New Protocol for Evaluating Maximum Inspiratory Pressure: Concurrent Validity and Test-Retest Reliability.

OBJECTIVE: The purpose of this study was to validate a maximum inspiratory pressure test protocol based on the principles of the one-repetition maximum test, assess its test-retest reliability, and establish minimal detectable change in individuals with chronic obstructive pulmonary disease (COPD). METHODS: Forty-nine individuals with COPD were included in the study, of whom 44 individuals attended 2 appointments separated by 7 to 10 days for test-retest reliability. The maximum inspiratory pressure test was performed using a threshold valve device (one-repetition maximum-based protocol) and the digital manometer (reference test). The one-repetition maximum-based protocol consisted of an incremental phase (inspiratory load increase [10 cmH2O] to achieve respiratory failure) and an approach phase (load halfway between the lowest failed attempt and the last valid attempt was prescribed). RESULTS: The concurrent validity of the one-repetition maximum-based protocol for the maximum inspiratory pressure test was good with respect to the reference test (day 1, ICC = 0.81; day 2, ICC = 0.85). The test-retest reliability was excellent (ICC = 0.92), with a standard error of measurement of 6.3 cmH2O and a minimal detectable change of 17.5 cmH2O. CONCLUSION: This study validated a new one-repetition maximum-based protocol for the maximum inspiratory pressure test using an inspiratory muscle training device in individuals with COPD, showing good concurrent validity compared with the reference test, as well as excellent test-retest reliability. The minimal detectable change reported can be interpreted and applied in the clinical setting. IMPACT: There was a need for developing new, inexpensive, simple, and feasible methods for the maximum inspiratory pressure test. The validation of the one-repetition maximum-based protocol addresses this issue, allowing for the appropriate prescription of inspiratory muscle training, favoring its widespread use in people with COPD and therefore improving their physical therapist care.

Have changes in colorectal surgery training impacted on mortality in cancer patients? A retrospective cohort study of 51,562 procedures.

INTRODUCTION: The aim of this study was to explore whether there were any differences in consultant colorectal surgeon training and adjusted 90-day postoperative colorectal cancer mortality rates (AMR). METHODS: We undertook a retrospective analysis of outcomes data published on the Association of Coloproctology of Great Britain and Ireland (ACPGBI) website. A total of 51,562 procedures for patients in England diagnosed with large bowel cancer between 2010 and 2015, registered under 551 consultants were included. Consultants were split into two cohorts. The first group were the pre-Calman Trained Consultants (pre-CTr), who completed their training before 1998. The second group-the post-Calman Trained Consultants (post-CTr)-included those who received their Certificate of Completion of Training (CCT) under the Calman Training Principles (CTC, 1998-2007) and the Modernising Medical Careers Curriculum (MMC, 2008 and onwards). The outcome measure was an AMR. RESULTS: The pre-CTr cohort (n=84) consisted of 3.6% female colorectal consultants (n=3/84), whereas the post-CTr cohort (n=467) consisted of 14.3% female colorectal consultants (n=67/467) (p=0.006). In this cross-sectional analysis over 5 years, the average pre-CTr undertook a greater number of colorectal resections than their post-CTr peers: median procedures (interquartile range, IQR): 104 (59) vs 89 (57) respectively, p=0.008. The median AMR was significantly greater among pre-CTrs compared with post-CTrs, median AMR (IQR): 2.7% (2.0) vs 2.1% (2.9), p=0.022. CONCLUSIONS: These data indicate that the implementation of the MMC and Calman training principles for colorectal training is associated with a statistically lower AMR compared with other historical training periods. This merits further exploration.

N-of-1 trials in epilepsy: A systematic review and lessons paving the way forward.

