Cardiovascular Disease Risk Scores and Incident Dementia and Cognitive Decline in Older Men and Women.

INTRODUCTION: Risk factors for cardiovascular disease (CVD) also increase the risk of dementia. However, whether commonly used CVD risk scores are associated with dementia risk in older adults who do not have a history of CVD, and potential gender differences in this association, remains unclear. The aim of this study was to determine whether CVD risk scores are prospectively associated with cognitive decline and dementia in initially healthy older men and women. METHODS: A total of19,114 participants from a prospective cohort of individuals aged 65+ years without known CVD or dementia were recruited. The atherosclerotic cardiovascular disease risk score (ASCVDRS), Systematic Coronary Risk Evaluation 2-Older Persons (SCORE2-OP), and the Framingham risk score (FRS) were calculated at baseline. Risk of dementia (according to DSM-IV criteria) and cognitive decline (defined as a >1.5 standard deviation decline in global cognition, episodic memory, psychomotor speed, or verbal fluency from the previous year) were assessed using hazard ratio. RESULTS: Over a median follow-up of 6.4 years, 850 individuals developed dementia and 4,352 cognitive decline. Men and women in the highest ASCVDRS tertile had a 41% (95% CI 1.08, 1.85) and 45% (1.11, 1.89) increased risk of dementia compared to the lowest tertile, respectively. Likewise, men and women in the highest SCORE2-OP tertile had a 64% (1.24, 2.16) and 60% (1.22, 2.11) increased risk of dementia compared to the lowest tertile, respectively. Findings were similar, but the risk was slightly lesser when examining risk of cognitive decline for both ASCVDRS and SCORE2-OP. However, FRS was only associated with the risk of cognitive decline among women (highest vs. lowest tertiles: 1.13 [1.01-1.26]). CONCLUSION: These findings suggest the utility of the ASCVDRS and SCORE2-OP in clinical practice, to not only assess future risk of CVD, but also as potential early indicators of cognitive impairment, even in relatively healthy older men and women.

Cognitive trajectories and incident dementia after a cardiovascular event in older adults.

INTRODUCTION: Cardiovascular disease (CVD) is a recognized risk factor for dementia. Here we determined the extent to which an incident CVD event modifies the trajectory of cognitive function and risk of dementia. METHODS: 19,114 adults (65+) without CVD or dementia were followed prospectively over 9 years. Incident CVD (fatal coronary heart disease, nonfatal myocardial infarction [MI], stroke, hospitalization for heart failure) and dementia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria) were adjudicated by experts. RESULTS: Nine hundred twenty-two participants had incident CVD, and 44 developed dementia after CVD (4.9% vs. 4.4% for participants without CVD). Following a CVD event there was a short-term drop in processing speed (-1.97, 95% confidence interval [CI]: -2.57 to -1.41), but there was no significant association with longer-term processing speed. In contrast, faster declines in trajectories of global function (-0.56, 95% CI: -0.76 to -0.36), episodic memory (-0.10, 95% CI: -0.16 to -0.04), and verbal fluency (-0.19, 95% CI: -0.30 to -0.01) were observed. DISCUSSION: Findings highlight the importance of monitoring cognition after a CVD event.

Cognitive Decline and Risk of Dementia in Individuals With Heart Failure: A Systematic Review and Meta-analysis.

BACKGROUND: We sought to determine the association between heart failure (HF) and cognitive change and dementia. METHODS AND RESULTS: Systematic search of three electronic databases was performed and 29 eligible studies involving approximately 3 million participants were identified. Twelve studies examined dementia and 20 cognitive change, but only a subset of studies could be included in the meta-analysis. These findings indicated that HF was not significantly associated with dementia (n = 8, hazard ratio 1.18, 95% confidence interval 0.93-1.50), but increased the risk of cognitive impairment (n = 3, hazard ratio 1.80, 95% confidence interval 1.14-2.86) . Additionally, HF was associated with poorer mean cognitive performance in global cognition (Hedges' g -0.73, 95% confidence interval -1.12 to -0.35), memory (Hedges' g -0.57, 95% confidence interval -0.72 to -0.42), executive function (Hedges' g -0.58, 95% confidence interval -0.72 to -0.43), attention/speed (Hedges' g -0.50, 95% confidence interval -0.63 to -0.37) and language (Hedges' g -0.61, 95% confidence interval -1.05 to -0.17). CONCLUSIONS: Patients with HF perform worse on all cognitive tests and have an increased risk of cognitive impairment. These findings highlight the need for clinicians to consider cognition as part of routine care for patients with HF.

Test-Retest Reliability of the BREAST-Q IS in the Australian Breast Device Registry.

