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. 2015 Sep 10;25(4):616–637. doi: 10.1111/ecc.12361

Table 1.

Criteria for judging risk of bias of selected studies, adapted from the criteria suggested by the Cochrane Handbook for systematic reviews of interventions

Selection bias of participants
‘Low risk’ of bias Sites
  • Multicentred

  • Bicentred

Recruitment
  • Random selection

  • Sequential selection (e.g. first 50 volunteers)

  • Patient list from set criteria (e.g. age)

Inclusion/Exclusion
  • Children of parents in the study group have cancer diagnoses

  • Homogeneous times since diagnoses

‘High risk’ of bias Sites
  • Monocentred

Recruitment
  • Convenience sample

Inclusion/Exclusion
  • Children of parents in the study group have heterogeneous diagnoses (cancer and other condition)

  • Heterogeneous times since diagnoses

‘Unclear risk’ of bias Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’
Attribution bias (incomplete outcome data from participants)
‘Low risk’ of bias
  • Statistical comparisons between participants and non‐participants

  • High response rate (questionnaires: ≥65%; interviews: ≥75%)

  • Low attrition (according to number of measures used and length of follow‐up)

  • Missing data identified and managed for analysis

‘High risk’ of bias
  • Low response rate (questionnaires: 65%; interviews: 75%; Arber, 2001)

  • High attrition (according to number of measures used and length of follow‐up)

  • Missing data identified but not managed for analysis

‘Unclear risk’ of bias Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’
Reporting bias (from authors) due to selective outcome reporting
‘Low risk’ of bias Objectives/Hypotheses
  • Objectives/hypotheses clearly stated

  • Objectives/hypotheses addressed accordingly

Demographics
  • Demographic information on participants available

Outcome data/confounds
  • All collected data available in the results section

  • All data acknowledged (whether approving or disproving the hypotheses)

  • Confound variables acknowledged and controlled for statistically (e.g. as covariate in multivariate analyses)

  • Reasons for missing data acknowledged

  • Use of multi‐informant strategy when collecting data in children

  • Consideration of effect sizes (e.g. Cohen's d)

Discussion/Conclusions
  • Conclusions based on results

  • Limitations acknowledged

  • If preliminary study/pilot: acknowledged

  • No conflict of interest (source of funding acknowledged)

‘High risk’ of bias Objectives/Hypotheses
  • Objectives/hypotheses not clearly stated

  • Not all of the study's objectives/hypotheses addressed

Demographics
  • Missing demographic information on participants

Outcome data/Confounds
  • Missing collected data in the results section

  • Missing data disproving the hypotheses

  • Confound variables not acknowledged

  • No acknowledgement of reasons for missing data

  • No use of multi‐informant strategy when collecting data in children

  • No consideration of effect sizes (Cohen's d)

Discussion/Conclusions
  • Conclusions depart from results

  • Limitations are not acknowledged

  • If preliminary study/pilot: not acknowledged

  • Conflict of interest (source of funding not acknowledged)

‘Unclear risk’ of bias Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’
  • Confound variables acknowledged but not controlled for statistically

Other bias
‘Low risk’ of bias Participants
  • Large sample (Ratio of participants to predictors satisfying Tabachnick & Fidell's (2007) guidelines: N > 50 + 8p, where p: number of predictors)

Measures
  • Structured clinical interview

  • Measures with satisfactory pre‐established psychometric properties

  • Multimodal assessment (e.g. medical records and self‐reports)

Procedures
  • Use of procedures to maximise response rate or limit attrition

Design
  • Longitudinal

  • Data analysis strategy appropriate for exploring longitudinal causal effects (e.g. predicted outcome controlled for at baseline)

‘High risk’ of bias Participants
  • Small sample (Ratio of participants to predictors not satisfying Tabachnick & Fidell's (2007) guidelines: N > 50 + 8p, where p: number of predictors)

Measures
  • Measures have not been validated or insufficient pre‐established psychometric properties (e.g. ad hoc or home‐made measures)

  • Composite measures (e.g. combining subscales of parental distress and other constructs)

Procedures
  • No procedures used to limit attrition

Design
  • Cross‐sectional

‘Unclear risk’ of bias Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’

Arber S. (2001) Designing samples. In: Researching Social Life (ed. Gilbert N). SAGE Publications, London.

Tabachnick B.G. & Fidell, L.S. (2007) Using Multivariate Statistics, 5th edn. Pearson, Boston, MA.