The impact of a permanent stoma, such as post-abdominoperineal resection (APR), on quality of life (QoL) is well-documented. While stoma-related QoL tools exist, their relationship with stoma satisfaction is unclear. This study aimed to identify which aspects of QoL were most associated with stoma satisfaction. A cross-sectional study of consecutive patients who had an APR for rectal cancer at an Australian tertiary hospital (2012-2021), identified from a prospectively maintained database, was conducted. The Stoma-QoL questionnaire was used. Overall patient satisfaction with stoma function, and whether healthcare advice was sought for stoma dysfunction, were explored. Linear regression assessed the association between individual issues examined in the Stoma-QoL questionnaire and overall patient satisfaction with stoma function. Overall, 64 patients (62.5% male, mean 68.1 years) participated. Stoma-QoL score was associated with stoma satisfaction (P < 0.05). QoL items impacting satisfaction were: needing to know nearest toilet location (P = 0.04), pouch smell concerns (P = 0.008), needing daytime rest (P = 0.02), clothing limitations (P = 0.02), sexual attractiveness concerns (P < 0.05), embarrassment (P < 0.05), difficulty hiding the pouch (P = 0.02), concerns about being burdensome (P = 0.04) and difficulty with interpersonal interaction (P = 0.03). Only 11 (17.2%) patients sought healthcare advice for stoma dysfunction. While stoma-specific QoL is associated with stoma satisfaction, individual QoL aspects impact differently on satisfaction in permanent colostomy patients. These findings may help identify focus areas for peri-operative counselling for clinicians and stomal therapists, highlight the importance of tailored multidisciplinary care in ostomates and suggests that a stoma type-specific Stoma-QoL questionnaire is required.

Clinical Trial registry name and registration number: ClinicalTrials.gov Identifiers: NCT02065791 (CREDENCE), NCT03036150 (DAPA-CKD), NCT03594110 (EMPA-KIDNEY).

Lower doses of irradiation (≤ 5 Mrad) during the manufacture of highly crosslinked polyethylene acetabular liners may result in less crosslinking and an increased wear rate. Radiostereometric analysis (RSA) studies have found that wear of more highly irradiated highly crosslinked polyethylene liners (7 to 10 Mrad) decreases at longer-term follow-up compared with earlier reports of the same cohorts. Although wear of 5-Mrad irradiated liners appears to increase at midterm follow-up, it is unclear whether that remains true at longer follow-up. We asked: (1) In patients who underwent THA with a 5-Mrad highly crosslinked polyethylene liner, what is the wear rate evaluated with RSA during the first 14 years? (2) Does the wear rate decrease after 6 years in situ? This is a brief follow-up of prior RSA studies performed at 2 and 6 years. We prospectively reviewed the longer-term wear rate in 13 patients who underwent primary THAs with the same design of a 5-MRad irradiated crosslinked acetabular liner and a 28-mm cobalt-chromium articulation. Of the initial 30 patients who were enrolled, 13 (43%) were available at the 14-year timepoint; nine patients had died, 1 patient had withdrawn, 1 had an intraoperative fracture, 3 patients were too infirm to have radiographs, 2 had no baseline RSA radiographs, and 1 had poor-quality RSA images. Tantalum markers were inserted during surgery, and all patients had RSA radiographic examinations at 1 week, 6 months, and 1, 2, 6, and 14 years postoperatively. The mean ± standard deviation proximal, 2D, and 3D wear rates calculated between 1 year and 14 years were 0.019 ± 0.013 mm, 0.022 ± 0.015 mm, and 0.025 ± 0.019 mm per year, respectively. No patient had proximal 2D or 3D wear rates exceeding 0.06 mm per year. An increasing wear rate over time was measured for proximal and 2D wear rates between 6 and 14 years (0.024 and 0.030 mm per year) compared with that between 1 and 6 years (0.008 and 0.010 mm per year; p = 0.03). The proximal, 2D, and 3D wear of a highly crosslinked polyethylene liner produced using 5-Mrad radiation remains low in the longer-term. With the small numbers available in a long-term RSA study such as this, we confirmed that the wear rate did not decrease at longer-term follow-up, unlike previous RSA studies of more highly irradiated highly crosslinked polyethylene liners. Nevertheless, the wear rate remains very low and below the threshold typically associated with the development of osteolysis (0.1 mm/year of wear). This should provide assurance to orthopaedic surgeons monitoring patients with this 5-Mrad irradiated liner in situ, while providing useful information to manufacturers of future highly crosslinked polyethylene liners. Level IV therapeutic study.

