Reporting quality of randomised controlled trials published in prosthodontic and implantology journals

The purpose of this study was to examine the reporting quality of randomised controlled trials (RCTs) published in prosthodontic and implantology journals. Thirty issues of nine journals in prosthodontics and implant dentistry were searched for RCTs, covering the years 2005-2012: The Journal of Prosthetic Dentistry, Journal of Oral Rehabilitation, The International Journal of Prosthodontics, The International Journal of Periodontics & Restorative Dentistry, Clinical Oral Implants Research, Clinical Implant Dentistry & Related Research, The International Journal of Oral & Maxillofacial Implants, Implant Dentistry and Journal of Dentistry. The reporting quality was assessed using a modified Consolidated Standards of Reporting Trials (CONSORT) statement checklist. Data were analysed using descriptive statistics followed by univariable and multivariable examination of statistical associations (α = 0·05). A total of 147 RCTs were identified with a mean CONSORT score of 69·4 (s.d. = 9·7). Significant differences were found among journals with the Journal of Oral Rehabilitation achieving the highest score (80·6, s.d. = 5·5) followed by Clinical Oral Implants Research (73·7, s.d. = 8·3). Involvement of a statistician/methodologist was significantly associated with increased CONSORT scores. Overall, the reporting quality of RCTs in major prosthodontic and implantology journals requires improvement. This is of paramount importance considering that optimal reporting of RCTs is an important prerequisite for clinical decision-making.

Planning and reporting of quality-of-life outcomes in cancer trials.

BACKGROUND Information about the impact of cancer treatments on patients' quality of life (QoL) is of paramount importance to patients and treating oncologists. Cancer trials that do not specify QoL as an outcome or fail to report collected QoL data, omit crucial information for decision making. To estimate the magnitude of these problems, we investigated how frequently QoL outcomes were specified in protocols of cancer trials and subsequently reported. DESIGN Retrospective cohort study of RCT protocols approved by six research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We compared protocols to corresponding publications, which were identified through literature searches and investigator surveys. RESULTS Of the 173 cancer trials, 90 (52%) specified QoL outcomes in their protocol, 2 (1%) as primary and 88 (51%) as secondary outcome. Of the 173 trials, 35 (20%) reported QoL outcomes in a corresponding publication (4 modified from the protocol), 18 (10%) were published but failed to report QoL outcomes in the primary or a secondary publication, and 37 (21%) were not published at all. Of the 83 (48%) trials that did not specify QoL outcomes in their protocol, none subsequently reported QoL outcomes. Failure to report pre-specified QoL outcomes was not associated with industry sponsorship (versus non-industry), sample size, and multicentre (versus single centre) status but possibly with trial discontinuation. CONCLUSIONS About half of cancer trials specified QoL outcomes in their protocols. However, only 20% reported any QoL data in associated publications. Highly relevant information for decision making is often unavailable to patients, oncologists, and health policymakers.

Global Estimates of the Prevalence and Incidence of Four Curable Sexually Transmitted Infections in 2012 Based on Systematic Review and Global Reporting.

BACKGROUND Quantifying sexually transmitted infection (STI) prevalence and incidence is important for planning interventions and advocating for resources. The World Health Organization (WHO) periodically estimates global and regional prevalence and incidence of four curable STIs: chlamydia, gonorrhoea, trichomoniasis and syphilis. METHODS AND FINDINGS WHO's 2012 estimates were based upon literature reviews of prevalence data from 2005 through 2012 among general populations for genitourinary infection with chlamydia, gonorrhoea, and trichomoniasis, and nationally reported data on syphilis seroprevalence among antenatal care attendees. Data were standardized for laboratory test type, geography, age, and high risk subpopulations, and combined using a Bayesian meta-analytic approach. Regional incidence estimates were generated from prevalence estimates by adjusting for average duration of infection. In 2012, among women aged 15-49 years, the estimated global prevalence of chlamydia was 4.2% (95% uncertainty interval (UI): 3.7-4.7%), gonorrhoea 0.8% (0.6-1.0%), trichomoniasis 5.0% (4.0-6.4%), and syphilis 0.5% (0.4-0.6%); among men, estimated chlamydia prevalence was 2.7% (2.0-3.6%), gonorrhoea 0.6% (0.4-0.9%), trichomoniasis 0.6% (0.4-0.8%), and syphilis 0.48% (0.3-0.7%). These figures correspond to an estimated 131 million new cases of chlamydia (100-166 million), 78 million of gonorrhoea (53-110 million), 143 million of trichomoniasis (98-202 million), and 6 million of syphilis (4-8 million). Prevalence and incidence estimates varied by region and sex. CONCLUSIONS Estimates of the global prevalence and incidence of chlamydia, gonorrhoea, trichomoniasis, and syphilis in adult women and men remain high, with nearly one million new infections with curable STI each day. The estimates highlight the urgent need for the public health community to ensure that well-recognized effective interventions for STI prevention, screening, diagnosis, and treatment are made more widely available. Improved estimation methods are needed to allow use of more varied data and generation of estimates at the national level.

