Single vs. multiple fraction non-inferiority trial of stereotactic ablative radiotherapy for the comprehensive treatment of oligo-metastases/progression: SIMPLIFY-SABR-COMET.

BACKGROUND: Radiotherapy delivery regimens can vary between a single fraction (SF) and multiple fractions (MF) given daily for up to several weeks depending on the location of the cancer or metastases. With limited evidence comparing fractionation regimens for oligometastases, there is support to explore toxicity levels to nearby organs at risk as a primary outcome while using SF and MF stereotactic ablative radiotherapy (SABR) as well as explore differences in patient-reported quality of life and experience. METHODS: This study will randomize 598 patients in a 1:1 ratio between the standard arm (MF SABR) and the experimental arm (SF SABR). This trial is designed as two randomized controlled trials within one patient population for resource efficiency. The primary objective of the first randomization is to determine if SF SABR is non-inferior to MF SABR, with respect to healthcare provider (HCP)-reported grade 3-5 adverse events (AEs) that are related to SABR. Primary endpoint is toxicity while secondary endpoints include lesional control rate (LCR), and progression-free survival (PFS). The second randomization (BC Cancer sites only) will allocate participants to either complete quality of life (QoL) questionnaires only; or QoL questionnaires and a symptom-specific survey with symptom-guided HCP intervention. The primary objective of the second randomization is to determine if radiation-related symptom questionnaire-guided HCP intervention results in improved reported QoL as measured by the EuroQoL-5-dimensions-5levels (EQ-5D-5L) instrument. The primary endpoint is patient-reported QoL and secondary endpoints include: persistence/resolution of symptom reporting, QoL, intervention cost effectiveness, resource utilization, and overall survival. DISCUSSION: This study will compare SF and MF SABR in the treatment of oligometastases and oligoprogression to determine if there is non-inferior toxicity for SF SABR in selected participants with 1-5 oligometastatic lesions. This study will also compare patient-reported QoL between participants who receive radiation-related symptom-guided HCP intervention and those who complete questionnaires alone. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT05784428. Date of Registration: 23 March 2023.

RCPAQAP audit of antimicrobial reporting in Australian and New Zealand laboratories: opportunities for laboratory contribution to antimicrobial stewardship.

Objectives: A 2017 laboratory survey conducted by the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) asked participants which antimicrobials they would report for given organisms in either blood or urine cultures in order to identify opportunities for improvement of antimicrobial reporting. Methods: Over-reporting was defined as reporting of broad-spectrum antimicrobials on isolates susceptible to narrow-spectrum antimicrobials. Inappropriate reporting was defined as reporting antimicrobials not appropriate for the site of infection. Results: For a fully susceptible Escherichia coli in blood culture, 65% of laboratories (55/84) over-reported at least one antimicrobial. Importantly, 15% (10/65) of laboratories that tested meropenem reported the result. A significant proportion of laboratories (12%, 10/84) reported antimicrobials generally considered inappropriate for treatment of bacteraemia on blood culture isolates. Overall, 82% (77/94) of laboratories either over-reported or inappropriately reported at least one antimicrobial. Conclusions: This survey identifies significant opportunities for improvement and standardization of 'cascade' or 'selective' reporting of antimicrobials and highlights ways in which microbiology laboratories can contribute to antimicrobial stewardship and judicious use of antimicrobials.

Anxiety: etiology, treatment, and Christian perspectives.

Anxiety disorders are the most common mental illness in the United States, affecting 18% or more of adults. Anxiety is a natural response to stress and danger but becomes pathological when excessive and uncontrollable. This article discusses symptoms, risk factors, neurobiology and pathophysiology, psychotherapies and medications used in treatment, nursing interventions, and biblical Christian understanding and support for managing anxiety.

Psychoactive and other ceremonial plants from a 2,000-year-old Maya ritual deposit at Yaxnohcah, Mexico.

