Linking Angelman and dup15q data for expanded research (LADDER) database: a model for advancing research, clinical guidance, and therapeutic development for rare conditions.

Angelman syndrome (AS) and duplication 15q (dup15q) syndrome are rare neurogenetic conditions arising from a common locus on the long arm of chromosome 15. Individuals with both conditions share some clinical features (e.g. intellectual disability, epilepsy) and often require lifelong care. Disease-modifying therapies for both conditions are emerging, resulting in a significant need for a better understanding of the natural history of both AS and dup15q. Patient advocacy groups for both conditions recognized a need for a data repository that would link data on individuals from multiple sources to expand research, increase understanding of natural history, and accelerate the development of treatments, resulting in the Linking Angelman and Dup15q Data for Expanded Research (LADDER) Database. This paper describes the development and functionality of the LADDER Database - including challenges, lessons learned, and preliminary feasibility - and how it can be used as a model for other rare conditions.

The LADDER database: a model for advancing research, clinical guidance, and therapeutic development for rare conditions This paper describes the development and functionality of the Linking Angelman and Dup15q Data for Expanded Research (LADDER) Database, which is a data repository for two rare neurogenetic conditions: Angelman syndrome (AS) and duplication 15q (dup15q) syndrome. AS and dup15q syndrome arise from genetic abnormalities on chromosome 15 and share some clinical features (e.g. intellectual disability, epilepsy). LADDER was developed by patient advocacy organizations representing each condition in partnership with RTI International. LADDER links data on individuals from multiple sources to expand research, increase understanding of natural history, and accelerate the development of treatments for both AS and dup15q syndrome. The LADDER Database can be used as a model for expanding research and enhancing clinical trial readiness in other rare conditions.

The PhenX Toolkit: standard measurement resources for cancer outcomes and survivorship research.

This brief report introduces the Cancer Outcomes and Survivorship domain in the PhenX Toolkit (consensus measures for Phenotypes and eXposures), which includes 15 validated measurement protocols for cancer survivorship research that were recommended for inclusion in this publicly available resource. Developed with input from the scientific community, the domain provides researchers with well-established measurement protocols for evaluating physical and psychological effects, financial toxicity, and patient experiences with cancer care. The PhenX Toolkit, funded by the National Human Genome Research Institute since 2007, is an online resource that provides high-quality standard measurement protocols for a wide range of research areas (eg, smoking cessation, harm reduction and biomarkers, and social determinants of health). Use of the PhenX Cancer Survivorship Outcomes and Survivorship domain can simplify the selection of measurement protocols, data sharing, and comparisons across studies investigating the cancer survivorship experience.

Virtual integration of patient education in radiotherapy (VIPER).

Purpose: Pre-radiotherapy patient education led by Radiation Therapists (RTT) has been shown to improve patients' distress and overall experiences. In an effort to offer a remote delivery method while allowing for visual learning and face-to-face communication, this pilot project evaluated the feasibility and acceptability of using virtual videoconferencing for patient education. Methods: This prospective pilot study integrated virtual patient education into standard care. This workflow consisted of a one-on-one, 45-minute tele-education session with an RTT on the day prior to CT-simulation. For this study, patients were offered the option to complete the session using web-based videoconferencing if they had the capability for it. Feasibility was evaluated as the proportion of patients who agreed to and completed virtual education. To evaluate acceptability, patients and RTTs were then emailed post-intervention surveys evaluating their satisfaction with virtual patient education. Results: Over three months 106 of 139 patients (76%) approached consented to virtual education. The median (range) age was 65 (27-93), 69% were male and most had genitourinary (38%) or head-and-neck (29%) cancers. Ninety patients (85%) completed virtual education as planned, with incompletions due to scheduling (8) or patient technical issues (7), or treatment cancellation (1). Sixty-eight patients completed surveys, with the vast majority agreeing virtual education was clear (94%) and helped them prepare (100%), they were comfortable with the technology (96%) and they were satisfied overall (99%). Twelve RTTs responded, suggesting overall that virtual education was higher quality though less feasible than tele-education, and comparable to in-person education. Conclusion: Offering individual, RTT-led virtual education using videoconferencing to patients pre-radiotherapy was feasible and acceptable in this pilot study, and is therefore being recommended as an option for all our patients. Future work will directly compare the effectiveness of in-person versus virtual education, and incorporate individual patient needs and preferences.

Effect of Function-Based Approach to Nontraumatic Major Lower Extremity Amputation on 5-Year Mortality.

