Methods to Include Environmental Impacts in Health Economic Evaluations and Health Technology Assessments: A Scoping Review.

OBJECTIVES: The environmental impacts of healthcare are important factors that should be considered during health technology assessments. This study aims to summarize the evidence that exists about methods to include environmental impacts in health economic evaluations and health technology assessments. METHODS: We identified records for screening using an existing scoping review and a systematic search of academic databases and gray literature up to September 2023. We screened the identified records for eligibility and extracted data using a narrative synthesis approach. The review was conducted following the JBI Manual for Evidence Synthesis and reported according to the Preferred Reporting Items for Systematic Reviews and Meta Analyses Extension for Scoping Reviews checklist. RESULTS: We identified 2898 records and assessed the full text of 114, of which 54 were included in this review. Ten methods were identified to include environmental impacts in health economic evaluations and health technology assessments. Methods included converting environmental impacts to dollars or disability-adjusted life years and including them in a cost-effectiveness, cost-utility, or cost-benefit analysis, calculating an incremental carbon footprint effectiveness ratio or incremental carbon footprint cost ratio, incorporating impacts as one criteria of a multi-criteria decision analysis, and freely considering impacts during health technology assessment deliberation processes. CONCLUSIONS: Methods to include environmental impacts in health economic evaluations and health technology assessments exist but have not been tested for widespread use by health technology assessment agencies. Further research and implementation work is needed to determine which method can best aid decision makers to choose low environmental impact healthcare interventions.

Applying the Milan models to setting analytical performance specifications - considering all the information.

Analytical performance specifications (APS) are used for decisions about the required analytical quality of pathology tests to meet clinical needs. The Milan models, based on clinical outcome, biological variation, or state of the art, were developed to provide a framework for setting APS. An approach has been proposed to assign each measurand to one of the models based on a defined clinical use, physiological control, or an absence of quality information about these factors. In this paper we propose that in addition to such assignment, available information from all models should be considered using a risk-based approach that considers the purpose and role of the actual test in a clinical pathway and its impact on medical decisions and clinical outcomes in addition to biological variation and the state-of-the-art. Consideration of APS already in use and the use of results in calculations may also need to be considered to determine the most appropriate APS for use in a specific setting.

Outcome-based analytical performance specifications: current status and future challenges.

Analytical performance specifications (APS) based on outcomes refer to how 'good' the analytical performance of a test needs to be to do more good than harm to the patient. Analytical performance of a measurand affects its clinical performance. Without first setting clinical performance requirements, it is difficult to define how good analytically the test needs to be to meet medical needs. As testing is indirectly linked to health outcomes through clinical decisions on patient management, often simulation-based studies are used to assess the impact of analytical performance on the probability of clinical outcomes which is then translated to Model 1b APS according to the Milan consensus. This paper discusses the related key definitions, concepts and considerations that should assist in finding the most appropriate methods for deriving Model 1b APS. We review the advantages and limitations of published methods and discuss the criteria for transferability of Model 1b APS to different settings. We consider that the definition of the clinically acceptable misclassification rate is central to Model 1b APS. We provide some examples and guidance on a more systematic approach for first defining the clinical performance requirements for tests and we also highlight a few ideas to tackle the future challenges associated with providing outcome-based APS for laboratory testing.

First implantable cardiac defibrillator insertions in New South Wales, 2005-2020: an analysis of linked administrative data.

OBJECTIVES: To determine the annual numbers of first ICD insertions in New South Wales during 2005-2020; to examine health outcomes for people who first received ICDs during this period. STUDY DESIGN: Retrospective cohort study; analysis of linked administrative health data. SETTING, PARTICIPANTS: All first insertions of ICDs in NSW, 2005-2020. MAIN OUTCOME MEASURES: Annual numbers of first ICD insertions, and of emergency department presentations and hospital re-admissions 30 days, 90 days, 365 days after first ICD insertions; all-cause and disease-specific mortality (to ten years after ICD insertion). RESULTS: During 2005-2020, ICDs were first inserted into 16 867 people (18.5 per 100 000 population); their mean age was 65.7 years (standard deviation, 13.5 years; 7376 aged 70 years or older, 43.7%), 13 214 were men (78.3%). The annual number of insertions increased from 791 in 2005 to 1256 in 2016; the first ICD insertion rate increased from 15.5 in 2005 to 18.9 per 100 000 population in 2010, after which the rate was stable until 2019 (19.8 per 100 000 population). Of the 16 778 people discharged alive from hospital after first ICD insertions, 54.4% presented to emergency departments within twelve months, including 1236 with cardiac arrhythmias (7.4%) and 434 with device-related problems (2.6%); 56% were re-admitted to hospital, including 1944 with cardiac arrhythmias (11.5%) and 2045 with device-related problems (12.1%). A total of 5624 people who received first ICDs during 2005-2020 (33.3%) died during follow-up (6.7 deaths per 100 person-years); the survival rate was 94.4% at one year, 76.5% at five years, and 54.2% at ten years. CONCLUSIONS: The annual number of new ICDs inserted in NSW has increased since 2005. A substantial proportion of recipients experience device-related problems that require re-admission to hospital. The potential harms of ICD insertion should be considered when assessing the likelihood of preventing fatal ventricular arrhythmia.

