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https://www.readbyqxmd.com/read/28928186/recombinant-human-tnk-tissue-type-plasminogen-activator-rhtnk-tpa-versus-alteplase-rt-pa-as-fibrinolytic-therapy-for-acute-st-segment-elevation-myocardial-infarction-china-tnk-stemi-protocol-for-a-randomised-controlled-non-inferiority-trial
#1
Hai-Bo Wang, Ping Ji, Xing-Shan Zhao, Haiyan Xu, Xiao-Yan Yan, Qin Yang, Chen Yao, Run-Lin Gao, Yang-Feng Wu, Shu-Bin Qiao
AIM: To evaluate the efficacy and safety of recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) in lowering major adverse cardiovascular and cerebrovascular events (MACCEs) in Chinese acute ST-segment elevation myocardial infarction (STEMI) patients. METHODS AND ANALYSIS: The study is designed as a multicentre, randomised, controlled non-inferiority phase IV trial with balanced randomisation (1:1) in patients with STEMI. The planned sample size is 6200 participants (or 3100 per arm)...
September 18, 2017: BMJ Open
https://www.readbyqxmd.com/read/28918381/assessing-decisional-capacity-for-research-participation-in-psychiatric-patients-and-their-relatives
#2
Donae Elizabeth George, Saumil Dholakia, Prathap Tharyan
A cross-sectional study among adult inpatients with non-organic psychiatric disorders, and among their key relatives, assessed their comprehension and recall of key information in consent forms. It also assessed their capacity to consent to participate in two hypothetical randomised controlled trials (RCTs) with different potential risks and burdens, using structured questionnaires and recorded interviews. Of the 24 participants (12 patient-key relative dyads), seven patients (58%) and three key relatives (25%) were clinically judged to lack the capacity to consent...
August 8, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28915865/informed-consent-and-registry-based-research-the-case-of-the-danish-circumcision-registry
#3
Thomas Ploug, Søren Holm
BACKGROUND: Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of 'big data'. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark...
September 15, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28915851/assessment-of-consent-models-as-an-ethical-consideration-in-the-conduct-of-prehospital-ambulance-randomised-controlled-clinical-trials-a-systematic-review
#4
Stephanie Armstrong, Adele Langlois, Despina Laparidou, Mark Dixon, Jason P Appleton, Philip M Bath, Helen Snooks, A Niroshan Siriwardena
BACKGROUND: We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. METHODS: A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data...
September 16, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28913505/periorbital-facial-rejuvenation-applied-anatomy-and-pre-operative-assessment
#5
REVIEW
Mohsen Bahmani Kashkouli, Parya Abdolalizadeh, Navid Abolfathzadeh, Hamed Sianati, Maria Sharepour, Yasaman Hadi
PURPOSE: Since different subspecialties are currently performing a variety of upper facial rejuvenation procedures, and the level of knowledge on the ocular and periocular anatomy and physiology is different, this review aims to highlight the most important preoperative examinations and tests with special attention to the eye and periocular adnexal structures for general ophthalmologist and specialties other than oculo-facial surgeons in order to inform them about the fine and important points that should be considered before surgery to have both cosmetic and functional improvement...
September 2017: Journal of Current Ophthalmology
https://www.readbyqxmd.com/read/28900315/efficacy-and-safety-of-deferasirox-in-pediatric-patients-of-thalassemia-at-a-tertiary-care-teaching-hospital
#6
Dhaval R Thakor, Chetna K Desai, Jigar D Kapadia, Ram K Dikshit, K M Mehariya
OBJECTIVE: To evaluate efficacy, safety and utilization pattern of deferasirox in paediatric patients of transfusion dependant β Thalassemia Major at a tertiary care teaching hospital in Gujarat. MATERIALS AND METHODS: This observational, prospective-retrospective, single centre, continuous study was conducted in a tertiary care teaching hospital among paediatric patients of transfusion dependent β Thalassemia Major. Patients treated with deferasirox for not more than 12 weeks were enrolled...
