Article Text

Cohort profile
Cohort profile: Bladder Cancer Data Base Sweden (BladderBaSe) 2.0
  1. Christel Häggström1,2,
  2. Oskar Hagberg3,
  3. Truls Gårdmark4,
  4. Firas Aljabery5,
  5. Viveka Ströck6,7,
  6. Abolfazl Hosseini8,
  7. Amir Sherif9,
  8. Per-Uno Malmstrom1,
  9. Karin Söderkvist10,
  10. Anders Ullén11,12,
  11. Tomas Jerlström13,
  12. Staffan Jahnson5,
  13. Fredrik Liedberg3,14,
  14. Lars Holmberg1,15
  1. 1Department of Surgical Sciences, Uppsala University, Uppsala, Sweden
  2. 2Northern Registry Centre, Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden
  3. 3Department of Translational Medicine, Lund University, Lund, Sweden
  4. 4Department of Clinical Sciences, Karolinska Institute, Danderyd Hospital, Stockholm, Sweden
  5. 5Department of Clinical and Experimental Medicine, Division of Urology, Linköping University, Linköping, Sweden
  6. 6Department of Urology, Sahlgrenska University Hospital, Gothenburg, Sweden
  7. 7Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden
  8. 8Department of Urology, Karolinska University Hospital, Stockholm, Sweden
  9. 9Department of Surgical and Perioperative Sciences, Urology and Andrology, Umeå University, Umeå, Sweden
  10. 10Department of Radiation Sciences, Umeå University, Umeå, Sweden
  11. 11Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden
  12. 12Department of Pelvic Cancer, Genitourinary Oncology and Urology unit, Karolinska University Hospital, Stockholm, Sweden
  13. 13School of Medical Sciences, Örebro University, Örebro, Sweden
  14. 14Department of Urology, Skåne University Hospital, Malmö, Sweden
  15. 15Translational Oncology & Urology Research (TOUR), School of Cancer and Pharmaceutical Sciences, King's College London, London, UK
  1. Correspondence to Dr Christel Häggström; christel.haggstrom{at}umu.se

Abstract

Purpose We constructed Bladder Cancer Data Base Sweden (BladderBaSe) 2.0 to expand studies in BladderBaSe on incidence, treatment outcomes, side effects, survival and health economic aspects of men and women with cancer in the urinary bladder, upper tract urothelial carcinoma (UTUC) (renal pelvis and ureter) and urethral carcinoma.

Participants BladderBaSe 2.0 includes 53 298 patients with cancer in the urinary bladder, diagnosed from 1 January 1997 to 31 December 2019, and 961 patients with UTUC in the renal pelvis and 792 in the ureter, and 146 patients with urethral urothelial carcinoma, diagnosed from 1 January 2015 to 31 December 2019, and in total 275 816 participants in reference groups, free of cancer in the urinary tract, matched 1:5 on sex, age and county.

Findings to date To date, 18 published studies based on data from the BladderBaSe have investigated calendar time trends in survival; impact of gender, socioeconomic factors, tumour aggressiveness and hospital volume for radical cystectomy on prognosis; survival after radical cystectomy compared with radical radiotherapy; risk factors for complications and side effects after radical cystectomy such as thromboembolism, strictures of ureteroenterostomies and incisional hernia.

Future plans The BladderBaSe initiators are currently investigating gender-dependent detection delays due to urinary tract infections; survival after non-muscle invasive bladder cancer with respect to the number of transurethral resections; short-term outcomes comparing open and robot-assisted radical cystectomy; studies on risk for intravesical recurrence after different diagnostic measures in UTUC, and suicide risk after bladder cancer diagnosis. The BladderBaSe project group is open for collaborations with national and international colleagues.

  • Adult urology
  • Urological tumours
  • Radiation oncology
  • Urological tumours
  • Adult surgery

Data availability statement

Data are available on reasonable request. Reports from the SNRUBC are available online (only in Swedish). Researchers can apply for data by submitting a proposal to the BladderBaSe 2.0 steering committee and data files for studies can be uploaded to remote servers for secure analysis. For more information contact the corresponding author.