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly employed in healthcare to assess outcomes. The BREAST-Q Implant Surveillance module (BREAST-Q IS) is a 5-question PROM utilized by the Australian Breast Device Registry to monitor the performance of breast devices. Validation of this tool is needed to assess its utility in this setting. OBJECTIVES: The objective of this study was to assess the test-retest reliability of the BREAST-Q IS among breast implant recipients within a registry setting. METHODS: A test-retest reliability study was undertaken. Patients who underwent breast augmentation or breast reconstruction and registered with the Australian Breast Device Registry were eligible to participate. A total of 250 surveys were distributed. The BREAST-Q IS was administered to the same group of participants on 2 separate occasions with a 2-week test interval. Participants were divided into 2 groups: breast augmentation and breast reconstruction. A weighted kappa coefficient was calculated to assess the degree of test-retest reliability of the BREAST-Q IS. RESULTS: A total of 207 participants completed both tests. The response rate was 82% (n = 113) for the breast augmentation group and 94% (n = 94) for the breast reconstruction group. All 5 questions on the BREAST-Q IS obtained weighted kappa scores above 0.74 among both groups. CONCLUSIONS: The BREAST-Q IS has good to excellent test-retest reliability for utilization among breast implant recipients in a registry setting. Further validation of the BREAST-Q IS will be required to establish the BREAST-Q IS as a valid and reliable PROM tool for breast implant recipients following breast device surgery.

Patient-Reported Outcome Measures for Breast Implant Surgery: A Pilot Study.

BACKGROUND: The Breast-Q Implant Surveillance module (BREAST-Q IS) is a patient-reported outcome measure (PROM) that asks 5 questions on satisfaction (shape, feel, and rippling) and symptoms (pain and tightness) derived from the BREAST-Q. OBJECTIVES: We aimed to pilot BREAST-Q IS on patients within the Australian Breast Device Registry (ABDR), an opt-out clinical quality device registry, and explored Short Message Service (SMS) communication as a follow-up method. METHODS: Patients with a breast device surgery in the previous 10 to 15 months, age ≥18 years, with a mobile phone number, were invited to complete the 5-question PROM via SMS initially, followed by 3 phone call attempts if no response, an e-mail, and then a letter by post as a final engagement strategy. RESULTS: The study included 197 participants [breast augmentation (BA) = 118; breast reconstruction (BR) = 79]. Mean ± SD age was 40 ± 12 years (BA) and 44 ± 11 years (BR). Mean ± SD time since surgery was 414 ± 36 days (BA) and 413 ± 51 days (BR). The total response rate, including opt-outs, was 76%. Responses indicated that >90% of BA and >79% of BR were very or somewhat satisfied with shape, feel, and wrinkling; >70% of BA and >46% of BR reported no pain or tightness. Completion of survey via SMS was 51% (BA) and 55% (BR). Further responses were received by phone (25%, 26%), post (21%, 16%), and e-mail (3%, 3%). CONCLUSIONS: This pilot demonstrated high levels of satisfaction and low levels of pain and tightness in patients with breast augmentation and breast reconstruction 1 year postoperatively. It also showed the effectiveness of our engagement strategy, which achieved a 76% response rate. Over 50% of respondents used SMS to reply to a 5-question PROM assessing long-term surgical outcomes. This engagement strategy will be used as BREAST-Q IS is rolled out nationally.

The impact of incident stroke on cognitive trajectories in later life.

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.

Experience of waiting for seizure freedom and perception of machine learning technologies to support treatment decision: A qualitative study in adults with recent onset epilepsy.

PURPOSE: With no reliable surrogate biomarkers for treatment response, people with epilepsy currently await the passage of time to determine whether prescribed treatments are effective. Few studies have examined the issues faced by people with epilepsy during this waiting period. We aim to explore the experiences of people with recently diagnosed epilepsy as they wait to achieve seizure freedom. METHODS: We purposively sampled adults of working age who had been diagnosed and treated for epilepsy for less than four years. Semi-structured interviews were undertaken between July and September 2021. A thematic analysis using a framework approach was performed. RESULTS: We recruited 15 patients. Results revealed four main themes: 1) Impact on mental health, as people with newly diagnosed epilepsy described waiting for seizure freedom as a time of vulnerability, uncertainty, and confusion. 2) Participants described their life as "on hold", prior to achieving effective seizure control 3) Difficulty navigating health systems to find and understand information about epilepsy, tests, and medications, and to find the 'right' health professional to address their needs. 4) Technology systems that support clinician decision making with selecting effective medications early after diagnosis were cautiously welcomed by participants. CONCLUSION: Interventions are needed to reduce the negative impacts experienced by people who are newly diagnosed with epilepsy while waiting for effective seizure control. Technology systems that support clinician decision making were acceptable, as people with epilepsy sought accessible and effective solutions to restore a sense of control in their lives.

Mixed methods study to understand the experiences of adults with acquired brain injury and their family members who receive specialised rehabilitation.

