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Keywords:

  • database;
  • epidemiology;
  • outcome assessment;
  • population health;
  • prostate cancer;
  • quality indicators;
  • quality of care;
  • registries

Abstract

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

What's known on the subject? and What does the study add?

Operating principles exist both within Australia and internationally to provide guidance on how to establish clinical registries. In establishing a registry, consideration needs to be given to its purpose, the stakeholders and the output it will generate and to whom output will be disseminated

The present study describes how a prostate cancer-specific registry was developed that aligns with generic operating principles. We describe the governance model, the data items collected, the collection methodology clinical indicators selected for reporting and the reporting framework.

OBJECTIVE

  • • 
    To establish a pilot population-based clinical registry with the aim of monitoring the quality of care provided to men diagnosed with prostate cancer.

PATIENTS AND METHODS

  • • 
    All men aged >18 years from the contributing hospitals in Victoria, Australia, who have a diagnosis of prostate cancer confirmed by histopathology report notified to the Victorian Cancer Registry are eligible for inclusion in the Prostate Cancer Registry (PCR).
  • • 
    A literature review was undertaken aiming to identify existing quality indicators and source evidence-based guidelines from both Australia and internationally.

RESULTS

  • • 
    A Steering Committee was established to determine the minimum dataset, select quality indicators to be reported back to clinicians, identify the most effective recruitment strategy, and provide a governance structure for data requests; collection, analysis and reporting of data; and managing outliers.
  • • 
    A minimum dataset comprising 72 data items is collected by the PCR, enabling ten quality indicators to be collected and reported.
  • • 
    Outcome measures are risk adjusted according to the established National Comprehensive Cancer Network and Cancer of the Prostate Risk Assessment Score (surgery only) risk stratification model. Recruitment to the PCR occurs concurrently with mandatory notification to the state-based Cancer Registry.
  • • 
    The PCR adopts an opt-out consent process to maximize recruitment.
  • • 
    The data collection approach is standardized, using a hybrid of data linkage and manual collection, and data collection forms are electronically scanned into the PCR.
  • • 
    A data access policy and escalation policy for mortality outliers has been developed.

CONCLUSIONS

  • • 
    The PCR provides potential for high-quality population-based data to be collected and managed within a clinician-led governance framework.
  • • 
    This approach satisfies the requirement for health services to establish quality assessment, at the same time as providing clinically credible data to clinicians to drive practice improvement.

Abbreviations
CAPRA

Cancer of the Prostate Risk Assessment

NCCN

National Comprehensive Cancer Network

PCR

Prostate Cancer Registry

QoL

quality of life

UCLA-PCI

University of California Los Angeles-Prostate Cancer Index.

INTRODUCTION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

Prostate cancer is the most commonly diagnosed internal malignancy and the second commonest cause of death from cancer in Australian men [1]. The risk of being diagnosed with prostate cancer to age 75 years is estimated at 1:7 [2].

The incidence of prostate cancer is rising: there are predicted to be 46% more diagnoses and 27% more deaths directly attributable to prostate cancer in 2016 compared to 2007 [3]. The increasing incidence of the disease will be associated with an increasing cost of treatment. New South Wales simulation data, which take into account both direct healthcare costs and the indirect impact of death and disability on wages, corporate profits and tax revenue, estimate that prostate cancer is currently the most costly of all internal cancer types [3]. The economic impact of prostate cancer for the years 2006–2016 is estimated to be more than twice that of breast cancer and colorectal cancer, and more than three times that of lung cancer. This trend is predicted to continue over the next 30 years. It is expected that prostate cancer will cost the New South Wales economy $27 billion in the next 10 years and $77 billion in the next 30 years.

Management options for men with this problem include watchful waiting, active surveillance, surgery to remove the prostate gland (prostatectomy), high-intensity focused ultrasonography, external beam radiotherapy, interstitial radiotherapy (brachytherapy) and androgen deprivation therapy. Men often receive combination therapy. Few studies have directly compared the survival advantage associated with the different treatment modalities. Newly-released results from the Prostate Cancer Intervention Versus Observation Trial randomized controlled trial in the USA comparing radical prostatectomy with watchful waiting for men with localized disease suggest that the only benefit of surgery on survival is for men in higher-risk groups and with a PSA >10 ng/mL (absolute reduction in prostate-cancer mortality of 7.2–8.4%) [4]. No modern randomized clinical trials have compared the survival advantage of surgery with brachytherapy. However, the results obtained from a large US prospective cohort study on men with low- and intermediate-risk disease have shown no significant difference in prostate cancer-specific mortality between the two groups [5].

