Systematic review and meta-analysis of neurofeedback and its effect on posttraumatic stress disorder.

Background: To date, only one systematic review and meta-analysis of randomized controlled trials (RCTs) has evaluated the effect of neurofeedback in PTSD, which included only four studies and found an uncertainty of the effect of EEG-NF on PTSD symptoms. This meta-analysis is an update considering that numerous studies have since been published. Additionally, more recent studies have included fMRI-NF as well as fMRI-guided or -inspired EEG NF. Methods: Systematic literature searches for RCTs were conducted in three online databases. Additional hand searches of each study identified and of systematic reviews and meta-analyses published were also undertaken. Outcomes evaluated the effect of neurofeedback vs. a control (active, sham, and waiting list) on their effects in reducing PTSD symptoms using various health instruments. Meta-analytical methods used were inverse variance random-effects models measuring both mean and standardized mean differences. Quality and certainty of the evidence were assessed using GRADE. Adverse events were also evaluated. Results: A total of 17 studies were identified evaluating a total of 628 patients. There were 10 studies used in the meta-analysis. Results from all studies identified favored neurofeedback's effect on reducing PTSD symptoms including BDI pretest-posttest [mean difference (MD): 8.30 (95% CI: 3.09 to 13.52; P = 0.002; I 2 = 0%)]; BDI pretest-follow-up (MD: 8.75 (95% CI: 3.53 to 13.97; P < 0.00001; I 2 = 0%); CAPS-5 pretest-posttest [MD: 7.01 (95% CI: 1.36 to 12.66; P = 0.02; I 2 = 86%)]; CAPS-5 pretest-follow-up (MD: 10 (95% CI: 1.29 to 21.29; P = 0.006; I 2 = 77%); PCL-5 pretest-posttest (MD: 7.14 (95% CI: 3.08 to 11.2; P = 0.0006; I 2 = 0%); PCL-5 pretest-follow-up (MD: 14.95 (95% CI: 7.95 to 21.96; P < 0.0001; I 2 = 0%). Other studies reported improvements using various other instruments. GRADE assessments of CAPS, PCL, and BDI demonstrated a moderate/high level in the quality of the evidence that NF has a positive clinical effect. Conclusion: Based on newer published studies and the outcomes measured, NF has demonstrated a clinically meaningful effect size, with an increased effect size at follow-up. This clinically meaningful effect appears to be driven by newer fMRI-guided NF and deeper brain derivates of it.

Lifetime cost-effectiveness analysis osseointegrated transfemoral versus socket prosthesis using Markov modelling.

Aims: Prior cost-effectiveness analyses on osseointegrated prosthesis for transfemoral unilateral amputees have analyzed outcomes in non-USA countries using generic quality of life instruments, which may not be appropriate when evaluating disease-specific quality of life. These prior analyses have also focused only on patients who had failed a socket-based prosthesis. The aim of the current study is to use a disease-specific quality of life instrument, which can more accurately reflect a patient's quality of life with this condition in order to evaluate cost-effectiveness, examining both treatment-naïve and socket refractory patients. Methods: Lifetime Markov models were developed evaluating active healthy middle-aged male amputees. Costs of the prostheses, associated complications, use/non-use, and annual costs of arthroplasty parts and service for both a socket and osseointegrated (OPRA) prosthesis were included. Effectiveness was evaluated using the questionnaire for persons with a transfemoral amputation (Q-TFA) until death. All costs and Q-TFA were discounted at 3% annually. Sensitivity analyses on those cost variables which affected a change in treatment (OPRA to socket, or socket to OPRA) were evaluated to determine threshold values. Incremental cost-effectiveness ratios (ICERs) were calculated. Results: For treatment-naïve patients, the lifetime ICER for OPRA was $279/quality-adjusted life-year (QALY). For treatment-refractory patients the ICER was $273/QALY. In sensitivity analysis, the variable thresholds that would affect a change in the course of treatment based on cost (from socket to OPRA), included the following for the treatment-naïve group: yearly replacement components for socket > $8,511; cost yearly replacement parts OPRA < $1,758; and for treatment-refractory group: yearly replacement component for socket of > $12,467. Conclusion: The use of the OPRA prosthesis in physically active transfemoral amputees should be considered as a cost-effective alternative in both treatment-naïve and treatment-refractory socket prosthesis patients. Disease-specific quality of life assessments such as Q-TFA are more sensitive when evaluating cost-effectiveness.

