Implementation and evaluation of a quality improvement initiative to reduce late gestation stillbirths in Australia: Safer Baby Bundle study protocol.

BACKGROUND: In 2015, the stillbirth rate after 28 weeks (late gestation) in Australia was 35% higher than countries with the lowest rates globally. Reductions in late gestation stillbirth rates have steadily improved in Australia. However, to amplify and sustain reductions, more needs to be done to reduce practice variation and address sub-optimal care. Implementing bundles for maternity care improvement in the UK have been associated with a 20% reduction in stillbirth rates. A similar approach is underway in Australia; the Safer Baby Bundle (SBB) with five elements: 1) supporting women to stop smoking in pregnancy, 2) improving detection and management of fetal growth restriction, 3) raising awareness and improving care for women with decreased fetal movements, 4) improving awareness of maternal safe going-to-sleep position in late pregnancy, 5) improving decision making about the timing of birth for women with risk factors for stillbirth. METHODS: This is a mixed-methods study of maternity services across three Australian states; Queensland, Victoria and New South Wales. The study includes evaluation of 'targeted' implementer sites (combined total approximately 113,000 births annually, 50% of births in these states) and monitoring of key outcomes state-wide across all maternity services. Progressive implementation over 2.5 years, managed by state Departments of Health, commenced from mid-2019. This study will determine the impact of implementing the SBB on maternity services and perinatal outcomes, specifically for reducing late gestation stillbirth. Comprehensive process, impact, and outcome evaluations will be conducted using routinely collected perinatal data, pre- and post- implementation surveys, clinical audits, focus group discussions and interviews. Evaluations explore the views and experiences of clinicians embedding the SBB into routine practice as well as women's experience with care and the acceptability of the initiative. DISCUSSION: This protocol describes the evaluation of the SBB initiative and will provide evidence for the value of a systematic, but pragmatic, approach to strategies to reduce the evidence-practice gaps across maternity services. We hypothesise successful implementation and uptake across three Australian states (amplified nationally) will be effective in reducing late gestation stillbirths to that of the best performing countries globally, equating to at least 150 lives saved annually. TRIAL REGISTRATION: The Safer Baby Bundle Study was retrospectively registered on the ACTRN12619001777189 database, date assigned 16/12/2019.

Clinical management of Australian adolescents and young adults with acute lymphoblastic and myeloid leukemias: A national population-based study.

BACKGROUND: While several studies have examined the treatment of adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL), studies of acute myeloid leukemia (AML) are rare. Using national data for Australia, we describe (i) the number and type of treatment centers caring for AYAs, (ii) induction/first-line treatments, and (iii) survival outcomes. PROCEDURE: National population-based study assessing treatment of 15- to 24-year-olds diagnosed with ALL or AML between 2007 and 2012. Treatment details were abstracted from hospital medical records. Treatment centers were classified as pediatric or adult (adult AYA-focused or other adult; and by AYA volume [high/low]). Cox proportional hazard regression analyses examined associations between treatment and overall, event-free, and relapse-free survival outcomes. RESULTS: Forty-seven hospitals delivered induction therapy to 351 patients (181 ALL and 170 AML), with 74 (21%) treated at pediatric centers; 70% of hospitals treated less than two AYA leukemia patients per year. Regardless of treatment center, 82% of ALL patients were on pediatric protocols. For AML, pediatric protocols were not used in adult centers, with adult centers using a non-COG 7+3-type induction protocol (51%, where COG is Cooperative Oncology Group) or an ICE-type protocol (39%, where ICE is idarubicin, cytarabine, etoposide). Exploratory analyses suggested that for both ALL and AML, AYAs selected for adult protocols have worse overall, event-free, and relapse-free survival outcomes. CONCLUSIONS: Pediatric protocols were commonly used for ALL patients regardless of where they are treated, indicating rapid assimilation of recent evidence by Australian hematologists. For AML, pediatric protocols were only used at pediatric centers. Further investigation is warranted to determine the optimal treatment approach for AYA AML patients.

