Skip to main content
. Author manuscript; available in PMC: 2017 Sep 11.
Published in final edited form as: J Urol. 2016 May 6;196(4):989–999. doi: 10.1016/j.juro.2016.04.081

PICOTS (population, interventions, comparators, outcomes, timing, and setting) for the Key Questions

Population(s) Newly diagnosed adults (18 years or older) with solid renal masses (or cystic renal masses with a solid component) suspicious for stage I and II renal cell carcinoma, which corresponds to clinical stage T1 (less than 7 cm and organ confined) or T2 (greater than 7 cm and organ confined) renal masses
Interventions
  • Radical nephrectomy (open and minimally invasive)

  • Partial nephrectomy (open and minimally invasive)

  • Thermal ablation (e.g., radiofrequency ablation, cryoablation; surgical versus image-guided)

  • Active surveillance

  • Minimally invasive surgery may refer to standard laparoscopy or robot-assisted laparoscopy

  • No microwave ablation

Comparators Comparisons include all of the management options listed above
Outcomes Final health outcomes
  • Oncologic efficacy: Local recurrence-free survival, Metastasis-free survival, Cancer-specific survival

  • Renal functional outcomes: Glomerular filtration rate decline, Incidence of chronic kidney disease, Incidence of end-stage renal disease

  • Overall survival

  • Quality of life


Adverse effects of management strategies
  • Urologic complications: Acute kidney Injury, Hemorrhage, Urine leak, Hematuria, Loss of kidney, Ureteral injury (any injury of collecting system and ureter), Urinary tract infection

  • Non-urologic complications (by organ system): Hematologic (thromboembolic), Gastrointestinal, Cardiovascular, Respiratory, Neurologic, Wound complications (e.g. hernia and dehiscence), Infectious disease, Listed by severity of complications (using the Clavien Grading System if available):


Minor versus major
Minor (Clavien 1–2)*: conservative management or medications only
Major (Clavien 3–4)**: requiring intervention, resulting in permanent disability or death
  • Need for subsequent interventions: embolization, drain placement, stent placement, etc.

  • Perioperative outcomes: Blood loss (cc or mL), Blood transfusion (yes or no), Conversion to open surgery (%), Conversion to radical nephrectomy (%), Length of stay (days)

Type of study Controlled studies (randomized controlled trials, non-randomized controlled trials, and comparative cohort studies): All comparisons between interventions
Uncontrolled studies (single cohort studies): Data from uncontrolled studies that addressed active surveillance are described in the report.
Every other uncontrolled study that addressed Key Question 3 is listed in the appendix with the following data: Author, publication year, Study design, Intervention name, Number of patients, Followup, List of outcomes
Timing and Setting Any time point and setting

Clavien-Dindo system currently used for reporting of complications related to urologic surgical interventions (http://www.surgicalcomplication.info/index-2.html).