April 2017: Indian Journal of Medical and Paediatric Oncology
https://www.readbyqxmd.com/read/28893655/laparoscopic-blinded-endometrial-cavity-resection-for-robert-s-uterus
#7
Huseyin Kiyak, Tolga Karacan, Lale Susan Wetherilt, Kerem Doga Seckin, Eser Sefik Ozyurek
Study Objective To demonstrate that laparoscopic excision of the endometrial tissue of a blind endometrial cavity in a patient with a Robert's uterus who did not consent to hysteroscopic surgery due to her virgin state and religious beliefs was an effective alternative treatment option for progressive dismenorrhea and pelvic pain. Design To describe a rare müllerian anomaly and the step by step laparoscopic excision technique of the endometrium of a blind uterine cavity. Setting Robert's uterus is a rare müllerian anomaly characterized by the presence of a blind endometrial cavity and an asymmetric septum...
September 8, 2017: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/28893046/the-association-between-cariogenic-factors-and-the-occurrence-of-early-childhood-caries-in-children-from-salem-district-of-india
#8
Arokiaraj Stephen, Ramesh Krishnan, Paul Chalakkal
INTRODUCTION: Various aetiological factors for Early Childhood Caries (ECC) have been suggested in literature, but the role of each factor has been disputed in various studies. AIM: To evaluate the association between ECC and its related factors in children between three to six years of age, from rural, semi-urban and urban schools in the district of Salem (India). MATERIALS AND METHODS: The study consisted of children between three to six years of age, selected randomly from schools in semi-urban, urban and rural schools at Salem...
July 2017: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28891878/using-high-fidelity-simulation-and-video-assisted-debriefing-to-enhance-obstetrical-hemorrhage-mock-code-training
#9
Peggy J Jacobs
The purpose of this descriptive, one-group posttest study was to explore the nursing staff's perception of the benefits of using high-fidelity simulation during mandated obstetrical hemorrhage mock code training. In addition, the use of video-assisted debriefing was used to enhance the nursing staff's evaluation of their communication and teamwork processes during a simulated obstetrical crisis. The convenience sample of 84 members of the nursing staff consented to completing data collection forms and being videotaped during the simulation...
September 2017: Journal for Nurses in Professional Development
https://www.readbyqxmd.com/read/28884273/validation-of-the-chinese-mandarin-version-of-the-oxford-knee-score-in-patients-with-knee-osteoarthritis
#10
Kai Lin, Liangxiao Bao, Jian Wang, Kimie Fujita, Kiyoko Makimoto, Xiaoyan Liao
BACKGROUND: With the increasing number of patients with knee osteoarthritis undergoing TKAs in China, there is a clear need for a valid, short, joint-specific patient-reported outcome measure such as the Oxford Knee Score (OKS). QUESTIONS/PURPOSES: To test the translated and cross-culturally adapted Chinese (Mandarin) version of the Oxford Knee Score (OKS-CV) and its (1) reliability, (2) construct validity, (3) dimensionality, and (4) responsiveness. METHODS: Three native Chinese bilingual translators (a professional English translator, an experienced orthopaedic surgeon, an advanced-practice nursing specialist) translated the English-language OKS into Mandarin Chinese...
September 7, 2017: Clinical Orthopaedics and related Research
https://www.readbyqxmd.com/read/28879336/the-use-of-general-anesthesia-to-facilitate-dental-treatment-in-adult-patients-with-special-needs
#11
REVIEW
Mathew Albert Wei Ting Lim, Gelsomina Lucia Borromeo
General anesthesia is commonly used to facilitate dental treatment in patients with anxiety or challenging behavior, many of whom are children or patients with special needs. When performing procedures under general anesthesia, dental surgeons must perform a thorough pre-operative assessment, as well as ensure that the patients are aware of the potential risks and that informed consent has been obtained. Such precautions ensure optimal patient management and reduce the frequency of morbidities associated with this form of sedation...
