Research Review Board Research Articles

Mirogabalin treatment of postoperative neuropathic pain after thoracic surgery: study protocol for a multicenter, randomized, open-label, parallel-group, interventional trial.

BackgroundIntercostal nerve damage due to thoracotomy or thoracoscopic manipulation is a major contributor to chronic postsurgical pain after pulmonary resection. Chronic postsurgical pain may last for months or years and can negatively impair physical functioning and daily activities. Global consensus on severe postoperative pain management is lacking, and chronic pain incidence after thoracic surgery remains high. Many patients report neuropathic pain, which can be difficult to treat with currently available therapies. The efficacy and safety of mirogabalin have been demonstrated for other types of neuropathic pain; thus, this study was planned to investigate the efficacy and safety of mirogabalin to treat neuropathic pain after thoracic surgery.MethodsIn this multicenter, randomized, open-label, parallel-group, interventional study, patients who are diagnosed with neuropathic pain following removal of a chest drain after lung resection will receive conventional therapy (non-steroidal anti-inflammatory drugs and/or acetaminophen) with or without the addition of a clinical dose of mirogabalin for 8 weeks. For patient stratification, a visual analog scale pain intensity score at baseline of <60 vs. ≥60 mm will be used. Treatment efficacy and safety with and without the addition of mirogabalin will be assessed using a questionnaire evaluating postoperative changes in pain severity and activity. The primary study endpoint is the change in pain intensity from baseline to Week 8, measured by the visual analog scale. Additionally, the presence of chronic pain at 12 weeks after enrollment in each treatment group will be recorded.DiscussionThis protocol has been reviewed and approved by the Clinical Research Review Board of Nagasaki University. Study data will be published in the Japan Registry of Clinical Trials database and peer-reviewed journals. Mirogabalin is already approved for the treatment of other types of neuropathic pain. It is anticipated that this study will provide data to elucidate the impact of mirogabalin treatment, in combination with conventional therapy, to benefit patients with neuropathic pain following thoracic surgery.Trial RegistrationJapan Registry of Clinical Trials Identifier: jRCTs071200053.

INSTITUTIONAL RESEARCH REVIEW BOARD - SCHOOL SOMEONE IN SOMETHING

The Research Review Board (RRB) is an appropriately constituted unit of Research &amp; Development Cell of an institution and is formally designated to review, monitor and regulate research in the institution. The RRB has the authority to approve, modify or disapprove research. This group serves an important role in promotion of original research, prevention against plagiarism and improving the quality of research culture. It also ensures that appropriate steps are taken during the research process and the research protocols are being followed. Another purpose of RRB is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. It also keeps abreast of ethical issues related to research with human participants, educates faculty and students and formulates policies on these issues. The board has the power to review, approve, reject or modify any proposed or ongoing research involving human participants conducted in an institution.

#MeToo Online Disclosures: A Survivor-Informed Approach to Open Science Practices and Ethical Use of Social Media Data

With social media data widely available, researchers are increasingly incorporating tweets, posts, and blogs in their work. While easily accessible, the use of “public” posts raises important questions about the ethics of mining, storing, analyzing, and reporting publicly available social media data—especially when gathering sensitive information such as sexual violence disclosures. Online movements including #MeToo and #WhyIDidntReport emerged to shed light on gender-based violence. These movements generate large quantities of data with little consistency and oversight across research groups, disciplines, and review boards on data ethics. With the recent push in social science to publish data to open science databases, the concerns of feminist psychologists and ethical concerns of social media research with survivors have become more salient. In this article, we describe and address these ethical issues by reviewing existing social media sexual assault disclosure research and make concrete recommendations for authors seeking to use social media data. We also seek to address these ethical concerns by noting the work of some feminist researchers, but also by pushing researchers to do more for survivors through a survivor-informed approach to this research in an open science context. We propose four survivor-informed recommendations for research with this vulnerable population: (a) get input from survivors, (b) update ethics review boards, (c) maximize benefits to participants, and (d) utilize study-appropriate datasets with informed consent.