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STRENGTHS AND LIMITATIONS OF THIS STUDY

  • The Bladder Cancer Data Base Sweden (BladderBaSe 2.0) includes data from 55 197 patients with cancers in the urinary tract, using national registers with high coverage collected during more than 20 years.

  • The BladderBaSe 2.0 includes information on tumour characteristics and treatments, extensive follow-up through registers, and data on important confounding factors such as socioeconomic variables and comorbidity.

  • The BladderBaSe 2.0 includes data of 275 816 randomly selected matched reference participants to the cancer cases.

  • Results from specific validation studies are included as attachments.

  • Limitations are lack of lifestyle data such as smoking and alcohol use, and molecular information of the cancer cases.

Introduction

We have previously linked data from The Swedish National Register for Urinary Bladder Cancer (SNRUBC) to several national healthcare and demographic registers to construct the Bladder Cancer Data Base Sweden (BladderBaSe).1 The linkage created a comprehensive and population-based cohort of patients with bladder cancer with detailed data on background and tumour characteristics, treatment, socioeconomic factors, comorbidity and causes of death enabling studies of incidence trends, effects of treatment, overall and disease- specific survival.

For further studies of the epidemiology, care, management and outcomes for patients with cancer in the urinary tract, we constructed the BladderBaSe 2.0. This novel research database expands the previous version to also include: (1) longer follow-up, with data additional from patients diagnosed through 2019 and updated data in the SNRUBC (described below in further detail); (2) patients with urothelial carcinoma of the upper urinary tract (UTUC) (renal pelvis and ureter) and urethra; (3) data from the Prescribed Drug Register; (4) reference populations free of cancer in the urinary tract, randomly selected from the background population and individually matched on age, sex and county, at the date of diagnosis of the patients. The matched participants can be used as a prospective comparison cohort or as controls in case–control designs.

Cohort description

The Swedish National Register for Urinary Bladder Cancer (SNRUBC)

The BladderBaSe 2.0 like the previous version builds on SNRUBC1 with its current updates. SNRUBC is a clinical database created for clinical audit and research. Data in the SNRUBC are updated with half-year intervals and presented in an interactive online report.2 All new diagnoses of a tumour in the urinary tract for individuals 18 years or older are requested to be reported into the SNRUBC. The specific coding criteria for inclusion are shown in online supplemental table 1. The records in SNRUBC are validated and checked for completeness by comparison with the Swedish Cancer Register, to which reporting is mandated by law (see below). The total capture ratio as compared with the Swedish Cancer Registry was 2017–2019 between 97% and 99%. For the same years, the capture ratios stratified by cancer sites were >98%, for cancer in the urinary bladder and UTUC, and around 90% for urethral carcinoma.2

Patient records in the SNRUBC are standardised into different registration forms. For bladder cancer, five different forms are used and for UTUC and urethral carcinoma, three different forms are used, with separate variables adapted for each cancer site. An overview of the different forms and their included variables is shown in table 1. For bladder cancer, the forms for tumour information at diagnosis and primary treatment have been used since the initiation of the SNRUBC, 1 January 1997. Participants with non-muscle invasive bladder cancer (NMIBC) (stage Ta, Tis or T1) without metastases diagnosed 2004 and onwards are followed up at 5 years after diagnosis for relapse, progression, and death. From 1 January 2011, detailed data in conjunction with radical cystectomy are registered including surgical parameters, complications and reoperations up to 90 days postoperatively.

Table 1

Standardised forms with data collection in the SNRUBC for BladderBaSe 2.0

Updates in SNRUBC included in BladderBaSe 2.0 are data on UTUC and urethral carcinomas since 1 January 2015, including forms for tumour information at diagnosis and primary treatment. From 1 January 2017, oncological treatments are reported with details on neoadjuvant, adjuvant, induction or palliative systemic treatment for all patients with any urinary tract cancer. Sequential reporting of oncological systemic treatments for locally advanced and/or metastatic disease can also be reported in the SNRUBC.