Factors influencing the documentation of fertility-related discussions for adolescents and young adults with cancer.

PURPOSE: A cancer diagnosis and treatment may have significant implications for a young patient's future fertility. Documentation of fertility-related discussions and actions is crucial to providing the best follow-up care, which may occur for many years post-treatment. This study examined the rate of medical record documentation of fertility-related discussions and fertility preservation (FP) procedures for adolescents and young adults (AYAs) with cancer in Australia. METHODS: A retrospective review of medical records for 941 patients in all six Australian states. Patients were identified through population-based cancer registries (four states) and hospital admission lists (two states). Trained data collectors extracted information from medical records using a comprehensive data collection survey. Records were reviewed for AYA patients (aged 15-24 years at diagnosis), diagnosed with acute myeloid leukaemia, acute lymphoblastic leukaemia, central nervous system (CNS) tumours, soft tissue sarcomas (STS), primary bone cancer or Ewing's family tumours between 2007 and 2012. RESULTS: 47.2% of patients had a documented fertility discussion and 35.9% had a documented FP procedure. Fertility-related documentation was less likely for female patients, those with a CNS or STS diagnosis and those receiving high-risk treatments. In multivariable models, adult hospitals with an AYA focus were more likely to document fertility discussions (odds ratio[OR] = 1.60; 95%CI = 1.08-2.37) and FP procedures (OR = 1.74; 95%CI = 1.17-2.57) than adult hospitals with no AYA services. CONCLUSIONS: These data provide the first national, population-based estimates of fertility documentation for AYA cancer patients in Australia. Documentation of fertility-related discussions was poor, with higher rates observed in hospitals with greater experience of treating AYA patients.

Inconsistencies and time delays in site-specific research approvals hinder collaborative clinical research in Australia.

BACKGROUND/AIM: The aim of this study was to describe the time and documentation needed to gain ethics and governance approvals in Australian states with and without a centralised ethical review system. METHODS: This is a prospective descriptive study undertaken between February 2012 and March 2015. Paediatric and adult hospitals (n = 67) in Australian states were approached to allow the review of their medical records. Participants included 15- to 24-year-olds diagnosed with cancer between 2008 and 2012. The main outcomes measures were time (weeks) to approval for ethics and governance and the number and type of documents submitted. RESULTS: Centralised ethics approval processes were used in five states, with approval taking between 2 and 18 weeks. One state did not use a centralised process, with ethics approval taking a median of 4.5 weeks (range: 0-15) per site. In four states using a centralised ethics process, 33 governance applications were submitted, with 20 requiring a site clinician listed as an investigator. Governance applications required the submission of 11 documents on average, including a Site-Specific Assessment form. Thirty-two governance applications required original signatures from a median of 3.5 (range: 1-10) non-research persons, which took a median of 5 weeks (range: 0-15) to obtain. Governance approval took a median of 6 weeks (range: 1-45). Twelve research study agreements were needed, each taking a median of 7.5 weeks (range: 1-20) to finalise. CONCLUSION: The benefits of centralised ethics review systems have not been realised due to duplicative, inflexible governance processes. A system that allowed the recognition of prior ethical approval and low-risk applications was more efficient than a central ethics and site-specific governance process.

Cancer survival in Australia, Canada, Denmark, Norway, Sweden, and the UK, 1995-2007 (the International Cancer Benchmarking Partnership): an analysis of population-based cancer registry data.

