Documentation Of Informed Consent Research Articles

Informed consent in cancer clinical care: Perspectives of healthcare professionals on information disclosure at a tertiary institution in Uganda.

While there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners' experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals' perspectives on information disclosure during the consenting process in cancer care. A qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results. There were five key themes, and these included information disclosure to patients; assessment of patients' cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that patients should be the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process. Overall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication.

Standardized Informed Consent Form for Clinicians Administering Platelet-Rich Plasma.

Introduction When it comes to medico-legal malpractice suits, lawyers and insurers tend to focus on informed consent documentation. Unfortunately, there is no standard protocol for obtaining informed consent for the use of platelet-rich plasma (PRP) injections, which might cause problems. This study aimed to mitigate this concern through the development of a standardized informed consent document for PRPinjections, grounded in evidence-based practices. Materials and methods An examination of databases was conducted to explore the medico-legal ramifications associated with PRPinjections, as well as the broader topic of informed consent, with a particular focus on the context of PRP injections. Moreover, interviews were carried out with healthcare providers and individuals who had received PRP injections within the preceding year, utilizing a semi-structured methodology. Results We developed an evidence-based informed consent document tailored for PRPinjections. To guarantee its legal validity, the document underwent review by a legal specialist. Subsequently, our institutions implemented the finalized form for PRP injection procedures over one year. Conclusion A legally valid and evidence-based informed consent form for PRP injections would ensure patient's rights, and encourage open communication and transparency between them and the doctor. Moreover, if a lawsuit were to arise, it would serve as a critical document in the doctor's defense and withstand scrutiny from lawyers and the judiciary.

Impact of a Clinical Decision Support Alert on Informed Consent Documentation in the Neonatal Intensive Care Unit.

Informed consent is necessary to preserve patient autonomy and shared decision-making, yet compliant consent documentation is suboptimal in the intensive care unit (ICU). We aimed to increase compliance with bundled consent documentation, which provides consent for a predefined set of common procedures in the neonatal ICU from 0% to 50% over 1 year. We used the Plan-Do-Study-Act model for quality improvement. Interventions included education and performance awareness, delineation of the preferred consenting process, consent form revision, overlay tool creation, and clinical decision support (CDS) alert use within the electronic health record. Monthly audits categorized consent forms as missing, present but noncompliant, or compliant. We analyzed consent compliance on a run chart using standard run chart interpretation rules and obtained feedback on the CDS as a countermeasure. We conducted 564 audits over 37 months. Overall, median consent compliance increased from 0% to 86.6%. Upon initiating the CDS alert, we observed the highest monthly compliance of 93.3%, followed by a decrease to 33.3% with an inadvertent discontinuation of the CDS. Compliance subsequently increased to 73.3% after the restoration of the alert. We created a consultant opt-out selection to address negative feedback associated with CDS. There were no missing consent forms within the last 7 months of monitoring. A multi-faceted approach led to sustained improvement in bundled consent documentation compliance in our neonatal intensive care unit, with the direct contribution of the CDS observed. A CDS intervention directed at the informed consenting process may similarly benefit other ICUs.

Large Language Model−Based Chatbot vs Surgeon-Generated Informed Consent Documentation for Common Procedures