How should artificial intelligence be used in Australian health care? Recommendations from a citizens' jury.

OBJECTIVE: To support a diverse sample of Australians to make recommendations about the use of artificial intelligence (AI) technology in health care. STUDY DESIGN: Citizens' jury, deliberating the question: "Under which circumstances, if any, should artificial intelligence be used in Australian health systems to detect or diagnose disease?" SETTING, PARTICIPANTS: Thirty Australian adults recruited by Sortition Foundation using random invitation and stratified selection to reflect population proportions by gender, age, ancestry, highest level of education, and residential location (state/territory; urban, regional, rural). The jury process took 18 days (16 March - 2 April 2023): fifteen days online and three days face-to-face in Sydney, where the jurors, both in small groups and together, were informed about and discussed the question, and developed recommendations with reasons. Jurors received extensive information: a printed handbook, online documents, and recorded presentations by four expert speakers. Jurors asked questions and received answers from the experts during the online period of the process, and during the first day of the face-to-face meeting. MAIN OUTCOME MEASURES: Jury recommendations, with reasons. RESULTS: The jurors recommended an overarching, independently governed charter and framework for health care AI. The other nine recommendation categories concerned balancing benefits and harms; fairness and bias; patients' rights and choices; clinical governance and training; technical governance and standards; data governance and use; open source software; AI evaluation and assessment; and education and communication. CONCLUSIONS: The deliberative process supported a nationally representative sample of citizens to construct recommendations about how AI in health care should be developed, used, and governed. Recommendations derived using such methods could guide clinicians, policy makers, AI researchers and developers, and health service users to develop approaches that ensure trustworthy and responsible use of this technology.

A summary of the 2023 Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) hypertension in pregnancy guideline.

INTRODUCTION: Hypertensive disorders of pregnancy (HDP) affect up to 10% of all pregnancies annually and are associated with an increased risk of maternal and fetal morbidity and mortality. This guideline represents an update of the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) guidelines for the management of hypertensive disorders of pregnancy 2014 and has been approved by the National Health and Medical Research Council (NHMRC) under section 14A of the National Health and Medical Research Council Act 1992. In approving the guideline recommendations, NHMRC considers that the guideline meets NHMRC's standard for clinical practice guidelines. MAIN RECOMMENDATIONS: A total of 39 recommendations on screening, preventing, diagnosing and managing HDP, especially preeclampsia, are presented in this guideline. Recommendations are presented as either evidence-based recommendations or practice points. Evidence-based recommendations are presented with the strength of recommendation and quality of evidence. Practice points were generated where there was inadequate evidence to develop specific recommendations and are based on the expertise of the working group. CHANGES IN MANAGEMENT RESULTING FROM THE GUIDELINE: This version of the SOMANZ guideline was developed in an academically robust and rigorous manner and includes recommendations on the use of combined first trimester screening to identify women at risk of developing preeclampsia, 14 pharmacological and two non-pharmacological preventive interventions, clinical use of angiogenic biomarkers and the long term care of women who experience HDP. The guideline also includes six multilingual patient infographics which can be accessed through the main website of the guideline. All measures were taken to ensure that this guideline is applicable and relevant to clinicians and multicultural women in regional and metropolitan settings in Australia and New Zealand.

Low-risk prostate lesions: An evidence review to inform discussion on losing the "cancer" label.

