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BACKGROUND: Healthcare systems data (HSD) has the potential to optimise the efficiency of randomised controlled trials (RCTs), by decreasing trial-specific data demands. Therefore, the use of HSD in trials is expected to increase. In 2019, it was estimated that 47% of NIHR-funded trials were planning to use HSD. We aim to understand the extent and nature of its current use and its evolution over time. METHODS: We identified a cohort of RCTs within the NIHR Journals Library that commenced after 2019 and were described as being in progress on 6 June 2022. Details on the source and use of HSD were extracted from eligible RCTs. The use of HSD was categorised according to whether it was used as the sole data source for outcomes and whether the outcomes were primary or secondary. HSD is often insufficient for patient-reported outcomes (PROs). We aimed to determine methods used by trialists for collecting PRO data alongside HSD. RESULTS: Of the 84 eligible studies, 52 (62%) planned to use HSD and 79 (94%) planned to collect PROs. The number of RCTs planning to use HSD for at least one outcome was 28 (54%) with 24 of these planning to use HSD as the sole data source for at least one outcome. The number of studies planning to use HSD for primary and secondary outcomes was 10 (20%) and 21 (40%) respectively. The sources of HSD were National Health Service (NHS) Digital (n = 37, 79%), patient registries (n = 7, 29%), primary care (n = 5, 21%), The Office for National Statistics (ONS) (n = 3, 13%) and other (n = 2, 8%). PROs were collected for 92% of the trials planning to use HSD. Methods for collection of PROs included in-person (n = 26, 54%), online (n = 22, 46%), postal (n = 18, 38%), phone (n = 14, 29%) and app (n = 2, 4%). CONCLUSIONS: HSD is being used in around two thirds of the studies but cannot yet be used to support PRO data collection within the cohort we examined. Comparison with an earlier cohort demonstrates an increase in the number of RCTs planning to use HSD.

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Routinely collected data about health in medical records, registries and hospital activity statistics is now routinely collected in an electronic form. The extent to which such sources of data are now being routinely accessed to deliver efficient clinical trials, is unclear. The aim of this study was to ascertain current practice amongst a United Kingdom (UK) cohort of recently funded and ongoing randomised controlled trials (RCTs) in relation to sources and use of routinely collected outcome data. Recently funded and ongoing RCTs were identified for inclusion by searching the National Institute for Health Research journals library. Trials that have a protocol available were assessed for inclusion and those that use or plan to use routinely collected health data (RCHD) for at least one outcome were included. RCHD sources and outcome information were extracted. Of 216 RCTs, 102 (47%) planned to use RCHD. A RCHD source was the sole source of outcome data for at least one outcome in 46 (45%) of those 102 trials. The most frequent sources are Hospital Episode Statistics (HES) and Office for National Statistics (ONS), with the most common outcome data to be extracted being on mortality, hospital admission, and health service resource use. Our study has found that around half of publicly funded trials in a UK cohort (NIHR HTA funded trials that had a protocol available) plan to collect outcome data from routinely collected data sources.

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Common loons (Gavia immer) are at risk of elevated dietary mercury (Hg) exposure in portions of their breeding range. To assess the level of risk among loons in Minnesota (USA), we investigated loon blood Hg concentrations in breeding lakes across Minnesota. Loon blood Hg concentrations were regressed on predicted Hg concentrations in standardized 12-cm whole-organism yellow perch (Perca flavescens), based on fish Hg records from Minnesota lakes, using the US Geological Survey National Descriptive Model for Mercury in Fish. A linear model, incorporating common loon sex, age, body mass, and log-transformed standardized perch Hg concentration representative of each study lake, was associated with 83% of the variability in observed common loon blood Hg concentrations. Loon blood Hg concentration was positively related to standardized perch Hg concentrations; juvenile loons had lower blood Hg concentrations than adult females, and blood Hg concentrations of juveniles increased with body mass. Blood Hg concentrations of all adult common loons and associated standardized prey Hg for all loon capture lakes included in the study were well below proposed thresholds for adverse effects on loon behavior, physiology, survival, and reproductive success. The fish Hg modeling approach provided insights into spatial patterns of dietary Hg exposure risk to common loons across Minnesota. We also determined that loon blood selenium (Se) concentrations were positively correlated with Hg concentration. Average common loon blood Se concentrations exceeded the published provisional threshold. Environ Toxicol Chem 2019;38:524-532. Published 2018 Wiley Periodicals Inc. on behalf of SETAC. This article is a US government work and, as such, is in the public domain in the United States of America.