OBJECTIVE: Defined as prospective single-patient crossover studies with repeated paired cycles of active and control intervention, N-of-1 trials have gained attention as an option to obtain high-quality evidence of efficacy, particularly for patients with rare epilepsies in whom conduction of well-powered randomized controlled trials can be challenging. The objective of this systematic review is to provide an appraisal of the literature on N-of-1 trials in individuals with epilepsy. METHODS: We searched PubMed and Embase on January 12, 2024, for studies meeting the following criteria: prospectively planned, within-patient, multiple-crossover design in individuals with epilepsy and outcomes related to comorbidities. Information on design, outcome measurements, intervention, and analyses was retrieved. Risk of bias assessment was performed using the Risk of Bias in N-of-1 Trials (RoBiNT) scale. We highlighted methodological aspects of the N-of-1 trials identified and discuss future recommendations. RESULTS: Five studies met our inclusion criteria. An additional multiple-crossover trial that evaluated treatment effects exclusively at group level was also included because of its relevance to N-of-1 study methodology. The studies enrolled individuals with focal seizures, absences or cognitive impairement and electrographic discharges. Treatments included established or investigational antiseizure medications, off-label medications, neurostimulation or lifestyle intervention. Three of the five N-of-1 trials reported on individual cases. The studies' strengths were the use of individualized treatment dosages and symptom-specific patient-reported outcomes. Limitations were related to minimal reporting of baseline characteristics and seizure burden. SIGNIFICANCE: The trials identified by our search exemplify how the N-of-1 design can be applied to assess interventions in individuals with epilepsy-related disorders. Future N-of-1 trials of antiseizure interventions should take into account baseline seizure frequency, should apply statistical models suited to capture seizure frequency changes reliably and make predefined interim assessments. Non-seizure outcome measures evaluable over short periods should be considered. Tailored N-of-1 methodology could pave the way to evidence-based, treatment selection for patients with rare epilepsies.

Clinical and cost-effectiveness of spironolactone in treating persistent facial acne in women: SAFA double-blinded RCT.

Background: Acne is common, can cause significant impact on quality of life and is a frequent reason for long-term antibiotic use. Spironolactone has been prescribed for acne in women for many years, but robust evidence is lacking. Objective: To evaluate whether spironolactone is clinically effective and cost-effective in treating acne in women. Design: Pragmatic, parallel, double-blind, randomised superiority trial. Setting: Primary and secondary healthcare and community settings (community and social media advertising). Participants: Women aged 18 years and older with facial acne persisting for at least 6 months, judged to potentially warrant oral antibiotic treatment. Interventions: Participants were randomised 1 : 1, using an independent web-based procedure, to either 50 mg/day spironolactone or matched placebo until week 6, increasing to 100 mg/day spironolactone or matched placebo until week 24. Participants continued usual topical treatment. Main outcome measures: Primary outcome was the adjusted mean difference in Acne-Specific Quality of Life symptom subscale score at 12 weeks. Secondary outcomes included Acne-Specific Quality of Life total and subscales; participant self-assessed improvement; Investigator's Global Assessment; Participant's Global Assessment; satisfaction; adverse effects and cost-effectiveness. Results: Of 1267 women assessed for eligibility, 410 were randomised (201 intervention, 209 control), 342 in the primary analysis (176 intervention, 166 control). Mean age was 29.2 years (standard deviation 7.2) and 7.9% (28/356) were from non-white backgrounds. At baseline, Investigator's Global Assessment classified acne as mild in 46%, moderate in 40% and severe in 13%. At baseline, 82.9% were using topical treatments. Over 95% of participants in both groups tolerated the treatment and increased their dose. Mean baseline Acne-Specific Quality of Life symptom subscale was 13.0 (standard deviation 4.7) across both groups. Mean scores at week 12 were 19.2 (standard deviation 6.1) for spironolactone and 17.8 (standard deviation 5.6) for placebo [difference favouring spironolactone 1.27 (95% confidence interval 0.07 to 2.46) adjusting for baseline variables]. Mean scores at week 24 were 21.2 (standard deviation 5.9) in spironolactone group and 17.4 (standard deviation 5.8) in placebo group [adjusted difference 3.77 (95% confidence interval 2.50 to 5.03) adjusted]. Secondary outcomes also favoured spironolactone at 12 weeks with greater differences at 24 weeks. Participants taking spironolactone were more likely than those taking placebo to report overall acne improvement at 12 weeks {72.2% vs. 67.9% [adjusted odds ratio 1.16 (95% confidence interval 0.70 to 1.91)]} and at 24 weeks {81.9% vs. 63.3% [adjusted odds ratio 2.72 (95% confidence interval 1.50 to 4.93)]}. Investigator's Global Assessment was judged successful at week 12 for 31/201 (18.5%) taking spironolactone and 9/209 (5.6%) taking placebo [adjusted odds ratio 5.18 (95% confidence interval 2.18 to 12.28)]. Satisfaction with treatment improved in 70.6% of participants taking spironolactone compared with 43.1% taking placebo [adjusted odds ratio 3.12 (95% confidence interval 1.80 to 5.41)]. Adverse reactions were similar between groups, but headaches were reported more commonly on spironolactone (20.4% vs. 12.0%). No serious adverse reactions were reported. Taking account for missing data through multiple imputation gave an incremental cost per quality-adjusted life-year of £27,879 (adjusted) compared to placebo or £2683 per quality-adjusted life-year compared to oral antibiotics. Conclusions: Spironolactone resulted in better participant-reported and investigator-reported outcomes than placebo, with greater differences at week 24 than week 12. Trial registration: This trial is registered as ISRCTN12892056 and EudraCT (2018-003630-33). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/13/02) and is published in full in Health Technology Assessment; Vol. 28, No. 56. See the NIHR Funding and Awards website for further award information.

