Frank Molnar

Emotional impact of dementia diagnosis: Exploring persons with dementia and caregivers’ perspectives

This paper examined the emotional impact of diagnosis disclosure on recently diagnosed people with dementia. Thirty patient/caregiver dyads attending a Geriatric Day Hospital Program in Ottawa, Canada participated in this qualitative exploratory study. Data sources included: (a) audio-tapes of diagnosis disclosure meeting, (b) in-depth interviews with patients and caregivers within one week of disclosure, and (c) focus group interviews with caregivers within one month. Patients exhibited a range of emotional responses which can be divided into three broad categories: (a) responses suggesting a lack of insight and/or an active denial of the diagnosis, (b) grief reactions/emotional crisis related to the experience of actual or anticipated losses associated with dementia, and (c) positive coping responses to maximize the disease outcome. Participants went through stages of emotional response to their diagnosis: not noticing symptoms, noticing & covering up, or noticing & revealing; diagnostic process & disclosure; confirming or shock; denial, crisis, or maximizing; disorganization or adaptation. There is a need to develop a better understanding of the experience of people with dementia at the critical point of diagnosis disclosure in order to design supportive interventions to maximize adaptive coping responses.

Clinical utility of office-based cognitive predictors of fitness to drive in persons with dementia: A systematic review.

OBJECTIVES: To perform a systematic review of evidence available regarding in‐office cognitive tests that differentiate safe from unsafe drivers with dementia.

Systematic Review of Driving Risk and the Efficacy of Compensatory Strategies in Persons with Dementia

OBJECTIVES: To determine whether persons with dementia are at greater driving risk and, if so, to estimate the magnitude of this risk and determine whether there are efficacious methods to compensate for or accommodate it.

Predictors of Driving Ability Following Stroke: A Systematic Review

Abstract Background and Purpose: The objective of this review is to identify the most consistent predictors of driving ability post stroke. Method: A computerized search of numerous databases from 1966 forward was completed. Measured outcomes included voluntary driving cessation or results of on-road driving evaluation. Studies were evaluated using the Newcastle-Ottawa Quality Assessment Scale. Results: 17 eligible studies were identified. The most useful screening tests were tests assessing cognitive abilities. These included the Trail Making A and B tests, the Rey–Osterreith Complex Figure Design, and the Useful Field of View Test. Conclusion: Cognitive tests that assess multiple cognitive domains relevant to driving appear to have the best reproducibility in predicting fitness to drive in stroke patients.

Determination of the clinical importance of study results

Formal statistical methods for analyzing clinical trial data are widely accepted by the medical community. Unfortunately, the interpretation and reporting of trial results from the perspective of clinical importance has not received similar emphasis. This imbalance promotes the historical tendency to consider clinical trial results that are statistically significant as also clinically important, and conversely, those with statistically insignificant results as being clinically unimportant. In this paper, we review the present state of knowledge in the determination of the clinical importance of study results. This work also provides a simple, systematic method for determining the clinical importance of study results. It uses the relationship between the point estimate of the treatment effect (with its associated confidence interval) and the estimate of the smallest treatment effect that would lead to a change in a patient’s management. The possible benefits of this approach include enabling clinicians to more easily interpret the results of clinical trials from a clinical perspective, and promoting a more rational approach to the design of prospective clinical trials.

Does analysis using “last observation carried forward” introduce bias in dementia research?

If there were a prize for the most inappropriate analytical technique in dementia research, “last observation carried forward” would be the runaway winner. As a society, we have spent millions of dollars on drug research in the hope of improving the care of the estimated 24.3 million people who

Key methodological features of randomized controlled trials of Alzheimer's disease therapy. Minimal clinically important difference, sample size and trial duration.

Background: The results of clinical trials are routinely presented in terms of statistical significance, which may or may not indicate clinical significance. Analysis of the minimal clinically important difference (MCID) of cognitive scales has received little attention to date. Objectives: By reviewing the key methodological features (sample size, duration, statistical and clinical significance) of clinical trials examining the efficacy of tacrine in the treatment of Alzheimer’s disease (AD), we assessed their ability to detect clinically important changes in cognition. Design: The value for the MCID of the Mini-Mental State Examination (MMSE) was determined by surveying specialists in neurology and geriatric medicine. This value was then used to interpret the clinical significance of the results of published randomized controlled trials (RCTs) assessing the efficacy of tacrine in the treatment of AD and to retrospectively determine their optimal sample size and trial duration. Results: The mean survey MCID for the MMSE was 3.72 (95% confidence interval 3.50–3.95) points. Only 2 of 12 tacrine RCTs using the MMSE found a statistically significant difference in MMSE scores for patients taking tacrine compared with those taking placebo. These improvements were not clinically significant when compared with the survey MMSE MCID. For parallel trials of tacrine in AD, the smallest sample size and minimum trial duration required to demonstrate a clinically significant difference were calculated to be 53 subjects and 1 year, respectively. Five of the 7 parallel trials met the required sample size; however, none of them met the criteria for trial duration. Conclusions: When using the MMSE as an outcome measure, no tacrine trial reported results that were clinically significant as perceived by clinicians working with dementia patients. Application of a range of plausible MCIDs to the parallel design RCTs also demonstrated that 2 of 7 of these trials did not have sufficient sample size, and none had sufficient duration of treatment to reliably detect clinically meaningful changes in cognition. Future clinical trials in this area will need to incorporate the evolving knowledge of MCIDs in order to increase their chance of detecting clinically relevant results.