Informed consent is a critical component of patient care before invasive procedures, yet it is frequently inadequate. Electronic consent forms have the potential to facilitate patient comprehension if they provide information that is readable, accurate, and complete; it is not known if large language model (LLM)-based chatbots may improve informed consent documentation by generating accurate and complete information that is easily understood by patients. To compare the readability, accuracy, and completeness of LLM-based chatbot- vs surgeon-generated information on the risks, benefits, and alternatives (RBAs) of common surgical procedures. This cross-sectional study compared randomly selected surgeon-generated RBAs used in signed electronic consent forms at an academic referral center in San Francisco with LLM-based chatbot-generated (ChatGPT-3.5, OpenAI) RBAs for 6 surgical procedures (colectomy, coronary artery bypass graft, laparoscopic cholecystectomy, inguinal hernia repair, knee arthroplasty, and spinal fusion). Readability was measured using previously validated scales (Flesh-Kincaid grade level, Gunning Fog index, the Simple Measure of Gobbledygook, and the Coleman-Liau index). Scores range from 0 to greater than 20 to indicate the years of education required to understand a text. Accuracy and completeness were assessed using a rubric developed with recommendations from LeapFrog, the Joint Commission, and the American College of Surgeons. Both composite and RBA subgroup scores were compared. The total sample consisted of 36 RBAs, with 1 RBA generated by the LLM-based chatbot and 5 RBAs generated by a surgeon for each of the 6 surgical procedures. The mean (SD) readability score for the LLM-based chatbot RBAs was 12.9 (2.0) vs 15.7 (4.0) for surgeon-generated RBAs (P = .10). The mean (SD) composite completeness and accuracy score was lower for surgeons' RBAs at 1.6 (0.5) than for LLM-based chatbot RBAs at 2.2 (0.4) (P < .001). The LLM-based chatbot scores were higher than the surgeon-generated scores for descriptions of the benefits of surgery (2.3 [0.7] vs 1.4 [0.7]; P < .001) and alternatives to surgery (2.7 [0.5] vs 1.4 [0.7]; P < .001). There was no significant difference in chatbot vs surgeon RBA scores for risks of surgery (1.7 [0.5] vs 1.7 [0.4]; P = .38). The findings of this cross-sectional study suggest that despite not being perfect, LLM-based chatbots have the potential to enhance informed consent documentation. If an LLM were embedded in electronic health records in a manner compliant with the Health Insurance Portability and Accountability Act, it could be used to provide personalized risk information while easing documentation burden for physicians.

502 A Retrospective Review of Laparoscopic Colectomies Informed Consent Documentation, with a View of Standardisation Are Patients Properly Informed?

Abstract Introduction Shared decision-making and consents are fundamental to good medical practice and are paramount to our surgical practice. A lack of clear recorded information given to patients about the surgical procedure, associated risks and potential complications can cause harm. Landmark cases such as Montgomery vs Lanarkshire Health Board, emphasized the importance of accurate and informative consent forms. Aim To improve the quality of our consent forms. To standardize our consent forms for laparoscopic colectomy resection surgeries performed at The Department of General Surgery at Wye Valley NHS Trust. To produce a model consent form to reduce future medicolegal issues related to poor documentation. Method We identified 22 common risks and complications associated with any laparoscopic colectomy surgery. Consent forms were analysed for documentation of: Demographics, risk factors, clear handwriting; Known relevant risk factors associated with the procedure; Benefits and any additional procedures required and Name &amp; grade of healthcare professional. Results The most common complications mentioned across the consent forms were Anastomotic leak /Collection (94%), Wound infection, Bleeding, and DVT/PE (90%). Complications like post-op pain, post-op ileus, stoma complications, iatrogenic bladder/ureter injuries, and mortality were under-recorded. As a result, the quality of our consent forms and information provided to our patients is widely variable. Conclusions Proper completion of consent forms is crucial. Introducing a modified consent form with pre-filled risk factors/complications will allow for more accurate consent form completion ensuring relevant complications are discussed with patients.

Revisiting best practice guidelines and patient care workflow for managing the risk of medication-related osteonecrosis of the jaw: comparative summary and case studies.

Patients taking antiresorptive medications in dental clinics are at risk of medication-related osteonecrosis of the jaw (MRONJ), which poses daily challenges for their clinicians. Types of practice guideline reviewed: This paper aimed to summarize and revisit three most recognized practice guidelines for the management and prevention of MRONJ, which were proposed by the American Association of Oral and Maxillofacial Surgeons (AAOMS), presented by the Journal of Bone and Mineral Research (JBMR), and the Journal of Clinical Oncology (JCO). Results and Case Studies: The AAOMS position paper focused on risk stratification by different medications, management decision trees, risk factors, pathophysiology, and disease staging. The JBMR international consensus presented eight focused questions, which were addressed by systematic reviews. The JCO Clinical Practice Guideline presented six clinical questions, and each concluded with practical recommendations. Practical information was summarized and converted into an adoptable patient care workflow for clinicians to follow and apply in daily practice. Three case studies presented were treated following these guidelines. Each patient underwent advanced surgeries including alveoloplasty, tooth extraction, implant placement, and particulate bone grafting. Some of the considerations not fully informed were discussed and illustrated in each step of the patient care workflow, which included specifics for risk communication, updates on the use of antibiotics, biomarkers, and drug holidays. Structured risk communication with official informed consent documentation should be considered before initiating invasive treatments. Disease control phase with home care therapy should be provided prior to staged reconstructive therapy. Drug holidays and antibiotics coverage can be customized based on individual conditions and related procedures with interprofessional coordination.