Discrepancies in Outcome Reporting Exist Between Protocols and Published Oral Health Cochrane Systematic Reviews

OBJECTIVES To assess discrepancies in the analyzed outcomes between protocols and published reviews within Cochrane oral health systematic reviews (COHG) on the Cochrane Database of Systematic Reviews (CDSR). STUDY DESIGN AND SETTING All COHG systematic reviews on the CDSR and the corresponding protocols were retrieved in November 2014 and information on the reported outcomes was recorded. Data was collected at the systematic review level by two reviewers independently. RESULTS One hundred and fifty two reviews were included. In relation to primary outcomes, 11.2% were downgraded to secondary outcomes, 9.9% were omitted altogether in the final publication and new primary outcomes were identified in 18.4% of publications. For secondary outcomes, 2% were upgraded to primary, 12.5% were omitted and 30.9% were newly introduced in the publication. Overall, 45.4% of reviews had at least one discrepancy when compared to the protocol; these were reported in 14.5% reviews. The number of review updates appears to be associated with discrepancies between final review and protocol (OR: 3.18, 95% CI: 1.77, 5.74, p<0.001). The risk of reporting significant results was lower for both downgraded outcomes [RR: 0.52, 95% CI: 0.17, 1.58, p = 0.24] and upgraded or newly introduced outcomes [RR: 0.77, 95% CI: 0.36, 1.64, p = 0.50] compared to outcomes with no discrepancies. The risk of reporting significant results was higher for upgraded or newly introduced outcomes compared to downgraded outcomes (RR = 1.19, 95% CI: 0.65, 2.16, p = 0.57). None of the comparisons reached statistical significance. CONCLUSION While no evidence of selective outcome reporting was found in this study, based on the present analysis of SRs published within COHG systematic reviews, discrepancies between outcomes in pre-published protocols and final reviews continue to be common. Solutions such as the use of standardized outcomes to reduce the prevalence of this issue may need to be explored.

Investigating the potential of reported cattle mortality data in Switzerland for syndromic surveillance

Systems for the identification and registration of cattle have gradually been receiving attention for use in syndromic surveillance, a relatively recent approach for the early detection of infectious disease outbreaks. Real or near real-time monitoring of deaths or stillbirths reported to these systems offer an opportunity to detect temporal or spatial clusters of increased mortality that could be caused by an infectious disease epidemic. In Switzerland, such data are recorded in the "Tierverkehrsdatenbank" (TVD). To investigate the potential of the Swiss TVD for syndromic surveillance, 3 years of data (2009-2011) were assessed in terms of data quality, including timeliness of reporting and completeness of geographic data. Two time-series consisting of reported on-farm deaths and stillbirths were retrospectively analysed to define and quantify the temporal patterns that result from non-health related factors. Geographic data were almost always present in the TVD data; often at different spatial scales. On-farm deaths were reported to the database by farmers in a timely fashion; stillbirths were less timely. Timeliness and geographic coverage are two important features of disease surveillance systems, highlighting the suitability of the TVD for use in a syndromic surveillance system. Both time series exhibited different temporal patterns that were associated with non-health related factors. To avoid false positive signals, these patterns need to be removed from the data or accounted for in some way before applying aberration detection algorithms in real-time. Evaluating mortality data reported to systems for the identification and registration of cattle is of value for comparing national data systems and as a first step towards a European-wide early detection system for emerging and re-emerging cattle diseases.