BACKGROUND: Active surveillance (AS) mitigates harms from overtreatment of low-risk prostate lesions. Recalibration of diagnostic thresholds to redefine which prostate lesions are considered "cancer" and/or adopting alternative diagnostic labels could increase AS uptake and continuation. METHODS: We searched PubMed and EMBASE to October 2021 for evidence on: (1) clinical outcomes of AS, (2) subclinical prostate cancer at autopsy, (3) reproducibility of histopathological diagnosis, and (4) diagnostic drift. Evidence is presented via narrative synthesis. RESULTS: AS: one systematic review (13 studies) of men undergoing AS found that prostate cancer-specific mortality was 0%-6% at 15 years. There was eventual termination of AS and conversion to treatment in 45%-66% of men. Four additional cohort studies reported very low rates of metastasis (0%-2.1%) and prostate cancer-specific mortality (0%-0.1%) over follow-up to 15 years. Overall, AS was terminated without medical indication in 1%-9% of men. Subclinical reservoir: 1 systematic review (29 studies) estimated that the subclinical cancer prevalence was 5% at <30 years, and increased nonlinearly to 59% by >79 years. Four additional autopsy studies (mean age: 54-72 years) reported prevalences of 12%-43%. Reproducibility: 1 recent well-conducted study found high reproducibility for low-risk prostate cancer diagnosis, but this was more variable in 7 other studies. Diagnostic drift: 4 studies provided consistent evidence of diagnostic drift, with the most recent (published 2020) reporting that 66% of cases were upgraded and 3% were downgraded when using contemporary diagnostic criteria compared to original diagnoses (1985-1995). CONCLUSIONS: Evidence collated may inform discussion of diagnostic changes for low-risk prostate lesions.

Should low-risk DCIS lose the cancer label? An evidence review.

BACKGROUND: Population mammographic screening for breast cancer has led to large increases in the diagnosis and treatment of ductal carcinoma in situ (DCIS). Active surveillance has been proposed as a management strategy for low-risk DCIS to mitigate against potential overdiagnosis and overtreatment. However, clinicians and patients remain reluctant to choose active surveillance, even within a trial setting. Re-calibration of the diagnostic threshold for low-risk DCIS and/or use of a label that does not include the word 'cancer' might encourage the uptake of active surveillance and other conservative treatment options. We aimed to identify and collate relevant epidemiological evidence to inform further discussion on these ideas. METHODS: We searched PubMed and EMBASE databases for low-risk DCIS studies in four categories: (1) natural history; (2) subclinical cancer found at autopsy; (3) diagnostic reproducibility (two or more pathologist interpretations at a single time point); and (4) diagnostic drift (two or more pathologist interpretations at different time points). Where we identified a pre-existing systematic review, the search was restricted to studies published after the inclusion period of the review. Two authors screened records, extracted data, and performed risk of bias assessment. We undertook a narrative synthesis of the included evidence within each category. RESULTS: Natural History (n = 11): one systematic review and nine primary studies were included, but only five provided evidence on the prognosis of women with low-risk DCIS. These studies reported that women with low-risk DCIS had comparable outcomes whether or not they had surgery. The risk of invasive breast cancer in patients with low-risk DCIS ranged from 6.5% (7.5 years) to 10.8% (10 years). The risk of dying from breast cancer in patients with low-risk DCIS ranged from 1.2 to 2.2% (10 years). Subclinical cancer at autopsy (n = 1): one systematic review of 13 studies estimated the mean prevalence of subclinical in situ breast cancer to be 8.9%. Diagnostic reproducibility (n = 13): two systematic reviews and 11 primary studies found at most moderate agreement in differentiating low-grade DCIS from other diagnoses. Diagnostic drift: no studies found. CONCLUSION: Epidemiological evidence supports consideration of relabelling and/or recalibrating diagnostic thresholds for low-risk DCIS. Such diagnostic changes would need agreement on the definition of low-risk DCIS and improved diagnostic reproducibility.

Regular high-frequency whole blood donation and risk of cardiovascular disease in middle-aged and older blood donors in Australia.

