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Objective: To investigate whether a virtual reality learning environment (VRLE) enhanced student understanding and knowledge compared with a traditional tutorial. Method: A randomized controlled trial involving medical students from University College Dublin, Ireland. Participants were assigned to an intervention (VRLE involving a 15‐min learning experience on the stages of fetal development) or control (PowerPoint tutorial on the same topic) group. Multiple choice questionnaires (MCQs) assessed knowledge at three time points: preintervention, immediately postintervention, and 1 week postintervention. Primary outcomes were differences in MCQ knowledge scores postintervention between groups. Secondary outcomes included attitudes on the learning experience assessed using the Student Satisfaction and Self‐Confidence in Learning Scale (SCLS) and the Virtual Reality Design Scale (VRDS). Results: No statistically significant between‐group differences were found in the primary outcome assessing postintervention knowledge scores. Within‐group differences in knowledge scores were significant among the three time points for both the intervention (P < 0.01 [95% confidence interval, 5.33–6.19]) and control (P = 0.02 [95% confidence interval, 5.74–6.49]) groups. Mean levels of satisfaction and self‐confidence in learning were higher in the intervention group compared with the control group: 54.2 (standard deviation, 7.5) and 50.5 (standard deviation, 7.2), respectively (P = 0.21). Conclusion: VRLEs are a learning tool that can support knowledge development. Synopsis: This study supports the benefit of three‐dimensional lessons to improve knowledge and understanding of complex topics in obstetrics and gynecology education. [ABSTRACT FROM AUTHOR]

Background: In the absence of dose-response data, Dietary ReferenceValues for vitaminDin nonpregnant adults are extended to pregnancy. Objective: The aim was to estimate vitamin D intake needed to maintain maternal 25-hydroxyvitamin D [25(OH)D] in late gestation at a concentration sufficient to prevent newborn 25(OH)D <25-30 nmol/L, a threshold indicative of increased risk of nutritional rickets. Design: We conducted a 3-arm, dose-response, double-blind, randomized placebo-controlled trial in Cork, Ireland (51.9°N). A total of 144 white-skinned pregnant women were assigned to receive 0, 10 (400 IU), or 20 (800 IU) µg vitamin D3/d from ≤18 wk of gestation. Vitamin D metabolites at 14, 24, and 36 wk of gestation and in cord sera, including 25(OH)D3, 3-epi-25(OH)D3, 24,25(OH)2D3, and 25(OH)D2 were quantified by liquid chromatography--tandem mass spectrometry. A curvilinear regression model predicted the total vitamin D intake (from diet and antenatal supplements plus treatment dose) that maintained maternal 25(OH)D in late gestation at a concentration sufficient to maintain cord 25(OH)D at ≥25-30 nmol/L. Results: Mean ± SD baseline 25(OH)D was 54.9 ± 10.7 nmol/L. Total vitamin D intakes at the study endpoint (36 wk of gestation) were 12.1 ± 8.0, 21.9 ± 5.3, and 33.7 ± 5.1 µg/d in the placebo and 10-µg and 20-µg vitamin D3 groups, respectively; and 25(OH)D was 24.3 ± 5.8 and 29.2 ± 5.6 nmol/L higher in the 10- and 20-µg groups, respectively, compared with placebo (P < 0.001). For maternal 25(OH)D concentrations ≥50 nmol/L, 95% of cord sera were ≥30 nmol/L and 99% were >25 nmol/L. The estimated vitamin D intake required to maintain serum 25(OH)D at ≥50 nmol/L in 97.5% of women was 28.9 µg/d. Conclusions: Thirty micrograms of vitamin D per day safely maintained serum 25(OH)D concentrations at ≥50 nmol/L in almost all white-skinned women during pregnancy at a northern latitude, which kept 25(OH)D at >25 nmol/L in 99% and ≥30 nmol/L in 95% of umbilical cord sera. This trial was registered at www.clinicaltrials. gov as NCT02506439. [ABSTRACT FROM AUTHOR]

Objectives To design and evaluate the effectiveness of a pre-notification leaflet about research to increase recruitment to a randomized controlled trial (RCT). Methods A methodological, two-arm, RCT was conducted, embedded within an existing cohort RCT (REFORM). Participants were randomized for the embedded trial, using a 1:2 ratio (intervention : control) before being randomized for REFORM. Controls received a trial recruitment pack. The intervention group received an additional pre-notification leaflet 2-3 weeks before the recruitment pack. Primary and secondary analyses were conducted using relative risk, the Cox proportional hazards model and incremental cost-effectiveness ratios. Results Of the 1436 intervention group participants, 73 (5.1%) were randomized into the REFORM trial compared with 126 (4.4%) of the 2878 control group participants. The associated relative risk (1.16) was not statistically significant [95% confidence interval (CI) 0.88-1.56]. Return rate was not significantly increased (relative risk 1.10, 95% CI 0.92-1.28) nor time to return decreased (hazard ratio: 1.11, 95% CI 0.93-1.33). Incremental cost-effectiveness ratios indicated the intervention may be cost-effective if the true estimate of effect was close to the upper bound of the associated 95% CI. Conclusion Pre-notification for potential trial participants demonstrated a small difference to randomization (0.7% difference) and return rates (1.1% difference) in favour of the intervention. Results should however be interpreted with caution as CIs for these estimates cross the point of no effect. Nevertheless, this research enhances existing evidence for pre-notification to increase recruitment rates, with further development and assessment of this potentially cost-effective intervention being recommended. [ABSTRACT FROM AUTHOR]