Although stage-to-stage comparisons suggest that survival is similar, regardless of what treatment men chose, there is variation in survival outcome after the diagnosis of prostate cancer, depending on where men live. Australian regional or rural dwellers have higher age-standardized mortality rates compared to their urban counterparts [6]; in Victoria, men who reside in metropolitan Melbourne have significantly higher survival than men who live in rural and regional Victoria (5 year-survival 86% vs 80% in the rest of Victoria, P< 0.01) [7]. It is not known whether this represents a real difference in prostate cancer outcomes for men in those areas because insufficient data are available to allow exact comparisons.

In the absence of definitive data, there are many possible explanations for variation in survival across geographical regions, including intrinsic differences in populations, differences in quality of care or data inaccuracies. It may be that men living outside metropolitan areas have a higher incidence of clinical disease or present for treatment at a later stage of their disease. Limited data indicate that men in rural areas of Australia have a lower probabilty than their city counterparts of undergoing tests of PSA levels [6], although it is not known whether this relates to reduced ad hoc population screening of asymptomatic men compared to those in urban areas or to an inappropriately low use of a diagnostic test for men at risk of prostate cancer.

Treatments may be different in a manner that is amenable to improvement. Evidence acquired in New South Wales between 1993 and 2002 showed that, after adjusting for age and disease stage, men residing in rural and socioeconomically disadvantaged areas had a significantly lower probabilty of undergoing radical prostatectomy than those residing in urban areas from the least disadvantaged groups [8]. There were no data available with which to determine whether these men chose radiotherapy instead of surgery.

Case numbers and clinician expertise and experience in specific centres may affect outcome. In the population of men choosing to have surgery to treat their prostate cancer, the presence of positive surgical margins after prostatectomy has been positively and independently associated with disease progression, even after accounting for the stage of disease [9]. Surgical experience and technique have been shown to influence margin positivity [10]. There is some evidence from the USA that the volume of men operated on by surgeons will predict disease-free survival, regardless of their preoperative risk group [11].

Although variation in the quality of care provided to men with prostate cancer treated in radiotherapy centres has not been widely studied, a large national patterns of care survey in the USA conducted in the 1970s provided compelling evidence that disease control was higher with better radiation technology, and that complications were related to dose and technique. Smaller and non-Academic centres had a lower probability of having management processes in place consistent with contemporaneous best practice. There was no relationship between disease control and the size of the centre, nor with academic-linkages, although the volume of patients with prostate cancer treated was not directly assessed [12]. Only one recent US study has assessed compliance with radiotherapy and general prostate cancer quality indicators, and this focused primarily on documentation of the appropriate radiation technique [13].

MATERIALS AND METHODS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

As a means of investigating variation in cancer presentation and care provided to men with prostate cancer in Victoria, a pilot prostate cancer clinical quality registry was established in 2009. The purpose of the Prostate Cancer Registry (PCR) is to collect information systematically on all men diagnosed with prostate cancer aiming to assess patterns of presentation, care and outcomes, allowing an assessment of quality measures and the evaluation of variation, as well as the potential causes of this variation. In the present study, we outline the governance structure for the PCR, the population and recruitment strategy, the process for determining the minimum dataset, the data collection methodology, and the reporting framework for the PCR.

RESULTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

The PCR governance model is outlined in Fig. 1. The PCR Steering Committee comprises a radiation oncologist, surgeons (n= 3), a medical oncologist, epidemiologists (n= 3), a basic scientist, consumers (n= 2) and a representative from a funding body and a regional health authority.

image

Figure 1. Governance structure of the Prostate Cancer Registry.

