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IntroductionThe world is undergoing a demographic transition to an older population. Preventive healthcare has reduced the burden of chronic illness at younger ages but there is limited evidence that these advances can improve health at older ages. Statins are one class of drug with the potential to prevent or delay the onset of several causes of incapacity in older age, particularly major cardiovascular disease (CVD). This paper presents the protocol for the STAtins in Reducing Events in the Elderly (STAREE) trial, a randomised double-blind placebo-controlled trial examining the effects of statins in community dwelling older people without CVD, diabetes or dementia.Methods and analysisWe will conduct a double-blind, randomised placebo-controlled trial among people aged 70 years and over, recruited through Australian general practice and with no history of clinical CVD, diabetes or dementia. Participants will be randomly assigned to oral atorvastatin (40 mg daily) or matching placebo (1:1 ratio). The co-primary endpoints are disability-free survival defined as survival-free of dementia and persistent physical disability, and major cardiovascular events (cardiovascular death or non-fatal myocardial infarction or stroke). Secondary endpoints are all-cause death, dementia and other cognitive decline, persistent physical disability, fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, heart failure, atrial fibrillation, fatal and non-fatal cancer, all-cause hospitalisation, need for permanent residential care and quality of life. Comparisons between assigned treatment arms will be on an intention-to-treat basis with each of the co-primary endpoints analysed separately in time-to-first-event analyses using Cox proportional hazards regression models.Ethics and disseminationSTAREE will address uncertainties about the preventive effects of statins on a range of clinical outcomes important to older people. Institutional ethics approval has been obtained. All research outputs will be disseminated to general practitioner co-investigators and participants, published in peer-reviewed journals and presented at national and international conferences.Trial registration numberNCT02099123.

Background Strict isolation of COVID-19 patients to prevent cross infection may inadvertently cause serious adverse outcomes including psychological harm, limitations to care, increased incidence of delirium, deconditioning and reduced quality of life. Previous research exploring the staff perspective of the effect of isolation on patients is limited. The aim of this study is to understand staff perceptions and interpretations of their experiences of the care and treatment of isolated patients and the impact of isolation on patients, families, and staff. Method This qualitative, exploratory study is set in a major metropolitan, quaternary hospital in Melbourne, Australia. Data was collected in focus groups with clinical and non-clinical staff and analysed using content analysis. The hospital ethics committee granted approval. Each participant gave informed verbal consent. Results Participants included 58 nursing, medical, allied health, and non-clinical staff. Six main themes were identified: 1) Communication challenges during COVID-19; 2) Impact of isolation on family; 3) Challenges to patients’ health and safety; 4) Impact on staff; 5) Challenging standards of care; 6) Contextual influences: policy, decision-makers and the environment. Conclusion Isolating patients and restricting visitors resulted in good pandemic management, but staff perceived it came at considerable cost to staff and consumers. Innovative communication technology may facilitate improved connection between all parties. Mental health support is needed for patients, families, and staff. Further research using a co-design model with input from patients, families and staff is recommended to determine appropriate interventions to improve care. Preventing the spread of infection is essential for good pandemic management, but the cost to consumers and staff must be mitigated. Preparation for future pandemics must consider workforce preparedness, adapted models of care and workflow.

Abstract Aims Socioeconomic status (SES) is recognizably linked with incident heart failure (HF) risk and the association of SES with geography presents a potential target for geographical location of preventive health services. To better inform policy we sought to quantify the independent association between SES and incident HF and investigate differences by type of SES measure. Methods and results MEDLINE and EMBASE were searched up to August 2018. Observational studies and randomized trials reporting adjusted HF incidence by stratified socioeconomic measures were included. Effect sizes reflected HF incidence in the lowest vs. highest SES stratum and were pooled using a random-effects model. Low SES referred to the lowest resource stratum, the definition of which varied across studies: meta-analysis was only performed where strata were comparable. Statistical heterogeneity was assessed using the I2 statistic. Eleven studies comprising 6 308 006 individuals and 104 217 HF events found that low SES was associated with an increase in risk of incident HF ranging between 43% and 87% depending on SES measure, with an overall estimate of 62% [hazard ratio (HR) 1.62, 95% confidence interval (CI) 1.50–1.76]. By individual measure, HRs of 1.66 (95% CI 1.3–2.11), 1.87 (95% CI 1.33–2.62), and 1.54 (95% CI 1.22–1.95) were observed for education, income, and occupation, respectively. For area-level indexes, HRs were 1.43 (95% CI 1.2–1.69) (Carstairs index) and 1.61 (95% CI 1.56–1.65) (index of multiple deprivation). Conclusion Low SES assessed by all common measures confers independent risk for incident HF. These findings carry implications for the design and delivery of HF prevention programmes.