BACKGROUND: Previous mixed findings on the associations between whole blood (WB) donation and risk of cardiovascular diseases (CVD) may in part reflect inadequate adjustment for the "healthy donor effect" (HDE). METHODS: We used the Sax Institute's 45 and Up Study linked with blood donation history and other health-related databases to examine the association between regular, high-frequency WB donation and the risk of CVD. To mitigate the impact of HDE, we used a "5-years qualification period," in which donors must donate at least 1 WB donation in the 1st and 5th year of "qualification period." We then compared the risk of CVD in the years following the "qualification period" between the regular high-frequency WB donors (≥2 WB donation in each qualification year) and others using Cox proportional-hazards models. Analyses were adjusted for potential confounders, such as sociodemographic, lifestyle, and health-related variables, and results are reported separately for male and female donors. RESULTS: A total of 2736 male and 2917 female donors were included in the analyses. The median years of follow-up per donor was 5.84 years (Q1-Q3, 5.47-6.23). The rate of CVD hospitalization was 11.20 and 4.50 per 1000 person-years for males and females, respectively. In fully adjusted models, the risk (hazard ratio) of CVD in regular high-frequency donors compared to other donors was 0.93 (95% Confidence Interval (CI), 0.68-1.29) for males and 0.79 (95% CI, 0.49-1.28) for females. CONCLUSIONS: We did not observe a statistically significant reduction of CVD risk in regular, high-frequency WB donors when adjusted for potential confounders.

Increased diagnosis of attention-deficit hyperactivity disorder despite stable hyperactive/inattentive behaviours: evidence from two birth cohorts of Australian children.

BACKGROUND: Globally, ADHD diagnoses have increased substantially and there is concern that this trend does not necessarily reflect improved detection of cases but that overdiagnosis may be occurring. We directly compared ADHD diagnoses with ADHD-related behaviours and looked for changes across time among Australian children in a large, population-based prospective cohort study. METHODS: We conducted a secondary analysis of the Longitudinal Study of Australian Children, including 4,699 children born 1999/2000 (cohort 1) and 4,425 children born 2003/2004 (cohort 2), followed from 4 to 13 years of age. We compared pre-diagnosis parent-reported hyperactive/inattentive behaviour scores between newly diagnosed (incident cases) and undiagnosed children and fitted Cox's proportional hazards regression models to examine the relationship between birth cohorts 1 and 2 and the risk of incident ADHD diagnosis. RESULTS: Cumulative incident ADHD diagnoses increased from 4.6% in cohort 1 (born in 1999/2000) to 5.6% in cohort 2 (born in 2003/2004), while hyperactive/inattentive behaviour scores remained steady. Among ADHD diagnosed children, 26.5% (88/334) recorded pre-diagnosis behaviours in the normal range, 27.6% (n = 92) had borderline scores and 45.8% (n = 153) scored within the clinical range. Children born in 2003/2004 were more likely to be diagnosed with ADHD compared with those born in 1999/2000 (aHR = 1.33, 95% CI = 1.06-1.67, p = .012), regardless of their ADHD behaviour score (p = .972). CONCLUSIONS: Diagnostic increases were not driven by rises in hyperactive/inattentive behaviours. A quarter of all children with an ADHD diagnosis recorded pre-diagnosis behaviours within the normal range. The increased likelihood of being diagnosed with ADHD for children from the later birth cohort was observed for children across the full range of ADHD-related behaviours.

COVID-19 rapid antigen tests approved for self-testing in Australia: published diagnostic test accuracy studies and manufacturer-supplied information. A systematic review.

OBJECTIVES: To review evaluations of the diagnostic accuracy of coronavirus disease 2019 (COVID-19) rapid antigen tests (RATs) approved by the Therapeutic Goods Administration (TGA) for self-testing by ambulatory people in Australia; to compare these estimates with values reported by test manufacturers. STUDY DESIGN: Systematic review of publications in any language that reported cross-sectional, case-control, or cohort studies in which the participants were ambulatory people in the community or health care workers in hospitals in whom severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was suspected, and the results of testing self-collected biological samples with a TGA-approved COVID-19 RAT were compared with those of reverse transcription-polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Estimates of diagnostic accuracy (sensitivity, specificity) were checked and compared with manufacturer estimates published on the TGA website. DATA SOURCES: Publications (to 1 September 2022) identified in the Cochrane COVID-19 Study Register and the World Health Organization COVID-19 research database. Information on manufacturer diagnostic accuracy evaluations was obtained from the TGA website. DATA SYNTHESIS: Twelve publications that reported a total of eighteen evaluations of eight RATs approved by the TGA for self-testing (manufacturers: All Test, Roche, Flowflex, MP Biomedicals, Clungene, Panbio, V-Chek, Whistling) were identified. Five studies were undertaken in the Netherlands, two each in Germany and the United States, and one each in Denmark, Belgium, and Canada; test sample collection was unsupervised in twelve studies, and supervised by health care workers or researchers in six. Estimated sensitivity with unsupervised sample collection ranged from 20.9% (MP Biomedicals) to 74.3% (Roche), and with supervised collection from 7.7% (V-Chek) to 84.4% (Panbio); the estimates were between 8.2 and 88 percentage points lower than the values reported by the manufacturers. Test specificity was high for all RATs (97.9-100%). CONCLUSIONS: The risk of false negative results when using COVID-19 RATs for self-testing may be considerably higher than apparent in manufacturer reports on the TGA website, with implications for the reliability of these tests for ruling out infection.

