Reliability and validity of the Japanese version of the Biological Rhythms Interview of assessment in neuropsychiatry-self report for delayed sleep-wake phase disorder

ObjectiveThe Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) might be applicable for assessing delayed sleep-wake phase disorder (DSWPD). We aimed to investigate the reliability and validity of the Japanese version of the BRIAN self-report (J-BRIAN-SR) in DSWPD patients and determine a cutoff score to identify the presence of the disorder.MethodsWe enrolled 60 newly diagnosed DSWPD outpatients and 64 age-matched healthy controls. We used Cronbach's alpha for internal reliability to evaluate J-BRIAN-SR. We confirmed the reliability of the A test and re-test using Pearson's correlation coefficient in the controls. We used confirmatory factor analysis to evaluate the factor structure of J-BRIAN-SR and referenced the Morningness-Eveningness Questionnaire (MEQ) to check concurrent validity. We analyzed the receiver operating characteristic curve (ROC) to determine the J-BRIAN-SR cutoff point for the presence of DSWPD.ResultsThe 18-component scores of the J-BRIAN-SR had an overall reliability coefficient (Cronbach's alpha) of 0.82. We confirmed a high test-retest reliability using an intraclass correlation coefficient (r = 0.84). The correlation between J-BRIAN-SR and MEQ was 0.38 (p = 0.003). The J-BRIAN-SR that we extracted by exploratory factor analysis consisted of three factors. A score of 40 points provided a sensitivity of 80.0% and a specificity of 75.6% for the positivity of DSWPD.ConclusionsThe results of the present study revealed that J-BRIAN-SR is a valid and reliable instrument for screening and evaluating the severity of DSWPD. Our findings will be useful to physicians and patients in Japan and those in clinical settings.     

Effects of a projector-based hybrid virtual reality on pain in young children with burn injuries during hydrotherapy sessions: A within-subject randomized crossover trial

AimThe aim of this study was to examine the effect of a water-friendly Projector-Based Hybrid Virtual Reality (VR) dome environment combined with standard pharmacological treatment on pain in young children undergoing burn wound care in hydrotherapy.MethodsThis study was a prospective, within-subject crossover trial of 38 children aged 6 months to 7 years old (mean age = 1.8 years old). Each hydrotherapy procedure was divided into two equivalent wound care segments (No hybrid VR during one segment vs. Hybrid VR during the other segment, treatment order was randomized). Pain was measured using the 0–10 FLACC (Face, Legs, Activity, Cry Consolability scale) and the 0–10 NRS-obs (Numerical Rating Scale-obs).ResultsProjector-Based Hybrid VR significantly reduced procedural pain levels measured by the FLACC (p = 0.026) and significantly increased patients' comfort levels (p = 0.002). Patients' pain levels rated by the nurses using the NRS-obs were non-significant between both groups (p = 0.135). No side effects were reported.ConclusionProjector-Based Hybrid VR helped in reducing the pain related to hydrotherapy procedures in young children with burn wound injuries. This is the first study using virtual reality distraction with young children, and our findings are especially important because a large percentage of pediatric burn patients are very young. Additional research and development are recommended.Trial registrationClinicalTrials.gov, NCT02986464, registered on June 12, 2016.     

Évaluation de l’utilisabilité des poches industrielles de nutrition parentérale

ObjectivesTo assess the compliance of parenteral nutrition bags to standards and to evaluate the ease of use and the time required to mix the different compartments of bags sold on the French market in 2014.Materials and methodsThree in vitro tests have been carried out: volume measurement, tests of penetration and adhesion of the infusion needle. Users evaluated the various stages of bags preparation using the Likert scale. The reading time of the instruction guide and the preparation time of the bags were recorded.ResultsAccording to in vitro tests, all bags were in conformity with the standards. The assessment of ease of use revealed variations between the different bags. Bags with two compartments displayed similar general appreciation but a different handling time. Two ranges of bags with three compartments for central line (Olimel^® and Kabiven^®) obtained different results in terms of general appreciation and handling time. One of three ranges of bags with three compartments for administration via peripheral route got better appreciations and a lower handling time than the two others.ConclusionAll bags were in conformity with standards in terms of volume and connection between the bag and the infusion set. The handling test showed variations of the preparation time and the ease of use.     

Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM)

Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM’s initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements.Using a case study approach, we evaluated ODM’s ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard.     