Objective. To investigate demographics, clinical patterns and outcomes of rapid response reviews in hospital, reviewing indications for and outcomes of rapid response reviews initiated for clinical concern and to understand the role of clinical concern in identifying the deteriorating patient and at-risk patient populations. Method. This was a retrospective analysis of General Medical inpatients at Alfred Hospital from 1 January 2018 to 31 July 2020. Data extraction from electronic medical records identified patients who had a rapid response review during admission. Demographic and clinical data, investigations and clinical outcomes from rapid response reviews were investigated. Comparisons were performed using x2 or Fisher's exact test where appropriate. Odds ratios and 95% confidence intervals were calculated for factors associated with rapid response reviews for clinical concern and clinical outcomes. Results. There were 10 797 admissions of 7409 individual patients. There were 2359 rapid response reviews during the study period, occurring in 13% of admissions. Patients were majority female (50.4%), and the median age was 79 ± 17.6 years. Rapid response reviews were for cardiovascular (46.8%), respiratory (25.3%) and neurological (14.3%) indications. A total of 11% of rapid response reviews (n = 258) were for clinical concern. Inpatient falls accounted for a significant proportion of rapid response reviews for clinical concern. Reviews were more common in older patients, those admitted after-hours, and patients with disabilities. The latter group were more likely to have rapid response reviews for clinical concern. Rapid response reviews initiated for clinical concern were more likely than those initiated for standard criteria to change patients' clinical status, particularly the withdrawal of active management. Conclusions. Rapid response reviews for clinical concern are important triggers to identify clinical deterioration in vulnerable patients. Reviews were initiated for clinical concern were more likely than those initiated for standard criteria to result in a change in patients' resuscitation status and care trajectory. Clinician concern, even when prompting review for parameters outside of standard clinical review criteria, remains an important factor in recognising the deteriorating patient.

Background With technological advances, there has been increasing interest in developing contactless and/or non-invasive wearable technologies that continuously monitor vital signs in the clinical setting, and in particular in the deteriorating patient. These devices as of yet have not been well validated in the clinical setting in the clinical ranges observed in a critically unwell patient. We will perform a systematic review of all novel wearable and contactless devices in the clinical setting with focus on degree of novelty and the range of vital signs captured. Methods Ovid MEDLINE including Epub Ahead of Print and In-Process & Other Non-Indexed Citations, Ovid Embase, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL) Health Technology Assessment (HTA) database (Ovid), CINAHL with Full Text, searches of the grey literature, cited references of eligible studies through Web of Science, and reference lists of eligible studies will be searched. Outcomes of interest will include the quality of studies in relation to reporting guidelines, limitations of non-invasive technology, and application in different clinical populations. We will perform a qualitative assessment of the novelty of the device and discuss its validation in deteriorating patients. Discussion While novel monitoring devices are often proposed as a solution to problems with infection, discomfort, and frequency of monitoring in the clinical setting it has not yet been established which devices have been validated in clinical settings in the pathological ranges of vital signs that reflect patient deterioration. It is equally unclear what additional value these devices might provide. This systematic review will synthesize published data regarding devices that have been tested and validated in patients AND in a clinical setting AND in reference ranges that reflect severe illness. Systematic review registration PROSPERO CRD42019130091

Research has shown that vaccination with Streptococcus pneumoniae reduced the extent of atherosclerosis in experimental animal models. It is thought that phosphorylcholine lipid antigens in the S. pneumoniae cell wall induce the production of antibodies that cross-react with oxidized low-density lipoprotein, a component of atherosclerotic plaques. These antibodies may bind to and facilitate the regression of the plaques. Available data provide evidence that similar mechanisms also occur in humans, leading to the possibility that pneumococcal vaccination protects against atherosclerosis. A systematic review and meta-analysis, including 8 observational human studies, of adult pneumococcal polysaccharide vaccination for preventing cardiovascular disease in people older than 65 years, showed a 17% reduction in the odds (odds ratio 0.83, 95% CI 0.71-0.97) of having an acute coronary syndrome event. The AUSPICE is a multicenter, randomized, placebo-controlled, double-blind, clinical trial to formally test whether vaccination with the pneumococcal polysaccharide vaccine protects against cardiovascular events (fatal and nonfatal acute coronary syndromes and ischemic strokes). Cardiovascular outcomes will be obtained during 4 to 5 years of follow-up, through health record linkage with state and national administrative data sets. This is the first registered randomized controlled trial (on US, World Health Organization, Australia and New Zealand trial registries) to be conducted to test whether vaccination with the pneumococcal polysaccharide vaccine will reduce cardiovascular events. If successful, vaccination can be readily extended to at-risk groups to reduce the risk of cardiovascular diseases.

