INTRODUCTION

data-mce-style="text-align: justify;">Documenting a research participant’s awareness of the bill of rights is achieved with an informed consent. In recent years, the informed consent document has increasingly become confounding to research participants in its complexity. As such, the awareness of research participants’ bill of rights has emerged as a lingering issue since studies that test awareness of research participants’ bill of rights are limited. Hence, this study aimed to determine the participants’ awareness of the bill of rights after an educational intervention.

data-mce-style="text-align: justify;">A quasi-experimental study was done where participants’ awareness of clinical trial participants’ bill of rights was determined after an educational intervention.

data-mce-style="text-align: justify;">There was a significant difference (pCONCLUSIONS

data-mce-style="text-align: justify;">Significant difference in the awareness of bill of rights was observed after the educational intervention. Additional intervention could be given to participants who are females, of older age group (middle age and older), did not complete high school, and the unemployed when they participate in clinical trials to ensure their awareness of the bill of rights of clinical trial participants. Varied learning materials must be given to participants to emphasize the clinical research objectives and activities as well.

OBJECTIVE

data-mce-style="text-align: justify;">To determine the perceptions of persons with tuberculosis (TB) and health workers on Care TB – a mobile application for the community-led monitoring (CLM) of TB services.

data-mce-style="text-align: justify;">We used a qualitative research method. Six people with tuberculosis and ten health workers were chosen through purposive sampling for semi-structured interviews. The narrative data produced from the interviews were subjected to qualitative content analysis in order to uncover salient themes and patterns.

data-mce-style="text-align: justify;">The community-led monitoring mobile application was shown to be acceptable both to TB healthcare providers and patients. It enhances information access and streamlines the process of reporting care barriers. The application also allows persons with TB to interact with one another, potentially eliminating stigma and discrimination. Potential challenges to implementing the CLM program include issues with internet connectivity, costs, and human resources.

data-mce-style="text-align: justify;">This study provides preliminary evidence of the acceptability and perceived feasibility of a mobile application for the community-led monitoring of TB services. For the CLM initiative to be scaled up across the country, more financial and technical support is required.

Humans ; Informed Consent

With the establishment of the Republic Act No. 11036, more popularly known as the Mental Health Act, improvement in the mental, neurologic, and psychosocial health took a step forward in the Philippines. This law, which was signed on June 2018, gave specific provisions in different aspects of delivery of mental health services to Filipinos. This law proved very useful in the dilemma faced in the following case where a potential problem in confidentiality was encountered.
Mental Health Services ; Confidentiality ; Mental Health ; Philippines

At present, medical disputes are still widely-concerned social problems and occasionally evolve into severe social events. In the dispute settlement mechanism, forensic identification opinion is the important technical support. Due to the high professionalism and complexity of medicine, the identification of medical malpractice has become major and difficult problem in the identification. This paper systematically analyze the concept of medical malpractice and five legal theories of malpractice determination, pointing out that China's forensic identification of medical damage should be led by the theory of "medical standards", supplemented by "prudent patient" standard and strengthen "peer review" in form. At the same time, seven main identification principles should be followed in practice: (1) take "obligation of diagnosis and treatment" as the basic principle of medical malpractice identification; (2) take whether to fulfill the obligation of diagnosis and treatment corresponding to current medical level as the specific principle; (3) take diagnosis and treatment routine, norms and guidelines as the main basis; (4) the principle of "peer review"; (5) the principle of "the generality of medical emergency action"; (6) the principle of "notification-informed-consent"; (7) the principle of "review of complications". This paper also puts forward the corresponding identification ideas in view of the above principles, hoping this helps standardize medical damage forensic identification activities.
Dissent and Disputes ; Forensic Medicine ; Humans ; Informed Consent ; Malpractice

The Vaccine Administration Law of the People's Republic of China and other relevant laws require that vaccine recipients or their guardians be educated about vaccines and how they work, and described in general the methods and contents of such vaccination education. With the new law and "Standard Operational Procedures for Immunization" as foundation documents, and in consultation with experts at home and abroad, the Chinese Preventive Medicine Association developed a consensus statement about informed consent for vaccination. This consensus statement is written for disease control and prevention health care personnel in vaccination services and describes the educational content of informed consent, a theoretical framework for immunization and immunization knowledge, the informed consent processes, principles of planning for vaccination, and an informed consent form. Part Two of the consensus includes influenza vaccine, pneumococcal vaccine, haemophilus influenzae type b containing vaccine, enterovirus type 71 inactivated vaccine, rotavirus vaccine, varicella attenuated live vaccine, herpes-zoster vaccine, human papillomavirus vaccine, rabies vaccine, hemorrhagic fever with renal syndrome vaccine, leptospira vaccine, anthrax vaccine, hepatitis E vaccine, cholera vaccine, typhoid vaccine, and tick-borne encephalitis vaccine.
China ; Consensus ; Humans ; Influenza Vaccines ; Informed Consent ; Vaccination

data highlight the risks of altered glans sensation, recurrent curvature, and/or loss of penile length from graft contracture, as well as the development of erectile dysfunction. Complex penile reconstruction with the concurrent placement of a penile prosthesis and/or graft material is a demanding operation that should be performed by surgeons with extensive prosthetic and reconstructive experience, as the risk of sensory loss, glans ischemia/necrosis, prosthesis-related complications, and failure to gain any meaningful length are serious concerns and cannot be underestimated. While surgical approaches remain the standard of care, they pose considerable risks and require prolonged postoperative rehabilitation. Obtaining proper informed consent and establishing realistic outcome expectations are imperative for successful postoperative outcomes.]]>
Congenital Abnormalities ; Contracture ; Erectile Dysfunction ; Humans ; Informed Consent ; Male ; Penile Induration ; Penile Prosthesis ; Penis ; Rehabilitation ; Sensation ; Standard of Care ; Surgeons ; Transplants