What is the prevalence of fear of cancer recurrence in cancer survivors and patients? A systematic review and individual participant data meta-analysis.

OBJECTIVE: Care for fear of cancer recurrence (FCR) is considered the most common unmet need among cancer survivors. Yet the prevalence of FCR and predisposing factors remain inconclusive. To support targeted care, we provide a comprehensive overview of the prevalence and severity of FCR among cancer survivors and patients, as measured using the short form of the validated Fear of Cancer Recurrence Inventory (FCRI-SF). We also report on associations between FCR and clinical and demographic characteristics. METHODS: This is a systematic review and individual participant data (IPD) meta-analysis on the prevalence of FCR. In the review, we included all studies that used the FCRI-SF with adult (≥18 years) cancer survivors and patients. Date of search: 7 February 2020. Risk of bias was assessed using the Joanna Briggs Institute critical appraisal tool. RESULTS: IPD were requested from 87 unique studies and provided for 46 studies comprising 11,226 participants from 13 countries. 9311 respondents were included for the main analyses. On the FCRI-SF (range 0-36), 58.8% of respondents scored ≥13, 45.1% scored ≥16 and 19.2% scored ≥22. FCR decreased with age and women reported more FCR than men. FCR was found across cancer types and continents and for all time periods since cancer diagnosis. CONCLUSIONS: FCR affects a considerable number of cancer survivors and patients. It is therefore important that healthcare providers discuss this issue with their patients and provide treatment when needed. Further research is needed to investigate how best to prevent and treat FCR and to identify other factors associated with FCR. The protocol was prospectively registered (PROSPERO CRD42020142185).

The impact of health literacy on psychosocial and behavioural outcomes among people at low risk of cardiovascular disease.

This study aimed to explore the impact of health literacy on psychosocial and behavioural outcomes for people who were not at high risk of cardiovascular disease receiving a hypothetical blood pressure reading of 135/85 mmHg. We performed a secondary analysis of data from a national sample of Australians aged 40 to 50 years (n = 1318) recruited online. Health literacy was measured using the validated Newest Vital Sign (inadequate: 0-3; adequate: 4-6). Analysed outcomes included: willingness to increase exercise and accept medication; perceived severity; positive and negative affect; illness perceptions and impacts on life and motivation. Participants with inadequate levels of health literacy perceived a blood pressure reading of 135/85 mmHg to be less serious compared to individuals with adequate health literacy (Mean Difference [MD]:0.21; 95%CI 0.03-0.39; p = .024; d = 0.13), and reported less motivation to eat well (MD:0.44; 95%CI 0.31-0.58; p < .001; d = 0.38) and exercise (MD:0.43; 95%CI 0.31-0.58; p < .001; d = 0.36). However, they were more willing to accept medication (MD:0.20; 95%CI 0.07-0.34; p = .004; d = 0.17). Participants with inadequate health literacy also perceived the condition to have fewer negative impacts on aspects of life and work than individuals with adequate health literacy, but reported greater negative emotion and more negative illness perceptions (all p < .001). Tailored communication and behaviour change support may be needed when communicating blood pressure information to people with lower health literacy and not at high risk of cardiovascular disease given the differential impacts on medication (increased willingness) and healthy exercise and diet behaviours (decreased willingness) observed in this study.

Adenotonsillectomy and adenoidectomy in children: The impact of timing of surgery and post-operative outcomes.