Second, do less harm: The state of states' medical error reporting programs

Statement of the problem and public health significance. Hospitals were designed to be a safe haven and respite from disease and illness. However, a large body of evidence points to preventable errors in hospitals as the eighth leading cause of death among Americans. Twelve percent of Americans, or over 33.8 million people, are hospitalized each year. This population represents a significant portion of at risk citizens exposed to hospital medical errors. Since the number of annual deaths due to hospital medical errors is estimated to exceed 44,000, the magnitude of this tragedy makes it a significant public health problem. ^ Specific aims. The specific aims of this study were threefold. First, this study aimed to analyze the state of the states' mandatory hospital medical error reporting six years after the release of the influential IOM report, "To Err is Human." The second aim was to identify barriers to reporting of medical errors by hospital personnel. The third aim was to identify hospital safety measures implemented to reduce medical errors and enhance patient safety. ^ Methods. A descriptive, longitudinal, retrospective design was used to address the first stated objective. The study data came from the twenty-one states with mandatory hospital reporting programs which report aggregate hospital error data that is accessible to the public by way of states' websites. The data analysis included calculations of expected number of medical errors for each state according to IOM rates. Where possible, a comparison was made between state reported data and the calculated IOM expected number of errors. A literature review was performed to achieve the second study aim, identifying barriers to reporting medical errors. The final aim was accomplished by telephone interviews of principal patient safety/quality officers from five Texas hospitals with more than 700 beds. ^ Results. The state medical error data suggests vast underreporting of hospital medical errors to the states. The telephone interviews suggest that hospitals are working at reducing medical errors and creating safer environments for patients. The literature review suggests the underreporting of medical errors at the state level stems from underreporting of errors at the delivery level. ^

Identification of maltreatment type in children with disabilities using the National Child Abuse and Neglect Data System (NCANDS)

This study was a retrospective design and used secondary data from the National Child Abuse and Neglect Data System (NCANDS), provided by the National Data Archive on Child Abuse and Neglect Family Life Development Center administered by Cornell University. The dataset contained information for the year 2005 on children from birth to 18 years of age. Child abuse and neglect for disabled children, was evaluated in-depth in the present study. Descriptive and statistical analysis was performed using the children with and without disabilities. It was found that children with disabilities have a lower rate of substantiation that likely indicates the interference of reporting due to their handicap. The results of this research demonstrate the important need to teach professionals and laypersons alike on how to recognize and substantiate abuse among disabled children.^

Secondary data analysis of a pilot study of use of an instructional video for dietary assessment

Introduction. Food frequency questionnaires (FFQ) are used study the association between dietary intake and disease. An instructional video may potentially offer a low cost, practical method of dietary assessment training for participants thereby reducing recall bias in FFQs. There is little evidence in the literature of the effect of using instructional videos on FFQ-based intake. Objective. This analysis compared the reported energy and macronutrient intake of two groups that were randomized either to watch an instructional video before completing an FFQ or to view the same instructional video after completing the same FFQ. Methods. In the parent study, a diverse group of students, faculty and staff from Houston Community College were randomized to two groups, stratified by ethnicity, and completed an FFQ. The "video before" group watched an instructional video about completing the FFQ prior to answering the FFQ. The "video after" group watched the instructional video after completing the FFQ. The two groups were compared on mean daily energy (Kcal/day), fat (g/day), protein (g/day), carbohydrate (g/day) and fiber (g/day) intakes using descriptive statistics and one-way ANOVA. Demographic, height, and weight information was collected. Dietary intakes were adjusted for total energy intake before the comparative analysis. BMI and age were ruled out as potential confounders. Results. There were no significant differences between the two groups in mean daily dietary intakes of energy, total fat, protein, carbohydrates and fiber. However, a pattern of higher energy intake and lower fiber intake was reported in the group that viewed the instructional video before completing the FFQ compared to those who viewed the video after. Discussion. Analysis of the difference between reported intake of energy and macronutrients showed an overall pattern, albeit not statistically significant, of higher intake in the video before versus the video after group. Application of instructional videos for dietary assessment may require further research to address the validity of reported dietary intakes in those who are randomized to watch an instructional video before reporting diet compared to a control groups that does not view a video.^

The movement toward patient safety: State action related to reporting and disclosure of healthcare-associated infections

Increasing attention has been given to the problem of medical errors over the past decade. Included within that focused attention has been a strong interest in reducing the occurrence of healthcare-associated infections (HAIs). Acting concurrently with federal initiatives, the majority of U.S. states have statutorily required reporting and public disclosure of HAI data. Although the occurrence of these state statutory enactments and other state initiatives represent a recognition of the strong concern pertaining to HAIs, vast differences in each state’s HAI reporting and public disclosure requirements creates a varied and unequal response to what has become a national problem.^ The purpose of this research was to explore the variations in state HAI legal requirements and other state mandates. State actions, including statutory enactments, regulations, and other initiatives related to state reporting and public disclosure mechanisms were compared, discussed, and analyzed in an effort to illustrate the impact of the lack of uniformity as a public health concern.^ The HAI statutes, administrative requirements, and other mandates of each state and two U.S. territories were reviewed to answer the following seven research questions: How far has the state progressed in its HAI initiative? If the state has a HAI reporting requirement, is it mandatory or voluntary? What healthcare entities are subject to the reporting requirements? What data collection system is utilized? What measures are required to be reported? What is the public disclosure mechanism? How is the underlying reported information protected from public disclosure or other legal release?^ Secondary publicly available data, including state statutes, administrative rules, and other initiatives, were utilized to examine the current HAI-related legislative and administrative activity of the study subjects. The information was reviewed and analyzed to determine variations in HAI reporting and public disclosure laws. Particular attention was given to the seven key research questions.^ The research revealed that considerable progress has been achieved in state HAI initiatives since 2004. Despite this progress, however, when reviewing the state laws and HAI programs comparatively, considerable variations were found to exist with regards to the type of reporting requirements, healthcare facilities subject to the reporting laws, data collection systems utilized, reportable measures, public disclosure requirements, and confidentiality and privilege provisions. The wide variations in state statutes, administrative rules, and other agency directives create a fragmented and inconsistent approach to addressing the nationwide occurrence of HAIs in the U.S. healthcare system. ^