Amygdala-derived-EEG-fMRI-pattern neurofeedback for the treatment of chronic post-traumatic stress disorder. A prospective, multicenter, multinational study evaluating clinical efficacy.

We conducted a prospective, single arm, multisite, multinational, open label trial assessing the safety and efficacy of a novel amygdala derived neurofeedback treatment, designated Amygdala-Derived-EFP, for chronic PTSD. Participants, including veterans and civilians, underwent screening, training, 15 neurofeedback sessions over 8 weeks and; baseline, termination (8 weeks) and 3 month post treatment assessments with validated measures. The primary endpoint was more than 50 % of the participants demonstrating a Minimally Clinically Important Difference (MCID) defined as a 6-point reduction, on the Clinician Administered PTSD Scale (CAPS-5) total score at 3 months. Secondary measures included the PCL-5, ERQ, PHQ-9, and CGI. Statistical analyses were performed using SAS®V9.4. The primary endpoint was met, with a CAPS-5 MCID response rate of 66.7 %. The average reduction in CAPS-5 total scores at 3 month follow up was 13.5 points, more than twice the MCID. Changes from baseline in CAPS-5, PCL-5, PHQ-9 scores at 8 weeks and the 3 month follow-up demonstrated statistically significant improvements in response and; demonstrated effect sizes ranging from 0.46 to 1.07. Adverse events were mild and resolved after treatment. This study builds on prior research demonstrating similar outcomes using amygdala-derived neurofeedback. Positive attributes of this therapy include monitoring by non-physician personnel, affordability, accessibility, and tolerability.

Multicenter Registry Using Propensity Score Analysis to Compare a Novel Transport/Preservation System to Traditional Means on Postoperative Hospital Outcomes and Costs for Heart Transplant Patients.

The standard method for cardiac allograft preservation for the past 50 years has been static storage using crushed ice. A heart transplant transportation system designed to improve preservation quality with temperature monitoring, the Paragonix SherpaPak Cardiac Transport System (SCTS), was evaluated for its impact on postoperative costs relative to conventional ice storage. Observational US multicenter registry data collected during the August 2015 to November 2021 timeframe from 12 transplant hospitals were analyzed using logistic regression analysis and propensity matching to balance measured baseline covariates and to reduce selection bias. Hospital cost and outcome data post-transplant were then evaluated using various statistical methods. One hundred seventy-four (174) patients were identified resulting in 87 matches. Baseline characteristics were similar between groups. The SCTS group had a significantly lower proportion of ICU days on post-transplant mechanical circulatory support ( p < 0.0001); significantly fewer patients on extracorporeal membrane oxygenation ( p = 0.017); and significantly fewer patients experiencing severe primary graft dysfunction (PGD) ( p = 0.03). Overall hospital plus mechanical circulatory support post-transplant costs were significantly lower by $26.7K in the CTS cohort ( p = 0.03). Use of the SCTS is associated with improved clinical outcomes resulting in significantly lower overall hospital care costs.

Lactobacillus rhamnosus Used in the Perinatal Period for the Prevention of Atopic Dermatitis in Infants: A Systematic Review and Meta-Analysis of Randomized Trials.

