The rapid assessment for prostate imaging and diagnosis (RAPID) prostate cancer diagnostic pathway.

OBJECTIVE: To report outcomes within the Rapid Assessment for Prostate Imaging and Diagnosis (RAPID) diagnostic pathway, introduced to reduce patient and healthcare burdens and standardize delivery of pre-biopsy multiparametric magnetic resonance imaging (MRI) and transperineal biopsy. PATIENTS AND METHODS: A total of 2130 patients from three centres who completed the RAPID pathway (3 April 2017 to 31 March 2020) were consecutively entered as a prospective registry. These patients were also compared to a pre-RAPID cohort of 2435 patients. Patients on the RAPID pathway with an MRI score 4 or 5 and those with PSA density ≥0.12 and an MRI score 3 were advised to undergo a biopsy. Primary outcomes were rates of biopsy and cancer detection. Secondary outcomes included comparison of transperineal biopsy techniques, patient acceptability and changes in time to diagnosis before and after the introduction of RAPID. RESULTS: The median patient age and PSA level were 66 years and 6.6 ng/mL, respectively. Biopsy could be omitted in 43% of patients (920/2130). A further 7.9% of patients (168/2130) declined a recommendation for biopsy. The percentage of biopsies avoided among sites varied (45% vs 36% vs 51%; P < 0.001). In all, 30% (221/742) had a local anaesthetic (grid and stepper) transperineal biopsy. Clinically significant cancer detection (any Gleason score ≥3 + 4) was 26% (560/2130) and detection of Gleason score 3 + 3 alone constituted 5.8% (124/2130); detection of Gleason score 3 + 3 did not significantly vary among sites (P = 0.7). Among participants who received a transperineal targeted biopsy, there was no difference in cancer detection rates among local anaesthetic, sedation and general anaesthetic groups. In the 2435 patients from the pre-RAPID cohor, time to diagnosis was 32.1 days (95% confidence interval [CI] 29.3-34.9) compared to 15.9 days (95% CI 12.9-34.9) in the RAPID group. A total of 141 consecutive patient satisfaction surveys indicated a high satisfaction rate with the pathway; 50% indicated a preference for having all tests on a single day. CONCLUSIONS: The RAPID prostate cancer diagnostic pathway allows 43% of men to avoid a biopsy while preserving good detection of clinically significant cancers and low detection of insignificant cancers, although there were some centre-level variations.

The Cost Consequences of the Gold Coast Integrated Care Programme.

INTRODUCTION: The Australian Gold Coast Integrated Care programme trialled a model of care targeting those with chronic and complex conditions at highest risk of hospitalisation with the goal of producing the best patient outcomes at no additional cost to the healthcare system. This paper reports the economic findings of the trial. METHODS: A pragmatic non-randomised controlled study assessed differences between patients enrolled in the programme (intervention group) and patients who received usual care (control group), in health service utilisation, including Medicare Benefits Schedule and Pharmaceutical Benefits Scheme claims, patient-reported outcome measures, including health-related quality of life, mortality risk, and cost. RESULTS: A total of 1,549 intervention participants were enrolled and matched on the basis of patient level data to 3,042 controls. We found no difference in quality of life between groups, but a greater decrease in capability, social support and satisfaction with care scores and higher hospital service use for the intervention group, leading to a greater cost to the healthcare system of AUD$6,400 per person per year. In addition, the per person per year cost of being in the GCIC programme was AUD$8,700 equating to total healthcare expenditures of AUD$15,100 more for the intervention group than the control group. CONCLUSION: The GCIC programme did not show value for money, incurring additional costs to the health system and demonstrating no significant improvements in health-related quality of life. Because patient recruitment was gradual throughout the trial, we had only one year of complete data for analysis which may be too short a period to determine the true cost-consequences of the program.

Additional Treatments to the Local tumour for metastatic prostate cancer-Assessment of Novel Treatment Algorithms (IP2-ATLANTA): protocol for a multicentre, phase II randomised controlled trial.