POOR COMPLIANCE DOCUMENTING INFORMED CONSENT IN TRAUMA PATIENTS WITH DISTAL RADIUS FRACTURES COMPARED WITH ELECTIVE TOTAL KNEE ARTHROPLASTY

The purpose of this study was (1) to evaluate the adequacy of informed consent documentation in the trauma setting for distal radius fracture surgery compared with the elective setting for total knee arthroplasty (TKA) at a large public hospital and (2) to explore the relevant guidelines in New Zealand relating to consent documentation.Consecutive adult patients (≥16 years) undergoing operations for distal radius fractures and elective TKA over a 12-month period in a single-centre were retrospectively identified. All medical records were reviewed for the risks and complications recorded. The consent form was analysed using the Flesch Reading Ease Score (FRES) and the Simple Measure of Gobbledygook (SMOG) index readability scores.A total of 133 patients undergoing 134 operations for 135 distal radius fractures and 239 patients undergoing 247 TKA were included. Specific risks of surgery were recorded significantly less frequently for distal radius fractures than TKA (43.3% versus 78.5%, P &lt; 0.001). Significantly fewer risks were recorded in the trauma setting compared to the elective (2.35 ± 2.98 versus 4.95 ± 3.33, P &lt; 0.001). The readability of the consent form was 40.5 using the FRES and 10.9 using the SMOG index, indicating a university undergraduate level of reading.This study has shown poor compliance in documenting risks of surgery during the informed consent process in an acute trauma setting compared to elective arthroplasty. Institutions must prioritise improving documentation of informed consent for orthopaedic trauma patients to ensure a patient-centred approach to healthcare.

Legally Sound, Evidence-Based Informed Consent Form for Total Hip Arthroplasty.

Informed consent documentation is often the first area of interest for lawyers and insurers when a medico-legal malpractice suit is concerned. However, there is a lack of uniformity and standard procedure for obtaining informed consent for total hip arthroplasty (THA). We aimed to develop a solution for this need for a pre-designed, evidence-based informed consent form for THA cases. We extensively reviewed the literature on the medico-legal aspects of THA, medico-legal aspects of informed consent, and medico-legal aspects of informed consent in THA. We then conducted semi-structured interviews with orthopaedic surgeons and patients who had previously undergone THA in the previous year. Based on all of the above, we developed an informed consent form that was evidence-based. We then had the form reviewed by a legal expert. The final form was utilised for THA cases at our institution for 1year. Legally sound, evidence-based Informed Consent Form for Total Hip Arthroplasty is given in Form A. The use of legally sound, evidence-based informed consent for total hip arthroplasty cases would be beneficial to orthopaedic surgeons and patients alike. It would uphold the rights of the patient, and promote open discussion and transparency. In the event of a lawsuit, it would be a vital document in the defence of the surgeon and withstand the scrutiny of lawyers and the judiciary.

Guidelines in Practice: Patient Information Management.

Patient information management can involve paper and electronic documentation. Because the patient's health care record (HCR) is a legal document, it must provide an accurate representation of care. The record contains protected health information and must be secure. In addition, the documentation must adhere to local, state, and federal regulations and facility policies; it also may incorporate recommendations from national professional guidelines. The AORN "Guideline for patient information management" was recently updated and provides evidence-based best practices for comprehensive perioperative documentation that aligns with the nursing workflow. This article includes an overview of patient information management and discusses recommendations for health information technology, the patient HCR, perioperative record design, documentation and nursing workflow, informed consent documentation, order documentation, modifying patient HCRs, education, policies and procedures, and quality. Perioperative nurses should review the guideline in its entirety and apply the recommendations for patient information management as applicable to their individual roles.

More Than Just a Check-the-Box Form: Informed Consent.

More Than Just a Check-the-Box Form: Informed Consent.

Poor compliance documenting informed consent in trauma patients with distal radius fractures compared to elective total knee arthroplasty.