A STUDY ON ADVERSE DRUG REACTIONS IN PATIENTS ON ANTIRETROVIRAL THERAPY IN A TERTIARY CARE HOSPITAL AT JAIPUR, RAJASTHAN

Background: The present study was conducted to know the status of ADRs caused due to the first line ART in the ART center of SMS Hospital Jaipur, Rajasthan. This study would be beneficial to the HIV infected patients, with the ultimate goal of improving the tolerability and effectiveness of HIV treatment by promoting the early recognition of potentially serious adverse effects.&#x0D; Methods: Hospital based Prospective, Observational study conducted after approval by research review board and ethics committee SMS Medical College Jaipur (Rajasthan). WHO definition of ADR was used (any response to a medicine which is noxious and unintended and which occurs at doses normally used in man). The detail of ADRs collected including suspected drug involved, treatment given for ADRs and outcome.&#x0D; Results: Majority of ADRs were related to central and peripheral nervous system related 55 (47%) followed by gastro intestinal 28 (23.9%), dermatological 15 (12.8%), musculoskeletal 9 (7.7%) and metabolic 5 (4.3%).&#x0D; Conclusion: Majority of ADRs were related to central and peripheral nervous system related followed by gastro intestinal.&#x0D; Keywords: ADRs, HIV, WHO.

Visuomotor Synchronization: Military Normative Performance.

Cognitive processes such as perception and reasoning are preceded and dependent on attention. Because of the close overlap between neural circuits of attention and eye movement, attention may be objectively quantified with recording of eye movements during an attention-dependent task. Our previous work demonstrated that performance scores on a circular visual tracking task that requires dynamic synchronization of the gaze with the target motion can be impacted by concussion, sleep deprivation, and attention deficit/hyperactivity disorder. The current study examined the characteristics of performance on a standardized predictive visual tracking task in a large sample from a U.S. Military population to provide military normative data. The sample consisted of 1,594 active duty military service members of either sex aged 18-29 years old who were stationed at Fort Hood Army Base. The protocol was reviewed and approved by the U.S. Army Medical Research and Materiel Command Institutional Review Board. Demographic, medical, and military history data were collected using questionnaires, and performance-based data were collected using a circular visual tracking test and Trail Making Test. Differences in visual tracking performance by demographic characteristics were examined with a multivariate analysis of variance, as well as a Kolmogorov-Smirnov test and a rank-sum test. Associations with other measures were examined with a rank-sum test or Spearman correlations. Robust sex differences in visual tracking performance were found across the various statistical models, as well as age differences in several isolated comparisons. Accordingly, norms of performance scores, described in terms of percentile standings, were developed adjusting for age and sex. The effects of other measures on visual tracking performance were small or statistically non-significant. An examination of the score distributions of various metrics suggested that strategies preferred by men and women may optimize different aspects of visual tracking performance. This large-scale quantification of attention, using dynamic visuomotor synchronization performance, provides rigorously characterized age- and sex-based military population norms. This study establishes analytics for assessing normal and impaired attention and detecting changes within individuals over time. Practical applications for combat readiness and surveillance of attention impairment from sleep insufficiency, concussion, medication, or attention disorders will be enhanced with portable, easily accessible, fast, and reliable dynamic eye-tracking technologies.

Comparison of respiratory-triggered 3D MR cholangiopancreatography and breath-hold compressed-sensing 3D MR cholangiopancreatography at 1.5 T and 3 T and impact of individual factors on image quality