BACKGROUND: Cancer survival is a key measure of the effectiveness of health-care systems. Persistent regional and international differences in survival represent many avoidable deaths. Differences in survival have prompted or guided cancer control strategies. This is the first study in a programme to investigate international survival disparities, with the aim of informing health policy to raise standards and reduce inequalities in survival. METHODS: Data from population-based cancer registries in 12 jurisdictions in six countries were provided for 2·4 million adults diagnosed with primary colorectal, lung, breast (women), or ovarian cancer during 1995-2007, with follow-up to Dec 31, 2007. Data quality control and analyses were done centrally with a common protocol, overseen by external experts. We estimated 1-year and 5-year relative survival, constructing 252 complete life tables to control for background mortality by age, sex, and calendar year. We report age-specific and age-standardised relative survival at 1 and 5 years, and 5-year survival conditional on survival to the first anniversary of diagnosis. We also examined incidence and mortality trends during 1985-2005. FINDINGS: Relative survival improved during 1995-2007 for all four cancers in all jurisdictions. Survival was persistently higher in Australia, Canada, and Sweden, intermediate in Norway, and lower in Denmark, England, Northern Ireland, and Wales, particularly in the first year after diagnosis and for patients aged 65 years and older. International differences narrowed at all ages for breast cancer, from about 9% to 5% at 1 year and from about 14% to 8% at 5 years, but less or not at all for the other cancers. For colorectal cancer, the international range narrowed only for patients aged 65 years and older, by 2-6% at 1 year and by 2-3% at 5 years. INTERPRETATION: Up-to-date survival trends show increases but persistent differences between countries. Trends in cancer incidence and mortality are broadly consistent with these trends in survival. Data quality and changes in classification are not likely explanations. The patterns are consistent with later diagnosis or differences in treatment, particularly in Denmark and the UK, and in patients aged 65 years and older. FUNDING: Department of Health, England; and Cancer Research UK.

Histopathology reporting of breast cancer in Queensland: the impact on the quality of reporting as a result of the introduction of recommendations.

AIMS: Recommendations for the pathology reporting of breast cancer were released in Australia to ensure detailed communication of important prognostic features and good patient management. An audit of the reporting of invasive breast cancer in Queensland was conducted to determine how well these guidelines were utilised in 2004. METHODS: A random sample of reports was audited for inclusion of recommended criteria. The proportion of reports meeting each of the criteria was determined and compared across whether the report was in a synoptic report template or in a free text format. Comparison was made with published data from prior to the release of the recommendations. RESULTS: Of the 419 reports in the sample, at least 90% of reports included lesion size, histological type, histological grade, lymph node involvement, margins of excision, lymphovascular invasion, and changes in adjacent breast tissue individually, and 74% included all seven of these essential criteria. Synoptic reports accounted for 76% of the sample and were significantly more likely to have documented grade (p < 0.001), quadrant (p = 0.003), calcification (p < 0.001), lymphovascular invasion (p < 0.001), changes in non-neoplastic breast (p < 0.001) and ductal carcinoma in situ criteria (p < 0.001) compared with free text report format. The most notable improvements since the implementation of the recommendations were in documentation of adjacent breast tissue (92% versus 49%) and lymphovascular invasion (97% versus 54%). CONCLUSION: Breast cancer reporting in Queensland has improved since the implementation of the recommendations, however further improvements would likely be seen if there is more widespread utilisation of a synoptic report format.

Association of diabetes with survival among cohorts of Indigenous and non-Indigenous Australians with cancer.

