Population and contact tracer uptake of New Zealand's QR-code-based digital contact tracing app for COVID-19.

This study aimed to understand the population and contact tracer uptake of the quick response (QR)-code-based function of the New Zealand COVID Tracer App (NZCTA) used for digital contact tracing (DCT). We used a retrospective cohort of all COVID-19 cases between August 2020 and February 2022. Cases of Asian and other ethnicities were 2.6 times (adjusted relative risk (aRR) 2.58, 99 per cent confidence interval (95% CI) 2.18, 3.05) and 1.8 times (aRR 1.81, 95% CI 1.58, 2.06) more likely than Maori cases to generate a token during the Delta period, and this persisted during the Omicron period. Contact tracing organization also influenced location token generation with cases handled by National Case Investigation Service (NCIS) staff being 2.03 (95% CI 1.79, 2.30) times more likely to generate a token than cases managed by clinical staff at local Public Health Units (PHUs). Public uptake and participation in the location-based system independent of contact tracer uptake were estimated at 45%. The positive predictive value (PPV) of the QR code system was estimated to be close to nil for detecting close contacts but close to 100% for detecting casual contacts. Our paper shows that the QR-code-based function of the NZCTA likely made a negligible impact on the COVID-19 response in New Zealand (NZ) in relation to isolating potential close contacts of cases but likely was effective at identifying and notifying casual contacts.

Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials: a meta-epidemiological study.

BACKGROUND: Researchers and decision-makers often use evidence from randomised controlled trials (RCTs) to determine the efficacy or effectiveness of a treatment or intervention. Studies with observational designs are often used to measure the effectiveness of an intervention in 'real world' scenarios. Numerous study designs and their modifications (including both randomised and observational designs) are used for comparative effectiveness research in an attempt to give an unbiased estimate of whether one treatment is more effective or safer than another for a particular population. An up-to-date systematic analysis is needed to identify differences in effect estimates from RCTs and observational studies. This updated review summarises the results of methodological reviews that compared the effect estimates of observational studies with RCTs from evidence syntheses that addressed the same health research question. OBJECTIVES: To assess and compare synthesised effect estimates by study type, contrasting RCTs with observational studies. To explore factors that might explain differences in synthesised effect estimates from RCTs versus observational studies (e.g. heterogeneity, type of observational study design, type of intervention, and use of propensity score adjustment). To identify gaps in the existing research comparing effect estimates across different study types. SEARCH METHODS: We searched MEDLINE, the Cochrane Database of Systematic Reviews, Web of Science databases, and Epistemonikos to May 2022. We checked references, conducted citation searches, and contacted review authors to identify additional reviews. SELECTION CRITERIA: We included systematic methodological reviews that compared quantitative effect estimates measuring the efficacy or effectiveness of interventions tested in RCTs versus in observational studies. The included reviews compared RCTs to observational studies (including retrospective and prospective cohort, case-control and cross-sectional designs). Reviews were not eligible if they compared RCTs with studies that had used some form of concurrent allocation. DATA COLLECTION AND ANALYSIS: Using results from observational studies as the reference group, we examined the relative summary effect estimates (risk ratios (RRs), odds ratios (ORs), hazard ratios (HRs), mean differences (MDs), and standardised mean differences (SMDs)) to evaluate whether there was a relatively larger or smaller effect in the ratio of odds ratios (ROR) or ratio of risk ratios (RRR), ratio of hazard ratios (RHR), and difference in (standardised) mean differences (D(S)MD). If an included review did not provide an estimate comparing results from RCTs with observational studies, we generated one by pooling the estimates for observational studies and RCTs, respectively. Across all reviews, we synthesised these ratios to produce a pooled ratio of ratios comparing effect estimates from RCTs with those from observational studies. In overviews of reviews, we estimated the ROR or RRR for each overview using observational studies as the reference category. We appraised the risk of bias in the included reviews (using nine criteria in total). To receive an overall low risk of bias rating, an included review needed: explicit criteria for study selection, a complete sample of studies, and to have controlled for study methodological differences and study heterogeneity. We assessed reviews/overviews not meeting these four criteria as having an overall high risk of bias. We assessed the certainty of the evidence, consisting of multiple evidence syntheses, with the GRADE approach. MAIN RESULTS: We included 39 systematic reviews and eight overviews of reviews, for a total of 47. Thirty-four of these contributed data to our primary analysis. Based on the available data, we found that the reviews/overviews included 2869 RCTs involving 3,882,115 participants, and 3924 observational studies with 19,499,970 participants. We rated 11 reviews/overviews as having an overall low risk of bias, and 36 as having an unclear or high risk of bias. Our main concerns with the included reviews/overviews were that some did not assess the quality of their included studies, and some failed to account appropriately for differences between study designs - for example, they conducted aggregate analyses of all observational studies rather than separate analyses of cohort and case-control studies. When pooling RORs and RRRs, the ratio of ratios indicated no difference or a very small difference between the effect estimates from RCTs versus from observational studies (ratio of ratios 1.08, 95% confidence interval (CI) 1.01 to 1.15). We rated the certainty of the evidence as low. Twenty-three of 34 reviews reported effect estimates of RCTs and observational studies that were on average in agreement. In a number of subgroup analyses, small differences in the effect estimates were detected: - pharmaceutical interventions only (ratio of ratios 1.12, 95% CI 1.04 to 1.21); - RCTs and observational studies with substantial or high heterogeneity; that is, I2 ≥ 50% (ratio of ratios 1.11, 95% CI 1.04 to 1.18); - no use (ratio of ratios 1.07, 95% CI 1.03 to 1.11) or unclear use (ratio of ratios 1.13, 95% CI 1.03 to 1.25) of propensity score adjustment in observational studies; and - observational studies without further specification of the study design (ratio of ratios 1.06, 95% CI 0.96 to 1.18). We detected no clear difference in other subgroup analyses. AUTHORS' CONCLUSIONS: We found no difference or a very small difference between effect estimates from RCTs and observational studies. These findings are largely consistent with findings from recently published research. Factors other than study design need to be considered when exploring reasons for a lack of agreement between results of RCTs and observational studies, such as differences in the population, intervention, comparator, and outcomes investigated in the respective studies. Our results underscore that it is important for review authors to consider not only study design, but the level of heterogeneity in meta-analyses of RCTs or observational studies. A better understanding is needed of how these factors might yield estimates reflective of true effectiveness.