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OBJECTIVE: To study differences in imaging utilization downstream to initial emergency department (ED) ultrasound examinations interpreted by radiologists versus nonradiologists. METHODS: Using 5% Medicare Research Identifiable Files from 2009 to 2014, we identified episodes where the place of service was "emergency room hospital" and the patient also underwent an ultrasound examination. We determined whether the initial ultrasound was interpreted by a radiologist or nonradiologist and then summed all additional imaging events occurring within 7, 14, and 30 days of each initial ED ultrasound. For each year and each study window, we calculated the mean number of downstream imaging procedures by specialty group. RESULTS: Of 200,357 ED ultrasound events, 163,569 (81.6%) were interpreted by radiologists and 36,788 (18.4%) by nonradiologists. Across all study years, ED patients undergoing ultrasound examinations interpreted by nonradiologists underwent 1.08, 1.22, and 1.34 additional diagnostic imaging studies at 7, 14, and 30 days, respectively (P < .01) compared with when the initial ultrasound examination was interpreted by a radiologist. From 2010 to 2014, the volume of downstream imaging for both radiologists and nonradiologists significantly decreased, with each year resulting in 0.08 fewer imaging examinations (P < .001) 14 days after the ED ultrasound event. Despite that decline, differences in downstream imaging between radiologists and nonradiologists persisted over time. CONCLUSION: Downstream imaging after an initial ED ultrasound is significantly reduced when the ultrasound examination is interpreted by a radiologist rather than a nonradiologist.

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PLAIN LANGUAGE SUMMARY: Funders of research are increasingly requiring researchers to involve patients and the public in their research. Patient and public involvement (PPI) in research can potentially help researchers make sure that the design of their research is relevant, that it is participant friendly and ethically sound. Using and sharing PPI resources can benefit those involved in undertaking PPI, but existing PPI resources are not used consistently and this can lead to duplication of effort. This paper describes how we are developing a toolkit to support clinical trials teams in a clinical trials unit. The toolkit will provide a key 'off the shelf' resource to support trial teams with limited resources, in undertaking PPI. Key activities in further developing and maintaining the toolkit are to: ● listen to the views and experience of both research teams and patient and public contributors who use the tools; ● modify the tools based on our experience of using them; ● identify the need for future tools; ● update the toolkit based on any newly identified resources that come to light; ● raise awareness of the toolkit and ● work in collaboration with others to either develop or test out PPI resources in order to reduce duplication of work in PPI. ABSTRACT: Background Patient and public involvement (PPI) in research is increasingly a funder requirement due to the potential benefits in the design of relevant, participant friendly, ethically sound research. The use and sharing of resources can benefit PPI, but available resources are not consistently used leading to duplication of effort. This paper describes a developing toolkit to support clinical trials teams to undertake effective and meaningful PPI. Methods The first phase in developing the toolkit was to describe which PPI activities should be considered in the pathway of a clinical trial and at what stage these activities should take place. This pathway was informed through review of the type and timing of PPI activities within trials coordinated by the Clinical Trials Research Centre and previously described areas of potential PPI impact in trials. In the second phase, key websites around PPI and identification of resources opportunistically, e.g. in conversation with other trialists or social media, were used to identify resources. Tools were developed where gaps existed. Results A flowchart was developed describing PPI activities that should be considered in the clinical trial pathway and the point at which these activities should happen. Three toolkit domains were identified: planning PPI; supporting PPI; recording and evaluating PPI. Four main activities and corresponding tools were identified under the planning for PPI: developing a plan; identifying patient and public contributors; allocating appropriate costs; and managing expectations. In supporting PPI, tools were developed to review participant information sheets. These tools, which require a summary of potential trial participant characteristics and circumstances help to clarify requirements and expectations of PPI review. For recording and evaluating PPI, the planned PPI interventions should be monitored in terms of impact, and a tool to monitor public contributor experience is in development. Conclusions This toolkit provides a developing 'off the shelf' resource to support trial teams with limited resources in undertaking PPI. Key activities in further developing and maintaining the toolkit are to: listen to the views and experience of both research teams and public contributors using the tools, to identify the need for future tools, to modify tools based on experience of their use; to update the toolkit based on any newly identified resources that come to light; to raise awareness of the toolkit and to work in collaboration with others to both develop and test out PPI resources in order to reduce duplication of work in PPI.