BACKGROUND: Five-year mortality rates after lower extremity amputation in the chronic wound population have long been regarded as high and inevitable. We theorize that function-based surgical technique and multidisciplinary care improve mortality and assess our institution's mortality rates after major lower extremity amputation (MLEA). STUDY DESIGN: We performed a retrospective review of patients who underwent primary nontraumatic MLEA at our institution from 2010 to 2013. Major amputations included below knee amputation, through knee amputation, and above knee amputation. Our function-based surgical approach to MLEA is guided by 4 tenets: (1) optimization of limb biomechanics, (2) maximal soft tissue preservation, (3) multidisciplinary team approach, and (4) addressing nerves during primary amputation to prevent postamputation pain. Kaplan-Meier analysis and Cox regression were performed to estimate cumulative 5-year mortality and to identify predictors of 5-year mortality, respectively. RESULTS: A total of 188 patients underwent MLEA. Median Charlson Comorbidity Index was 4. Estimated 5-year mortality was 40% overall and 43% for diabetic patients. When stratified by amputation level, 5-year mortalities were 36.3% for below knee amputation, 60.9% for through knee amputation, and 44.0% for above knee amputation. Charlson Comorbidity Index (hazard ratio 1.24, p < 0.001) and end-stage renal disease (hazard ratio 3.38, p < 0.001) were the strongest predictors of 5-year mortality. CONCLUSIONS: We demonstrate the lowest mortality rate reported for MLEA. Improved functional and mortality outcomes can be achieved with a function-based surgical approach to MLEA and close follow-up by a multidisciplinary team. Future studies, using standardized reporting of mortality data and incorporating patient-reported outcomes, are warranted to correlate return to function and mortality.

Could knowledge of patient demographics facilitate a personalized approach to radiation therapy patient education?

INTRODUCTION: Using patient demographics to tailor cancer patient education processes results in improved patient outcomes. However, there is little information on how to successfully tailor radiation therapy (RT) educational content and delivery. The aim of this quality improvement project was to describe the information preferences of a diverse group of patients undergoing RT and determine if different RT education processes were associated with certain patient demographics. MATERIALS AND METHODS: An educational needs assessment questionnaire, based on a validated tool, was offered to all patients undergoing RT on a single day. Questionnaire sections included demographics and questions regarding the importance of topics related to RT treatments, desired mode of information delivery, quantity of information, desired timing of information, and satisfaction with information received. Patients were also asked to answer qualitative questions focused on what was working well and what could be improved. Participants' responses were cohorted based on demographic groupings (age, gender, education level) and were tested for statistically significant differences and associations. RESULTS: 130 patients completed the questionnaire. Compared to those over 60 years, more participants who were 50 - 59 years old thought the topics were 'very important' (96% vs 77%, p<0.001) and wanted a higher quantity of information about the topics (80% vs 66%, p<0.001). More participants over 70 years old preferred pamphlets compared to those less than 70 years (48% vs 30%, p<0.047) while more participants under 50 years old preferred one-on-one sessions compared to those older than 50 years (40% vs 25%, p<0.038). Fewer participants <50 years wanted information at their first meeting with the Radiation Oncologist compared to those older than 50 years (57% vs 73%, p<0.001). Compared to the male cohort, more female participants felt the information topics were more important (83% vs 74%, p<0.0001) and had more unmet education needs (29% vs 17%, p<0.001). Compared to those with post-secondary education, more participants with primary or high school education desired a higher quantity of information (76% vs 65%, p<0.001), preferred to receive that information using pamphlets (43% vs 32%, p=0.006) and wanted all the information at the first opportunity (81% vs 67%, p<0.001). CONCLUSIONS: This quality improvement project found that age, gender and education level influenced patient preferences for information quantity, delivery mode and timing of RT education. These findings are promising and support further evaluations to determine a more precise definition of the personal factors that could help to individualize our approach to educating patients receiving RT.

Long-Term Outcome Assessment Between Antiseptic and Normal Saline for Negative Pressure Wound Therapy with Instillation.

Objective: To analyze long-term outcomes following inpatient treatment of infected wounds with antimicrobial or normal saline instillation during negative pressure wound therapy (NPWT). Approach: This was a single-center retrospective study analyzing the course of patients receiving 0.9% normal saline or 0.1% polyhexanide plus 0.1% betaine as instillation for wounds requiring surgery. Measured outcomes included rates of dehiscence, new wounds, re-operations, amputations, and mortality over 5 years. The article adheres to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. Results: Forty-two patients received normal saline instillation and 41 the antiseptic solution. Rates of dehiscence, wound recurrence, and re-operations in the saline and antiseptic cohorts were 6.3% and 5.6%, 9.4% and 5.6%, and 14.3% and 9.8%, respectively (p > 0.05). In patients requiring further surgery, time to wound closure averaged 104 and 130 days in the saline and antiseptic cohorts, respectively (p = 0.81). Five-year amputation and mortality rates were 14.3% and 22% (p = 0.36) and 24% and 17% (p = 0.45) in the saline and antiseptic cohorts, respectively. Innovation: To compare clinical outcomes associated with two fundamentally different instillation solutions over the full wound care episode and elucidate the potential impact of these results for future applications. Conclusion: This is the first evaluation of nonsurrogate outcomes of different instillations for NPWT in infected wounds. The results indicate that normal saline instillation outcomes are comparable to those of 0.1% polyhexanide plus 0.1% betaine. The clinical success, cost benefit, and accessibility of normal saline can expand the utilization of this therapeutic approach for larger patient populations.