Sexually Transmitted Infections and the Risk of Reinfection Within 12 Months: A Population-Based Cohort.

BACKGROUND: Chlamydia, gonorrhea, and syphilis are common sexually transmitted infections that disproportionately affect specific groups in New Zealand (NZ). Predictors of reinfection are not well studied in NZ but could inform public health strategies to decrease sexually transmitted infection (STI) incidence. METHODS: New Zealand-wide chlamydia, gonorrhea, and syphilis cases during 2019 were identified using nationally collected data. Cases were followed-up to identify reinfection with the same STI within 12 months of initial infections. Logistic regression models were used to identify predictors for each STI reinfection. RESULTS: Determinants identified for increased odds of chlamydia reinfection were age groups 16-19 and 20-24 years, females, Maori and Pacific peoples, cases in the Northern region, and cases with at least one test before the initial infection. Age 40 years and older was associated with lower odds of gonorrhea reinfection, as was being of Asian ethnicity, living in Midland or Southern regions, and reporting heterosexual behavior. Region was the only statistically significant predictor for syphilis reinfection, with higher odds of reinfection for people living in the Central region. CONCLUSIONS: Our findings reflect disproportionate STI rates for some groups in NZ, with younger age groups, Maori and Pacific peoples, men who have sex with men, and people living in the Northern region experiencing higher odds of reinfection. Groups identified with higher odds for reinfection require increased access to culturally responsive health services to treat, understand, and prevent possible reinfection. Changes to current public health strategies could include culturally specific behavioral counseling, and improvements to and adherence to effective contract tracing.

Pilot of a digital contact tracing card in a hospital setting in New Zealand, 2020.

Countries are rapidly developing digital contact tracing solutions to augment manual contact tracing. There is limited empirical evidence evaluating these tools. We conducted a feasibility study of a Bluetooth-enabled card with hospital staff in New Zealand (n = 42). We compared the card data against self-report contact surveys and a stronger Bluetooth device. The cards detected substantially more contacts than self-report contact surveys, while the concordance between Bluetooth devices was high, suggesting that the cards detected clinically relevant close contacts. There was high acceptability among participants, suggesting that their integration would be accepted by healthcare staff. As the pandemic shifts, there is a need to rapidly contact trace and conduct informed risk management, particularly in critical settings such as healthcare.