BACKGROUND: Numerous systematic reviews and meta-analyses have examined the effects of probiotics used perinatally on prevention or treatment of atopic disease in infants and children. However, to date, no review has examined randomized controlled trials of Lactobacillus rhamnosus, specifically, administered both prenatally and postnatally and its effect over a long period of time. OBJECTIVE: The objective was to determine if L. rhamnosus either used solely or in conjunction with other probiotics demonstrates a long-term preventive effect on atopic disease in pediatric patients when used perinatally. METHODS: A systematic review was undertaken to identify those studies where L. rhamnosus was used (either solely or in conjunction with other probiotics). The following databases were searched from the year 2000 through December 8, 2021: PubMed, Cochrane Reviews and Cochrane Central Database of Controlled Trials; systematic reviews were hand searched to identify randomized controlled trials (RCTs). Meta-analytic statistical techniques were then employed. Evaluation of the incidence of atopic eczema was also examined longitudinally based on timeframe. Grading of Recommendations, Assessment, Development and Evaluations (GRADE) assessments were employed to determine the quality of the evidence. RESULTS: Eleven randomized controlled trials were identified which examined L. rhamnosus in its effect on atopy. Risk of bias was low on the majority of the domains assessed. Meta-analysis of the timeframes ≤ 2 years (RR 0.60, 95% CI 0.47-0.75; p < 0.00001) and 6-7 years (RR 0.62, 95% CI 0.50-0.75; p < 0.00001) demonstrated statistically significant reductions in atopic eczema with use of L. rhamnosus. For the 4 to 5-year (RR 0.74, 95% CI 0.55-1.00; p = 0.05) and 10-11-year (RR 0.68, 95% CI 0.37-1.27; p = 0.23) timeframes there was no statistically significant reduction. GRADE assessment for each timeframe was considered moderate in two, owing to high attrition rates in all of the studies, and low in two due to imprecision. CONCLUSION: Based on the meta-analysis and GRADE assessments, the use of L. rhamnosus with or without other probiotics appears to have a positive effect in reducing the incidence of atopic eczema in pediatric patients at least out to 7 years. Attrition rates temper these findings.

Examining spoken words and acoustic features of therapy sessions to understand family caregivers' anxiety and quality of life.

BACKGROUND: Speech and language cues are considered significant data sources that can reveal insights into one's behavior and well-being. The goal of this study is to evaluate how different machine learning (ML) classifiers trained both on the spoken word and acoustic features during live conversations between family caregivers and a therapist, correlate to anxiety and quality of life (QoL) as assessed by validated instruments. METHODS: The dataset comprised of 124 audio-recorded and professionally transcribed discussions between family caregivers of hospice patients and a therapist, of challenges they faced in their caregiving role, and standardized assessments of self-reported QoL and anxiety. We custom-built and trained an Automated Speech Recognition (ASR) system on older adult voices and created a logistic regression-based classifier that incorporated audio-based features. The classification process automated the QoL scoring and display of the score in real time, replacing hand-coding for self-reported assessments with a machine learning identified classifier. FINDINGS: Of the 124 audio files and their transcripts, 87 of these transcripts (70%) were selected to serve as the training set, holding the remaining 30% of the data for evaluation. For anxiety, the results of adding the dimension of sound and an automated speech-to-text transcription outperformed the prior classifier trained only on human-rendered transcriptions. Specifically, precision improved from 86% to 92%, accuracy from 81% to 89%, and recall from 78% to 88%. INTERPRETATION: Classifiers can be developed through ML techniques which can indicate improvements in QoL measures with a reasonable degree of accuracy. Examining the content, sound of the voice and context of the conversation provides insights into additional factors affecting anxiety and QoL that could be addressed in tailored therapy and the design of conversational agents serving as therapy chatbots.

Theta burst stimulation for the acute treatment of major depressive disorder: A systematic review and meta-analysis.

