Recommendations for the National Institute for Neurologic Disorders and Stroke spinal cord injury common data elements for children and youth with SCI.

STUDY DESIGN: In 2014, the adult spinal cord injury (SCI) common data element (CDE) recommendations were made available. This project was a review of the adult SCI CDE for relevance to children and youth with SCI. OBJECTIVES: The objective of this study was to review the National Institute of Neurologic Disorders and Stroke (NINDS) adult SCI CDEs for relevance to children and youth with SCI. SETTING: International. METHODS: The pediatric working group consisted of international members with varied fields of expertise related to pediatric SCI. The group convened biweekly meetings for 6 months in 2015. All of the adult SCI CDEs were reviewed, evaluated and modified/created for four age groups: 0-5 years, 6-12 years, 13-15 years and 16-18 years. Whenever possible, results of published research studies were used to guide recommendations. In the absence of empirical support, grey literature and international content expert consensus were garnered. Existing pediatric NINDS CDEs and new CDEs were developed in areas where adult recommendations were not appropriate. After internal working group review of domain recommendations, these pediatric CDEs were vetted during a public review from November through December 2015. RESULTS: Version 1.0 of the pediatric SCI CDEs was posted in February 2016. CONCLUSION: The pediatric SCI CDEs are incorporated directly into the NINDS SCI CDE sets and can be found at https://commondataelements.ninds.nih.gov.

Common data elements for spinal cord injury clinical research: a National Institute for Neurological Disorders and Stroke project.

OBJECTIVES: To develop a comprehensive set of common data elements (CDEs), data definitions, case report forms and guidelines for use in spinal cord injury (SCI) clinical research, as part of the CDE project at the National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health. SETTING: International Working Groups. METHODS: Nine working groups composed of international experts reviewed existing CDEs and instruments, created new elements when needed and provided recommendations for SCI clinical research. The project was carried out in collaboration with and cross-referenced to development of the International Spinal Cord Society (ISCoS) International SCI Data Sets. The recommendations were compiled, subjected to internal review and posted online for external public comment. The final version was reviewed by all working groups and the NINDS CDE team before release. RESULTS: The NINDS SCI CDEs and supporting documents are publically available on the NINDS CDE website and the ISCoS website. The CDEs span the continuum of SCI care and the full range of domains of the International Classification of Functioning, Disability and Health. CONCLUSION: Widespread use of CDEs can facilitate SCI clinical research and trial design, data sharing and retrospective analyses. Continued international collaboration will enable consistent data collection and reporting, and will help ensure that the data elements are updated, reviewed and broadcast as additional evidence is obtained.

Incorporation of the International Spinal Cord Injury Data Set elements into the National Institute of Neurological Disorders and Stroke Common Data Elements.

OBJECTIVES: To develop consistent variable names and a common database structure for the data elements in the International Spinal Cord Injury (SCI) Data Sets. SETTING: National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDE) Project and The Executive Committee of the International SCI Standards and Data Sets committees (ECSCI). METHODS: The NINDS CDE team creates a variable name for each defined data element in the various International SCI Data Sets. Members of the ECSCI review these in an iterative process to make the variable names logical and consistent across the data sets. Following this process, the working group for the particular data set reviews the variable names, and further revisions and adjustments may be made. In addition, a database structure for each data set is developed allowing data to be stored in a uniform way in databases to promote sharing data from different studies. RESULTS: The International SCI Data Sets variable names and database specifications will be available through the web sites of the International Spinal Cord Society (http://www.iscos.org.uk), the American Spinal Injury Association (http://www.asia-spinalinjury.org) and the NINDS CDE project web site (http://www.CommonDataElements.ninds.nih.gov). CONCLUSION: This process will continue as additional International SCI Data Sets fulfill the requirements of the development and approval process and are ready for implementation.

Applicability of NINDS-sponsored studies to community-based physician involvement.

BACKGROUND: The National Institute of Neurological Disorders and Stroke (NINDS) Clinical Trials Group established the Clinical Research Collaboration (CRC) Project in 2005 to increase community-based physician involvement in NINDS-sponsored research. METHODS: We assessed a random sample of 112 of the more than 1,000 current NINDS-sponsored clinical research studies to determine which could involve community physicians in enrollment or follow-up. Scoring factors were based on the premise that participation is feasible for noninvasive studies with simple screening, and follow-up criteria and visit frequency consistent with usual care. Scored studies included 26 Phase III, 31 Phase I/II, and 55 nonclinical trials. RESULTS: Overall, 41% of the sampled research studies were considered conducive to community physician participation that exceeds referral only; 21% with participation in all study activities and 20% with ability to provide some follow-up. Specialized neuropsychological or neurologic scale testing was judged to exclude community physician participation in 16% of studies. CONCLUSION: Many National Institute of Neurological Disorders and Stroke studies are available in which community-based physicians could participate. Involving community physicians may increase efficiency of completing clinical research and encourage application of research findings in community practices.

Promoting smoking cessation in the United States: effect of public service announcements on the Cancer Information Service telephone line.

BACKGROUND: Although many smokers report making attempts to quit, few seek help or are successful in their attempts. Some of the barriers to seeking help can be overcome by a telephone counseling and information service like that offered by the Cancer Information Service of the National Cancer Institute. This service has been promoted by antismoking public service announcements produced by the Office on Smoking and Health, Centers for Disease Control, Public Health Service, U.S. Department of Health and Human Services. PURPOSE: We determined whether such nationally televised public service announcements were associated with increased use of the Cancer Information Service. We assessed the importance of specifically promoting the telephone line and identified the characteristics of the individuals who responded to such promotion. METHODS: We combined the frequency-of-call data from the Cancer Information Service with the data on the frequency and reach of the television spots. RESULTS: During this 5-year study (1983-1987), the Cancer Information Service received a notably disproportionate number of calls in 3 specific months (August 1983, January 1985, and January 1987). In each case, more than 20% of all calls in that year were received in that month (expected percentage = 8% if the calls had been evenly distributed). These peak periods were associated with the showing of the three public service announcements that mentioned the telephone number of the Cancer Information Service. These promotions were particularly effective in increasing the percentage of callers who were male, who were under the age of 40 years, or who had received a high school education or less. CONCLUSIONS: Television is an effective medium for supporting antismoking goals by motivating more smokers to seek help to quit. IMPLICATIONS: It is important to identify whether the aid offered by the Cancer Information Service hotline is effective in helping the caller to quit. Future work must concentrate on the most effective strategies for using this initial contact to provide aid to prevent relapse, thus maximizing the potential impact of the public service announcement campaigns.

Meeting information needs of significant others: use of the Cancer Information Service.

Although significant others (spouses, relatives and friends) of cancer patients play an important role in providing support and assistance to the patient, their need for information regarding the disease is frequently overlooked by the health care system. This analysis examines information needs of (1) diagnosed cancer patients, (2) significant others of diagnosed cancer patients and (3) the general public, as reflected in their calls to the Cancer Information Service (CIS), a national toll-free telephone inquiry service. Major focus is on the types of cancer-related subjects significant others inquire about, as well as how they first found out about the CIS. Results indicate that significant others are similar to diagnosed cancer patients in their need for additional information on specific cancer sites, treatment, and referrals for second opinions, but differ in their request for information on counseling services and clinical trials. Additionally, significant others and cancer patients are similar in how they find out about the CIS. In contrast, significant others differ from the general public in their information requirements, as well as in their source of referral to the CIS. While the CIS appears to be a channel of communication capable of addressing the dynamic information needs of significant others, further research concerning the effectiveness of the CIS and other channels of cancer information in satisfying the information requirements of significant others is recommended.