Acne (or spots) is common and often persists into adulthood. Many people take long courses of antibiotic tablets, but concerns about antibiotic resistance mean alternatives are needed. Spironolactone is a medicine that is sometimes used for acne in women. However, we do not know whether it works. This trial aimed to answer this question. We invited women aged over 18 who had acne on their face for at least 6 months to take part via their general practitioner surgery, hospital or advertising. Women were randomly assigned to two groups: one group was given spironolactone and the other group was given identical-looking placebo ('dummy pill') daily for 24 weeks. Women in both groups could continue using acne treatments applied to the skin (gels/creams/lotions). We asked participants to rate their acne using a questionnaire called Acne-Specific Quality of Life, asked whether they felt their skin had improved and asked skin specialists to assess their skin. Four hundred and ten women took part, many of whom had had acne for a long time. Acne-Specific Quality of Life scores improved in both groups by 12 weeks but improved more in the spironolactone group at 12 and 24 weeks. When asked directly whether their skin had improved, 71% of participants in the spironolactone group said it had, compared with 43% on placebo. Skin specialists were also more likely to report that the acne had improved in the spironolactone group. Side effects were mild and similar in both groups but there were slightly more headaches on spironolactone (20% compared with 12%). Spironolactone is likely to represent value for money for the National Health Service, though this depends on a number of factors including what it is compared to. This trial suggests that spironolactone is a useful additional treatment for women with persistent acne.

Derived Time in Range and Other Metrics of Poor Glycemic Control Associated With Adverse Hospital Outcomes in Patients With Diabetes Mellitus Admitted to Non-ICU Wards at a Tertiary-Level Hospital in Colombia: A Cross-Sectional Study.

Aim: This study is aimed at assessing the prevalence of poor glycemic control using different metrics and its association with in-hospital adverse outcomes. Methods: This cross-sectional study was conducted in diabetic patients admitted to a third-level hospital in Colombia between January and July 2022. Poor glycemic control was determined using capillary glucose metrics, including mean glucose values outside the target range, derived time in range (dTIR) (100-180 mg/dL) < 70%, coefficient of variation (CV > 36%), and hypoglycemia (<70 mg/dL). Multiple regression models were adjusted for hospital outcomes based on glycemic control, as well as other sociodemographic and clinical covariates. Results: A total of 330 Hispanic patients were included. A total of 27.6% had mean glucose measurements outside the target range, 33% had a high CV, 64.8% had low dTIR, and 28.8% experienced hypoglycemia. The in-hospital mortality rate was 8.8%. An admission HbA1c level greater than 7% was linked to an increased mortality risk (p = 0.016), as well as a higher average of glucometer readings (186 mg/dL vs. 143 mg/dL; p < 0.001). A lower average of dTIR (41.0% vs. 60.0%; p < 0.001) was also associated with a higher mortality risk. Glycemic variability was correlated with an increased risk of mortality, hypoglycemia, delirium, and length of hospital stay (LOS). Conclusion: A significant number of hospitalized diabetic patients exhibit poor glycemic control, which has been found to be associated with adverse outcomes, including increased mortality. Metrics like dTIR and glycemic variability should be considered as targets for glycemic control, highlighting the need for enhanced management strategies.

Spillover effects from a type 2 diabetes integrated model of care in 22,706 Australians: an open cohort stepped wedge trial.