Prevention of road traffic collisions and associated neurotrauma in Colombia: An exploratory qualitative study.

INTRODUCTION: Neurotrauma is an important but preventable cause of death and disability worldwide, with the majority being associated with road traffic collisions (RTCs). The greatest burden is seen in low -and middle- income countries (LMICs) where variations in the environment, infrastructure, population and habits can challenge the success of conventional preventative approaches. It is therefore necessary to understand local perspectives to allow for the development and implementation of context-specific strategies which are effective and sustainable. METHODS: This study took place in Colombia where qualitative data collection was carried out with ten key informants between October and November 2019. Semi-structured interviews were conducted and explored perceptions on RTCs and neurotrauma, preventative strategies and interventions, and the role of research in prevention. Interview transcripts were analysed by thematic analysis using a framework approach. RESULTS: Participants' confirmed that RTCs are a significant problem in Colombia with neurotrauma as an important outcome. Human and organisational factors were identified as key causes of the high rates of RTCs. Participants described the current local preventative strategies, but were quick to discuss limitations and challenges to their success. Key barriers reported were poor attitudes and knowledge, particularly in the community. Suggestions were provided on ways to improve prevention through better education and awareness, stricter enforcement and new policies on prevention, proper budgeting and resource allocation, as well as through collaboration and changes in attitudes and leadership. Participants identified four key research areas they felt would influence prevention of RTCs and associated neurotrauma: causes of RTCs; consequences and impact of RTCs; public involvement in research; improving prevention. CONCLUSION: RTCs are a major problem in Colombia despite the current preventative strategies and interventions. Findings from this study have a potential to influence policy, practice and research by illustrating different solutions to the challenges surrounding prevention and by highlighting areas for further research.

An exploratory qualitative study of the prevention of road traffic collisions and neurotrauma in India: perspectives from key informants in an Indian industrial city (Visakhapatnam).

BACKGROUND: Despite current preventative strategies, road traffic collisions (RTCs) and resultant neurotrauma remain a major problem in India. This study seeks to explore local perspectives in the context within which RTCs take place and identify potential suggestions for improving the current status. METHODS: Ten semi-structured interviews were carried out with purposively selected key informants from the city of Visakhapatnam, Andhra Pradesh. Participants were from one of the following categories: commissioning stakeholders; service providers; community or local patient group/advocacy group representatives. Transcripts from these interviews were analysed qualitatively using the Framework Method. RESULTS: Participants felt RTCs are a serious problem in India and a leading cause of neurotrauma. Major risk factors identified related to user behaviour such as speeding and not using personal safety equipment, and the user state, namely drink driving and underage driving. Other reported risk factors included poor infrastructure, moving obstacles on the road such as other vehicles, pedestrians and animals, overloaded vehicles and substandard safety equipment. Participants discussed how RTCs affect not only the health of the casualty, but are also a burden to the healthcare system, families, and the national economy. Although there are ongoing preventative strategies being carried out by both the government and the community, challenges to successful prevention emerged from the interviews which included resource deficiencies, inconsistent implementation, lack of appropriate action, poor governance, lack of knowledge and the mindset of the community and entities involved in prevention. Recommendations were given on how prevention of RTCs and neurotrauma might be improved, addressing the areas of education and awareness, research, the pre-hospital and trauma systems, enforcement and legislation, and road engineering, in addition to building collaborations and changing mindsets. CONCLUSIONS: RTCs remain a major problem in India and a significant cause of neurotrauma. Addressing the identified gaps and shortfalls in current approaches and reinforcing collective responsibility towards road safety would be the way forward in improving prevention and reducing the burden.

A Prospective Study of the Relationship of Sleep Quality and Duration with Gestational Weight Gain and Fat Gain.