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POPULATION AND RECRUITMENT STRATEGY

The PCR was initially established as a pilot project to assess its feasibility. As such, sites contributing to the PCR were selected to represent metropolitan and regional hospitals and both private and public sectors. There were five sites were selected in Victoria: two major metropolitan public hospitals, two major metropolitan private hospitals and one regional health service. In total, the five sites account for ≈32% of newly-diagnosed prostate cancer cases in Victoria.

INCLUSION AND EXCLUSION CRITERIA REGISTRY GOVERNANCE

Men are eligible for inclusion on the PCR if they have a diagnosis of prostate cancer confirmed by histopathology report notified to the Victorian Cancer Registry from the contributing hospital. Evidence from data collected by the Victorian Cancer Registry indicates that, in 1997, ≈94% of prostate cancer diagnoses were histologically verified [14]. Cases are excluded if they are aged <18 years or if they have prostate cancer diagnosed before the date at which the hospital commenced recruitment. For example, a person for whom a histopathology specimen showing prostate cancer was collected at prostatectomy would only be eligible if the biopsy was performed after the date of site recruitment. This ensures the PCR captures incident rather than prevalent cases.

RECRUITMENT FRAME

The recruitment frame is outlined in Fig. 2. Recruitment occurs from hospitals concurrently with cancer notifications to the Victorian Cancer Registry. All Victorian Hospitals, Pathology Services and Prescribed Registers (public or private) have a statutory obligation to report cancer diagnosis information to the Victorian Cancer Registry by the Cancer Act 1958, as amended [15].

image

Figure 2. Recruitment frame for the Prostate Cancer Registry (PCR).

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The registry has been assessed and approved by each participating hospital's human research ethics committee, Cancer Council Victoria and Monash University (application number CF09/0931-2009000436). A waiver of consent has been provided by the ethics committee to the PCR to release the name and address of newly-diagnosed prostate cancer cases (for the purpose of contacting the case if necessary); case vital status; the language spoken if an interpreter was required; and the procedure resulting in the notification and treating doctor (i.e. TURP, TRUS or prostatectomy).

In the case of private clinics or health services, all treating doctors linked with the cancer registrations were provided with information, and they provided consent for recruitment of all cases that they diagnosed at recruiting hospitals. The exception is men diagnosed at TURP, for which individual consent is obtained from the associated doctor to recruit men. In the case of Public Health Services, the head of the relevant clinical units provided the consent to contact cases.

After confirming vital status with the Health Service or treating doctor, an explanatory statement is sent to men 9–10 months after diagnosis inviting participation in the PCR and providing details of a freecall number that they can telephone should they wish to opt-out of the PCR. Opt-out consent was used to optimize recruitment rates. There is good evidence that registries who use opt-in consent do not recruit high numbers, resulting in important selection biases [16]. Both an English and translated explanatory statement is sent to men who, according to the medical records, required a translator when admitted to hospital.

A period of at least 2 weeks must elapse between the date the explanatory statement is sent and data collection commences. Opt-off can occur later; in which case, any data details collected are expunged.

DETERMINING THE MINIMUM DATASET AND QUALITY INDICATORS

Data elements collected by the PCR are outlined in Table 1. The national metadata standards repository was sourced for definitions where they existed [17]. Where national definitions were not available, Facility Oncology Data Standards were used to define data elements [18]. In addition to obtaining case identifying information, next of kin and general practitioner identifiers were collected aiming to minimize the opportunity for loss to follow-up.

Table 1. Data elements collected by the Prostate Cancer Registry
VariableElements 
  1. *Sourced from the case's medical record and/or data collection tool. †Sourced from Cancer Council of Victoria. ‡Sourced from case at follow-up. §Sourced from Registry of Births, Deaths and Marriages. ¶Barwon South Western/Loddon Mallee Integrated Cancer Services only. ADT, androgen deprivation therapy; GP, general practioner; PCR, Prostate Cancer Registry; QoL, quality of life.