BACKGROUND AND AIM: Rehabilitation therapy is a key part of the recovery pathway for people with severe acquired brain injury (ABI). The aim of this study was to explore inpatients' and their family members' experiences of a specialist ABI rehabilitation service. METHODS: A cross sectional, prospective mixed method study was undertaken at a metropolitan specialist ABI rehabilitation unit in Victoria, Australia. All inpatients and their family members of the service were invited to complete a satisfaction survey. Employing purposive sampling, semi-structured interviews were conducted with inpatients and/or their family members. RESULTS: In total, 111 people completed the satisfaction survey and 13 were interviewed. High levels of satisfaction with the specialist service were reported; the majority of inpatients (74%) and family members (81%) rated the overall quality of care received in the service as 'high' or 'very high'. Interviews revealed four main themes: (i) satisfaction with rehabilitation services, (ii) inconsistent communication, (iii) variable nursing care, and (iv) strengths and weakness of the rehabilitation environment. Overall, important components of a positive experience were being involved in decision making and discharge planning, effective communication and information processes, and being able to form therapeutic relationships with staff. Key sources of dissatisfaction for inpatients and family members related to inconsistency in care, accessing information about treatments in a format easily understood, and communication. CONCLUSION: Specialised rehabilitation is valued by inpatients and their family members alike. The findings highlight the importance of exploring inpatient experiences to optimise service delivery in a tailored, specialised rehabilitation programme.

Epigenetic aging as a biomarker of dementia and related outcomes: a systematic review.

Background: Biological aging may be a robust biomarker of dementia or cognitive performance. This systematic review synthesized the evidence for an association between epigenetic aging and dementia, mild cognitive impairment and cognitive function. Methods: A systematic search was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results: 30 eligible articles were included. There was no strong evidence that accelerated epigenetic aging was associated with dementia/mild cognitive impairment (n = 7). There was some evidence of an association with poorer cognition (n = 20), particularly with GrimAge acceleration, but this was inconsistent and varied across cognitive domains. A meta-analysis was not performed due to high study heterogeneity. Conclusion: There is insufficient evidence to indicate that current epigenetic aging clocks can be clinically useful biomarkers of dementia or cognitive aging.

As individuals get older, changes in cognitive performance are common, including some degree of cognitive decline. Dementia is a symptom characterized by significant decline in cognitive function that affects daily living, and age is the biggest risk factor. Researchers have now identified ways to estimate a person's biological age from a blood sample (referred to as 'epigenetic aging'), and this measure is thought to better estimate an individual's rate of aging than his or her chronological age. This study brought together all of the previous studies, 30 in total, that have investigated links between biological aging and cognitive performance, as well as dementia risk. Synthesizing all of this evidence, the authors found no strong evidence that the individuals with dementia had accelerated aging. However, there was some evidence, although inconsistent, indicating that accelerated aging was associated with worse cognitive performance.

Preferences and User Experiences of Wearable Devices in Epilepsy: A Systematic Review and Mixed-Methods Synthesis.

BACKGROUND AND OBJECTIVES: To examine the preferences and user experiences of people with epilepsy and caregivers regarding automated wearable seizure detection devices. METHODS: We performed a mixed-methods systematic review. We searched electronic databases for original peer-reviewed publications between January 1, 2000, and May 26, 2021. Key search terms included "epilepsy," "seizure," "wearable," and "non-invasive." We performed a descriptive and qualitative thematic analysis of the studies included according to the technology acceptance model. Full texts of the discussion sections were further analyzed to identify word frequency and word mapping. RESULTS: Twenty-two observational studies were identified. Collectively, they comprised responses from 3,299 participants including patients with epilepsy, caregivers, and healthcare workers. Sixteen studies examined user preferences, 5 examined user experiences, and 1 examined both experiences and preferences. Important preferences for wearables included improving care, cost, accuracy, and design. Patients desired real-time detection with a latency of ≤15 minutes from seizure occurrence, along with high sensitivity (≥90%) and low false alarm rates. Device-related costs were a major factor for device acceptance, where device costs of <$300 USD and a monthly subscription fee of <$20 USD were preferred. Despite being a major driver of wearable-based technologies, sudden unexpected death in epilepsy was rarely discussed. Among studies evaluating user experiences, there was a greater acceptance toward wristwatches. Thematic coding analysis showed that attitudes toward device use and perceived usefulness were reported consistently. Word mapping identified "specificity," "cost," and "battery" as key single terms and "battery life," "insurance coverage," "prediction/detection quality," and the effect of devices on "daily life" as key bigrams. DISCUSSION: User acceptance of wearable technology for seizure detection was strongly influenced by accuracy, design, comfort, and cost. Our findings emphasize the need for standardized and validated tools to comprehensively examine preferences and user experiences of wearable devices in this population using the themes identified in this study. Greater efforts to incorporate perspectives and user experiences in developing wearables for seizure detection, particularly in community-based settings, are needed. TRIAL REGISTRATION INFORMATION: PROSPERO Registration CRD42020193565.

