Clinical performance of existing diagnostic criteria for pneumonia in older emergency patients: A prospective cohort study.

BACKGROUND: Pneumonia accounts for over half a million older adult emergency department (ED) visits annually, but ED pneumonia diagnosis is inaccurate. Geriatric-specific pneumonia diagnostic criteria exist for other settings; no prospective data exist to determine if application in the older adult ED population is feasible. The objective was to prospectively evaluate the utility of four current diagnostic criteria (Loeb; Modified McGeer; Infectious Disease Society of America/American Thoracic Society; American College of Emergency Physicians) in older adult ED patients. METHODS: This was a prospective, observational cohort study of older adult ED patients ≥65 years of age in two U.S. EDs with suspected pneumonia defined as having chest radiography ordered and treating physician suspicion. The standard we used for defining the presence, absence, or inability to determine a diagnosis of pneumonia diagnosis was expert physician chart adjudication. We report the summary statistics for demographic characteristics and symptoms/exam findings and sensitivity, specificity, and likelihood ratios with 95% confidence intervals of the existing diagnostic criteria. Pre-specified cutoff values of a positive LR >10 and a negative LR <0.3 were considered clinically significant. RESULTS: Of 135 patients enrolled, 27 had pneumonia by adjudicator review. Typical patient-reported pneumonia symptoms, such as fever (18.5%) and new/worse cough (51.9%), were not consistently present in pneumonia. The IDSA/ATS and ACEP criteria had positive LR >10 and negative LR <0.3; however, all confidence intervals included pre-specified cutoffs. CONCLUSIONS: Older adults presented to the ED with low frequency of typical pneumonia symptoms. Although existing diagnostic definitions had promising test characteristics, they may not perform well enough for clinical application without refinement.

Institutionally chartered Data and Safety Monitoring Boards: structured approaches to assuring participant safety in clinical research.

Data and Safety Monitoring Boards (DSMBs) derived from the need to monitor large federally funded multi-center clinical trials and evolved to include commercial and other large and complex trials. Eventually, academic health centers also created institutionally focused trial monitoring mechanisms. The basic general principles that define traditional DSMBs extend to the institutional level. The primary responsibilities are assuring safety of the participants, preserving the integrity of the trial, and ensuring the reliability of the results. Institutionally chartered DSMBs meet these responsibilities but usually have fewer members, have a structure specific to the needs of the trial, are more focused and/or have different scope reviewing smaller, single site, higher risk, and investigator-initiated studies and are flexible to accommodate institution-specific requirements and approaches. Their purpose is to meet the responsibilities of oversight for safety and data integrity, ensure proper study design, rigor and conduct, as well as provide statistical support appropriate to the setting of the research. Academic health centers should recognize the importance and existence of institution level safety and data monitoring and provide support as much as possible. Investigators should have sufficient resources available to assemble DSMBs. The Clinical and Translational Science Awards Collaborative DSMB Workgroup provides an online manual to assist investigators.

Alzheimer's Disease and Related Disorders Prevalence Differs by Appalachian Residence in Ohio.

BACKGROUND: Areas within the Appalachian region may have a greater burden of under diagnosed Alzheimer's disease and related disorders (ADRD). OBJECTIVE: To estimate the prevalence of ADRD in the Appalachian counties of Ohio, and to determine if differences exist by geographic location (Appalachian/non-Appalachian and rural/urban) and across time among Medicare beneficiaries. METHODS: Centers for Medicare and Medicaid Services Public Use Files from 2007-2017 were used to estimate county-level ADRD prevalence among all fee-for-service beneficiaries in Ohio. Negative binomial regression was used to estimate prevalence overall, by Appalachian Regional Commission's Appalachian/non-Appalachian designation, and by rural/urban (Rural-Urban Continuum Codes) classification. Models were repeated, adjusting for county-level demographics and comorbidities. RESULTS: The prevalence of ADRD varied by both Appalachian residence and rural status (p = 0.008). Before adjustment by county-level demographics and comorbidities, the prevalence of ADRD in urban Appalachian counties was 1-3% lower than in urban non-Appalachian counties, while rural Appalachian counties had 2-3% higher prevalence compared to rural non-Appalachian counties. After adjustment, the differences between prevalence ratios were accentuated; the prevalence ratio was consistently higher for rural Appalachian counties, yet varied across the study period for urban counties (1.03 in 2007 to 0.97 in 2017). CONCLUSION: The results suggest a disparate burden of ADRD in Ohio with higher prevalence in rural Appalachian counties. This potential difference by Appalachian region is important to consider for availability of services and subsequent delivery of care. In order to better understand the disparity, further epidemiologic studies are necessary to better estimate the burden of ADRD.

