Gabapentin for pain management after osmotic dilator insertion and prior to dilation and evacuation: A randomized controlled trial.

ObjectiveTo evaluate if gabapentin 600 mg reduces pain after osmotic dilator placement the day before a dilation and evacuation (D&E) procedure.Study designWe conducted a double-blind, placebo-controlled, randomized (stratified by vaginal parity) trial among women undergoing osmotic dilator placement before D&E at 15-23 5/7 weeks gestation. Subjects received gabapentin 600 mg or placebo 30 min before dilator placement, with re-dosing 8 h later. We assessed pain after dilator placement using a numeric rating scale (NRS; scale 0-10) at 5 min, 2, 4, and 8 h, and at presentation for D&E. The primary outcome was median NRS pain score change from baseline to 8 h after dilator placement. Secondary outcomes included gabapentin-related side effects and analgesic use.ResultsOf 121 randomized women, we excluded three subjects (allergic reaction [placebo], randomization error, no NRS data), leaving 60 gabapentin and 58 placebo subjects. Of 110 (93%) women who provided 8-hour data, median pain score changes from baseline did not differ between gabapentin and placebo groups overall (2 vs. 2.5, p = 0.52), in vaginally nulliparous women (2 vs. 4, p = 0.10) or in parous women (2 vs. 1.5, p = 0.37). We found no statistically significant differences in median pain score change from baseline to any timepoint overall or when stratified by parity. Beginning at 2 h after dilator placement, more gabapentin than placebo users experienced dizziness (29/53[55%] vs. 11/53[21%], p = 0.001) and tiredness (34/54[63%] vs. 17/54[31%], p = 0.002). The proportion of women using narcotics did not differ between gabapentin (35/60[58%]) or placebo (40/58[69%]) users (p = 0.26).ConclusionsGabapentin does not reduce pain with overnight osmotic dilator placement prior to D&E and causes drug-related side effects.Implications statementWomen experience pain, mostly mild to moderate, with overnight cervical dilator placement at 15-23 5/7 weeks gestation. About 2/3 of women will use a limited quantity of narcotics if provided. Gabapentin does not decrease the pain with or following dilator placement and does not decrease narcotic use

Utilisation of 3D body scanning technology as a research tool when establishing adequate bra fit

Aims Profile the relationship and differences in bust size, position and shape in a sample of UK bra consumers using 3D anthropometric body scan data. Evaluate the presentation of bra sizing by retailers and identify areas of miss communication to characterize effective application to the bra market. Collate and validate criteria for achieving adequate bra fit and quantify the physical impact on the bust size, shape and position. Methods Three quantitative methods were applied rich data to achieve the research aims. Profiling the variation in bust size shape and positioning within a bank of 3D Body scanning data into Bust height, Breast size, Bust Spread, Breast Drop and Breast Symmetry using the 30th and 70th percentiles as category dividers. Evaluating variation found in bra sizing and fit information provided by retailers and the deviation from the British Standard guidelines and Laboratory fit trials to assess the application of retailer bra fit criteria with grades in four categories; Underband, Cup Volume, Underwire and Bra Strap to a sample of UK bra consumers. Findings The findings from this research indicate potential for 3D Body Scanning Technology as a tool to quantify the relationships and differences in five bust characteristics. The technology is applicable in profiling the relationship between the bust and the body. The research presents a new method for measuring breast size which accounts for the prominence independently from the circumferential measurements. . Variation is found among retailers and researchers in bra sizing strategies in the baseline for the size range and the inclusion or exclusion of ‘FF’ causes greater variance above an F cup. The application of a bra fit criteria has a medium to large statistically significant impact reducing the areas where the fit is too big or small and increasing the cases where the bra fit is adequate. Post Hoc analysis revealed a medium to large negative affect on the bra fit small and bra fit too big classifications and a large positive effect on the bra fit adequate score when tested. Underband category findings are consistent with current research which suggests consumers are more likely to wear a bra which is too big in the underband. Recommendations The research built on previous findings while identifying gaps in the field of research. Further research is recommended into the variation in bra sizing which has been highlighted by this research. A recommendation is to link bra pattern cutting and grading to bra size communication to customers. This is seen as key to reducing communication of sizing to the consumer. Current bra fit advise is inadequate in assisting the consumer in selecting adequate support from a bra. Professional fitting is recommended to support this. A key recommendation from this work is that future Bra fit criteria applied to research should include a Bra cup neck edge category. Bra styling should also be considered as the correct size is not sufficient to achieve adequate fit

Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol.

