The use of linked administrative data in Australian randomised controlled trials: A scoping review.

BACKGROUND/AIMS: The demand for simplified data collection within trials to increase efficiency and reduce costs has led to broader interest in repurposing routinely collected administrative data for use in clinical trials research. The aim of this scoping review is to describe how and why administrative data have been used in Australian randomised controlled trial conduct and analyses, specifically the advantages and limitations of their use as well as barriers and enablers to accessing administrative data for use alongside randomised controlled trials. METHODS: Databases were searched to November 2022. Randomised controlled trials were included if they accessed one or more Australian administrative data sets, where some or all trial participants were enrolled in Australia, and where the article was published between January 2000 and November 2022. Titles and abstracts were independently screened by two reviewers, and the full texts of selected studies were assessed against the eligibility criteria by two independent reviewers. Data were extracted from included articles by two reviewers using a data extraction tool. RESULTS: Forty-one articles from 36 randomised controlled trials were included. Trial characteristics, including the sample size, disease area, population, and intervention, were varied; however, randomised controlled trials most commonly linked to government reimbursed claims data sets, hospital admissions data sets and birth/death registries, and the most common reason for linkage was to ascertain disease outcomes or survival status, and to track health service use. The majority of randomised controlled trials were able to achieve linkage in over 90% of trial participants; however, consent and participant withdrawals were common limitations to participant linkage. Reported advantages were the reliability and accuracy of the data, the ease of long term follow-up, and the use of established data linkage units. Common reported limitations were locating participants who had moved outside the jurisdictional area, missing data where consent was not provided, and unavailability of certain healthcare data. CONCLUSIONS: As linked administrative data are not intended for research purposes, detailed knowledge of the data sets is required by researchers, and the time delay in receiving the data is viewed as a barrier to its use. The lack of access to primary care data sets is viewed as a barrier to administrative data use; however, work to expand the number of healthcare data sets that can be linked has made it easier for researchers to access and use these data, which may have implications on how randomised controlled trials will be run in future.

Feasibility of Symptom monitoring WIth Feedback Trial (SWIFT) for adults on hemodialysis: a registry-based cluster randomized pilot trial.

BACKGROUND: Patients with kidney failure on hemodialysis (HD) experience considerable symptom burden and poor health-related quality of life (HRQoL). There is limited use of patient reported outcome measures (PROMs) in facility HD units to direct immediate care, with response rates in other studies between 36 to 70%. The aim of this pilot study was to evaluate feasibility of electronic PROMs (e-PROMs) in HD participants, with feedback 3-monthly to the participants' treating team, for severe or worsening symptoms as identified by the Integrated Palliative Outcome Scale (IPOS-Renal), with linkage to the Australian and New Zealand Dialysis and Transplant (ANZDATA) registry, compared with usual care. METHODS: This is a registry-based cluster-randomized controlled pilot trial involving all adults receiving HD in 4 satellite units in Australia over a 6-month period. HD units were cluster randomized 1:1 to the control (HRQoL data collection only) or intervention arm (symptom monitoring with feedback to treating team every 3 months). Feasibility was assessed by participant response rate (percentage of eligible HD participants, including new incident participants, who completed the questionnaire at each time point); retention rate (percentage of participants who completed the baseline questionnaire and all subsequent measures); and completion time. HRQoL and symptom burden scores are described. RESULTS: There were 226 unique participants who completed the e-PROMs (mean age 62 years, 69% males, 78% White-European, median dialysis vintage 1.62 years). At 6 months, response rate and retention rate for the intervention arm were 54% and 68%, respectively, and 89% and 97% in the control arm. Median time to complete IPOS-Renal was 6.6 min (5.3, 10.1) at 3 months, and when combined with the outcome measure (EQ-5D-5L), the median time was 9.4 min (6.9, 13.6) at 6 months. CONCLUSIONS: Electronic symptom monitoring among HD participants with feedback to clinicians is feasible. Variations in response and retention rates could be potentially explained by the lengthier questionnaire, and higher frequency of data collection time points for participants in the intervention arm. A definitive national RCT is underway. TRIAL REGISTRATION: ACTRN12618001976279 (07/12/2018).

Cannabinoids for Symptom Management in Patients with Kidney Failure: A Narrative Review.