INTRODUCTION: Survival in men diagnosed with de novo synchronous metastatic prostate cancer has increased following the use of upfront systemic treatment, using chemotherapy and other novel androgen receptor targeted agents, in addition to standard androgen deprivation therapy (ADT). Local cytoreductive and metastasis-directed interventions are hypothesised to confer additional survival benefit. In this setting, IP2-ATLANTA will explore progression-free survival (PFS) outcomes with the addition of sequential multimodal local and metastasis-directed treatments compared with standard care alone. METHODS: A phase II, prospective, multicentre, three-arm randomised controlled trial incorporating an embedded feasibility pilot. All men with new histologically diagnosed, hormone-sensitive, metastatic prostate cancer, within 4 months of commencing ADT and of performance status 0 to 2 are eligible. Patients will be randomised to Control (standard of care (SOC)) OR Intervention 1 (minimally invasive ablative therapy to prostate±pelvic lymph node dissection (PLND)) OR Intervention 2 (cytoreductive radical prostatectomy±PLND OR prostate radiotherapy±pelvic lymph node radiotherapy (PLNRT)). Metastatic burden will be prespecified using the Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease (CHAARTED) definition. Men with low burden disease in intervention arms are eligible for metastasis-directed therapy, in the form of stereotactic ablative body radiotherapy (SABR) or surgery. Standard systemic therapy will be administered in all arms with ADT±upfront systemic chemotherapy or androgen receptor agents. Patients will be followed-up for a minimum of 2 years. PRIMARY OUTCOME: PFS. Secondary outcomes include predictive factors for PFS and overall survival; urinary, sexual and rectal side effects. Embedded feasibility sample size is 80, with 918 patients required in the main phase II component. Study recruitment commenced in April 2019, with planned follow-up completed by April 2024. ETHICS AND DISSEMINATION: Approved by the Health Research Authority (HRA) Research Ethics Committee Wales-5 (19/WA0005). Study results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03763253; ISCRTN58401737.

Clinical, fiscal and environmental benefits of a specialist-led virtual ureteric colic clinic: a prospective study.

OBJECTIVES: To evaluate the clinical, fiscal and environmental impact of a specialist-led acute ureteric colic virtual clinic (VC) pathway. PATIENTS AND METHODS: All patients with uncomplicated acute ureteric colic, referred to a single tertiary centre, were prospectively entered into the study over a 4-year period (January 2015-December 2018). Inclusion criteria were: low-dose non-contrast computed tomography of kidneys, ureters and bladder; white blood cell count <16 × 109/L; pain controlled; normal renal function; and no clinical concern. Primary outcomes were: time (days) from referral to VC outcome; VC outcome (discharge, further VC, face-to-face [FTF] clinic, extracorporeal shockwave lithotripsy [ESWL], ureterorenoscopy [URS], percutaneous nephrolithotomy [PCNL]); and adverse events (sepsis or obstruction). Secondary outcomes were patient and stone demographics, cost and environmental analysis. The minimum follow-up was 3 months. RESULTS: A total of 1008 patients entered the study, of whom 91.5% (n = 922) were of working age. The median (interquartile range) time from presentation to VC outcome was 2 (4) days. VC outcomes were as follows: 16.3% of patients (n = 164) were discharged; 18.2% (n = 183) were discharged after further VC; 17.2% (n = 173) underwent an intervention; and 48.4% (n = 488) were referred to an FTF clinic. Interventions comprised: PCNL 0.5% (n = 5); ESWL 7.7% (n = 78); and URS 8.9% (n = 90). Stone demographics were as follows: 570 patients (56.5%) had lower, 157 (15.6%) had upper, 96 (9.5%) had mid-ureteric and 163 (16.2%) had renal calculi, and in 22 patients (2.2%) the stones had recently passed. The mean (sd) stone size was 3.5  (2.3) mm. Two adverse events (0.2%) were reported. Introducing a VC saved £145,152 for Clinical Commissioning Groups, the equivalent NHS tariff payment of performing 106 URS procedures or 211 ureteric stent insertions. Overall, 15,085 patient journey kilometres were avoided, equal to 0.70-2.93 metric tonnes of carbon dioxide equivalent production and the need to plant 14.7 trees to achieve carbon balance. CONCLUSION: A specialist-led acute ureteric colic VC reduced time to treatment decision to a median of 2 days. This creates additional clinic capacity and reduces the fiscal burden of traditional clinics and their associated carbon footprint.

Transition of care in patients with anorectal malformations: Consensus by the ARM-net consortium.

OBJECTIVES: To develop the first consensus to standardize the management of patients with Anorectal Malformations (ARMs) transitioning from childhood to adulthood. METHODS: A dedicated task force of experts performed an extensive literature review and multiple meetings to define the most important aspects of transition of care. The findings were discussed with all ARM-net consortium members and a set of practical recommendations agreed upon at the annual meeting in 2016. RESULT: We defined seven domains that are essential to provide an effective and practical transition process. Within each domain we have developed a set of key recommendations that are important to be considered for ARM patients entering the age of transition. CONCLUSIONS: It is crucial that transition begins at an early age with regular and well-structured follow-up. Cooperation with a selected multidisciplinary team of pediatric and adult practitioners is required to prepare patients and families for effective transition to adult care and to reduce long term morbidity. TYPE OF STUDY: Review/Consensus paper. LEVEL OF EVIDENCE: III.

