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Background: The EORTC QLQ-C30 Physical Functioning (PF) subscale is a widely used patient-reported outcome (PRO) measure that quantifies cancer patients’ physical function. Responsiveness, the degree to which a scale can assess clinical... more
Background: The EORTC QLQ-C30 Physical Functioning (PF) subscale is a widely used patient-reported outcome (PRO) measure that quantifies cancer patients’ physical function. Responsiveness, the degree to which a scale can assess clinical deterioration and improvement, is an important measurement characteristic that can be assessed by looking at floor and ceiling effects. A floor effect is defined as a high proportion of study participants reporting the lowest possible score in the variable of interest, while a ceiling effect is the opposite. We characterized floor and ceiling effects of the PF subscale in patients with breast cancer enrolled in commercial clinical trials vs. a community-based trial.Objectives: (1) Determine floor/ceiling effects of the QLQ-C30 PF items and subscale among patients receiving treatment for breast cancer (2) Compare floor/ceiling effects among patients enrolled in randomized clinical trials vs. those treated in a community care trial.Methods: PF data fro...
On December 16, 2020, the FDA granted regular approval to margetuximab-cmkb (MARGENZA), in combination with chemotherapy, for the treatment of adult patients with HER2-positive (HER2+) metastatic breast cancer who have received two or... more
On December 16, 2020, the FDA granted regular approval to margetuximab-cmkb (MARGENZA), in combination with chemotherapy, for the treatment of adult patients with HER2-positive (HER2+) metastatic breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Approval was based on data from SOPHIA, a multicenter, randomized, open-label, active controlled study comparing margetuximab with trastuzumab, in combination with chemotherapy. The primary efficacy endpoint was progression-free survival (PFS) by blinded independent central review. SOPHIA demonstrated a 0.9-month difference in median PFS between the two treatment arms [5.8 vs. 4.9 months, respectively; stratified HR, 0.76 (95% confidence interval: 0.59–0.98; P = 0.0334)]. Overall survival (OS) was immature at the data cut-off date of September 10, 2019. Infusion-related reactions (IRR) are an important safety signal associated with margetuximab plus chemotherapy. In SOPHIA...
e13027 Background: Despite the ubiquitous prescribing of pain medications (PMs) in cancer clinical trials, the impact of such prescribing patterns and reporting on the experience of pain is not often investigated. We examined... more
e13027 Background: Despite the ubiquitous prescribing of pain medications (PMs) in cancer clinical trials, the impact of such prescribing patterns and reporting on the experience of pain is not often investigated. We examined patient-reported pain before initiation of PM reporting and at the next available pain assessment. Our aim was to understand change in patient-reported pain. Methods: We pooled data from 7 phase 3 randomized, controlled, registration trials of CDKI with endocrine therapy in patients with hormone receptor positive, human epidermal growth factor receptor-2 negative MBC. We restricted our analyses to patients who started therapy with no PM reported and looked at patients who had NSAID or opioid medication documented. We calculated change between 2 assessments in patient-reported pain before and after PM using the pain occurrence item (Q9) on the EORTC Quality of Life questionnaire (QLQ-C30). Results: Of the 4200 patients who received at least 1 dose of CDKI/placeb...
Objectives. We developed and examined the effectiveness of the Florida Brief Intervention and Treatment for Elders (BRITE) project, a 3-year, state-funded pilot program of screening and brief intervention for older adult substance... more
Objectives. We developed and examined the effectiveness of the Florida Brief Intervention and Treatment for Elders (BRITE) project, a 3-year, state-funded pilot program of screening and brief intervention for older adult substance misusers. Methods. Agencies in 4 counties conducted screenings among 3497 older adults for alcohol, medications, and illicit substance misuse problems and for depression and suicide risk. Screening occurred in elders' homes, senior centers, or other selected sites. Individuals who screened positive for substance misuse were offered brief intervention with evidence-based practices and rescreened at discharge from the intervention program and at follow-up interviews. Results. Prescription medication misuse was the most prevalent substance use problem, followed by alcohol, over-the-counter medications, and illicit substances. Depression was prevalent among those with alcohol and prescription medication problems. Those who received the brief intervention h...