PURPOSE: The aim of this study is to investigate the clinical performance and safety of Zimmer® natural nail cephalomedullary nail (ZNN CM nail) in the treatment of proximal femur fractures. MATERIALS AND METHODS: The following research was conducted as a prospective, non-comparative, single center outcome study. Upon providing written informed consent, enrolled patients' data were collected and analyzed. Postoperative follow-up visits were scheduled at 6 weeks, 3 months, 6 months, and 1 year. Follow-up evaluation included radiographic assessment, physical examination, and quality of life and adverse events reports. RESULTS: Thirty-nine patients were available for evaluation at one year postoperative. The patients reported the mean EuroQol-5 Dimension score increased after surgery: from 0.4 points at discharge (n=49) to 0.6 points at 1-year post-surgery (n=39). The mean Harris hip score also increased after surgery: from 56.3 points at discharge (n=49) to 72.1 points at 1 year (n=12). Bone union was seen in 64% (n=16) in 6 months and 95% (n=37) in 1 year. CONCLUSION: The results of this 1-year follow-up study affirmed the effectiveness and safety of the ZNN CM nail in the treatment of proximal femur fractures.
Femoral Fractures ; Femur ; Follow-Up Studies ; Fracture Fixation ; Fracture Fixation, Intramedullary ; Hip ; Hip Fractures ; Humans ; Informed Consent ; Outcome Assessment (Health Care) ; Physical Examination ; Prospective Studies ; Quality of Life

BACKGROUND/AIMS: The abdominal pain-related functional gastrointestinal disorders (AP-FGIDs) affect a significant proportion of the pediatric population and consist 1 of the most frequent causes for seeking medical advice. In this study, we aimed to assess the relation of dietary habits with the likelihood of AP-FGIDs. METHODS: This was a school-based, cross-sectional study approved by the Greek Government authorities, after obtaining informed consent by the legal representatives of the children. Diagnoses of AP-FGIDs were based on the Greek official translation of the Rome III questionnaire. Demographic, socioeconomic and dietary data were collected through self-reporting or parent-reporting questionnaires. Associations between the probability of AP-FGIDs and dietary practices were assessed after adjusting for known confounders through a multiple logistic regression analysis. RESULTS: A total of 1365 children (147 AP-FGIDs and 1218 controls, 52.4% females, mean age: 12.8 ± 2.8 years) were included. Multiple regression analysis identified the following statistically significant confounders: victimization, the presence of a person with a severe health problem at home, female sex, engaging in limited physical exercise, and living in a single adult family. Subsequently, logistic regression, adjusted for the abovementioned confounders, showed that reduced fish and increased junk food consumption were related to a higher likelihood of AP-FGIDs. CONCLUSIONS: Children with AP-FGIDs report excessive junk-food and reduced fish intake compared to controls. Further studies are needed in order to clarify the nature of this observation.
Adolescent ; Adult ; Child ; Crime Victims ; Cross-Sectional Studies ; Diagnosis ; Exercise ; Feeding Behavior ; Female ; Food Habits ; Gastrointestinal Diseases ; Humans ; Informed Consent ; Logistic Models

OBJECTIVE: To analyze the complications of percutaneous transthoracic needle biopsy using CT-based imaging modalities for needle guidance in comparison with fluoroscopy in a large retrospective cohort. MATERIALS AND METHODS: This study was approved by multiple Institutional Review Boards and the requirement for informed consent was waived. We retrospectively included 10568 biopsies from eight referral hospitals from 2010 through 2014. In univariate and multivariate logistic analyses, 3 CT-based guidance modalities (CT, CT fluoroscopy, and cone-beam CT) were compared with fluoroscopy in terms of the risk of pneumothorax, pneumothorax requiring chest tube insertion, and hemoptysis, with adjustment for other risk factors. RESULTS: Pneumothorax occurred in 2298 of the 10568 biopsies (21.7%). Tube insertion was required after 316 biopsies (3.0%), and hemoptysis occurred in 550 cases (5.2%). In the multivariate analysis, pneumothorax was more frequently detected with CT {odds ratio (OR), 2.752 (95% confidence interval [CI], 2.325–3.258), p < 0.001}, CT fluoroscopy (OR, 1.440 [95% CI, 1.176–1.762], p < 0.001), and cone-beam CT (OR, 2.906 [95% CI, 2.235–3.779], p < 0.001), but no significant relationship was found for pneumothorax requiring chest tube insertion (p = 0.497, p = 0.222, and p = 0.216, respectively). The incidence of hemoptysis was significantly lower under CT (OR, 0.348 [95% CI, 0.247–0.491], p < 0.001), CT fluoroscopy (OR, 0.594 [95% CI, 0.419–0.843], p = 0.004), and cone-beam CT (OR, 0.479 [95% CI, 0.317–0.724], p < 0.001) guidance. CONCLUSION: Hemoptysis occurred less frequently with CT-based guidance modalities in comparison with fluoroscopy. Although pneumothorax requiring chest tube insertion showed a similar incidence, pneumothorax was more frequently detected using CT-based guidance modalities.
Biopsy ; Biopsy, Needle ; Chest Tubes ; Cohort Studies ; Cone-Beam Computed Tomography ; Ethics Committees, Research ; Fluoroscopy ; Hemoptysis ; Image-Guided Biopsy ; Incidence ; Informed Consent ; Lung Neoplasms ; Multivariate Analysis ; Needles ; Pneumothorax ; Referral and Consultation ; Retrospective Studies ; Risk Factors