Delays in reporting and publishing trial results during pandemics: cross sectional analysis of 2009 H1N1, 2014 Ebola, and 2016 Zika clinical trials.

BACKGROUND: Pandemic events often trigger a surge of clinical trial activity aimed at rapidly evaluating therapeutic or preventative interventions. Ensuring rapid public access to the complete and unbiased trial record is particularly critical for pandemic research given the urgent associated public health needs. The World Health Organization (WHO) established standards requiring posting of results to a registry within 12 months of trial completion and publication in a peer reviewed journal within 24 months of completion, though compliance with these requirements among pandemic trials is unknown. METHODS: This cross-sectional analysis characterizes availability of results in trial registries and publications among registered trials performed during the 2009 H1N1 influenza, 2014 Ebola, and 2016 Zika pandemics. We searched trial registries to identify clinical trials testing interventions related to these pandemics, and determined the time elapsed between trial completion and availability of results in the registry. We also performed a comprehensive search of MEDLINE via PubMed, Google Scholar, and EMBASE to identify corresponding peer reviewed publications. The primary outcome was the compliance with either of the WHO's established standards for sharing clinical trial results. Secondary outcomes included compliance with both standards, and assessing the time elapsed between trial completion and public availability of results. RESULTS: Three hundred thirty-three trials met eligibility criteria, including 261 H1N1 influenza trials, 60 Ebola trials, and 12 Zika trials. Of these, 139 (42%) either had results available in the trial registry within 12 months of study completion or had results available in a peer-reviewed publication within 24 months. Five trials (2%) met both standards. No results were available in either a registry or publication for 59 trials (18%). Among trials with registered results, a median of 42 months (IQR 16-76 months) elapsed between trial completion and results posting. For published trials, the median elapsed time between completion and publication was 21 months (IQR 9-34 months). Results were available within 24 months of study completion in either the trial registry or a peer reviewed publication for 166 trials (50%). CONCLUSIONS: Very few trials performed during prior pandemic events met established standards for the timely public dissemination of trial results.

Innovative curriculum: Integrating the bio-behavioral and social science principles across the LifeStages in basic science years.

Behavioral and social science integration in clinical practice improves health outcomes across the life stages. The medical school curriculum requires an integration of the behavioral and social science principles in early medical education. We developed and delivered a four-week course entitled "LifeStages" to the first year medical students. The learning objectives of the bio-behavioral and social science principles along with the cultural, economic, political, and ethical parameters were integrated across the lifespan in the curriculum matrix. We focused on the following major domains: Growth and Brain Development; Sexuality, Hormones and Gender; Sleep; Cognitive and Emotional Development; Mobility, Exercise, Injury and Safety; Nutrition, Diet and Lifestyle; Stress and coping skills, Domestic Violence; Substance Use Disorders; Pain, Illness and Suffering; End of Life, Ethics and Death along with Intergenerational issues and Family Dynamics. Collaboration from the clinical and biomedical science departments led to the dynamic delivery of the course learning objectives and content. The faculty developed and led a scholarly discussion, using the case of a multi-racial, multi-generational family during Active Learning Group (ALG) sessions. The assessment in the LifeStages course involved multiple assessment tools: including the holistic assessment by the faculty facilitator inside ALGs, a Team-Based Learning (TBL) exercise, multiple choice questions and Team Work Assessment during which the students had to create a clinical case on a LifeStages domain along with the facilitators guide and learning objectives.

Meeting the challenge of evidence-based medicine in the family medicine clerkship: closing the loop from academics to office.

An EBM Seminar and POEM® project was developed to teach evidence-based medicine in a family medicine clerkship. The seminar focused on the application of preclinical coursework in biostatistics and epidemiology to the clinical third year. POEM projects involved answering clinical questions, derived from patient cases in the family medicine offices, with best available evidence. These questions and answers were archived in a wiki which was made available to the institution's family medicine physicians. Selected POEMs were also published in the in-house family medicine newsletter. The POEM projects evolved from an educational exercise for medical students to a valuable repository of evidence for clinicians.