e18612 Background: Effective communication of treatment tolerability data is essential for clinical decision making and improved patient outcomes, yet standardized approaches to the analysis and visualization of tolerability data in... more
e18612 Background: Effective communication of treatment tolerability data is essential for clinical decision making and improved patient outcomes, yet standardized approaches to the analysis and visualization of tolerability data in cancer clinical trials are currently limited. To address this need, the Standardization Working Group (SWG) was established within the NCI Cancer Moonshot Tolerability Consortium. This abstract describes the SWG’s initiative to develop a publicly accessible online toolkit with a comprehensive set of guidelines, references, and resources for graphical displays of tolerability data. Methods: A multidisciplinary group of PRO researchers including biostatisticians, clinicians, epidemiologists, and representatives from the NCI and FDA convened monthly to discuss toolkit development and content. Considerations for standardization of graphical displays of tolerability data included (1) types of graphical displays, (2) incorporation of missing data, (3) labeling...
Uren A1, Cotterill N1, Lasch K2, Deshpande C2, King-Kallimanis B2, van Koeveringe G3, Harding C4, Oelke M5, Chapple C6, Hillary C6, Belal M7, Bosch R8, Blok B9, Klaver M10, Bongaerts D10, Hakimi Z10, Abrams P1 1. Bristol Urological... more
Uren A1, Cotterill N1, Lasch K2, Deshpande C2, King-Kallimanis B2, van Koeveringe G3, Harding C4, Oelke M5, Chapple C6, Hillary C6, Belal M7, Bosch R8, Blok B9, Klaver M10, Bongaerts D10, Hakimi Z10, Abrams P1 1. Bristol Urological Institute, Bristol, UK, 2. Pharmerit, Boston, United States, 3. Maastricht University Medical Centre, Maastricht, The Netherlands, 4. Freeman Hospital, Newcastle-upon-Tyne, 5. Hannover Medical School, Hannover, Germany, 6. Royal Hallamshire Hospital, Sheffield, 7. Queen Elizabeth Hospital, Birmingham, UK, 8. University Medical Centre Utrecht, Utrecht, The Netherlands, 9. Erasmus Medical Centre, Rotterdam, The Netherlands, 10. Astellas Pharma B.V., Leiden, The Netherlands
e20017 Background: Multiple Myeloma (MM) is predominantly a disease of older adults with a median age of onset at 70 years. There is growing interest in using criterion other than chronological age, like frailty, to determine fitness for... more
e20017 Background: Multiple Myeloma (MM) is predominantly a disease of older adults with a median age of onset at 70 years. There is growing interest in using criterion other than chronological age, like frailty, to determine fitness for treatment and ultimately improve clinical outcomes in MM. Frailty is the accumulation of aging-associated diseases and disabilities, making patients more vulnerable to adverse outcomes when exposed to stressors like anti-cancer treatment. MM frailty measures have primarily been developed and tested in newly diagnosed patients. MM patients typically relapse, but there is limited knowledge regarding the prevalence of frailty in the relapsed/refractory (RRMM) setting. The aim of this research was to determine the prevalence of frailty in RRMM commercial clinical trials, at the time of trial enrollment, using the International Myeloma Working Group (IMWG) Frailty Index. Methods: We pooled baseline data from 6 RRMM clinical trials submitted for FDA regul...
Previous research has suggested that older adults who misuse alcohol frequently report depressive symptoms as an antecedent to drinking. The objective of the present study was to investigate the extent to which higher levels of depressive... more
Previous research has suggested that older adults who misuse alcohol frequently report depressive symptoms as an antecedent to drinking. The objective of the present study was to investigate the extent to which higher levels of depressive symptoms were associated with elders' problem drinking by examining screening data from a three-year pilot program known as the Florida BRITE Project. BRITE (BRief Intervention and Treatment for Elders) is a multisite program offering brief interventions for community-based older adults screening positive for alcohol or medication misuse. Depressive symptoms were assessed using the Short Geriatric Depression Scale: alcohol use was assessed with the first three questions from the Alcohol Use Disorders Identification Test and the Short-Michigan Alcoholism Screening Test-Geriatric version. Multivariate logistic regression revealed that older adults with higher levels of depressive symptoms were at greater risk for screening positive for alcohol pr...