Invasive Pneumococcal Disease: Concerning Trends in Serotype 19A Notifications in New Zealand.

New Zealand (NZ) is one of few countries to shift from PCV13 to PCV10. The number of serotype 19A cases in young children and the proportions of isolates that are penicillin-resistant have been steadily increasing since. It is time for NZ to reconsider its choice of pneumococcal vaccine.

Population rates of HIV, gonorrhoea and syphilis diagnoses by sexual orientation in New Zealand.

INTRODUCTION: Globally, gay and bisexual men (GBM) are over-represented in HIV, syphilis and gonorrhoea cases. However, surveillance systems rarely provide meaningful measures of inequity, such as population-specific rates, due to a lack of sexual orientation denominators. HIV, gonorrhoea and syphilis are legally notifiable diseases in New Zealand (NZ); we calculate rates by sexual orientation for the first time. METHODS: We analysed 2019 national surveillance data on HIV, syphilis and gonorrhoea notifications disaggregated by sexual orientation. Unique health records identified duplicate notifications and reinfections. Missing data were imputed from known cases. We used the NZ Health Survey 2014/2015 to estimate population sizes by sexual orientation, measured in two ways (current sexual identity, sexual contact in the previous 12 months with men, women or both). We calculated notification rates per 100 000 for each sexual orientation subgroup and rate ratios. RESULTS: In 2019, GBM accounted for 76.3%, 65.7% and 39.4% of HIV, syphilis and gonorrhoea notifications, respectively. Population rates per 100 000 for HIV were 158.3 (gay/bisexual men) and 0.5 (heterosexuals); for syphilis, population rates per 100 000 were 1231.1 (gay/bisexual men), 5.0 (lesbian/bisexual women) and 7.6 (heterosexuals); for gonorrhoea (imputed), population rates per 100 000 were 6843.2 (gay/bisexual men), 225.1 (lesbian/bisexual women) and 120.9 (heterosexuals). The rate ratios for GBM compared with heterosexuals were: 348.3 (HIV); 162.7 (syphilis); and 56.6 (gonorrhoea). Inequities remained in sensitivity analysis (substituting sexual identity with sexual behaviour in the previous 12 months). CONCLUSION: GBM in NZ experience profound inequities in HIV, syphilis and gonorrhoea. Rate ratios by sexual orientation provide useful 'at-a-glance' measures of inequity in disease incidence.

Will Coronavirus Disease 2019 Become Seasonal?

This manuscript explores the question of the seasonality of severe acute respiratory syndrome coronavirus 2 by reviewing 4 lines of evidence related to viral viability, transmission, ecological patterns, and observed epidemiology of coronavirus disease 2019 in the Southern Hemispheres' summer and early fall.

Digital contact tracing technologies in epidemics: a rapid review.