AIM: To investigate the impact of adenotonsillectomy (ADT) and adenoidectomy (AD) on child health and evaluated their post-operative complications. METHODS: We included all children aged <16 years undergoing ADT (tonsillectomy ± adenoidectomy) or AD in New South Wales, Australia, 2008-2017. Health information was obtained from administrative hospitalisation data. Rates of post-operative complications and reoperation were evaluated using generalised estimating equations and Kaplan-Meier methods, respectively. RESULTS: Out of 156 500 included children, 112 361 had ADT and 44 139 had AD. Population rates increased during 2008-2017 (ADT: 68-79 per 10 000 children; AD: 25-34 per 10 000), and children were increasingly operated on at a younger age. Overall, 7262 (6.5%) and 1276 (2.9%) children had post-operative complications (mostly haemorrhage), and 4320 (3.8%) and 5394 (12.2%) required reoperation, following ADT and AD, respectively. Complication rates were highest among children aged 0-1 years, lowest for those 2-5 years and increased with age thereafter. Three-year reoperation rates for children aged 0-1 years were 9.0% and 25.9% following ADT and AD, respectively, decreasing thereafter to 0.5% and 2.1% in children aged 12-13 years. CONCLUSIONS: ADT and AD in Australian children have both increased in frequency and are being done at a younger age. Post-operative complications and reoperation rates highlight surgery is not without risk, especially for children under 2 years old. These findings support a more conservative approach to management of upper respiratory symptoms, with surgery reserved for cases where potential benefits are most likely to outweigh harms.

Understanding women's choices for management of cervical intraepithelial neoplasia 2 (CIN2): Qualitative analysis of a randomised experimental study.

BACKGROUND: Active surveillance for cervical intraepithelial neoplasia 2 (CIN2) would allow time for most cases to regress naturally and in turn avoid potentially unnecessary and harmful treatment. AIM: To determine reasons for choosing active surveillance over surgery among women given a hypothetical diagnosis of CIN2. MATERIALS AND METHODS: Women residing in Australia aged 25-40 years with no prior diagnosis of cervical cancer, cervical abnormality CIN2 or above, and/or previous hysterectomy, were randomised to one of four identical hypothetical scenarios of testing human papillomavirus (HPV)-positive: high-grade cytology and a diagnosis of CIN2 that used alternate terminology to describe resolution of abnormal cells and/or inclusion of an overtreatment statement. Participants selected active surveillance or surgery after viewing the scenario and free-text reason/s for their choice were thematically analysed. RESULTS: Of the 1638 women randomised, 79% (n = 1293) opted for active surveillance. The most common reasons for choosing active surveillance included concerns about surgery and associated risks, preferring to 'wait and see', trusting the doctor's recommendations and having an emotional response toward surgery. For women who chose surgery, being risk-averse, addressing the issue straight away and perceiving surgery to be the better option for them were the most common themes identified. CONCLUSION: When presented with balanced information on the benefits and harms of different management options for CIN2 and given a choice, most women in this hypothetical situation chose active surveillance over surgery. Addressing women's concerns about active surveillance may open up the possibility that if deemed safe, it could be an acceptable alternative for women.

Clinician views and experiences of non-invasive prenatal genetic screening tests in Australia.

BACKGROUND: Non-invasive prenatal screening (NIPS) is being increasingly used by expectant parents. Much provision of this test in Australia is occurring in clinical settings where specialised genetic counselling is unavailable, such as general practice. Potential psychosocial consequences from this kind of prenatal genetic screening remain largely unexplored. AIMS: To explore clinicians' experiences with NIPS for aneuploidy, their perspectives of the benefits and harms of NIPS, clinicians' information needs, and their perceptions of the needs of expectant parents. MATERIALS AND METHODS: Qualitative, semi-structured interviews with 17 health professionals (clinical geneticists, obstetricians, genetic counsellors and general practitioners) who request and counsel for NIPS in Australian hospital and private practice settings, conducted between June 2019 and February 2020. RESULTS: Five themes were identified relating to clinicians' perceptions and experiences of NIPS in their practice: perceived benefits of NIPS, perceived harms of NIPS (with two subthemes: clinical harms and psychosocial harms), financial and equity-related concerns, counselling as a protective buffer against perceived harms, and clinicians' unmet education needs. While clinicians view NIPS as a useful and high-quality screening test, especially for detection of common trisomies, many participants had concerns about how NIPS has been implemented in practice, particularly the quality (and often absence) of pre-/post-test counselling and the routinisation of testing for sex chromosome aneuploidies, microdeletion and microduplication syndromes. CONCLUSION: These findings support the need for targeted clinician training around NIPS, and for a shared decision-making approach to support expectant parents' autonomous decisions about NIPS.

