Migraine-attributed burden, impact and disability, and migraine-impacted quality of life : Expert consensus on definitions from a Delphi process

Migraine-attributed burden, impact, disability and migraine-impacted quality of life are important concepts in clinical management, clinical and epidemiological research, and health policy, requiring clear and agreed definitions. We aimed to formulate concise and precise definitions of these concepts by expert consensus. We searched the terms migraine-attributed burden, impact, disability and migraine-impacted quality of life in Embase and Medline from 1974 and 1946 respectively. We followed a Delphi process to reach consensus on definitions. We found widespread conflation of concepts and inconsistent terminology within publications. Following three Delphi rounds, we defined migraine-attributed burden as "the summation of all negative consequences of the disease or its diagnosis"; migraine-attributed impact as "the effect of the disease, or its diagnosis, on a specified aspect of life, health or wellbeing"; migraine-attributed disability as "physical, cognitive and mental incapacities imposed by the disease"; and migraine-impacted quality of life as "the subjective assessment by a person with the disease of their general wellbeing, position and prospects in life". We complemented each definition with a detailed description. These definitions and descriptions should foster consistency and encourage more appropriate use of currently available quantifying instruments and aid the future development of other

Migraine-attributed burden, impact and disability, and migraine-impacted quality of life : Expert consensus on definitions from a Delphi process

Migraine-attributed burden, impact, disability and migraine-impacted quality of life are important concepts in clinical management, clinical and epidemiological research, and health policy, requiring clear and agreed definitions. We aimed to formulate concise and precise definitions of these concepts by expert consensus. We searched the terms migraine-attributed burden, impact, disability and migraine-impacted quality of life in Embase and Medline from 1974 and 1946 respectively. We followed a Delphi process to reach consensus on definitions. We found widespread conflation of concepts and inconsistent terminology within publications. Following three Delphi rounds, we defined migraine-attributed burden as "the summation of all negative consequences of the disease or its diagnosis"; migraine-attributed impact as "the effect of the disease, or its diagnosis, on a specified aspect of life, health or wellbeing"; migraine-attributed disability as "physical, cognitive and mental incapacities imposed by the disease"; and migraine-impacted quality of life as "the subjective assessment by a person with the disease of their general wellbeing, position and prospects in life". We complemented each definition with a detailed description. These definitions and descriptions should foster consistency and encourage more appropriate use of currently available quantifying instruments and aid the future development of other

Relationship of Hippocampal Volume to Amyloid Burden across Diagnostic Stages of Alzheimer’s Disease

Aims: To assess how hippocampal volume (HV) from volumetric magnetic resonance imaging (vMRI) is related to the amyloid status at different stages of Alzheimer's disease (AD) and its relevance to patient care. Methods: We evaluated the ability of HV to predict the florbetapir positron emission tomography (PET) amyloid positive/negative status by group in healthy controls (HC, n = 170) and early/late mild cognitive impairment (EMCI, n = 252; LMCI, n = 136), and AD dementia (n = 75) subjects from the Alzheimer's Disease Neuroimaging Initiative Grand Opportunity (ADNI-GO) and ADNI2. Logistic regression analyses, including elastic net classification modeling with 10-fold cross-validation, were used with age and education as covariates. Results: HV predicted amyloid status only in LMCI using either logistic regression [area under the curve (AUC) = 0.71, p < 0.001] or elastic net classification modeling [positive predictive value (PPV) = 72.7%]. In EMCI, age (AUC = 0.70, p < 0.0001) and age and/or education (PPV = 63.1%), but not HV, predicted amyloid status. Conclusion: Using clinical neuroimaging, HV predicted amyloid status only in LMCI, suggesting that HV is not a biomarker surrogate for amyloid PET in clinical applications across the full diagnostic spectrum

Caregiver Burden in Alzheimer's Disease: Differential Associations in Adult-Child and Spousal Caregivers in the GERAS Observational Study

