Age group-specific changes in keratinocyte cancer treatment rates in Australia, 2012-2021: a retrospective cohort study based on MBS claims data.

OBJECTIVES: To examine recent changes in the numbers of Medicare-subsidised keratinocyte cancer excisions, particularly for younger people exposed to primary prevention campaigns since the early 1980s. STUDY DESIGN: Retrospective cohort study; analysis of administrative data. SETTING, PARTICIPANTS: Analysis of Medicare Benefits Schedule (MBS) claims data for procedures related to the diagnosis and treatment of keratinocyte cancer in Australia, 2012-2021. MAIN OUTCOME MEASURES: Age-standardised rates for MBS-subsidised claims for first surgical squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) excisions, Mohs surgery, surgical excisions of benign lesions, skin biopsies, and cryotherapy or serial curettage of premalignant and malignant lesions, overall, and by sex, state/territory, and age group; average annual percentage change in rate for time intervals determined by joinpoint regression. RESULTS: In men, the age-standardised rate of BCC/SCC excisions increased by 1.9% (95% confidence interval [CI], 1.4-2.4%) per year during 2012-2019 (from 2931 to 3371 per 100 000 men) and then declined by 3.8% (95% CI, 0.5-7.0%) per year during 2019-2021 (to 3152 per 100 000). In women, the age-standardised rate increased by 2.2% (95% CI, 1.7-2.8%) per year during 2012-2019 (from 1798 to 2093 per 100 000 women); the decline to 1967 excisions per 100 000 women in 2021 was not statistically significant. BCC/SCC excision rates declined for men under 55 years of age (by 1.0-3.4% per year) and women under 45 years of age (by 1.7-2.3% per year). Age-standardised biopsy rates increased during 2012-2021 in all age groups (by 2.8-6.9% per year). CONCLUSIONS: Rates of MBS-subsidised treatment for keratinocyte cancers increased during 2012-2019, but BCC/SCC treatment rates declined among younger Australians, who have probably been exposed to less sunlight than earlier generations because of public health interventions and population-wide lifestyle changes related to technology use.

Gestational diabetes mellitus screening and diagnosis criteria before and during the COVID-19 pandemic: a retrospective pre-post study.

OBJECTIVE: To determine whether perinatal outcomes after excluding gestational diabetes mellitus (GDM) on the basis of fasting venous plasma glucose (FVPG) assessment during the coronavirus disease 2019 (COVID-19) pandemic in 2020 were similar to those during the preceding year after excluding GDM using the standard oral glucose tolerance test (OGTT) procedure. DESIGN: Retrospective pre-post study. SETTING, PARTICIPANTS: All women who gave birth in Queensland during 1 July - 31 December 2019 and 1 July - 31 December 2020. MAIN OUTCOME MEASURES: Perinatal (maternal and neonatal) outcomes for pregnant women assessed for GDM, by assessment method (2019: OGTT/glycated haemoglobin [HbA1c ] assessment; 2020: GDM could be excluded by an FVPG value below 4.7 mmol/L). RESULTS: 3968 of 29 113 pregnant women in Queensland during 1 July - 31 December 2019 (13.6%) were diagnosed with GDM, and 4029 of 28 778 during 1 July - 31 December 2020 (14.0%). In 2020, FVPG assessments established GDM in 216 women (1.1%) and excluded it in 1660 (5.8%). The frequencies of most perinatal outcomes were similar for women without GDM in 2019 and those for whom it was excluded in 2020 on the basis of FVPG values; the exception was caesarean delivery, for which the estimated probability increase in 2020 was 3.9 percentage points (95% credibility interval, 2.2-5.6 percentage points), corresponding to an extra 6.5 caesarean deliveries per 1000 births. The probabilities of several outcomes - respiratory distress, neonatal intensive care or special nursery admission, large for gestational age babies - were about one percentage point higher for women without GDM in 2020 (excluding those diagnosed on the basis of FVPG assessment alone) than for women without GDM in 2019. CONCLUSIONS: Identifying women at low absolute risk of gestational diabetes-related pregnancy complications on the basis of FVPG assessment as an initial step in GDM screening could reduce the burden for pregnant women and save the health system substantial costs.

The diagnosis and initial management of melanoma in Australia: findings from the prospective, population-based QSkin study.

