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  • 1
    In: Alzheimer's & Dementia, Wiley, Vol. 17, No. S9 ( 2021-12)
    Abstract: Pivotal to clinical trial success is the recruitment and retention of participants. To improve both, it is important to know which trial features increase willingness to enroll and are appreciated by participants. We examined experiences of trial participants, and their suggestions on how to optimize clinical trial design. Method In this mixed‐methods study, we included participants via the Dutch Brain Research Center (11 different international sponsor‐initiated Alzheimer’s disease trials). An online study‐specific questionnaire was distributed among current and past participants addressing four topics; participant’s motives to enroll, experienced burden, preferred frequency of visits, and attitudes towards participation. Subsequently, we organized three focus groups to gain more in‐depth understanding of negative and positive aspects of trial design. Audio recordings from focus group interviews were transcribed verbatim and analysed by thematic content analysis by two independent raters. Results The questionnaire was completed by 71 participants (age 69±6.5, 54% female, 19 cognitively normal, 19 Mild Cognitive Impairment (MCI), and 33 Alzheimer’s dementia). To benefit future generations was most frequently (34%) reported as a motive for enrolment, Figure 1. The lumbar puncture (40%) and memory assessments (15%) were most often experienced as being of high burden. The most frequently mentioned features to increase the likelihood and willingness to enroll were a low probability to get allocated to the placebo group (27%), and the possibility to obtain personal test results (21%). Negative trial experiences according to focus group participants (N=12, 8 cognitively normal, 4 MCI) included the themes ‘not obtaining their own results during or at the end of a clinical trial’ and ‘no follow up enquiries after participating in the trial’. Among the positive aspects were ‘professionalism’, ‘accuracy’ and ‘empathy of research staff’. Conclusion Our findings provide input for how priorities of participants can be used in clinical trial design to optimize recruitment and ensure trial success. Relevant factors include expectation management and careful planning of high burden assessments, provision of individual feedback and prioritizing professionalism and empathy throughout conduct of the trial. Thus selection of experienced and well‐equipped trial centres is a key component.
    Type of Medium: Online Resource
    ISSN: 1552-5260 , 1552-5279
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2201940-6
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  • 2
    Online Resource
    Online Resource
    Springer Science and Business Media LLC ; 2022
    In:  Health and Quality of Life Outcomes Vol. 20, No. 1 ( 2022-12)
    In: Health and Quality of Life Outcomes, Springer Science and Business Media LLC, Vol. 20, No. 1 ( 2022-12)
    Abstract: Everyday functioning is a clinically relevant concept in dementia, yet little is known about the clinical meaningfulness of scores on functional outcome measures. We aimed to establish clinically meaningful scoring categories for the Amsterdam Instrumental Activities of Daily Living Questionnaire (A-IADL-Q), representing no, mild, moderate and severe problems in daily functioning. Methods Informal caregivers ( n = 6) of memory-clinic patients and clinicians ( n = 13), including neurologists and nurse specialists, working at various memory clinics in The Netherlands. In focus groups, participants individually ranked nine summaries of fictional patients from least to most impairment in daily functioning. Then, they placed bookmarks to demarcate the thresholds for mild, moderate and severe problems. Individual bookmark placements were then discussed to reach consensus. Clinicians completed a survey in which they placed bookmarks, individually. Results While individual categorizations varied somewhat, caregivers and clinicians generally agreed on the thresholds, particularly about the distinction between ‘no’ and ‘mild’ problems. Score categories were no problems ( T -score ≥ 60), mild problems ( T -score 50–59), moderate problems ( T -score 40–49), and severe problems in daily functioning ( T -score 〈 40), on a scale ranging 20–80. Conclusions Our findings provide categories for determining the level of functional impairment, which can facilitate interpretation of A-IADL-Q scores. These categories can subsequently be used by clinicians to improve communication with patients and caregivers.