Background/Aims: To examine factors influencing the caregiver burden in adult-child and spousal caregivers of community-dwelling patients with Alzheimer's disease (AD). Methods: Baseline data from the 18-month, prospective, observational GERAS study of 1,497 patients with AD in France, Germany, and the UK were used. Analyses were performed on two groups of caregivers: spouses (n = 985) and adult children (n = 405). General linear models estimated patient and caregiver factors associated with subjective caregiver burden assessed using the Zarit Burden Interview. Results: The caregiver burden increased with AD severity. Adult-child caregivers experienced a higher burden than spousal caregivers despite spending less time caring. Worse patient functional ability and more caregiver distress were independently associated with a greater burden in both adult-child and spousal caregivers. Additional factors were differentially associated with a greater caregiver burden in both groups. In adult-child caregivers these were: living with the patient, patient living in an urban location, and patient with a fall in the past 3 months; in spouses the factors were: caregiver gender (female) and age (younger), and more years of patient education. Conclusion: The perceived burden differed between adult-child and spousal caregivers, and specific patient and caregiver factors were differentially associated with this burden

Caregiver Burden in Alzheimer's Disease: Differential Associations in Adult-Child and Spousal Caregivers in the GERAS Observational Study.

To examine factors influencing the caregiver burden in adult-child and spousal caregivers of community-dwelling patients with Alzheimer's disease (AD). Baseline data from the 18-month, prospective, observational GERAS study of 1,497 patients with AD in France, Germany, and the UK were used. Analyses were performed on two groups of caregivers: spouses (n = 985) and adult children (n = 405). General linear models estimated patient and caregiver factors associated with subjective caregiver burden assessed using the Zarit Burden Interview. The caregiver burden increased with AD severity. Adult-child caregivers experienced a higher burden than spousal caregivers despite spending less time caring. Worse patient functional ability and more caregiver distress were independently associated with a greater burden in both adult-child and spousal caregivers. Additional factors were differentially associated with a greater caregiver burden in both groups. In adult-child caregivers these were: living with the patient, patient living in an urban location, and patient with a fall in the past 3 months; in spouses the factors were: caregiver gender (female) and age (younger), and more years of patient education. The perceived burden differed between adult-child and spousal caregivers, and specific patient and caregiver factors were differentially associated with this burden.To examine factors influencing the caregiver burden in adult-child and spousal caregivers of community-dwelling patients with Alzheimer's disease (AD). METHODS: Baseline data from the 18-month, prospective, observational GERAS study of 1,497 patients with AD in France, Germany, and the UK were used. Analyses were performed on two groups of caregivers: spouses (n = 985) and adult children (n = 405). General linear models estimated patient and caregiver factors associated with subjective caregiver burden assessed using the Zarit Burden Interview. RESULTS: The caregiver burden increased with AD severity. Adult-child caregivers experienced a higher burden than spousal caregivers despite spending less time caring. Worse patient functional ability and more caregiver distress were independently associated with a greater burden in both adult-child and spousal caregivers. Additional factors were differentially associated with a greater caregiver burden in both groups. In adult-child caregiver

Migraine-attributed burden, impact and disability, and migraine-impacted quality of life: Expert consensus on definitions from a Delphi process

Background Migraine-attributed burden, impact, disability and migraine-impacted quality of life are important concepts in clinical management, clinical and epidemiological research, and health policy, requiring clear and agreed definitions. We aimed to formulate concise and precise definitions of these concepts by expert consensus. Methods We searched the terms migraine-attributed burden, impact, disability and migraine-impacted quality of life in Embase and Medline from 1974 and 1946 respectively. We followed a Delphi process to reach consensus on definitions. Results We found widespread conflation of concepts and inconsistent terminology within publications. Following three Delphi rounds, we defined migraine-attributed burden as "the summation of all negative consequences of the disease or its diagnosis"; migraine-attributed impact as "the effect of the disease, or its diagnosis, on a specified aspect of life, health or wellbeing"; migraine-attributed disability as "physical, cognitive and mental incapacities imposed by the disease"; and migraine-impacted quality of life as "the subjective assessment by a person with the disease of their general wellbeing, position and prospects in life". We complemented each definition with a detailed description. Conclusion These definitions and descriptions should foster consistency and encourage more appropriate use of currently available quantifying instruments and aid the future development of others.Paroxysmal Cerebral Disorder

A non-comparative assessment of tolerability and efficacy of duloxetine in the treatment of depressed patients with Parkinson's disease