OBJECTIVES: To determine the proportions of newly diagnosed melanomas treated by different medical specialist types, to describe the types of excisions performed, and to investigate factors associated with treating practitioner specialty and excision type. DESIGN, SETTING: Prospective cohort study; analysis of linked data: baseline surveys, hospital, pathology, Queensland Cancer Register, and Medical Benefits Schedule databases. PARTICIPANTS: Random sample of 43 764 Queensland residents aged 40-69 years recruited during 2011, with initial diagnoses of in situ or invasive melanoma diagnosed to 31 December 2019. MAIN OUTCOME MEASURES: Treating practitioner type and treatment modality for first incident melanoma; second and subsequent treatment events for the primary melanoma. RESULTS: During a median follow-up of 8.4 years (interquartile range, 8.3-8.8 years), 1683 eligible participants (720 women, 963 men) developed at least one primary melanoma (in situ melanoma, 1125; invasive melanoma, 558), 1296 of which (77.1%) were initially managed in primary care; 248 were diagnosed by dermatologists (14.8%), 83 by plastic surgeons (4.9%), 43 by general surgeons (2.6%), and ten by other specialists (0.6%). The most frequent initial procedures leading to histologically confirmed melanoma diagnosis were first excision (854, 50.7%), shave biopsy (549, 32.6%), and punch biopsy (178, 10.6%); 1339 melanomas (79.6%) required two procedures, 187 (11.1%) three. Larger proportions of melanomas diagnosed by dermatologists (87%) or plastic surgeons (71%) were in people living in urban areas than of those diagnosed in primary care (63%); larger proportions of melanomas diagnosed by dermatologists or plastic surgeons than of those diagnosed in primary care were in people with university degrees (45%, 42% v 23%) or upper quartile clinical risk scores (63%, 59% v 47%). CONCLUSIONS: Most incident melanomas in Queensland are diagnosed in primary care, and nearly half are initially managed by partial excision (shave or punch biopsy). Second or third, wider excisions are undertaken in about 90% of cases.

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.

The cost-effectiveness of coronary calcium score-guided statin therapy initiation for Australians with family histories of premature coronary artery disease.

OBJECTIVES: To compare the cost-effectiveness of coronary artery calcium (CAC) score-guided statin therapy criteria and American College of Cardiology/American Heart Association (ACC/AHA) guidelines (10-year pooled cohort equation [PCE] risk ≥ 7.5%) with selection according to Australian guidelines (5-year absolute cardiovascular disease risk [ACVDR] ≥ 10%), for people with family histories of premature coronary artery disease. STUDY DESIGN, SETTING: Markov microsimulation state transition model based on data from the Coronary Artery calcium score: Use to Guide management of Hereditary Coronary Artery Disease (CAUGHT-CAD) trial and transition probabilities derived from published statin prescribing and adherence outcomes and clinical data. PARTICIPANTS: 1083 people with family histories of premature coronary artery disease but no symptomatic cardiovascular disease. MAIN OUTCOME MEASURES: Relative cost-effectiveness over fifteen years, from the perspective of the Australian health care system, compared with usual care (Australian guidelines), assessed as incremental cost-effectiveness ratios (ICERs), with a notional willingness-to-pay threshold of $50 000 per quality-adjusted life-year (QALY) gained. RESULTS: Applying the Australian guidelines, 77 people were eligible for statin therapy (7.1%); with ACVDR 5-year risk ≥ 2% and CAC score > 0, 496 people (46%); with ACVDR 5-year risk ≥ 2% and CAC score ≥ 100, 155 people (14%); and with the ACC/AHA guidelines, 256 people (24%). The ICERs for CAC-guided selection were $33 108 (CAC ≥ 100) and $53 028 per QALY gained (CAC > 0); the ACC/AHA guidelines approach (ICER, $909 241 per QALY gained) was not cost-effective. CAC score-guided selection (CAC ≥ 100) was cost-effective for people with 5-year ACVDR of at least 5%. CONCLUSION: Expanding the number of people at low to intermediate CVD risk eligible for statin therapy should selectively target people with subclinical atherosclerosis identified by CAC screening. This approach can be more cost-effective than simply lowering treatment eligibility thresholds.

Aldosterone and renin concentrations and blood pressure in young Indigenous and non-Indigenous adults in the Northern Territory: a cross-sectional study.

