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

Touati 2014.

Study characteristics
Methods Secondary citation(s)
  • NA


Language of publication
  • English


Study design
  • Retrospective, single‐centre study


Study centre(s)
  • University Hospital of Limoges, France


Country
  • France


Median follow‐up time (range)
  • 65.8 months (2.2‐194.5)

Participants Number of included participants
  • Total: 158

  • With interim‐PET: 68


Inclusion criteria
  • Histologically proven, classic HL


Exclusion criteria
  • Nodular lymphocyte predominant HL


Consent
  • Not reported


Recruitment period
  • February 1995 to July 2011


Age (range, in years)
  • 38 (16‐85)


Ethnic group(s)
  • Not reported


Stages of disease
  • All stages


Comorbidities
  • Not reported


Therapy regimen
  • According to the standard of care at the time of diagnosis therapy regimens included ABVD, MOPP/ABV hybrid or BEACOPP; number of cycles not reported

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


Definition of prognostic factor(s)
  • Not reported


Timing of prognostic factor measurement
  • After cycle 2 of chemotherapy


Method for measurement (use of specific scale and cut‐off)
  • Visual evaluation

  • PET‐positive if focal or diffuse accumulation of FDG in lesions higher than in surrounding tissue

  • FDG‐PET‐CT data (2005 and later) retrospectively reinterpreted using the Deauville 5‐point scoring system


Was the same definition and method for measurement used in all participants?
  • Different PET imaging techniques over time (dual‐head coincidence until 2005, then FDG‐PET‐CT), quality assurance and quality control program to ensure comparability of methods


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

Outcome(s) Primary outcome(s) and definition(s)
  • Progression‐free survival (PFS), defined as time from date of diagnosis until relapse or death

  • Overall survival (OS), defined as time from first day of diagnosis until death from any cause


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


Timing of outcome measurement
  • At 5 years


Was the same definition and method for measurement used in all participants?
  • Yes


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 univariable analysis for each outcome
  • PFS: 68

  • OS: 68


Statistical method
  • Kaplan‐Meier (survival analysis)

  • Chi‐squared test or t‐test (differences between groups)

  • ANOVA (comparison of means)


How was the prognostic factor treated?
  • Binary


Multivariable analysis: No
Risk of bias (QUIPS) Study participation
  • Unclear risk

  • Availability of interim PET as part of inclusion criteria, but not clear why less than 50% of participants had interim PET data. No comparison of baseline study sample (n = 357) with included participants (n = 158).


Study attrition
  • Low risk

  • All participants with available interim PET included.


Prognostic factor measurement
  • Moderate risk

  • Retrospective reinterpretation of PET scans using the Deauville criteria. Method described, but unclear whether assessors were blinded to initial interpretation.


Outcome: Overall survival
Outcome measurement
  • Low risk

  • Clear definition. 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 appropriate for the data.


Outcome: Progression‐free survival
Outcome measurement
  • Low risk

  • Clear definition. 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 appropriate for the data.


Outcome: Adverse events
Not reported
Notes Conflict of interest
  • Not reported


Funding
  • This work was supported by the University Hospital of Limoges, CHU Limoges, F‐87042 France.