BACKGROUND: The association between diabetes and cancer incidence has been well documented, but relatively little research has been undertaken on the potential influence of diabetes on cancer survival and the research that is available has produced inconsistent results. Because Indigenous Australians have a high prevalence of diabetes, we assessed survival, stratified by diabetes, among Indigenous Australian cancer patients. We also assessed survival, stratified by diabetes, amongst a cohort of non-Indigenous Australian cancer patients. METHODS: All-cause survival and cancer-specific survival in diabetic versus non-diabetic cancer patients were assessed in Indigenous and non-Indigenous cohorts separately, using proportional hazards models. FINDINGS: Indigenous cancer patients with diabetes (n = 140) had an overall survival disadvantage compared to Indigenous cancer patients without diabetes (n = 675) with all-cause Hazard Ratio (HR) = 1.4 (95% CI 1.1-1.8) adjusted for age, sex, and cancer site. After further adjustment to take into account the greater number of non-cancer deaths and co-morbidities in Indigenous cancer patients with diabetes, and their later stage at cancer diagnosis with less cancer treatment, there was no residual difference in cancer-specific survival compared to Indigenous cancer patients without diabetes (cancer-specific HR = 1.0, 95% CI 0.8, 1.3). Fewer non-Indigenous cancer patients had diabetes (n = 52) and they showed no differences in survival compared to their counterparts without diabetes. INTERPRETATION: The poorer survival of Indigenous Australian cancer patients with diabetes was due to more non-cancer deaths, later stage at cancer diagnosis, less cancer treatment, and more co-morbidities than Indigenous Australian cancer patients without diabetes. In contrast, diabetes did not appear to affect survival in non-Indigenous Australians with cancer, either because there were too few to detect a moderate deleterious effect or because there was no association. Understanding the relation between diabetes and cancer treatment and survival is important because both diabetes and cancer are relatively common diseases, increasingly likely to co-exist.

Completeness of histopathology reporting of melanoma in a high-incidence geographical region.

BACKGROUND: Appropriate histopathology reporting helps to ensure effective therapy and prognosis. OBJECTIVE: To examine compliance with clinical practice guidelines for histopathology reports of melanomas. METHODS: A sample of melanoma histopathology reports in Queensland was audited for inclusion of recommended information. The quality of documentation was constructed and multivariate analysis used to determine factors affecting the quality of reporting practices. RESULTS: Documentation of the most important features of melanoma was high: clear diagnosis (99.8%; 95% CI 98.6-100), thickness (99.8%; 95% CI 98.6-100), comment on adequacy of excision (87.9%; 95% CI 84.9-91.0) and measurement of margins (91.9%; 95% CI 88.8-91.4). Overall reporting of ulceration and regression was of lesser completeness (83.0 and 77.8%, respectively) and these features were more likely to be reported by high-volume laboratories (p < 0.001 and p = 0.037, respectively). This trend was not apparent for other features. Fewer than 50% of reports documented mitotic rate per square millimetre, predominant cell type, microsatellites, growth phase and desmoplasia. CONCLUSION: Awareness of current reporting practices and identification of areas in which insufficiencies exist enable the revision of systems and potential improvements to the transfer of information to treating clinicians.

Statistical inference is overemphasized in cluster investigations: the case of the cluster of breast cancers at the Australian Broadcasting Corporation studios in Brisbane, Australia.

The aim of statistical analyses in cluster investigations is to estimate the probability that the aggregation of cases could be due to chance. As a result of several statistical problems - including the post-hoc nature of the analysis and the subjective nature of implied multiple comparisons - this cannot be carried out with any certainty. In cluster investigations, expert opinion should carry much more weight than P-values, which are exceedingly difficult to interpret.

Systematic review of multidisciplinary teams in the management of lung cancer.

BACKGROUND: In several countries, clinical practice guidelines for lung cancer recommend that multidisciplinary (MD) teams should be used to plan the management of all lung cancer patients. We conducted a systematic review to evaluate and critically appraise the effectiveness of multidisciplinary teams for lung cancer. MATERIALS AND METHODS: Medline searches were carried out for the period 1984 to July 2007. We included any study that mentioned team working among specialists with diagnostic and curative therapeutic intent, where members of the team met at a specified time, either in person or by video or teleconferencing, to discuss the diagnosis and management of patients with suspected lung cancer. All study designs were included. We were particularly interested in whether multidisciplinary working improved survival but also considered other outcomes such as practice patterns and waiting times. RESULTS: Sixteen studies met the criteria for inclusion. Statistical pooling was not possible due to clinical heterogeneity. Only two of the primary studies reported an improvement in survival. Both were before-and-after designs, providing weak evidence of a causal association. Evidence of the effect of MD teams was stronger for changing patient management than for affecting survival. Six of the studies reported an increase in the percentage of patients undergoing surgical resection or an increase in the percentage of patients undergoing chemotherapy or radiotherapy with curative intent. CONCLUSION: This systematic review shows limited evidence linking MD teams with improved lung cancer survival. This does not mean that MD teams do not improve survival, merely that currently available evidence of this is limited. It seems intuitively obvious that MD teams should improve outcomes for lung cancer patients, but there are difficulties in conducting randomised trials to show this. The best way forward would be prospective evaluation of the effectiveness of MD teams as they are implemented, paying particular attention to collecting data on potential confounders.