OBJECTIVES: To evaluate aldosterone and renin levels and aldosterone-to-renin ratios (ARRs) in young Indigenous and non-Indigenous adults in the Northern Territory, and their association with blood pressure levels. DESIGN: Cross-sectional study; single time point sub-study of two prospective birth cohort studies. SETTING, PARTICIPANTS: Participants in the Aboriginal Birth Cohort (ABC) - born to Indigenous mothers at the Royal Darwin Hospital during 1987-1990 - and the Top End Cohort (TEC) - people born to non-Indigenous mothers in Darwin, recruited during 2007-2009 - aged 32-35 years at the time of this sub-study. MAIN OUTCOME MEASURES: Plasma aldosterone and direct renin concentrations; ARRs (positive screening test result for primary aldosteronism defined as > 70 pmol/mU); systolic and diastolic blood pressure. RESULTS: A total of 255 ABC (205 in remote, 50 in urban locations) and 76 TEC members participated. Median aldosterone concentration was similar for all three groups. The median renin concentration was 7.5 mU/L (interquartile range [IQR], 4.1-12.4 mU/L) in the TEC group, 12.4 mU/L (IQR, 5.1-19 mU/L) in the urban ABC group, and 29.3 mU/L (IQR, 15.0-52.9 mU/L) in the remote ABC group. The median ARR was 10 pmol/mU (IQR, 6-19 pmol/mU) in the remote ABC group, 28 pmol/mU (IQR, 16-70 pmol/mU) in the urban ABC group, and 43 pmol/mU (IQR, 26-74 pmol/mU) in the TEC group. Thirteen urban ABC participants (26%), 21 TEC participants (28%), and six people in the remote ABC group (3%) had ARR values above 70 pmol/mU. Adjusted for age and body mass index (BMI), mean systolic and diastolic blood pressure were lower for women than men in all participant groups; after adjusting for age, sex, and BMI, larger ARR was associated with higher systolic blood pressure in the TEC group but not the two ABC groups. CONCLUSION: Screening test results for primary aldosteronism were positive for about one-quarter of urban Indigenous and non-Indigenous participants. A prospective study that includes confirmatory testing would more accurately assess the prevalence of primary aldosteronism among Indigenous Australians in the Northern Territory.

The acceptability and usability of two HIV self-test kits among men who have sex with men: a randomised crossover trial.

OBJECTIVES: To compare the usability and acceptability of oral fluid- and blood-based HIV self-test kits among men who have sex with men in Australia. DESIGN: Randomised crossover trial. SETTING, PARTICIPANTS: Gay, bisexual, and other men aged 18 years or older who have sex with men, who attended two metropolitan sexual health clinics in Sydney and Melbourne, 7 January - 10 December 2019. MAIN OUTCOME MEASURES: Ease of use of HIV self-test kits; preferred HIV self-test type; difficulties encountered during HIV self-testing. RESULTS: 170 men were recruited (median age, 34 years; interquartile range, 29-43 years); 144 identified as gay (85%), 96 were born outside Australia (57%). Participants were more likely to report the oral fluid HIV self-test was easy to use than the blood-based self-test (oral fluid, 99%; blood, 86%; odds ratio [OR], 3.0; 95% confidence interval [CI], 1.4-6.6). The oral fluid test was preferred by 98 participants (58%; 95% CI, 50-65%), the blood-based test by 69 (41%; 95% CI, 33-48%). Difficulties with the oral fluid test kit identified by observing nurses included problems placing the buffer solution into the stand (40 of 170 participants, 24%) and not swabbing both gums (23 of 169, 14%); difficulties with the blood-based test kit included problems filling the device test channel (69 of 170, 41%) and squeezing the finger firmly enough to generate a blood drop (42 of 170, 25%). No participant received an invalid result with the oral fluid self-test; two of 162 participants (1%) received invalid results with the blood self-test. After adjusting for age, education level, and ethnic background, characteristics associated with higher odds of using HIV self-testing in the future were overseas birth (adjusted OR, 3.07; 95% CI, 1.42-6.64), and self-evaluated ease of use and confidence in using the kits. CONCLUSION: It is important to provide options for obtaining both oral fluid- and blood-based HIV self-tests. The usability and acceptability of both kits were high, but the ease of use and perceived accuracy influenced test kit preference.

Socioeconomic and immigration status and COVID-19 testing in Toronto, Ontario: retrospective cross-sectional study.

BACKGROUND: Preliminary evidence suggests that individuals living in lower income neighbourhoods are at higher risk of COVID-19 infection. The relationship between sociodemographic characteristics and COVID-19 risk warrants further study. METHODS: We explored the association between COVID-19 test positivity and patients' socio-demographic variables, using neighborhood sociodemographic data collected retrospectively from two COVID-19 Assessment Centres in Toronto, ON. RESULTS: Eighty-three thousand four hundred forty three COVID-19 tests completed between April 5-September 30, 2020, were analyzed. Individuals living in neighbourhoods with the lowest income or highest concentration of immigrants were 3.4 (95% CI: 2.7 to 4.9) and 2.5 (95% CI: 1.8 to 3.7) times more likely to test positive for COVID-19 than those in highest income or lowest immigrant neighbourhoods, respectively. Testing was higher among individuals from higher income neighbourhoods, at lowest COVID-19 risk, compared with those from low-income neighbourhoods. CONCLUSIONS: Targeted efforts are needed to improve testing availability in high-risk regions. These same strategies may also ensure equitable COVID-19 vaccine delivery.