Objective/Background: Fewer than one-third of U.S. women meet the Institute of Medicine guidelines for healthy gestational weight gain (GWG). While poor sleep quality and short sleep duration have been associated with weight gain and obesity in the general population, the relationship of sleep with pregnancy weight and body composition changes is unclear. This study aimed to examine associations of sleep duration and quality with pregnancy-related changes in body weight and fat. Participants: Pregnant women obtaining obstetric care through the University of North Carolina at Chapel Hill Healthcare System (UNC) (n = 339 who reported any sleep data) participating in the Pregnancy Eating Attributes Study. Materials and Methods: Participants were recruited at ≤12 weeks gestation and followed through delivery. The Pittsburgh Sleep Quality Index measured sleep duration and quality in early and late pregnancy. Weight was measured at each pregnancy medical visit and skinfolds were measured each trimester. t-tests examined sleep changes from early to late pregnancy and regression analyses estimated associations of sleep quality and duration with GWG and gestational fat gain (GFG). Results: Sleep quality and duration declined across pregnancy. A greater proportion of women with high early pregnancy body mass index (>25) reported low sleep quality and short sleep duration. Sleep quality was not associated with GWG adequacy, whereas longer late pregnancy sleep duration was associated with greater odds of inadequate GWG. Shorter sleep duration and lower sleep quality in late, but not early, pregnancy were associated with greater GFG. Conclusions: Lower sleep quality and shorter sleep duration in late pregnancy were associated with greater GFG. Experimental studies are needed to test the direction of causality between GFG and sleep attributes. ClinicalTrials.gov ID: NCT02217462.

Mapping global evidence on strategies and interventions in neurotrauma and road traffic collisions prevention: a scoping review.

BACKGROUND: Neurotrauma is an important global health problem. The largest cause of neurotrauma worldwide is road traffic collisions (RTCs), particularly in low- and middle-income countries (LMICs). Neurotrauma and RTCs are preventable, and many preventative interventions have been implemented over the last decades, especially in high-income countries (HICs). However, it is uncertain if these strategies are applicable globally due to variations in environment, resources, population, culture and infrastructure. Given this issue, this scoping review aims to identify, quantify and describe the evidence on approaches in neurotrauma and RTCs prevention, and ascertain contextual factors that influence their implementation in LMICs and HICs. METHODS: A systematic search was conducted using five electronic databases (MEDLINE, EMBASE, CINAHL, Global Health on EBSCO host, Cochrane Database of Systematic Reviews), grey literature databases, government and non-government websites, as well as bibliographic and citation searching of selected articles. The extracted data were presented using figures, tables, and accompanying narrative summaries. The results of this review were reported using the PRISMA Extension for Scoping Reviews (PRISMA-ScR). RESULTS: A total of 411 publications met the inclusion criteria, including 349 primary studies and 62 reviews. More than 80% of the primary studies were from HICs and described all levels of neurotrauma prevention. Only 65 papers came from LMICs, which mostly described primary prevention, focussing on road safety. For the reviews, 41 papers (66.1%) reviewed primary, 18 tertiary (29.1%), and three secondary preventative approaches. Most of the primary papers in the reviews came from HICs (67.7%) with 5 reviews on only LMIC papers. Fifteen reviews (24.1%) included papers from both HICs and LMICs. Intervention settings ranged from nationwide to community-based but were not reported in 44 papers (10.8%), most of which were reviews. Contextual factors were described in 62 papers and varied depending on the interventions. CONCLUSIONS: There is a large quantity of global evidence on strategies and interventions for neurotrauma and RTCs prevention. However, fewer papers were from LMICs, especially on secondary and tertiary prevention. More primary research needs to be done in these countries to determine what strategies and interventions exist and the applicability of HIC interventions in LMICs.

Cryoballoon ablation for gastric pouch and/or outlet reduction in patients with weight regain post Roux-en-Y gastric bypass.

BACKGROUND: Cryoballoon ablation could induce stricture formation to achieve outlet and pouch reduction in patients regaining weight after Roux-en-Y gastric bypass (RYGB). This pilot study aimed to assess technical feasibility and short-term efficacy. METHODS: A retrospective chart review (January - November 2018) at two academic centers identified patients with weight regain post-RYGB, treated with cryoablation if pouch > 4 cm and/or outlet > 15 mm. Patients were scheduled for surveillance endoscopies at 8 weeks. RESULTS: 22 patients presented 10.5 years (SD 4.42) post-RYGB with weight regain of 30.9 kg (SD 13.7). Technical success was 89.5 % for outlet ablation and 93.0 % for pouch ablation. From baseline to 8 weeks, the outlet was reduced from 24.1 mm (95 % confidence interval [CI] 19.8 to 28.5) to 17.1 mm (95 %CI 13.1 to 21.1; P < 0.001), and pouch from 5 cm (95 %CI 4.1 to 5.9) to 3.9 cm (95 %CI 2.6 to 5.1; P < 0.05). Total body weight loss at 8 weeks was 8.1 % (SD 12.8 %). CONCLUSION: Cryoablation appears technically feasible and effective for outlet and/or pouch reduction in the short term.

Universal screening for SARS-CoV-2 infection: a rapid review.

