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.

Measuring attitudes, behaviours, and influences in inner city victims of interpersonal violence (VIVs) - a Swiss emergency room pilot study

Background Switzerland is confronted with the problem of interpersonal violence. Violence is in the increase and the potential for aggression seems to be rising. Observations by hospitals discern an appalling increase of the severity of the injuries. The aim of this study is to collect accurate information about the social environment, the motivation and possible reasons for violence. We also intend to investigate whether sociocultural, or ethnic differences among male victims exist. Materials and methods For the first time in Switzerland, this survey employed a validated questionnaire from the division of violence prevention, Atlanta, Georgia. The first part of the questionnaire addressed social and demographic factors which could influence the risk of violence: age, gender, duration of stay in Switzerland, nationality and educational level. Beside these social structural factors, the questionnaire included questions on experience of violent offences in the past, information about the most recent violent offence and intra and interpersonal facts. The questionnaire itself consists of 27 questions, translated into German and French. In a pilot study, the questionnaire was checked with adolescents for feasibility and comprehensibility. Results 69 male VIVs were interviewed at two hospitals in the Canton of Bern. Most of the adolescents emphasised that weapons were not used during their confrontations. It is astonishing that all of the young men considered themselves to be victims. Most of the brawls were incited after an exchange of verbal abuse and provocations with unfamiliar individuals. The rivals could neither be classified with the help of ethnic categories nor identifiable groups of the youth scenes. The incidents took place in scenes, where violence was more likely to happen. Interestingly and contrary to a general perception the offenders are well integrated into sport and leisure clubs. A further surprising result of our research is that the attitude towards religion differs between young men with experience of violence and non-violent men. Discussion Youth violence is a health issue, which concerns us globally. The human and economic toll of violence on victims and offenders, their families, and on society in general is high. The economic costs associated with violence-related illness and disability is estimated to be millions of Swiss francs each year. Physicians and psychologists are compelled to identify the factors, which cause young people to be violent, to find out which interventions prove to be successful, and to design effective prevention programs. The identification of effective programs depends on the availability of reliable and valid measures to assess changes in violence-related attitudes. In our efforts to create healthier communities, we need to investigate; document and do research on the causes and circumstances of youth violence.

Detection of chest trauma with whole-body low-dose linear slit digital radiography: a multireader study

The objective of our study was to compare the performance of low-dose linear slit digital radiography (DR) with computed radiography (CR) for the detection of trauma sequelae in the chest including rib fractures, pneumothorax, and lung contusion.

Trauma mechanisms, patterns of injury, and outcomes in a retrospective study of 71 burns from civil gas explosions

Although explosion injuries caused by terror attacks or in war are evaluated in many studies, limited information about civil explosion injuries can be found in the literature.

Pretreatment and outcome correlates of sexual and physical trauma in an epidemiological cohort of first-episode psychosis patients

High prevalence of trauma has been reported in psychosis. While role of trauma as a risk factor for developing psychosis is still debated, its negative impact on outcome has been described. Few studies have explored this issue in first-episode psychosis (FEP) patients. We assessed rate of stressful events, as well as premorbid and outcome correlates of past sexual and/or physical abuse (SPA) in an epidemiological FEP patients cohort.

Appropriateness of reporting statistical results in orthodontics: the dominance of P values over confidence intervals

The purpose of this study was to search the orthodontic literature and determine the frequency of reporting of confidence intervals (CIs) in orthodontic journals with an impact factor. The six latest issues of the American Journal of Orthodontics and Dentofacial Orthopedics, the European Journal of Orthodontics, and the Angle Orthodontist were hand searched and the reporting of CIs, P values, and implementation of univariate or multivariate statistical analyses were recorded. Additionally, studies were classified according to the type/design as cross-sectional, case-control, cohort, and clinical trials, and according to the subject of the study as growth/genetics, behaviour/psychology, diagnosis/treatment, and biomaterials/biomechanics. The data were analyzed using descriptive statistics followed by univariate examination of statistical associations, logistic regression, and multivariate modelling. CI reporting was very limited and was recorded in only 6 per cent of the included published studies. CI reporting was independent of journal, study area, and design. Studies that used multivariate statistical analyses had a higher probability of reporting CIs compared with those using univariate statistical analyses. Misunderstanding of the use of P values and CIs may have important implications in implementation of research findings in clinical practice.