Systematic Review of Measures of Clinical Significance Employed in Randomized Controlled Trials of Drugs for Dementia

The ability to define thresholds for the clinical significance (clinical importance) of outcome measures in dementia drug research is critical to determining the changes on outcome measures that patients and families would consider worth the cost and worth risking the side effects of medications (i.e., clinical importance is central to informed consent when starting such medications). Thresholds for clinical significance are also required for drug trial sample size calculation (if the studies are to be powered to detect clinically important difference) and for decisions regarding whether medications should be accepted on formularies and should be funded. To better understand what measures of clinical significance have been employed in dementia drug research, a systematic review was performed of double‐blind randomized controlled trials (RCTs) of cholinesterase inhibitors and memantine in subjects with Alzheimers disease, vascular dementia, mixed dementia, and mild cognitive impairment. Of the 57 dementia drug RCTs reviewed, only 46% discussed the clinical significance of their results. The most commonly cited measures of clinical significance were a 4‐point change in the Alzheimers Disease Assessment Scale—Cognitive Subscale and changes on global scales. The majority of measures of clinical significance were opinion based. Only one study empirically measured patient perspective regarding thresholds for clinical significance. Despite being central to the interpretation of trial results and to decisions regarding whether to employ trial findings in clinical practice, patient‐ and caregiver‐centered measures of clinical significance have not been adequately studied and integrated into dementia drug RCTs. It is recommended that discussions of clinical importance receive greater emphasis in research standards published by organizations such as the CONSORT group (http://www.consort‐statement.org). Drug formulary review committees and licensing agencies (e.g., U.S. Food and Drug Administration, European Agency for the Evaluation of Medicinal Products, Health Canada) should consider requiring an assessment of clinical significance of the drugs they review. To move this field forward, funding agencies should consider initiating requests for proposals focused on the determination of the minimally clinically important difference (MCID) of outcome measures employed in dementia research. Once empirical data on MCIDs are available, then these funding agencies should consider supporting a consensus conference to review and select the optimal measures of clinical importance in dementia research. A preliminary organizational framework of measures of clinical significance is presented in this article to facilitate the work of such a consensus forum.

Dementia diagnosis disclosure : A study of patient and caregiver perspectives

This paper reports the findings of a descriptive, exploratory, qualitative study of patient and caregiver perspectives of the disclosure of a dementia diagnosis. Data were collected at 3 points in time: (1) the disclosure meeting, (2) patient and caregiver interviews, and (3) focus group interviews. Thirty patient-caregiver dyads participated in the disclosure meetings at the Geriatric Day Hospital at the Ottawa Hospital, Ottawa, Canada. Within a week of the disclosure of diagnosis, 27 (90%) patients and 29 (97%) caregivers were interviewed in their homes, and 12 caregivers participated in 3 focus group interviews within 1 month after the disclosure meeting. Most patients and caregivers said they preferred full disclosure of the diagnosis. Patients expressed satisfaction with the physician providing the diagnosis and with their caregivers being present at the disclosure meeting, however, wanted more information about their condition. Caregivers provided further insight regarding the patient response, and suggested the need to emphasize hope in the face of a difficult diagnosis, the use of progressive disclosure to allow the person (and caregivers) to prepare, and the provision of detail about the disease and its progression.

A Review of Barriers and Enablers to Diagnosis and Management of Persons with Dementia in Primary Care

Background With the rise in the prevalence of dementia disorders and the growing critical impact of dementia on health-care resources, the provision of dementia care has increasingly come under scrutiny, with primary care physicians (PCP) being at the centre of such attention. Purpose To critically examine barriers and enablers to timely diagnosis and optimal management of community living persons with dementia (PWD) in primary care. Methods An interpretive scoping review was used to synthesize and analyze an extensive body of heterogeneous Western literature published over the past decade. Results The current primary care systems in many Western countries, including Canada, face many challenges in providing responsive, comprehensive, safe, and cost-effective dementia care. This paper has identified a multitude of highly inter-related obstacles to optimal primary dementia care, including challenges related to: a) the complex biomedical, psychosocial, and ethical nature of the condition; b) the gaps in knowledge, skills, attitudes, and resources of PWD/caregivers and their primary care providers; and c) the broader systemic and structural barriers negatively affecting the context of dementia care. Conclusions Further progress will require a coordinated campaign and significantly increased levels of commitment and effort, which should be ideally orchestrated by national dementia strategies focusing on the barriers and enablers identified in this paper.