BACKGROUND: Reducing the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a global priority. Contact tracing identifies people who were recently in contact with an infected individual, in order to isolate them and reduce further transmission. Digital technology could be implemented to augment and accelerate manual contact tracing. Digital tools for contact tracing may be grouped into three areas: 1) outbreak response; 2) proximity tracing; and 3) symptom tracking. We conducted a rapid review on the effectiveness of digital solutions to contact tracing during infectious disease outbreaks. OBJECTIVES: To assess the benefits, harms, and acceptability of personal digital contact tracing solutions for identifying contacts of an identified positive case of an infectious disease. SEARCH METHODS: An information specialist searched the literature from 1 January 2000 to 5 May 2020 in CENTRAL, MEDLINE, and Embase. Additionally, we screened the Cochrane COVID-19 Study Register. SELECTION CRITERIA: We included randomised controlled trials (RCTs), cluster-RCTs, quasi-RCTs, cohort studies, cross-sectional studies and modelling studies, in general populations. We preferentially included studies of contact tracing during infectious disease outbreaks (including COVID-19, Ebola, tuberculosis, severe acute respiratory syndrome virus, and Middle East respiratory syndrome) as direct evidence, but considered comparative studies of contact tracing outside an outbreak as indirect evidence. The digital solutions varied but typically included software (or firmware) for users to install on their devices or to be uploaded to devices provided by governments or third parties. Control measures included traditional or manual contact tracing, self-reported diaries and surveys, interviews, other standard methods for determining close contacts, and other technologies compared to digital solutions (e.g. electronic medical records). DATA COLLECTION AND ANALYSIS: Two review authors independently screened records and all potentially relevant full-text publications. One review author extracted data for 50% of the included studies, another extracted data for the remaining 50%; the second review author checked all the extracted data. One review author assessed quality of included studies and a second checked the assessments. Our outcomes were identification of secondary cases and close contacts, time to complete contact tracing, acceptability and accessibility issues, privacy and safety concerns, and any other ethical issue identified. Though modelling studies will predict estimates of the effects of different contact tracing solutions on outcomes of interest, cohort studies provide empirically measured estimates of the effects of different contact tracing solutions on outcomes of interest. We used GRADE-CERQual to describe certainty of evidence from qualitative data and GRADE for modelling and cohort studies. MAIN RESULTS: We identified six cohort studies reporting quantitative data and six modelling studies reporting simulations of digital solutions for contact tracing. Two cohort studies also provided qualitative data. Three cohort studies looked at contact tracing during an outbreak, whilst three emulated an outbreak in non-outbreak settings (schools). Of the six modelling studies, four evaluated digital solutions for contact tracing in simulated COVID-19 scenarios, while two simulated close contacts in non-specific outbreak settings. Modelling studies Two modelling studies provided low-certainty evidence of a reduction in secondary cases using digital contact tracing (measured as average number of secondary cases per index case - effective reproductive number (R eff)). One study estimated an 18% reduction in R eff with digital contact tracing compared to self-isolation alone, and a 35% reduction with manual contact-tracing. Another found a reduction in R eff for digital contact tracing compared to self-isolation alone (26% reduction) and a reduction in R eff for manual contact tracing compared to self-isolation alone (53% reduction). However, the certainty of evidence was reduced by unclear specifications of their models, and assumptions about the effectiveness of manual contact tracing (assumed 95% to 100% of contacts traced), and the proportion of the population who would have the app (53%). Cohort studies Two cohort studies provided very low-certainty evidence of a benefit of digital over manual contact tracing. During an Ebola outbreak, contact tracers using an app found twice as many close contacts per case on average than those using paper forms. Similarly, after a pertussis outbreak in a US hospital, researchers found that radio-frequency identification identified 45 close contacts but searches of electronic medical records found 13. The certainty of evidence was reduced by concerns about imprecision, and serious risk of bias due to the inability of contact tracing study designs to identify the true number of close contacts. One cohort study provided very low-certainty evidence that an app could reduce the time to complete a set of close contacts. The certainty of evidence for this outcome was affected by imprecision and serious risk of bias. Contact tracing teams reported that digital data entry and management systems were faster to use than paper systems and possibly less prone to data loss. Two studies from lower- or middle-income countries, reported that contact tracing teams found digital systems simpler to use and generally preferred them over paper systems; they saved personnel time, reportedly improved accuracy with large data sets, and were easier to transport compared with paper forms. However, personnel faced increased costs and internet access problems with digital compared to paper systems. Devices in the cohort studies appeared to have privacy from contacts regarding the exposed or diagnosed users. However, there were risks of privacy breaches from snoopers if linkage attacks occurred, particularly for wearable devices. AUTHORS' CONCLUSIONS: The effectiveness of digital solutions is largely unproven as there are very few published data in real-world outbreak settings. Modelling studies provide low-certainty evidence of a reduction in secondary cases if digital contact tracing is used together with other public health measures such as self-isolation. Cohort studies provide very low-certainty evidence that digital contact tracing may produce more reliable counts of contacts and reduce time to complete contact tracing. Digital solutions may have equity implications for at-risk populations with poor internet access and poor access to digital technology. Stronger primary research on the effectiveness of contact tracing technologies is needed, including research into use of digital solutions in conjunction with manual systems, as digital solutions are unlikely to be used alone in real-world settings. Future studies should consider access to and acceptability of digital solutions, and the resultant impact on equity. Studies should also make acceptability and uptake a primary research question, as privacy concerns can prevent uptake and effectiveness of these technologies.