Flow chart and number of participants included in each registration form are shown in figure 1 for bladder cancer, and in online supplemental figure 1 for patients with (A) UTUC in the renal pelvis and ureter, and (B) urethral carcinoma. The variables and different options included in the forms for diagnosis of bladder cancer, primary treatment, radical cystectomy and 5-year follow-up for NMIBC and their capture ratios are shown in tables 2–5. Detailed data of complications and reoperations registered in the radical cystectomy form is listed in online supplemental table 2. Variables and options for diagnosis and primary treatment for UTUC in the renal pelvis and ureter, and for urethral carcinoma are shown in online supplemental tables 3–5. Capture ratios for the four different parts of the oncological treatment form for all cancer sites included are shown in online supplemental table 6. Detailed data on neoadjuvant, induction, adjuvant and palliative systemic oncological treatment is listed in online supplemental table 7.

Figure 1

Flow chart and number of participants with bladder cancer included in the different forms of SNRUBC and included in the BladderBaSe 2.0. BladderBaSe, Bladder Cancer Data Base Sweden; SNRUBC, Swedish National Register for Urinary Bladder Cancer.

Table 2

Variables, their options and proportions, and variable capture ratios in the standardised form for diagnostic variables for bladder cancer of the SNRUBC in the BladderBaSe 2.0

Table 3

Variables, their options and proportions, and variable capture ratios in the standardised form for primary treatment variables for bladder cancer of the SNRUBC in the BladderBaSe 2.0

Table 4

Variables, their options and proportions, and variable capture ratios in the standardised form for preoperative perioperative and postoperative variables radical cystectomy variables for bladder cancer of the SNRUBC in the BladderBaSe 2.0

Table 5

Variables, their options and proportions, and variable capture ratios in the standardised form for 5 years follow-up for non-muscle invasive bladder cancer (NMIBC) of the SNRUBC in the BladderBaSe 2.0

Table 6

Retrieved register information linked to both cases and reference populations from nation-wide healthcare and demographic registries included in the BladderBaSe 2

Table 7

Baseline data of bladder cancer cases and their reference population in the BladderBaSe 2.0

The BladderBaSe 2.0

In 2020, data on participants in the SNRUBC with date of diagnosis from 1 January 1997 to 31 December 2019, were linked to a number of healthcare and demographic registries at the National Board of Health and Welfare and the Statistics Sweden by use of the personal identification number (PIN)3 (see figure 2). A matched reference group with individuals free from cancer in the urinary tract at the time of diagnosis of the index case were randomly selected from the background population at Statistics Sweden. Five reference participants were selected without replacement for each index cancer patient at date of diagnosis, matched for sex, year of birth and county, separately for each cancer site in the urinary tract. The referent participants were allowed to later develop cancer in the urinary tract; hence one individual could first be a referent in the database and later a patient, with corresponding new referents allocated.

Figure 2

Flow chart of register linkages to construct the BladderBaSe 2.0. LISA, Labour Market Studies; SNRUBC, Swedish National Register for Urinary Bladder Cancer.

Selected data from the Swedish Household Census and the Register of Total Population and Population Changes, and the Longitudinal Integration Database for Health Insurance and Labour Market Studies (LISA) were also linked to the data in SNRUBC and the reference population. Data for all individuals (participants in the SNRUBC and the reference population) was linked at the National Board of Health and Welfare to the Cancer Register, The Patient Register, The Cause of Death Register and The Prescribed Drug Register. Participants in the BladderBaSe 2.0 have been assigned an internal identification number, for which the key between the PIN and internal id number is kept exclusively by Statistics Sweden. An overview of variables retrieved from each register is shown in table 6. More details of each register and selected variables are described below. The BladderBase 2.0 is structured as four different study databases, one for each cancer site included.

