A home-based, multidisciplinary liver optimisation programme for the first 28 days after an admission for acute-on-chronic liver failure (LivR well): a study protocol for a randomised controlled trial.

BACKGROUND: Acute-on-chronic liver failure (ACLF) represents a rising global healthcare burden, characterised by increasing prevalence among patients with decompensated cirrhosis who have a 28-day transplantation-free mortality of 33.9%. Due to disease complexity and a high prevalence of socio-economic disadvantage, there are deficits in quality of care and adherence to guideline-based treatment in this cohort. Compared to other chronic conditions such as heart failure, those with liver disease have reduced access to integrated ambulatory care services. The LivR Well programme is a multidisciplinary intervention aimed at improving 28-day mortality and reducing 30-day readmission through a home-based, liver optimisation programme implemented in the first 28 days after an admission with either ACLF or hepatic decompensation. Outcomes from our feasibility study suggest that the intervention is safe and acceptable to patients and carers. METHODS: We will recruit adult patients with chronic liver disease from the emergency departments, in-patient admissions, and an ambulatory liver clinic of a multi-site quaternary health service in Melbourne, Australia. A total of 120 patients meeting EF-Clif criteria will be recruited to the ACLF arm, and 320 patients to the hepatic decompensation arm. Participants in each cohort will be randomised to the intervention arm, a 28-day multidisciplinary programme or to standard ambulatory care in a 1:1 ratio. The intervention arm includes access to nursing, pharmacy, physiotherapy, dietetics, social work, and neuropsychiatry clinicians. For the ACLF cohort, the primary outcome is 28-day mortality. For the hepatic decompensation cohort, the primary outcome is 30-day re-admission. Secondary outcomes assess changes in liver disease severity and quality of life. An interim analysis will be performed at 50% recruitment to consider early cessation of the trial if the intervention is superior to the control, as suggested in our feasibility study. A cost-effectiveness analysis will be performed. Patients will be followed up for 12 weeks from randomisation. Three exploratory subgroup analyses will be conducted by (a) source of referral, (b) unplanned hospitalisation, and (c) concurrent COVID-19. The trial has been registered with the Australian New Zealand Clinical Trials Registry. DISCUSSION: This study implements a multidisciplinary intervention for ACLF patients with proven benefits in other chronic diseases with the addition of novel digital health tools to enable remote patient monitoring during the COVID-19 pandemic. Our feasibility study demonstrates safety and acceptability and suggests clinical improvement in a small sample size. An RCT is required to generate robust outcomes in this frail, high healthcare resource utilisation cohort with high readmission and mortality risk. Interventions such as LivR Well are urgently required but also need to be evaluated to ensure feasibility, replicability, and scalability across different healthcare systems. The implications of this trial include the generalisability of the programme for implementation across regional and urban centres. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621001703897 . Registered on 13 December 2021. WHO Trial Registration Data Set. See Appendix 1.

Short-term intraperitoneal catheters: An ambulatory care intervention for refractory ascites secondary to cirrhosis during COVID-19.

BACKGROUND AND AIM: Patients with refractory ascites have frequent hospital admissions, which pose exposure risks in the context of the COVID-19 pandemic. The aim of this study was to investigate the safety and efficacy of a novel 12-week, multidisciplinary ambulatory care program allowing frequent low-volume ascitic drainage through a tunneled, intraperitoneal catheter (IPC). METHODS: Adult patients with cirrhosis complicated by refractory ascites were recruited through a liver clinic in a tertiary health service in Melbourne, Australia from April to December 2020. All patients were enrolled in a 12-week multidisciplinary program including medical, nursing, dietetics, and pharmacy support. A Rocket Medical IPC was inserted on day 1 with 1-2 L of ascitic fluid drained over 1-3 sessions per week either at the patients' homes or at the hospital day ward. Patients' demographics, death, complications, and self-reported outcomes were recorded. RESULTS: Twelve patients were enrolled with a median of 65-day (interquartile range [IQR]: 16.5-93) IPC duration between April and December 2020 across two periods of COVID-related lockdown in Melbourne, Australia. There were no IPC-related deaths. Early removal was necessitated in three patients due to leakage, nonadherence, and bacteremia. On day 30, the median self-reported health score increased from 50 (IQR: 50-70) to 78 (IQR: 50-85), attributable to a reduction in symptom burden. CONCLUSION: A multidisciplinary IPC program including the use of short-term IPC was safe and associated with a self-reported improvement in perceptions of health. In the context of the COVID-19 pandemic, the program aimed to reduce patient and clinician exposure, which is maintaining engagement and management of decompensated cirrhosis.

