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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/OutcomesLinked 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 studyCOS 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 MNPCR D plus Mortality PCBaSe
Overall survival Requires identifying patients in H and measuring mortality in MNPCR D plus Mortality; PCBaSe
Cause (disease) specific survival Requires identifying patients in H and measuring cause of death in MNPCR D plus Mortality; PCBaSe
  Relative survival Requires comparing the above measures to a similar population (by age, sex) without the diseaseNPCR 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 timeNPCR 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 availableNPCR 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 HNPCR 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 aboveNPCR 5yrf-up; PCBaSe
Development of metastases  Requires identifying codes for metastatic carcinoma (196–199) or secondary cancersNPCR 5yrf-up; PCBaSe
  Metastases-free probability  Requires measuring probability using the outcome aboveNPCR 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 failureRequires 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 PMPCBaSe
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 PMPCBaSe
  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 outcomesPCBaSe
  Costs Requires measuring costs in H, e.g., using DRG tariffs, and medication costs in PMPCBaSe
  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 PMPCBaSe
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 outcomePCBaSe
 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)