The Prescribed Drug Register

The Swedish Prescribed Drug Register started in July 2005, and includes all prescribed drugs dispensed at pharmacies.4 Each row in the register corresponds to one dispensation at a pharmacy with dose and Anatomical Therapeutic Chemical code. Data on drugs for hormonal treatment, antibiotics, osteoporosis treatment, psychiatric drugs, tuberculosis and cancer treatment, and data on all medications to calculate the Drug Comorbidity Index5 were retrieved from this register. The Drug Comorbidity Index is built of data of prescribed drugs within 1-year period before diagnosis/index date for cases/referents.

The Patient Register

The Swedish Patient Register includes information regarding inpatient and outpatient care from 1987. The Charlson Comorbidity Index (CCI) was calculated with data from the Patient Register to estimate the concomitant disease burden of the both the cases and the reference population in BladderBaSe 2.0.6 The CCI was calculated based on recorded diagnoses withing 10 years prior to diagnosis/index date for cases/referents. A validation study of the Patient Register reported high validity for most diagnoses, with a positive predictive value about 85%–95%.7 Furthermore, data were retrieved both prior to and after the date of bladder cancer diagnosis from the Patient Register on risk factors for bladder cancer, risk factors of treatment side effects and/or modifiers of treatment response and natural history of the disease. Examples of such data are urinary tract infections, diabetes mellitus, chronic obstructive pulmonary disease and abdominal or pelvic surgery.

The Cancer Register

In Sweden, all new histologically, cytologically or clinically diagnosed tumours are by law reported to the Regional Cancer Centres, and these regional registries report once a year to the national Swedish Cancer Registry.8 The Swedish Cancer Register was initiated 1958 and has due to mandatory reporting high coverage.9 We retrieved data on all other cancer diagnoses and their dates from this register, irrespective of date of bladder cancer diagnosis for all participants in the BladderBaSe 2.0.

The Cause of Death Register

From the Cause of Death Register, we retrieved data on underlying and contributing causes of death and dates of death. The Cause of Death Register was initiated on 1953, and proportion of missing death certificates in 2014 was 1%.10

Swedish Household Census and the Register of Total Population and Population Changes

We retrieved data from the Register of Total Population and Population Changes and the Swedish Household Census on marital status, continent of birth, dates of immigration and emigration.11 Furthermore, we retrieved data from the Swedish Household Census from year 1990 on socioeconomic status based on the Swedish Socio-Economic Index and profession.

Longitudinal Integration Database for Health Insurance and Labour Market Studies (LISA)

The LISA database holds annual registers from 1990 of data based on the labour market, educational and social sectors.12 The LISA database provides information at an individual level, and at a group level such as families, companies and places of employment. From the LISA database we retrieved information about socioeconomic variables such as educational level, annual family and individual income.

Socioeconomic background factors and comorbidity of participants diagnosed with bladder cancer and their reference group are shown in table 7, and similar data for patients with UTUC and urethral carcinoma and their corresponding reference groups in online supplemental tables 8–10.

Table 8

Publications based on the BladderBaSe version 1.0

Patient and public involvement

Patients’ advocates or public representatives were not involved in the design or conduct of studies in BladderBaSe 2.0. The SNRUBC is, like other Swedish National Quality Registers, obliged to inform all patients prior to registration with an option to opt-out. The SNRUBC steering committee have patient representatives from two organisations and the results from research based on the SNRUBC, including the BladderBaSe 2.0, are transferred back to patient advocates and support groups through the quality assurance system at the Regional Cancer Centres.