PurposeTo evaluate the image quality of an accelerated compressed-sensing single-breath-hold 3D magnetic resonance cholangiopancreatography (BH-CS-MRCP) prototype sequence compared to the standard 3D sequence with respiratory triggering (STD-MRCP) at 1.5 T and 3 T. To assess the individual factors that can affect image quality. MethodThis is a retrospective analysis. Both sequences (BH-CS-MRCP and STD-MRCP) were performed in 200 patients at 1.5 T and 200 patients at 3 T. Overall image quality and the visualization of the bilio-pancreatic ducts were rated on a 5-point scale. Image sharpness and background suppression were rated on a 4-point scale. A double reading was performed in 50 patients to assess the inter-observer reproducibility.Individual characteristics studied were gender, age, BMI, ascites, abdominal surface and breath-hold quality. ResultsAt 1.5 T, BH-CS-MRCP was inferior to STD-MRCP in terms of overall quality (p = 0.0046), background suppression (p < 0.0001), visualization of the cystic duct (p < 0.0001), the right bile duct (p = 0.0008), the left bile duct (p = 0.0152), and the main pancreatic duct (p < 0.0001). However, BH-CS-MRCP was sharper than STD-MRCP (p = 0.028).At 3 T, BH-CS-MRCP was superior to STD-MRCP for overall quality (p < 0.0001), sharpness (p < 0.0001), and visualization of the bilio-pancreatic ducts (p < 0.0001). Background signal was conversely better suppressed in STD-MRCP (p < 0.0001).At 1.5 T, the volume of ascites was inversely correlated with image quality for BH-CS-MRCP while BMI was inversely correlated with image quality for STD-MRCP.Breath-hold quality was correlated with image quality for BH-CS-MRCP at 1.5 T and 3 T. ConclusionBH-CS-MRCP is feasible in clinical routine at 1.5 and 3 T, yielding significantly better perceived image quality at 3 T but not at 1.5 T.BH-CS-MRCP appears to be influenced by ascites whereas STD-MRCP is influenced by BMI at 1.5 T.This study was approved by the Ethics Review Board for Research in Medical Imaging (IRB: CRM-2003–065).

INSTITUTIONAL RESEARCH REVIEW BOARD - SCHOOL SOMEONE IN SOMETHING

The Research Review Board (RRB) is an appropriately constituted unit of Research &amp; Development Cell of an institution and is formally designated to review, monitor and regulate research in the institution. The RRB has the authority to approve, modify or disapprove research. This group serves an important role in promotion of original research, prevention against plagiarism and improving the quality of research culture. It also ensures that appropriate steps are taken during the research process and the research protocols are being followed. Another purpose of RRB is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. It also keeps abreast of ethical issues related to research with human participants, educates faculty and students and formulates policies on these issues. The board has the power to review, approve, reject or modify any proposed or ongoing research involving human participants conducted in an institution.

Antibody Specificity in Alloimmunised Thalassemia Patients Attending Tertiary Care Center in Western Part of India.

Abstract Introduction: In thalassemia major patients there is marked ineffective erythropoiesis occur leading to intramedullary hemolysis. To suppress the ineffective erythropoiesis allogenic transfusion is given. So alloimmunisation is a common problem in transfusion dependant thalassemic patients leading to delayed hemolytic transfusion reaction. Aim & Objective: The aim of this study to identify the antibody specificity pattern in transfusion dependant thalassemia patients at our center. Material & Method: The study was conducted on 210 transfusion dependant thalassemic patients registered at SMS hospital for regular blood transfusion and give valid consent to participate in the study. Data collection was started after approval of plan from research review board of institute in April 2019 onwards till significant sample size was collected. Total 210 patients were selected and included in the study with 95% confidence and 10% allowable error. The qualitative data was expressed as percentage . The difference in proportion was analysed by using Chi square test. Quantitative data was expressed as mean. Result : Out of 210 patients, 8 patients were screen positive, Out of which 7 having alloantibody and 1 patient having autoantibody. Antibody identified were belongs to Rh & Kell blood group system. Keyword: Alloimmunisation, thalassemia, transfusion dependant

Evaluation of the Effect of Laparoscopic Sleeve Gastrectomy Operation on Short-Term Nutrition, Biochemical Blood Parameters and Anthropometric Measurements

