Interobserver and intraobserver variability of RECIST assessment in ovarian cancer.

OBJECTIVES: Measurement of Response Evaluation Criteria In Solid Tumors (RECIST) relies on reproducible unidimensional tumor measurements. This study assessed intraobserver and interobserver variability of target lesion selection and measurement, according to RECIST version 1.1 in patients with ovarian cancer. METHODS: Eight international radiologists independently viewed 47 images demonstrating malignant lesions in patients with ovarian cancer and selected and measured lesions according to RECIST V.1.1 criteria. Thirteen images were viewed twice. Interobserver variability of selection and measurement were calculated for all images. Intraobserver variability of selection and measurement were calculated for images viewed twice. Lesions were classified according to their anatomical site as pulmonary, hepatic, pelvic mass, peritoneal, lymph nodal, or other. Lesion selection variability was assessed by calculating the reproducibility rate. Lesion measurement variability was assessed with the intra-class correlation coefficient. RESULTS: From 47 images, 82 distinct lesions were identified. For lesion selection, the interobserver and intraobserver reproducibility rates were high, at 0.91 and 0.93, respectively. Interobserver selection reproducibility was highest (reproducibility rate 1) for pelvic mass and other lesions. Intraobserver selection reproducibility was highest (reproducibility rate 1) for pelvic mass, hepatic, nodal, and other lesions. Selection reproducibility was lowest for peritoneal lesions (interobserver reproducibility rate 0.76 and intraobserver reproducibility rate 0.69). For lesion measurement, the overall interobserver and intraobserver intraclass correlation coefficients showed very good concordance of 0.84 and 0.94, respectively. Interobserver intraclass correlation coefficient showed very good concordance for hepatic, pulmonary, peritoneal, and other lesions, and ranged from 0.84 to 0.97, but only moderate concordance for lymph node lesions (0.58). Intraobserver intraclass correlation coefficient showed very good concordance for all lesions, ranging from 0.82 to 0.99. In total, 85% of total measurement variability resulted from interobserver measurement difference. CONCLUSIONS: Our study showed that while selection and measurement concordance were high, there was significant interobserver and intraobserver variability. Most resulted from interobserver variability. Compared with other lesions, peritoneal lesions had the lowest selection reproducibility, and lymph node lesions had the lowest measurement concordance. These factors need consideration to improve response assessment, especially as progression free survival remains the most common endpoint in phase III trials.

Implementing voluntary assisted dying in Victoria, Australia.

This paper describes the process undertaken to implement voluntary assisted dying (VAD) in Victoria, Australia. While the Bill became law in December 2017, an 18-month implementation period was allocated to anticipate the clinical complexities of how VAD would occur in various settings, requiring an exhaustive process to address the significant changes required of health services.Implementation involved detailed health planning, and the process included a large range of health practitioners and community members, keeping a close eye to the complementarity of the various pieces of work, as well as the many safeguards required.Written from the perspective of those involved in planning the implementation, it is hoped that articulating this Victorian experience will assist others. Implementation is a complex process and takes time; it must be broadly collaborative and reflective, to ensure both health professionals and community members understand the legislative changes, as well as the responses required.

Analysis of gender in radiology in Australia and its importance to the profession and workforce planning.

Medical workforce diversity is important with gender constituting a significant role. Male and female medical practitioners participate in the workforce differently: understanding the cultural and social expectations, economic productivity, professional opportunities, and the effects on workforce supply, will aid workforce planning. Having a workforce that reflects the diversity of the community is important in providing patient-centred care. As more than half of medical graduates are female, it would be expected that this is reflected in radiology specialty. We analyse the Australian gender-specific data from the Royal Australian and New Zealand Clinical Radiology (RANZCR) clinical radiology workforce census from 1992 to 2020, focusing on changes in gender representation, number of hours worked per week, differences in subspecialisation and geographical distribution. This analysis found that the proportion of the female radiologists increased from 13% to 29%: still an underrepresentation of women radiologists when compared with the gender distribution of medical students and junior doctors. This will persist in the short to medium term, given the tapering of female doctors entering radiology training. In terms of workforce planning, women are more likely to work less than their male counterparts in the early to mid-career. Women are underrepresentated in interventional and neurointerventional radiology. There is more self-reported subspecialty interest in breast and women's imaging. A review of the literature demonstrated a similar situation in comparable countries. We also considered the reasons, potential solutions for this, and knowledge gaps where research is needed.