BackgroundThe purpose of this study was (1) to evaluate the adequacy of informed consent documentation in the trauma setting for distal radius fracture surgery compared with the elective setting for total knee arthroplasty (TKA) at a large public hospital and (2) to explore the relevant guidelines in New Zealand relating to consent documentation.MethodsConsecutive adult patients (≥16 years) undergoing operations for distal radius fractures and elective TKA over a 12‐month period in a single‐centre were retrospectively identified. All medical records were reviewed for the risks and complications recorded. The consent form was analysed using the Flesch Reading Ease Score (FRES) and the Simple Measure of Gobbledygook (SMOG) index readability scores.ResultsA total of 133 patients undergoing 134 operations for 135 distal radius fractures and 239 patients undergoing 247 TKA were included. Specific risks of surgery were recorded significantly less frequently for distal radius fractures than TKA (43.3% versus 78.5%, P < 0.001). Significantly fewer risks were recorded in the trauma setting compared to the elective (2.35 ± 2.98 versus 4.95 ± 3.33, P < 0.001). The readability of the consent form was 40.5 using the FRES and 10.9 using the SMOG index, indicating a university undergraduate level of reading.ConclusionsThis study has shown poor compliance in documenting risks of surgery during the informed consent process in an acute trauma setting compared to elective arthroplasty. Institutions must prioritize improving documentation of informed consent for orthopaedic trauma patients to ensure a patient‐centred approach to healthcare.

Conducting a representative national randomized control trial of tailored clinical decision support for nurses remotely: Methods and implications

Clinical Decision Support (CDS) systems, patient specific evidence delivered to clinicians via the electronic health record (EHR) at the right time and in the right format, has the potential to improve patient outcomes. Unfortunately, outcomes of CDS research are mixed. A potential cause lies in its testing. Many CDS are implemented in practice without sufficient testing, potentially leading to patient harm. When testing is conducted, most research has focused on “what” evidence to provide with little attention to the impact of the CDS display format (e.g., textual, graphical) on the user.In an adequately powered randomized control trial with 220 hospital based registered nurses, we will compare 4 randomly assigned CDS format groups (text, text table, text graphs, tailored to subject's graph literacy score) for effects on decision time and simulated patient outcomes. We recruit using state based professional registries, which allows access to participants from multiple institutions across the nation. We use online survey software (REDCap) for efficient study workflow including screening, informed consent documentation, pre-experiment demographic data collection including a graph literacy questionnaire used in randomization. The CDS prototype is accessed via a web app and the simulation-based experiment is conducted remotely at a subject's local computer using video-conferencing software. Also included are 6 post intervention surveys to assess cognitive workload, usability, numeracy, format preference, CDS utilization rationale, and CDS interpretation. Our methods are replicable and scalable for testing of health information technologies and have the potential to improve the safety and effectiveness of these technologies across disciplines.

Monitoring Analysis of Filling The Informed Consent of Blood Transfusion

Informed consent is evidence of the accountability of health service providers in the hospital. it is carried out in every carrying out the procedure of actions that have the risk of causing disability or death. Incomplete documentation of patient informed consent can reduce the quality of hospital services. the implementation of informed consent documentation in hospitals often faces obstacles. this is due to the lack of human resources and the high workload available. This case study aims to determine the filling of informed consent documentation in the patient's blood transfusion. This study uses interviews, observation and document study by developing approaches to the nursing management function, organizing functions, personnel, direction, supervision, care management, logistics management, quality assurance programs and patient safety. The results showed that in one month there were 20 patients with blood transfusions, and 11 out of 20 patients did not have informed consent. The problem that arises is the incomplete documentation of medical records at the time of carrying out blood transfusions to patients. Supervision that is not optimal is the cause of this problem.

Re-exploring Saliva as an Analyte in Estimation of Lithium in Stable Bipolar Patients – A Pilot Study in a Tertiary Care Hospital in West Bengal

Background: Lithium a frequently prescribed drug in the treatment of bipolar affective disorder, due to its inherent adverse potential and narrow therapeutic index, demands for regular therapeutic drug monitoring (TDM). Although the term TDM seems to be tedious, the most tedious job is to collect blood samples from patients with psychiatric illness. In this study, we aimed to find out an alternative method to serum lithium monitoring. Although saliva as an analyte is non-popular, the presence of lithium in the saliva in patients who consumes lithium makes procedure of collection easier. The rate of elimination of lithium is slower from saliva than from serum, which makes the concentration of lithium higher in saliva than in blood. Lithium elimination follows two compartment pharmacokinetic models, where important part of compartment is saliva and salivary glands. The trouble of repeated venipuncture can be done away with, if a non-invasive method for serum lithium concentration is taken into consideration. An alternative method of determining lithium level could be saliva. The aim of this study was to find out whether estimation of lithium in saliva can replace serum lithium estimation. Materials and Methods: In this cross-sectional study, 60 stable patients of bipolar disorder attending psychiatry outdoor on lithium therapy for 3 months or more were considered. After informed consent documentation serum and saliva samples were collected after 12 h of last dose of lithium carbonate intake. Assessment was done based on atomic absorption spectrometry. After statistical analysis, it was found that that there is a correlation between serum and saliva lithium level. The 60 patients were divided into two groups, consisting of 30 patients each. Linear regression was done in both the groups thereby the formula obtained from the first group, was utilized to calculate the saliva concentration form serum concentration. The mean values were compared at the last. Results: The mean serum lithium obtained was 0.99 ± 0.257 SD (mEq/L) and mean salivary lithium obtained was 1.63 ± 0.51 SD (mEq/L) in Group 1. Whereas, the mean serum lithium obtained was 0.79 ± 0.26 SD (mEq/L) and mean salivary lithium obtained was 1.67 ± 0.49 SD (mEq/L) in group 2. Lithium concentration from both the samples showed a positive correlation as obtained from the scatter plot. Conclusion: Salivary Li estimation seems to yield positive results, yet more research should be done in this regard. Since saliva method for estimation is non-invasive, the idea could be utilized in designing other devices