Objective: To evaluate the effect of laparoscopic sleeve gastrectomy on food intake, anthropometric measurements and biochemical blood parameters in the short term (6 months) postoperatively. Materials and Methods: Twenty-one volunteer women who had undergone laparoscopic sleeve gastrectomy between June 2018 and September 2018 at Acıbadem Hospital participated in this study. A questionnaire was used to determine the general characteristics of the women who participated in the study, and food consumption, body weight and biochemical blood parameters were evaluated before and after the operation. SPSS Windows 22.0 statistical package program was used to evaluate the data. This study was evaluated by the Medical Research Review Board of Acıbadem University and found to be appropriate in terms of medical ethics with decision number 2017-4 / 20. Results: The mean age of the women was 42.04 years. The mean preoperative BMI values were 40.7 ± 8.0 kg / m2 and 28.9 ± 5.7 kg / m2 at the end of six months and the difference was statistically significant (p = 0.00). At the end of six months, fasting blood glucose, triglyceride, LDL-cholesterol, total cholesterol, ALT and AST values were decreased, HDL-cholesterol levels were increased and the difference was statistically significant (p <0.05). There was a significant decrease in total energy and macronutrient intake of women after the operation (p <0.05). Conclusion: At the end of the study, it was concluded that there is a significant decrease in biochemical blood parameters and anthropometric measurements after the laparoscopic sleeve gastrectomy operation compared to the preoperative period, and the possibility of developing obesity-related diseases may be reduced if this condition persists for a long time and preserves the lost weight.

Protocol for studying the efficiency of ChemoCalc software in helping patients to understand drug treatment costs for breast cancer: A multicenter, open-label, randomized phase 2 study

Survival of patients with breast cancer can be prolonged by treatment with drugs, particularly new molecular-targeted drugs. However, these agents can be expensive and such treatments can be “an economic burden.” In this ongoing trial, we aim to assess the usefulness of ChemoCalc, a software package for calculating drug costs, to help patients understand the financial outlays. In this multicenter, randomized controlled phase 2 trial, 106 patients with advanced breast cancer will be assigned to either the “ChemoCalc” or “Usual Explanation” group. Treatment using ChemoCalc will be discussed with patients in the ChemoCalc group, whereas standard treatments, without using ChemoCalc, will be discussed with patients in the Usual Explanation group. Subsequently, the participants will decide the treatment and complete a five-grade evaluation questionnaire; those in the Usual Explanation group will receive information about ChemoCalc. Investigators will report if patients subsequently decide to change treatments. The primary endpoint will be the scores of two key questions compared between the groups: “Did you understand the cost of treatment in today's discussion?” and “Do you think the cost of treatment is important in choosing a treatment?“. The secondary endpoints will be to compare discrepancies between treatments recommended by physicians and those selected by patients, the time required for discussion, other questionnaire factors, and the relationship between Comprehensive Score for Financial Toxicity tool and treatment selection. This will be the first randomized controlled trial to assess the efficacy of software to help patients understand drug cost estimates and whether it subsequently affects treatment choice. This study will be conducted according to the CONSORT statement. All participants will sign a written consent form. The study protocol was reviewed and approved by the Clinical Research Review Board of Nagasaki University (19070801). The protocol (version 1) was designed and will be conducted in accordance with the Declaration of Helsinki (1964) and the Ethical Guidelines for Medical and Health Research Involving Human Subjects (2017). The findings will be disseminated through scientific and professional conferences, and in peer-reviewed journals. Trial registrationUMIN Clinical Trials Registry, UMIN000039904. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041968

The timing of continuous renal replacement therapy initiation in sepsis-associated acute kidney injury in the intensive care unit: the CRTSAKI Study (Continuous RRT Timing in Sepsis-associated AKI in ICU): study protocol for a multicentre, randomised controlled trial

IntroductionAcute kidney injury (AKI) is one of the most common organ dysfunction in sepsis, and increases the risk of unfavourable outcomes. Renal replacement therapy (RRT) is the predominant treatment for...

