Reporting quality of abstracts of randomized controlled trials published in dental specialty journals

OBJECTIVES A widespread assessment of the reporting of RCT abstracts published in dental journals is lacking. Our aim was to investigate the quality of reporting of abstracts published in leading dental specialty journals using, as a guide, the CONSORT for abstracts checklist. METHODS Electronic and supplementary hand searching were undertaken to identify RCTs published in seven dental specialty journals. The quality of abstract reporting was evaluated using a modified checklist based on the CONSORT for abstracts checklist. Descriptive statistics followed by univariate and multivariate analyses were conducted. RESULTS 228 RCT abstracts were identified. Reporting of interventions, objectives and conclusions within abstracts were adequate. Inadequately reported items included: title, participants, outcomes, random number generation, numbers randomized and effect size estimate. Randomization restrictions, allocation concealment, blinding, numbers analyzed, confidence intervals, intention-to-treat analysis, harms, registration and funding were rarely described. CONCLUSIONS The mean overall reporting quality score was suboptimal at 62.5% (95% CI: 61.9, 63.0). Significantly better abstract reporting was noted in certain specialty journals and in multicenter trials.

Researcher allegiance in psychotherapy outcome research: an overview of reviews

Researcher allegiance (RA) is widely discussed as a risk of bias in psychotherapy outcome research. The relevance attached to RA bias is related to meta-analyses demonstrating an association of RA with treatment effects. However, recent meta-analyses have yielded mixed results. To provide more clarity on the magnitude and robustness of the RA-outcome association this article reports on a meta-meta-analysis summarizing all available meta-analytic estimates of the RA-outcome association. Random-effects methods were used. Primary study overlap was controlled. Thirty meta-analyses were included. The mean RA-outcome association was r=.262 (p=.002, I(2)=28.98%), corresponding to a moderate effect size. The RA-outcome association was robust across several moderating variables including characteristics of treatment, population, and the type of RA assessment. Allegiance towards the RA bias hypothesis moderated the RA-outcome association. The findings of this meta-meta-analysis suggest that the RA-outcome association is substantial and robust. Implications for psychotherapy outcome research are discussed.

Efficacy of psychological interventions for sexual dysfunction: a systematic review and meta-analysis

Sexual dysfunction is highly prevalent in the general population and associated with psychological distress and impaired sexual satisfaction. Psychological interventions are promising treatment options, as sexual dysfunction is frequently caused by and deteriorates because of psychological factors. However, research into the efficacy of psychological interventions is rather scarce and an up-to-date review of outcome studies is currently lacking. Therefore, we conducted a systematic review and meta-analysis of all available studies from 1980 to 2009 to examine the efficacy of psychological interventions for patients with sexual dysfunction. A total of 20 randomized controlled studies comparing a psychological intervention with a wait-list were included in the meta-analysis. The overall post-treatment effect size for symptom severity was d = 0.58 (95% CI: 0.40 to 0.77) and for sexual satisfaction d = 0.47 (95% CI: 0.27 to 0.70). Psychological interventions were shown to especially improve symptom severity for women with Hypoactive Sexual Desire Disorder and orgasmic disorder. Our systematic review of 14 studies comparing at least two active interventions head-to-head revealed that very few comparative studies are available with large variability in effect sizes across studies (d between -0.69 and 2.29 for symptom severity and -0.56 and 14.02 for sexual satisfaction). In conclusion, psychological interventions are effective treatment options for sexual dysfunction. However, evidence varies considerably across single disorders. Good evidence exists to date for female hypoactive sexual desire disorder and female orgasmic disorder. Further research is needed on psychological interventions for other sexual dysfunctions, their long-term and comparative effects.

Effects of study precision and risk of bias in networks of interventions: a network meta-epidemiological study

BACKGROUND Empirical research has illustrated an association between study size and relative treatment effects, but conclusions have been inconsistent about the association of study size with the risk of bias items. Small studies give generally imprecisely estimated treatment effects, and study variance can serve as a surrogate for study size. METHODS We conducted a network meta-epidemiological study analyzing 32 networks including 613 randomized controlled trials, and used Bayesian network meta-analysis and meta-regression models to evaluate the impact of trial characteristics and study variance on the results of network meta-analysis. We examined changes in relative effects and between-studies variation in network meta-regression models as a function of the variance of the observed effect size and indicators for the adequacy of each risk of bias item. Adjustment was performed both within and across networks, allowing for between-networks variability. RESULTS Imprecise studies with large variances tended to exaggerate the effects of the active or new intervention in the majority of networks, with a ratio of odds ratios of 1.83 (95% CI: 1.09,3.32). Inappropriate or unclear conduct of random sequence generation and allocation concealment, as well as lack of blinding of patients and outcome assessors, did not materially impact on the summary results. Imprecise studies also appeared to be more prone to inadequate conduct. CONCLUSIONS Compared to more precise studies, studies with large variance may give substantially different answers that alter the results of network meta-analyses for dichotomous outcomes.