Cosmetic breast augmentation procedures are commonly performed breast device surgeries. The Australian Breast Device Registry (ABDR) administers a five-question patient reported outcome measure (PROM), the BREAST-Q Implant Surveillance module (BREAST-Q IS), to patients 1, 2 and 5 years after breast device surgery. The measure includes an open-ended question to add any comments. This study aimed to use the responses to this open-ended question to assess participants' experiences of breast devices 1 and 2 years after breast augmentation. The secondary objective was to identify emerging and important issues relating to breast augmentation and devices. This qualitative descriptive study was conducted using a randomly selected sample of 268 responses to the open-ended question in the BREAST-Q IS, from the ABDR database. These responses were from patients who underwent breast augmentation between 2015 and 2018. Comments were analyzed using conventional content analysis in NVivo 12. Four major themes were identified: satisfaction following breast augmentation, dissatisfaction following breast augmentation, complications and breast symptoms following breast augmentation and other comments. Two dominant themes were regarding satisfaction (n = 112) with overall surgical outcome, medical team, and post-operative appearance and complications and breast symptoms (n = 177) following breast augmentation. Emerging issues identified were rippling of breast implants and breast implant illness (BII). PROMs can be used to understand patients' perspectives on various aspects of their own surgical experiences. Participants provided responses regarding complications and breast symptoms experienced, and rippling of the breast implants and BII are emerging issues after breast augmentation.

Little is known about the methods and outcomes of patient-reported outcome measure (PROM) use among high-risk medical device registries. The objective of this scoping review was to assess the utility and predictive ability of PROMs in high-risk medical device registries. We searched Ovid Medline, Embase, APA PsychINFO, Cochrane Library, and Scopus databases for published literature. After searching, 4323 titles and abstracts were screened, and 262 full texts were assessed for their eligibility. Seventy-six papers from across orthopedic (n = 64), cardiac (n = 10), penile (n = 1), and hernia mesh (n = 1) device registries were identified. Studies predominantly used PROMs as an outcome measure when comparing cohorts or surgical approaches (n = 45) or to compare time points (n = 13) including pre- and postintervention. Fifteen papers considered the predictive ability of PROMs. Of these, 8 treated PROMs as an outcome, 5 treated PROMs as a risk factor through regression analysis, and 2 papers treated PROMs as both a risk factor and as an outcome. One paper described PROMs to study implant survival. To advance methods of PROM integration into clinical decision-making for medical devices, an understanding of their use in high-risk device registries is needed. This scoping review found that there is a paucity of studies using PROMs to predict long-term patient and clinical outcomes in high-risk medical device registries. Determination as to why PROMs are rarely used for predictive purposes in long-term data collection is needed if PROM data are to be considered suitable as real-world evidence for high-risk device regulatory purposes, as well as to support clinical decision-making. Level of Evidence: 4

Background Cognitive impairment is common after stroke, and a large proportion of stroke patients will develop dementia. However, there have been few large prospective studies which have assessed cognition both prior to and after stroke. This study aims to determine the extent to which incident stroke impacts different domains of cognitive function in a longitudinal cohort of older community-dwelling individuals. Methods 19,114 older individuals without cardiovascular disease or major cognitive impairment were recruited and followed over a maximum 11 years. Stroke included ischaemic and haemorrhagic stroke and was adjudicated by experts. Cognitive function was assessed regularly using Modified Mini-Mental State Examination (3MS), Hopkins Verbal Learning Test–Revised (HVLT-R), Symbol Digit Modalities Test (SDMT), and Controlled Oral Word Association Test (COWAT). Linear mixed models were used to investigate the change in cognition at the time of stroke and decline in cognitive trajectories following incident stroke. Results During a median follow-up period of 8.4 [IQR: 7.2, 9.6] years, 815 (4.3%) participants experienced a stroke. Over this time, there was a general decline observed in 3MS, HVLT-R delayed recall, and SDMT scores across participants. However, for individuals who experienced a stroke, there was a significantly greater decline across all cognitive domains immediately after the event immediately after the event (3MS: -1.03 [95%CI: -1.45, -0.60]; HVLT-R: -0.47 [-0.70, -0.24]; SDMT: -2.82 [-3.57, -2.08]; COWAT: -0.67 [-1.04, -0.29]) and a steeper long-term decline for three of these domains (3MS -0.62 [-0.88, -0.35]; COWAT: -0.30 [-0.46, -0.14]); HVLT-R: -0.12 [95%CI, -0.70, -0.24]). However individuals with stroke experienced no longer-term decline in SDMT compared to the rest of the participants. Conclusions These findings highlight the need for comprehensive neuropsychology assessments for ongoing monitoring of cognition following incident stroke; and potential early intervention.