June 2017: J Dent Anesth Pain Med
https://www.readbyqxmd.com/read/28876312/screening-for-sexually-transmitted-infections-in-adolescent-girls-and-young-women-in-mombasa-kenya-feasibility-prevalence-and-correlates
#12
Linnet N Masese, George Wanje, Emmanuel Kabare, Valentine Budambula, Francis Mutuku, Grace Omoni, Anisa Baghazal, Barbra A Richardson, R Scott McClelland
INTRODUCTION: As adolescents and young women become sexually active, they are at risk of adverse reproductive health outcomes including sexually transmitted infections (STIs). We assessed feasibility and acceptability of STI screening among 15- to 24-year-old women in Mombasa, Kenya. METHODS: After sensitization activities, participants were recruited from 3 high schools and 1 university. Study staff conducted informational sessions. Students interested in participating were given consent forms to take home, and invited to visit our clinic for STI screening...
June 28, 2017: Sexually Transmitted Diseases
https://www.readbyqxmd.com/read/28875493/prevalence-of-high-risk-hpv-dna-in-esophagus-is-high-in-brazil-but-not-related-to-esophageal-squamous-cell-carcinoma
#13
Allini Mafra da Costa, José Humberto Tavares Guerreiro Fregnani, Paula Roberta Aguiar Pastrez, Vânia Sammartino Mariano, Cristovam Scapulatempo Neto, Denise Peixoto Guimarães, Kelly Menezio Giordina de Oliveira, Said Abdala Zemi Neto, Emily Montosa Nunes, Silvaneide Ferreira, Laura Sichero, Luisa Lina Villa, Kari Juhani Syrjanen, Adhemar Longatto-Filho
The first publication that associated Human Papillomavirus (HPV) infection and esophageal cancer was published in 1982. However, data are still contradictory and require further investigation. The aim of this study was to identify high risk HPV DNA in esophageal tissue of patients with and without esophageal squamous cell carcinoma (ESCC) and correlate HPV presence with classical risk factors. METHODS: Invited patients signed the informed consent form, and interviews were conducted in order to obtain information about sociodemographic and lifestyle behavior...
September 6, 2017: Histology and Histopathology
https://www.readbyqxmd.com/read/28870724/tubal-sterilization-in-women-under-30-case-series-and-ethical-implications
#14
Dylan Ehman, Dustin Costescu
OBJECTIVE: According to the SOGC Contraception Consensus, it is recommended that permanent contraception be offered to women regardless of age or parity. Many women who desire sterilization at a young age experience barriers from physicians who decline to facilitate the request. METHODS: As part of a quality assurance project, we performed a review of cases where tubal sterilization was performed in women under 30 over a 42-month period (September 2013-March 2017)...
September 1, 2017: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
https://www.readbyqxmd.com/read/28866123/a-systematic-review-finds-underreporting-of-ethics-approval-informed-consent-and-incentives-in-clinical-trials
#15
Ly Quoc Trung, Mostafa Ebraheem Morra, Nguyen Duc Truong, Tarek Turk, Ahmed Elshafie, Amr Foly, Dao Ngoc Hien Tam, Ahmed Iraqi, Trinh Thi Hong Van, Ahmed Elgebaly, Tran Nhu Ngoc, Tran Le Huy Vu, Ngan Thy Chu, Kenji Hirayama, Juntra Karbwang, Nguyen Tien Huy
OBJECTIVES: In this study, we aim to review researchers' reporting practices of the ethics statement, financial incentives, and local ethical committees' profile in their clinical trials. STUDY DESIGN AND SETTING: A systematic search was done through top ranked 50 medical journals (Scimago Ranking) to retrieve 2000 latest publications. Only primary clinical trials were included with no restriction to language or participants. RESULT: Among the 927 included trials, 14 (1...