From ED overcrowding to jail overcrowding: a cautionary tale of a Serial Inebriate Programme (SIP).

INTRODUCTION: Community-based programmes have been implemented to curtail ED use by individuals with chronic public intoxication. Among these programmes is the Serial Inebriate Programme (SIP), which aims to reduce use of ED and emergency medical services. We present the results of an evaluation of the SIP in Santa Cruz, California, including data on the participants' police and jail history, information not considered in prior analyses of SIPs. METHODS: In the present study, we used a retrospective cohort to evaluate the effectiveness of the SIP in Santa Cruz, California from 2013 to 2015. Specifically, we looked at the programme effects on participants' arrests, nights in jail, use of the local ED and ambulance services after programme adjudication. RESULTS: The median number of visits to the ED for participants before and after adjudication was reduced from 4 to 1, and participants showed a significant decrease in their number of jail bookings following adjudication (-4.5 bookings; p=0.004). However, the average number of nights in jail served by participants after adjudication was 2.1 times the average number of nights spent in jail spent before programme adjudication (58.5 vs 27.6 nights in jail for postadjudication and preadjudication groups, respectively; p=0.009). CONCLUSIONS: Our findings suggest that the Santa Cruz SIP had some impact in reducing participants' use of emergency services, but at the cost of increased jail time. The burdens of placing chronically intoxicated individuals in jail for extended periods of time are not trivial and should not be overlooked when designing and implementing a SIP.

Measuring the Value of a Clinical Practice Guideline for Children With Perforated Appendicitis.

OBJECTIVE: To determine the incremental cost-effectiveness of a clinical practice guideline (CPG) compared with "usual care" for treatment of perforated appendicitis in children. Secondary objective was to compare cost analyses using hospital accounting system data versus data in the Pediatric Health Information System (PHIS). BACKGROUND: Value-based surgical care (outcomes relative to costs) is frequently touted, but outcomes and costs are rarely measured together. METHODS: During an 18-month period, 122 children with perforated appendicitis at a tertiary referral children's hospital were treated using an evidence-based CPG. Clinical outcomes and costs for the CPG cohort were compared with patients in the 30-month period before CPG implementation (n = 191 children). RESULTS: With CPG-directed care, intra-abdominal abscess rate decreased from 0.24 to 0.10 (adjusted risk ratio 0.44, 95% confidence interval [CI] 0.26-0.75). The rate of any adverse event decreased from 0.30 to 0.23 (adjusted risk ratio 0.82, 95% CI 0.58-1.17). Mean total hospital costs per patient (hospital accounting system) decreased from $16,466 to $10,528 (adjusted absolute difference-$5451, 95% CI -$7755 to -$3147), leading to estimated adjusted total savings of $665,022 during the study period. Costs obtained from the PHIS database also showed reduction with CPG-directed care (-$6669, 95% CI -$8949 to -$4389 per patient). In Bayesian cost-effectiveness analyses, likelihood that CPG was the dominant strategy was 91%. CONCLUSIONS: An evidence-based CPG increased the value of surgical care for children with perforated appendicitis by improving outcomes and lowering costs. Hospital cost accounting data and pre-existing cost data within the PHIS database provided similar results.

Nonindustry-sponsored preclinical studies on statins yield greater efficacy estimates than industry-sponsored studies: a meta-analysis.

Industry-sponsored clinical drug studies are associated with publication of outcomes that favor the sponsor, even when controlling for potential bias in the methods used. However, the influence of sponsorship bias has not been examined in preclinical animal studies. We performed a meta-analysis of preclinical statin studies to determine whether industry sponsorship is associated with either increased effect sizes of efficacy outcomes and/or risks of bias in a cohort of published preclinical statin studies. We searched Medline (January 1966-April 2012) and identified 63 studies evaluating the effects of statins on atherosclerosis outcomes in animals. Two coders independently extracted study design criteria aimed at reducing bias, results for all relevant outcomes, sponsorship source, and investigator financial ties. The I(2) statistic was used to examine heterogeneity. We calculated the standardized mean difference (SMD) for each outcome and pooled data across studies to estimate the pooled average SMD using random effects models. In a priori subgroup analyses, we assessed statin efficacy by outcome measured, sponsorship source, presence or absence of financial conflict information, use of an optimal time window for outcome assessment, accounting for all animals, inclusion criteria, blinding, and randomization. The effect of statins was significantly larger for studies sponsored by nonindustry sources (-1.99; 95% CI -2.68, -1.31) versus studies sponsored by industry (-0.73; 95% CI -1.00, -0.47) (p value<0.001). Statin efficacy did not differ by disclosure of financial conflict information, use of an optimal time window for outcome assessment, accounting for all animals, inclusion criteria, blinding, and randomization. Possible reasons for the differences between nonindustry- and industry-sponsored studies, such as selective reporting of outcomes, require further study.