People with kidney failure can experience a range of symptoms that lead to suffering and poor quality of life. Available therapies are limited, and evidence for new treatment options is sparse, often resulting in incomplete relief of symptoms. There is growing interest in the potential for cannabinoids, including cannabidiol and tetrahydrocannabinol, to treat symptoms across a wide range of chronic diseases. As legal prohibitions are withdrawn or minimized in many jurisdictions, patients are increasingly able to access these agents. Cannabinoid receptors, CB1 and CB2, are widely expressed in the body, including within the nervous and immune systems, and exogenous cannabinoids can have anxiolytic, antiemetic, analgesic, and anti-inflammatory effects. Considering their known physiologic actions and successful studies in other patient populations, cannabinoids may be viewed as potential therapies for a variety of common symptoms affecting those with kidney failure, including pruritus, nausea, insomnia, chronic neuropathic pain, anorexia, and restless legs syndrome. In this review, we summarize the pharmacology and pharmacokinetics of cannabinoids, along with what is known about the use of cannabinoids for symptom relief in those with kidney disease, and the evidence available concerning their role in management of common symptoms. Presently, although these agents show varying efficacy with a reasonable safety profile in other patient populations, evidence-based prescribing of cannabinoids for people with symptomatic kidney failure is not possible. Given the symptom burden experienced by individuals with kidney failure, there is an urgent need to understand the tolerability and safety of these agents in this population, which must ultimately be followed by robust, randomized controlled trials to determine if they are effective for symptom relief.

An Initiative to Improve 30-Day Readmission Rates Using a Transitions-of-Care Clinic Among a Mixed Urban and Rural Veteran Population.

BACKGROUND/OBJECTIVE: Hospital readmissions in the United States, especially in patients at high-risk, cost more than $17 billion annually. Although care transitions is an important area of research, data are limited regarding its efficacy, especially among rural patients. In this study, we describe a novel transitions-of-care clinic (TOCC) to reduce 30-day readmissions in a Veterans Health Administration setting that serves a high proportion of rural veterans. METHODS: In this quality improvement initiative we conducted a pre-post study evaluating clinical outcomes in adult patients at high risk for 30-day readmission (Care Assessment Needs score > 85) discharged from the Iowa City Veterans Affairs (ICVA) Health Care System from 2017 to 2020. The ICVA serves 184,000 veterans across 50 counties in eastern Iowa, western Illinois, and northern Missouri, with more than 60% of these patients residing in rural areas. We implemented a multidisciplinary TOCC to provide in-person or virtual follow-up to high-risk veterans after hospital discharge. The main purpose of this study was to assess how TOCC follow-up impacted the monthly 30-day patient readmission rate. RESULTS: The TOCC resulted in a 19.2% relative reduction in 30-day readmission rates in the 12-month postimplementation period compared to the preimplementation period (9.2% vs 11.4%, P = .04). Virtual visits were more popular than in-person visits among both urban and rural veterans. There was no difference in outcomes between these two follow-up options, and both groups had reduced readmission rates compared to non-TOCC follow-up. CONCLUSIONS: A multidisciplinary TOCC within the ICVA featuring both virtual and in-person visits reduced the 30-day readmission rate. This reduction was particularly notable among patients with congestive heart failure.

Management practices in Australian healthcare: can NSW public hospitals do better?

Purpose - The purpose of this paper is to investigate the determinants of best management practices in an Australian state-run healthcare system, namely New South Wales (NSW), and studies the impact of a range of hospital factors in driving best management practices as a means of enhancing healthcare delivery. Design/methodology/approach - This study adapts a unique survey instrument globally tested to quantify the multi-dimensional nature of hospital management practices in 42 acute care public hospitals of NSW. The authors then analysed the role of hospital-specific characteristics in driving best management practices, namely hospital size (measured by the number of hospital beds, employees and doctors), level of skill and education, degree of hospital manager autonomy and organisational hierarchy. Findings - The findings of this study show the areas of strength and potential areas of improvement in NSW hospitals. The authors find a positive association between the adoption of better management practices and hospital size (measured by the number of hospital beds and employees), level of skills and education, degree of hospital manager autonomy and organisational hierarchy. However, hospital size as measured by the number of doctors did not have a statistically significant relationship. Practical implications - This paper is of interest to both hospital administrators, clinical doctors and healthcare policy-makers who want to improve and develop strategies for better management in the healthcare sector. Originality/value - This study provides an internationally comparable robust measure of management capability in public hospitals, and contributes to the evidence-base of management practices and performance in hospitals.

Benchmarking management practices in Australian public healthcare.