Pulmonary artery catheters for adult patients in intensive care.

BACKGROUND: Since pulmonary artery balloon flotation catheterization was first introduced in 1970, by HJ Swan and W Ganz, it has been widely disseminated as a diagnostic tool without rigorous evaluation of its clinical utility and effectiveness in critically ill patients. A pulmonary artery catheter (PAC) is inserted through a central venous access into the right side of the heart and floated into the pulmonary artery. PAC is used to measure stroke volume, cardiac output, mixed venous oxygen saturation and intracardiac pressures with a variety of additional calculated variables to guide diagnosis and treatment. Complications of the procedure are mainly related to line insertion. Relatively uncommon complications include cardiac arrhythmias, pulmonary haemorrhage and infarct, and associated mortality from balloon tip rupture. OBJECTIVES: To provide an up-to-date assessment of the effectiveness of a PAC on mortality, length of stay (LOS) in intensive care unit (ICU) and hospital and cost of care in adult intensive care patients. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 12); MEDLINE (1954 to January 2012); EMBASE (1980 to January 2012); CINAHL (1982 to January 2012), and reference lists of articles. We contacted researchers in the field. We did a grey literature search for articles published until January 2012. SELECTION CRITERIA: We included all randomized controlled trials conducted in adults ICUs, comparing management with and without a PAC. DATA COLLECTION AND ANALYSIS: We screened the titles and abstracts and then the full text reports identified from our electronic search. Two authors (SR and MG) independently reviewed the titles, abstracts and then the full text reports for inclusion. We determined the final list of included studies by discussion among the group members (SR, ND, MG, AK and SC) with consensus agreement. We included all the studies that were in the original review. We assessed seven domains of potential risk of bias for the included studies. We examined the clinical, methodological and statistical heterogeneity and used random-effects model for meta-analysis. We calculated risk ratio for mortality across studies and mean days for LOS. MAIN RESULTS: We included 13 studies (5686 patients). We judged blinding of participants and personnel and blinding of outcome assessment to be at high risk in about 50% of the included studies and at low risk in 25% to 30% of the studies. Regardless of the high risk of performance bias these studies were included based on the low weight the studies had in the meta-analysis. We rated 75% of the studies as low risk for selection, attrition and reporting bias. All 13 studies reported some type of hospital mortality (28-day, 30-day, 60-day or ICU mortality). We considered studies of high-risk surgery patients (eight studies) and general intensive care patients (five studies) separately as subgroups for meta-analysis. The pooled risk ratio (RR) for mortality for the studies of general intensive care patients was 1.02 (95% confidence interval (CI) 0.96 to 1.09) and for the studies of high-risk surgery patients the RR was 0.98 (95% CI 0.74 to 1.29). Of the eight studies of high-risk surgery patients, five evaluated the effectiveness of pre-operative optimization but there was no difference in mortality when these studies were examined separately. PAC did not affect general ICU LOS (reported by four studies) or hospital LOS (reported by nine studies). Four studies, conducted in the United States (US), reported costs based on hospital charges billed, which on average were higher in the PAC groups. Two of these studies qualified for analysis and did not show a statistically significant hospital cost difference (mean difference USD 900, 95% CI -2620 to 4420, P = 0.62). AUTHORS' CONCLUSIONS: PAC is a diagnostic and haemodynamic monitoring tool but not a therapeutic intervention. Our review concluded that use of a PAC did not alter the mortality, general ICU or hospital LOS, or cost for adult patients in intensive care. The quality of evidence was high for mortality and LOS but low for cost analysis. Efficacy studies are needed to determine if there are optimal PAC-guided management protocols, which when applied to specific patient groups in ICUs could result in benefits such as shock reversal, improved organ function and less vasopressor use. Newer, less-invasive haemodynamic monitoring tools need to be validated against PAC prior to clinical use in critically ill patients.

The value of library and information services in patient care: results of a multisite study.