BACKGROUND: Coronavirus disease 2019 (COVID-19) is caused by the novel betacoronavirus, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Most people infected with SARS-CoV-2 have mild disease with unspecific symptoms, but about 5% become critically ill with respiratory failure, septic shock and multiple organ failure. An unknown proportion of infected individuals never experience COVID-19 symptoms although they are infectious, that is, they remain asymptomatic. Those who develop the disease, go through a presymptomatic period during which they are infectious. Universal screening for SARS-CoV-2 infections to detect individuals who are infected before they present clinically, could therefore be an important measure to contain the spread of the disease. OBJECTIVES: We conducted a rapid review to assess (1) the effectiveness of universal screening for SARS-CoV-2 infection compared with no screening and (2) the accuracy of universal screening in people who have not presented to clinical care for symptoms of COVID-19. SEARCH METHODS: An information specialist searched Ovid MEDLINE and the Centers for Disease Control (CDC) COVID-19 Research Articles Downloadable Database up to 26 May 2020. We searched Embase.com, the CENTRAL, and the Cochrane Covid-19 Study Register on 14 April 2020. We searched LitCovid to 4 April 2020. The World Health Organization (WHO) provided records from daily searches in Chinese databases and in PubMed up to 15 April 2020. We also searched three model repositories (Covid-Analytics, Models of Infectious Disease Agent Study [MIDAS], and Society for Medical Decision Making) on 8 April 2020. SELECTION CRITERIA: Trials, observational studies, or mathematical modelling studies assessing screening effectiveness or screening accuracy among general populations in which the prevalence of SARS-CoV2 is unknown. DATA COLLECTION AND ANALYSIS: After pilot testing review forms, one review author screened titles and abstracts. Two review authors independently screened the full text of studies and resolved any disagreements by discussion with a third review author. Abstracts excluded by a first review author were dually reviewed by a second review author prior to exclusion. One review author independently extracted data, which was checked by a second review author for completeness and accuracy. Two review authors independently rated the quality of included studies using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool for diagnostic accuracy studies and a modified form designed originally for economic evaluations for modelling studies. We resolved differences by consensus. We synthesized the evidence in narrative and tabular formats. We rated the certainty of evidence for days to outbreak, transmission, cases missed and detected, diagnostic accuracy (i.e. true positives, false positives, true negatives, false negatives) using the GRADE approach. MAIN RESULTS: We included 22 publications. Two modelling studies reported on effectiveness of universal screening. Twenty studies (17 cohort studies and 3 modelling studies) reported on screening test accuracy. Effectiveness of screening We included two modelling studies. One study suggests that symptom screening at travel hubs, such as airports, may slightly slow but not stop the importation of infected cases (assuming 10 or 100 infected travellers per week reduced the delay in a local outbreak to 8 days or 1 day, respectively). We assessed risk of bias as minor or no concerns, and certainty of evidence was low, downgraded for very serious indirectness. The second modelling study provides very low-certainty evidence that screening of healthcare workers in emergency departments using laboratory tests may reduce transmission to patients and other healthcare workers (assuming a transmission constant of 1.2 new infections per 10,000 people, weekly screening reduced infections by 5.1% within 30 days). The certainty of evidence was very low, downgraded for high risk of bias (major concerns) and indirectness. No modelling studies reported on harms of screening. Screening test accuracy All 17 cohort studies compared an index screening strategy to a reference reverse transcriptase polymerase chain reaction (RT-PCR) test. All but one study reported on the accuracy of single point-in-time screening and varied widely in prevalence of SARS-CoV-2, settings, and methods of measurement. We assessed the overall risk of bias as unclear in 16 out of 17 studies, mainly due to limited information on the index test and reference standard. We rated one study as being at high risk of bias due to the inclusion of two separate populations with likely different prevalences. For several screening strategies, the estimates of sensitivity came from small samples. For single point-in-time strategies, for symptom assessment, the sensitivity from 12 cohorts (524 people) ranged from 0.00 to 0.60 (very low-certainty evidence) and the specificity from 12 cohorts (16,165 people) ranged from 0.66 to 1.00 (low-certainty evidence). For screening using direct temperature measurement (3 cohorts, 822 people), international travel history (2 cohorts, 13,080 people), or exposure to known infected people (3 cohorts, 13,205 people) or suspected infected people (2 cohorts, 954 people), sensitivity ranged from 0.00 to 0.23 (very low- to low-certainty evidence) and specificity ranged from 0.90 to 1.00 (low- to moderate-certainty evidence). For symptom assessment plus direct temperature measurement (2 cohorts, 779 people), sensitivity ranged from 0.12 to 0.69 (very low-certainty evidence) and specificity from 0.90 to 1.00 (low-certainty evidence). For rapid PCR test (1 cohort, 21 people), sensitivity was 0.80 (95% confidence interval (CI) 0.44 to 0.96; very low-certainty evidence) and specificity was 0.73 (95% CI 0.39 to 0.94; very low-certainty evidence). One cohort (76 people) reported on repeated screening with symptom assessment and demonstrates a sensitivity of 0.44 (95% CI 0.29 to 0.59; very low-certainty evidence) and specificity of 0.62 (95% CI 0.42 to 0.79; low-certainty evidence). Three modelling studies evaluated the accuracy of screening at airports. The main outcomes measured were cases missed or detected by entry or exit screening, or both, at airports. One study suggests very low sensitivity at 0.30 (95% CI 0.1 to 0.53), missing 70% of infected travellers. Another study described an unrealistic scenario to achieve a 90% detection rate, requiring 0% asymptomatic infections. The final study provides very uncertain evidence due to low methodological quality. AUTHORS' CONCLUSIONS: The evidence base for the effectiveness of screening comes from two mathematical modelling studies and is limited by their assumptions. Low-certainty evidence suggests that screening at travel hubs may slightly slow the importation of infected cases. This review highlights the uncertainty and variation in accuracy of screening strategies. A high proportion of infected individuals may be missed and go on to infect others, and some healthy individuals may be falsely identified as positive, requiring confirmatory testing and potentially leading to the unnecessary isolation of these individuals. Further studies need to evaluate the utility of rapid laboratory tests, combined screening, and repeated screening. More research is also needed on reference standards with greater accuracy than RT-PCR. Given the poor sensitivity of existing approaches, our findings point to the need for greater emphasis on other ways that may prevent transmission such as face coverings, physical distancing, quarantine, and adequate personal protective equipment for frontline workers.