The experiences of privately practising midwives in Australia who have been reported to the Australian Health Practitioner Regulation Agency: A qualitative study.

BACKGROUND: In Australia the majority of homebirths are attended by privately practising midwives (PPMs). In recent years PPMs have been increasingly reported to the Australian Health Practitioner Regulation Agency (AHPRA) mostly by other health professionals. PURPOSE: to explore the experiences of PPMs in Australia who have been reported to the AHPRA. METHODS: A qualitative interpretive approach, employing in-depth interviews with eight PPMs was undertaken and analysed using thematic analysis. A feminist theoretical framework was used to underpin the research. RESULTS: The majority of reports made to AHPRA occurred when midwives supported women who chose care considered outside the recommended Australian College of Midwives (ACM) Consultation and Referral Guidelines. During data analysis an overarching theme emerged, "Caught between women and the system", which described the participants' feelings of working as a PPM in Australia. There were six themes and several sub-themes: The suppression of midwifery, A flawed system, Lack of support, Devastation on so many levels, Making changes in the aftermath and Walking a tight rope forever. The findings from this study reveal that midwives who are under investigation suffer from emotional and psychological distress. Understanding the effects of the process of investigation is important to improve the quality of professional and personal support available to PPMs who are reported to AHPRA and to streamline processes. CONCLUSION: It is becoming increasingly difficult for PPMs to support the wishes and needs of individual women and also meet the requirements of the regulators, as well as the increasingly risk averse health service.

An unusual late complication with tension-free vaginal tape (TVT): A case report.

BACKGROUND: Stress urinary incontinence is a common problem affecting women's quality of life. The retropubic mid-urethral sling accounts for the majority of surgical interventions for stress incontinence. Complications of the procedure are rare. We present an unusual late complication with tension-free vaginal tape (TVT). CASE: Two years after insertion of a TVT for stress incontinence, a patient noticed a foreign body intermittently exiting through her anus. Initial clinical examinations and investigations were unremarkable. Five years after insertion she represented with faecal matter in the vagina and a TVT erosion. Imaging confirmed a colo-vaginal fistula. She underwent a vaginal excision of the TVT but this did not cure her problem and she subsequently had a laparoscopic sigmoid colectomy. Thereafter she remained well and asymptomatic. CONCLUSION: This case report describes an unusual late complication. It is likely that the left arm of the mesh entered the serosa of the sigmoid colon and eroded into it over time. Complications associated with TVT are rare, but when they occur they need to be recorded. Only surgeons who have experience and expertise in the procedure should perform it, such as subspecialty trained urogynaecologists.

Can we replace the catheter when evaluating urinary residuals?