Breast Device Surgery in Australia: Early Results from the Australian Breast Device Registry.

BACKGROUND: The Australian Breast Device Registry (ABDR) is a clinical quality registry designed to monitor the performance of breast devices; and the quality and safety of breast device surgery. OBJECTIVE: To report on breast device surgery characteristics across Australia. METHODS: Participants were registered patients in the ABDR from 2012 to 2018. Results are described using percentages, mean and median. Revision rates were calculated using survival analysis methods. RESULTS: A total of 37,603 patients were registered and had undergone reconstruction (post-cancer 15.1%, risk-reducing mastectomy 3.4% and developmental deformity 2.4%) or cosmetic augmentation (74.7%) procedures. The majority of breast implant devices were silicone filled with textured surface (reconstruction 74.0% and augmentation 64.0%). Sub-pectoral plane was the most common for both reconstruction (60.1%) and augmentation (76.6%) procedures. For reconstruction surgery, the most common surgical incision was previous mastectomy scar (44.0%) and inframammary (31.8%), and for augmentation, it was inframammary (83.4%). Intraoperative/postoperative antibiotic usage for reconstruction was 85.8% and augmentation was 89.4%. Revision incidence due to complication at 12 months post-cancer reconstruction was 5.1%, risk-reducing reconstruction 5.7% and developmental deformity implants 4.5%. Revision incidence due to complication at 12 months after augmentation procedure was 1.1%. Patient-reported outcome measures (PROMs) indicate high levels of satisfaction at 1 year for augmentation and reconstruction procedures. CONCLUSION: We report on early data from the ABDR and reflect on the uptake of the registry by surgeons and patients. The registry also benefits from international collaborative approaches to addressing challenges and is committed to facilitate international post-market surveillance.

Toward International Harmonization of Breast Implant Registries: International Collaboration of Breast Registry Activities Global Common Data Set.

BACKGROUND: The Poly Implant Prothèse incident and breast implant-associated anaplastic large cell lymphoma have pointed to the need for uniform registries for breast implants as key features to monitoring the outcomes of breast implant surgeries internationally. The purpose of this study was to identify and harmonize common data elements collected by breast implant registries across the International Collaboration of Breast Registry Activities (ICOBRA) global consortium. METHODS: The authors convened an international group of surgeons, consumers, nurses, registry experts, and regulators to review the data points. A modified Delphi approach was applied, to rate the importance of each point on a six-point Likert scale. RESULTS: Data points from six national breast implant registries were divided into categories: clinical, implant-related, patient-reported findings; operation details and implanting technique details; patient characteristics; unique device identifiers; unique patient identifiers; and clinical demographics. A total of 52 data points collected by over 33 percent of national registries were identified. After five rounds, 34 data points formed the final set with agreed definitions. The group recognized the critical importance of additional elements that are currently not uniformly collected (e.g., patient-reported outcomes and long-term data) and set out the process for the dynamic global set updates driven by evidence gaps. CONCLUSIONS: The authors defined internationally agreed on common data elements and definitions used in breast implant registries. This collaboration will allow data sets to be combined, enabling an effective global early warning system of implant-related problems and further work on data sets.

Defining Quality Indicators for Breast Device Surgery: Using Registries for Global Benchmarking.

Breast device registries monitor devices encompassing breast implants, tissue expanders and dermal matrices, and the quality of care and patient outcomes for breast device surgery. Defining a standard set of quality indicators and risk adjustment factors will enable consistency and adjustment for case-mix in benchmarking quality of care across breast implant registries. This study aimed to develop a set of quality indicators to enable assessment and reporting of quality of care for breast device surgery which can be applied globally. METHODS: A scoping literature review was undertaken, and potential quality indicators were identified. Consensus on the final list of quality indicators was obtained using a modified Delphi approach. This process involved a series of online surveys, and teleconferences over 6 months. The Delphi panel included participants from various countries and representation from surgical specialty groups including breast and general surgeons, plastic and reconstructive surgeons, cosmetic surgeons, a breast-care nurse, a consumer, a devices regulator (Therapeutic Goods Administration), and a biostatistician. A total of 12 candidate indicators were proposed: Intraoperative antibiotic wash, intraoperative antiseptic wash, preoperative antibiotics, nipple shields, surgical plane, volume of implant, funnels, immediate versus delayed reconstruction, time to revision, reoperation due to complications, patient satisfaction, and volume of activity. RESULTS: Three of the 12 proposed indicators were endorsed by the panel: preoperative intravenous antibiotics, reoperation due to complication, and patient reported outcome measures. CONCLUSION: The 3 endorsed quality indicator measures will enable breast device registries to standardize benchmarking of care internationally for patients undergoing breast device surgery.