    Type of Medium: Online Resource
    ISSN: 1477-7525
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2098765-1
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  • 3
    In: Alzheimer's & Dementia, Wiley, Vol. 16, No. S9 ( 2020-12)
    Abstract: Although often used as outcome measure in treatment studies, the clinical meaningfulness of scores on instrumental activities of daily living (IADL) questionnaires is not yet well‐established. We aimed to establish cut‐offs for clinically meaningful categories of IADL functioning, as determined by caregivers of dementia patients using the Amsterdam IADL Questionnaire (A‐IADL‐Q). Secondly, we examined category change within a 1‐year follow‐up period in memory clinic patients. Method First, we performed a qualitative study to determine four clinically meaningful categories on the A‐IADL‐Q: ‘no impairment’, ‘mild’, ‘moderate’, or ‘severe impairment’. T ‐scores ranged from 20–70, with lower scores representing more severe impairment. In focus groups, caregivers ( n =6) were invited to rate written scenarios representing various levels of IADL impairment (‘vignettes’). The vignettes were based on the most likely item responses at given total scores of the A‐IADL‐Q, to which caregivers were blinded. First, caregivers individually categorized the vignettes. Based on nominal group technique, they subsequently placed votes for a category on each vignette. Then, they engaged in group discussion to reach consensus about the categorization. From this, we derived cut‐offs on the A‐IADL‐Q T ‐score. Second, in a quantitative study, we applied the cut‐offs in a longitudinal sample of 169 patients (Table 1) from the Amsterdam Dementia Cohort, diagnosed with either subjective cognitive decline, mild cognitive impairment, Alzheimer’s disease dementia, and other dementias. We assessed what proportion of patients changed to worse categories. Result There was some discussion about the categorization, in particular for deciding which vignettes represented ‘moderate’ and ‘severe impairment’. Consensus cut‐offs were established for mild (≥57.5), moderate (≥47.5), and severe impairment (≥42.5). Figure 1 shows the proportion of patients in each category for the different diagnoses, at baseline and after 1 year. Within one year, 45 patients (26.6%) progressed to a worse clinical category. Conclusion This study provides cut‐off values for clinically meaningful categories, which seem to be in correspondence with disease severity. Over a relatively short follow‐up period of 1 year, approximately one quarter of patients declined to a worse category, providing support for the ability of the A‐IADL‐Q to measure clinically meaningful change.
    Type of Medium: Online Resource
    ISSN: 1552-5260 , 1552-5279
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 2201940-6
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  • 4
    In: Alzheimer's & Dementia, Wiley, Vol. 17, No. S6 ( 2021-12)
    Abstract: With the shift towards preclinical phases of Alzheimer’s disease (AD) and other neurodegenerative diseases in research studies and clinical trials, the question arises if participants can reliably self‐report their level of everyday functioning. Here, we aim to investigate the factors related to concordance between participant‐ and study partner‐report versions of the Amsterdam Instrumental Activities of Daily Living Questionnaire (A‐IADL‐Q) in a community‐based volunteer population. Method Community based volunteers (participants) and their study partners were recruited from a Dutch brain research registry. IADL concordance between participant and study partner was investigated using intraclass correlation coefficient (ICC). Dyads were subsequently categorized as (1) concordant ( 〈 2 points differences in A‐IADL‐Q score); (2) discordant, with study partner reporting more difficulties (study partner 〉 participant) and (3) discordant, participant 〉 study partner. Multinomial logistic regression models were used to investigate the association between subjective cognitive decline, depressive symptoms (Geriatric Depression Scale‐5), type of relationship, objective cognitive functioning (Cognitive Online Self‐Test Amsterdam), and concordance as dependent variable. Result A total of 1213 participants (18‐93 years of age, 68.3% female) and 1213 study partners (18‐88 years, 45.8% female) completed the A‐IADL‐Q. The majority of participants (52.8%) and study partners (59.5%) reported no IADL difficulties. Figure 1 shows the percentage of IADL difficulty reported for individual activities by both participants and study partners. Of the dyads, 653 (53.8%) were in concordance, with an ICC of .55 (95%CI=[.51, .59] , Figure 2). Depressive symptoms and memory complaints increased the odds of participants reporting more IADL difficulties compared to their study partner (odds ratio (OR)=1.31, p 〈 .01 and OR=2.56, p 〈 .01, Table 1). An inverse association was found between A‐IADL‐Q and concordance, to the extent that higher A‐IADL‐Q scores were associated with a lower odds of study partner 〉 participant discordance (OR=0.68, p 〈 .01). Conclusion A slight majority of dyads showed concordance between participant‐ and study partner‐reported IADL scores. Our findings suggest that concordance is less likely in the presence of memory complaints, depressive symptoms and with lower levels of everyday functioning. These findings implicate that participant‐ and study partner report capture different aspects of functional decline, which might influence the study design of longitudinal aging studies.
