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Table 2 Adapted SPIRIT figure showing the visits and documented parameters of the PATRONUS study

From: Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) – study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study)

Activity

Visit 1 (screening, consent)

Visit 2 (surgery)

Visit 3–6 (POD 3–5, 6–8, 10–14, 30–35 or at discharge)

Visit 6TEL (POD 30–35 if patient has been discharged before)

Visit 7/8 (postoperative month 3 and 6)

expenditure of time per visit approx

20–25 min

15 min

15 min

15 min

Inclusion/exclusion criteria

X

    

Informed consent

X

    

Demographics and baseline data

X

    

Documentation of PROMs:

 a.) 12 symptoms PRO-CTCAE*

 b.) cancer-specific HRQoL**

X

 

X§

X

X

Surgery

 

X

   

Postoperative morbidity***

  

X

X

 

SSI$

  

X

X

 

Length of hospital stay

  

X

X

X

Reoperations

  

X

X

X

(Re)admissions

  

X

X

X

Overall survival

  

X

X

X

  1. * 12 symptoms as recommended by the National Cancer Institute: fatigue, insomnia, pain, anorexia, dyspnoea, cognitive problems, anxiety, nausea, depression, neuropathy, constipation, diarrhoea assessed via PRO-CTCAE™
  2. ** according to the EORTC quality of life questionnaire C30
  3. *** according to Clavien-Dindo
  4. $ Documentation of SSI according to CDC [40, 41]
  5. § HRQoL once only on POD 30–35 or at discharge (Visit 6)
  6. TEL Visit can be performed by telephone
  7. SSI surgical site infection, CDC Centers of Disease Control and Prevention, POD postoperative day, OS overall survival, PROM patient-reported outcome measure, CTCAE Common Terminology Criteria of Adverse Events, HRQoL health-related quality of life