August 30, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28860228/anterior-transversalis-fascia-approach-versus-preperitoneal-space-approach-for-inguinal-hernia-repair-in-residents-in-northern-china-study-protocol-for-a-prospective-multicentre-randomised-controlled-trial
#16
Qing Fan, De-Wei Zhang, Da-Ye Yang, Hong-Wu Li, Shi-Bo Wei, Liang Yang, Fu-Quan Yang, Shao-Jun Zhang, Yao-Qiang Wu, Wei-de An, Zhong-Shu Dai, Hui-Yong Jiang, Fu-Rong Wang, Shi-Feng Qiao, Hang-Yu Li
INTRODUCTION: Many surgical techniques have been used to repair abdominal wall defects in the inguinal region based on the anatomic characteristics of this region and can be categorised as 'tension' repair or 'tension-free' repair. Tension-free repair is the preferred technique for inguinal hernia repair. Tension-free repair of inguinal hernia can be performed through either the anterior transversalis fascia approach or the preperitoneal space approach. There are few large sample, randomised controlled trials investigating the curative effects of the anterior transversalis fascia approach versus the preperitoneal space approach for inguinal hernia repair in patients in northern China...
August 31, 2017: BMJ Open
https://www.readbyqxmd.com/read/28859617/factors-associated-with-attrition-in-a-longitudinal-online-study-results-from-the-habids-panel
#17
Nicole Rübsamen, Manas K Akmatov, Stefanie Castell, André Karch, Rafael T Mikolajczyk
BACKGROUND: Knowing about predictors of attrition in a panel is important to initiate early measures against loss of participants. We investigated attrition in both early and late phase of an online panel with special focus on preferences regarding mode of participation. METHODS: We used data from the HaBIDS panel that was designed to investigate knowledge, attitudes, and practice regarding infections in the German general population. HaBIDS was divided into two phases: an initial phase when some participants could choose their preferred mode of participation (paper-and-pencil or online) and an extended phase when participants were asked to become members of an online panel that was not limited regarding its duration (i...
August 31, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28858002/patient-recall-of-informed-consent-at-4-weeks-after-total-hip-replacement-with-standardized-versus-procedure-specific-consent-forms
#18
Eoghan Pomeroy, Shahril Shaarani, Robert Kenyon, James Cashman
OBJECTIVES: Informed consent plays a pivotal role in the operative process, and surgeons have an ethical and legal obligation to provide patients with information to allow for shared decision-making. Unfortunately, patient recall after the consent process is frequently poor. This study aims to evaluate the effect of procedure-specific consent forms on patient's recall four weeks after total hip replacement (THR). METHODS: This is a prospective study using a posttest-only control group design...
August 25, 2017: Journal of Patient Safety
https://www.readbyqxmd.com/read/28857299/eadv-european-prurigo-project-expert-consensus-on-the-definition-classification-and-terminology-of-chronic-prurigo
#19
M P Pereira, S Steinke, C Zeidler, C Forner, C Riepe, M Augustin, S Bobko, F Dalgard, J Elberling, S Garcovich, U Gieler, M Gonçalo, J A Halvorsen, T Leslie, M Metz, A Reich, E Şavk, G Schneider, E Serra-Baldrich, H Ständer, M Streit, J Wallengren, K Weller, A Wollenberg, P Bruland, I Soto-Rey, M Storck, M Dugas, E Weisshaar, J C Szepietowski, F J Legat, S Ständer
BACKGROUND: The term prurigo has been used for many decades in dermatology without clear definition and currently used terminology of prurigo is inconsistent and confusing. Especially itch-related prurigo remains unexplored regarding the epidemiology, clinical profile, natural course, underlying causes, available treatments and economic burden, although burdensome and difficult to treat. OBJECTIVE: To address these issues, the multicenter European Prurigo Project (EPP) was designed to increase knowledge on chronic prurigo (CPG)...
August 31, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28856579/readability-of-informed-consent-forms-for-whole-exome-and-whole-genome-sequencing
#20
Emilia Niemiec, Danya F Vears, Pascal Borry, Heidi Carmen Howard
Whole-exome and whole-genome sequencing (WES, WGS) can generate an unprecedented amount of complex information, making the informed consent (IC) process challenging. The aim of our study was to assess the readability of English IC forms for clinical whole-exome and whole-genome sequencing using the SMOG and Flesch-Kincaid formulas. We analysed 36 forms, most of which were from US providers. The median readability grade levels were 14.75 (the SMOG formula) and 12.2 (the Flesch-Kincaid formula); these values indicate the years of education after which a person would be able to understand a text studied...
August 31, 2017: Journal of Community Genetics
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