INTRODUCTION: Following cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier. METHODS AND ANALYSES: This is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18-80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial. ETHICS AND DISSEMINATION: Ethics approval was granted by East Midlands-Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN80441309

Implementing mental health training programmes for non-mental health trained professionals : a qualitative synthesis

Introduction Given the prevalence of mental health problems globally, there is an increasing need for the police and other non-mental health trained professionals to identify and manage situations involving individuals with mental health problems. The review aimed to identify and explore qualitative evidence on views and experiences of non-mental health professionals receiving mental health training and the barriers and facilitators to training delivery and implementation. Methods A meta-synthesis of qualitative evidence on the barriers, facilitators and perceived impact of mental health training programmes for non-mental health trained professionals. Systematic literature searches were undertaken of the following databases: Criminal Justice Abstracts (CJA); MEDLINE; Embase; PsycINFO; ASSIA; CENTRAL; SSCI; ERIC; Campbell Library;Social Care Online and EPOC from 1995 to 2016. Records were independently screened for eligibility by two researchers, data extraction and quality appraisal of studies was also undertaken independently by two researchers. The CASP tool was used to quality appraise included studies. Included studies were synthesised using a meta-ethnographic approach as outlined by Noblit and Hare. Results 10,282 records were identified and eight qualitative studies were included. A range of barriers and facilitators to training were identified and related to the delivery and content of training; the use of additional resources; and staff willingness to engage with training and organisational factors. The perceived impact of training was also discussed in terms of how it affects trainees; perceptions of mental health; self-perception; responses to situations involving mental health and the potential of training to reduce injury or physical harm in situations involving mental health. The value of training and how to measure its impact were also discussed. Conclusion Findings from this review have implications for those designing, implementing and evaluating mental health training programmes. It is recommended that research evaluating mental health training includes a qualitative component to ensure that the barriers and facilitators to training and its impact on trainees’ perceptions of mental health are understood. Protocol registration number: PROSPERO: CRD4201501598

Evidence-based sizing of non-inferiority trials using decision models

Abstract Background There are significant challenges to the successful conduct of non-inferiority trials because they require large numbers to demonstrate that an alternative intervention is “not too much worse” than the standard. In this paper, we present a novel strategy for designing non-inferiority trials using an approach for determining the appropriate non-inferiority margin (δ), which explicitly balances the benefits of interventions in the two arms of the study (e.g. lower recurrence rate or better survival) with the burden of interventions (e.g. toxicity, pain), and early and late-term morbidity. Methods We use a decision analytic approach to simulate a trial using a fixed value for the trial outcome of interest (e.g. cancer incidence or recurrence) under the standard intervention (pS) and systematically varying the incidence of the outcome in the alternative intervention (pA). The non-inferiority margin, pA – pS = δ, is reached when the lower event rate of the standard therapy counterbalances the higher event rate but improved morbidity burden of the alternative. We consider the appropriate non-inferiority margin as the tipping point at which the quality-adjusted life-years saved in the two arms are equal. Results Using the European Polyp Surveillance non-inferiority trial as an example, our decision analytic approach suggests an appropriate non-inferiority margin, defined here as the difference between the two study arms in the 10-year risk of being diagnosed with colorectal cancer, of 0.42% rather than the 0.50% used to design the trial. The size of the non-inferiority margin was smaller for higher assumed burden of colonoscopies. Conclusions The example demonstrates that applying our proposed method appears feasible in real-world settings and offers the benefits of more explicit and rigorous quantification of the various considerations relevant for determining a non-inferiority margin and associated trial sample size.https://deepblue.lib.umich.edu/bitstream/2027.42/146777/1/12874_2018_Article_643.pd

Evaluation of the Music Engagement Program for people with Alzheimer's disease and dementia: Study protocol for a pilot trial