Demographics  
 CaseFamily name*†§Middle initial*†§
Given name*†§PCR unique identifier
Medicare number*§Date of birth*†§
Address*Case telephone number*
E-mail*Person country of birth*
Preferred language* 
 Next of kin/contact personContact person*Relationship to case*
Address*Telephone number*
Provider details  
 HospitalInstitution*†Hospital unit record number*
 General practitionerGP family name*GP given name*
GP telephone number*GP address*†
Key clinical information  
 DiagnosisDiagnosis code*Date of diagnosis
PSA level at diagnosis * 
 Risk factorsFamilial cancer history*‡¶Dialysis*‡
History of stroke*‡¶Warfarin use*‡¶
Diabetes status*‡¶ 
 AssessmentClinical TNM stage*Date of biopsy
Gleason scores and sumTertiary score*
Morphology% Cores/cassettes positive*
Pathological TNM staging at biopsy and surgery * 
 Treatment (surgery)Date of surgery*Surgeon*†
Surgical margins*PSA before surgery*
Surgery approach* 
 Treatment (radiotherapy)Date of radiotherapy start date *Radiation oncologist*
Radiotherapy approach*PSA before radiotherapy*
 Treatment (androgen deprivation therapy)ADT start date*Medical oncologist*
PSA before commencing ADT* 
 Treatment (chemotherapy)Chemotherapy: start date*PSA before commencing chemotherapy*
Outcome assessment  
 MortalityDate of death 
 MorbiditySalvage radiation therapy*PSA at 12 and 24 months*
General health QoL (12 items) at 12 and 24 months after diagnosisDisease-specific QoL (6 items) at 12 and 24 months after diagnosis
PSA at 12 and 24 months*‡ 

A key goal of Australian clinical quality registries is to assess the quality of care [19]. Accordingly, a review was undertaken of existing quality indicators and evidence-based guidelines. Guidelines from Australia [20], the USA [21] and the UK [22] were considered. Quality indicators developed for the RAND Corporation [23] were reviewed and assessed using predefined criteria [24]. Indicators were selected if it there was agreement by the Steering Committee that the health service or clinician had the ability to impact on whether the indicator was met (or not) and where there was agreement that the indicator could be reliably collected by trained research staff with limited clinical skills (reliable). A list of quality indicators collected by the PCR is provided in Table 2.

Table 2. Quality indicators collected by the registry
  1. CAPRA, Cancer of the Prostate Risk Assessment; NCCN, National Comprehensive Cancer Network.

Quality indicators and rationale for inclusion
Structural indicators
 Volume (number) of cases treated (by type of treatment) at each site
  There is evidence that quality of care may be impacted by volume of cases treated[10,23]
Process indicators
 Clear documentation of clinical TNM stage
  Documentation of clinical TNM provides evidence that a physical assessment has been undertaken in the assessment of case risk and disease progression[23]
 Percentage of men with advanced disease (high- and very high-risk groups according to NCCN or CAPRA 6–10) who were given brachytherapy
  Brachytherapy is NOT recommended for men with advanced prostate disease[22]
 Percentage of men with advanced disease (high- and very high-risk groups according to NCCN or CAPRA 6–10) who receive adjuvant hormonal therapy after post radical radiotherapy
  Adjuvant hormonal therapy is recommended for at least 2 years in men receiving radical radiotherapy for localized prostate cancer who have a Gleason score of8[22]
 Percentage of men with PSA level recorded post prostatectomy
  PSA levels for all men with prostate cancer who are having radical treatment should be checked at the earliest 6 weeks after treatment, at least every 6 months for the first 2 years and then at least once a year thereafter[22]
 Percentage of men with high-risk disease who were managed with active surveillance
  Active surveillance is NOT recommended for men with advanced prostate disease[22]
 Percentage of cases where positive margins were reported on the histopathology report stratified by NCCN and CAPRA risk categories
  The presence of a positive surgical margin in the radical prostatectomy specimen has an adverse effect on prognosis[9]. Positive margin positivity may be impacted by clinician experience[10]
Outcome indicators
 Risk-adjusted mortality rate
 Disease-free survival at 24 months. For those who have had surgery before 12-month follow-up: a PSA level increase of ≥0.4 ng/mL at 24 months compared to 12 months OR a PSA level of ≥0.5 ng/mL at 24 months. For those who have had radiotherapy in year 1, a PSA increase of 2 ng/mL at 24 months compared to 12 months OR a PSA level greater than the baseline PSA level (i.e. the highest level before treatment)
 Case-reported assessment of urinary, sexual and bowel function and bother at 12 and 24 months after diagnosis