A STUDY TO ASCERTAIN THE ADVERSE EFFECTS OF MORPHINE IN CANCER PATIENTS BEING TREATED FOR SEVERE PAIN

Pain is a distressing symptom of cancer that affects the quality of life of patients, families, and caregivers. Moderate to severe pain is common throughout the disease trajectory of cancer, and its prevalence increases throughout the course of illness, it has been reported in 59% of patients undergoing anticancer treatment, in 64% of those with advanced/metastatic cancer, and in 33% of those having completed curative treatment. Adequate management of cancer pain is the cornerstone of symptom management for patients with cancer. [1] WHO guidelines on cancer pain continue to provide a framework approach for pharmacologic management of cancer pain management in terms of a Pain Ladder, wherein Step 1 for mild pain is prescribed NSAIDS, Step 2 for moderate pain is prescribed NSAIDS along with synthetic opioids and adjuvants and step 3 for severe pain is prescribed strong opioids like Morphine along with NSAIDS and adjuvants. Morphine being an excellent analgesic for severe pain is nowadays standard of care for terminal cancer patients with severe pain. However, its potency is a double edged sword and can give rise to side effects as well as much feared adverse effects. This study was undertaken to assess the undesirable effects on cancer patients being treated with Morphine. AIM To find the association of morphine and its adverse effects (by 4 point verbal rating scale) in cancer patient on long term morphine therapy. MATERIAL AND METHODS It is a hospital based longitudinal observational study, conducted in palliative care center, SMS hospital, Jaipur, after obtaining due approval from ethics committee and research review board of the institution. DURATION OF STUDY: One year. TOTAL PATIENTS: 30 patients evaluated one month after initiation of opioid therapy. ELIGIBILITY CRITERIA: Inclusion criteria 1. Cancer patients visiting palliative care OPD for distressing, somatic symptom like pain requiring treatment with strong opioids (step 3 WHO ladder). 2. Patients of all ages and both sexes. 3. Patients willing to give informed consent 4. Patients who understand the four point symptom rating scale. Exclusion Criteria: 1. Patients with deranged liver and kidney functions. 2. Patient with predominantly neuropathic pain. 3. Patients with altered sensorium. 4. Patient not willing to give informed consent.

Serology Suggests Adequate Safety Measures to Protect Healthcare Workers From COVID-19 in Shiga Prefecture, Japan

Background: Healthcare workers (HCWs), especially frontline workers against coronavirus disease 2019 (COVID-19), are considered to be at increased risk of infection because of occupational exposure to infected patients. This study evaluated the correlation between seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies among HCWs and the implementation of personal protective equipment (PPE) & infection prevention and control (IPC). Methods: We prospectively recruited 1237 HCWs from nine public COVID-19-designated hospitals in Shiga Prefecture, central Japan, between 15–26 February 2021. All participants answered a self-administered questionnaire and provided blood samples to evaluate SARS-CoV-2 antibodies. Findings: A total of 22 cases (1·78%) were seropositive among the 1237 study participants. Half of the participants (n=500; 48·8%) had worked in red zones designated for COVID-19, where high exposure to SARS-CoV-2 was suspected in the past months. Seven (7/1025; 0·68%) HCWs were suspected to have had previous SARS-CoV-2 infections. From these, binomial logistic regression from individual questionnaires and seropositivity predicted a significant correlation with N95 mask usage under aerosol conditions and work duration in a red zone. The institutional questionnaire suggested that IPC education was correlated with reduced seropositivity at hospitals. Interpretation: Seroprevalence and questionnaire analyses among HCWs indicated that secure implementation of PPE and re-education of IPC are essential to prevent SARS-CoV-2 infection within healthcare facilities. Occupational infections from SARS-CoV-2 in healthcare settings can be prevented by adhering to adequate measures and appropriate use of PPE. With these measures securely implemented, HCWs should not be discriminated against as risky or dirty by local communities. Funding Information: Shiga Prefecture and Shiga University of Medical Science Hospital funded the administrative costs of this study.Declaration of Interests: No authors have conflicts of interest to declare.Ethics Approval Statement: This study was approved as an administrative investigation of Shiga Prefecture by the Research Review Board of Shiga University of Medical Science (No. RRB20-032). Written informed consent and self-administered questionnaires were obtained from all study participants.