e24145 Background: Pain medications (PMs) are commonly used to treat pain in patients (pts) with advanced/metastatic breast cancer (MBC). We examined PM usage patterns in pts receiving CDK 4/6 inhibitor (CDKI) based treatment. Methods: We... more
e24145 Background: Pain medications (PMs) are commonly used to treat pain in patients (pts) with advanced/metastatic breast cancer (MBC). We examined PM usage patterns in pts receiving CDK 4/6 inhibitor (CDKI) based treatment. Methods: We pooled data from seven phase 3 randomized, controlled trials of CDKI + endocrine therapy in pts with hormone receptor positive, human epidermal growth factor receptor-2 negative MBC. PM were categorized as opioid (includes codeine-containing), NSAID, or other (i.e. bone-directed, antiepileptic, topical PMs). All analyzed pts received at least 1 dose of CDKI/placebo and had concomitant PM with a documented start date. Medications prescribed during hospitalizations were not included. We evaluated percent PM by demographic factors and pts with bone mets, and liver/lung mets. Results: 2416 pts met the inclusion criteria, of which 928 pts started a PM before the study and 1488 pts did not start PM before the study. Of the 1488 pts not on a PM before the...
Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients’ symptoms, function and quality of life. High-quality PRO data from trials can inform shared... more
Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients’ symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the reco...
e19101 Background: Efficient and thoughtful collection of PROs in randomized cancer trials is necessary, especially when comparing drugs with differing administration schedules. Assessment timing for PROs can dramatically influence... more
e19101 Background: Efficient and thoughtful collection of PROs in randomized cancer trials is necessary, especially when comparing drugs with differing administration schedules. Assessment timing for PROs can dramatically influence results. We sought to better understand how different assessment schedules affect interpretation of toxicity using PRO data. Methods: We reviewed 3 randomized trials in advanced/metastatic RCC with a control arm of sunitinib administered 4 weeks on/2 weeks off. All 3 trials used FACT Kidney Symptom Index (FKSI-19 or -DRS) and one also used EORTC QLQ-C30. For each trial, we chose patient-reported diarrhea and bone pain due to their strong association with the therapeutic intervention and the disease, respectively. Results: For the first 12 weeks, all trials had PRO assessments at baseline but had differing schedules thereafter. PRO assessment in Trial 1 was every 3 weeks; Trial 2: week 6 and week 12; Trial 3: every 3 weeks on the investigational arm and at...
e19105 Background: Patient-reported outcomes can provide symptom and function data that complement standard oncology endpoints. Frequently, trials will conclude there was no clinically meaningful detriment to health-related quality of... more
e19105 Background: Patient-reported outcomes can provide symptom and function data that complement standard oncology endpoints. Frequently, trials will conclude there was no clinically meaningful detriment to health-related quality of life (HRQL) or function, even when notable toxicity is observed. It is possible that mean change from baseline analyses obscures meaningful change in subgroups experiencing symptomatic toxicity. In this study, we explore how patients’ response to a diarrhea item related to physical function (PF) and HRQL in trials submitted to US FDA. Methods: We analyzed 3 randomized, double-blind breast cancer trials (early to late line metastatic) where diarrhea was a more common AE-symptom in the treatment arm, but there was not a large detriment in the mean change from baseline for HRQL and PF. Trials included the EORTC Quality of Life Questionnaire (QLQ-C30), which captures patient-reported HRQL, symptoms, and functioning. Higher scores (range 0-100) indicate bet...
e19370 Background: Financial toxicity (FT) is a major concern for patients receiving standard cancer treatment, and FT can lead to worse cancer outcomes. However, little is known about the FT of patients enrolled in clinical trials (CT).... more
e19370 Background: Financial toxicity (FT) is a major concern for patients receiving standard cancer treatment, and FT can lead to worse cancer outcomes. However, little is known about the FT of patients enrolled in clinical trials (CT). While investigational treatment may be provided by sponsors free of charge, patients are subject to increased clinic visits (ie, missed workdays, travel costs) and still bear the cost of usual care. This analysis evaluates patient-reported FT in multiple myeloma (MM) trials submitted to US FDA and explores the relationship between baseline FT and overall response rate (ORR). Methods: We pooled data from 9 MM registration CTs submitted to the FDA that included the EORTC Quality of Life questionnaire (QLQ-C30). The QLQ-C30 includes an item asking patients “Has your physical condition or medical treatment caused you financial difficulties?”. We looked at proportion of patients at baseline reporting any FT and their ORR. We also report prevalence, incid...