Suicide Rates and Methods in Active Duty Military Personnel, 2005 to 2011: A Cohort Study.

BACKGROUND: Suicide prevention programs have become ubiquitous among military units; identifying temporal trends and nonclinical factors associated with the chosen suicide methods may help improve suicide prevention strategies. OBJECTIVE: To calculate suicide rates of active duty military personnel and identify those who are at risk for firearm-specific suicide. DESIGN: Retrospective cohort study. SETTING: Military units in the United States. PATIENTS: All active duty enlisted U.S. military personnel from 2005 to 2011. MEASUREMENTS: Suicide rates per 100 000 were calculated for each branch. Adjusted odds ratios for firearm-specific suicide were calculated with 95% CIs. RESULTS: 1455 military personnel committed suicide from 2005 to 2011. From 2006 to 2011, the rates were highest among army personnel (19.13 to 29.44 cases per 100 000). Among suicides with a known cause of death, 62% were attributed to firearms. The results of this study also suggest that among army personnel or marines who committed suicide, those with infantry or special operations job classifications were more likely than those in noninfantry positions to use a firearm. LIMITATIONS: Results are generalizable only to enlisted personnel and reflect only stateside suicides. Data regarding previous psychiatric illness, deployment history, and firearms ownership were lacking. CONCLUSION: These results may help inform policymakers and advisors about differences in risks of suicide and violent suicide among the armed services and may help guide efforts to prevent self-harm within the military. PRIMARY FUNDING SOURCE: None.

Results of the Women's Self-Performed Anal Pap Trial in Human Immunodeficiency Virus-Infected Women.

High-risk human papillomavirus anal infections are common in human immunodeficiency virus-infected women. We conducted a cross-over study in 30 women seen in a California human immunodeficiency virus clinic, to test the feasibility of self-performed anal Pap smears. Women found the tests acceptable and feasible. Compared with physician-collected specimens, results were highly concordant for anal cytology (κ = 0.53) and high-risk human papillomavirus typing (κ = 0.59 inclusive of equivocal results, or κ = 0.81 excluding equivocal results).

A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial of Aminophylline to Prevent Acute Kidney Injury in Children Following Congenital Heart Surgery With Cardiopulmonary Bypass.

OBJECTIVES: Acute kidney injury occurs commonly in children following congenital cardiac surgery with cardiopulmonary bypass and has been associated with increased morbidity and mortality. Aminophylline, a methylxanthine nonselective adenosine receptor antagonist, has been effective in the management of acute kidney injury in certain populations. This study sought to determine whether postoperative administration of aminophylline attenuates acute kidney injury in children undergoing congenital cardiac surgery with cardiopulmonary bypass. DESIGN: Single-center, double-blinded, placebo-controlled, randomized clinical trial. SETTING: Tertiary center, pediatric cardiovascular ICU. PATIENTS: A total of 144 children after congenital heart surgery with cardiopulmonary bypass. INTERVENTIONS: Seventy-two patients were randomized to receive aminophylline and 72 patients received placebo. Study drug was administered every 6 hours for 72 hours. MEASUREMENTS AND MAIN RESULTS: The primary outcome variable was the development of any acute kidney injury, defined by the serum creatinine criteria of the Kidney Diseases: Improving Global Outcomes. Secondary outcomes included the development of severe acute kidney injury, time between cardiovascular ICU admission and first successful extubation, percent fluid overload, total fluid balance, urine output, bioelectrical impedance, and serum neutrophil gelatinase-associated lipocalin. The unadjusted rate and severity of acute kidney injury were not different between groups; 43 of 72 (60%) of the treatment group and 36 of 72 (50%) of the placebo group developed acute kidney injury (p = 0.32). Stage 2/3 acute kidney injury occurred in 23 of 72 (32%) of the treatment group and 15 of 72 (21%) of the placebo group (p = 0.18). Secondary outcome measures also demonstrated no significant difference between treatment and placebo groups. Aminophylline administration was safe; no deaths occurred in either group, and rates of adverse events were similar (14% in the treatment group vs 18% in the placebo group; p = 0.30). CONCLUSIONS: In this placebo-controlled randomized clinical trial, we found no effect of aminophylline to prevent acute kidney injury in children recovering from cardiac surgery performed with cardiopulmonary bypass. Future study of preoperative aminophylline administration to prevent acute kidney injury may be warranted.