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BACKGROUND: Publication of complete trial results is essential if people are to be able to make well-informed decisions about health care. Selective reporting of randomised controlled trials (RCTs) is a common problem. OBJECTIVES: To systematically review studies of cohorts of RCTs to compare the content of trial reports with the information contained in their protocols, or entries in a trial registry. SEARCH STRATEGY: We conducted electronic searches in Ovid MEDLINE (1950 to August 2010); Ovid EMBASE (1980 to August 2010); ISI Web of Science (1900 to August 2010) and the Cochrane Methodology Register (Issue 3, 2010), checked reference lists, and asked authors of eligible studies to identify further studies. Studies were not excluded based on language of publication or our assessment of their quality. SELECTION CRITERIA: Published or unpublished cohort studies comparing the content of protocols or trial registry entries with published trial reports. DATA COLLECTION AND ANALYSIS: Data were extracted by two authors independently. Risk of bias in the cohort studies was assessed in relation to follow up and selective reporting of outcomes. Results are presented separately for the comparison of published reports to protocols and trial registry entries. MAIN RESULTS: We included 16 studies assessing a median of 54 RCTs (range: 2 to 362). Twelve studies compared protocols to published reports and four compared trial registry entries to published reports. In two studies, eligibility criteria differed between the protocol and publication in 19% and 100% RCTs. In one study, 16% (9/58) of the reports included the same sample size calculation as the protocol. In one study, 6% (4/63) of protocol-report pairs gave conflicting information regarding the method of allocation concealment, and 67% (49/73) of blinded studies reported discrepant information on who was blinded. In one study unacknowledged discrepancies were found for methods of handling protocol deviations (44%; 19/43), missing data (80%; 39/49), primary outcome analyses (60%; 25/42) and adjusted analyses (82%; 23/28). One study found that of 13 protocols specifying subgroup analyses, 12 of these 13 trials reported only some, or none, of these. Two studies found that statistically significant outcomes had a higher odds of being fully reported compared to nonsignificant outcomes (range of odds ratios: 2.4 to 4.7). Across the studies, at least one primary outcome was changed, introduced, or omitted in 4-50% of trial reports. AUTHORS' CONCLUSIONS: Discrepancies between protocols or trial registry entries and trial reports were common, although reasons for these were not discussed in the reports. Full transparency will be possible only when protocols are made publicly available or the quality and extent of information included in trial registries is improved, and trialists explain substantial changes in their reports.

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Possible biochemical parameters that can distinguish clinically-failing people living with HIV/AIDS (PLWHA) from clinically-stable PLWHA on antiretroviral therapy (ART) were investigated in a north central location of Nigeria. The major aim of the study was to determine possible diagnostic biochemical markers that can be helpful in resource- and manpower-poor environments. Eighty (80) consenting persons living with HIV/AIDS who were on combined ART while attending a tertiary hospital in the North Central part of Nigeria were recruited for the study. Fifty (50) persons had clinically failing (CF) conditions while 32 were clinically stable (CS). Of the 50 CF cases 32 persons switched drugs while 18 did not in the course of their ART. In all, serum total bilirubin, total protein, total cholesterol, albumin, alkaline phosphatase (ALP), glucose, creatinine, urea and CD4 cell count were assayed. The values of these parameters in the CF and CS persons were statistically compared. The same parameters in the CF cases that switched drugs and those that maintained their drugs were also statistically compared with the corresponding values for the same parameters in the clinically stable persons. Alkaline phosphatase activity and total cholesterol levels and CD4 count in the CF cases were significantly (pd"0.05) different from the values for the CS persons. Only creatinine levels in CF persons that switched drugs differed significantly (pd"0.05) from the corresponding values in CF, persons that did not switch drugs even when there was no difference in creatinine values between the latter and the CS persons. CD4 count and total cholesterol levels may serve as useful indicators of potential clinically-failing and/or clinically stable cases of PLWHA on antiretroviral therapy. Creatinine levels on the other hand, may be useful in distinguishing PLWHA that switched drugs and those that did not. These parameters may serve as reliable rapid assessment tools for HIV/AIDS research and diagnosis in resources-poor areas.

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BACKGROUND: Anthrax is a bacterial zoonosis that occasionally causes human disease and is potentially fatal. Anthrax vaccines include a live-attenuated vaccine, an alum-precipitated cell-free filtrate vaccine, and a recombinant protein vaccine. OBJECTIVES: To evaluate the effectiveness, immunogenicity, and safety of vaccines for preventing anthrax. SEARCH STRATEGY: We searched the following databases (November 2008): Cochrane Infectious Diseases Group Specialized Register; CENTRAL (The Cochrane Library 2008, Issue 4); MEDLINE; EMBASE; LILACS; and mRCT. We also searched reference lists. SELECTION CRITERIA: We included randomized controlled trials (RCTs) of individuals and cluster-RCTs comparing anthrax vaccine with placebo, other (non-anthrax) vaccines, or no intervention; or comparing administration routes or treatment regimens of anthrax vaccine. DATA COLLECTION AND ANALYSIS: Two authors independently considered trial eligibility, assessed risk of bias, and extracted data. We presented cases of anthrax and seroconversion rates using risk ratios (RR) and 95% confidence intervals (CI). We summarized immunoglobulin G (IgG) concentrations using geometric means. We carried out a sensitivity analysis to investigate the effect of clustering on the results from one cluster-RCT. No meta-analysis was undertaken. MAIN RESULTS: One cluster-RCT (with 157,259 participants) and four RCTs of individuals (1917 participants) met the inclusion criteria. The cluster-RCT from the former USSR showed that, compared with no vaccine, a live-attenuated vaccine (called STI) protected against clinical anthrax whether given by a needleless device (RR 0.16; 102,737 participants, 154 clusters) or the scarification method (RR 0.25; 104,496 participants, 151 clusters). Confidence intervals were statistically significant in unadjusted calculations, but when a small amount of association within clusters was assumed, the differences were not statistically significant. The four RCTs (of individuals) of inactivated vaccines (anthrax vaccine absorbed and recombinant protective antigen) showed a dose response relationship for the anti-protective antigen IgG antibody titre. Intramuscular administration was associated with fewer injection site reactions than subcutaneous injection, and injection site reaction rates were lower when the dosage interval was longer. AUTHORS' CONCLUSIONS: One cluster-RCT provides limited evidence that a live-attenuated vaccine is effective in preventing cutaneous anthrax. Vaccines based on anthrax antigens are immunogenic in most vaccinees with few adverse events or reactions. Ongoing randomized controlled trials are investigating the immunogenicity and safety of anthrax vaccines.

