariates
  • 3


List of all candidate covariates
  • Interim PET (positive or negative)

  • Extranodal involvement

  • Disease stage (early or advanced stage)

Risk of bias (QUIPS) Study participation
  • Low risk

  • Description of participants and study characteristics given. No inclusion and exclusion criteria. Consecutive sampling and no exclusion based on interim PET availability. Detailed description of treatment regimen.


Study attrition
  • Low risk

  • No loss to follow‐up.


Prognostic factor measurement
  • Low risk

  • Adequate measurement and description. Prognostic factor measured the same way for all participants.


Outcome: Overall survival
Outcome measurement
  • Low risk

  • Adequate measurement and description. Prognostic factor measured the same way for all participants.


'Other prognostic factors (covariates)'
  • High risk

  • Disease stage not accounted for.


Statistical analysis and reporting
  • Low risk

  • Statistical method in univariable analysis appropriate for the data.


Outcome: Progression‐free survival
Outcome measurement
  • Low risk

  • No definition of outcome. Outcome measured the same way for all participants.


'Other prognostic factors (covariates)'
  • High risk

  • Disease stage not accounted for.


Statistical analysis and reporting
  • Low risk

  • Statistical method in univariable analysis appropriate for the data.


Outcome: Adverse events
Not reported
Notes Conflict of interest
  • The author(s) indicated no potential conflicts of interest.


Funding
  • Not reported