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Table 4 Mapping COS onto RWD sources in selected European countries: an exercise in feasibility

From: A scoping review of core outcome sets and their ‘mapping’ onto real-world data using prostate cancer as a case study

Outcome classification/Outcomes Linked administrative databases (Finland, Norway, Sweden, Hungary, Italy) Prostate Cancer data Base Sweden (PCBaSe): National Prostate Cancer Register (NPCR) linked to administrative databases (Sweden)
High-quality study COS for practice   Hospital discharges (H) Mortality (M) Purchased medication (PM) Notes   Notes
   Mortality and survival       
   Survival   Requires identifying patients in H and measuring mortality in M NPCR D plus Mortality PCBaSe
Overall survival   Requires identifying patients in H and measuring mortality in M NPCR D plus Mortality; PCBaSe
Cause (disease) specific survival   Requires identifying patients in H and measuring cause of death in M NPCR D plus Mortality; PCBaSe
   Relative survival   Requires comparing the above measures to a similar population (by age, sex) without the disease NPCR D plus Mortality; PCBaSe
Metastasis-free survival   Requires measuring survival in patients for whom no metastatic carcinoma codes (codes 196–199) or secondary cancers are discernible over time NPCR 5yrf-up; PCBaSe
   Progression-free survival   Requires stratifying patients for evidence of progression compared to those without, using codes identified as indicating disease progression (e.g., castration-resistant disease, metastases, recurrence) NPCR 5yrf-up; NCPR Tx; PCBaSe
Biochemical recurrence-free survival     No clinical test data is available NPCR 5yrf-up includes PSA levels at diagnosis and over time (changes), some indications in NPCR RT or RP
   Outcomes relating to neoplasms       
   (Change in) prostate-specific antigen (PSA) levels     Clinical test data are not available but the code for elevated prostate specific antigen (PSA) (e.g., 790.93) could be checked over time in the H NPCR 5yrf-up includes PSA levels at diagnosis and over time (changes), some indications in NPCR RT or RP
   Measurable disease response     Clinical data are not available   Might be possible using NPCR, but only RT and RP forms collect imaging data
   Time to progression    Requires identifying codes for indicating progression (e.g., castrationresistant disease, metastases, recurrence) NPCR 5yrf-up; NPCR Tx; PCBaSe
  Disease progression/Progression rate    Requires identifying codes for indicating progression (e.g., castrationresistant disease, metastases, recurrence) NPCR 5yrf-up; NPCR Tx; PCBaSe
   Progression-free probability    Requires measuring probability using the outcome above NPCR 5yrf-up; PCBaSe
Development of metastases    Requires identifying codes for metastatic carcinoma (196–199) or secondary cancers NPCR 5yrf-up; PCBaSe
   Metastases-free probability    Requires measuring probability using the outcome above NPCR 5yrf-up; PCBaSe
Symptomatic skeletal event    Requires identifying codes for pathologic fracture (e.g., 733.1), surgery or radiation to bone (e.g., ICD9 procedure codes indicating bone surgery, 79*) or radiation (e.g., ICD9 V58.0) combined with bone diagnoses, or spinal cord compression (e.g., 336.9) NPCR 5yrf-up; PCBaSe
  Local disease     Local disease recurrence would be difficult to discern, except the case where patients with established diagnoses (e.g., 185) over time, present later with an in situ diagnosis (233.4)   Difficult to discern but could follow technique at left; also may be helpful to stratify patients according to NPCR Tx.