Safety and Efficacy of Lysergic Acid Diethylamide-Assisted Psychotherapy for Anxiety Associated With Life-threatening Diseases

A double-blind, randomized, active placebo-controlled pilot study was conducted to examine safety and efficacy of lysergic acid diethylamide (LSD)-assisted psychotherapy in 12 patients with anxiety associated with life-threatening diseases. Treatment included drug-free psychotherapy sessions supplemented by two LSD-assisted psychotherapy sessions 2 to 3 weeks apart. The participants received either 200 μg of LSD (n = 8) or 20 μg of LSD with an open-label crossover to 200 μg of LSD after the initial blinded treatment was unmasked (n = 4). At the 2-month follow-up, positive trends were found via the State-Trait Anxiety Inventory (STAI) in reductions in trait anxiety (p = 0.033) with an effect size of 1.1, and state anxiety was significantly reduced (p = 0.021) with an effect size of 1.2, with no acute or chronic adverse effects persisting beyond 1 day after treatment or treatment-related serious adverse events. STAI reductions were sustained for 12 months. These results indicate that when administered safely in a methodologically rigorous medically supervised psychotherapeutic setting, LSD can reduce anxiety, suggesting that larger controlled studies are warranted.This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.

An examination of the Gonorrhea Cases & Places Study: An analysis of the Theory of Gender and Power, Situational/Environmental Variables Theory, and Sexual Script Theory as it relates to risky sexual behavior in African American adults

Objective. The purpose of the study is to provide a holistic depiction of behavioral & environmental factors contributing to risky sexual behaviors among predominantly high school educated, low-income African Americans residing in urban areas of Houston, TX utilizing the Theory of Gender and Power, Situational/Environmental Variables Theory, and Sexual Script Theory. Methods. A cross-sectional study was conducted via questionnaires among 215 Houston area residents, 149 were women and 66 were male. Measures used to assess behaviors of the population included a history of homelessness, use of crack/cocaine among several other illicit drugs, the type of sexual partner, age of participant, age of most recent sex partner, whether or not participants sought health care in the last 12 months, knowledge of partner's other sexual activities, symptoms of depression, and places where partner's were met. In an effort to determine risk of sexual encounters, a risk index employing the variables used to assess condom use was created categorizing sexual encounters as unsafe or safe. Results. Variables meeting the significance level of p<.15 for the bivariate analysis of each theory were entered into a binary logistic regression analysis. The block for each theory was significant, suggesting that the grouping assignments of each variable by theory were significantly associated with unsafe sexual behaviors. Within the regression analysis, variables such as sex for drugs/money, low income, and crack use demonstrated an effect size of ≥ ± 1, indicating that these variables had a significant effect on unsafe sexual behavioral practices. Conclusions. Variables assessing behavior and environment demonstrated a significant effect when categorized by relation to designated theories.

Moving beyond transition outcomes: meta-analysis of remission rates in individuals at high clinical risk for psychosis

Recent evidence suggests that transition risks from initial clinical high risk (CHR) status to psychosis are decreasing. The role played by remission in this context is mostly unknown. The present study addresses this issue by means of a meta-analysis including eight relevant studies published up to January 2012 that reported remission rates from an initial CHR status. The primary effect size measure was the longitudinal proportion of remissions compared to non-remission in subjects with a baseline CHR state. Random effect models were employed to address the high heterogeneity across studies included. To assess the robustness of the results, we performed sensitivity analyses by sequentially removing each study and rerunning the analysis. Of 773 subjects who met initial CHR criteria, 73% did not convert to psychosis along a 2-year follow. Of these, about 46% fully remitted from the baseline attenuated psychotic symptoms, as evaluated on the psychometric measures usually employed by prodromal services. The corresponding clinical remission was estimated as high as 35% of the baseline CHR sample. The CHR state is associated with a significant proportion of remitting subjects that can be accounted by the effective treatments received, a lead time bias, a dilution effect, a comorbid effect of other psychiatric diagnoses.