Background Alzheimer's disease and dementia are prevalent conditions globally. People with Alzheimer's disease and dementia commonly experience mental health problems, negative emotional states, and behavioural disturbance. Music therapy has previously been used in this population to improve symptoms of mental health problems; however, there is a paucity of evidence-based programs that also explore positive outcomes such as overall quality of life, social outcomes, as well as the acceptability and sustainability of these programs. Aims This project aims to evaluate the effectiveness of the specialised Music Engagement Program (MEP) in improving quality of life, wellbeing, and depression symptoms, in aged-care residents with Alzheimer's disease and dementia. The project also aims to explore how the MEP could be applied and maintained on a broader level throughout the aged-care community. Methods The intervention will take place over 8 weeks in an aged-care facility for people living with dementia in Canberra, Australia. Weekly 45-60-min group singing sessions will be led by a music facilitator. Results The results of the study will be submitted for publication in relevant academic journals and mental health conferences, disseminated to participants on request, to the residential care facility, and via the lead researcher's website. Conclusions This study can provide an indication of the feasibility of the MEP in enhancing the mental health and wellbeing of individuals with Alzheimer's disease and dementia. Further investigation will be required to establish the MEP's ability to be maintained on an ongoing basis with minimal costs and administrative support.This project is supported by a 2017 Excellence in Population Health Research Award, Research School of Population Health, ANU (AG, MP), and by funding provided by ACT Health for ACACIA: The ACT Consumer and Carer Mental Health Research Unit. The project is also supported by in-kind resources from the Centre for Mental Health Research, ANU. The lead author (AG) can disseminate the results of this trial without the express permission of the funding bodies. MB is supported by Medical Research Future Fund (MRFF) Fellowship 1150698

Pragmatic cluster randomised controlled trial of contextualised grammar teaching and small group teaching to improve the writing skills of 11 year old children

Introduction: We evaluated two interventions: a contextualised grammar teaching intervention – Grammar for Writing - to assess whether it improved 11 year old children’s writing skills; and a small group literacy intervention to assess whether or not this was effective. Design and method: We used a pragmatic cluster randomised trial with partial split plot design. Independent concealed randomisation was undertaken at the class level, and, within the intervention group, children were also individually randomised to receive the whole class intervention plus a small group intervention or to receive the intervention in a whole class setting only. The main outcomes were writing and reading assessed by the Progress in English 11 (Long Form) test (GL Assessment). Results: In 2013, 55 schools in England, each with two classes, were recruited and randomised. Within each school, the two classes were randomly allocated to receive either the intervention or the control condition. After randomisation, 2 schools withdrew, leaving 53 schools, 106 classes and 2510 pupils. We observed an effect size (ES) of 0.10 favouring the Grammar for Writing classes; however, this was not statistically significant (95% confidence interval (CI) -0.10 to 0.31). Pupils randomised to the small groups had an increased literacy score when compared with the control classes (ES = 0.24, 95% CI 0.00 to 0.49) and when compared with the intervention children taught in the whole class (ES = 0.21, 95% CI 0.04 to 0.38). Conclusion: There is little evidence that this form of contextualised grammar teaching had an effect on 11 year old children’s writing skills. There was some evidence of an effect for small group teaching

Referral Center Experience With Nonpalpable Contraceptive Implant Removals.

ObjectiveTo describe our experience with office removal of nonpalpable contraceptive implants at our referral center.MethodsWe performed a retrospective cohort study by reviewing the charts of patients referred to our family planning specialty center for nonpalpable or complex contraceptive implant removal from January 2015 through December 2018. We localized nonpalpable implants using high-frequency ultrasonography and skin mapping in radiology, followed by attempted removal in the office using local anesthesia and a modified vasectomy clamp. We abstracted information on demographics, implant location, and outcomes.ResultsOf 61 referrals, 55 patients attended their scheduled appointments. Seven patients had palpable implants; six elected removal. The other 48 patients had ultrasound localization, which identified 47 (98%) of the implants; the remaining patient had successful localization with computed tomography imaging. Nonpalpable implants were suprafascial (n=22), subfascial (n=25) and intrafascial (n=1); four of these patients opted to delay removal. Of 50 attempted office removals, all palpable (n=6), all nonpalpable suprafascial (n=21 [100%, 95% CI 83-100%]), and 19 out of 23 (83%, 95% CI 67-98%) subfascial implants were successful. Three of the four patients with failed subfascial implant office removal had successful operating room removal with a collaborative orthopedic surgeon; the other patient sought removal elsewhere. Transient postprocedure neuropathic complaints were noted in 7 out of 23 (30%, 95% CI 12-49%) subfascial and 1 out of 21 (5%, 95% CI 0-13%) suprafascial removals (P=.048). Nonpalpable implants were more likely to be subfascial in nonobese patients (24/34, 71%) as compared with obese (1/13, 8%) patients (P<.001). Seven (28%) of the 25 subfascially located implants had been inserted during a removal-reinsertion procedure through the same incision.ConclusionMost nonpalpable contraceptive implants can be removed in the office by an experienced subspecialty health care provider after ultrasound localization. Some patients may experience transient postprocedure neuropathic pain. Nonpalpable implants in thinner women are more likely to be in a subfascial location