  Positive surgical margins      NPCR 5yrf-up; NPCR RP
   Response duration       
   Failure-free probability       
   Development of castration-resistant disease20   Requires identifying patients with evidence of surgical castration (ICD9 procedure codes 62.3, 62.41, 62.42) or medical castration using ADT (e.g., ATC code L02BB03), noting also abiraterone (ATC L02BX03), and disease progression (e.g., metastases codes 196–199) subsequent to ADT or abiraterone; check also for elevated PSA (e.g., 790.93). NPCR 5yrf-up; NPCR RP subgroup; PCBaSe
  Treatment failure Requires measuring mortality and/or evidence of disease progression (e.g., metastases) for groups of patients stratified for various treatments (e.g., radical prostatectomy, ADT) NPCR 5yrf-up for failure of conservative therapy; PCBaSe
   Renal and urinary outcomes       
Urinary incontinence    Requires identifying relevant codes (e.g., 788.30) NPCR PROMs; PCBaSe
Urinary obstruction/irritation    Requires identifying relevant codes (e.g., 599.60) NPCR PROMs; PCBaSe
Urinary symptoms    Requires identifying relevant codes (e.g., 788*) NPCR PROMs; NPCR 5yrf-up; PCBaSe
   Voiding behaviour    Requires identifying relevant codes (e.g., 596.59, 788.69) NPCR PROMs; NPCR 5yrf-up; PCBaSe
   Haematuria    Requires identifying relevant codes (e.g., 599.7) PCBaSe
   Pelvic pain    Requires identifying relevant codes (e.g., 608.9) PCBaSe
   Lymphedema    Requires identifying relevant codes (e.g., 457.1) PCBaSe
  Urinary functioning    Requires identifying relevant codes (e.g., 788*) NPCR PROMs; NPCR 5yrf-up; PCBaSe
   Gastrointestinal outcomes       
Bowel symptoms    Requires identifying relevant codes (e.g., 787.99) NPCR PROMs; NPCR 5yrf-up; PCBaSe
  Faecal incontinence    Requires identifying relevant codes (e.g., 787.6) NPCR PROMs; PCBaSe
  Bowel functioning    Requires identifying relevant codes (e.g., 787.99) NPCR PROMs; NPCR 5yrf-up; PCBaSe
   Diarrhoea    Requires identifying relevant codes (e.g., 787.91, 564.5) PCBaSe
   Endocrine outcomes       
Hormonal symptoms   Requires identifying relevant codes related to side-effects from hormonal treatments (e.g., fatigue 780.79, weight loss 783.21) in patients with evidence of ADT (e.g., ATC code L02BB03), checking for chemotherapy with docetaxel (ATC code L01CD02) in PM. NPCR 5yrf-up;
NPCR Tx; PCBaSe
   Reproductive system outcomes       
  Erectile/sexual function    Requires identifying relevant codes (e.g., 607.84 and/or procedure codes 60.94, 60.95, 60.96, 60.97) NPCR PROMs; PCBaSe
Erectile/sexual dysfunction (impotence)    Requires identifying relevant codes (e.g., 607.84 and/or procedure codes 60.94, 60.95, 60.96, 60.97) NPCR PROMs; PCBaSe
Sexual symptoms    Requires identifying relevant codes (e.g., 607.84 and/or procedure codes 60.94, 60.95, 60.96, 60.97) NPCR PROMs; PCBaSe
   General outcomes       
Pain   Requires identifying relevant codes (e.g., 338*, 780.96, various) in H, ATC codes (N02*) in PM PCBaSe
Fatigue    Requires identifying relevant codes (e.g., 780.79) PCBaSe
   Weight loss    Requires identifying relevant codes (e.g., 783.21) PCBaSe
   Bone pain   Requires identifying relevant codes (e.g., 733.90), though the code is not specific only to bone pain, suggesting a need for further identification of codes for pain (e.g., 388*) in H and ATC codes for pain medications (e.g., N02*) in PM PCBaSe
   Anaemia    Requires identifying relevant codes (e.g., 285.9) PCBaSe
Performance status       
   Physical functioning       
Physical wellbeing/functioning      NPCR PROMs
   Emotional functioning/wellbeing       
Mental/emotional wellbeing/functioning     Not possible, although some measures of well-being, such as depression codes (e.g., 311, 2962 or 2963) in H or anti-depressives (ATC code N06A) in PM could be identified. NPCR PROMs
   Social functioning       
   Social functioning       
   Role functioning       
   Role functioning       
   Global quality of life       
  Quality of life      NPCR PROMs
   Economic outcomes       
   Cost-effectiveness   Requires measuring costs in H, e.g., using DRG tariffs, and medication costs in PM, and constructing cost-effectiveness measures for various treatments and outcomes PCBaSe
   Costs   Requires measuring costs in H, e.g., using DRG tariffs, and medication costs in PM PCBaSe
   Need for intervention       