Patients with major depressive disorder (MDD) may be refractory to or have contraindications that preclude treatment with antidepressant pharmacotherapies. Alternative therapies such as repetitive transcranial magnetic stimulation (rTMS) continue to evolve, and include theta burst stimulation (TBS), which has advantages over conventional rTMS. The aim of this study was to identify and meta-analyze efficacy data from all randomized controlled trials (RCTs) investigating TBS as a treatment for MDD. Published reports of RCTs (January 1, 2010 to October 23, 2020) were identified via systematic searches in computerized databases, followed by review of individual reports for inclusion. Inclusion criteria included primary diagnosis of MDD ≥ 1 week duration of therapy with ≥10 sessions, and treatment with any form of TBS. The Cochrane GRADE methodology and PRISMA criteria were used for evaluation of individual trials. Data from ten RCTs were included, representing 667 patients. Of these, 8 RCTs compared TBS to sham treatment and one compared TBS to standard rTMS (i.e., high frequency stimulation over left dorsolateral prefrontal cortex [HFL]). Quality of evidence assessment yielded high confidence in the finding of TBS being superior to sham on response measured by the Hamilton Depression Rating Scale (HRSD) (RR = 2.4; 95% CI: 1.27 to 4.55; P = 0.007; I2 = 40%). Comparison of HRSD response rates for TBS versus rTMS produced no statistically significant difference (RR = 1.02; 95% CI: 0.85 to 1.23; P = 0.80; I2 = 0%). The incidence of adverse events between TBS and rTMS was not statistically different. The findings of a positive effect of TBS vs. sham, and noninferiority of TBS vs. standard HFL rTMS support the continued development of TBS to treat depression.

Colonoscopy in poorly prepped colons: a cost effectiveness analysis comparing standard of care to a new cleansing technology.

BACKGROUND: The objective of this Markov model lifetime cost-effectiveness analysis was to evaluate a new medical device technology which minimizes redo colonoscopies on the outcomes of cost, quality of life, and aversion of colorectal cancers (CRC). METHODS: A new technology (PureVu® System) which cleans inadequately prepped colons was evaluated using TreeAge 2019 software in patients who presented with inadequate prep in outpatient settings in the US. PureVu was compared to the standard of care (SOC). Peer reviewed literature was used to identify the CRC incidence cancers based on missing polyps. Costs for procedures were derived from 2019 Medicare and from estimated private payer reimbursements. Base case costs, sensitivity analysis and incremental cost effectiveness (ICE) were evaluated. The cost of PureVu was $750. RESULTS: Assuming a national average compliance rate of 60% for colonoscopy, the use of PureVu saved the healthcare system $833-$992/patient depending upon the insurer when compared to SOC. QALYs were also improved with PureVu mainly due to a lower incidence of CRCs. In sensitivity analysis, SOC becomes less expensive than PureVu when compliance to screening for CRC using colonoscopy is ≤ 28%. Also, in order for SOC to be less expensive than PureVu, the list price of PureVu would need to exceed $1753. In incremental cost effectiveness analysis, PureVu dominated SOC. CONCLUSION: Using the PureVu System to improve bowel prep can save the healthcare system $3.1-$3.7 billion per year, while ensuring a similar quality of life and reducing the incidence of CRCs.

Comparison of the Costs of Reusable Versus Disposable Equipment for Endoscopic Carpal Tunnel Release Procedures Using Activity-Based Costing Analysis.

PURPOSE: Guidelines for sterilization of reusable equipment (eg, arthroscopes, surgical equipment) have recently been established. These guidelines are supported by the U.S. Food and Drug Administration and affect costs for sterilization. The current analysis was undertaken to understand if reusable or disposable endoscopic carpal tunnel release (ECTR) equipment is a less-expensive option. METHODS: An activity-based cost analysis was undertaken to determine the costs of reusable versus disposable equipment for ECTR. Costs of disposable equipment were obtained from manufacturers. Costs of processing reusable equipment including labor, time, cost of operating room time, and sterilization supplies and equipment were obtained from the literature and from recent reports identifying these costs. Infection rates and costs of infection were also factored in. Decision analysis software was used to determine the expected costs of each option (disposable vs reusable). A sensitivity analysis was undertaken on those variables that were determined to have the greatest effect on the overall costs of the procedure and sterilization. RESULTS: Costs for each option when totaled were $917 for disposable and $1,019 for reusable equipment, resulting in cost savings of $102 with disposable equipment. Reusable equipment was the least costly option when the following costs/events occurred: cost of a disposable arthroscope, >$452; cost of disposable ECTR, >$647; costs of operating room time, <$28.63/min; set up time, <6.8 minutes for reusable equipment; and cost of disposable ECTR blade used with reusable equipment, <$160. CONCLUSIONS: When considering the cost of operating room time, preparation, and processing of reusable equipment for ECTR, the disposable equipment for this procedure is less costly. TYPE OF STUDY/LEVEL OF EVIDENCE: Economic Analysis II.