PURPOSE: The purpose of this paper is to investigate the quality of management practices of public hospitals in the Australian healthcare system, specifically those in the state-managed health systems of Queensland and New South Wales (NSW). Further, the authors assess the management practices of Queensland and NSW public hospitals jointly and globally benchmark against those in the health systems of seven other countries, namely, USA, UK, Sweden, France, Germany, Italy and Canada. DESIGN/METHODOLOGY/APPROACH: In this study, the authors adapt the unique and globally deployed Bloom et al. (2009) survey instrument that uses a "double blind, double scored" methodology and an interview-based scoring grid to measure and internationally benchmark the management practices in Queensland and NSW public hospitals based on 21 management dimensions across four broad areas of management - operations, performance monitoring, targets and people management. FINDINGS: The findings reveal the areas of strength and potential areas of improvement in the Queensland and NSW Health hospital management practices when compared with public hospitals in seven countries, namely, USA, UK, Sweden, France, Germany, Italy and Canada. Together, Queensland and NSW Health hospitals perform best in operations management followed by performance monitoring. While target management presents scope for improvement, people management is the sphere where these Australian hospitals lag the most. PRACTICAL IMPLICATIONS: This paper is of interest to both hospital administrators and health care policy-makers aiming to lift management quality at the hospital level as well as at the institutional level, as a vehicle to consistently deliver sustainable high-quality health services. ORIGINALITY/VALUE: This study provides the first internationally comparable robust measure of management capability in Australian public hospitals, where hospitals are run independently by the state-run healthcare systems. Additionally, this research study contributes to the empirical evidence base on the quality of management practices in the Australian public healthcare systems of Queensland and NSW.

Study of coronary atherosclerosis by modified american heart association classification of atherosclerosis-an autopsy study.

BACKGROUND: The study was designed to assess the atherosclerotic lesions in coronary arteries in cases subjected to autopsy to grade by applying Modified American Heart Association (AHA) classification, evaluate the atheromatous & vulnerable plaques to find out the to age and sex related prevalence of atherosclerosis in the semi-urban & urban population of Jamnagar, a district in Western India. MATERIAL & METHODS: Autopsy was conducted on 264 cases whose age ranged from 8-79 years, by the conventional technique; heart was removed & dissected along the direction of blood flow. Microscopic assessment of the three main coronary arteries was done. RESULT: According to Modified AHA classification of atherosclerosis, maximum number of cases were in the 40-49 years age group. Intimal xanthoma was the most common type in all three coronary arteries. The number of males was 168(64%) and females was 96(36%). 59% males & 52% female were affected from atherosclerosis. An intermediate lesion was noted commonly in young individuals (10-39 years) and older individuals (40-79 years) were 46% & 41% respectively. Pathological Intimal thickening was more common in left anterior descending coronary artery compared to others. Thin fibrous cap atheroma was more common in Left circumflex artery than compared to Left anterior descending artery & Right coronary artery. CONCLUSION: The study highlights the impact of atherosclerotic lesions in the population of Jamnagar, a district in Gujarat state of Western India. The increased amount of intermediate atherosclerotic lesions found in the young population gives an indication that anti-atherogenic preventive measures and drastic dietary & life style modification need to be implemented in young individuals, this will help to prevent coronary artery disease from causing premature death that lead to huge financial burden on the economy and health sector of India.

Clinical and histopathological study of mass in ear: a study of fifty cases.

Study of mass in ear was undertaken with the aim that clinical diagnosis was in most but not all cases consistent with the histo-pathological diagnosis. Therefore incisional or excisional biopsy with histo-pathological study is a must in all types of small masses in ear. A study of 50 patients, attending Ear, Nose and Throat department, was done and specimen collected from them and subjected to histopathological examination. These masses were further classified as inflammatory, benign and malignant lesions and the frequency of their occurrence in saurashtra region (Jamnagar, GUJARAT), their age and sex distribution were observed. Most common lesion was found to be inflammatory Polyps (20), followed by Cholesteatomas (12) and chronic non-specific inflammations (7), Abscess (1). In malignant lesions Squamous cell carcinoma (7) was the commonest followed by Embryonal rhabdomyosarcoma (1) and in benign lesion, Carcinoid tumor (1) and Nevus (1) were diagnosed on histo-pathological examination. Right side masses were more common than left side; males were more affected than females. Adolescents/children more affected than adults for benign lesions while reverse was true for malignant lesions.