Development of a Bayesian Joint Logistic Model to Better Study the Association between Haplotypes and Disease

In 2011, there will be an estimated 1,596,670 new cancer cases and 571,950 cancer-related deaths in the US. With the ever-increasing applications of cancer genetics in epidemiology, there is great potential to identify genetic risk factors that would help identify individuals with increased genetic susceptibility to cancer, which could be used to develop interventions or targeted therapies that could hopefully reduce cancer risk and mortality. In this dissertation, I propose to develop a new statistical method to evaluate the role of haplotypes in cancer susceptibility and development. This model will be flexible enough to handle not only haplotypes of any size, but also a variety of covariates. I will then apply this method to three cancer-related data sets (Hodgkin Disease, Glioma, and Lung Cancer). I hypothesize that there is substantial improvement in the estimation of association between haplotypes and disease, with the use of a Bayesian mathematical method to infer haplotypes that uses prior information from known genetics sources. Analysis based on haplotypes using information from publically available genetic sources generally show increased odds ratios and smaller p-values in both the Hodgkin, Glioma, and Lung data sets. For instance, the Bayesian Joint Logistic Model (BJLM) inferred haplotype TC had a substantially higher estimated effect size (OR=12.16, 95% CI = 2.47-90.1 vs. 9.24, 95% CI = 1.81-47.2) and more significant p-value (0.00044 vs. 0.008) for Hodgkin Disease compared to a traditional logistic regression approach. Also, the effect sizes of haplotypes modeled with recessive genetic effects were higher (and had more significant p-values) when analyzed with the BJLM. Full genetic models with haplotype information developed with the BJLM resulted in significantly higher discriminatory power and a significantly higher Net Reclassification Index compared to those developed with haplo.stats for lung cancer. Future analysis for this work could be to incorporate the 1000 Genomes project, which offers a larger selection of SNPs can be incorporated into the information from known genetic sources as well. Other future analysis include testing non-binary outcomes, like the levels of biomarkers that are present in lung cancer (NNK), and extending this analysis to full GWAS studies.

Cost and power analysis of linkage disequilibrium methods for locating genes influencing quantitative traits in humans

Linkage disequilibrium methods can be used to find genes influencing quantitative trait variation in humans. Linkage disequilibrium methods can require smaller sample sizes than linkage equilibrium methods, such as the variance component approach to find loci with a specific effect size. The increase in power is at the expense of requiring more markers to be typed to scan the entire genome. This thesis compares different linkage disequilibrium methods to determine which factors influence the power to detect disequilibrium. The costs of disequilibrium and equilibrium tests were compared to determine whether the savings in phenotyping costs when using disequilibrium methods outweigh the additional genotyping costs.^ Nine linkage disequilibrium tests were examined by simulation. Five tests involve selecting isolated unrelated individuals while four involved the selection of parent child trios (TDT). All nine tests were found to be able to identify disequilibrium with the correct significance level in Hardy-Weinberg populations. Increasing linked genetic variance and trait allele frequency were found to increase the power to detect disequilibrium, while increasing the number of generations and distance between marker and trait loci decreased the power to detect disequilibrium. Discordant sampling was used for several of the tests. It was found that the more stringent the sampling, the greater the power to detect disequilibrium in a sample of given size. The power to detect disequilibrium was not affected by the presence of polygenic effects.^ When the trait locus had more than two trait alleles, the power of the tests maximized to less than one. For the simulation methods used here, when there were more than two-trait alleles there was a probability equal to 1-heterozygosity of the marker locus that both trait alleles were in disequilibrium with the same marker allele, resulting in the marker being uninformative for disequilibrium.^ The five tests using isolated unrelated individuals were found to have excess error rates when there was disequilibrium due to population admixture. Increased error rates also resulted from increased unlinked major gene effects, discordant trait allele frequency, and increased disequilibrium. Polygenic effects did not affect the error rates. The TDT, Transmission Disequilibrium Test, based tests were not liable to any increase in error rates.^ For all sample ascertainment costs, for recent mutations ($<$100 generations) linkage disequilibrium tests were less expensive than the variance component test to carry out. Candidate gene scans saved even more money. The use of recently admixed populations also decreased the cost of performing a linkage disequilibrium test. ^

Robust estimates of climate-induced hydrological change in a temperate mountainous region

