INTRODUCTION

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.

A quasi-experimental study was done where participants’ awareness of clinical trial participants’ bill of rights was determined after an educational intervention.

There was a significant difference (pCONCLUSIONS

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.

Humans ; Informed Consent

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

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

OBJECTIVE: According to the current guidelines, arterial hyperenhancement for diagnosis of hepatocellular carcinoma (HCC) is determined using the arterial phase only. We investigated the optimal definition of arterial hyperenhancement in patients with HCC using computed tomography (CT) and magnetic resonance imaging (MRI). MATERIALS AND METHODS: The Institutional Review Board approved this retrospective study. The requirement for informed consent was waived. Between January 2011 and September 2013, 147 consecutive patients with surgically proven HCCs with both pre-operative CT and MRI were included. Identification rates of arterial hyperenhancement on CT and magnetic resonance (MR) images using arterial phase only, dual phase (unenhanced and arterial phases), and also subtraction MR images were assessed qualitatively. RESULTS: The identification rates for arterial hyperenhancement on CT were significantly different between arterial phase and dual phase (72.8% vs. 90.5%; p < 0.001), whereas the rates were similar on MRI (91.8% vs. 93.9%; p = 0.257). The identification rate of arterial hyperenhancement in MRI increased to 98.6% using subtraction MR images. CONCLUSION: Visual comparison of arterial and unenhanced phases could be recommended instead of conventional qualitative arterial phase alone assessment to determine arterial hyperenhancement of HCCs, especially when using CT.
Carcinoma, Hepatocellular ; Diagnosis ; Ethics Committees, Research ; Humans ; Informed Consent ; Magnetic Resonance Imaging ; Retrospective Studies

OBJECTIVE: To assess whether virtual expiratory (VE)-computed tomography (CT)/ultrasound (US) fusion imaging is more effective than conventional inspiratory (CI)-CT/US fusion imaging for hepatic interventional procedures. MATERIALS AND METHODS: This prospective study was approved by the Institutional Review Board, and informed consent was obtained from each patient. In total, 62 patients with focal hepatic lesions referred for hepatic interventional procedures were enrolled. VE-CT images were generated from CI-CT images to reduce the effects of respiration-induced liver motion. The two types of CT images were fused with real-time US images for each patient. The operators scored the visual similarity with the liver anatomy upon initial image fusion and the summative usability of complete image fusion using the respective five-point scales. The time required for complete image fusion and the number of point locks used were also compared. RESULTS: In comparison with CI-CT/US fusion imaging, VE-CT/US fusion imaging showed significantly higher visual similarity with the liver anatomy on the initial image fusion (mean score, 3.9 vs. 1.7; p < 0.001) and higher summative usability for complete image fusion (mean score, 4.0 vs. 1.9; p < 0.001). The required time (mean, 11.1 seconds vs. 22.5 seconds; p < 0.001) and the number of point locks (mean, 1.6 vs. 3.0; p < 0.001) needed for complete image fusion using VE-CT/US fusion imaging were significantly lower than those needed for CI-CT/US fusion imaging. CONCLUSION: VE-CT/US fusion imaging is more effective than CI-CT/US fusion imaging for hepatic interventional procedures.
Ethics Committees, Research ; Humans ; Informed Consent ; Liver ; Prospective Studies ; Respiration ; Ultrasonography ; Weights and Measures