Enhanced recovery after surgery (ERAS) protocol reduces perioperative narcotic requirement and length of stay in patients undergoing mastectomy with implant-based reconstruction.

INTRODUCTION: Enhanced Recovery after Surgery (ERAS) protocols have contributed to shortened hospital stays and reduced narcotic use after common surgical procedures. Though ERAS protocols exist for breast surgery, they have not been studied for implant-based reconstruction after mastectomy. METHODS: Twenty-three consecutive patients undergoing mastectomy with implant-based reconstruction were treated with perioperative gabapentin, acetaminophen, and NSAIDs. Data regarding clinical course and medication requirement were compared to a historical control cohort (n = 23) receiving usual care after mastectomy. Opioid analgesics were converted to oral morphine equivalents (OMEs) for comparison between groups. RESULTS: Patients treated with the ERAS protocol required significantly fewer narcotics as measured in OMEs over postoperative days 0-2. Patient reported pain scores were equivalent between groups, as were postoperative complication rates of nausea, hematoma, and infection. Additionally, ERAS patients had significantly shorter mean length of hospital stay (1.3 vs. 2.5 days, p = 0.037). CONCLUSIONS: Patients receiving perioperative gabapentin, acetaminophen, and NSAIDs under an ERAS protocol required significantly fewer narcotics and shorter length of stay. This protocol may merit consideration for use at other centers.

Endoscopic sleeve gastroplasty versus high-intensity diet and lifestyle therapy: a case-matched study.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is a safe and effective minimally invasive bariatric procedure. This study compared weight loss in patients undergoing ESG with that of matched patients undergoing high-intensity diet and lifestyle therapy (HIDLT). METHODS: In this case-matched study, patients were matched 2/3:1 (HIDLT/ESG) by age, sex, and body mass index (BMI). One hundred five patients (30 men) who underwent ESG + low-intensity diet and lifestyle therapy (LIDLT) between 2016 and 2018 were compared with 281 patients (92 men) who underwent HIDLT at the Johns Hopkins Medical Institutions from 2013 to 2014. Weight was evaluated 1, 3, 6, and 12 months after beginning HIDLT or post-ESG to determine the mean percent total body weight loss (%TBWL). RESULTS: Mean age across both cohorts was 48.0 ± 12.1, and baseline BMI was 40.0 ± 7.7 kg/m2. In multivariable analysis controlling for age, sex, and baseline BMI, the mean %TBWL at 1, 3, 6, and 12 months was significantly higher in patients undergoing ESG than matched patients undergoing HIDLT. Specifically, at 3 months, the mean %TBWL in the ESG cohort was 14.0% compared with 11.3% in the HIDLT cohort (P <.011), and at 12 months the mean %TBWL in the ESG cohort was 20.6% versus 14.3% in the HIDLT cohort (P < .001). ESG patients with baseline BMI ≤40 kg/m2 continued to show significantly greater %TBWL than those of the same BMI group in the HIDLT group at 1, 3, 6, and 12 months after intervention (3 months, coefficient = 3.43 [P < .001]; 12 months, coefficient = 8.14 [P < .001]). CONCLUSIONS: Through 12 months of follow-up, patients who underwent ESG achieved significantly greater weight loss than patients enrolled in HIDLT. ESG appears to be a valuable alternative for patients who experience difficulty complying with HIDLT.

Mapping global evidence on strategies and interventions in neurotrauma and road traffic collisions prevention: a scoping review protocol.