Cost utility analysis of cryopreserved amniotic membrane versus topical cyclosporine for the treatment of moderate to severe dry eye syndrome.

BACKGROUND: The purpose is to perform a cost effectiveness analysis amniotic membrane vs. topical medications in the use of treating dry eye disease. A cost effectiveness analysis comparing amniotic membrane + other topical medications to topical cyclosporine A + other topical medications was evaluated using accepted decision tree modeling software. METHODS: TreeAge Pro 2019 software was used to evaluate the base case costs over a one year timeframe. Sensitivity analysis was performed on those variables which had the greatest effect on choosing one therapy versus the other based on cost. Monte Carlo simulation was run 1,000 times to determine the most effective, least costly alternative. Costs were evaluated from a societal level (direct + indirect). Quality of life utility scores were evaluated using known time tradeoffs from prior studies (scale 0-1; with 1 being perfect vision). RESULTS: Over a one year timeframe, the base case demonstrated that amniotic membrane + topical medications was the less expensive alternative and provided for incremental utilities versus topical cyclosporine + other medications (Cost/utility: $18,275/0.78 vs. $20,740/0.74). If examining direct costs only, topical cyclosporine was the least expensive option over a one year timeframe: $4,112 vs. $10,300. Sensitivity analysis demonstrated that in order for topical cyclosporine to be the less expensive alternative the following variables would need to be: < 68 days productivity lost; < $161 productivity lost/day; > 79% of amniotic membrane implants would need to be re-implanted at month 4 (for whatever reason); > $2677 per amniotic membrane implant procedure (Medicare reimbursement rate); > 96% positive response to topical cyclosporine A at month 4; > 58% positive response to topical cyclosporine A at month 6 and; < 54% probability clinical improvement with amniotic membrane. Monte Carlo simulation demonstrated that amniotic membrane was the less costly, most effective alternative 91.5% of the time. CONCLUSION: Based on improved outcomes using amniotic membrane, patient productivity was improved resulting in lower societal costs (less days lost from work). When considering the untoward effects of dry eye disease on societal costs, an improvement of the dry eye disease condition was accomplished most often with amniotic membrane.

Spoken words as biomarkers: using machine learning to gain insight into communication as a predictor of anxiety.

OBJECTIVE: The goal of this study was to explore whether features of recorded and transcribed audio communication data extracted by machine learning algorithms can be used to train a classifier for anxiety. MATERIALS AND METHODS: We used a secondary data set generated by a clinical trial examining problem-solving therapy for hospice caregivers consisting of 140 transcripts of multiple, sequential conversations between an interviewer and a family caregiver along with standardized assessments of anxiety prior to each session; 98 of these transcripts (70%) served as the training set, holding the remaining 30% of the data for evaluation. RESULTS: A classifier for anxiety was developed relying on language-based features. An 86% precision, 78% recall, 81% accuracy, and 84% specificity were achieved with the use of the trained classifiers. High anxiety inflections were found among recently bereaved caregivers and were usually connected to issues related to transitioning out of the caregiving role. This analysis highlighted the impact of lowering anxiety by increasing reciprocity between interviewers and caregivers. CONCLUSION: Verbal communication can provide a platform for machine learning tools to highlight and predict behavioral health indicators and trends.