  Need for salvage therapy     Salvage therapies might be partially identified by stratifying patients for therapies, e.g., radical prostatectomy (60.5 procedure code) followed by external beam radiotherapy (92.29 procedure code) or ADT (e.g., ATC L02BB03) NPCR 5yrf-up, to some extent;
NPCR Tx; PCBaSe, to some extent
  Need for curative treatment     This outcome seems to refer specifically to patients under active surveillance, difficult to ascertain, other than by observing a total lack of treatment upon and after diagnosis, followed by eventual treatment after some time. NPCR 5yrf-up, related to questions regarding reasons for terminating conservative therapy
Need for pain medication   Requires identifying relevant codes for pain (e.g., 338*, 780.96) in H, or pain medication (ATC codes N02*) in PM PCBaSe
Procedures need for local progression     As described for “need for salvage therapy” or “local disease”, such measures could follow a similar logic.   PCBaSe, to some extent
   Delivery of care       
   Time to treatment failure       
   Adverse events/effects       
Adverse events   Requires stratifying patients by therapy and then measuring any adverse events, i.e., complications of surgical and medical care, not elsewhere classified (996-999), urinary complications (997.5), bowel obstruction (560.9) or effects of radiation, unspecified (990). See also “major systemic therapy effects”. NPCR 5yrf-up; NPCR Tx; NPCR RP; NPCR RT; NPCR PROMs; PCBaSe
  Perioperative deaths   Requires measuring in-hospital deaths for surgical admissions and deaths within a certain timeframe from surgery (M) to give a (potentially incomplete) indication of this outcome PCBaSe
  Thromboembolic disease    Requires identifying relevant codes (e.g., 451*, 453*), pulmonary embolism (415.1), peripheral arterial occlusion disease (443.9), deep vein thrombosis codes, especially for ADT patients. Possibly also related procedure codes (e.g., venography, 886*). PCBaSe
  Bothersome or symptomatic urethral or anastomotic stricture    Requires identifying relevant codes (e.g., 598.9, 997.49). NPCR 5yrf-up; NPCR PROMs; PCBaSe
  Side-effects of hormonal therapy   Requires identifying relevant codes related to side-effects from hormonal treatments (e.g., fatigue 780.79, weight loss 783.21) in ADT patients (e.g., ATC code L02BB03). Also, see “Hormonal symptoms”. NPCR 5yrf-up; NPCR Tx; PCBaSe
Major systemic therapy effects   Requires stratifying patients into groups with evidence of systemic therapy, i.e., hormonal therapy (e.g., ATC L02BB04 in PM), chemotherapy (e.g., docetaxel L01CD02 or cabazitaxel L01CD04 in PM), immunotherapy (e.g., sipuleucel-T L03AX17), treatments for bone metastases (e.g., denosumab M05BX53 in PM). Evidence of side effects are then sought in H and/or PM. NPCR 5yrf-up; NPCR Tx; PCBaSe
  1. LEGEND: √ indicates that the outcome comes from a high-quality study [25, 26, 28] or from a 'COS for practice' one [26, 28], and that measures for the outcome can be constructed using the source of the data. Blank: There is no evidence of information in the database(s) that can be used to measure the outcome
  2. A description of the country-level databases investigated for the mapping exercise is provided in Table S1. All codes refer to (ICD9) diagnostic codes unless otherwise indicated. ATC codes refer to medications. All techniques assume that time is measured from incidence (first date of diagnosis, indate) to evidence of the code(s) for the symptom, treatment or outcome. In PCBaSe data, NPCR 5yrf-up are variables collected to measure 5-year follow-up for a group of patients with incident prostate cancer registered between 2003 and 2005 [19]. We assume administrative database techniques are used with the PCBaSe, including its recent developments (i.e. PCBaSeTraject tracking treatment trajectories over time, and Patient-overview Prostate Cancer (PPC) for hormonally treated prostate cancer) [18, 20]
  3. Abbreviations: ICD9 International Classification of Diseases (Ninth Edition), ATC Anatomical Therapeutic Chemical Classification System, PSA Prostate-specific antigen, ADT Androgen deprivation therapy, DRG Diagnosis-Related Group. NPCR D NPCR diagnostic (form), NPCR Tx NPCR work up and treatment (form), NPCR RT NPCR curative radiotherapy (form), NPCR RP NPCR radical prostatectomy (form), NPCR PROMs NPCR PROMs (form)