Knowledge, Attitude and Practices of Informed Consent Documentation Among Researchers in Medical Colleges in Tamil Nadu - a QuestionnaireBased Study

Knowledge, Attitude and Practices of Informed Consent Documentation Among Researchers in Medical Colleges in Tamil Nadu - a QuestionnaireBased Study

Returning Results of Stored Biological Samples and Biobanks: Perspectives of Saudi Arabian Biomedical Researchers

Scientific medical research involving human samples often leads to improved diagnosis, the discovery of treatment modalities, or the identification of possible risk factors for many diseases. Some findings, including incidental findings, may be important to donors, and some may require intervention. This study aimed to explore the perspectives of health care professionals in their use of stored biological samples for biomedical research regarding the concept of the research results and the challenges of informing donors regarding the results. This qualitative study involved 19 medical researchers doing research with stored biological samples and biobanks. The data were gathered during face-to-face interviews in English using a semistructured interview technique. The participants provided rich and illuminating experiences, framed in the following themes: the professional duty of researchers to return the research results and the right of donors to know; factors affecting informing donors of results (e.g., severity of disease; impact of the provided information; reliability of the research results; and donor approval); challenges to physically returning the results; and the nature of the informed consent, as well as the elements required in the informed consent documentation. Although the majority of researchers agree on the importance of returning research results, some have contradictory views such as that returning research results is not the researcher's responsibility. The study results also support the view that a number of elements should be included in the informed consent, such as the intention of informing the donors of the results as well as the benefits and risks.

Psychological Distress Experiences of Nigerians Amid COVID-19 Pandemic

This study examined the psychological distress experience of Nigerians amid COVID-19 pandemic. From March 20, 2020 to April 12, 2020, this descriptive survey used a snowballing sampling technique to select 502-Nigerian with an online semi-structured questionnaire containing Impact of Event Scale-Revised, GAD-7, Patient Health Questionnaire and Insomnia Severity Index. Gender had insignificant difference in the level of insomnia (χ2=04.93; df=3; p>0.05), however, 20.8% of males had sub-threshold of insomnia, 8.2% experienced moderate insomnia and 5.9% had severe insomnia; 32% females reported sub-threshold of insomnia, 12.4% had moderate insomnia while, 3.6% had severe insomnia. Also, gender had insignificant difference in the measures of depression (χ2=01.94; df=4; p>0.05); 55.4% males reported minimal depression, 22.3% had mild depression, 11.9% had moderate depression; 6.7% to 3.7% males had moderately to severe depression while, 49.3% of the females had minimal depression, 26.7% reported mild depression, 14.29% had moderate depression, 4.4% to 5.3% had moderately to severe depressive symptoms. Posttraumatic Stress Symptoms (PTSS) has no gender difference among respondents (χ2=02.51; df =3; p>0.05); 23% of males reported partial PTSS, 17.5% presented clinical PTSS, and 21.6% males had severe PTSS; while 29.3% of females had severe PTSS, 24% reported partial PTSS and 18.7% had clinical PTSS. Respondents reported insignificant gender difference on anxiety (χ2=0.08; df=1; p>0.05), while 51% reported moderate anxiety and 49% exhibited severe anxiety during COVID-19 pandemic in Nigeria. Findings revealed that Nigerians experienced psychological distress during COVID-19 pandemic. Government and stakeholders in health sectors should provide psychological health services for the residents in Nigeria.Funding: This research did not receive any specific grant from funding agenciesin the public, commercial, or not-for-profit sectors. Declaration of Interest: We declare no conflict of interestEthical Approval: Ethical review and approval was not obtained for the study due to theprevailing COVID-19 pandemic lockdown in Nigeria. Written informed consent to participate in the study was, however, provided by the participants via completion of the questionnaire/survey. Please find the attached informed consent documentation form used in the study.