AIMS: To test the different formulae to calculate the bladder volume using ultrasound; the accuracy of patients hearing/feeling "bubbles" at the end of urodynamics testing as a measure of being empty; and how good we are at estimating PVR using X-ray at the end of video urodynamics testing. METHODS: This was a prospective cohort study. Using Sonosite 180 plus, bladder volumes were calculated as, height × width × depth × proportionality constant (0.52, 0.625, 0.65, and 0.7) Patients were asked whether the patient heard or felt "bubbles" at the end of the investigation. Each patient was fluoroscopically screened and the clinician estimated the volume and compared with single-use catheter volume. RESULTS: A total of 85 patients were assessed. All four formulae were significantly correlated. The PC, 0.52, correlated best (r = 0.938, P < 0.001) with no significant difference with the actual volumes ( P = 0.275). The "bubbles test" had a positive predictive value of 93%. A video postvoid residual (PVR) estimation significantly correlated with catheterised bladder volume ( r = 0.842, P < 0.001). There was no significant difference between the estimated and actual bladder volumes ( P = 0.579). CONCLUSION: This study showed that although all four formulae correlated significantly, the PC of 0.52 was the only formula without a significant difference from the actual volume. More work is needed to produce patient individualised PC. Our clinicians were able to accurately estimate the PVR on X-ray. This study has identified the best formula to accurately estimate bladder volume and that video estimation along with the "bubbles" test can avoid unnecessary intervention.

Anticholinergic prescription: are healthcare professionals the real burden?

INTRODUCTION AND HYPOTHESIS: Anticholinergic medication is the medical treatment for overactive bladder (OAB). These drugs can act on the central nervous system and can lead to cognitive decline, dementia, and potentially death. Patients taking drugs with anticholinergic effects increase their anticholinergic burden-defined as the cumulative effect of taking one or more drugs that can have adverse effects. When prescribing anticholinergic medication for the elderly, we must choose the right drug. We aimed to discover the level of understanding on this subject and its application to real clinical practice amongst our healthcare professionals (HCPs). METHODS: An 18-point questionnaire was distributed to urogynaecologists, general gynaecologists, urologists, geriatricians, general practitioners (GPs), and nurse specialists to assess knowledge on the subject. RESULTS: A total of 96 HCPs completed the questionnaire. The nurse specialists had the highest score in identifying that oxybutynin was the drug most likely to cross the blood-brain barrier (BBB). The urogynaecologists had the highest score in identifying that trospium chloride was least likely to cross the BBB, whereas the GPs had the lowest score. Solifenacin was the most popular anticholinergic drug prescribed in the elderly without dementia. Trospium chloride was the most popular drug prescribed in the elderly with dementia. CONCLUSIONS: We have found that knowledge is lacking amongst all our HCPs, but especially amongst our first-line doctors, our GPs. Education is key in developing knowledge and safe prescribing, to improve the care we give to our patients.

Improving outpatient services: the Southampton IBD virtual clinic.

The follow-up of inflammatory bowel disease (IBD) patients is challenging due to the relapsing remitting nature of the diseases, the wide spectrum of severity and complexity as well as the need for monitoring of long-term complications and drug treatments. Conventional outpatient follow-up lacks flexibility for patients and there are competing pressures for clinic time. Alternative follow-up pathways include telephone clinics, self-management programmes or discharging patients. The IBD virtual clinic (VC) is a further option. Patients with an established diagnosis for >2 years, who have been stable for >1 year, do not have primary sclerosing cholangitis and who give their consent, are entered into the VC system. Two months before their annual follow-up is due patients are sent blood test forms and a simple questionnaire with an information sheet. If they meet any of the criteria on the questionnaire, they are asked to contact the IBD specialist nursing team to discuss their situation. The blood test results and the patient's database entry are reviewed to ensure that they are not due surveillance investigations. The patients and their GPs then receive a letter informing them of their management plan. We currently follow-up 20% of the Southampton IBD cohort using the VC. The VC system is an innovative, efficient and patient-responsive method for following up mild to moderate IBD. It is well liked by patients but is dependent on a well-maintained database with good integration of IT systems and requires both clerical and IBD nurse specialist support.

Improving outpatient services: the Southampton IBD virtual clinic.

