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Table 1 Overview of outcome measures

From: Decision aids for second-line palliative chemotherapy: a randomised phase II multicentre trial

  

Timing of measurements1

Measures

Operationalisation

Baseline

T1

1 week

follow-up

T2

8 weeks

follow-up

T3

Main outcome measures

 Well-being

  Anxiety2

Hospital Anxiety and Depression Scale

x

x

x

  Depression

Hospital Anxiety and Depression Scale

x

x

x

  General health

0-10 (worst-best imaginable)

x

x

x

  Cancer Worries

Adapted Lerman’s Cancer Worry Scale

x

x

x

  Health-related quality of life

EORTC QLQ-C15-PAL

x

x

x

Additional outcome measures

 Coping

  Helplessness/hopelessness

Mental Adjustment to Cancer Scale

x

x

x

  Fighting spirit

Mental Adjustment to Cancer Scale

x

x

x

  Avoidance

Mental Adjustment to Cancer Scale

x

x

x

  Perceived participation

Problem-Solving Decision Making Scale

 

x

x

  Perceived involvement

yes/no

 

x

x

 Information-related measures

  Amount of information

1-7 (I received way too little-way too much information)

x

x

x

  Undesired information

yes/no

 

x

 

  Satisfaction with quality of information

1-6 (not satisfied-very much satisfied)

 

x

x

  Balanced presentation of information

1-5 (clearly in favour of chemotherapy plus BSC - clearly in favour of BSC alone)

 

x

 

  Evaluation of information

1-5 (no negative experience-very negative experience)

 

x

 

 Knowledge

  Subjective knowledge

1-10 (extremely poor-excellent)

x

x

 

  Objective knowledge

five statements to be judged as right or wrong

 

x

 

  Subjective risk perception

1-5 (very high-very low)3

 

x

 
 

1-7 (much higher-much lower)4

 

x

 

  Objective risk perception

0-100%5

 

x

 

 Decision-related measures

  Decision satisfaction-uncertainty

Decision Evaluation Scales

 

x

x

  Decision control

Decision Evaluation Scales

 

x

x

  Weighing pros and cons

Decision Evaluation Scales

 

x

x

  Treatment choice

chemotherapy + BSC /BSC alone/don’t know

 

x

x

  Strength of treatment preference

1-5 (not strong-very strong)6

 

x

 

 Treatment attitudes

  Valuations

1-10 (extremely poor-excellent)

 

x

x

  Treatment satisfaction

1-6 (dissatisfied-very satisfied)

  

x

  1. Abbreviation: BSC best supportive care
  2. 1Baseline: at inclusion; follow-up: 1 and 8 weeks after receiving the treatment-related information
  3. 2Anxiety is the primary outcome measure
  4. 3Question 1: 'the chance of experiencing an adverse event'
  5. 4Question 2: 'the chance of experiencing a beneficial effect on the tumour when having treatment with chemotherapy and BSC, as compared with BSC alone' and question 3 'the chance of experiencing pain when having treatment with chemotherapy and BSC, as compared with BSC alone'
  6. 5The absolute deviation between patient's objective risk perception and the actual risk (as identified in the literature reviews [7, 8] and presented in the DAs) was calculated.
  7. 6For patients whose treatment choice was ‘undecided’, the strength of the treatment preference was scored as zero