Table 3 Core area “death”, “physiological/clinical outcomes,” and “adverse events” (taxonomy based on Dodd et al. [18])
Core area | Outcome domain | Further definition of outcome (if applicable) | No. of studies, n (%) | No. of studies reporting as primary outcome | Variation in reported outcome |
|---|---|---|---|---|---|
Death | Mortality/survival | Mortality | 0/5 | - Reported as number or percentage of patients deceased - Time points: from up to 30 days to 6 months after intervention | |
Physiological/clinical outcomes | Blood and lymphatic system outcomes | Hemoglobin (Hb) levels | 6/12 | - Continuous variable: reported as mean ± SD concentrations or differences in concentrations - Categorical variable: success versus failure in reaching target Hb (10g/dL); number/percentage of patients reaching Hb >10g/dL - Time points: at baseline, 28-35 days prior to surgery, at day of surgery, 1 day to 6 months postoperatively, at discharge - 2 studies reported number of patients reaching a Hb level of 10 g/dL before surgery and time needed for it | |
Change in iron metabolism parameters | 1/6 | - Reported as mean ± SD concentrations or differences in concentrations of iron parameters: ferritin, transferrin, transferrin saturation, iron, iron-binding capacity - Time points: up to 4 preoperatively and up to 4 postoperatively or not specified | |||
Blood loss | 0/2 | - Reported as estimated mean blood loss ± SD and blood loss in drainage - Time points: 5 and 7 days postoperatively | |||
Other outcomes regarding hematopoiesis | 0/2 | - Reported as mean ± SD or differences in number of white and red blood cells, and mean cell volume - Time points: preoperatively up to 4 weeks and up to 4 weeks postoperatively | |||
Adverse events | Adverse events (AE) | See variation in reported outcome | 0/10 | - Reported as incidence/number of AEs with various definitions: ‘Clavien-Dindo-Classification’, ‘Common Terminology Criteria for Adverse Events’, overall complications, mild AEs, AEs with need for further intervention, serious AEs, AEs related to study drug, specific AEs (blood and lymphatic system, gastrointestinal system, immune system, infection and infestation, nervous system, respirator system, renal and urinary system, vascular system; general symptoms such as pain, nausea), or not further specified - Reported as odds ratio with 95% CI (association of factors with outcome of interest), median with IQR - Categorical analysis of subtypes of adverse events (e.g., surgical wound as subtype of infection etc.) or subdivision of Clavien Dindo Score (1/2 vs. 3a-5 vs. 3 vs. 4 vs. 5) Time points: 4 weeks preoperatively and 4 days postoperatively, preoperatively, during treatment, and up to 30 days postoperatively |