Predicting extended hospital stay after deep brain stimulation surgery in Parkinson's patients.

BACKGROUND: The goal of deep brain stimulation (DBS) is to achieve maximal benefit for the patient while minimizing the likelihood of adverse effects. Currently, no standardized criteria exist that predicts extended hospital stay in DBS patients, although careful patient selection is recognized as a very important step for successful DBS therapy. OBJECTIVES AND METHODS: The objective of this study was to identify eight key factors that predicted extended post-operative hospital stay following DBS lead implantation, in an effort to better identify patients that would require minimal hospital stay, resulting in reduced cost and reduced exposure to hospital- related problems. Univariate logistic regression models were used to examine associations between each factor and patients' post-surgical outcomes. RESULTS: Using data collected from 183 patients, we found that 53 patients required a hospital stay longer than two days within one month post-procedure. Those who were 70 years or older and those who had frequent falls were significantly more likely to require extended post-surgical care. Patients that scored three points or higher on our eight-factor assessment scale had a greater likelihood of experiencing an event that would require an extended hospital stay following DBS lead placement, regardless of what three factors were present. CONCLUSIONS: Any PD patient who is 70 years or older, incurring frequent falls, or with more than three points on our scale, should be carefully screened and cautioned about likely prolonged recovery and extended post-operative hospital stay.

Implementation of a Research Participant Satisfaction Survey at an Academic Medical Center.

This descriptive case study covers the development of a survey to assess research subject satisfaction among those participating in clinical research studies at an academic medical center (AMC). The purpose was twofold: to gauge the effectiveness of the survey, as well as to determine the level of satisfaction of the research participants. The authors developed and implemented an electronic research participant satisfaction survey. It was created to provide research teams at the authors' AMC with a common instrument to capture research participant experiences in order to improve upon the quality of research operations. The instrument captured participant responses in a standardized format. Ultimately, the results are to serve as a means to improve the research experience of participants for single studies, studies conducted within a division or department of the AMC, or across the entire research enterprise at the institution. For ease of use, the survey was created within an electronic data capture system known as REDCap, which is used by a consortium of more than 1,800 institutional partners as a tool from the Clinical and Translational Science Awards (CTSA) program of the National Institutes of Health (NIH). Participants in the survey described in this article were more than 18 years of age and participating in an institutional review board (IRB)-approved study. Results showed that the vast majority of participants surveyed had a positive experience engaging in research at the authors' AMC. Further, the tool was found to be effective in making that determination. The authors hope to expand the use of the survey as a means to increase research satisfaction and quality at their university.

StudySearch: a web-based application for posting and searching clinical research studies.

Participant accrual into research studies is critical to advancing clinical and translational research to clinical care. Without sufficient recruitment, the purpose of any research study cannot be realized; yet, low recruitment and enrollment of participants persist. StudySearch is a web-based application designed to provide an easily readable, publicly accessible, and searchable listing of IRB-approved protocols that are accruing study participants. The Regulatory, Recruitment and Biomedical Informatics Cores of the Center for Clinical and Translational Science (CCTS) at The Ohio State University developed this research study posting platform. Postings include basic descriptive information: study title, purpose of the study, eligibility criteria and study personnel contact information. Language concerning benefits and/or inducements is not included; therefore, while IRB approval for a study to be listed on StudySearch is required, IRB approval of the posted language is not. Studies are listed by one of two methods; one automated and one manual: (1). Studies registered on ClinicalTrials.gov are automatically downloaded once a month; or (2). Studies are submitted directly by researchers to the CCTS Regulatory Core staff. In either case, final language is a result of an iterative process between researchers and CCTS staff. Deployed in January 2011 at OSU, this application has grown to approximately 200 studies currently posted and 1500 unique visitors per month. Locally, StudySearch is part of the CCTS recruitment toolkit. Features continue to be modified to better accommodate user behaviors. Nationally, this open source application is available for use.

Building a Central Repository for Research Ethics Consultation Data: A Proposal for a Standard Data Collection Tool.

Clinical research ethics consultation services have been established across academic health centers over the past decade. This paper presents the results of collaboration within the CTSA consortium to develop a standard approach to the collection of research ethics consultation information to serve as a foundation for quality improvement, education, and research efforts. This approach includes categorizing and documenting descriptive information about the requestor, research project, the ethical question, the consult process, and describing the basic structure for a consult note. This paper also explores challenges in determining how to share some of this information between collaborating institutions related to concerns about confidentially, data quality, and informatics. While there is much still to be learned to improve the process of clinical research ethics consultation, these tools can advance these efforts, which, in turn, can facilitate the ethical conduct of research.

The establishment of research ethics consultation services (RECS): an emerging research resource.