Outcome measures (mortality, quality of life and disease progression) are risk adjusted using both National Comprehensive Cancer Network (NCCN) [25] and, for cases undergoing radical prostatectomy, the Cancer of the Prostate Risk Assessment (CAPRA) model (Table 3) [26]. The CAPRA model was introduced when evidence emerged of its superior ability to predict biochemical recurrence after radical prostatectomy compared to the D'Amico and the Stephenson nomogram [27]. Our pilot testing of the CAPRA score determined that the percentage of positive cores was difficult to infer from pathology reports because the biopsy cores often fragmented when placed in specimen processing cassettes, such that the reported cores (or core fragments) were not related to the actual cores obtained. For this reason, the definition of ‘percent positive cores’ was substituted with ‘percent positive cassettes’ that are described on the histopathological report.

Table 3. Risk adjustment model adopted by the Prostate Cancer Registry
VariableNCCNCAPRA score*
  • *

    CAPRA algorithm:

  • Age at diagnosis <50 = 0 ≥50 = 1.

  • PSA level (ng/mL) at diagnosis: ≤6 = 0, 6.1–10 = 1, 10.1–20 = 2, 20.1–30 = 3, >30 = 4.

  • Gleason at biopsy: no pattern 4 or 5 = 0; Secondary pattern 4 or 5 = 1; Primary pattern 4 or 5 = 3.

  • Clinical stage: T1 or T2 = 0; T3a = 1.

  • Percentage of biopsy cores involved with cancer: <34% = 0 ≥34% = 1.

  • CAPRA, Cancer of the Prostate Risk Assessment; NCCN, National Comprehensive Cancer Network.

LowClinical T1–T2a stage AND Gleason score 2–6 AND PSA level <10 ng/mL0–2
IntermediateClinical T2b–T2c stage OR Gleason = 7 OR PSA level 10–20 ng/mL3–5
HighClinical T3a stage OR Gleason 8–10 OR PSA level >20 ng/mL6–10
Locally advancedClinical T3b–T4 
Locally advancedAny T, N1 
MetastaticAny T, Any N, M1 

The general health-related quality of life (QoL) tool selected for use by the PCR was the SF12v2 (Quality Metric, RI, USA). It was selected because the Steering Committee was cognisant of the need to take into consideration the cost of data collection, the large population to be interviewed and the need to balance the need for precision with respondent burden. The SF12v2 is the most commonly used tool for population surveys that require maximum efficiency with fewer than 36 questions [28]; it was shown to be a useful tool for assessing cost-effectiveness of interventions [29] and is incorporated within the University of California Los Angeles-Prostate Cancer Index (UCLA-PCI) Short Form [30].

To determine disease-specific QoL, a number of tools were reviewed, including the 25-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [31], the 46-item Functional Assessment of Cancer Therapy–Prostate [32], the 32-item Expanded Prostate Cancer Index Composite [33] and both the 56-item UCLA-PCI [34] and its 21-item short form [30]. A review of the literature suggested that the UCLA-PCI was the most commonly used of these tools; neither the SF-12v2, nor any of the disease-specific QoL tools have been validated for telephone completion. Given the extended length of each disease-specific tool, the sensitive nature of the questions and the fact that they were being administered over the telephone, a decision was made to develop three questions to elicit case-reported urinary, sexual and bowel function and use the urinary, sexual and bowel bother questions from the UCLA-short form tool. Validation work would be undertaken of the six-item tool.

DATA COLLECTION

Collection of clinical data commences after inferred consent has been provided by the case. Histopathology data and additional demographic data reported to the Victorian Cancer Registry are imported into the PCR (Table 1). Pre-populated forms are then printed out and additional treatment data collected from electronic or paper-based medical records in private consulting rooms and hospitals. Data entered onto the paper forms are then scanned into the PCR using Teleform technology (Cardiff Teleform, IL, USA), an approach that has been shown to be more cost effective and provide fewer errors compared with single manual data entry [35].