12024 Background: Patients with poor performance status are often excluded from clinical trials. The FDA has published several guidances on modernizing oncology clinical trial eligibility criteria to more accurately reflect the patient... more
12024 Background: Patients with poor performance status are often excluded from clinical trials. The FDA has published several guidances on modernizing oncology clinical trial eligibility criteria to more accurately reflect the patient population. Many patients receiving novel oncology therapeutics are heavily pretreated, and often have comorbidities, organ dysfunction, and frailty syndromes. Little is known about the safety of novel therapeutics in patients with poor performance status. Methods: Data from six randomized trials (n=4465) leading to registration for several solid tumor and malignant hematologic cancers, including multiple therapeutic mechanisms of action, such as EGFR TKI’s, immune checkpoint inhibitors (ICI), and chemotherapy, were pooled. Cumulative incidence of Grade 3-5 adverse events and serious adverse events at Days 30, 90, and 180 were evaluated based on ECOG 0-2. Rates of treatment discontinuation by ECOG was also examined. Results: Cumulative incidence of to...
134 Background: Patient-reported outcome measures (PROs) can capture the patient’s experience with disease and treatment. Anti-PD-1/PD-L1 therapies have unique symptomatic side effects; PRO data can help to better understand the patient... more
134 Background: Patient-reported outcome measures (PROs) can capture the patient’s experience with disease and treatment. Anti-PD-1/PD-L1 therapies have unique symptomatic side effects; PRO data can help to better understand the patient experience on therapy. Health-related quality of life (HRQL) components most impacted by therapy include disease symptoms, symptomatic toxicity and physical function. Methods: We reviewed FDA registration trials for 5 immunotherapy agents (anti-PD-1/PD-L1) to evaluate trial design and PRO assessment. We assessed whether the PRO strategy assessed physical function and symptomatic immune-related adverse events (irAEs) by reviewing whether trials used a well-defined physical function domain and 8 symptoms related to irAEs reported in product labels (fatigue, diarrhea, cough, shortness of breath, musculoskeletal pain, rash, pruritis and fever). Results: Data from 25 trials across 7 disease types and 1 tumor agnostic indication were evaluated. Of these, 1...
Previous research has suggested that older adults who misuse alcohol frequently report depressive symptoms as an antecedent to drinking. The objective of the present study was to investigate the extent to which higher levels of depressive... more
Previous research has suggested that older adults who misuse alcohol frequently report depressive symptoms as an antecedent to drinking. The objective of the present study was to investigate the extent to which higher levels of depressive symptoms were associated with elders' problem drinking by examining screening data from a three-year pilot program known as the Florida BRITE Project. BRITE (BRief Intervention and Treatment for Elders) is a multisite program offering brief interventions for community-based older adults screening positive for alcohol or medication misuse. Depressive symptoms were assessed using the Short Geriatric Depression Scale: alcohol use was assessed with the first three questions from the Alcohol Use Disorders Identification Test and the Short-Michigan Alcoholism Screening Test-Geriatric version. Multivariate logistic regression revealed that older adults with higher levels of depressive symptoms were at greater risk for screening positive for alcohol pr...
Little is known on the impact of emerging treatments for advanced melanoma (stages III and IV) on patients' functioning and well-being. The objective of this study was to describe the patient-reported treatment-related symptom (TRS)... more
Little is known on the impact of emerging treatments for advanced melanoma (stages III and IV) on patients' functioning and well-being. The objective of this study was to describe the patient-reported treatment-related symptom (TRS) burden in advanced melanoma. Twenty-nine in-depth, qualitative interviews were conducted among adult patients with advanced melanoma in Canada using a semi-structured interview method. Interviews were transcribed verbatim, and key concepts were identified using a grounded theory analytic approach. The 29 patients reported 13 unique treatment journeys involving the following drug therapy categories: cytotoxic chemotherapies, CTLA-4 inhibitors, BRAF or MEK inhibitors, and PD-1 inhibitors. Patients typically underwent multiple treatment episodes over time. Common TRSs included nausea, fatigue, diarrhea or constipation, and skin rashes. Patients described these as impacting their physical functioning, ability to perform activities of daily living, social...
