Abstract and Introduction
Abstract
Background and Objective: Upper tract urothelial cancer (UTUC) lacks high-quality evidence to appraise current patterns of presentation, diagnosis, treatment and outcomes as a result of disease rarity and patient heterogeneity. Registries may overcome many of the challenges making clinical trials challenging in UTUC and provide answers to many of the clinical questions that afflict UTUC management. In this narrative review we aim to summarise the design of registries that have contributed to the UTUC literature, discuss their strengths and limitations and the future directions of registries in UTUC.
Methods: Two independent reviewers conducted a search of the OVID MEDLINE database from July 2002–July 2022. Included articles were required to be published in peer reviewed journals and use registry-based methodology to report on UTUC. Search was limited by MeSH and key words and was limited to the English language.
Key Content and Findings: One hundred and forty-four articles were identified and included as reporting on UTUC from a registry-based methodology. Articles utilising registry-based data have substantially increased over the study period with the majority of articles arising from large generalised cancer databases in North America. There has been an increase in UTUC-specific registries in the previous five years that have offered the most granular, complete analysis and these will continue to report in the coming years. The majority of published data assessed epidemiological factors and compared outcomes of treatment modalities with a small proportion of articles focusing on prognostic nomograms and quality of life. Larger cancer registries that contribute the majority of the published analysis are likely subject to significant selection bias when comparing cohorts for treatment analysis and the need for prospective UTUC specific registries is apparent. Future directions include the potential for registry-based randomised controlled trials (RCTs) and clinical quality registries (CQR) that have the ability to change practice and improve care.
Conclusions: The utilisation of registry-based methodology for analysis in UTUC has increased substantially over the last 20 years. In addition to the utilisation of large cancer registries, the creation of UTUC specific registries is likely to contribute the most granular, translatable data in diagnosis and management.
Introduction
Upper tract urothelial cancer (UTUC) arises from the urothelial lining of the kidney or ureter and accounts for approximately 5–10% of all urothelial cancer (UC).[1] Whilst incidence of UTUC remains low at 1–3 cases/100,000 people/year, it is rising in many nations around the world.[2] There are histological similarities between UTUC and bladder UC however the presentation, diagnosis, treatment and outcomes differ significantly. Patients diagnosed with UTUC are likely to be older with more comorbidities and are presenting with more invasive disease.[3] This in combination with a low incidence often makes recruitment into clinical trials challenging and costly. For this reason, much of the understanding of UTUC is extrapolated from bladder UC or from systematic reviews that often rely on low-level evidence with many clinical questions remaining unanswered.
Registries are structured data repositories that systematically collect and store health related data.[4] Registries collect observational data about a specific exposure, disease, treatment or healthcare resource.[5] In general health registries are designed to be broad and have few if any exclusion criteria in order to quickly capture large patient cohorts and relay a real-world experience of patient care. Health related registries come in several different forms with different purposes and requirements.
Disease- or condition-specific registries are the most common form of registry and collect information on patients diagnosed with that disease in a specific setting such as a hospital or outpatient setting.[6] These registries provide varied levels of epidemiological, diagnostic, treatment and outcome data. Common examples are cancer registries or rare-disease registries. These are often maintained at a state or national level and many countries around the world maintain comprehensive repositories that can be accessed for clinical research.[7]
Drug or medical device registries are designed to monitor the safety and efficacy of medication or devices utilised in healthcare. Their main purpose is to monitor long-term real-world outcomes of medical devices and facilitate recalls where required.[8] They are usually maintained by the medical device company, may not be publicly accessible and often collect a very narrow range of data.
Clinical quality registries (CQR) are similar to disease or condition specific registries however collect data to evaluate defined outcomes at predetermined intervals. Outcomes are then benchmarked against set standards, either local or international, and reported in a timely fashion to healthcare providers.[9] Commonly assessed predefined outcomes include pre-operative waiting times, surgical margin status and 30-day post-operative complication rates. Whilst observational data analysis and contribution to the literature is provided the extra utility is provided in the ability to identify variations in the process and outcomes of care and adherence to evidence based guidelines. This information can then be reported back to providers and quality improvement processes undertaken with the eventual outcome of improving and standardising patient care. Interest in CQR has increased substantially in recent years as safety and quality of health provision continues to grow as a pillar of healthcare delivery.[10]
In this narrative review, we aim to summarise the design of recent and current registries that have contributed to the UTUC literature, discuss their strengths and limitations and the future directions of registries in UTUC in the hope of improving awareness and collaboration with such registries. We present the following article in accordance with the Narrative Review reporting checklist (available at https://tau.amegroups.com/article/view/10.21037/tau-22-641/rc).
Transl Androl Urol. 2023;12(3):497-507. © 2023 AME Publishing Company