A Mixed-Methods Systematic Review of the Effectiveness and Experiences of Quality Improvement Interventions in Radiology.

OBJECTIVE: This study aimed to compile and synthesize evidence regarding the effectiveness of quality improvement interventions in radiology and the experiences and perspectives of staff and patients. METHODS: Databases searched for both published and unpublished studies were as follows: EMBASE, MEDLINE, CINAHL, Joanna Briggs Institute, Cochrane Central Register of Controlled Trials, PsycINFO, Scopus, Web of Science, Mednar, Trove, Google Gray, OCLC WorldCat, and Dissertations and Theses. This review included both qualitative and quantitative studies of patients undergoing radiological examinations and/or medical imaging health care professionals; a broad range of quality improvement interventions including introduction of health information technology, effects of training and education, improved reporting, safety programs, and medical devices; the experiences and perspectives of staff and patients; context of radiological setting; a broad range of outcomes including patient safety; and a result-based convergent synthesis design. RESULTS: Eighteen studies were selected from 4846 identified by a systematic literature search. Five groups of interventions were identified: health information technology (n = 6), training and education (n = 6), immediate and critical reporting (n = 3), safety programs (n = 2), and the introduction of mobile radiography (n = 1), with demonstrated improvements in outcomes, such as improved operational and workflow efficiency, report turnaround time, and teamwork and communication. CONCLUSIONS: The findings were constrained by the limited range of interventions and outcome measures. Further research should be conducted with study designs that might produce findings that are more generalizable, examine the other dimensions of quality, and address the issues of cost and risk versus benefit.

Whole brain radiotherapy after local treatment of brain metastases in melanoma patients--a randomised phase III trial.

BACKGROUND: Cerebral metastases are a common cause of death in patients with melanoma. Systemic drug treatment of these metastases is rarely effective, and where possible surgical resection and/or stereotactic radiosurgery (SRS) are the preferred treatment options. Treatment with adjuvant whole brain radiotherapy (WBRT) following neurosurgery and/or SRS is controversial. Proponents of WBRT report prolongation of intracranial control with reduced neurological events and better palliation. Opponents state melanoma is radioresistant; that WBRT yields no survival benefit and may impair neurocognitive function. These opinions are based largely on studies in other tumour types in which assessment of neurocognitive function has been incomplete. METHODS/DESIGN: This trial is an international, prospective multi-centre, open-label, phase III randomised controlled trial comparing WBRT to observation following local treatment of intracranial melanoma metastases with surgery and/or SRS. Patients aged 18 years or older with 1-3 brain metastases excised and/or stereotactically irradiated and an ECOG status of 0-2 are eligible. Patients with leptomeningeal disease, or who have had previous WBRT or localised treatment for brain metastases are ineligible. WBRT prescription is at least 30 Gy in 10 fractions commenced within 8 weeks of surgery and/or SRS. Randomisation is stratified by the number of cerebral metastases, presence or absence of extracranial disease, treatment centre, sex, radiotherapy dose and patient age. The primary endpoint is the proportion of patients with distant intracranial failure as determined by MRI assessment at 12 months. Secondary end points include: survival, quality of life, performance status and neurocognitive function. DISCUSSION: Accrual to previous trials for patients with brain metastases has been difficult, mainly due to referral bias for or against WBRT. This trial should provide the evidence that is currently lacking in treatment decision-making for patients with melanoma brain metastases. The trial is conducted by the Australia and New Zealand Melanoma Trials Group (ANZMTG-study 01-07), and the Trans Tasman Radiation Oncology Group (TROG) but international participation is encouraged. Twelve sites are open to date with 43 patients randomised as of the 31st March 2011. The target accrual is 200 patients. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12607000512426.

Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan.