Emphasis on translational research to facilitate progression from the laboratory into the community also creates a dynamic in which ethics and social policy questions and solutions are ever pressing. In response, academic institutions are creating Research Ethics Consultation Services (RECS). All Clinical Translational Science Award institutions were surveyed in early 2010 to determine which institutions have a RECS in operation and what is their composition and function. Of the 46 institutions surveyed, 33 (70%) have a RECS. Only 15 RECS have received any consult requests in the last year. Issues that are common among these relatively nascent services include relationships with institutional oversight committees, balancing requestor concerns about confidentiality with research integrity and human subjects protection priorities, tracking consult data and outcomes, and developing systems for internal evaluation. There is variability in how these issues are approached. It will be important to be attentive to the institutional context to develop an appropriate approach. Further data about the issues raised by requestors and the recommendations provided are necessary to build a community of scholars who can navigate and resolve ethical issues encountered along the translational research pathway.

Research subject advocacy: program implementation and evaluation at clinical and translational science award centers.

PURPOSE: In 2000, the National Center for Research Resources mandated that general research centers create a research subject advocate (RSA) position. In 2008, the Clinical and Translational Science Award (CTSA) consortium endorsed a new advocacy model based on four RSA Best Practice Functions. The authors surveyed CTSA centers to learn about their implementation of programs to fulfill the RSA functions. METHOD: In 2010, the RSA taskforce developed a two-part online survey to examine leadership, organizational structure, governance, scope, collaboration and integration, and funding and evaluation of RSA activities implemented at CTSA centers. RESULTS: Respondents from 45 RSA programs at 43 CTSA centers completed the survey. Senior university or CTSA officials led all programs. Ninety-six percent (43/45) of programs were funded by a CTSA core. Eighty percent (36/45) designated an individual "RSA." Ninety-eight percent (44/45) provided diverse services either in collaboration with or complementary to other departments, including development of data and safety monitoring plans (16/45; 36%), informed consent observation (10/45; 22%), training responsive to audit findings (12/45; 27%), and direct advocacy services to participants (11/45; 24%). Eighty-six percent (24/28) reported qualitative evaluation methods for these activities. CONCLUSIONS: RSA programs conduct both collaborative and unique research protection activities. This survey, an initial step in developing a more robust mechanism for evaluating RSA programs, collected valuable feedback. The authors recommend defining and developing outcome-based evaluation measures that take the heterogeneity of the individual RSA programs into account while advancing their value and effectiveness in protecting human research subject participants.

Reliability of reported age at onset for Parkinson's disease.

An individual's age at onset of Parkinson disease (PD) can be collected through a variety of sources, including medical records, family report, and clinical observation. The most common source of PD age at onset information in the research setting is family-report, which is then typically used to classify a subject as juvenile, young, or late age at onset. The reliability of the family-reported age at onset of PD has not been rigorously examined. The present study used data from individuals diagnosed with PD to evaluate the reliability of age at onset information by comparing data obtained from three sources: 1) the subject's medical records, 2) a Family History Questionnaire, and 3) a Subject History Questionnaire. Among the 149 subjects with data for all three age at onset sources, the estimated reliability was R = 0.94. Similar reliability was observed when the sample was stratified based on gender, age at examination, disease duration, first symptom of PD, and years of education. The three measures of age at onset of PD show excellent agreement, strengthening confidence in the reliability of the reported age of clinical onset for PD.

PARK3 influences age at onset in Parkinson disease: a genome scan in the GenePD study.

Parkinson disease (PD) is a late-onset neurodegenerative disorder. The mean age at onset is 61 years, but the disease can range from juvenile cases to cases in the 8th or 9th decade of life. The parkin gene on chromosome 6q and loci on chromosome 1p35-36 and 1p36 are responsible for some cases of autosomal recessive early-onset parkinsonism, but they do not appear to influence susceptibility or variability of age at onset for idiopathic PD. We have performed a genomewide linkage analysis using variance-component methodology to identify genes influencing age at onset of PD in a population of affected relatives (mainly affected sibling pairs) participating in the GenePD study. Four chromosomal loci showed suggestive evidence of linkage: chromosome 2p (maximum multipoint LOD [MaxLOD] = 2.08), chromosome 9q (MaxLOD = 2.00), chromosome 20 (MaxLOD = 1.82), and chromosome 21 (MaxLOD = 2.21). The 2p and 9q locations that we report here have previously been reported as loci influencing PD affection status. Association between PD age at onset and allele 174 of marker D2S1394, located on 2p13, was observed in the GenePD sample (P=.02). This 174 allele is common to the PD haplotype observed in two families that show linkage to PARK3 and have autosomal dominant PD, which suggests that this allele may be in linkage disequilibrium with a mutation influencing PD susceptibility or age at onset of PD.