BACKGROUND: Many Australian adults are not receiving timely or effective diabetes management to prevent or delay the onset of diabetes related complications. Integrated care, a worldwide trend in healthcare reform, aims to reduce the fragmented delivery of health services and improve outcomes. This study aimed to test whether a specialist-led integrated model of care provided to a small subset of patients in general practices leads to spillover clinical improvements in all patients of the practice with type 2 diabetes. METHODS: Seventy-two general practice sites (clusters) in New South Wales, Australia received the Diabetes Alliance intervention, creating a non-randomised open cohort stepped wedge trial. The intervention comprised of case conferencing, delivered directly to a small proportion of adults with type 2 diabetes (n = 1,072) of the general practice sites; as well as practice feedback, education and training. Spillover clinical improvements were assessed on all adults with type 2 diabetes within the general practice sites (n = 22,706), using practice level data recorded in the MedicineInsight electronic database, compared before and after the intervention. Outcome measures included frequency of diabetes screening tests in line with the Annual Cycle of Care, and clinical results for weight, blood pressure, HbA1c, lipids, and kidney function. RESULTS: Compared to before Diabetes Alliance, the odds of all practice patients receiving screening tests at or above the recommended intervals were significantly higher for all recommended tests after Diabetes Alliance (odds ratio range 1.41-4.45, p < 0.0001). Significant improvements in clinical outcomes were observed for weight (absolute mean difference: -1.38 kg), blood pressure (systolic - 1.12 mmHg, diastolic - 1.18 mmHg), HbA1c (-0.03% at the mean), total cholesterol (-0.11 mmol/L), and triglycerides (-0.02 mmol/L) (p < 0.05). There were small but significant declines in kidney function. CONCLUSIONS: Integrated care delivered to a small subset of patients with type 2 diabetes across a large geographic region has spillover benefits that improve the process measures and clinical outcomes for all practice patients with type 2 diabetes. TRIAL REGISTRATION: ACTRN12622001438741; 10th November 2022, retrospectively registered: https://www.anzctr.org.au/ACTRN12622001438741.aspx .

Mental disorders in adults from Ribeirão Preto, Brazil: a cross-sectional analysis of two birth cohorts.

BACKGROUND: In Brazil, the prevalence of mental disorders is heterogeneous, with most studies conducted in large cities with high population density. This study aimed to assess the prevalence of mental disorders and psychiatric comorbidities among young adults (22-23 years old) and adults (37-38 years old) from Ribeirão Preto, a city located in the Northeast of the São Paulo state, with approximately 700,000 inhabitants, and to explore associations with sociodemographic variables, suicide risk, and health service usage. Second, we aimed to evaluate the performance of the Self-Report Questionnaire (SRQ-20) as a screening tool for mental disorders to be applied to the local population. METHODS: Participants from the 1978/1979 and 1994 Ribeirão Preto birth cohorts were evaluated using the Mini International Neuropsychiatric Interview (MINI) and the SRQ-20 at mean ages of 22-23, and 37-38 years, respectively. RESULTS: Our sample comprised 1,769 individuals from the 1978/1979 cohort and 1,037 from the 1994 cohort. The prevalence of mental disorders ranged from 28.6% (1978/79) to 31% (1994), with frequent comorbid diagnoses (42.7% and 43.3%, respectively). Men and women had a similar prevalence of mental disorders in the younger cohort, while women had a higher prevalence in the older cohort. Low educational attainment was associated with higher rates of diagnosis. In both cohorts, alcohol and other psychoactive substance use was higher among those with a psychiatric diagnosis. Although those with a psychiatric diagnosis were less satisfied with their own health, only one-fifth had seen a mental health professional in the previous year. A psychiatric diagnosis increased the suicide risk by 5.6 to 9.1 times. Regarding the SRQ-20, the best cutoff points were 5/6 for men and 7/8 for women, with satisfactory performance. CONCLUSIONS: The prevalence and comorbidity of mental disorders were high in both cohorts and comparable to those in larger Brazilian cities. However, few individuals with a diagnosis had sought specialized care. These data suggest that the mental health gap is still significant in Brazil.

Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT.