Industry sponsorship and publication bias among animal studies evaluating the effects of statins on atherosclerosis and bone outcomes: a meta-analysis.

BACKGROUND: The effect that sponsorship has on publication rates or overall effect estimates in animal studies is unclear, though methodological biases are prevalent in animal studies of statins and there may be differences in efficacy estimates between industry and non-industry sponsored studies. In the present analysis, we evaluated the impact of funding source on publication bias in animal studies estimating the effect of statins on atherosclerosis and bone outcomes. METHODS: We conducted two independent systematic reviews and meta-analyses identifying animal studies evaluating the effect of statins on reducing the risk of atherosclerosis outcomes (n = 49) and increasing the likelihood of beneficial bone outcomes (n = 45). After stratifying the included studies within each systematic review by funding source, three separate analyses were employed to assess publication bias in these meta-analyses­funnel plots, Egger's Linear Regression, and the Trim and Fill methods. RESULTS: We found potential evidence of publication bias, primarily in non-industry sponsored studies. In all 3 assessments of publication bias, we found evidence of publication bias in non-industry sponsored studies, while in industry-sponsored studies publication bias was not evident in funnel plots and Egger's regression tests. We also found that inadequate reporting of sponsorship in animal studies is still exceedingly common. CONCLUSIONS: In meta-analyses assessing the effects of statins on atherosclerosis and bone outcomes in animal studies, we found evidence of publication bias, though small numbers of industry-sponsored studies limit the interpretation of the trim-and-fill results. This publication bias is more prominent in non-industry sponsored studies. Industry and non-industry funded researchers may have different incentives for publication. Industry may have a financial interest to publish all preclinical animal studies to maximize the success of subsequent trials in humans, whereas non-industry funded academics may prefer to publish high impact statistically significant results only. Differences in previously published effect estimates between industry- and non-industry sponsored animal studies may be partially explained by publication bias.

The accessibility of firearms and risk for suicide and homicide victimization among household members: a systematic review and meta-analysis.

BACKGROUND: Research suggests that access to firearms in the home increases the risk for violent death. PURPOSE: To understand current estimates of the association between firearm availability and suicide or homicide. DATA SOURCES: PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, and Web of Science were searched without limitations and a gray-literature search was performed on 23 August 2013. STUDY SELECTION: All study types that assessed firearm access and outcomes between participants with and without firearm access. There were no restrictions on age, sex, or country. DATA EXTRACTION: Two authors independently extracted data into a standardized, prepiloted data extraction form. DATA SYNTHESIS: Odds ratios (ORs) and 95% CIs were calculated, although published adjusted estimates were preferentially used. Summary effects were estimated using random- and fixed-effects models. Potential methodological reasons for differences in effects through subgroup analyses were explored.Data were pooled from 16 [not 15] observational studies that assessed he odds of suicide or homicide, yielding pooled ORs of 3.24(95% CI, 2.41 to 4.40) and 2.00 (CI, 1.56 to 3.02) [not 1.94 (CI, .44 to 2.93)], respectively [corrected], respectively. When only studies that used interviews to determine firearm accessibility were considered, the pooled OR for suicide was 3.14 (CI, 2.29 to 4.43). LIMITATIONS: Firearm accessibility was determined by survey interviews in most studies; misclassification of accessibility may have occurred. Heterogeneous populations of varying risks were synthesized to estimate pooled odds of death. CONCLUSION: Access to firearms is associated with risk for completed suicide and being the victim of homicide. PRIMARY FUNDING SOURCE: None.