Pulmonary embolism: update on diagnosis and management.

Pulmonary embolism (PE) is a potentially life-threatening condition, mandating urgent diagnosis and treatment. The symptoms of PE may be non-specific; diagnosis therefore relies on a clinical assessment and objective diagnostic testing. A clinical decision rule can determine the pre-test probability of PE. If PE is "unlikely", refer for a D-dimer test. If the D-dimer result is normal, PE can be excluded. If D-dimer levels are increased, refer for chest imaging. If PE is "likely", refer for chest imaging. Imaging with computed tomography pulmonary angiogram is accurate and preferred for diagnosing PE, but may detect asymptomatic PE of uncertain clinical significance. Imaging with ventilation-perfusion (VQ) scan is associated with lower radiation exposure than computed tomography pulmonary angiogram, and may be preferred in younger patients and pregnancy. A low probability or high probability VQ scan is helpful for ruling out or confirming PE, respectively; however, an intermediate probability VQ scan requires further investigation. The direct oral anticoagulants have expanded the anticoagulation options for PE. These are the preferred anticoagulant for most patients with PE because they are associated with a lower risk of bleeding, and have the practical advantages of fixed dosage, no need for routine monitoring, and fewer drug interactions compared with vitamin K antagonists. Initial parenteral treatment is required before dabigatran and edoxaban.

Deep vein thrombosis: update on diagnosis and management.

Diagnosis of deep vein thrombosis (DVT) requires a multifaceted approach that includes clinical assessment, evaluation of pre-test probability, and objective diagnostic testing. Common symptoms and signs of DVT are pain, swelling, erythema and dilated veins in the affected limb. The pre-test probability of DVT can be assessed using a clinical decision rule that stratifies DVT into "unlikely" or "likely". If DVT is "unlikely", refer for D-dimer test. If the D-dimer level is normal, DVT can be excluded; if the D-dimer level is increased, refer for compression ultrasound. If DVT is "likely", refer for compression ultrasound. When DVT is confirmed, anticoagulation is indicated to control symptoms, prevent progression and reduce the risk of post-thrombotic syndrome and pulmonary embolism. Anticoagulation may consist of a parenteral anticoagulant overlapped by warfarin or followed by a direct oral anticoagulant (DOAC) (dabigatran or edoxaban), or of a DOAC (apixaban or rivaroxaban) without initial parenteral therapy. DOACs are the preferred treatment for DVT because they are at least as effective, safer and more convenient than warfarin. DOACs may require dose reduction or avoidance in patients with renal dysfunction, and should be avoided in pregnancy. Recent evidence shows that DVT in patients with cancer may be treated with edoxaban (after discontinuation of 5 days of initial heparin or low molecular weight heparin [LMWH]) or rivaroxaban if patients prefer not to have daily injections of LMWH, but the risk of gastrointestinal bleeding is higher with DOACs than with LMWH in patients with gastrointestinal cancer.

The impact of rapid molecular diagnostic testing for respiratory viruses on outcomes for emergency department patients.

OBJECTIVE: To determine whether rapid polymerase chain reaction (PCR) testing for influenza and respiratory syncytial viruses (RSV) in emergency departments (EDs) is associated with better patient and laboratory outcomes than standard multiplex PCR testing. DESIGN, SETTING: A before-and-after study in four metropolitan EDs in New South Wales. PARTICIPANTS: 1491 consecutive patients tested by standard multiplex PCR during July-December 2016, and 2250 tested by rapid PCR during July-December 2017. MAIN OUTCOME MEASURES: Hospital admissions; ED length of stay (LOS); test turnaround time; patient receiving test result before leaving the ED; ordering of other laboratory tests. RESULTS: Compared with those tested by standard PCR, fewer patients tested by rapid PCR were admitted to hospital (73.3% v 77.7%; P < 0.001) and more received their test results before leaving the ED (67.4% v 1.3%; P < 0.001); the median test turnaround time was also shorter (2.4 h [IQR, 1.6-3.9 h] v 26.7 h [IQR, 21.2-37.8 h]). The proportion of patients admitted to hospital was also lower in the rapid PCR group for both children under 18 (50.6% v 66.6%; P < 0.001) and patients over 60 years of age (84.3% v 91.8%; P < 0.001). Significantly fewer blood culture, blood gas, sputum culture, and respiratory bacterial and viral serology tests were ordered for patients tested by rapid PCR. ED LOS was similar for the rapid (7.4 h; IQR, 5.0-12.9 h) and standard PCR groups (6.5 h; IQR, 4.2-11.9 h; P = 0.27). CONCLUSION: Rapid PCR testing of ED patients for influenza virus and RSV was associated with better outcomes on a range of indicators, suggesting benefits for patients and the health care system. A formal cost-benefit analysis should be undertaken.