The follow-up of inflammatory bowel disease (IBD) patients is challenging due to the relapsing remitting nature of the diseases, the wide spectrum of severity and complexity as well as the need for monitoring of long-term complications and drug treatments. Conventional outpatient follow-up lacks flexibility for patients and there are competing pressures for clinic time. Alternative follow-up pathways include telephone clinics, self-management programmes or discharging patients. The IBD virtual clinic (VC) is a further option. Patients with an established diagnosis for >2 years, who have been stable for >1 year, do not have primary sclerosing cholangitis and who give their consent, are entered into the VC system. Two months before their annual follow-up is due patients are sent blood test forms and a simple questionnaire with an information sheet. If they meet any of the criteria on the questionnaire, they are asked to contact the IBD specialist nursing team to discuss their situation. The blood test results and the patient's database entry are reviewed to ensure that they are not due surveillance investigations. The patients and their GPs then receive a letter informing them of their management plan. We currently follow-up 20% of the Southampton IBD cohort using the VC. The VC system is an innovative, efficient and patient-responsive method for following up mild to moderate IBD. It is well liked by patients but is dependent on a well-maintained database with good integration of IT systems and requires both clerical and IBD nurse specialist support.

SB-742457 and donepezil in Alzheimer disease: a randomized, placebo-controlled study.

OBJECTIVE: To estimate the treatment effects of SB-742457 and donepezil in Alzheimer disease (AD) in a contemporary clinical trial. METHOD: Randomized, controlled, parallel-group, exploratory study with a 4-week, single-blind, placebo run-in phase and 24-week, double-blind treatment phase. Primary endpoints were Clinician's Interview-Based Impression of Change with caregiver input (CIBIC+) and the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog). RESULTS: One hundred ninety eight subjects with mild-to-moderate probable AD (MMSE scores 12-26) were randomized; 196 were included in the intent-to-treat population (placebo, n = 61; SB-742457 35 mg/day, n = 68; donepezil 10 mg/day, n = 67), and 161 completed. Drug-placebo treatment differences in CIBIC+ score at week 24 were -0.17 (90% confidence interval [CI]: -0.50, 0.16) for SB-742457 and -0.28 (90% CI: -0.61, 0.05) for donepezil. Drug-placebo treatment differences (90% CI) in change from baseline ADAS-Cog score at Week 24 were -0.4 (-2.2, 1.4) for SB-742457 and -1.2 (-3.0, 0.6) for donepezil. All treatments were generally safe and well tolerated. CONCLUSIONS: In this exploratory study, SB-742457 and donepezil were associated with improvements in global function. Treatment effect on cognition for both SB-742457 and donepezil was smaller than those previously observed in previous clinical studies with donepezil.

Is nurse-managed blood glucose control in critical care as safe and effective as the traditional sliding scale method?

BACKGROUND: Hyperglycaemia occurs in a substantial proportion of critically ill patients. Recent studies have demonstrated that controlling blood glucose in critically ill patients can improve outcomes (Boord et al., 2001). Traditionally, blood glucose is controlled by the sliding scale method. A pre-defined dose of intravenous insulin is infused for each glucose level. Revisions to the prescription are frequently necessary when it is ineffective. The objective of this review is to assess the effectiveness, safety and feasibility of nurse-managed protocols that require minimal physician input. METHODS: An electronic search was performed on the Medline, CINAHL and EMBASE databases from 1996 to 2008. The objective of this work was to assess nurse-managed glycaemic control in critically ill patients. The target blood glucose was required to be less than 8.3mmol/L. RESULTS: Fourteen papers met the inclusion criteria. Eight studies compared their protocol to the previous method of glucose control (Table 1). In all cases there was an improvement. Time to reach target was less and time spent within target range was greater. All but one study reduced episodes of hypoglycaemia with the new protocol. Six studies developed their protocol as a quality improvement project and did not use a control group (Table 2). CONCLUSION: An insulin infusion protocol (IIP) that uses the last two blood glucose levels in order to determine the new infusion rate is better at maintaining glycaemic control than the traditional sliding scale method. A protocol that allows a nurse to commence and maintain the infusion is as safe and more effective than the traditional sliding scale method.