The Effect of a Prescription Audit, Feedback, and Small Group Education Intervention on the Who/Inrud Prescribing Indicators in Eswatini – a Controlled Before and after Study

Background: Irrational use of antibiotics is a global problem that may potentiate antimicrobial resistance. Objective: We assessed prescribing practices in Eswatini and the effect of a short intervention - prescription audit and feedback coupled with small group education on prescribing indicators. Methods: This was a pre-post intervention study using the World Health Organization/ International Network for the Rational Use of Drugs (WHO/INRUD) prescribing indicators at three time points: baseline, post-intervention, and post-follow-up. Baseline results were used to design a six-months’ unblinded intervention in 32 health facilities, randomly allocated to intervention (16) and control (16) arms. Prescribing patterns were assessed immediate post-intervention, and six months after the end of the intervention, through an audit of 100 randomly selected prescriptions from each facility. Comparison of WHO/INRUD prescribing indicators were carried out using intention to treat analysis at the two time points. Results: At baseline, in both intervention and control facilities, rational prescribing standards were only met by the average number of medicines per prescription and the percentage of prescriptions with injections. The use of antibiotics was above 50% in both intervention and control facilities. At the end of the follow-up period, there was a significant decrease in the use of antibiotics in intervention facilities, compared to control facilities (MD = -8·31, 95% CI = -15·74 - -0·89; p = 0·03). Conclusion: In a low-and-middle-income setting with a high prevalence of irrational prescribing practices, a prescription audit, feedback, and small group education intervention may have benefits in improving rational antibiotics prescribing. Funding Information: The Institute of Tropical Medicine (ITM) financially supported the conduct of this study through the School of Public Health at the University of the Western Cape. Declaration of Interests: None to declare. Ethics Approval Statement: Ethics clearance was granted by the University of the Western Cape Higher Degrees Committee (reference BM/16/4/2) and the National Health Research Review Board in Eswatini. Permission to access healthcare facilities was granted by the office of the Deputy Director Pharmaceutical Services in the Ministry of Health in Eswatini.

The Causes of Low Birthweight Among Term Singletons in Japan: National Database Analysis

Background: Progress on reducing global low birthweight (LBW) prevalence has been insufficient. Although focus has been on preventing preterm birth, evidence surrounding LBW in term birth is limited. Japan has a higher LBW proportion despite a low preterm birth prevalence than other developed countries. The study aim is to examine LBW prevalence in term singleton birth and investigate their causes using a national database. Methods: Retrospective analysis was conducted on 852,351 babies born between 2013 and 2017 registered in the Japan Society of Obstetrics and Gynecology Successive Pregnancy Birth Registry System. Findings: Prevalence of LBW was 18·3%, and a third (35·7%) of LBW derived from singleton term pregnancy. Multiple logistic regression analysis indicated various factors to be independently associated with LBW in term babies. Modifiable maternal factors included pre-pregnancy underweight (adjusted odds ratios [aOR] 1·65, 95% confidence intervals [CI] 1·62-1·69), inadequate gestational weight gain (aOR 1·90, 1·86-1·94), and smoking during pregnancy (aOR 1·78, 1·71-1·85). Non-modifiable factors included younger maternal age, nulliparity, hypertensive disorder of pregnancy, pre-eclampsia, delivery at 37 gestational weeks, cesarean section, female offspring, and congenital anomaly. Interpretation: LBW in term singleton birth was as common as in multiple and preterm births in Japan. Factors causing LBW in term singletons were similar to those in preterm birth, including maternal malnutrition, suggesting that strategies to reduce preterm birth could be equally effective in preventing LBW in term pregnancy. Evaluating the status and monitoring progress within countries on this issue may contribute to the overall reduction of LBW worldwide. Funding: None to declare. Declaration of Interest: None to declare. Ethical Approval: This study was approved by the Ethics committee of the Keio University School of Medicine, Tokyo, Japan (No. 20190220, approved November 25, 2019) and the Clinical Research Review Board, Japan Society of Obstetrics and Gynecology, Tokyo, Japan, (No. 2019-15, approved September 14, 2020).