For millennia, healing and psychoactive plants have been part of the medicinal and ceremonial fabric of elaborate rituals and everyday religious practices throughout Mesoamerica. Despite the essential nature of these ritual practices to the societal framework of past cultures, a clear understanding of the ceremonial life of the ancient Maya remains stubbornly elusive. Here we record the discovery of a special ritual deposit, likely wrapped in a bundle, located beneath the end field of a Late Preclassic ballcourt in the Helena complex of the Maya city of Yaxnohcah. This discovery was made possible by the application of environmental DNA technology. Plants identified through this analytical process included Ipomoea corymbosa (xtabentun in Mayan), Capsicum sp. (chili pepper or ic in Mayan), Hampea trilobata (jool), and Oxandra lanceolata (chilcahuite). All four plants have recognized medicinal properties. Two of the plants, jool and chilcahuite, are involved in artifact manufacture that have ceremonial connections while chili peppers and xtabentun have been associated with divination rituals. Xtabentun (known to the Aztecs as ololiuhqui) produces highly efficacious hallucinogenic compounds and is reported here from Maya archaeological contexts for the first time.

Blood culture quality assurance: what Australasian laboratories are measuring and opportunities for improvement.

Blood cultures are among the most important specimen types received and processed by the microbiology laboratory. Several publications list which variables should be measured to ensure quality. We undertook a qualitative structured questionnaire of Australian and New Zealand clinical microbiology laboratories to document current blood culture practices and to determine whether expected quality standards are being met. Questions included a wide range of pre-analytical, analytical, and post-analytical aspects of blood cultures from adults. The responses from 71 laboratories were analysed. Compliance was high for use of a biological safety cabinet (90%), incubating for 5 days (86%), and commenting on likely contaminants (85%). While Gram stains were reported within 2 hours during normal hours (93%), reporting was slower after hours (59%), p<0.001. The volume of blood collected for a clinical episode was poorly monitored with only 11% (n=8) of laboratories regularly auditing the number of blood culture sets and 3% (n=2) monitoring adequacy of fill. Most laboratories received blood cultures from off-site with just 34% (n=21) meeting guidance for loading bottles onto the analyser within 4 hours. More laboratories met standards for loading bottles onto the analyser during working hours than after hours: 87% vs 56%, p<0.001. Most laboratories did not monitor the contamination rate, 56% (n=40), and only 27% (n=19) knew their rate was below the guidance threshold of less than -3%. Considerable opportunities exist to improve quality assurance of blood culture practice in Australia and New Zealand, especially for the most critical aspect affecting culture sensitivity, the volume of blood collected.

The frequency and potential clinical impact of non-analytical errors in the RCPA Microbiology QAP 1987-2008.

BACKGROUND: Reliable reporting of laboratory results is an important component in the diagnosis and management of infectious diseases. We investigated the frequency of pre- and post-analytical errors by participants in the Royal College of Pathologists of Australasia (RCPA) Microbiology Quality Assurance Program (MQAP). METHODS: We retrospectively reviewed MQAP data 1987-1991 and 2004-2008. Pre-analytical error rates were based on participants' detection rate of clerical error for patient name and identification number for the given test item. Fictitious errors were defined as the reporting of a labelling error when in fact there was no discrepancy. Post-analytical error rates were based on clear transcription errors resulting in the test result being incorrectly assigned to another test item. FINDINGS: When there was one clerical error 10.6% of participants failed to report it. When there were two errors 5.3% failed to report either error and 8.8% only reported one error. Fictitious errors were reported by 1.1% of participants. Pre-analytical errors have not decreased over time. Of the 106 items where direct transposition errors were possible, 73 (69%) had at least one participant who transposed the results. During 2004-2008 transposition of mycobacterial smear and culture results occurred in 18% and 16% of participants, respectively. INTERPRETATIONS: Pre- and post-analytical errors are not rare amongst participants in the RCPA MQAP. These non-analytical components of the testing pathway require improvement because of their potential to adversely affect patient care.