OBJECTIVE: The research conducted a large-scale, multisite study on the value and impact of library and information services on patient care. METHODS: THE STUDY USED: (1) 2 initial focus groups of librarians; (2) a web-based survey of physicians, residents, and nurses at 56 library sites serving 118 hospitals; and (3) 24 follow-up telephone interviews. Survey respondents were asked to base their responses on a recent incident in which they had sought information for patient care. RESULTS: Of the 16,122 survey respondents, 3/4 said that they had definitely or probably handled aspects of the patient care situation differently as a result of the information. Among the reported changes were advice given to the patient (48%), diagnosis (25%), and choice of drugs (33%), other treatment (31%), and tests (23%). Almost all of the respondents (95%) said the information resulted in a better informed clinical decision. Respondents reported that the information allowed them to avoid the following adverse events: patient misunderstanding of the disease (23%), additional tests (19%), misdiagnosis (13%), adverse drug reactions (13%), medication errors (12%), and patient mortality (6%). CONCLUSIONS: Library and information resources were perceived as valuable, and the information obtained was seen as having an impact on patient care.

A hospital-based patient and family education center: if you build it, will they come?

Librarians located in a 560-bed, inner city academic medical center with 25,000 + admissions per year planned and opened a Patient and Family Education Center (PFEC) in the lobby of a new patient care pavilion. A review of use in the first 19 months revealed that expected needs were being met while a variety of unexpected needs were identified. Ongoing use continues to be monitored by a detailed log of patron visits maintained by library staff. This article describes the evolution of the Patient and Family Education Center, outreach to the hospital community, and plans for the future.

Education for inpatients: working with nurses through the clinical information system.

Librarians at the UMDNJ Cooper Library have been filling orders for patient education materials through Cooper University Hospital's Clinical Information System (CIS) since December 2000. This service was instituted in response to a JCAHO survey, which revealed that although patient education was being provided, it was not being routinely documented. Patient education orders fall into two categories: customized disease/procedure information and smoking cessation information. Nurses note the condition(s) and/or procedure(s) regarding which information is needed and indicate the education level of the material desired (basic, intermediate or advanced). Requests are received via a dedicated printer in the reference office. Librarians rely heavily upon a wide variety of Web-based consumer health resources, including proprietary resources such as MD Consult and Micromedex CareNotes. Patient Transport staff delivers two copies of all materials to nursing stations on patient care floors. One copy is for the patient to keep, while the other is attached to the patient's chart. To complete and document that patient education was provided, librarians record the order as filled in the CIS system.

Analysis of current nuclear cardiology literature in MEDLINE database: a study of gated SPECT imaging using PubMed.

BACKGROUND: Easy access to relevant clinical information is necessary for physicians to make the best decisions for patient management. The increasing amount of information available has made it difficult for physicians to retrieve up-to-date information efficiently. We sought to determine the accessibility and accuracy of indexing in the nuclear cardiology literature by conducting sample searches in the MEDLINE database on the topic of gated single photon emission computed tomography (SPECT) imaging. METHODS AND RESULTS: The MEDLINE database was initially searched by use of both a primary and a comprehensive search strategy on PubMed for publications in English from 1994 to 2000. A total of 260 papers were retrieved from the primary search and 306 additional papers from the comprehensive search. Only 204 of the 566 citations from the combined electronic searches were truly relevant to gated SPECT. The resulting specificity index (precision) was 36%. A hand search was conducted in 11 top journals from 1994 to 2000. It yielded 81 additional citations that were missed by the PubMed search. The sensitivity index (recall) was calculated for all 11 journals. The Journal of Nuclear Cardiology had the highest rate of publication but the lowest rate of recall (44%). The clinical nuclear cardiology terminology and classifications were compared with the available Medical Subject Headings (MeSH) and MeSH Trees used for indexing in MEDLINE. CONCLUSIONS: There are 6 nuclear cardiology techniques, including gated SPECT and myocardial perfusion imaging, that are not specifically indexed in the current MEDLINE database. The lack of specific MeSH headings and indexing structure results in low recall and precision for retrieval of nuclear cardiology literature. We recommend 2 additions to the MeSH Tree Structure and 6 new MeSH headings.