Objective: Depression is a comorbidity affecting quality of life (QoL) in patients with Parkinson's disease (PD) and requires appropriate treatment. This study evaluated the tolerability, safety, and efficacy of duloxetine 60 mg once daily for 12 weeks in PD patients with major depressive disorder (MDD). Research and design methods: Non-comparative, open-label, multi-center study. Main outcome measures: Tolerability was evaluated by discontinuation rate (acceptable if ≤ 19%) due to treatment-emergent adverse events (TEAEs) and motor symptoms (UPDRS). Safety measures were TEAEs, the UKU side effect rating scale, vital signs, weight, laboratory tests, and ECG. Efficacy measures included HAMD-17, BDI, CGI-S, PGI-I, and pain VAS. QoL was measured by PDQ-39. Results: Of the 151 patients enrolled, 8.6% (95% upper CI: 13.3%) discontinued the study due to TEAEs. Worsening in PD-related tremor and rigidity was not observed, activities of daily living significantly improved and UKU subscales progressively decreased. Clinically significant abnormalities in laboratory findings were limited to four cases of hypercholesterolemia and one increase of total bilirubin, CPK, and fasting glucose. Blood pressure, weight, and ECG did not change from baseline. HAMD-17 and PDQ-39 total score and individual domains, BDI, CGI-S, and PGI-I total scores significantly improved. Conclusions: Duloxetine seems well tolerated and likely effective in the treatment of depression associated with PD, with no detrimental effects in PD signs and symptoms. © 2012 Informa UK, Ltd

A non-comparative assessment of tolerability and efficacy of duloxetine in the treatment of depressed patients with Parkinson's disease

Objective: Depression is a comorbidity affecting quality of life (QoL) in patients with Parkinson's disease (PD) and requires appropriate treatment. This study evaluated the tolerability, safety, and efficacy of duloxetine 60 mg once daily for 12 weeks in PD patients with major depressive disorder (MDD). Research and design methods: Non-comparative, open-label, multi-center study. Main outcome measures: Tolerability was evaluated by discontinuation rate (acceptable if ≤ 19%) due to treatment-emergent adverse events (TEAEs) and motor symptoms (UPDRS). Safety measures were TEAEs, the UKU side effect rating scale, vital signs, weight, laboratory tests, and ECG. Efficacy measures included HAMD-17, BDI, CGI-S, PGI-I, and pain VAS. QoL was measured by PDQ-39. Results: Of the 151 patients enrolled, 8.6% (95% upper CI: 13.3%) discontinued the study due to TEAEs. Worsening in PD-related tremor and rigidity was not observed, activities of daily living significantly improved and UKU subscales progressively decreased. Clinically significant abnormalities in laboratory findings were limited to four cases of hypercholesterolemia and one increase of total bilirubin, CPK, and fasting glucose. Blood pressure, weight, and ECG did not change from baseline. HAMD-17 and PDQ-39 total score and individual domains, BDI, CGI-S, and PGI-I total scores significantly improved. Conclusions: Duloxetine seems well tolerated and likely effective in the treatment of depression associated with PD, with no detrimental effects in PD signs and symptoms. © 2012 Informa UK, Ltd

Effectiveness of Florbetapir PET Imaging in Changing Patient Management

Aims: To evaluate the impact of amyloid PET imaging on diagnosis and patient management in a multicenter, randomized, controlled study. Methods: Physicians identified patients seeking a diagnosis for mild cognitive impairment or dementia, possibly due to Alzheimer disease (AD), and recorded a working diagnosis and a management plan. The patients underwent florbetapir PET scanning and were randomized to either immediate or delayed (1-year) feedback regarding amyloid status. At the 3-month visit, the physician updated the diagnosis and recorded a summary of the actual patient management since the post-scan visit. The study examined the impact of immediate versus delayed feedback on patient diagnosis/management at 3 and 12 months. Results: A total of 618 subjects were randomized (1:1) to immediate or delayed feedback arms, and 602 subjects completed the 3-month primary endpoint visit. A higher proportion of patients in the immediate feedback arm showed a change in diagnosis compared to the controls (32.6 vs. 6.4%; p = 0.0001). Similarly, a higher proportion of patients receiving immediate feedback had a change in management plan (68 vs. 55.5%; p < 0.002), mainly driven by changes in AD medication. Specifically, acetylcholinesterase inhibitors were prescribed to 67% of the amyloid-positive and 27% of the amyloid-negative subjects in the information group compared with 56 and 43%, respectively, in the control group (p < 0.0001). These between-group differences persisted until the 12-month visit. Conclusion: Knowledge of the amyloid status affects the diagnosis and alters patient management