The current pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), commonly referred to as COVID-19, brings myriad challenges to research conducted among those more susceptible to the virus. Accordi...The current pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), commonly referred to as COVID-19, brings myriad challenges to research conducted among those more susceptible to the virus. According to the United States (US) Centers for Disease Control (CDC), eight out of ten re-ported COVID-19 deaths are among people > 65 years of age and older. Nonetheless, researchers must continue the crucial work of investigating and understanding diseases that affect the elderly. The focus of this white paper is to assess the challenges associated with research within the elderly population with neurocognitive conditions. Specifically, this paper addresses the need for the standardized administration of performance measures (e.g., neurocognitive assessments) among a dementia population while ensuring the physical safety of participants. Consideration is given to the administration of performance measures and the availability and feasibility of administering these measures remotely to a population that may have difficulty using novel technologies. In implementing remote research assessments, it is suggested that researchers fol-low a GAMMA approach by: 1) establishing clear Guidance on remote visit expectations and processes;2) establishing Appropriate exclusionary criteria in the development of the study design;3) providing subjects Appropriate study Materials for visual processing;4) incorporating Multiple data sources in the overall study design (e.g., caregiver input);and 5) Acknowledging that there will be study limitations as researchers use emerging technology with this patient population, and using mitigation strategies for these limitations where possible.展开更多
Background: Many instruments used to assess outcomes of treatment for Alzheimer’s disease (AD) have no published evidence of their relevance and content validity in earlier stages of the disease, i.e., mild cognitive...Background: Many instruments used to assess outcomes of treatment for Alzheimer’s disease (AD) have no published evidence of their relevance and content validity in earlier stages of the disease, i.e., mild cognitive impairment, or prodromal AD (pAD). The objective of this project was to evaluate the applicability and usefulness of the Perceived Deficits Questionnaire (PDQ) as an outcome measure in this population using qualitative methodology to support content validity. Method: Two waves of qualitative interviews were conducted in patients with MCI and pAD. Results: Evidence for content validity and usefulness of the instrument was demonstrated in the patient interviews. Minor modifications to the wording of several items were suggested for the PDQ and the recall period was changed. Conclusion: With these modifications, the PDQ has improved content validity and relevance. It is therefore a potentially useful outcome measure to evaluate therapeutic benefit in interventional studies of patients in the early stages of AD.展开更多
文摘The current pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), commonly referred to as COVID-19, brings myriad challenges to research conducted among those more susceptible to the virus. According to the United States (US) Centers for Disease Control (CDC), eight out of ten re-ported COVID-19 deaths are among people > 65 years of age and older. Nonetheless, researchers must continue the crucial work of investigating and understanding diseases that affect the elderly. The focus of this white paper is to assess the challenges associated with research within the elderly population with neurocognitive conditions. Specifically, this paper addresses the need for the standardized administration of performance measures (e.g., neurocognitive assessments) among a dementia population while ensuring the physical safety of participants. Consideration is given to the administration of performance measures and the availability and feasibility of administering these measures remotely to a population that may have difficulty using novel technologies. In implementing remote research assessments, it is suggested that researchers fol-low a GAMMA approach by: 1) establishing clear Guidance on remote visit expectations and processes;2) establishing Appropriate exclusionary criteria in the development of the study design;3) providing subjects Appropriate study Materials for visual processing;4) incorporating Multiple data sources in the overall study design (e.g., caregiver input);and 5) Acknowledging that there will be study limitations as researchers use emerging technology with this patient population, and using mitigation strategies for these limitations where possible.
文摘Background: Many instruments used to assess outcomes of treatment for Alzheimer’s disease (AD) have no published evidence of their relevance and content validity in earlier stages of the disease, i.e., mild cognitive impairment, or prodromal AD (pAD). The objective of this project was to evaluate the applicability and usefulness of the Perceived Deficits Questionnaire (PDQ) as an outcome measure in this population using qualitative methodology to support content validity. Method: Two waves of qualitative interviews were conducted in patients with MCI and pAD. Results: Evidence for content validity and usefulness of the instrument was demonstrated in the patient interviews. Minor modifications to the wording of several items were suggested for the PDQ and the recall period was changed. Conclusion: With these modifications, the PDQ has improved content validity and relevance. It is therefore a potentially useful outcome measure to evaluate therapeutic benefit in interventional studies of patients in the early stages of AD.