BACKGROUND: The WBRTMel trial is a multinational, open-label, phase III randomised controlled trial comparing whole brain radiotherapy (WBRT) to observation following local treatment of one to three melanoma brain metastases with surgery and/or stereotactic irradiation. The primary trial endpoint was to determine the effect of adding WBRT to local treatment on distant intracranial control, and the secondary endpoints were neurocognitive function, quality of life (QoL), performance status, overall survival, death from intracranial causes, death from melanoma and cost-effectiveness. OBJECTIVE: The objective of this update is to outline and publish the pre-determined statistical analysis plan (SAP) before the database lock and the start of analysis. METHODS: The SAP describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues and the specific statistical procedures for analysing efficacy and safety outcomes. The SAP was approved after closure of recruitment and before completion of patient follow-up. It outlines the planned primary analyses and a range of subgroup and sensitivity analyses regarding the clinical and QoL outcomes. Health economic outcomes are not included in this plan but will be analysed separately. The SAP will be adhered to for the final data analysis of this trial to avoid analysis bias arising from knowledge of the data. RESULTS: The resulting SAP is consistent with best practice and will allow open and transparent reporting. CONCLUSION: We have developed a SAP for the WBRTMel trial which will be followed to ensure high-quality standards of internal validity to minimise analysis bias. TRIAL REGISTRATION: ANZ Clinical Trials Registry, ACTRN12607000512426 . Registered on 9 October 2007. ClinicalTrials.gov, NCT01503827 . Registered on 4 January 2012. Trial group reference numbers ANZMTG 01.07, TROG 08.05.

Adjuvant Whole-Brain Radiation Therapy Compared With Observation After Local Treatment of Melanoma Brain Metastases: A Multicenter, Randomized Phase III Trial.

PURPOSE: The brain is a common site of metastasis for patients with high-risk melanoma. Although surgery or stereotactic radiosurgery are highly effective local treatments for a small number of metastases, there is a high risk of developing additional brain metastases. The role of adjuvant whole-brain radiotherapy (WBRT) in reducing new metastases is controversial, with a lack of high-level evidence specifically for melanoma. METHODS: In this randomized phase III trial, patients who had local treatment of one to three melanoma brain metastases were randomly assigned to WBRT or observation. The primary end point was distant intracranial failure within 12 months, and secondary end points included time to intracranial failure, survival, and time to deterioration in performance status. RESULTS: Between April 2009 and September 2017, 215 patients were randomly assigned from 24 centers. Median follow-up was 48.1 months (range, 39.6 to 68 months). Forty-two percent of patients in the WBRT group and 50.5% of those in the observation developed distant intracranial failure within 12 months (odds ratio, 0.71; 95% CI, 0.41 to 1.23; P = .22) and the rates over the entire follow-up period were 52.0% and 57.9%, respectively (odds ratio, 0.79; 95% CI, 0.45 to 1.36; P = .39). Local failure rate was lower after WBRT (20.0% v 33.6%; P = .03). At 12 months, 41.5% of patients in the WBRT group and 51.4% of patients in the observation group had died (P = .28), with no difference in the rate of neurologic death. Median time to deterioration in performance status was 3.8 months after WBRT and 4.4 months with observation (P = .32). WBRT was associated with more grade 1 to 2 acute toxicity. CONCLUSION: After local treatment of one to three melanoma brain metastases, adjuvant WBRT does not provide clinical benefit in terms of distant intracranial control, survival, or preservation of performance status.

Mixed methods study on the use of and attitudes towards safety checklists in interventional radiology.

INTRODUCTION: The use of safety checklists in interventional radiology is an intervention aimed at reducing mortality and morbidity. Currently there is little known about their practical use in Australian radiology departments. The primary aim of this mixed methods study was to evaluate how safety checklists (SC) are used and completed in radiology departments within Australian hospitals, and attitudes towards their use as described by Australian radiologists. METHODS: A mixed methods approach employing both quantitative and qualitative techniques was used for this study. Direct observations of checklist use during radiological procedures were performed to determine compliance. Medical records were also audited to investigate whether there was any discrepancy between practice (actual care measured by direct observation) and documentation (documented care measured by an audit of records). A focus group with Australian radiologists was conducted to determine attitudes towards the use of checklists. RESULTS: Among the four participating radiology departments, overall observed mean completion of the components of the checklist was 38%. The checklist items most commonly observed to be addressed by the operating theatre staff as noted during observations were correct patient (80%) and procedure (60%). Findings from the direct observations conflicted with the medical record audit, where there was a higher percentage of completion (64% completion) in comparison to the 38% observed. The focus group participants spoke of barriers to the use of checklists, including the culture of radiology departments. CONCLUSION: This is the first study of safety checklist use in radiology within Australia. Overall completion was low across the sites included in this study. Compliance data collected from observations differed markedly from reported compliance in medical records. There remain significant barriers to the proper use of safety checklists in Australian radiology departments.

[Preliminary result of dynamic contrast-enhanced MR imaging in assessment of cellularity characteristics of bone marrow in patients with haematological malignancies].