    Type of Medium: Online Resource
    ISSN: 1552-5260 , 1552-5279
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2201940-6
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  • 5
    In: Alzheimer's & Dementia, Wiley, Vol. 19, No. S4 ( 2023-06)
    Abstract: The Amsterdam Instrumental Activities of Daily Living Questionnaire (A‐IADL‐Q) is a proxy‐based instrument aimed at measuring difficulties in daily functioning due to cognitive decline in the context of dementia. To facilitate its interpretation and clinical implementation, normative data from the general population are necessary. Here, we aimed to compose normative scores for the A‐IADL‐Q and provide clinical cutoff values for mild cognitive impairment (MCI) and dementia. Method Cross‐sectional data from three Dutch cohorts (i.e., Dutch Brain Research Registry, European Medial Information Framework‐Alzheimer’s Disease (EMIF‐AD) 90+, and Amsterdam Dementia Cohort (ADC)) were used, including 1127 cognitively healthy individuals and 380 individuals with MCI and/or dementia. Regression‐based norms were constructed in the healthy sample, using linear models including age, sex, education(high/low) and their interactions, and the optimal model was selected using backward elimination. Individual differences between observed and expected IADL t‐scores were divided by the residual standard error of the model. Optimal normative score cutoffs to distinguish healthy from MCI and/or dementia were based on bootstrap average estimates(500 repeats) of the Youden Index. Diagnostic accuracy was evaluated using receiver operating curves (ROC), area under the curve (AUC), sensitivity and specificity. Result Normative data (mean age = 64±13year, 68.6%female, 67.8% highly educated) and memory clinic data (mean age = 66±8year, 43.9%female, 38.9% highly educated) were used (Table1). The best normative model (i.e., with the lowest Akaike information criterion) included age‐squared, sex, education and the interaction between age and education. The optimal normative score cutoffs to distinguish healthy from dementia and MCI/dementia were, respectively, 1.78SD and 1.79SD below the mean, with high AUCs of 0.96 [95%CI 0.95‐0.98] and 0.94 [95%CI 0.92,0.95] . The optimal cutoff to distinguish healthy from MCI was higher; 1.01SD below the mean, also with a high AUC‐score of 0.86 [95%C 0.81‐0.9])(Table2, Figure1). Conclusion We composed normative scores with clinical cutoff values that can aid in the distinction between cognitively healthy from MCI and/or dementia with high diagnostic accuracy. These normative scores are accessible via an online tool to further facilitate and implement clinical use of the A‐IADL‐Q. Future studies should include participants from different countries, cultures and different socio‐economic background to facilitate world‐wide use.
