Recruitment and Retention of Older Adults in Aging Research

Older adults continue to be underrepresented in clinical research despite their burgeoning population in the United States and worldwide. Physicians often propose treatment plans for older adults based on data from studies involving primarily younger, more‐functional, healthier participants. Major barriers to recruitment of older adults in aging research relate to their substantial health problems, social and cultural barriers, and potentially impaired capacity to provide informed consent. Institutionalized older adults offer another layer of complexity that requires cooperation from the institutions to participate in research activities. This paper provides study recruitment and retention techniques and strategies to address concerns and overcome barriers to older adult participation in clinical research. Key approaches include early in‐depth planning; minimizing exclusion criteria; securing cooperation from all interested parties; using advisory boards, timely screening, identification, and approach of eligible patients; carefully reviewing the benefit:risk ratio to be sure it is appropriate; and employing strategies to ensure successful retention across the continuum of care. Targeting specific strategies to the condition, site, and population of interest and anticipating potential problems and promptly employing predeveloped contingency plans are keys to effective recruitment and retention.     

Workshop on Immunizations in Older Adults: Identifying Future Research Agendas

Goals for immunization in older adults may differ from those in young adults and children, in whom complete prevention of disease is the objective. Often, reduced hospitalization and death but also averting exacerbation of underlying chronic illness, functional decline, and frailty are important goals in the older age group. Because of the effect of age on dendritic cell function, T cell‐mediated immune suppression, reduced proliferative capacity of T cells, and other immune responses, the efficacy of vaccines often wanes with advanced age. This article summarizes the discussion and proceedings of a workshop organized by the Association of Specialty Professors, the Infectious Diseases Society of America, the American Geriatrics Society, the National Institute on Aging, and the National Institute of Allergy and Infectious Diseases. Leading researchers and clinicians in the fields of immunology, epidemiology, infectious diseases, geriatrics, and gerontology reviewed the current status of vaccines in older adults, identified knowledge gaps, and suggest priority areas for future research. The goal of the workshop was to identify what is known about immunizations (efficacy, effect, and current schedule) in older adults and to recommend priorities for future research. Investigation in the areas identified has the potential to enhance understanding of the immune process in aging individuals, inform vaccine development, and lead to more‐effective strategies to reduce the risk of vaccine‐preventable illness in older adults.     

Fighting Against Age Discrimination in Clinical Trials

At the American Geriatrics Society 2008 Annual Meeting, representatives of two geriatric societies, the European Union Geriatric Medicine Societies and the American Geriatrics Society, and two regulatory agencies, the U.S. Food and Drug Administration and the European Medicine Agency, conducted a roundtable discussion aimed at reviewing the participation of older people in clinical trials. This article summarizes the important issues discussed at the meeting. Historically, regulatory agencies started to promote the inclusion of older participants in clinical trials in the late 1980s. The identification of the causes of delay in including older participants in clinical trials, as well as of the ongoing bias against including older participants with multiple comorbidities, is important to help geriatricians fight against age discrimination in clinical trials. To overcome this problem, geriatrics societies and regulatory agencies must work together to propose new definitions, study designs, and technologies aimed at improving the evaluation of drugs in older people with multiple comorbidities and polypharmacy.     

A Geriatric Emergency Service for Acutely Ill Elderly Patients: Pattern of Use and Comparison with a Conventional Emergency Department in Italy

The current disease‐oriented, episodic model of emergency care does not adequately address the complex needs of older adults presenting to emergency departments (EDs). Dedicated ED facilities with a specific organization (e.g., geriatric EDs (GEDs)) have been advocated. One of the few GED experiences in the world is described and its outcomes compared with those of a conventional ED (CED). In a secondary analysis of a prospective observational cohort of 200 acutely ill elderly patients presenting to two urban EDs in Ancona, Italy, identifiers and triage, clinical, and social data were collected and the following outcomes considered: early (30‐day) and late (6‐month) ED revisit, frequent ED return, hospital admission, and functional decline. Death, functional decline, any ED revisit and any hospital admission were also considered as a composite outcome. Odds ratios and 95% confidence intervals (CIs) were calculated. Overall, GED patients were older and frailer than CED patients. The two EDs did not differ in terms of early, late, or frequent ED return or in 6‐month hospital admission or functional decline. The mortality rate was slightly but significantly lower in the GED patients (hazard ratio=0.47, 95% CI=0.22–0.99, P=.047). The data suggest noninferiority and, indirectly, a slight superiority for the GED system in the acute care of elderly people, supporting the hypothesis that ED facilities specially designed for older adults may provide better care.     