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OBJECTIVES: To assess the clinical effectiveness of central venous catheters (CVCs) treated with anti-infective agents (AI-CVCs) in preventing catheter-related bloodstream infections (CRBSI). DATA SOURCES: MEDLINE (OVID), EMBASE, SCI//Web of Science, SCI/ISI Proceedings, and the Cochrane Library. STUDY SELECTION: A systematic review of the literature was conducted using internationally recognized methodology. All included articles were reports of randomized controlled trials comparing the clinical effectiveness of CVCs treated with AI-CVCs with either standard CVCs or another anti-infective treated catheter. Articles requiring in-house preparation of catheters or that only reported interim data were excluded. DATA EXTRACTION: Data extraction was carried out independently and crosschecked by two reviewers using a pretested data extraction form. DATA SYNTHESIS: Meta-analyses were conducted to assess the effectiveness of AI-CVCs in preventing CRBSI, compared with standard CVCs. Results are presented in forest plots with 95% confidence intervals. RESULTS: Thirty-eight randomized controlled trials met the inclusion criteria. Methodologic quality was generally poor. Meta-analyses of data from 27 trials assessing CRBSI showed a strong treatment effect in favor of AI-CVCs (odds ratio 0.49 (95% confidence interval 0.37-0.64) fixed effects, test for heterogeneity, chi-square = 28.78, df = 26, p = 0.321, I = 9.7). Results subgrouped by the different types of anti-infective treatments generally demonstrated treatment effects favoring the treated catheters. Sensitivity analyses investigating the effects of methodologic differences showed no differences to the overall conclusions of the primary analysis. CONCLUSION: AI-CVCs appear to be effective in reducing CRBSI compared with standard CVCs. However, it is important to establish whether this effect remains in settings where infection-prevention bundles of care are established as routine practice. This review does not address this question and further research is required.

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OBJECTIVE: To determine efficacy of hypertonic sodium bicarbonate in narrowing QRS prolongation produced by chloroquine. DESIGN: Randomized, controlled animal experiment using an accepted rat model of sodium channel blockade. METHODS: Hypotension and widening of QRS complexes (lead II) of the ECG were produced in 16 rats by administration of a total of 87 mg/kg chloroquine intravenously over 20 minutes. Eight rats were treated with 6 mL/kg 1 M sodium bicarbonate intravenously over two minutes beginning ten minutes into the chloroquine infusion. Serial measurements of QRS duration and systolic blood pressure were obtained for 30 minutes. RESULTS: QRS intervals narrowed more rapidly in animals receiving sodium bicarbonate (p = .045), although the difference in mean rate of narrowing between groups was modest at only .23 msec/min. Because of large variances, no statistically significant differences could be demonstrated in systolic blood pressure. CONCLUSIONS: Hypertonic sodium bicarbonate partially reversed sodium channel blockade and resultant QRS interval prolongation produced by chloroquine in rats. These data should be interpreted with caution, given the need to extrapolate to humans and the modest effect of sodium bicarbonate on QRS narrowing.

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It is a frequent observation that individuals differ markedly in their success at voluntary heart rate control. Several dispositional variables have now received attention as possible sources of such individual variation. These are critically reviewed under the following headings: resting and stimulus-elicited heart rate characteristics; autonomic and cardiac perception; imagery vividness; locus of control; trait anxiety. It is concluded that the research on individual differences in cardiac control to date is contributing to a clearer understanding of the mechanisms underlying control. However, for this contribution to be sustained, research needs to service explicit hypotheses about mediating processes. The often arbitrary and atheoretical practices that characterize much of the research in the more general context of individual differences in physiological activity must be avoided.

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