Metastatic melanoma is a highly aggressive cancer, often striking in the prime of life. This study provides new information directly from advanced melanoma (stage III and IV) patients on how their disease impacts their health-related... more
Metastatic melanoma is a highly aggressive cancer, often striking in the prime of life. This study provides new information directly from advanced melanoma (stage III and IV) patients on how their disease impacts their health-related quality of life (HRQL). Twenty-nine in-depth, qualitative interviews were conducted with adult patients with advanced melanoma in Canada. A semi-structured interview guide was used. Interviews were transcribed verbatim and key concepts were identified using a grounded theory analytic approach. Many patients' journeys began with the startling diagnosis of an invasive disease and a vastly shortened life expectancy. By the time they reached an advanced stage of melanoma, these patients' overall functioning and quality of life had been greatly diminished by this quickly progressing cancer. The impact was described in terms of physical pain and disability, emotional distress, diminished interactions with friends and family, and burden on caregivers. ...
To identify age differences in the 12-month and lifetime comorbidity of depressive and anxiety disorders for adults (18-64 years) compared with older adults (65 years and older) in a nationally representative sample of community-dwelling... more
To identify age differences in the 12-month and lifetime comorbidity of depressive and anxiety disorders for adults (18-64 years) compared with older adults (65 years and older) in a nationally representative sample of community-dwelling adults in the United States. Cross-sectional epidemiologic study, using data from the National Comorbidity Survey-Replication public use dataset. Community-based epidemiologic survey. Representative national sample of community-dwelling adults in the United States. The World Health Organization Composite International Diagnostic Interview was used to assess Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition psychiatric disorders. More than half of respondents with a 12-month major depressive disorder (MDD) had a comorbid anxiety disorder or dysthymia (18-64 years = 60.6%; 65 years and older = 51.8%). High rates of MDD were also found for those with anxiety disorders across both age groups, highest in the 18-64 years group for gene...
The Montreal Cognitive Assessment (MoCA) is a very widely used test for mild cognitive impairment. Differing recommendations have been made regarding its utility in providing a profile of performance across several cognitive domains. To... more
The Montreal Cognitive Assessment (MoCA) is a very widely used test for mild cognitive impairment. Differing recommendations have been made regarding its utility in providing a profile of performance across several cognitive domains. To examine the factor structure of the MoCA in a nationally representative population study of older Irish adults and evaluate its utility in providing domain-specific information. A cross-sectional analysis of wave 1 data from the Irish Longitudinal Study on Ageing was undertaken. Data from a subset of 2342 participants assessed using the MoCA were analyzed using both confirmatory factor analytic (CFA) and exploratory factor analytic (EFA) methods. Mean age was 72.64 (range 65 to 98), 53% female. The CFA provided evidence of adequate overall model fit for a previously proposed 6-factor model. In contrast, EFA yielded a 3-factor solution and test items cross-loaded onto a number of factors with no clear pattern of underlying cognitive domains. Using EFA...
Given the increasing diversity of the US population and the continued threat of hurricane devastation along the heavily populated Gulf Coast region, the lack of research on preparedness and sheltering activities across religious or... more
Given the increasing diversity of the US population and the continued threat of hurricane devastation along the heavily populated Gulf Coast region, the lack of research on preparedness and sheltering activities across religious or cultural groups represents a significant gap in the field of hazards and disaster research. To address this void, a questionnaire examining hurricane preparedness attitudes and sheltering preferences was administered to Muslims living in Tampa, Florida.
Research Interests:
The Factor Structure of the Long and Short Forms of the CES-D Scale and the Validity of Positive Affect in Older Irish Adults.
To explore the extent of and factors associated with male nursing home residents who wander, we conducted cross-sectional design with secondary data analyses. One hundred thirty-four nursing home facilities operated by the Department of... more
To explore the extent of and factors associated with male nursing home residents who wander, we conducted cross-sectional design with secondary data analyses. One hundred thirty-four nursing home facilities operated by the Department of Veterans Affairs with fifteen thousand ninety-two nursing home residents with moderate or severe cognitive impairment admitted over a 4-year period participated in this study. Selected variables from the Minimum Data Set included ratings recorded at residents' admission to the nursing home (cognitive impairment, mood, behavior problems, activities of daily living, and wandering). In this sample of residents with moderate or severe cognitive impairment, the proportion of wanderers was found to be 21%. Wanderers were more likely to exhibit severe (vs moderate) cognitive impairment, socially inappropriate behavior, resistance to care, use of antipsychotic medication, independence in locomotion or ambulation, and dependence in activities of daily liv...