Reporting quality of abstracts of randomized controlled trials published in leading orthodontic journals from 2006 to 2011

Optimal reporting of randomized trials and abstracts enhances transparency and facilitates assessment and identification of trials. The purpose of this study was to investigate the quality of reporting of abstracts of randomized controlled trials published in orthodontic journals.

A PRISMA assessment of the reporting quality of systematic reviews in orthodontics

Abstract Objectives: To assess the reporting quality of Cochrane and non-Cochrane systematic reviews (SR) in orthodontics and to compare the reporting quality (PRISMA score) with methodological quality (AMSTAR criteria). Materials and Methods: Systematic reviews (n  =  109) published between January 2000 and July 2011 in five leading orthodontic journals were identified and included. The quality of reporting of the included reviews was assessed by two authors in accordance with the PRISMA guidelines. Each article was assigned a cumulative grade based on fulfillment of the applicable criteria, and an overall percentage score was assigned. Descriptive statistics and simple and multiple linear regression analyses were undertaken. Results: The mean overall PRISMA score was 64.1% (95% confidence interval [CI], 62%-65%). The quality of reporting was considerably better in reviews published in the Cochrane Database of Systematic Reviews (P < .001) than in non-Cochrane reviews. Both multivariable and univariable analysis indicated that journal of publication and number of authors was significantly associated with the PRISMA score. The association between AMSTAR score and modified PRISMA score was also found to be highly statistically significant. Conclusion: Compliance of orthodontic SRs published in orthodontic journals with PRISMA guidelines was deficient in several areas. The quality of reporting assessed using PRISMA guidelines was significantly better in orthodontic SRs published in the Cochrane Database of Systematic Reviews.

The Rapid TEG α-Angle may be a sensitive predictor of transfusion in moderately injured blunt trauma patients

Background. To guide the administration of blood products, coagulation screening of trauma patients should be fast and accurate. The purpose of this study was to identify the correlation between CCT and TEG in trauma, to determine which CCT or TEG parameter is most sensitive in predicting transfusion in trauma, and to define TEG cut-off points for trauma care. Methods. A six-month, prospective observational study of 76 adult patients with suspected multiple injuries was conducted at a Level 1 trauma centre of a university hospital. Physicians blinded to TEG results made the decision to transfuse based on clinical evaluation. Results. The study results showed that conventional coagulation tests correlate moderately with Rapid TEG parameters (R: 0.44–0.61). Kaolin and Rapid TEG were more sensitive than CCTs, and the Rapid TEG α-Angle was identified as the single parameter with the greatest sensitivity (84%) and validity (77%) at a cut-off of 74.7 degrees. When the Rapid TEG α-Angle was combined with heart rate >75 bpm, or haematocrit < 41%, sensitivity (84%, 88%) and specificity (75%, 73%) were improved. Conclusion. Cutoff points for transfusion can be determined with the Rapid TEG α-Angle and can provide better sensitivity than CCTs, but a larger study population is needed to reproduce this finding.

Epidemiology and predictors of cervical spine injury in adult major trauma patients: a multicenter cohort study

Patients with cervical spine injuries are a high-risk group, with the highest reported early mortality rate in spinal trauma.

Completeness of reporting in randomized controlled trials of 3 vaccines: a review of adherence to the CONSORT checklist

Clear reporting of randomized controlled trials (RCTs) of vaccines is important for understanding results and assessing their validity. The CONsolidated Standards of Reporting Trials (CONSORT) statement provides guidance to help authors reporting RCTs. The objective was to assess the completeness of reporting of RCTs of vaccines based on the CONSORT 2010 checklist.