Nursing-related medication errors: A review of factors that facilitate and hinder error reporting, and recommendations for improvement

Medication errors, one of the most frequent types of medical errors, are a common cause of patient harm in hospital systems today. Nurses at the bedside are in a position to encounter many of these errors since they are there at the start of the process (ordering/prescribing) and the end of the process (administration). One of the recommendations from the IOM (Institute of Medicine) report, "To Err is Human," was for organizations to identify and learn from medical errors through event reporting systems. While many organizations have reporting systems in place, research studies report a significant amount of underreporting by nurses. A systematic review of the literature was performed to identify contributing factors related to the reporting and not reporting of medication errors by nurses at the bedside.^ Articles included in the literature review were primary or secondary studies, dated January 1, 2000 – July 2009, related to nursing medication error reporting. All 634 articles were reviewed with an algorithm developed to standardize the review process and help filter out those that did not meet the study criteria. In addition, 142 article bibliographies were reviewed to find additional studies that were not found in the original literature search.^ After reviewing the 634 articles and the additional 108 articles discovered in the bibliography review, 41 articles met the study criteria and were used in the systematic literature review results.^ Fear of punitive reactions to medication errors was a frequent barrier to error reporting. Nurses fear reactions from their leadership, peers, patients and their families, nursing boards, and the media. Anonymous reporting systems and departments/organizations with a strong safety culture in place helped to encourage the reporting of medication errors by nursing staff.^ Many of the studies included in this literature review do not allow results that can be generalized. The majority of them took place in single institutions/organizations with limited sample sizes. Stronger studies with larger sample sizes need to be performed, utilizing data collection methods that have been validated, to determine stronger correlations between safety cultures and nurse error reporting.^

Ascertainment, meta-analysis and reporting of adverse reactions in clinical trials of antibiotics

The ascertainment and analysis of adverse reactions to investigational agents presents a significant challenge because of the infrequency of these events, their subjective nature and the low priority of safety evaluations in many clinical trials. A one year review of antibiotic trials published in medical journals demonstrates the lack of standards in identifying and reporting these potentially fatal conditions. This review also illustrates the low probability of observing and detecting rare events in typical clinical trials which include fewer than 300 subjects. Uniform standards for ascertainment and reporting are suggested which include operational definitions of study subjects. Meta-analysis of selected antibiotic trials using multivariate regression analysis indicates that meaningful conclusions may be drawn from data from multiple studies which are pooled in a scientifically rigorous manner. ^

Returning Texas Senate Bill 530 back to 1100 Congress Avenue: The need for effective surveillance reporting of student fitness levels to Texas house representatives

Every Texas student is required to complete the FITNESSGRAM fitness assessment under legislation outlined in Senate Bill 530. This study described cardiovascular, body mass index (BMI), and overall fitness levels of students (grades 3–12) in the state of Texas during the 2009–2010 school year, and provides examples of how to effectively present results to Texas House Representatives using three unique health communication strategies. Given the Texas legislature mandates FITNESSGRAM collection yet did not require reporting according to their election district, the data were aggregated to 150 Texas House Representative Districts by sex and grade category to facilitate effective fitness data dissemination. Fitness data were also analyzed with results from the Texas Assessment of Knowledge and Skills (TAKS) to provide insight into potential relationships between fitness and academic achievement. ^ The majority of students in Texas need improvement on at least 1 fitness assessment. In general, female students have superior fitness in elementary and middle school but the fitness edge is erased by high school. Female cardiovascular fitness deteriorates faster from elementary to high school compared to male students. Female BMI deteriorates and male BMI improves from elementary to high school. Cardiovascular fitness and overall fitness decreases from elementary to high school for both male and female students. ^ Student fitness was significantly and strongly independently correlated with academic achievement. Further analysis showed that House Representatives with TAKS scores in the top quartile consistently showed superior fitness. Small significant partial correlations remain between fitness and TAKS assessment after controlling for socioeconomic status. In general, correlations were stronger between female BMI and TAKS assessment compared to male students. Cardiovascular fitness was significantly correlated with TAKS assessment for both genders. This paper supports student fitness as a confounder in the relationship between socioeconomic status and academic achievement. Plus, student fitness has a strong correlation with academic that deserves further exploration. ^ Senate Bill 530 fails to organize and implement a health communication strategy that effectively disseminates the health data collected to stakeholders of interest. The lack of a vital health communication strategy results in an incomplete student health surveillance system. This paper outlines three unique strategies tailored to legislators. It is important to disseminate health information using a variety of methods tailored to your targeted audience. The use of interactive mapping technology presented (GIS) uses new technology that has the potential to effectively reach a large audience.^

