Filling the information void for the benefit of patients: why AANZ need a population-based clinical quality registry for pancreatic cancer surgery

Abstract

Improving patient outcomes is the core goal of healthcare delivery. Quality of care assessment has evolved from being measured at individual and institutional levels, to monitoring of an agreed minimum dataset across state and national healthcare systems to benchmark centres against optimum standards. National clinical quality registries (CQRs) provide sophisticated and prospectively collected data.¹ These allow optimal standards of care to be developed and agreed, changing the paradigm from expert opinion to data-driven evidence-based benchmarks.² Currently, there is no pancreatic cancer surgery CQR in Australia and Aotearoa New Zealand (AANZ). Here we consider three fallacies that are cited as barriers to the establishment of a pancreatic cancer surgery registry.

 

Fallacy #1: We don't need a registry

CQRs improve patient outcomes through standardization of care through the provision of benchmarked data, adherence to evidence-based guidelines, and facilitation of research studies.^3-5 This is recognized in the Australian National Strategy for CQRs, which emphasizes the importance of registries in delivering timely, risk-adjusted benchmark information to stakeholders to enhance quality improvement.⁶ It references the successes of the AANZ prostate, joint replacement, and dialysis registries in achieving these aims. Data-driven benchmarks may be presented as a minimum standard, or a best achievable standard. This enables comparison of outcomes between centres and over time, to identify unwarranted variations in care. Optimal care processes are published for many procedures, including liver, colorectal, breast, and bariatric surgery,^7-11 and for pancreaticoduodenectomy (PD) in Europe, Asia and North America.^12-14 Twenty benchmarks were developed for open PD based on data from 23 high-volume centres.¹⁴ No AANZ centre contributed to the development of any of these benchmarks. The International Hepato-Pancreato Biliary Association (IHPBA) stated that quality performance indicators should be region-specific to account for differences in populations and healthcare systems.¹⁵ In AANZ, PD case volume per centre and even more so per surgeon is comparatively lower than in other regions of the world¹⁶ due to the relatively small populations, differences in healthcare systems, and lack of national mandates to centralize pancreatic surgery. Despite this lower volume caseload, published outcomes appear to be comparable to higher volume centres overseas.^{17, 18} However, more granular clinical data will provide local benchmarks; this process can only occur if we establish an AANZ CQR.

Germany, Sweden, the Netherlands, Bulgaria, Denmark, Slovenia, Ukraine, Belgium, and the United States have national CQRs for pancreatic cancer surgery, six of which mandate reporting.^19-26 These registries have allowed development of data-driven benchmarks, providing benefits to patients through centralization of care,²⁷ investigation of symptom patterns,²⁸ and analysis of medication use²⁹ or chemotherapy regimens.³⁰ Data from the registries have been combined for multinational studies on survival and treatment algorithms.^{31, 32} AANZ has not participated in these international collaborations and is therefore missing the benefits leveraged by other countries.

 

Fallacy #2: We already have a registry

Currently there are two registries in Australia for pancreatic cancer: the PURPLE Translational Registry³³ and the Upper Gastrointestinal Cancer Registry (UGICR).³⁴ While both have contributed to research in pancreatic cancer, neither has comprehensive data on pancreatic surgery. Many of the quality performance indicators defined by the IHPBA for pancreatic surgery¹⁵ and the Australian Gastrointestinal Trials Group³⁵ are missing from PURPLE and the UGICR. Of the 20 indicators benchmarked by Sanchez-Velasquez,¹⁴ only four are recorded in PURPLE and five in UGICR. A comparison of four national pancreatic registries (United States, Germany, Sweden, and the Netherlands) identified 55 core parameters that were collected for PD. The four registries included 82–96% of these parameters.³⁶ In comparison, UGICR and PURPLE include 42% and 35%, respectively (Table 1). Smaller registries exist in AANZ that are run by a single or small group of institutions, however, these are not able to achieve the aims of a national registry. Additionally, patient reported outcome measures (PROMs) are not reported at a national level, with PROMs increasingly recognized as crucial for patient-centred care³⁷ and a critical component of a CQR, a point made clearly in the National Strategy.⁶

 

Fallacy #3: A registry would not be cost-effective

The resources required to develop and maintain a registry are not insignificant, although they are more than counterbalanced by their benefits.⁴ A report examining five Australian CQRs found that the cost–benefit ratio was up to 7:1 in favour of registries, due to avoided costs and preserved quality-adjusted life years.³⁸ The cost benefits increase up to 12:1 as registries scale up,³⁸ when central infrastructure expenses become more economical, alongside an exponential increase in coverage and quality of outputs.³⁹ Additionally, registry-based trials may provide an economical and efficient alternative to conventional clinical trials.^{40, 41} Continuing to operate small volume, institutional pancreatic registries is inefficient, and pooling of resources would improve the economic returns in addition to creating a more powerful registry. Building the proposed registry onto existing registries such as PURPLE or UGICR, harnessing electronic data extraction where feasible, and setting up timely linkage processes will further lower costs and improve efficiency, all processes emphasized by the Australian Commission on Safety and Quality in Healthcare (ACSQH) Framework Report for CQRs.⁴² The economic benefits in addition to health benefits should prompt governments to provide sustainable funding, which is vital for an enduring registry.

A robust binational pancreatic surgery CQR is the path forward for AANZ to optimize pancreatic cancer surgery. This gap is recognized by the ACSQH that short-listed pancreatic surgery as a priority for development of a national CQR⁴³ and reinforced by the National Pancreatic Cancer Roadmap.⁴⁴ As such, Australian federal and state governments should take steps to underwrite their own recommendations and provide financial support, as has been the funding model for successful international registries. Other models for funding include input from industry partners, philanthropy, public donation campaigns (e.g., “Movember” that raises money to contribute to the Australian Prostate Cancer Outcomes Registry), and from surgeons who contribute to the registry. At a minimum, collecting information on surgical outcomes benchmarked internationally for AANZ patients is necessary. Benchmarked outcomes would give accurate measures of current processes, identify areas for improvement at institutions, and drive ongoing quality improvement. The registry should also include PROMs. A registry governing body with consumer collaboration would decide on strategic direction and infrastructure decisions, ensuring that guidelines for data sovereignty, data analysis, data reporting, and privacy are honoured. Leadership from the governing body and regional champions would be key to encourage collaboration and commitment from stakeholders. The Australian Prostate Cancer Outcomes Registry⁴⁵ has done important work in these areas, illustrating how a world-leading registry should operate and act as an example for an AANZ pancreatic cancer surgery registry.

Elizabeth Lockie: Conceptualization; writing – original draft; writing – review and editing. AO John Zalcberg: Conceptualization; writing – review and editing. Anita Skandarajah: Writing – review and editing. Benjamin Loveday: Conceptualization; writing – review and editing.