Decreasing mortality from non-Hodgkin lymphoma in Australia.

Based on the number of new cases (incidence), non-Hodgkin lymphoma is an increasingly common cancer in Australia and many developed countries. Until recently, mortality trends have been stable or slightly increasing. However, since the year 2000, mortality has decreased every year by an average of 5.1% per year (95% confidence interval (CI) -7.1 to -3.1%), whereas incidence has continued to increase at 0.9% per year (95%CI 0.6 to 1.2%). It was not possible with the population-based registry data available to us to untangle the causes of the decrease in mortality. The stable mortality rates during the 1990s (in the face of increasing incidence) might have been because of introduction of novel therapies such as autologous stem cell transplant for relapsed diffuse large cell lymphoma or the purine analogue-based therapy for indolent lymphomas. A plausible explanation for the large decrease in mortality since 2000 is the introduction of the monoclonal antibody rituximab.

Why we need a population-based approach to clinical indicators for cancer: a case study using microscopic confirmation of lung cancer in Queensland.

An important function of clinical cancer registries is to provide feedback to clinicians on various performance measures. To date, most clinical cancer registries in Australia are located in tertiary academic hospitals, where adherence to guidelines is probably already high. Microscopic confirmation is an important process measure for lung cancer care. We found that the proportion of patients with lung cancer without microscopic confirmation was much higher in regional public hospitals (27.1%) than in tertiary hospitals (7.5%), and this disparity remained after adjusting for age, sex and comorbidities. The percentage was also higher in the private than in the public sector. This case study shows that we need a population-based approach to measuring clinical indicators that includes regional public hospitals as a matter of priority and should ideally include the private sector.

International trends in prostate-cancer mortality: the decrease is continuing and spreading.

OBJECTIVE: To measure recent changes in prostate-cancer mortality across 24 developed countries. METHODS: Mortality data for men aged 50-79 years were obtained from the World Health Organisation mortality database and we assessed trends in age-standardised mortality rates using joinpoint regression models. RESULTS: Significant reductions in prostate-cancer mortality were observed in United Kingdom, United States, Austria, Canada, Italy, France, Germany, Australia and Spain, and downward trends were also observable in the Netherlands, Ireland and Sweden. CONCLUSIONS: Mortality declines for prostate cancer are now evident in 12 out of the 24 developed countries considered in this analysis. Increases in PSA screening and better treatment of early-stage disease, possibly acting in combination, remain plausible hypotheses.

What are appropriate rates of invasive procedures following acute myocardial infarction? A systematic review.