Findings to date

Published studies

To date, there are 18 published studies based on the BladderBaSe. A number of clinically relevant inferences have emerged: Age-related differences in prognosis in bladder cancer points to age-dependent differences in management and in tumour biology. Findings about risk of recurrence after stage TaG1 bladder cancer and papillary urothelial neoplasm of low malignant potential (PUNLMP) challenge the recently adapted notion that management strategies can be merged into one low-risk group of NMIBC. Treatment for bladder cancer, after or in conjunction with another primary cancer, should not be neglected and carries the same probability of success as treatment in patients with bladder cancer only. Survival after radical cystectomy in Sweden is similar during holiday and non-holiday periods, contradicting indications about season related survival differences in bladder and renal cancer in other studies. A study of possible factors explaining why a lower socioeconomic status (SES) is associated with lower survival in bladder cancer indicate that comorbidity and treatment delay contribute, but optimisation of all aspects of care across SES strata is necessary. A clinical challenge is an increasing proportion of node-positive patients with significant comorbidity, where one additional publication on the natural history of those patients unable to receive curatively intended therapy reported that they frequently are hospitalised during their final year of life and primarily die of bladder cancer. Our data makes a strong case for a randomised study defining the role of second look resection in stage T1 bladder cancer. The cumulative incidence of midline incisional hernia after cystectomy continues to rise over many years and avoiding postoperative wound dehiscence is a critical preventive measure. Ureteroenteric strictures after cystectomy requiring intervention is a larger clinical problem than previously anticipated and continue to be relevant many years after the primary operation. Findings of the association between caseload and outcome after radical cystectomy support centralisation for surgical treatment of bladder cancer. More details of all these studies are shown in table 8.

Some of these findings have changed practice for urothelial carcinoma care in Sweden and been incorporated in the Swedish National Guidelines on Urothelial carcinoma.13 For example, the regionalisation of the cystectomy care in Sweden during recent years is supported by the identification of an improved overall survival in hospitals in the highest period-specific mean annual hospital cystectomy volume tertile (above 25 cystectomies annually).14 The risk of venous thromboembolism after treatment for muscle-invasive bladder cancer, particularly after chemotherapy is increased also beyond 30 days, challenging the current recommendation of prolonged low molecular weight heparin for 4 weeks after radical cystectomy.15 Furthermore, during follow-up of patients with primary bladder cancer and PUNLMP, follow-up cystoscopies beyond 3 years are not recommended any longer in the Swedish national guidelines on urothelial carcinoma based on a lower risk of recurrence compared with TaG1-tumours.16

Ongoing investigations

The initiators of BladderBaSe are currently investigating survival of NMIBC, gender-dependent detection delays related to urinary tract infections, outcomes after robot-assisted and open radical cystectomy, studies of outcomes after different diagnostic modalities in UTUC, and psychological effects from a bladder cancer diagnosis, such as suicide. Furthermore, planned projects involve studies of; associations between hormonal pharmacological interventions and incidence and prognosis in bladder cancer; of risk factors for complications after radical cystectomy among women; of treatment patterns and outcomes for patients with UTUC and urethral carcinomas; of health economy studies in patients with advanced bladder cancer; of long-term consequences of urinary diversion on metabolism and bone health; of the association between different approaches to lymph node dissection and prognosis; and of associations between the metabolic syndrome and risk of and prognosis in bladder cancer.

Strengths and limitations

Strengths

To our knowledge, the BladderBaSe 2.0 forms the largest clinical database for cancers in the urinary tract, with data from 55 197 patients and 275 816 randomly selected reference participants. The cancer cases are recruited from an entire nation in a register with very high coverage, collected during more than 20 years. The main strengths of the BladderBaSe 2.0 are detailed information on tumour characteristics and treatments, extensive follow-up through registers for all individuals, data on important confounding factors such as socioeconomic variables and comorbidity, and access to a large reference population which can be used as a prospective comparison cohort or as controls in case–control designs. Information about prescribed drugs and hospitalisations can be used to address questions relating to intended treatment outcomes as well as side effects, and to study health economy. Another strength is the recent validation studies described below.

Validation of data for T1 patients in the SNRUBC as compared with medical charts

Specially trained nurses with extensive experience of registration in the SNRUBC and other national urological registries did a second registration using original data in the medical charts for all patients registered in the SNRUBC 2008 and 2009 with clinically stage T1 (cT1) tumours (N=1044).17 Variables validated were dates of referral to a urologic consultation and transurethral resection of the tumour. In addition, tumour characteristics such as tumour grade according to WHO 1999 system and clinical TNM category (TNM 2009) were reregistered as was the primary treatment. The validation registration was also completed with information about T category of the second-look resection. Results from this validation are shown in online supplemental file 2.