A sustainable water resources management depends on sound information about the impacts of climate change. This information is, however, not easily derived because natural runoff variability interferes with the climate change signal. This study presents a procedure that leads to robust estimates of magnitude and Time Of Emergence (TOE) of climate-induced hydrological change that also account for the natural variability contained in the time series. Firstly, natural variability of 189 mesoscale catchments in Switzerland is sampled for 10 ENSEMBLES scenarios for the control (1984–2005) and two scenario periods (near future: 2025–2046, far future: 2074–2095) applying a bootstrap procedure. Then, the sampling distributions of mean monthly runoff are tested for significant differences with the Wilcoxon-Mann–Whitney test and for effect size with Cliff’s delta d. Finally, the TOE of a climate change induced hydrological change is determined when at least eight out of the ten hydrological projections significantly differ from natural variability. The results show that the TOE occurs in the near future period except for high-elevated catchments in late summer. The significant hydrological projections in the near future correspond, however, to only minor runoff changes. In the far future, hydrological change is statistically significant and runoff changes are substantial. Temperature change is the most important factor determining hydrological change in this mountainous region. Therefore, hydrological change depends strongly on a catchment’s mean elevation. Considering that the hydrological changes are predicted to be robust in the near future highlights the importance of accounting for these changes in water resources planning.

Evidence from the real world: N-15 natural abundances reveal enhanced nitrogen use at high plant diversity in Central European grasslands

Complementarity that leads to more efficient resource use is presumed to be a key mechanism explaining positive biodiversity–productivity relationships but has been described solely for experimental set-ups with controlled environmental settings or for very short gradients of abiotic conditions, land-use intensity and biodiversity. Therefore, we analysed plant diversity effects on nitrogen dynamics across a broad range of Central European grasslands. The 15N natural abundance in soil and plant biomass reflects the net effect of processes affecting ecosystem N dynamics. This includes the mechanism of complementary resource utilization that causes a decrease in the 15N isotopic signal. We measured plant species richness, natural abundance of 15N in soil and plants, above-ground biomass of the community and three single species (an herb, grass and legume) and a variety of additional environmental variables in 150 grassland plots in three regions of Germany. To explore the drivers of the nitrogen dynamics, we performed several analyses of covariance treating the 15N isotopic signals as a function of plant diversity and a large set of covariates. Increasing plant diversity was consistently linked to decreased δ15N isotopic signals in soil, above-ground community biomass and the three single species. Even after accounting for multiple covariates, plant diversity remained the strongest predictor of δ15N isotopic signals suggesting that higher plant diversity leads to a more closed nitrogen cycle due to more efficient nitrogen use. Factors linked to increased δ15N values included the amount of nitrogen taken up, soil moisture and land-use intensity (particularly fertilization), all indicators of the openness of the nitrogen cycle due to enhanced N-turnover and subsequent losses. Study region was significantly related to the δ15N isotopic signals indicating that regional peculiarities such as former intensive land use could strongly affect nitrogen dynamics. Synthesis. Our results provide strong evidence that the mechanism of complementary resource utilization operates in real-world grasslands where multiple external factors affect nitrogen dynamics. Although single species may differ in effect size, actively increasing total plant diversity in grasslands could be an option to more effectively use nitrogen resources and to reduce the negative environmental impacts of nitrogen losses.

Effectiveness of integrated care including therapeutic assertive community treatment in severe schizophrenia spectrum and bipolar I disorders: the 24-month follow-up ACCESS II study

OBJECTIVE The ACCESS treatment model offers assertive community treatment embedded in an integrated care program to patients with psychoses. Compared to standard care and within a controlled study, it proved to be more effective in terms of service disengagement and illness outcomes in patients with schizophrenia spectrum disorders over 12 months. ACCESS was implemented into clinical routine and its effectiveness assessed over 24 months in severe schizophrenia spectrum disorders and bipolar I disorder with psychotic features (DSM-IV) in a cohort study. METHOD All 115 patients treated in ACCESS (from May 2007 to October 2009) were included in the ACCESS II study. The primary outcome was rate of service disengagement. Secondary outcomes were change of psychopathology, severity of illness, psychosocial functioning, quality of life, satisfaction with care, medication nonadherence, length of hospital stay, and rates of involuntary hospitalization. RESULTS Only 4 patients (3.4%) disengaged with the service. Another 11 (9.6%) left because they moved outside the catchment area. Patients received a mean of 1.6 outpatient contacts per week. Involuntary admissions decreased from 34.8% in the 2 previous years to 7.8% during ACCESS (P < .001). Mixed models repeated-measures analyses revealed significant improvements among all patients in psychopathology (effect size d = 0.64, P < .001), illness severity (d = 0.84, P = .03), functioning level (d = 0.65, P < .001), quality of life (d = 0.50, P < .001), and client satisfaction (d = 0.11, P < .001). At 24 months, 78.3% were fully adherent to medication, compared to 25.2% at baseline (P = .002). CONCLUSIONS ACCESS was successfully implemented in clinical routine and maintained excellent rates of service engagement and other outcomes in patients with schizophrenia spectrum disorders or bipolar I disorder with psychotic features over 24 months. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01888627.