    Type of Medium: Online Resource
    ISSN: 1552-5260 , 1552-5279
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 2201940-6
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  • 6
    In: Alzheimer's & Dementia, Wiley, Vol. 14, No. 7S_Part_10 ( 2018-07)
    Type of Medium: Online Resource
    ISSN: 1552-5260 , 1552-5279
    Language: English
    Publisher: Wiley
    Publication Date: 2018
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  • 7
    In: Alzheimer's & Dementia, Wiley, Vol. 14, No. 7S_Part_7 ( 2018-07)
    Type of Medium: Online Resource
    ISSN: 1552-5260 , 1552-5279
    Language: English
    Publisher: Wiley
    Publication Date: 2018
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  • 8
    In: Alzheimer's & Dementia, Wiley, Vol. 15, No. 7S_Part_17 ( 2019-07)
    Type of Medium: Online Resource
    ISSN: 1552-5260 , 1552-5279
    Language: English
    Publisher: Wiley
    Publication Date: 2019
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  • 9
    In: Alzheimer's & Dementia, Wiley, Vol. 16, No. S10 ( 2020-12)
    Abstract: Study partner report is used to assess cognitively complex everyday activities, or instrumental activities of daily living (IADL). Because a study partner is not always available, the question arises whether IADL can also be evaluated using self‐report. The aim of this study is to investigate the relationship between study partner‐ and self‐report IADL in individuals without objective cognitive impairment, and to explore its associated factors. Method Participants (N=3,295; mean age 61.0±12.1 years, 70.3% female; Table 1.) and their study partners (N=1,225) were recruited from the Dutch Brain Research Registry. They completed self‐ and study partner‐report versions of the Amsterdam IADL Questionnaire. For the 1,225 dyads, linear regression analyses were used to investigate the relationship between self‐ and study partner report. Age, sex, cohabitation, marital status, education and subjective memory complaints were explored as potential confounders and effect‐modifiers. Result A total of 1,544 (46.9%) participants and study partners (n=497, 40.6%) reported an increased level of difficulty in at least one IADL activity (Figure 1). Absolute agreement between self and study partner on item level was high, ranging from 93.3–99.2%. Participants self‐reported more IADL difficulties (M=65.9±SD=4.7), compared to their study partners (M=66.1±SD=4.6; p 〈 0.05). The study partner‐ and self‐ reported IADL scores were significantly associated (B=0.54). When participants experienced memory complaints, both the participant and study partner reported more IADL difficulties (both p 〈 0.001, Figure 2). Furthermore, we found an interaction effect indicating that the association between self and study partner was lower for those without memory complaints (B= 0.42, Figure 3). In addition, the association between self‐ and proxy was slightly lower for highly educated participants (B=0.47). Conclusion Subtle difficulties in IADL were present in about half of the population, and a high level of agreement between self and study partner was observed on both item and scale level IADL. We found several factors influencing the level of agreement, and in a next step we will include objective cognitive markers to explore the etiology of these differences. These findings provide support for the use of IADL self‐report in cognitively unimpaired individuals, in particular for use in primary or secondary prevention trials.
    Type of Medium: Online Resource
    ISSN: 1552-5260 , 1552-5279
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 2201940-6
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  • 10
    In: Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring, Wiley, Vol. 13, No. 1 ( 2021-01)
    Abstract: Heightened public awareness about Alzheimer's disease and dementia increases the need for at‐home cognitive self‐testing. We offered Cognitive Online Self‐Test Amsterdam (COST‐A) to independent groups of cognitively normal adults and investigated the robustness of a norm‐score formula and cutoff. Methods Three thousand eighty‐eight participants (mean age ± standard deviation = 61 ± 12 years, 70% female) completed COST‐A and evaluated it. Demographically adjusted norm scores were the difference between expected COST‐A scores, based on age, gender, and education, and actual scores. We applied the resulting norm‐score formula to two independent cohorts. Results Participants evaluated COST‐A to be of adequate difficulty and duration. Our norm‐score formula was shown to be robust: ≈8% of participants in two cognitively normal cohorts had abnormal scores. A cutoff of ‐1.5 standard deviations proved optimal for distinguishing normal from impaired cognition. Conclusion With robust norm scores, COST‐A is a promising new tool for research and clinical practice, providing low cost and minimally invasive remote assessment of cognitive functioning.
    Type of Medium: Online Resource
    ISSN: 2352-8729 , 2352-8729
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2832898-X
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