ObjectivesTo assess the risk of flare and damage accrual after tapering glucocorticoids (GCs) in modified serologically active clinically quiescent (mSACQ) patients with systemic lupus erythematosus (SLE).MethodsData from a 12-country longitudinal SLE cohort, collected prospectively between 2013 and 2020, were analysed. SLE patients with mSACQ defined as the state with serological activity (increased anti-dsDNA and/or hypocomplementemia) but without clinical activity, treated with ≤7.5 mg/day of prednisolone-equivalent GCs and not-considering duration, were studied. The risk of subsequent flare or damage accrual per 1 mg decrease of prednisolone was assessed using Cox proportional hazard models while adjusting for confounders. Observation periods were 2 years and censored if each event occurred.ResultsData from 1850 mSACQ patients were analysed: 742, 271 and 180 patients experienced overall flare, severe flare and damage accrual, respectively. Tapering GCs by 1 mg/day of prednisolone was not associated with increased risk of overall or severe flare: adjusted HRs 1.02 (95% CI, 0.99 to 1.05) and 0.98 (95% CI, 0.96 to 1.004), respectively. Antimalarial use was associated with decreased flare risk. Tapering GCs was associated with decreased risk of damage accrual (adjusted HR 0.96, 95% CI, 0.93 to 0.99) in the patients whose initial prednisolone dosages were >5 mg/day.ConclusionsIn mSACQ patients, tapering GCs was not associated with increased flare risk. Antimalarial use was associated with decreased flare risk. Tapering GCs protected mSACQ patients treated with >5 mg/day of prednisolone against damage accrual. These findings suggest that cautious GC tapering is feasible and can reduce GC use in mSACQ patients.

Abstract Background Drug–drug interactions (DDIs) remain a highly prevalent issue for patients in both community and hospital settings. Electronic medication management systems have implemented DDI alerts to mitigate DDI-related harm from occurring. Objectives The primary aim of this study was to explore factors that influence health care professionals' (hospital doctors, hospital pharmacists, general practitioners, and community pharmacists) perceptions and action taken by them in response to DDI alerts. Methods A qualitative study was conducted using semi-structured interviews between early January and late February 2021. The top 20 most frequently triggered DDI alerts previously identified were used as examples of alert prompts shown to participants. Results A total of 20 participants were recruited. General practitioners (n = 4) were most likely to consider DDI alerts to be clinically relevant and important, and hospital doctors (n = 4) were most likely to consider these alerts not being clinically relevant nor important. Three main factors were identified to influence health care professionals' perceptions of DDI alerts, which included clinical relevance, visual presentation, and content of alerts. Conclusion Health care professionals' perceptions of DDI alerts are influenced by multiple factors and considerations are required to create tailored alerts for users and their clinical contexts. Improvement in DDI alerts should be a priority to improve patient medication safety and health outcomes.

Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has experienced common issues affecting the implementation of randomised placebo-controlled surgery trials, accentuated by the COVID-19 pandemic. Using the SUcceSS trial as an example, we discuss key challenges and mitigation strategies specific to the conduct of a randomised placebo-controlled surgical trial. Overall, the key lessons learned were (i) involving key stakeholders early and throughout the trial design phase may increase clinician and patient willingness to participate in a placebo-controlled trial of surgical interventions, (ii) additional resources (e.g. budget, staff time) are likely required to successfully operationalise trials of this nature, (iii) the level of placebo fidelity, timing of randomisation relative to intervention delivery, and nuances of the surgical procedure under investigation should be considered carefully. Findings are based on one example of a placebo-controlled surgical trial; however, researchers may benefit from employing or building from the strategies described and lessons learned when designing or implementing future trials of this nature.

Rationale: About 20-35% of patients with obstructive sleep apnea (OSA) have supine-isolated OSA, for which supine sleep avoidance could be an effective therapy. However, traditional supine discomfort-based methods show poor tolerance and compliance to treatment and so cannot be recommended. Supine alarm devices show promise, but evidence to support favorable adherence to treatment and effectiveness at reducing excessive daytime sleepiness compared with continuous positive airway pressure (CPAP) remains limited. Objectives: To establish if alarm-based supine-avoidance treatment in patients with supine-isolated OSA is noninferior to CPAP in reducing daytime sleepiness. Methods: After baseline questionnaire administration and in-home supine-time and polysomnography assessments, patients with supine-isolated OSA and Epworth Sleepiness Scale scores ⩾8 were randomized to ⩾6 weeks of supine-avoidance or CPAP treatment, followed by crossover to the remaining treatment with repeat assessments. Noninferiority was assessed from change in Epworth Sleepiness Scale with supine avoidance compared with CPAP using a prespecified noninferiority margin of 1.5. Average nightly treatment use over all nights and treatment efficacy and effectiveness at reducing respiratory disturbances were also compared between treatments. Results: The reduction in sleepiness score with supine avoidance (mean [95% confidence interval], -1.9 [-2.8 to -1.0]) was noninferior to that with CPAP (-2.4 [-3.3 to -1.4]) (supine avoidance-CPAP difference, -0.4 [-1.3 to 0.6]), and the lower confidence limit did not cross the noninferiority margin of 1.5 (P = 0.021). Average treatment use was higher with supine avoidance compared with CPAP (mean ± standard deviation, 5.7 ± 2.4 vs. 3.9 ± 2.7 h/night; P < 0.001). Conclusions: In patients with supine-isolated OSA, vibrotactile supine alarm device therapy is noninferior to CPAP for reducing sleepiness and shows superior treatment adherence. Clinical trial registered with www.anzctr.org.au (ACTRN 12613001242718).