An observational study of antibody responses to a primary or subsequent pertussis booster vaccination in Australian healthcare workers

Adult pertussis vaccination is increasingly recommended to control pertussis in the community. However, there is little data on the duration and kinetics of immunity to pertussis boosters in adults. We compared IgG responses to vaccination with a tetanus, low-dose diphtheria, low-dose acellular pertussis (Tdap) booster at 1 week, 1 month and 1 year post-vaccination in whole-cell (wP)-primed Australian paediatric healthcare workers who had received an adult Tdap booster 5–12 years previously, to those who received their first Tdap booster.Tdap vaccination was well tolerated in both groups. Previously boosted adults had significantly higher pre-vaccination IgG concentrations for all vaccine-antigens, and more were seropositive for pertussis toxin (PT)-specific IgG (≥ 5 IU/mL) (69.5%; 95% confidence interval (CI) 59.5–79.5) than adults in the naïve group (45.2%; 95% CI 32.8-57.5). Tdap vaccination significantly increased IgG responses 1 month post-vaccination in both groups. This increase was more rapid in previously boosted than in naïve adults, with geometric mean fold-increases in PT-IgG at 1 week post vaccination of 3.6 (95% CI 2.9–4.3) and 2.6 (95% CI 2.2–3.2), respectively. Antibody waning between 1 month and 1 year post-vaccination was similar between groups for IgG specific to PT and filamentous haemagglutinin (FHA), but was faster for IgG against pertactin (PRN) in the naïve group (GMC ratio 0.36; 95% CI 0.31–0.42) than the previously boosted group (GMC ratio 0.45; 95% CI 0.39–0.50). At baseline, all but one adult had protective IgG titres against tetanus toxin (TT) (≥ 0.1 IU/mL), and 75.6% in the previously boosted and 61.3% in the naïve group had protective IgG titres against diphtheria toxoid (DT) of ≥ 0.1 IU/mL.This study shows that pertussis immune memory is maintained up to 12 years after Tdap vaccination in wP-primed Australian adults. There was no evidence that pertussis immune responses waned faster after a booster dose. These findings support current recommendations of repeating Tdap booster vaccination in paediatric healthcare workers at least every 10 years. Clinical trials registry: ACTRN12615001262594.     

The effect of malpractice law on physician supply: Evidence from negligence-standard reforms

We explore whether the composition of the physician workforce is impacted by the clinical standards imposed on physicians under medical liability rules. Specifically, we explore whether the proportion of non-surgeons practicing in a region decreases—and thus whether the proportion of surgeons increases—when liability standards are modified so as to expect that physicians practice more intensively. For these purposes, we draw on a quasi-experiment made possible by states shifting from local to national customs as the basis for setting liability standards. Using data from the Area Health Resource File from 1977 to 2005, we find that the rate of non-surgeons among practicing physicians decreases by 2–2.4 log points (or by 1.4–1.7 percentage points) following the adoption of national-standard laws in initially low surgery-rate regions—i.e., following a change in the law that effectively expects physicians to increase their use of surgical approaches.     

耳鸣评价量表（TEQ）的耳鸣疗效评定新标准探索

目的通过对比耳鸣评价量表(TEQ)治疗前后得分变化和等级变化计算的疗效,并与耳鸣残疾评估量表(THI)的疗效相对比,为TEQ评估耳鸣疗效的评定标准提供参考。方法 TEQ得分疗效是根据国际上使用的标准差/2原则,即治疗前后得分变化≥TEQ初诊得分标准差/2视为治疗有效;TEQ等级疗效是TEQ等级变化≥1级视为治疗有效。THI得分疗效标准分为文献推荐的变化≥7分和变化≥20分,及标准差/2计算的变化≥12分分别视为有效。结果本次调查的165例患者中,按TEQ得分原则(SD/2原则)、TEQ等级原则、THI7分原则、THI12分原则(SD/2原则)及THI20分原则计算的疗效分别为60.00%、49.09%、61.82%、52.73%、及32.73%。通过卡方检验,TEQ得分疗效及TEQ等级疗效与THI7分及THI12分疗效比较均无统计学差异(P>0.005),均明显高于THI20分疗效(P<0.005)。结论使用耳鸣评价量表(TEQ)进行耳鸣疗效评定时,除了通过等级变化外,还可以采用以治疗前后得分变化为基础的疗效评定标准。