Evaluation of Head and Body Kinematics Experienced During Parachute Opening Shock.

The U.S. Army conducts airborne operations in order to insert soldiers into combat. Military airborne operations are physically demanding activities with a unique loading environment compared with normal duties. A significant amount of research surrounding airborne operations has focused on assessing the incidence and type of associated injuries as well as the potential risk factors for injuries. During parachute opening shock and other high-acceleration events (e.g., fixed wing flight or vehicle crashes), the neck may be vulnerable to injury if inertial loads overcome the voluntary muscular control of the cervical spine and soft tissue structures. A recent epidemiological survey of sport skydivers showed that the neck, shoulders, and back were the most frequently reported sites of musculoskeletal pain. In addition, the survey indicated that wing loading (a measure of the jumper's weight divided by the size of the parachute canopy) was a potential contributing factor for developing musculoskeletal pain. Recently, there have been efforts to measure the severity of parachute opening shock as an additional potential risk factor for injury; however, no studies have measured both head and body accelerations and no studies have measured head or body angular rate during parachute opening shock. The purpose of this study was to measure and characterize the accelerations and angular rates of both the head and body during parachute opening shock as well as investigate potential factors contributing to higher severity opening shock, which may link to the development of musculoskeletal pain or injury. Data were collected from the U.S. Army Parachute Team, The Golden Knights, under an approved Medical Research and Material Command Institutional Review Board protocol. Subjects were instrumented with a helmet- and body-mounted sensor package, which included three angular rate sensors and three single-axis accelerometers each. Data were collected at 2,500 samples per second. Kruskal-Wallis tests were used to determine if helmet-mounted equipment (e.g., cameras), neck length, neck circumference, or wing loading (the ratio of jump weight to the size of the main parachute canopy) affected the accelerations or angular rates of the head or body. A total of 54 jumps conducted by 19 experienced free-fall jumpers were analyzed. For the head, the mean (± SD) resultant accelerations and angular rates were 5.8 (± 1.6) g and 255.9 (± 74.2) degrees per second (deg/s), respectively. For the body, the resultant accelerations and angular rates were 4.3 (± 1.5) g and 181.3 (± 61.2) deg/s, respectively. A wing loading above 1.4 pounds per square foot (lb/ft2) was found to have a significant effect on head (P = .001) and body (P = .001) resultant acceleration as well as body angular rate about the Y-axis (P = .001). There is evidence to suggest that wing loading has an influence on individual head and body resultant accelerations. However, no significant effects were found for the other variables (e.g., neck length and circumference, helmet-mounted equipment, etc.). Future research should focus on identifying additional factors that result in changes in accelerations and angular rates of the head and body during parachute opening shock events.

Nurses' perspectives of an environment of optimum mental health: a grounded theory study.

The Government's aspiration to make Kenya a middle-income country and achieve the United Nations' sustainable development goal 3, 'good health and well-being', are threatened by poor quality of mental health services. Environment and lack of a conceptual model of nursing to guide care were some of the reasons that were attributed to poor quality of mental health services. The purpose of the study was to discover and describe an appropriate conceptual model of mental health nursing practice. This paper describes the environment which is one of the metaparadigms of a conceptual model grounded on data collected from Kenyan mental health nurses. A grounded theory study was conducted with 33 mental health nurses selected by purposive, open and theoretical sampling procedures. The study sites were level 5 and 6 mental health facilities across the country. Data were collected over a period of 11 months through audio-recorded in-depth interviews and field notes. Analysis was performed using Straussian Grounded Theory steps of open, axial and selective coding processes aided by NVivo version 10. Dimensions and properties of environment metaparadigm grounded on nurses' views were discovered. The study was conducted within the dictates of the institutional and national ethics and research review boards. Environment evolved as an intervening condition and a supra-system for mental health nursing. A homely environment emerged as a space with properties that nurture optimum mental health contrary to a hostile environment that precipitates mental disorders and prolongs recovery. Grounded theory methodology was useful in discovering an environment metaparadigm as the context that influences mental health while nursing practice is the central phenomenon for optimum mental health. Nurses can ensure homely environments from diverse cultures and conduct comparative studies on the recovery of patients in the two environments.