Meta-Analysis Comparing Outcomes of Therapies for Patients With Central Sleep Apnea and Heart Failure With Reduced Ejection Fraction.

Patients with heart failure with reduced ejection fraction and predominant central sleep apnea pose treatment challenges. A system review and meta-analysis of randomized controlled trials (RCTs) were undertaken. Electronic searches of digital repositories, journals, specialty society and manufacturer websites, manual searches of reference sections of RCTs, and published clinical guidelines were performed. Studies were graded for bias. Meta-analytic random effects models were used. Outcomes of interest included: sleep, cardiovascular, mortality, and quality of life (QoL). Grading of recommendations assessment, development and evaluation was performed. Nineteen randomized studies were identified that met the inclusion criteria of apnea hypopnea index (AHI) ≥10, predominant central sleep apnea (CSA), and heart failure with reduced ejection fraction (HFrEF) ≤50%. Most trials examined adaptive servo ventilation (ASV) (8 studies) and continuous positive airway pressure (CPAP) (9 studies). Bias existed in that: 15 of 19 (79%) of the trials lacked blinding, 10 of 19 were manufacturer funded, and with attrition in 8 of 19 studies. In meta-analysis, ASV performed better than control on sleep but not on QoL or cardiovascular outcomes, including mortality. CPAP demonstrated positive short-term outcomes on sleep, cardiovascular, and QoL (3 months). Longer-term cardiovascular and mortality data did not show benefit. Drug therapies demonstrated a positive clinical effect short term on sleep outcomes only. Transvenous phrenic nerve stimulation (TPNS) demonstrated positive treatment outcomes on sleep and QoL at 6 months. Evidence suggests improvement in cardiovascular outcomes with TPNS. In conclusion, ASV and CPAP therapies improve sleep, but long-term QoL or cardiovascular benefit was lacking. TPNS exhibited positive outcomes on sleep and QoL at 6 months with positive trends in CV outcomes.

Cost-Effectiveness Analysis of Needle Arthroscopy Versus Magnetic Resonance Imaging in the Diagnosis and Treatment of Meniscal Tears of the Knee.

PURPOSE: To determine whether needle arthroscopy (NA) compared with magnetic resonance imaging (MRI) in the diagnosis and treatment of meniscal tears is cost-effective when evaluated over a 2-year period via patient-reported outcomes. The hypothesis is that improved diagnostic accuracy with NA would lead to less costly care and similar outcomes. METHODS: A Markov model/decision tree analysis was performed using TreeAge Pro 2017 software. Patients were evaluated for degenerative and traumatic damage to the lateral/medial meniscus. Assumed sensitivities and specificities were derived from the medical literature. The direct costs for care were derived from the 2017 Medicare fee schedule and from private payer reimbursement rates. Costs for care included procedures performed for false-positive findings and for care for false-negative findings. Effectiveness was examined using the global knee injury and osteoarthritis outcome score (KOOS). Patients were evaluated over 2 years for costs and outcomes, including complications. Dominance and incremental cost-effectiveness were evaluated, and 1- to 2-way sensitivity analysis was performed to determine those variables that had the greatest effect. The consolidated economics evaluation and reporting standards checklist for reporting economic evaluations was used. RESULTS: NA was less costly and had similar KOOS versus MRI for both the medial/lateral meniscus with private pay. Costs were less for both Medicare and private pay for medial meniscus, $780 to $1,862, and lateral meniscus, $314 to $1,256, respectively. CONCLUSIONS: Based on the reported MRI incidence of false positives with the medial meniscus and false negatives with the lateral meniscus and based on assumed standards of care, more costly care is provided when using MRI compared with NA. Outcomes were similar with NA compared with MRI. LEVEL OF EVIDENCE: Level II, economic and decision analysis.

A systematic literature review of the clinical efficacy of repetitive transcranial magnetic stimulation (rTMS) in non-treatment resistant patients with major depressive disorder.