Efficacy and Safety of a Once‐Yearly Intravenous Zoledronic Acid 5 mg for Fracture Prevention in Elderly Postmenopausal Women with Osteoporosis Aged 75 and Older

OBJECTIVES: To determine the efficacy of once‐yearly intravenous zoledronic acid (ZOL) 5 mg in reducing risk of clinical vertebral, nonvertebral, and any clinical fractures in elderly osteoporotic postmenopausal women. DESIGN: A post hoc subgroup analysis of pooled data from the Health Outcome and Reduced Incidence with Zoledronic Acid One Yearly (HORIZON) Pivotal Fracture Trial and the HORIZON Recurrent Fracture Trial. SETTING: Multicenter, randomized, double‐blind, placebo‐controlled trials. PARTICIPANTS: Postmenopausal women (aged ≥75) with documented osteoporosis (T‐score ≤?2.5 at femoral neck or ≥1 prevalent vertebral or hip fracture) or a recent hip fracture. INTERVENTION: Patients were randomized to receive an intravenous infusion of ZOL 5 mg (n=1,961) or placebo (n=1,926) at baseline and 12 and 24 months. MEASUREMENTS: Primary endpoints were incidence of clinical vertebral and nonvertebral and any clinical fracture after treatment. RESULTS: At 3 years, incidence of any clinical, clinical vertebral, and nonvertebral fracture were significantly lower in the ZOL group than in the placebo group (10.8% vs 16.6%, 1.1% vs 3.7%, and 9.9% vs 13.7%, respectively) (hazard ratio (HR)=0.65, 95% confidence interval (CI)=0.54–0.78, P<.001; HR=0.34, 95% CI=0.21–0.55, P<.001; and HR=0.73, 95% CI=0.60–0.90, P=.002, respectively). The incidence of hip fracture was lower with ZOL but did not reach statistical significance. The incidence rate of postdose adverse events were higher with ZOL, although the rate of serious adverse events and deaths was comparable between the two groups. CONCLUSION: Once‐yearly intravenous ZOL 5 mg was associated with a significant reduction in the risk of new clinical fractures (vertebral and nonvertebral) in elderly postmenopausal women with osteroporosis.     

Daily Medication Use in Nursing Home Residents with Advanced Dementia

OBJECTIVES: To describe the pattern and factors associated with daily medication use in nursing home (NH) residents with advanced dementia. DESIGN: Prospective cohort study. SETTING: Twenty‐two Boston‐area NHs. PARTICIPANTS: NH residents with advanced dementia (N=323). MEASUREMENTS: Data from residents' records were used to determine the number or daily medications, specific drugs prescribed, and use of drugs deemed “never appropriate” in patients with advanced dementia. Resident characteristics associated with the use of more daily medications and drugs deemed inappropriate were examined. RESULTS: Residents were prescribed a mean of 5.9 ± 3.0 daily medications, and 37.5% received at least one medication considered “never appropriate” in advanced dementia. Acetylcholinesterase inhibitors (15.8%) and lipid‐lowering agents (12.1%) were the most common inappropriate drugs. Twenty‐eight percent of residents took antipsychotics daily. Modest reductions in most daily medications occurred only during the last week of life. Factors independently associated with taking more daily medications included older age, male sex, non‐white race, dementia not due to Alzheimer's disease, better cognition, cardiovascular disease, acute illness, and hospice referral. Factors independently associated with greater likelihood of taking inappropriate medications included being male, shorter NH stay, better functional status, and diabetes mellitus, whereas a do‐not‐hospitalize order was associated with a lower likelihood. CONCLUSION: Questionably beneficial medications are common in advanced dementia, even as death approaches. Several characteristics can help identify residents at risk for greater medication burden. Medication use in advanced dementia should be tailored to the goals of care.     

Potentially Avoidable Hospitalizations of Nursing Home Residents: Frequency,Causes, and Costs

OBJECTIVES: To examine the frequency and reasons for potentially avoidable hospitalizations of nursing home (NH) residents. DESIGN: Medical records were reviewed as a component of a project designed to develop and pilot test clinical practice tools for reducing potentially avoidable hospitalization. SETTING: NHs in Georgia. PARTICIPANTS: In 10 NHs with high and 10 with low hospitalization rates, 10 hospitalizations were randomly selected, including long‐ and short‐stay residents. MEASUREMENTS: Ratings using a structured review by expert NH clinicians. RESULTS: Of the 200 hospitalizations, 134 (67.0%) were rated as potentially avoidable. Panel members cited lack of on‐site availability of primary care clinicians, inability to obtain timely laboratory tests and intravenous fluids, problems with quality of care in assessing acute changes, and uncertain benefits of hospitalization as causes of these potentially avoidable hospitalizations. CONCLUSION: In this sample of NH residents, experienced long‐term care clinicians commonly rated hospitalizations as potentially avoidable. Support for NH infrastructure, clinical practice and communication tools for health professionals, increased attention to reducing the frequency of medically futile care, and financial and other incentives for NHs and their affiliated hospitals are needed to improve care, reduce avoidable hospitalizations, and avoid unnecessary healthcare expenditures in this population.     

