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Table 1 Outcomes and their Operationalization

From: Protocol of the OPTIMAL study: Optimization of polypharmacy in geriatric oncology - A randomized controlled trial

Outcomes

Ascertainment/Operationalization

Time of assessment

Week

3

Month

4–5

Month

8–9

Month 12–13

Year 1–10

Total medication quality

Total FORTA score

x

 

x

  

Medication underuse

FORTA medication underuse sub-score

x

 

x

  

Medication overuse

FORTA medication overuse sub-score

x

 

x

  

PIM use

FORTA PIM use sub-score

x

 

x

  

Global health status

EORTC-QLQ-C30 questions: 29 + 30

 

x

x (primary)

x

 

Physical functioning

EORTC-QLQ-C30 questions: 1–5

 

x

x

x

 

Role functioning

EORTC-QLQ-C30 questions: 6,7

 

x

x

x

 

Emotional functioning

EORTC-QLQ-C30 questions: 21–24

 

x

x

x

 

Cognitive functioning

EORTC-QLQ-C30 questions: 20,25

 

x

x

x

 

Social functioning

EORTC-QLQ-C30 questions: 26,27

 

x

x

x

 

Dyspnoea

EORTC-QLQ-C30 question: 8

 

x

x

x

 

Pain

EORTC-QLQ-C30 questions: 9, 19

 

x

x

x

 

Insomnia

EORTC-QLQ-C30 question: 11

 

x

x

x

 

Appetite loss

EORTC-QLQ-C30 question: 13

 

x

x

x

 

Nausea and vomiting

EORTC-QLQ-C30 questions: 14,15

 

x

x

x

 

Constipation

EORTC-QLQ-C30 question: 16

 

x

x

x

 

Diarrhoea

EORTC-QLQ-C30 question: 17

 

x

x

x

 

Dizziness

Self-developed

     

Fatigue

EORTC-QLQ-C30 questions: 10,12,18

 

x

x

x

 

Physical fatigue

EORTC-FA12

questions: 1–5

 

x

x

x

 

Emotional fatigue

EORTC-FA12

questions: 6–8

 

x

x

x

 

Cognitive fatigue

EORTC-FA12

questions: 9–10

 

x

x

x

 

Interference of fatigue with daily life

EORTC-FA12

question: 11

 

x

x

x

 

Frailty

FRAIL-SCALE

   

x

 

Falls

Frequency, self-reported

   

x

 

Hospitalizations

Frequency, self-reported

   

x

 

All-cause mortality

All deaths

    

x

Cancer mortality

ICD-10 codes C00-C97

    

x

Non-cancer mortality

All ICD-10 codes except C00-C97

    

x

  1. Abbreviations: European Organisation for Research and Treatment of Cancer’s Quality of Life Questionnaire’s Core 30 items; EORTC-QLQ-FA12, EORTC’s Quality of Life Module Measuring Cancer Related Fatigue with 12 items; FORTA, Fit fOR The Aged; FRAIL-SCALE, Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight; ICD, International Classification of Diseases; PIM, potentially inappropriate medication