Research Interests:
ABSTRACT Background Depression is an important public health outcome in the older adult population. It is associated with declining physical and psychological well-being and increasing healthcare utilisation. The Center for... more
ABSTRACT Background Depression is an important public health outcome in the older adult population. It is associated with declining physical and psychological well-being and increasing healthcare utilisation. The Center for Epidemiological Studies Depression Scale (CES-D) although widely accepted as a screening tool for depressive symptoms in older adults, can be long and exhaustive as part of a comprehensive geriatric assessment. Aim We investigated the consistency, reliability and validity of the original and three short formats of the CES-D. Methods Six thousand six hundred and thirty-seven community-living adults, aged ≥ 50 years from The Irish Longitudinal Study on Ageing (TILDA), completed the 20-item CES-D. Confirmatory factor analysis determined the factor structures of the 20-, 10- and two 8-item formats of the CES-D. Latent factors from each format were validated against disability and perceived stress, particularly the Positive Affect factor. Analysis was also performed in a subset aged 65+ years. Results All formats of the CES-D displayed good internally consistency (0.87–0.72) and good model fit for the expected four- and three-factor structures of the CES-D. Latent factors from all formats were representative of each other and the Positive Affect factor was negatively correlated with disability and perceived stress on all CES-D formats. Conclusion Short forms of the CES-D are consistent, reliable and valid for use in the older adult population (50+ or 65+ years), where avoiding long assessments and response fatigue is warranted. These formats may be used to measure Positive Affect, an important construct related to physical health, resilience and psychological well-being in later life.
ABSTRACT Purpose: To examine the cognitive performance of subjects according to history and burden of syncope and non-accidental falls, in an unselected population representative sample. Methods: 5849 participants of the Irish... more
ABSTRACT Purpose: To examine the cognitive performance of subjects according to history and burden of syncope and non-accidental falls, in an unselected population representative sample. Methods: 5849 participants of the Irish longitudinal study on ageing (TILDA) were studied. Past history and recent burden of syncope and non-accidental falls were assessed during home interviewing. Cognitive performance was assessed during health assessment using the Montreal cognitive assessment (MOCA) score. Poor performance was defined as scoring in the lowest decile of MOCA scores. Multivariate analysis controlling for potential confounders was carried out to compare cognitive performance by syncope status. Results: In this Irish population (n=5849), mean age 63±9 (54% women), a past history of syncope (in youth only or in adulthood only) was more common in subjects with higher cognitive performance. However, recent burden of syncope (in the past 12 months) was higher in subjects with lower cognitive performance (5.3% vs 3.5%; P=0.04), specifically multiple events of syncope (2.8% vs 1.6%; P=0.01). The prevalence of non-accidental falls was higher in those with lower cognition (10.4% vs 4.7%; P<0.0001). Multivariate analysis adjusted for age, sex and education indicated that subjects with syncope in adulthood only had a lower odds of poor cognitive performance (OR=0.68, 95% CI=0.5, 0.95), whereas subjects reporting multiple events of syncope in the last year had an increased odds of poor cognition (OR=1.77, 95% CI=1, 3.12). Subjects with non-accidental falls in the last year were also at greater odds of scoring poorly (OR=1.55, 95% CI=1.12, 2.14). Both associations remained significant following additional adjustment for clinical profile, behavioural health, depression, cardiovascular disease and medication use. Conclusion: Recent burden of syncope and non-accidental falls were each independently associated with lower cognitive performance, in a large population based sample of older adults. Further studies are warranted to investigate the causality of this relationship. Our study highlights the potential importance of syncope in the context of cognition.
Walking speed is a meaningful marker of physical function in the aging population. While it is a primarily physical measure, experimental studies have shown that merely priming older adults with negative stereotypes about aging results in... more
Walking speed is a meaningful marker of physical function in the aging population. While it is a primarily physical measure, experimental studies have shown that merely priming older adults with negative stereotypes about aging results in immediate declines in objective walking speed. What is not clear is whether this is a temporary experimental effect or whether negative aging stereotypes have detrimental effects on long term objective health. We sought to explore the association between baseline negative perceptions of aging in the general population and objective walking speed 2 years later. 4,803 participations were assessed over 2 waves of The Irish Longitudinal Study on Ageing (TILDA), a prospective, population representative study of adults aged 50+ in the Republic of Ireland. Wave 1 measures - which included the Aging Perceptions Questionnaire, walking speed and all covariates - were taken between 2009 and 2011. Wave 2 measures - which included a second measurement of walking speed and covariates - were collected 2 years later between March and December 2012. Walking speed was measured as the number of seconds to complete the Timed Up-And-Go (TUG) task. Participations with a history of stroke, Parkinson's disease or an MMSE < 18 were excluded. After full adjustment for all covariates (age, gender, level of education, disability, chronic conditions, medications, global cognition and baseline TUG) negative perceptions of aging at baseline were associated with slower TUG speed 2 years later (B=.03, 95% CI = .01 to 05, p< .05). Walking speed has previously been considered to be a consequence of physical decline but these results highlight the direct role of psychological state in predicting an objective aging outcome. Negative perceptions about aging are a potentially modifiable risk factor of some elements of physical decline in aging.