Trail Making Test Predicts Physical Impairment and Mortality in Older Persons

OBJECTIVES: To examine whether performance in the Trail Making Test (TMT) predicts mobility impairment and mortality in older persons. DESIGN: Prospective cohort study. SETTING: Community‐dwelling older persons enrolled in the Invecchiare in Chianti (InCHIANTI) Study. PARTICIPANTS: Five hundred eighty‐three participants aged 65 and older and free of major cognitive impairment (Mini‐Mental State Examination score >21) with baseline data on TMT performance. Of these, 427 performed the Short Physical Performance Battery (SPPB) for the assessment of lower extremity function at baseline and after 6 years. Of the initial 583 participants, 106 died during a 9‐year follow‐up. MEASUREMENTS: The TMT Parts A and B (TMT‐A and TMT‐B) and SPPB were administered at baseline and 6‐year follow‐up. Impaired mobility was defined as an SPPB score less than 10. Vital status was ascertained over a 9‐year follow‐up. RESULTS: InCHIANTI participants in the fourth quartile of the time to complete TMT‐B minus time to complete TMT‐A (TMT (B‐A)) were significantly more likely to develop an SPPB score less than 10 during the 6‐year follow‐up than those in the first quartile (relative risk (RR)=2.4, 95% confidence interval (CI)=1.4–3.9, P=.001). After adjusting for potential confounders, these findings were substantially unchanged (RR=2.2, 95% CI=1.4–3.6, P=.001). Worse performance on the TMT was associated with significantly greater decline in SPPB score over the 6‐year follow‐up, after adjusting for age, sex, and baseline SPPB scores (β=?0.01, standard error=0.003, P=.004). During the 9‐year follow‐up, 18.2% of the participants died. After adjustment for age and sex, the proportion of participants who died was higher in participants in the worst than the best performance quartile of TMT (B‐A) scores (hazard ratio (HR)=1.7, 95% CI=1.0–2.9, P=.048). Results were similar in a parsimonious adjusted model (HR=1.8, 95% CI=1.0–3.2, P=.04). CONCLUSION: Performance on the TMT is a strong, independent predictor of mobility impairment, accelerated decline in lower extremity function, and death in older adults living in the community. The TMT could be a useful addition to geriatric assessment.     

Factors influencing Helicobacter pylori eradication with 2 week combination therapy of lansoprazole and amoxycillin: Intragastric distribution of colonization and gastric mucosal atrophy

In Japan, gastric ulcers are often accompanied by marked gastric mucosal atrophy. We evaluated the dual therapy of double-dose lansoprazole and amoxycillin for Helicobacter pylori eradication in Japanese ulcer patients and investigated the effects of intragastric distribution of H. pylori colonization and gastric mucosal atrophy on eradication with this combination therapy. Seventy-six H. pylori-positive ulcer patients received lansoprazole (30 mg) plus amoxycillin (500 mg) twice daily for 2 weeks (LA-60 group), lansoprazole (30 mg once daily) plus amoxycillin (500 mg twice daily) for 2 weeks (LA-30 group) or lansoprazole (30 mg once daily) for 6 or 8 weeks (LPZ group). Infection was evaluated by light microscopy, culture and biopsy urease tests. Helicobacter pylori colonization was classified as localized to the corpus (localized type) or involving the antrum and corpus (whole type). Fundic mucosal atrophy was graded according to endoscopic and histological features. Eradication was achieved in 67.6% in the LA-60 group, 31.6% in the LA-30 group, and 0% in the LPZ group, and moderate or severe histological gastritis was improved in the LA-60 group. Eradication was better in localized-type colonization (92%) than whole-type (56%), and better with fundic mucosal atrophy (84%) than without, but poor in both whole-type colonization and scanty mucosal atrophy (47%). The LA-60 therapy achieves better eradication in Japanese ulcer patients with localized H. pylori colonization and/or gastric mucosal atrophy, which are likely to be important predictors for the successful eradication with dual therapy.