Health researchers discussing publications

NERI at ISSAM

The International Society for Study of the Aging Male (ISSAM) recently held the 6th World Congress on the Aging Male in Tampa, Florida.  As part of this congress, NERI scientists contributed many posters and oral presentations, including two symposia highlighting current work.  The two sessions reported on the state of urologic health and androgen deficiency. Read more about the topics and view the presentations.

The first symposium entitled, "The Urologic Health of Aging Men," featured work from the Boston Area Community Health (BACH) Survey. 

The second NERI symposium, "Androgen Deficiency in Aging Men," featured work funded by GlaxoSmithKline reporting on manuscripts all currently underway or recently published.  The following topics were presented by the listed scientists.

A handout was presented at the meeting and offers a brief glimpse of the content of each talk.  For more information on a specific presentation, please contact Dr. McKinlay at jmckinlay@neriscience.com.

 

NERI’s Registries Respond to Unmet Industry and Patient Needs continued

NERI understands that registries have evolved from basic lists of people with specific medical conditions into more complex databases that carefully monitor disease states and track outcomes of various medical interventions. In general, NERI registries fall into three primary categories:

  1. Disease Registry
    1. Specific condition
    2. Rare diseases
    3. Exacerbation of underlying disease
  2. Product Registry
    1. Pregnancy exposure
    2. FDA regulated (as a condition of commercialization approval, such as post-market surveillance)
    3. CMS mandated (as a condition for reimbursement or certification)
  3. Health Services Registry
    1. Patient report outcomes
    2. Healthcare resource utilization

NERI has significant experience with the planning, implementation and management of multi-site registries. These cutting-edge resources are used for the following reasons:

  • Provide a source of potential patients for clinical trials.
  • Observe natural history and disease progression
  • Fulfill post-market (drug, device, biologic) surveillance
  • Obtain real-world clinical outcomes
  • Assess quality of life and cost effectiveness
  • Determine clinical practice patterns
  • Evaluate safety and effectiveness

NERI registries include men, women and children and address a variety of therapeutic areas. For example, some ongoing registries include information about endovascular grafts, sleep disorders, hormonal deficiency and sexual dysfunction. One of NERI’s longest running registries has been around for more than 12 years and is focused on pediatric cardiomyopathy.

 

NERI Tools and Talent Well-Suited for Registries continued

ADEPT data management systems are developed and hosted by NERI, and can be accessed from anywhere in the world using a standard browser and the Internet. The system is specifically designed to support secure data entry for research purposes.ADEPT can handle registries that vary in complexity, design, purpose and size. For example, ADEPT can combine existing registries and clinical trials into a single registry and integrate complementary registries, that are established for different purposes, but enrolling the same types of patients.

 

In addition to the technological support that ADEPT offers, NERI also has a team of senior-level statisticians with extensive registry experience. Collectively, this pool of talent provides hands-on direction in the following areas:

 

• Clinical trial design

• Sequential monitoring of trials

• Registry design and implementation (including Phase IV)

• Analysis, reports, and publications

• Regular benchmarking reports

• Longitudinal analysis

• Survival analysis

• Analysis of complex surveys

• Reliability and validity assessment

• Mixed model analytic methods

• Methods for categorical data analysis

• Propensity score methodology

 

By combining the right mix of tools and talent, NERI scientists understand that registries are now among the most important sources of information supporting medical progress.

Cognitive Training May Help Slow Decline of Daily Functioning continued

Older adults who received cognitive training reported improved cognitive function for up to 5 years afterwards and less decline in the ability to perform daily activities as compared to those who did not receive the training, according to a report of the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study in the December 20 issue of JAMA.

Decline in cognitive abilities has been shown to lead to an increased risk of difficulty in performing instrumental activities of daily living (IADL).  However, whether interventions to maintain or enhance cognitive abilities in older adults will prevent or delay these functional difficulties has been unclear..

 

The ACTIVE study is the first multicenter, randomized controlled trial to examine the long-term outcomes of cognitive interventions on the daily functioning of older individuals living independently. NERI is the Data Coordinating Center, led by Sharon Tennstedt PhD and Anne Stoddard ScD. The study was conducted at six field centers, including Pennsylvania State University (Sherry Willis PhD), Wayne State University and the University of Florida (Michael Marsiske PhD), the University of Alabama at Birmingham (Karlene Ball PhD), Indiana University (Frederick Unverzagt PhD), Johns Hopkins University (George Rebok PhD), and Hebrew Senior Life (John Morris PhD). The study is funded by the National Institute on Aging and the National Institute of Nursing Research.

 

The study was conducted between April 1998 and December 2004. Participants in the study included 2,832 persons (average age 73.6 years; 26 percent black), living independently in 6 U.S. cities, who were recruited from senior housing, community centers, and hospitals and clinics. Five-year follow-up was completed in 67 percent of the sample.

 

The study interventions included ten-session training for memory (verbal episodic memory), reasoning (inductive reasoning), or speed of processing (visual search and identification); and 4-session booster training at 11 and 35 months after training in a random sample of those who completed training.

 

At year 5, participants in all 3 intervention groups reported less difficulty compared with the control group in performing IADLs. However, this effect was significant only for the reasoning group. Neither speed of processing training nor memory training had a significant effect on IADL. The booster training for the speed of processing group, but not for the other 2 groups, showed a significant effect on the performance-based functional measure of everyday speed of processing.

 

No booster effects were seen for any of the groups for everyday problem-solving or self-reported difficulty in IADL. Each intervention maintained effects on its specific targeted cognitive ability through 5 years. Booster training produced additional improvement with the reasoning intervention for reasoning performance and the speed of processing intervention for speed of processing performance.

 

"The ACTIVE study is the first large-scale, randomized trial to show that cognitive training improves cognitive function in well-functioning older adults and that this improvement lasts up to 5 years from the beginning of the intervention," the researchers write. 

 

"In conclusion, declines in cognitive abilities have been shown to lead to increased risk of functional disabilities that are primary risk factors for loss of independence. The 5-year results of the ACTIVE study provide limited evidence that cognitive interventions can reduce age-related decline in self-reported IADLs that are the precursors of dependence in basic ADLs associated with increased use of hospital, outpatient, home health, nursing home services, and health care expenditures. However, given the lag in the relationship between cognitive decline and functional deficits, the full extent of intervention effects on daily function would take longer than 5 years to observe in a population that was highly functioning at enrollment. We consider these results promising and support future research to examine if these and other cognitive interventions can prevent or delay functional disability in an aging population," the authors write.

 

JAMA. 2006;296:2805-2814

 

For more information about the ACTIVE study contact:

Sharon Tennstedt 

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