Clinical and Microbiological Assessments of COVID-19 in Healthcare Workers: A Prospective Longitudinal Study

Background: A comprehensive assessment of COVID-19 in healthcare workers (HCWs) including the investigation of viral shedding duration is critical.Methods: A longitudinal study including 319 HCWs was conducted. After SARS-CoV-2 screening with RT-PCR assay, other respiratory pathogens were tested with a multiplex molecular panel. For SARS-CoV-2 positive HCWs, the normalized viral load was determined weekly; viral culture and virus neutralization assay were also performed. For 190 HCWs tested negative for SARS-CoV-2, serological testing was performed one month after the inclusion.Findings: Of the 319 HCWs included, 67 (21.0%) were tested positive for SARS-CoV-2; two of them developed severe COVID-19. The proportion of smell and taste dysfunction was significantly higher in SARS-CoV-2 positive HCWs than in negative ones (38.8% vs 9.5% and 37.3% vs 10.7%, respectively, p 5.0 log 10 cp/ml (Ct value 37). More than 90% of samples with cultivable virus had a viral load > 4.5 log 10 cp/ml (Ct Interpretation: Our data suggest that the monitoring of normalized viral load (or its estimation through Ct values) can be useful for discontinuing isolation of HCWs and facilitating their safe return to work. HCWs presenting mild COVID-19 are unlikely infectious 10 days after symptom onset.Trial Registration: The clinical study registered on ClinicalTrial.gov (NCT04341142) has been fully detailed.Funding: Fondation des Hospices Civils de Lyon. bioMérieux provided diagnostic kits.Declaration of Interests: Several authors (KBP, FAF, GO, VC) are bioMérieux employees. AB has received a grant from bioMérieux and has served as consultant for bioMérieux. KBP, FAF, GO VC and AB were involved in data analysis, interpretation and wrote the article.Ethics Approval Statement: Written informed consent was obtained from all participants and approval was obtained from the national review board for biomedical research in April 2020 (Comité de Protection des Personnes Sud Méditerranée I, Marseille, France; ID RCB 2020-A00932-37).

Factor Structure and Reliability of MOS Social Support Survey among Mexican Women with Breast Cancer

Background: Social Support (SS) has been an important variable to consider in the psychosocial understanding of patients with cancer. Objective: To test the 3-factor model for the Medical Outcomes Study Social Support Survey (MOS SSS) and estimate its internal consistency reliability in Mexican women with Breast Cancer (BC). Methods: 300 women diagnosed with BC were enrolled in a convenience sampling. Participants were asked to complete the Spanish version of the MOS SSS (Argentina). After the approval of the Ethics and Research Review Board of Instituto Nacional de Cancerología, the Mexican adaptation was created through three phases: 1) linguistically adaptation; 2) presentation of the corrected and integrated version to another expert, and 3) pilot study. Results: The MOS SSS obtained a factorial structure with 13 items distributed among three factors. A high internal consistency (Alpha=0.912) and an acceptable explained-variance value (67%) were obtained; finally, the confirmatory analysis determined a proper adjustment with that structure. Conclusions: This instrument has adequate psychometric properties and is useful for evaluation and culturally appropriate to the clinical management of SS.

Effects of multisession transcranial direct current stimulation as an augmentation to cognitive tasks in patients with neurocognitive disorders in Japan: a study protocol for a randomised controlled trial

IntroductionTranscranial direct current stimulation (tDCS) is a potentially novel strategy for cognitive enhancement in patients with disorders. We present a study protocol for a randomised controlled trial designed to evaluate...