BACKGROUND: The clinical efficacy of repetitive transcranial magnetic stimulation (rTMS) in treatment resistant patients (at least 4 medication trials) appears to be well accepted and forms the coverage policies and rTMS's use in many of the largest US payers. However, less is known about rTMS's use in patients who have undergone ≤1 failed medication trial. The purpose of this analysis was to determine the clinical efficacy of rTMS in patients after ≤1 medication trials. METHODS: A systematic review of the literature was undertaken to identify all articles which addressed the use of rTMS in ≤1 medication trial. All types of study designs were included and assessed for quality and strength of evidence using: GRADE and CEBM. Searches of peer reviewed articles were undertaken for the year 2000 to the present. All languages were considered. Electronic databases were searched and included: PubMed and EBSCO. Evidence assessment websites were also searched and included: Cochrane, NICE, AHRQ, and ICER. Additionally, the clinical guidelines for specialty societies which use rTMS was searched. Hand searches of the reference sections of identified articles was also undertaken. RESULTS: Electronic and other sources identified 165 after duplicates were removed. Twenty two articles were assessed for eligibility and ultimately 10 articles were included in the systematic review and graded. Six articles were graded high quality (CEBM/GRADE: 1c/B) demonstrating that the use of rTMS was clinically efficacious in patients after ≤1 medication trial. Four additional trials demonstrated a positive effect of rTMS in patients after ≤1 medication trial but were of a lower quality. CONCLUSION: The use of rTMS in patients after ≤1 medication trial should be considered. US payers should consider revising their coverage policies to include the use of rTMS in these patients.

Developing an In-House Biological Safety Cabinet Certification Program at the University of North Dakota.

Introduction: Biological safety cabinets (BSCs) are the primary means of containment used in laboratories worldwide. To ensure the proper functioning of BSCs, they need to be certified annually, at a minimum, per National Sanitation Foundation (NSF)/American National Standards Institute Standard 49. Objectives: A common problem most organizations face is that in many instances, the technicians who certify the cabinets are not accredited by the NSF. Additionally, in states or regions that do not have local NSF accredited field certifiers, it takes weeks to get a service request completed, thereby delaying the research work of the laboratory. Moreover, in such instances, the cost associated with cabinet certification and repair can be very high. Materials and Methods: This led the Office of Safety at the University of North Dakota to do a thorough cost-benefit analysis of developing an in-house BSC certification program. After completing the training and testing requirements for the NSF's advanced accreditation program, the BSC certification program was initiated on campus. Results: The identified benefits led to the initiation of a program in both local and regional capacity for repair, maintenance, and certification of BSCs, and the university's experiences were shared with other universities. Conclusions: By developing an in-house BSC certification program, the University of North Dakota was able to reduce wait times associated with service repairs, reduce costs, and generate revenue for the department. Furthermore, this led to improved hands-on training programs related to BSC use in laboratories working with biohazardous agents.

Scalp Hypothermia for Preventing Alopecia During Chemotherapy. A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Alopecia is a side effect of chemotherapy and affects a patient's quality of life. Cooling the scalp during chemotherapy might reduce alopecia. The objective of this systematic and meta-analysis was to examine the effects of scalp cooling on the end point of alopecia in randomized controlled trials. MATERIALS AND METHODS: Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Electronic searches of databases were undertaken through February 2017. In addition other sources were searched. All languages were considered for evaluation. Data were collected and evaluated using a data collection form. Assessment of biases was undertaken using Cochrane methods. When studies could be combined, binary outcomes were evaluated using risk ratio assessment and continuous outcomes were assessed using mean difference (MD). Confidence intervals (CIs) were included and heterogeneity using the I2 statistic. Grading of Recommendations, Assessment, Development, and Evaluation assessments were also made. RESULTS: Ten studies were included in the analysis comprised of 654 patients. Most were patients with breast cancer 432 patients [66%] mainly receiving anthracyclines. For the binary outcome of < 50% versus > 50% alopecia, the use of scalp cooling reduced relative risk (RR) of alopecia by 43% (RR, 0.57; 95% CI, 0.45-0.72; I2 = 11%; P < .00001). For ordinal outcomes (alopecia on a scale of 0-3), use of scalp cooling significantly reduced alopecia (MD, -0.80; 95% CI, -1.19 to -0.41; I2 = 0%; P < .0001). The quality of the evidence was graded as moderate. CONCLUSION: This systematic review and meta-analysis supports the use of scalp cooling to prevent alopecia in patients with solid tumors undergoing chemotherapy.