Objectives: The effect of chronic disease status on quality of life (QoL) has been well established. However, less is known about how chronic diseases affect QoL. This article examines impairment in three domains of the WHO International... more
Objectives: The effect of chronic disease status on quality of life (QoL) has been well established. However, less is known about how chronic diseases affect QoL. This article examines impairment in three domains of the WHO International Classification of Functioning, Health and Disability (ICF) - body function, activity and participation, as well as affective well-being, - as potential mediators of the relationship between chronic disease and QoL. Method: A cross-sectional sample (n = 4961) of the general Irish community-dwelling population aged 50+ years was obtained from the Irish Longitudinal Study of Ageing (TILDA). The CASP measure of QoL was examined as two dimensions - control/autonomy and self-realisation/pleasure. Structural equation modelling was used to test the direct and indirect effects of chronic disease on QoL, via variables capturing body function, activity, participation and positive affect. Results: A factor analysis showed that indicators of body function and ac...
The release of the report 'To err is human' put medical safety and the disclosure of errors to the forefront of the health care agenda. Disclosure of medical errors by physicians is vital in this process. We studied the role of... more
The release of the report 'To err is human' put medical safety and the disclosure of errors to the forefront of the health care agenda. Disclosure of medical errors by physicians is vital in this process. We studied the role of background and social psychological factors in internists' willingness to report medical errors. Survey among a random sample of internists from five teaching hospitals in the Netherlands, all internists and internists in training at the Departments of Internal Medicine of the participating hospitals. Questionnaires were received from 115 participants (response 51%). The willingness to disclose was related to the severity of the error, with the majority of near misses not reported to the head of department or the hospital error committees. Errors were more often reported to colleagues. Positive factors in favour of disclosing were reported more often than negative ones prohibiting disclosure. Motivation, behavioural control and social barriers wer...
To examine the physical health, anxiety, and depressive symptoms of homebound older adults in relation to a history of trauma exposure. Secondary analysis of cross-sectional data. Participants were recruited by in-home aging services case... more
To examine the physical health, anxiety, and depressive symptoms of homebound older adults in relation to a history of trauma exposure. Secondary analysis of cross-sectional data. Participants were recruited by in-home aging services case managers. The sample consisted of 136 older adults receiving in-home services. Participants completed a research battery that included the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID), Modified Mini-Mental Status Examination, and Brief Symptom Inventory-18 (BSI-18). Case managers provided standard assessments of health and functional status. Data were analyzed using t tests, chi tests, and logistic regression. Approximately half (49%) of the participants reported experiencing a traumatic event. When compared with participants who did not report a history of trauma, trauma-exposed participants were on average 3 years younger, had one more chronic medical condition, were taking two mor...
previously, frailty indices were constructed using mostly subjective health measures. The reporting error in this type of measure can have implications on the robustness of frailty findings. to examine whether frailty assessment differs... more
previously, frailty indices were constructed using mostly subjective health measures. The reporting error in this type of measure can have implications on the robustness of frailty findings. to examine whether frailty assessment differs when we construct frailty indices using solely self-reported or test-based health measures. secondary analysis of data from The Irish LongituDinal study on Ageing (TILDA). 4,961 Irish residents (mean age: 61.9 ± 8.4; 54.2% women) over the age of 50 years who underwent a health assessment were included in this analysis. We constructed three frailty indices using 33 self-reported health measures (SRFI), 33 test-based health measures (TBFI) and all 66 measures combined (CFI). The 2-year follow-up outcomes examined were all-cause mortality, disability, hospitalisation and falls. all three indices had a right-skewed distribution, an upper limit to frailty, a non-linear increase with age, and had a dose-response relationship with adverse outcomes. Levels o...

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