Background: Endometriosis affects 1 in 10 women, many of whom have surgery for persistent pain. Recurrence of symptoms following an operation is common. Although hormonal treatment can reduce this risk, there is uncertainty about the best option. Objectives: To evaluate the clinical and cost-effectiveness of long-acting progestogen therapy compared with the combined oral contraceptive pill in preventing recurrence of endometriosis-related pain and quality of life. Design: A multicentre, open, randomised trial with parallel economic evaluation. The final design was informed by a pilot study, qualitative exploration of women's lived experience of endometriosis and a pretrial economic model. Setting: Thirty-four United Kingdom hospitals. Participants: Women of reproductive age undergoing conservative surgery for endometriosis. Interventions: Long-acting progestogen reversible contraceptive (either 150 mg depot medroxyprogesterone acetate or 52 mg levonorgestrel-releasing intrauterine system) or combined oral contraceptive pill (30 µg ethinylestradiol, 150 µg levonorgestrel). Main outcome measures: The primary outcome was the pain domain of the Endometriosis Health Profile-30 questionnaire at 36 months post randomisation. The economic evaluation estimated the cost per quality-adjusted life-years gained. Results: Four hundred and five women were randomised to receive either long-acting reversible contraceptive (N = 205) or combined oral contraceptive pill (N = 200). Pain scores improved in both groups (24 and 23 points on average) compared with preoperative values but there was no difference between the two (adjusted mean difference: -0.8, 95% confidence interval -5.7 to 4.2; p = 0.76). The long-acting reversible contraceptive group underwent fewer surgical procedures or second-line treatments compared with the combined oral contraceptive group (73 vs. 97; hazard ratio 0.67, 95% confidence interval 0.44 to 1.00). The mean adjusted quality-adjusted life-year difference between two arms was 0.043 (95% confidence interval -0.069 to 0.152) in favour of the combined oral contraceptive pill, although this cost an additional £533 (95% confidence interval 52 to 983) per woman. Limitations: Limitations include the absence of a no-treatment group and the fact that many women changed treatments over the 3 years of follow-up. Use of telephone follow-up to collect primary outcome data in those who failed to return questionnaires resulted in missing data for secondary outcomes. The COVID pandemic may have affected rates of further surgical treatment. Conclusions: At 36 months, women allocated to either intervention had comparable levels of pain, with both groups showing around a 40% improvement from presurgical levels. Although the combined oral contraceptive was cost-effective at a threshold of £20,000 per quality-adjusted life-year, the difference between the two was marginal and lower rates of repeat surgery might make long-acting reversible contraceptives preferable to some women. Future work: Future research needs to focus on evaluating newer hormonal preparations, a more holistic approach to symptom suppression and identification of biomarkers to diagnose endometriosis and its recurrence. Trial registration: This trial is registered as ISRCTN97865475. https://doi.org/10.1186/ISRCTN97865475. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 11/114/01) and is published in full in Health Technology Assessment; Vol. 28, No. 55. See the NIHR Funding and Awards website for further award information. The NIHR recognises that people have diverse gender identities, and in this report, the word 'woman' is used to describe patients or individuals whose sex assigned at birth was female, whether they identify as female, male or non-binary.

Endometriosis is a condition where cells similar to ones that line the womb are found elsewhere in the body. Endometriosis affects 1 in 10 women, many of whom have surgery for persistent pain. Unfortunately, symptoms often return and some women will need repeat operations. Hormonal contraceptives can prevent the return of endometriosis-related pain: either long-acting reversible contraceptives (injections or a coil, fitted inside the womb) or the combined oral contraceptive pill (often called 'the pill'). We do not know which is the best option. The aim of this trial was to find out which of these two hormone treatments was more effective in terms of symptom relief, avoidance of further surgery and costs. Four hundred and five women with endometriosis, who were not intending to get pregnant, participated in a clinical trial. Half of the participants took long-acting reversible contraceptives, and the other half took the pill for 3 years following endometriosis surgery. The choice of treatment was made at random by a computer to ensure a fair comparison, although those allocated to the long-acting contraceptive could choose between injections or the coil. Participants completed questionnaires about their symptoms and life quality at intervals up to 3 years. Both treatments were equally good at reducing pain but more women using the pill had repeat operations. The pill was a little more costly overall but associated with a slightly higher quality of life. Both treatments are equally effective in reducing pain up to 3 years after surgery for endometriosis. The differences in costs are small and the choice of treatment should be based on personal preference.

Heterogenous relapse and efficacy endpoint definitions for neuromyelitis optica spectrum disorder studies: A systematic review.