Evaluation of the Gold Coast Integrated Care for patients with chronic disease or high risk of hospitalisation through a non-randomised controlled clinical trial: a pilot study protocol.

INTRODUCTION: Chronic diseases are the leading cause of illness, disability and death in Australia. The prevalence and associated health expenditure are projected to soar. There is no 'whole system' approach to healthcare in Australia. To overcome this fragmentation, the Gold Coast Hospital and Health Service (GCHHS) is developing a new model known as Gold Coast Integrated Care (GCIC). To evaluate GCIC a 4-year pilot trial commenced in March 2015. This protocol paper describes the evaluation of GCIC. METHODS AND ANALYSIS: A pragmatic non-randomised controlled clinical trial is conducted to test the hypothesis that GCIC will result in improved health and well-being at no additional cost to the healthcare system. Using a mixed methods approach, impact, outcome and process evaluations will be undertaken to assess the effectiveness and acceptability, including the balance of costs between primary and public secondary care sectors, staff and training requirements, clinical service delivery, and trial implementation.Fifteen general practices have agreed to deliver GCIC. One thousand five hundred of their adult patients with treated chronic diseases, high risk of hospitalisation or healthcare utilisation were recruited to the intervention arm. Approximately 3000 patients not associated with the participating general practices were identified as controls using propensity matching which will provide service utilisation and disease data for usual care.Baseline data and follow-up observations are collected annually until the end of 2018. Quantitative analyses will measure patient healthcare costs, utilisation of health services, and health outcomes, and general practice clinical service delivery according to clinical guidelines (number of foot exams, HbA1c tests). Qualitative analyses will focus on patient and staff experiences, satisfaction, engagement and implementation of the programme as planned. ETHICS AND DISSEMINATION: Approval was received from the GCHHS and Griffith University. The study is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12616000821493). Findings will be communicated via yearly reports to funding bodies and scientific publications. TRIAL REGISTRATION NUMBER: ACTRN12616000821493; Pre-results.

Transition Risk Assessment Score to Stratify Health Care Needs and Interventions in Adolescents with Anorectal Malformations: A Pilot Study.

Introduction Anorectal malformations (ARMs) are a complex collection of congenital disorders of the anus, rectum, and genitourinary system with possible active morbidities beyond adolescence. Aims To create the first evidence-based inclusive transition risk assessment score (TRAS) to stratify health care needs and interventions in teenagers with ARM transitioning to adult health care. Method MEDLINE, EMBASE, and the Cochrane Library were searched electronically for original articles containing published scoring systems evaluating children with ARM from January 1, 1990 to December 31, 2013. Current published scoring systems identified were weighted to create a novel score (TRAS) to objectively assess the most common active problems present in teenagers with ARM: fecal, urinary, and sexual functions; quality of life; and psychosocial well-being. The TRAS was applied to patients visiting our tertiary anorectal clinic in the period from January 2014 to March 2016. Patients were rescored on each visit to the clinic. Results Total 21 separate scoring systems were identified in the literature, with 3 scoring systems incorporated into the TRAS. The score divided patients into "low" (0-4), "medium" (5-10), and "high" (11-35) risk categories. The TRAS was used to assess 14 adolescents with ARMs during the study period; 14 patients had a single TRAS, 7 had two TRAS, and 3 had three TRAS assessments. At first visit 14 patients with a median age of 13 were assessed with TRAS ranging from 2 to 13 (M = 5, SD 3.33, 95% CI 3.08-7.68). At second visit seven patients with a median age of 15 were assessed with TRAS ranging from 2 to 12 (M = 6.43, SD 3.51, 95% CI 3.19-9.67). At third visit three patients with a median age of 16 were assessed with TRAS ranging from 6 to 12 (M = 8.33, SD 3.21, 95% CI 0.35-16.32). There was no significant difference (p > 0.05) between a patient's TRAS at different visits. Conclusion Preliminary data suggest that the TRAS is a holistic and effective clinical tool to help to objectively stratify ARM patients, identify active problems, and select those who may require intensive multidisciplinary input and interventions during the transition to adult health care services.

Semantic reasoning with image annotations for tumor assessment.

Identifying, tracking and reasoning about tumor lesions is a central task in cancer research and clinical practice that could potentially be automated. However, information about tumor lesions in imaging studies is not easily accessed by machines for automated reasoning. The Annotation and Image Markup (AIM) information model recently developed for the cancer Biomedical Informatics Grid provides a method for encoding the semantic information related to imaging findings, enabling their storage and transfer. However, it is currently not possible to apply automated reasoning methods to image information encoded in AIM. We have developed a methodology and a suite of tools for transforming AIM image annotations into OWL, and an ontology for reasoning with the resulting image annotations for tumor lesion assessment. Our methods enable automated inference of semantic information about cancer lesions in images.