OBJECTIVE: To evaluate the correlation of bone marrow status in haemotological malignancy patient with the variable value of dynamic contrast-enhanced MR (DCE-MRI). METHODS: DCE-MRI result were obtained from 25 patients with pathologically proven haematological malignancies. Time-signal intensity curves (TIC) was generated from the region of the iliac crest corresponding to the planned biopsy site. Enhancement characteristics including peak enhance ratio (PER) , maximum slope (Slopemax), time to peak ( TP) and mean time (MT) were analyzed. The patients received bone marrow biopsy on the crest 30 min after DCE-MRI, and then the parameters of bone marrow histology including cellularity was analyzed. RESULTS: In this series, 3 patients showed type B TIC, 7 type C, 13 type D and 2 type E. The bone marrow cellularity with haematological malignancies cannot be demostrated by TIC type. The mean PER value and Slopemax value in the patients with hypercellularity was significantly higher than that with normal cellularity and hypocellularity. The mean TTP value of the patients with hypercellularity (60.20 +/- 61.62) was significantly lower than that in the patients with hypocellularity (97.43 +/- 1.07) or normal cellularity (78.44 +/- 38.02). There was no significant difference in the mean MT value among three groups. CONCLUSION: Our preliminary findings suggest that the bone marrow cellularity in the patient with haematological malignancies can not be revealed by conventional MR, but it may be demonstrated by semi-quantitative calculation of the variable value from DCE-MR imaging.

Patient safety is everyone's business.

This editorial addresses the importance of incident reporting, checklists and a just culture to patient safety.

Use of surgical safety checklists in Australian operating theatres: an observational study.

INTRODUCTION: The use of surgical safety checklists (SSC) is an intervention aimed at reducing mortality and morbidity. Although the effectiveness of their use in surgery has been studied extensively, little is known about their practical use in Australian hospitals. The aim of this study was to observe and document the use of SSC in Australia. METHODS: This study employed direct observations of checklist use for surgical procedures by trained observers. Medical records were also audited to determine compliance with checklist use and to investigate whether there was any discrepancy between practice (actual care measured by direct observation) and documentation (documented care measured by an audit of records). RESULTS: Among the 11 participating hospitals, overall observed mean completion of the components of the checklist was 27%. Only one hospital used the original World Health Organization checklist. The checklist items most commonly observed to be addressed by the operating theatre staff as noted during observations were: correct patient (99%) and procedure (97%), whether the patient had any allergies (80%), and whether the instrument counts were performed correctly (56%). Findings from the direct observations conflicted with the medical record audit, where there was a higher percentage of completion (86% completion) in comparison to the 27% observed. CONCLUSION: This is the first study of surgical checklist use within Australia. Overall completion was low across the sites included in this study. Compliance data collected from observations differed markedly from reported compliance in medical records.

Tumor infiltration of bone marrow in patients with hemato-logical malignancies: dynamic contrast-enhanced magnetic resonance imaging.

BACKGROUND: Conventional magnetic resonance (MR) scanning techniques can identify bone marrow (BM) containing mostly fat cells. But they are not able to differentiate BM tumor infiltration, BM fibrosis and normal red BM. This is particularly problematic in assessment of recurrent or refractory hematological malignancy. This pilot study used dynamic contrast-enhanced MR imaging (DCE-MRI) to evaluate the bone marrow status and to determine whether several calculated parameters derived from the DCE-MRI correlate with histological characteristics of marrow, especially with the tumor fraction (TF). METHODS: DCE-MRI scans were performed in 25 patients with proven or known hematological malignancy who were about to undergo bone marrow biopsy of the posterior iliac crest. The location chosen for biopsy was examined with MRI approximately one hour prior to the biopsy. Time-signal intensity curves (TIC) were generated from the region of the iliac crest corresponding to the planned biopsy site. Enhancement parameters were calculated, including peak enhancement ratio (PER), maximum enhancement slope (Slope(max)), time to peak (TTP) and mean time (MT). The biopsy specimen was reported synoptically, with relevant reported parameters including cellularity and tumor fraction (TF). RESULTS: PER values were significantly higher for the bone marrow tumor infiltration group than for the normal bone marrow group (P < 0.05). A significant positive correlation was found between PER and TF as well as Slope(max) and TF. A negative correlation was found between TTP and TF. There was no significant difference in the mean TTP and MT values between the BM tumor infiltration group and the normal bone marrow group. CONCLUSIONS: The presence of diffuse bone marrow infiltration in patients with haematological malignancies could be verified using DCE-MRI.