Private Rooms in Low Acuity Settings: A Systematic Review of the Literature.

OBJECTIVES: Determine if the peer-reviewed evidence supports single-patient ward bedrooms in low-acuity care settings within a hospital. BACKGROUND: New evidence exists since the 2006 Facility Guideline Institute guideline recommended single-bedded rooms (SBRs) in low-acuity care settings. Additionally, prior studies evaluated high-acuity care settings (e.g., critical care) in their recommendations on SBRs. There is a need to reevaluate the evidence. METHODS: A systematic review of the literature was completed including electronic and hand searches of references. A data extraction form was utilized. Two reviewers evaluated the studies independently. Studies that were included examined the effect of single-patient rooms on medical surgical ward beds only. Each study was graded using accepted clinical evidence grading instruments. RESULTS: Over 1,400 records were identified. After excluding studies, a total of 49 records were graded. The highest quality evidence identified (Center for Evidence-Based Medicine [CEBM]: 2a, 2b, and Grading of Recommendations, Assessment, Development, and Evaluation [GRADE] C) did not support the use of single-patient rooms for reducing infections, for minimizing patient falls, for reducing medication errors, or for patient satisfaction. Operational efficiencies were improved with SBRs but only addressed the maternity ward. The lowest quality evidence (CEBM: 4/5 and GRADE D) supported the use of single-patient rooms. CONCLUSIONS: Based on CEBM and GRADE assessments, there is a lack of high-quality data supporting the use of low-acuity SBRs throughout the entire hospital. Furthermore, it is recommended that more research be conducted on the effect of SBRs, so higher quality evidence is developed.

Cost effectiveness analysis comparing repetitive transcranial magnetic stimulation to antidepressant medications after a first treatment failure for major depressive disorder in newly diagnosed patients - A lifetime analysis.

OBJECTIVE: Repetitive Transcranial Magnetic Stimulation (rTMS) commonly is used for the treatment of Major Depressive Disorder (MDD) after patients have failed to benefit from trials of multiple antidepressant medications. No analysis to date has examined the cost-effectiveness of rTMS used earlier in the course of treatment and over a patients' lifetime. METHODS: We used lifetime Markov simulation modeling to compare the direct costs and quality adjusted life years (QALYs) of rTMS and medication therapy in patients with newly diagnosed MDD (ages 20-59) who had failed to benefit from one pharmacotherapy trial. Patients' life expectancies, rates of response and remission, and quality of life outcomes were derived from the literature, and treatment costs were based upon published Medicare reimbursement data. Baseline costs, aggregate per year quality of life assessments (QALYs), Monte Carlo simulation, tornado analysis, assessment of dominance, and one way sensitivity analysis were also performed. The discount rate applied was 3%. RESULTS: Lifetime direct treatment costs, and QALYs identified rTMS as the dominant therapy compared to antidepressant medications (i.e., lower costs with better outcomes) in all age ranges, with costs/improved QALYs ranging from $2,952/0.32 (older patients) to $11,140/0.43 (younger patients). One-way sensitivity analysis demonstrated that the model was most sensitive to the input variables of cost per rTMS session, monthly prescription drug cost, and the number of rTMS sessions per year. CONCLUSION: rTMS was identified as the dominant therapy compared to antidepressant medication trials over the life of the patient across the lifespan of adults with MDD, given current costs of treatment. These models support the use of rTMS after a single failed antidepressant medication trial versus further attempts at medication treatment in adults with MDD.