OBJECTIVE: To assess the evidence that higher rates of coronary angiography (CA) and revascularisation (RV) in the subacute phase of acute myocardial infarction (AMI) improve patient outcomes. DATA SOURCES: MEDLINE 1990 - December 1999, Current Contents 1990-1999, Cochrane Library (Issue 4, 1999), HealthSTAR 1990-1999, selected websites and bibliographies of retrieved articles. STUDY SELECTION AND DATA EXTRACTION: Studies selected were (1) randomised trials comparing outcomes of "invasive" versus "conservative" use of CA and RV following AMI; (2) observational studies with formal methods comparing outcomes of high versus low rates of use of these procedures; and (3) clinical practice guidelines (CPGs), expert panel statements and decision analyses which met critical appraisal criteria, and which specified procedural indications. Outcome measures were rates of mortality, re-infarction and limiting or unstable angina. DATA SYNTHESIS: 56 articles were identified; 24 met inclusion criteria. Pooled data from nine RCTs of "invasive" (CA rate 96%; RV rate 66%) versus "conservative" (CA rate 28%; RV rate 19%) strategies showed no significant differences in mortality or re-infarction rates. Pooled results from 12 observational studies showed no mortality differences, but an excess reinfarction rate (8.0% vs 6.4%; P<0.001) in high- versus low-rate populations. Evidence of survival benefit from procedural intervention was strongest for patients with recurrent ischaemia combined with left ventricular dysfunction. CONCLUSIONS: In the subacute phase of AMI, rates of CA and RV in excess of 30% and 20%, respectively, may not confer additional benefit in preventing death or re-infarction. However, variability between studies in design, patient selection, and extent of cross-over from medical to procedural groups, as well as limited data on symptom status, limits generalisability of results.

Cancer among people living in rural and remote Indigenous communities in Queensland.

OBJECTIVE: To describe the pattern of cancer among people living in rural and remote Indigenous communities in Queensland and to consider what implications the results have for cancer control. DESIGN AND SETTING: Descriptive analysis of data on incidence and mortality from the population-based Queensland Cancer Registry for the years 1982-1996. MAIN OUTCOME MEASURES: Age-standardised incidence and mortality rates for different cancer sites. RESULTS: The pattern of cancer was different from that found in the Queensland population as a whole. Of all the cancer sites, cervical cancer showed the biggest difference: the age-standardised incidence was 4.7 times the State average (95% CI, 3.2-6.6) and the mortality rate was 13.4 times the State average (95% CI, 7.8-21.4). Rates of lung cancer and other smoking-related cancers, although not as high as those for cervical cancer, were also significantly higher than the Queensland average, while rates for prostate and colorectal cancer were significantly lower. CONCLUSION: The cancers that are over-represented among Indigenous people are amenable to preventive measures. The cancer burden among Indigenous people could be reduced by lowering the prevalence of smoking and improving participation in cervical cancer screening and follow-up of screening-detected abnormalities.

Colonic transit time assessed by 67 Ga-citrate in a case-series of patients with recto-sigmoid adenomas.

One plausible mechanism by which dietary factors may influence colorectal carcinogenesis is through their effect on intestinal transit time. This study examined colonic transit by means of oral 67Ga-citrate in a case-series of patients who had developed recto-sigmoid adenoma. Adenoma patients had a significantly shorter transit time than constipated patients (P = 0.01) and our results also suggest (but do not show conclusively) that colonic transit in adenoma patients is similar to that of normal controls. Although these findings require confirmation from a larger study, they raise the hypothesis that colonic transit times are not delayed in patients who harbour recto-sigmoid adenomas.

Effect of gestational age misclassification on the pattern of low birthweight in Aborigines.

Are most births of Aboriginal babies with low birthweight preterm or full term? There is no consensus because of the difficulty in obtaining valid measurements of gestational age. In Queensland, between 1988 and 1992, there were 519 births of Aboriginal babies with low birthweight in excess of the number expected if aborigines had the same risk of low birthweight as whites. Most of these were preterm (males 76 per cent, females 65 per cent). Sensitivity analyses were used to investigate whether this result was robust to gestational age misclassification. Implausibly large misclassification proportions were required to make preterm low birthweight an insignificant contributor to the low birthweight excess in Aborigines. Therefore, efforts to reduce the number of preterm births should be given high priority. Unfortunately, significant reductions in the number of preterm births will not be achieved by reducing the prevalence of traditional risk factors for full-term low birthweight (for example, maternal smoking, teenage pregnancy). More work is needed to identify potentially modifiable risk factors for preterm birth.