An evaluation of the centers for Medicare & Medicaid Services' Hospital Acquired Conditions and Present on Admission Indicator Reporting program

Objective: This dissertation evaluated three aspects of the Centers for Medicare and Medicaid Services' Hospital Acquired Conditions and Present on Admission Indicator Reporting program (HACPOA program) to produce three journal articles for publication. ^ Methods: All payer admission records from state inpatient databases from Arizona, New Jersey and Washington states were analyzed for the year 2008. However some analyses required a sample of adult only Medicare patients in the first two studies. California's inpatient data (2004 – 2010) was also analyzed in the third study to examine the reporting and non-payment program elements' impact on the incidence of hospital acquired conditions. ^ Results: Majority diagnoses reported in inpatient prospective payment systems hospitals were present on admission. However, some diagnoses are still coded as "not present on admission" and "insufficient documentation to determine whether or not conditions are present on admission or not". This is important because it reveals that hospital complications still occur in hospitals. Hospital fall and trauma injuries were the most common hospital acquired conditions observed in this study. Predictors of hospital fall injuries include age, gender, number of diagnoses, number of procedures, number of chronic conditions while predictors of hospital trauma injuries include number of e-codes, number of diagnoses and the presence of chronic conditions on a patient's admission records. Finally, the implementation of the present on admission reporting requirement increased reports of certain hospital acquired conditions while the non-payment policy element in the Hospital Acquired Conditions program reduced the incidence of hospital fall and trauma injuries in particular. ^ Conclusion: The implementation of the Hospital Acquired Conditions and Present on Admission Indicator Reporting program has made the state inpatient database a more useful source of data capable of now identifying hospital complications. The reporting and nonpayment program elements in the HACPOA program have also impacted the incidence of hospital acquired conditions. ^

Global distributions of picophytoplankton abundance and biomass - Gridded data product (NetCDF) - Contribution to the MAREDAT World Ocean Atlas of Plankton Functional Types

The smallest marine phytoplankton, collectively termed picophytoplankton, have been routinely enumerated by flow cytometry since the late 1980s, during cruises throughout most of the world ocean. We compiled a database of 40,946 data points, with separate abundance entries for Prochlorococcus, Synechococcus and picoeukaryotes. We use average conversion factors for each of the three groups to convert the abundance data to carbon biomass. After gridding with 1° spacing, the database covers 2.4% of the ocean surface area, with the best data coverage in the North Atlantic, the South Pacific and North Indian basins. The average picophytoplankton biomass is 12 ± 22 µg C L-1 or 1.9 g C m-2. We estimate a total global picophytoplankton biomass, excluding N2-fixers, of 0.53 - 0.74 Pg C (17 - 39 % Prochlorococcus, 12 - 15 % Synechococcus and 49 - 69 % picoeukaryotes). Future efforts in this area of research should focus on reporting calibrated cell size, and collecting data in undersampled regions.

A semantic middleware architecture focused on data and heterogeneity management within the Smart Grid

There is an increasing tendency of turning the current power grid, essentially unaware of variations in electricity demand and scattered energy sources, into something capable of bringing a degree of intelligence by using tools strongly related to information and communication technologies, thus turning into the so-called Smart Grid. In fact, it could be considered that the Smart Grid is an extensive smart system that spreads throughout any area where power is required, providing a significant optimization in energy generation, storage and consumption. However, the information that must be treated to accomplish these tasks is challenging both in terms of complexity (semantic features, distributed systems, suitable hardware) and quantity (consumption data, generation data, forecasting functionalities, service reporting), since the different energy beneficiaries are prone to be heterogeneous, as the nature of their own activities is. This paper presents a proposal on how to deal with these issues by using a semantic middleware architecture that integrates different components focused on specific tasks, and how it is used to handle information at every level and satisfy end user requests.