Validation of short-term outcomes of radical cystectomy in the SNRUBC

Data in the radical cystectomy form in the SNRUBC (variables listed in table 4) was validated using the linked data from the BladderBaSe 2.0. Data on unscheduled readmissions, reoperations, dates and causes of death within 90 days from radical cystectomy was compared with the Patient Register and the Cause of Death Register among patients undergoing radical cystectomy from 2011 to 2019. Results of this validation are shown in online supplemental file 3.

Validation of postoperative complications of radical cystectomy in the SNRUBC as compared with medical charts

Data on postoperative complications, readmission rates, and death in with 90 days from radical cystectomy was validated by a comparison between data in the SNRUBC and medical charts in two healthcare regions in Sweden in 2011 to 2016.18 The study included 429 randomly selected patients from a larger cohort of 949 patients and showed under-reporting in the SNRUBC of low-grade complications (Clavien-Dindo I–II), and readmissions, but less under-reporting of high-grade complications (Clavien-Dindo III–V).

Limitations

BladderBaSe 2.0 lacks information on tobacco and alcohol exposure. We have proxy information in the linked registers for these exposures consisting of data regarding diagnoses or medications for tobacco-related and alcohol-related diseases. However, these proxies will not adjust for all confounding by smoking and alcohol use. Additionally, we only have limited patient reported outcome measures. However, distribution of the validated Swedish version of the Functional Assessment of Cancer Therapy Scale Vanderbilt Cystectomy Index prior to radical cystectomy and 12 months postoperatively has been initiated on a national basis.19 Furthermore, as noted above, for some sites of the urinary tract we miss information for approx. 10% of the patients. However, we have to date no information to tell us that these are extreme outliers that would threaten the external validity for studies of patients with cancers at these sites. Another limitation is lack of molecular information for the cancer cases.

A limitation within the SNRUBC is that the tumour stage at progression for patients with NMIBC progressing to muscle-invasive disease is registered only from 2004 and onwards. However, the clinical tumour stage can also be ascertained from the radical cystectomy form for patients undergoing secondary cystectomy at progression. In addition, short follow-up time for recently introduced novel oncological systemic immunotherapies for advanced disease reduce the possibility to do studies with survival outcomes in these patients.

Collaboration

The steering group of the SNRUBC and the project group working with the BladderBaSe 2.0 are open for collaborations with national and international colleagues. For more information please access the SNRUBC website,2 or contact the corresponding author. De-identified data can be available to researchers after application to the BladderBaSe Steering Committee. Researchers have to provide a methodologically sound proposal for a project that conforms with the Swedish Ethical Review Authority permit for the project. Researchers will have to sign a data access agreement. Data to achieve the aims in the approved proposal will be made available at a secure remote server.

Data availability statement

Data are available on reasonable request. Reports from the SNRUBC are available online (only in Swedish). Researchers can apply for data by submitting a proposal to the BladderBaSe 2.0 steering committee and data files for studies can be uploaded to remote servers for secure analysis. For more information contact the corresponding author.

Ethics statements

Patient consent for publication

Ethics approval

This study was approved by The Research Ethics Board at Uppsala University, Sweden. (Dnr 2015-277, 2019-03574, 2020-05123, and 2022-01747-02)

Acknowledgments

This project was made possible with help of the data collected in the SNRUBC, and we would like to thank the steering committee, and all involved that support the SNRUBC. We thank Hans Garmo for calculations of the Drug Comorbidity Index 5. We also thank Pia Mårtensson-Löthgren, Anton Svensson, and Therese Lithner for organising the data deliveries from their different authorities.

References

Supplementary materials

Footnotes

  • Contributors CH, LH, FL and OH initiated the study and drafted the manuscript. TG, FA, VS, AH, AS, P-UM, KS, AU, TJ, SJ, FL and LH contributed with data and CH and OH analysed data. All authors revised the manuscript and approved the final version to be published. LH is the guarantor of the study.

  • Funding This work was supported by the Swedish Cancer Society, grant number CAN 2019/62 and CAN 2020/0709.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.