The increasing use of shave biopsy for diagnosing invasive melanoma in Australia.

OBJECTIVE: To assess changes in the choice of skin biopsy technique for assessing invasive melanoma in Victoria, and to examine the impact of partial biopsy technique on the accuracy of tumour microstaging. DESIGN: Retrospective cross-sectional review of Victorian Cancer Registry data on invasive melanoma histologically diagnosed in Victoria during 2005, 2010, and 2015. SETTING, PARTICIPANTS: 400 patients randomly selected from each of the three years, stratified by final tumour thickness: 200 patients with thin melanoma (< 1.0 mm), 100 each with intermediate (1.0-4.0 mm) and thick melanoma (> 4.0 mm). MAIN OUTCOME MEASURES: Partial and excisional biopsies, as proportions of all skin biopsies; rates of tumour base transection and T-upstaging, and mean tumour thickness underestimation following partial biopsy. RESULTS: 833 excisional and 337 partial diagnostic biopsies were undertaken. The proportion of partial biopsies increased from 20% of patients in 2005 to 36% in 2015 (P < 0.001); the proportion of shave biopsies increased from 9% in 2005 to 20% in 2015 (P < 0.001), with increasing rates among dermatologists and general practitioners. Ninety-four of 175 shave biopsies (54%) transected the tumour base; wide local excision subsequently identified residual melanoma in 65 of these cases (69%). Twenty-one tumours diagnosed by shave biopsy (12%) were T-upstaged. With base-transected shave biopsies, tumour thickness was underestimated by a mean 2.36 mm for thick, 0.48 mm for intermediate, and 0.07 mm for thin melanomas. CONCLUSION: Partial biopsy, particularly shave biopsy, was increasingly used for diagnosing invasive melanoma between 2005 and 2015. Shave biopsy has a high rate of base transection, reducing the accuracy of tumour staging, which is crucial for planning appropriate therapy, including definitive surgery and adjuvant therapy.

Faecal calprotectin testing for identifying patients with organic gastrointestinal disease: systematic review and meta-analysis.

OBJECTIVES: To assess the clinical effectiveness of faecal calprotectin (FC) testing for distinguishing between organic gastrointestinal diseases (organic GID), such as inflammatory bowel disease (IBD), and functional gastrointestinal disorders (functional GIDs). STUDY DESIGN: Studies that assessed the accuracy of FC testing for differentiating between IBD or organic GID and functional GIDs were reviewed. Articles published in English during January 1998 - June 2018 that compared diagnostic FC testing in primary care and outpatient hospital settings with a reference test and employed the standard enzyme-linked immunosorbent FC assay method with a cut-off of 50 or 100 µg/g faeces were included. Study quality was assessed with QUADAS-2, an evidence-based quality assessment tool for diagnostic accuracy studies. DATA SOURCES: MEDLINE and EMBASE; reference lists of screened articles. DATA SYNTHESIS: Eighteen relevant studies were identified. For distinguishing patients with organic GID (including IBD) from those with functional GIDs (16 studies), the estimated sensitivity of FC testing was 81% (95% CI, 74-86%), the specificity 81% (95% CI, 71-88%); area under the curve (AUC) was 0.87. For distinguishing IBD from functional GIDs (ten studies), sensitivity was 88% (95% CI, 80-93%), specificity 72% (95% CI, 59-82%), and AUC 0.89. Assuming a population prevalence of organic GID of 1%, the positive predictive value was 4.2%, the negative predictive value 100%. The difference in sensitivity and specificity between FC testing cut-offs of 50 µg/g and 100 µg/g faeces was not statistically significant (P = 0.77). CONCLUSIONS: FC testing is clinically useful for distinguishing organic GID (including IBD) from functional GIDs, and its incorporation into clinical practice for evaluating patients with lower gastrointestinal symptoms could lead to fewer patients with functional GIDs undergoing colonoscopy, reducing costs for both patients and the health system. PROSPERO REGISTRATION: CRD4201810507.