Visits to general practitioners after iron-related deferrals from blood donation in middle-aged and older Australian blood donors.

BACKGROUND: Australian Red Cross Lifeblood (Lifeblood) advises donors to visit their general practitioner (GP) for medical follow-up if they are deferred from donating due to having a lower than acceptable level of hemoglobin (Hb) and/or serum ferritin (iron-related deferrals). METHODS: We used the Sax Institute's 45 and Up Study data linked to Lifeblood's donor datasets and other health administrative datasets. We examined the rate of visits to a GP after iron-related deferral from donation, and investigated whether an early visit to a GP (within 30 days following the deferral) had an impact on return to make successful donation within 12, 18, and 24 months compared to a delayed or no GP visit. RESULTS: A total of 1928 donors underwent iron-related deferral. The rate of visits to a GP in the first month after deferral was double the rate observed a month prior. However, only 52.4% of those deferred visited a GP early with slightly more than half of those receiving an iron-monitoring test. Return to donate over the 24 months was lower in donors visiting their GP early (adjusted Hazard Ratio [aHR] 0.86, 95% CI 0.77-0.97). Early GP visitors were likely to have a relatively poorer health than the delayed or no GP visit group. CONCLUSIONS: Only half of the donors with an iron-related deferral followed advice from Lifeblood and visited their GP within 30 days of deferral, and these donors have a significantly reduced likelihood of future successful blood donation which may be due to their relatively poorer health status.

Willingness of blood donors in Australia to provide additional data and blood sample for health research.

BACKGROUND: Many blood collection agencies are generating important data on donor health outcomes using large-scale blood donor cohort studies. Such studies can be very effective when donors provide access to linkage of their data to external health databases, and storage and genomic testing of their blood sample. In this study, we aimed to assess the willingness of Australian blood donors to provide additional data and blood sample for donation-related and other health research. STUDY DESIGN AND METHODS: We invited 2017 donors to complete a survey using four methods (postal letter, postal letter and email, email only, and in-center recruitment). The survey asked for information on demographics, lifestyle behaviors, health, experience and attitude to blood donation, and willingness to give blood sample and additional data for research. RESULTS: Response rates ranged from 23.8% for email only to 77.2% for in-center recruitment. Of those who responded (n = 827), 95.5% indicated they would be willing to provide a blood sample for donation and transfusion-related research. Of these, >90.0% were willing for their sample to be used in research involving genetic testing and other health-related topics. Also, >90.0% were willing to consent for linkage of their information to external health databases. CONCLUSIONS: Donors surveyed reported a high willingness to participate in health research by completing surveys, allowing linkage to external datasets, and providing a blood sample. These findings provide strong support for future longitudinal research studies with Australian blood donors.

Active surveillance as a management option for cervical intraepithelial neoplasia 2: An online experimental study.

OBJECTIVE: To investigate framing of active surveillance as a management option for cervical intraepithelial neoplasia (CIN)2 in women of childbearing age. METHODS: We conducted a between-subjects factorial (2 × 2) randomised experiment. Women aged 25-40 living in Australia were presented with the same hypothetical pathway of testing human papillomavirus (HPV)-positive, high-grade cytology and a diagnosis of CIN2, through an online survey. They were randomised to one of four groups to evaluate the effects of (i) framing (method of explaining resolution of abnormal cells) and (ii) inclusion of an overtreatment statement (included versus not). Primary outcome was management choice following the scenario: active surveillance or surgery. RESULTS: 1638 women were randomised. Overall, preference for active surveillance was high (78.9%; n = 1293/1638). There was no effect of framing or providing overtreatment information, or their interaction, on management choice. After adjusting for intervention received, age, education, and other model covariates, participants were more likely to choose active surveillance over surgery if they had not already had children, had plans for children in the future, had no family history of cancer, had no history of endometriosis, had adequate health literacy, and more trust in their GP. Participants were less likely to choose active surveillance over surgery if they were more predisposed to seek health care for minor problems. CONCLUSIONS: Although we found no framing effect across the four conditions, we found a high level of preference for active surveillance with associations of increased preference that accord with the desire to minimise potential risks of CIN2 treatment on obstetric outcomes. These are valuable data for future clinical trials of active surveillance for management of CIN2 in younger women of childbearing age. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12618002043213, 20/12/2018, prior to participant enrolment).