Patient safety problems from healthcare information technology in medical imaging.

Health information technology (HIT) systems have been deployed extensively by healthcare organizations and promoted as a panacea to many of the challenges faced by medical imaging departments, particularly with respect to workflow, efficiency and diagnostic accuracy. This report describes how inadequate planning, integration, training and testing of HIT can impact on patient safety and result in patient harm.

Effectiveness of quality improvement interventions for patient safety in radiology: a systematic review protocol.

REVIEW QUESTION/OBJECTIVE: The objective of this review is to find the best available evidence regarding effectiveness of quality improvement interventions in clinical radiology and the experiences and perspectives of staff and patients. More specifically, the review questions are.

First interim analysis of a randomised trial of whole brain radiotherapy in melanoma brain metastases confirms high data quality.

BACKGROUND: Brain metastases are a common cause of death in patients with melanoma. The role of adjuvant whole brain radiotherapy (WBRT) following local treatment of intracranial melanoma metastases is controversial. The Australian and New Zealand Melanoma Trials Group (ANZMTG) and the Trans-Tasman Radiation Oncology Group (TROG) are leading the first ever single histology randomised trial investigating this question. The primary endpoint is distant intracranial failure on magnetic resonance imaging (MRI) within twelve months of randomisation. The first planned interim analysis was performed twelve months after randomisation of the 100(th) patient. The analysis was an opportunity to review completeness of the trial data to date. METHODS: All data received up to the end of twelve months after randomisation of the 100th patient was reviewed. RESULTS: Review of pathology reports confirmed that all 100 patients had stage IV melanoma and were appropriately entered into the study. Of the 47 distant intracranial events, 34 occurred in isolation (i.e. only distant failure was identified), whilst 13 were accompanied by local failure. Data review showed compliance with the protocol mandated MRI schedule and accuracy of intracranial failure reporting was very high. The Quality of Life (QoL) component of the study achieved a 91% completion rate. For the neurocognitive function (NCF) assessments, a high completion rate was maintained throughout the 12 month period. Where assessments were not performed at expected time points, valid reasons were noted. Radiotherapy quality was high. Of 50 patients who received WBRT, 32 were reviewed as per protocol design and there was only one major variation out of 308 data points reviewed (0.3%). There were minimal trial related adverse events (AEs) and no serious adverse events (SAEs). Pre-specified protocol stopping rules were not met. CONCLUSIONS: The Data Safety Monitoring Committee (DSMC) recommended the trial continue recruitment after reviewing the unblinded data. The data provision and quality to date indicates that a reliable outcome will be obtained when the final analysis is performed. Accrual is ongoing with 156 out of 200 patients randomised to date (26(th) November 2014).

Establishing national medical imaging incident reporting systems: issues and challenges.

Radiology incident reporting systems provide one source of invaluable patient safety data that, when combined with appropriate analysis and action, can result in significantly safer health care, which is now an urgent priority for governments worldwide. Such systems require integration into a wider safety, quality, and risk management framework because many issues have global implications, and they also require an international classification scheme, which is now being developed. These systems can be used to inform global research activities as identified by the World Health Organization, many of which intersect with the activities of and issues seen in medical imaging departments. How to ensure that radiologists (and doctors in general) report incidents, and are engaged in the process, is a challenge. However, as demonstrated with the example of the Australian Radiology Events Register, this can be achieved when the reporting system is integrated with their professional organization and its other related activities (such as training and education) and administered by a patient safety organization.

Where failures occur in the imaging care cycle: lessons from the radiology events register.

Adverse events contribute to significant patient morbidity and mortality on a global scale, and this has been documented in a number of international studies. Despite this, there is limited understanding of medical imaging's involvement in such events. Incident reporting is a key feature of high-reliability organizations because, understandably, it is essential to know where things go wrong and why as the very first step in formulating preventative and corrective strategies. Although anesthesiology has led the way, health care in general has been slow to adopt this technique, and this includes medical imaging. Knowledge as to where medical imaging incidents are initiated and detected, and why, is not well documented or appreciated, although this is critical information in relation to quality improvement. Using an online radiology reporting system, the authors therefore sought to gain further insight and also ascertain where failures are located in the imaging cycle, and whether different incidents sources provide different information. Last, the authors sought to examine the resilience of the imaging system using these incident data.