BACKGROUND: Over the last years, multiple studies have been dedicated to evaluate the efficacy of different treatment options for Neuromyelitis Optica Spectrum Disorder (NMOSD). However, there is a wide variety of endpoints employed across these studies. Our goal is to conduct a systematic review describing the endpoints utilized in studies related to NMOSD. METHODS: Medline, Embase, and Cochrane were searched from inception to May 2023, to identify studies analyzing treatment options in patients with NMOSD. We collected data on baseline study characteristics and all efficacy outcomes available. RESULTS: We included 127 studies and identified approximately 40 different efficacy endpoints, categorized into 1) relapse, 2) disability, 3) visual acuity, and 4) surrogate outcomes. Most studies were retrospective (54.3 %) and aimed at attack prevention (81.4 %). The most common relapse-related outcomes were annualized relapse rate (73.2 %), followed by relapse rate (50.4 %), and relapse-free rate (36.2 %). The relapse definition also varied widely among studies, with only 73 (57.4 %) studies explicitly addressing the definition used. The most common disability outcome was the Expanded Disability Scale (97.6 %), followed by the Modified Rankin Scale (7.9 %). Visual Acuity Score was employed in 14.2 % of studies, followed by Visual Evoked Potentials (6.3 %). Imaging was the most common surrogate (20.5 %), followed by the fraction of B cells (18.1 %). CONCLUSION: Publications were heterogeneous in measuring efficacy, with different use of endpoints and relapse definitions. Standardization across studies would improve data analysis and application in clinical practice.

Call to action: Blueprint for change in acute and critical care nursing.

Herein, we propose a blueprint for action to completely measure and recognize the care provided by acute and critical care nurses to be incorporated into policy that shapes and supports practice. We address the nature of nurses' work by identifying nine practice domains, hospital practice environment assumptions, and expected outcomes. Nurses' work, as a cross-system process, needs to be included in hospital-based core measures to fully reflect nurses' impact on patient care. We call for a balanced measurement portfolio focused on patient/family-, unit-, and systems-level outcomes. We focus on what nurses do and what patients and their families can expect rather than only on the elimination of select adverse events. We provide a way forward to allow measure development and implementation with incentives for their use. This approach to making nurses' contributions and impact on outcomes visible will enhance acute and critical care nursing practice and benefit patients and their families.

Management strategies and outcomes in pregnancy-related acute aortic dissection: a multicentre cohort study in China.

BACKGROUND: Acute aortic dissection (AD) in pregnancy poses a lethal risk to both mother and fetus. However, well-established therapeutic guidelines are lacking. This study aimed to investigate clinical features, outcomes and optimal management strategies for pregnancy-related AD. METHODS: We conducted a retrospective multicentre cohort study including 67 women with acute AD during pregnancy or within 12 weeks postpartum from three major cardiovascular centres in China between 2003 and 2021. Patient characteristics, management strategies and short-term outcomes were analysed. RESULTS: Median age was 31 years, with AD onset at median 32 weeks gestation. Forty-six patients (68.7%) had type A AD, of which 41 underwent immediate surgery. Overall maternal mortality was 10.4% (7/67) and fetal mortality was 26.9% (18/67). Compared with immediate surgery, selective surgery was associated with higher risk of composite maternal and fetal death (adjusted RR: 12.47 (95% CI 3.26 to 47.73); p=0.0002) and fetal death (adjusted RR: 8.77 (95% CI 2.33 to 33.09); p=0.001). CONCLUSIONS: Immediate aortic surgery should be considered for type A AD at any stage of pregnancy or postpartum. For pregnant women with AD before fetal viability, surgical treatment with the fetus in utero should be considered. Management strategies should account for dissection type, gestational age, and fetal viability. TRIAL REGISTRATION NUMBER: NCT05501145.

Psychological aspects of vestibular disorders: a national survey of clinical practice.

OBJECTIVE: This study examines how psychological aspects of vestibular disorders are currently addressed highlighting any national variation. METHOD: An online survey was completed by 101 UK healthcare professionals treating vestibular disorders. The survey covered service configurations, attitudes towards psychological aspects and current clinical practice. RESULTS: Ninety-six per cent of respondents thought there was a psychological component to vestibular disorders. There was a discrepancy between perceived importance of addressing psychological aspects and low confidence to undertake this. Those with more experience felt more confident addressing psychological aspects. History taking and questionnaires containing one or two psychological items were the most common assessment approaches. Discussing symptoms and signposting were the most frequent management approaches. Qualitative responses highlighted the interdependence of psychological and vestibular disorders which require timely intervention. Barriers included limited referral pathways, resources and interdisciplinary expertise. CONCLUSION: Although psychological distress is frequently identified, suitable psychological treatment is not routinely offered in the UK.