INTRODUCTION: Neurotrauma is an important global health problem. This 'silent epidemic' is a major cause of death and disability in adolescents and young adults, with significant societal and economic impacts. Globally, the largest cause of neurotrauma is road traffic collisions (RTCs). Neurotrauma and RTCs are largely preventable, and many preventative strategies and interventions have been established and implemented over the last decades, particularly in high-income countries. However, these approaches may not be applicable globally, due to variations in environment, resources, population, culture and infrastructure. This paper outlines the protocol for a scoping review, which seeks to map the evidence on strategies and interventions in neurotrauma and RTCs prevention globally, and to ascertain contextual factors that influence their implementation. METHODS AND ANALYSIS: This scoping review will use the established methodology by Arksey and O'Malley. Eligible studies will be identified from five electronic databases (MEDLINE, EMBASE, CINAHL, Global Health/EBSCO and Cochrane Database of Systematic Reviews) and grey literature sources. We will also carry out bibliographical and citation searching of included studies. A two-stage selection process, which involves screening of titles and abstracts, followed by full-text screening, will be used to determine eligible studies which will undergo data abstraction using a customised, piloted data extraction sheet. The extracted data will be presented using evidence mapping and a narrative summary. ETHICS AND DISSEMINATION: Ethical approval is not required for this scoping review, which is the first step in a multiphase public health research project on the global prevention of neurotrauma. The final review will be submitted for publication to a scientific journal, and results will be presented at appropriate conferences, workshops and meetings. Protocol registered on 5 April 2019 with Open Science Framework (https://osf.io/s4zk3/).

Reducing opioid usage: a pilot study comparing postoperative selective dorsal rhizotomy protocols.

OBJECTIVE: Selective dorsal rhizotomy (SDR) is a surgical procedure used to treat spasticity in children with spastic cerebral palsy. Currently, there is a lack of work examining the efficacy of optimizing pain management protocols after single-level laminectomy for SDR. This pilot study aimed to compare the clinical outcomes of SDR completed with a traditional pain management protocol versus one designed for opioid dosage reduction. METHODS: The Texas Comprehensive Spasticity Center prospective database was queried for all patients who underwent SDR between 2015 and 2018. Demographic, surgical, and postoperative data for all patients who underwent SDR were collected from medical records. The study was designed as a retrospective study between the patient-controlled analgesia (PCA) and dexmedetomidine infusion (INF) groups with 80% power to detect a 50% difference at a significance level of 0.05. Patients in the INF group received perioperative gabapentin, intraoperative dexmedetomidine infusion, and scheduled acetaminophen and NSAIDs postoperatively. RESULTS: Medication administration records, pain scores, and therapy notes were collected for 30 patients. Patients who underwent SDR between June 2015 and the end of December 2017 received traditional pain management (PCA group, n = 14). Patients who underwent SDR between January 2018 and the end of December 2018 received modified pain management (INF group, n = 16). No patients were lost to follow-up. Differences in age, weight, height, preoperative Gross Motor Function Classification System scores, operative duration, hospital length of stay, and sex distribution were not statistically different between the 2 groups (p > 0.05). Analysis of analgesic medication doses demonstrated that the INF group required fewer doses and lower amounts of opioids overall, and also fewer NSAIDs than the PCA group. When converted to the morphine milligram equivalent, the patients in the INF group used fewer doses and lower amounts of opioids overall than the PCA group. These differences were either statistically significant (p < 0.05) or trending toward significance (p < 0.10). Both groups participated in physical and occupational therapy similarly postoperatively (p > 0.05). Pain scores were comparable between the groups (p > 0.05) despite patients in the INF group requiring fewer opioids. CONCLUSIONS: Infusion with dexmedetomidine during SDR surgery combined with perioperative gabapentin and scheduled acetaminophen and NSAIDs postoperatively resulted in similar pain scores to traditional pain management with opioids. In addition, this pilot study demonstrated that patients who received the INF pain management protocol required reduced opioid dosages and were able to participate in therapy similarly to the control PCA group.

Accuracy of Self-Reported Height, Weight, and BMI Over Time in Emerging Adults.