BackgroundNight eating syndrome (NES) is a unique eating disorder characterised by evening hyperphagia and nocturnal ingestions which cause significant distress and/or impairment in functioning. Despite the growing literature, NES remains poorly understood and under diagnosed. As such, this study aims to compare the prevalence of physical health conditions in participants with NES when compared to participants without an eating disorder (ED) and participants with other eating disorders (including anorexia nervosa (AN), binge eating disorder (BED) and bulimia nervosa (BN)) in a general population Australian sample of adults.MethodsThe data for this study were obtained from the 2017 Health Omnibus Survey (HOS) a multi-stage, cross-sectional survey, conducted by Harrison Research in South Australia. This current study focused on 2547 participants over 18 years of age and specific questions from this population survey including those related to participant demographics and health.ResultsThis study identified that participants who screened positive for night eating syndrome (spNES) when compared to participants with other eating disorders (ED) or no ED diagnosis, were significantly more likely to have an increased age, be female, have lower levels of education and have lower household income. Additionally, the spNES group was significantly associated with sleep apnoea (p = 0.031), insomnia or other sleep problems (p < 0.0001), increased BMI (p < 0.0001), increased levels of pain/discomfort and lower physical health-related quality of life. Hypertension, hypercholesterolemia, and diabetes were not significantly associated with the spNES group or the “other ED” group which included participants with AN, BED, BN.ConclusionsSeveral physical health problems were found to be significantly associated with the spNES group including sleep problems, increased BMI, increased levels of pain and lower self-reported physical health-related quality of life. Consequently, future research exploring the complex interaction between NES and these medical conditions may provide further insight into the diagnosis, screening tools and management of NES. Additionally, this study highlights the need for future studies which use larger population-based samples.Level of evidenceLevel III. Evidence obtained from well-designed cohort or case–control analytic studies.

PurposeLaparoscopic giant hiatus hernia repair is technically difficult with ongoing debate regarding the most effective surgical technique. Repair of small hernia has been well described but data for giant hernia is variable. This study evaluated trends in outcomes of laparoscopic non-mesh repair of giant paraesophageal hernia (PEH) over 30 years.MethodsRetrospective analysis of a single-surgeon prospective database. Laparoscopic non-mesh repairs for giant PEH between 1991 and 2021 included. Three-hundred-sixty-degree fundoplication was performed routinely, evolving into “composite repair” (esophagopexy and cardiopexy to the right crus). Cases were chronologically divided into tertiles based on operation date (Group 1, 1991–2002; Group 2, 2003–2012; Group 3, 2012–2021) with trends in casemix, operative factors and outcomes evaluated. Hernia recurrence was plotted using weighted moving average and cumulative sum (CUSUM) analysis.Results862 giant PEH repairs met selection criteria. There was an increasing proportion of “composite repair” after the first decade (Group 1, 2.7%; Group 2, 81.9%; Group 3, 100%; p < 0.001). There were less anatomical hernia recurrence (Group 1, 36.6%; Group 2, 22.9%; Group 3, 22.7%; p < 0.001) and symptomatic recurrence (Group 1, 34.2%; Group 2, 21.9%; Group 3, 7%; p < 0.001) over time. The incidence of anatomical recurrence declined over time, decreasing from 30.8% and plateauing below 17.6% near the study’s end. Median followup (months) in the first decade was higher but followup between the latter two decades comparable (Group 1, 49 [IQR 20, 81]; Group 2, 30 [IQR 15, 65]; Group 3, 24 [14, 56]; p < 0.001). There were 10 (1.2%) Clavien–Dindo grade ≥ III complications including two perioperative deaths (0.2%).ConclusionHernia recurrence rates decreased with increasing case volume. This coincided with the increasing adoption of “composite repair”, supporting the possible improvement in recurrence rates with this approach.

PurposeTo investigate trends in SGLT2i and GLP-1RA use in Australia in the era of increased evidence of their cardiovascular benefits.MethodsWe used national dispensing claims for a 10% random sample of Australians to estimate the number of prevalent and new users (no dispensing in the prior year) of SGLT2i or GLP-1RA per month from January 2014 to July 2022. We assessed prescriber specialty and prior use of other antidiabetic and cardiovascular medicines as a proxy for evidence of type 2 diabetes (T2D) and cardiovascular conditions, respectively.ResultsWe found a large increase in the number of prevalent users (216-fold for SGLT2i; 11-fold for GLP-1RA); in July 2022 approximately 250,000 Australians were dispensed SGLT2i and 120,000 GLP-1RA. Most new users of SGLT2i or GLP-1RA had evidence of both T2D and cardiovascular conditions, although from 2022 onwards, approximately one in five new users of SGLT2i did not have T2D. The proportion of new users initiating SGLT2i by cardiologists increased after 2021, reaching 10.0% of initiations in July 2022. Among new users with evidence of cardiovascular conditions, empagliflozin was the most commonly prescribed SGLT2i, while dulaglutide or semaglutide was the most common GLP-1RA.ConclusionSGLT2i and GLP-1RA use is increasing in Australia, particularly in populations with higher cardiovascular risk. The increased use of SGLT2i among people without evidence of T2D suggests that best-evidence medicines are adopted in Australia across specialties, aligning with new evidence and expanding indications.