An audit of data completeness after 2 months showed that most data items collected by the PCR were routinely recorded in the medical record, with the exception of the clinical stage at diagnosis, which was uniformly poorly reported initially. Clinical stage is routinely used in both risk models selected for use by the PCR [25,27]. Although, historically, it has been regarded as an important predictor of poor outcome in men after surgery [36] and brachytherapy [37], more recent data suggest that it offers only marginal benefit in a risk prediction tool also comprising biopsy Gleason score, serum PSA level and percent positive cores [38]. This was considered to be largely a result of the frequent misclassification of clinical stage by clinicians [39]. Less than 5% of medical records reviewed in the first 3 months had documented clinical stage. This was significantly lower than the 66% of surgical cases and 93% of men receiving external beam radiation having the clinical stage documented in their medical record, as reported in a US population by Miller et al. [40]. Improvement in documentation of the clinical stage was included as a quality indicator to be reported back to clinicians. Future work will aim to determine the additional benefit of clinical stage and the effectiveness of reporting ‘documentation of clinical stage’ as a quality indicator back to clinicians in this Australian population.

At 12 and 24 months after the date of diagnosis, participants are contacted by telephone to verify management details and to measure general health and disease-specific quality of life.

REPORTING FRAMEWORK

A reporting framework has been established in compliance with National Operating Principles for Clinical Quality Registries [41]. An escalation policy has been developed in consultation with clinicians and health services to flag outliers in relation to risk-adjusted mortality. This will trigger action if a hospital is identified as having a statistically significant change from the benchmark of two standard deviations from the mean. Aggregate reports will be made available to hospital executives and identifiable case information will be accessible by the clinician and the head of unit in facilities that have a unit structure (in Australia, these usually comprise public rather than private hospitals).

DATA ACCESS

The PCR is web-enabled and can be accessed via a secure password protected login by registry personnel for data collection, audit purposes and central data management. Clinician reports are automatically generated by the registry. Researchers can apply to the registry to have access to de-identified data provided that the project has been approved by the relevant ethics committee(s). All requests for data are authorized by the Steering Committee. Data access forms can be downloaded from the Internet (http://www.pcr.registry.org.au).

DISCUSSION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

The PCR has been developed as Australia's first prostate cancer clinical quality registry. It has been developed with the same intention as the National Prostate Cancer Register of Sweden [42] (i.e. to monitor quality, benchmark outcomes and to assist clinical research). It aspires to achieve the impressive research output obtained by the Cancer of the Prostate Strategic Urologic Research Endeavor prostate cancer registry in the USA [43]. An important distinction between these two international registries in existence is coverage; the National Prostate Cancer Register captures 97% of cases registered by the Swedish Cancer Registry, whereas the Cancer of the Prostate Strategic Urologic Research Endeavor registry captures data from only 40 urological practice sites in the USA.

Funding for the pilot registry has been provided through a competitive research grant. Further grants and state government funding has enabled expansion of the registry, which now captures 85% of newly-diagnosed cases in Victoria. A sustainable funding model will require investment by institutions for data collection and central funding for maintenance of the registry, as well as an audit of data completeness and accuracy.

It is anticipated that, over time, the PCR will become population-based (i.e. similar to the Swedish registry) and will improve knowledge of patterns and quality of care; reduce variation of treatment and outcome; improve compliance with best practice guidelines for treatment of prostate cancer; and improve the understanding of factors that predict favourable and unfavourable treatment outcomes. The model outlined in the present study provides a template for those wishing to establish an effective monitoring tool.

ACKNOWLEDGEMENTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

SE and JM wrote the first draft of the document. JW has contributed to the development of the PCR. ID, DB, GG, MF, AF, AC and JMc have assisted in development of the protocol and contribute as members of the Steering Committee. All authors have read and approved the final manuscript. The authors gratefully acknowledge funding for this project provided by Cancer Australia (APP606927). IDD is an Australian National Health and Medical Research Council Practitioner Fellow.

CONFLICT OF INTEREST

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

The authors declare that there are no conflicts of interest.

REFERENCES

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES
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