Background and Objectives: The present study evaluated the effectiveness of a single clinician delivered brief intervention (BI) to reduce problem alcohol use and illicit substance use in an opiate-dependent methadone maintained cohort of patients attending for treatment. Methods: Four addiction treatment centers were randomly assigned to either treatment as usual (TAU; control group) or BI (intervention group). Clinicians screened patients using the alcohol, smoking, and substance involvement screening test (ASSIST) screening tool at baseline and again at three-month follow up. Fidelity checks were performed to ensure that training was delivered effectively and uniformly across all study sites. Feasibility of administering a BI within daily practice was assessed through intervention fidelity checks, patient satisfaction questionnaires and process evaluation. Results: A total of 465 patients were screened (66% of the overall eligible population) with a total of 433 (93%) ASSIST positive cases. Randomization was effective, with no differences in the control versus the intervention arms at baseline for key demographic or clinical indicators including substance us. There was a statistically significant difference between global risk score for the intervention (x = 39.36, sd = 25.91) group and the control group (x = 45.27, SD = 27.52) at 3-month follow-up (t(341) = −2.07, p <.05). Conclusions: This trial provides the first evidence that a single clinician delivered BI can result in a reduction in substance use within a methadone maintained opiate-dependent cohort, and this effect is sustained at three month follow up. [ABSTRACT FROM AUTHOR]

Purpose: Potentially inappropriate prescribing (PIP) is common in older people and can result in increased morbidity, adverse drug events, and hospitalizations. The OPTI-SCRIPT study (Optimizing Prescribing for Older People in Primary Care, a cluster-randomized controlled trial) tested the effectiveness of a multifaceted intervention for reducing PIP in primary care.Methods: We conducted a cluster-randomized controlled trial among 21 general practitioner practices and 196 patients with PIP. Intervention participants received a complex, multifaceted intervention incorporating academic detailing; review of medicines with web-based pharmaceutical treatment algorithms that provide recommended alternative-treatment options; and tailored patient information leaflets. Control practices delivered usual care and received simple, patient-level PIP feedback. Primary outcomes were the proportion of patients with PIP and the mean number of potentially inappropriate prescriptions. We performed intention-to-treat analysis using random-effects regression.Results: All 21 practices and 190 patients were followed. At intervention completion, patients in the intervention group had significantly lower odds of having PIP than patients in the control group (adjusted odds ratio = 0.32; 95% CI, 0.15-0.70; P = .02). The mean number of PIP drugs in the intervention group was 0.70, compared with 1.18 in the control group (P = .02). The intervention group was almost one-third less likely than the control group to have PIP drugs at intervention completion, but this difference was not significant (incidence rate ratio = 0.71; 95% CI, 0.50-1.02; P = .49). The intervention was effective in reducing proton pump inhibitor prescribing (adjusted odds ratio = 0.30; 95% CI, 0.14-0.68; P = .04).Conclusions: The OPTI-SCRIPT intervention incorporating academic detailing with a pharmacist, and a review of medicines with web-based pharmaceutical treatment algorithms, was effective in reducing PIP, particularly in modifying prescribing of proton pump inhibitors, the most commonly occurring PIP drugs nationally. [ABSTRACT FROM AUTHOR]

Overweight and obesity are common health risks, but it can be difficult to effect weight change. This randomized controlled trial examined the effects of a novel Cookery skills intervention on body mass index (BMI) in overweight and obese patients with cardiovascular disease, who had previously attended a cardiac rehabilitation programme. Patients with BMI >27 kg/m² were randomized to either a 5-week cookery skills course with written educational materials, or to written materials only. Questionnaires on lifestyle risk factors and food frequencies were administered at baseline, 6 and 24 months. The primary outcome in an intention-to-treat analysis was a change in BMI at 6 months. Secondary outcome was a change in BMI at 24 months. Changes in macronutrient consumption were examined in both analysis of covariance and repeated measures ANOVA models. Of the 172 patients, 116 (67.4%) patients consented to participate in the study. The intervention was found to be well accepted and attended by the patients (70.5% of patients in the intervention group attended the sessions). Whilst both intervention and control groups were noted to have a small reduction in BMI, there was no significant difference between the groups. There was no significant group effect noted for any change in macronutrient consumption at 6- or 24-month follow-up. This pilot study of a novel cookery skills project was well accepted amongst this population. Although the majority of participants had a net loss in BMI, the cookery skills intervention was not associated with any change in BMI beyond that achieved by written information alone. [ABSTRACT FROM AUTHOR]

Objective: Stimulated by findings that continuous feedback on client progress improves therapy outcomes (Lambert, Whipple, & Smart, 2001a, Patient-focused research: Using patient outcome data to enhance treatment effects. Journal of Consulting and Clinical Psychology, 69, 159–172) and by arguments that any instrument taking more than 5 min to implement is impractical, this study was a randomised controlled trial investigating the effects of session-by-session progress feedback using the ultra-brief Outcome Rating Scale. Method: A between-subjects design was used. Participants (n = 110) were randomly assigned ‘feedback’ or ‘no feedback’ status, and attended one of eight therapists in a university counselling service. Results: The results showed that there was not a significant difference between the feedback and no-feedback conditions. Both conditions improved therapeutically; however, the feedback condition had a greater effect size (0.85 vs. 0.64), suggesting that with a larger sample statistical significance may have been attained. Between the two conditions there was not a significant difference found in participants classified as reliably changed, unchanged, or deteriorated. However, when the clients were divided into groups on the basis of their presenting issue, the clients with anxiety whose therapists used feedback had significantly better outcomes at the end of therapy than the clients whose therapists did not receive the feedback. Conclusion: Contrary to previous studies, the feedback on the client's progression provided to the therapist had only a small effect on improving therapy outcome. The feedback, however, improved outcomes of the clients presenting with anxiety. [ABSTRACT FROM PUBLISHER]