Lifetime effects and cost-effectiveness of statin therapy for older people in the United Kingdom: a modelling study.

BACKGROUND: Cardiovascular disease (CVD) risk increases with age. Statins reduce cardiovascular risk but their effects are less certain at older ages. We assessed the long-term effects and cost-effectiveness of statin therapy for older people in the contemporary UK population using a recent meta-analysis of randomised evidence of statin effects in older people and a new validated CVD model. METHODS: The performance of the CVD microsimulation model, developed using the Cholesterol Treatment Trialists' Collaboration (CTTC) and UK Biobank cohort, was assessed among participants ≥70 years old at (re)surveys in UK Biobank and the Whitehall II studies. The model projected participants' cardiovascular risks, survival, quality-adjusted life years (QALYs) and healthcare costs (2021 UK£) with and without lifetime standard (35%-45% low-density lipoprotein cholesterol reduction) or higher intensity (≥45% reduction) statin therapy. CTTC individual participant data and other meta-analyses informed statins' effects on cardiovascular risks, incident diabetes, myopathy and rhabdomyolysis. Sensitivity of findings to smaller CVD risk reductions and to hypothetical further adverse effects with statins were assessed. RESULTS: In categories of men and women ≥70 years old without (15,019) and with (5,103) prior CVD, lifetime use of a standard statin increased QALYs by 0.24-0.70 and a higher intensity statin by a further 0.04-0.13 QALYs per person. Statin therapies were cost-effective with an incremental cost per QALY gained below £3502/QALY for standard and below £11778/QALY for higher intensity therapy and with high probability of being cost-effective. In sensitivity analyses, statins remained cost-effective although with larger uncertainty in cost-effectiveness among older people without prior CVD. CONCLUSIONS: Based on current evidence for the effects of statin therapy and modelling analysis, statin therapy improved health outcomes cost-effectively for men and women ≥70 years old.

Exploring factors associated with failure of totally implanted vascular access devices in a regional and rural health service: a retrospective case-control study.

BACKGROUND: The assessment and management of totally implanted vascular access devices (TIVAD) prior to the administration of medications/fluids are vital to ensuring the risk of harm is mitigated. While numerous guidelines exist for the insertion and management of TIVAD, the level of evidence and external validity to support these guidelines is lacking. OBJECTIVES: The purpose of this study was to identify factors associated with suboptimal TIVAD placement and with failure of TIVAD. METHODS: A retrospective case-control study (n=80) was conducted at a regional hospital and health service in Australia. Binomial logistic regression analysis was performed using a backward selection approach to establish variables associated suboptimal TIVAD placement and with TIVAD failure. FINDINGS: Significant associations were identified between the patient's primary diagnosis and suboptimal TIVAD insertion. Specifically, a prior diagnosis of breast cancer was associated with a decreased probability of optimal TIVAD tip placement (OR=0.236 (95% CI 0.058 to 0.960), p=0.044). A statistically significant association between TIVAD failure and the log of the heparinised saline flush rate and rate of undocumented flushes was also established. Further research is needed to identify and assess whether modification of these variables improves initial totally implantable venous access ports placement and risk of subsequent failure.

Intensity of Symptoms and Perception of Quality of Life on Admission to Palliative Care: Reality of a Portuguese Team.