Reporting of statistical results in prosthodontic and implantology journals: p values or confidence intervals?

PURPOSE Confidence intervals (CIs) are integral to the interpretation of the precision and clinical relevance of research findings. The aim of this study was to ascertain the frequency of reporting of CIs in leading prosthodontic and dental implantology journals and to explore possible factors associated with improved reporting. MATERIALS AND METHODS Thirty issues of nine journals in prosthodontics and implant dentistry were accessed, covering the years 2005 to 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 and Related Research, The International Journal of Oral & Maxillofacial Implants, Implant Dentistry, and Journal of Dentistry. Articles were screened and the reporting of CIs and P values recorded. Other information including study design, region of authorship, involvement of methodologists, and ethical approval was also obtained. Univariable and multivariable logistic regression was used to identify characteristics associated with reporting of CIs. RESULTS Interrater agreement for the data extraction performed was excellent (kappa = 0.88; 95% CI: 0.87 to 0.89). CI reporting was limited, with mean reporting across journals of 14%. CI reporting was associated with journal type, study design, and involvement of a methodologist or statistician. CONCLUSIONS Reporting of CI in implant dentistry and prosthodontic journals requires improvement. Improved reporting will aid appraisal of the clinical relevance of research findings by providing a range of values within which the effect size lies, thus giving the end user the opportunity to interpret the results in relation to clinical practice.

What constitutes vulnerable self-esteem? Comparing the prospective effects of low, unstable, and contingent self-esteem on depressive symptoms

A growing body of longitudinal studies suggests that low self-esteem is a risk factor for depression. However, it is unclear whether other characteristics of self-esteem, besides its level, explain incremental or even greater variance in subsequent depression. We examined the prospective effects of self-esteem level, instability (i.e., the degree of variability in self-esteem across short periods), and contingency (i.e., the degree to which self-esteem fluctuates in response to self-relevant events) on depressive symptoms in 1 overarching model, using data from 2 longitudinal studies. In Study 1, 372 adults were assessed at 2 waves over 6 months, including 40 daily diary assessments at Wave 1. In Study 2, 235 young adults were assessed at 2 waves over 6 weeks, including about 6 daily diary assessments at each wave. Self-esteem contingency was measured by self-report and by a statistical index based on the diary data (capturing event-related fluctuations in self-esteem). In both studies self-esteem level, but not self-esteem contingency, predicted subsequent depressive symptoms. Self-esteem instability predicted subsequent depressive symptoms in Study 2 only, with a smaller effect size than self-esteem level. Also, level, instability, and contingency of self-esteem did not interact in the prediction of depressive symptoms. Moreover, the effect of self-esteem level held when controlling for neuroticism and for all other Big Five personality traits. Thus, the findings provide converging evidence for a vulnerability effect of self-esteem level, tentative evidence for a smaller vulnerability effect of self-esteem instability, and no evidence for a vulnerability effect of self-esteem contingency.

Efficacy of motivational enhancement therapy on alcohol use disorders in patients with chronic hepatitis C: a randomized controlled trial

AIMS: To determine the efficacy of motivational enhancement therapy (MET) on alcohol use in patients with the hepatitis C virus (HCV) and an alcohol use disorder (AUD). DESIGN: Randomized, single-blind, controlled trial comparing MET to a control education condition with 6-month follow-up. SETTING: Patients were recruited from hepatitis clinics at the Minneapolis, Minnesota and Portland, Oregon Veterans Affairs Health Care Systems, USA. PARTICIPANTS AND INTERVENTION: Patients with HCV, an AUD and continued alcohol use (n = 139) were randomized to receive either MET (n = 70) or a control education condition (n = 69) over 3 months. MEASUREMENTS: Data were self-reported percentage of days abstinent from alcohol and number of standard alcohol drinks per week 6 months after randomization. FINDINGS: At baseline, subjects in MET had 34.98% days abstinent, which increased to 73.15% at 6 months compared to 34.63 and 59.49% for the control condition. Multi-level models examined changes in alcohol consumption between MET and control groups. Results showed a significant increase in percentage of days abstinent overall (F(1120.4)  = 28.04, P < 0.001) and a significant group × time effect (F(1119.9)  = 5.23, P = 0.024) with the MET group showing a greater increase in percentage of days abstinent at 6 months compared with the education control condition. There were no significant differences between groups for drinks per week. The effect size of the MET intervention was moderate (0.45) for percentage of days abstinent. CONCLUSION: Motivational enhancement therapy (MET) appears to increase the percentage of days abstinent in patients with chronic hepatitis C, alcohol use disorders and ongoing alcohol use. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.