INTRODUCTION: Self-reported height and weight may lead to inaccurate estimates of associations between BMI and health indicators. The purpose of this study is to assess anthropometric misreporting in emerging adults, compare weight classification by self-reported and direct measures, and examine associations of self-reported and direct measures with cardiometabolic biomarkers. METHODS: Self-reported and directly measured height and weight were obtained in five waves of a nationally representative cohort study of U.S. tenth graders (n=2,785) conducted in 2010-2016; data were analyzed in 2018. Cardiometabolic biomarkers were assessed in three waves in a systematically recruited subsample (n=567). Pearson correlations (r) and Lin's concordance correlations (ρc) evaluated misreporting. Gwet agreement coefficient-1 evaluated weight classification agreement by self-reported and direct measures. Generalized estimating equations examined associations of cardiometabolic biomarkers with self-reported and direct measures. RESULTS: Participants overreported height by 1.0-1.7 cm and underestimated weight by 0.6-1.7 kg. Self-reported BMI was 0.6-1.0 lower than measured. Self-reported and measured height, weight, and BMI were strongly correlated (r=0.88-0.97, 0.86-0.98, and 0.65-0.96, respectively) and concordant (ρc=0.82-0.96, 0.94-0.97, and 0.65-0.95, respectively). Agreement of weight classification by self-reported and direct measures ranged from Gwet agreement coefficient-1=0.79-0.94. Associations of ten cardiometabolic biomarkers with self-reported BMI, measured BMI, and waist circumference were similar in magnitude, direction, and precision. CONCLUSIONS: Self-reported and measured BMI were strongly correlated and concordant, providing substantial to near-perfect agreement in weight classification. Findings suggest self-reported BMI in U.S. emerging adults provides nearly identical estimates of associations with cardiometabolic biomarkers.

Endoscopic sleeve gastroplasty versus intragastric balloon insertion: efficacy, durability, and safety.

BACKGROUND: Intragastric balloon (IGB) placement and endoscopic sleeve gastroplasty (ESG) are reported to be safe and effective endoscopic bariatric therapies. This study aimed to compare the patient demographics and therapeutic outcomes between the IGB and ESG procedures. METHODS: This was a retrospective review of prospectively collected data from consecutive patients between December 2015 and October 2017 who underwent IGB or ESG at a single academic center. Fluid-filled IGBs implanted for a 6-month duration were used. IGB and ESG patients were subjected to identical post-procedure dietary instructions and follow-up protocols. Body weight was recorded at 1, 3, 6, and 12 months post-procedure. RESULTS: A total of 47 patients underwent IGB insertion and 58 underwent ESG. The IGB cohort had a lower baseline body mass index (BMI) than the ESG (34.5 vs. 41.5 kg/m2; P < 0.001) and a significantly lower proportion of men (2.1 % vs. 41.4 %; P < 0.001). IGB patients showed a mean (standard deviation [SD]) percentage total body weight loss (%TBWL) that was significantly lower than ESG patients at 1 month (6.6 % [2.6 %] vs. 9.9 % [2.4 %]; P < 0.001), 3 months (11.1 % [4.4 %] vs. 14.3 % [4.6 %]; P = 0.004), 6 months (15.0 % [7.6 %] vs. 19.5 % [5.7 %]; P = 0.01), and 12 months (13.9 % [9.0 %] vs. 21.3 % [6.6 %]; P = 0.005). The IGB cohort also experienced significantly more adverse events compared with the ESG (17 % vs. 5.2 %; P = 0.048). CONCLUSIONS: IGB placement and ESG result in clinically meaningful weight loss. However, ESG appears to provide clinically superior and more enduring weight loss with fewer adverse events compared with an IGB.

Implementing Workshops to Improve Radiation Therapists' Knowledge and Attitudes about Sexual Health Issues in Cancer Patients.

OBJECTIVES: Although it is widely acknowledged that radiotherapy treatments can have a negative impact on a patient's sexual health, this aspect of side effect management is not commonly addressed by radiation therapists or by other cancer specialists. It is important for radiation therapists to recognize and address possible sexual health issues to provide a holistic approach to care. This quality-improvement project was designed to help radiation therapists discuss the sexual health needs of patients undergoing radiotherapy by improving their clinical knowledge, skills, and comfort level about the topic. METHODS: This study used a cross-sectional descriptive prequestionnaire/postquestionnaire design, in which data were collected from a nonrandom sample of radiation therapists at a single urban radiation therapy center. Participants attended two 90-minute sexual health education workshops specifically designed for radiation therapists and completed online preworkshop/postworkshop questionnaires. All questions were quantitative in nature. The survey consisted of multiple-choice, multiple-select, and five-point Likert-scale questions. Descriptive analysis was used for data analysis. RESULTS: The results of this improvement project indicated that participants had introductory-level knowledge about how cancer treatments can impact patients' sexual health. Although there is potential for some changes in the general knowledge levels of the participants after the initiative, two general workshops about the topic are not enough to have radiation therapists feel comfortable enough with the topic to change their clinical practice. CONCLUSION: This project identified that although radiation therapists acknowledge the importance of discussing sexual health concerns as part of delivering holistic health care, lack of knowledge and expertise with the topic is a main barrier to initiating conversations. To help prepare radiation therapists, education and training initiatives, which build on knowledge and offer opportunities to develop and apply practical skills in both simulated and real-life situations, should be created. This can help to increase confidence in the sexual health counseling provided, which may result in more radiation therapists frequently engaging in these important sexual health conversations.