BACKGROUND: Palliative care (PC) corresponds to an approach that enhances the quality of life for patients facing life-threatening diseases, such as cancer, as well as for their families. There are various models for providing palliative care. Early referral to PC of patients with advanced cancer has a significant positive impact on their quality of life. However, the criteria for early referral still remain controversial. OBJECTIVES: To evaluate patients' symptomatic intensity and perception of quality of life on admission to a PC unit and to analyze these two variables according to different models of approach (outpatient and inpatient care). METHODS: A cross-sectional, descriptive, and correlational study was conducted with a sample of 60 patients sequentially admitted to a PC unit from palliative outpatient consultations or other inpatient services in a tertiary hospital dedicated to oncology care. The evaluation protocol included a sociodemographic and medical questionnaire, the Edmonton Symptom Assessment Scale (ESAS), and the Palliative Care Outcome Scale (POS) completed by patients within the first 24 h after admission. RESULTS: The participants were mostly male (61.7%), with a median age of 72 years. The majority of patients (n = 32; 53.3%) were undergoing outpatient treatment, while the remaining individuals (n = 28; 46.7%) were transferred from other hospital services (inpatient care). In the outpatient care group, higher scores for fatigue and dyspnea were observed. Conversely, in the inpatient care group, higher scores were observed for pain, depression, and anxiety. There were significant differences between the two groups regarding the POS dimensions of meaning of life, self-feelings, and lost time. In the inpatient group, there was a longer time between diagnosis and referral to PC; however, it was also in the inpatient group that there was less time between PC referral and first PC evaluation, between PC referral and PC unit admission, and between PC referral and death. There were no significant correlations between referral times and ESAS/POS scores in the inpatient and outpatient groups. CONCLUSIONS: The patients admitted to the Palliative Care Unit presented a high symptom burden and changes in the perception of quality of life. However, there are no statistically significant differences between one model of approach in relation to the other. It was found that poorer symptom control and quality of life were associated with a shorter referral time for PC, because this was only initiated after curative care was suspended, particularly in our institutional context. Early referrals to the PC team are essential not only to relieve symptom-related distress but also to improve treatment outcomes and quality of life for people with cancer.

Standard of care and outcomes for Maori patients with neck of femur fractures - an Australia & New Zealand Hip Fracture Registry (ANZHFR) study.

BACKGROUND: This study aimed to compare the demographic differences between Maori and NZ Europeans with neck of femur fracture (NOF), identify any differences in management, surgical and post-op care and outcomes. METHODS: All cases in New Zealand between 2018 and 2020 were collected from the Australia & New Zealand Hip Fracture Registry (ANZHFR). Basic demographics, management factors, and surgical factors were collected. Key outcomes at 120 days post-fracture included walking status, residential status and survival. Univariate analysis was performed to compare differences in demographics, and management factors between ethnicities. Multivariable analysis was conducted on key outcome comparisons and management differences. RESULTS: Data from 9432 patients were analyzed. 305 patients were Maori (3.2%). Age-standardized incidence between Maori and NZ European were similar (103 (95% CI 91-115) vs. 95 (95% CI 92-99)/100 000/year). Maori had a longer time to theatre (38.7 vs. 34.5 h, P = 0.01). The only difference between Maori and NZ European in the key outcomes was private residential status (67% vs. 62% P < 0.01). There was no difference in survival (87% vs. 87% P = 0.68) and decrease in walking status (0.43 vs. 0.41 P = 0.99). Following multivariable analysis, Maori ethnicity was an independent risk factor for time to theatre >48 hours after adjustment for other factors (OR 1.44 (95% CI 1.07, 1.93), P = 0.016). DISCUSSION: Although Maori were a small percentage of patients with NOFs, there was similar age-standardized incidence compared to NZ Europeans. While there were no differences in key outcomes, identifying reasons for longer time to theatre for Maori patients is required.

Molecular Hydrogen for Outpatients with COVID-19 (Hydro-COVID): A Phase 3 Randomised, Triple-Blinded, Pragmatic, Placebo-Controlled, Multicentre Trial.

Background. Due to its antioxidant, anti-inflammatory, anti-apoptosis, and anti-fatigue properties, molecular hydrogen (H2) is potentially a novel therapeutic nutrient for patients with coronavirus acute disease 2019 (COVID-19). We determined the efficacy and safety profile of hydrogen-rich water (HRW) to reduce the risk of COVID-19 progression. Methods: We also conducted a phase 3, triple-blind, randomised, placebo-controlled trial to evaluate treatment with HRW initiated within 5 days after the onset of signs or symptoms in primary care patients with mild-to-moderate, laboratory-confirmed COVID-19. Participants were randomised to receive HRW or placebo twice daily for 21 days. The incidence of clinical worsening and adverse events were the primary endpoints. Results: A total of 675 participants were followed up to day 30. HRW was not superior to placebo in preventing clinical worsening at day 14: in H2 group, 46.1% in the H2 group, 43.5% in the placebo group, hazard ratio 1.09, 90% confidence interval [0.90-1.31]. One death was reported at day 30 in the H2 group and two in the placebo group at day 30. Adverse events were reported in 91 (27%) and 89 (26.2%) participants, respectively. Conclusions: HRW taken twice daily from the onset of COVID-19 symptoms for 21 days did not reduce clinical worsening.