Synovial Fibroblasts-Derived Exosomes Overexpressing microRNA-106b Inhibits Chondrocyte Proliferation and Migration via Down-Regulation of PDK4 in Rheumatoid Arthritis

Background: Rheumatoid arthritis (RA), an autoimmune disorder, affects people of all demographics, and exosome-derived microRNAs (miRs) have also been documented to play an important role in inflammatory disease. In view of this, our study is performed to investigate the roles of synovial fibroblasts-derived exosomes expressing miR-106b in RA via regulating PDK4. Methods: The differentially expressed genes were screened by analyzing the microarray chips related to RA. The expression of PDK4 and miR-106b were determined, and their regulatory effects on RA were evaluated. Meanwhile, exosomes derived from synovial fibroblasts (SFBs) were isolated and transferred into chondrocytes to identify the role of exosomes in RA. Furthermore, the effects of SFBs-derived exosomes overexpressing miR-106b on chondrocyte proliferation and migration were assessed using lentiviral packaged antagomir miR-106b in vivo. Results: It was found that PDK4 was down-regulated while miR-106b was up-regulated in RA. PDK4 was a target gene of miR-106b. When PDK4 was over-expressed in chondrocytes, the abilities of proliferation and migration of chondrocytes were enhanced and the RANKL/RANK/OPG system was inhibited. However, when the miR-106b was transferred into the chondrocytes by exosomes derived from SFBs, the opposite growth characteristics were identified in chondrocytes. Moreover, the investigation in vivo revealed that inhibition of miR-106b in SFBs improved the symptoms of RA in mice. Conclusion: Collectively, our study demonstrates that the SFBs-derived exosomes overexpressing miR-106b aggravates RA and affected RANKL/RANK/OPG system via down-regulation of PDK4. Funding Statement: This study was supported by grants from National Natural Science Foundation of China (no.81302576), Six Talent Peak Research Project in Jiangsu Province (no. 2015-WSN-105), the 333 Project of Jiangsu Province, Jiangsu Province Youth Medical Talent Project, Yangzhou City's Key Medical Talents Program, as well as by Jiangsu Provincial Natural Science Foundation of China (no. BK20131234). Declaration of Interests: The authors declare that they have no conflict of interest. Ethics Approval Statement: This study was conducted with the approval of the Ethics Committee of Affiliated Hospital of Yangzhou University. All participating patients signed written informed consent documentation prior to enrollment into the study.

Exosomes Carrying microRNA-205 from Human Bone Marrow Mesenchymal Stem Cells Suppress the Progression of Prostate Cancer

Background: Human bone marrow mesenchymal stem cells (hBMSCs) are engaged in cancer initiation and metastasis, sometimes by releasing exosomes that mediate cell communication by delivering microRNAs (miRNAs). The study aims to investigate effects of exosomal miR-205 derived from hBMSCs on prostate cancer cell functions. Methods: Microarray analysis was adopted to predict interaction between RHPN2 and miR-205 in prostate cancer, which was further confirmed using RT-qPCR and western blot analysis. The levels of miR-205 and RHPN2 in prostate cancer were quantified. Prostate cancer cells were exposed to exosomes derived from hBMSCs that were treated with either miR-205 mimic or miR-205 inhibitor. Subsequently, prostate cancer cell proliferation, invasion, migration, and apoptosis were detected in vitro. The effects of hBMSCs-miR-205 on RHPN2 level and tumor growth were investigated in vivo. Results: miR-205 was downregulated while RHPN2 was upregulated in prostate cancer. Additionally, restoring miR-205 inhibited prostate cancer cell proliferation, invasion, and migration and promoted apoptosis by targeting RHPN2. Next, experiments demonstrated that hBMSCs-derived exosomes secreting miR-205 contributed to a repressed prostate cancer cell proliferation, invasion, and migration and an enhanced apoptosis. Furthermore, in vivo experiments confirmed the inhibitory effects of hBMSCs-derived exosomes carrying miR-205 on prostate cancer. Conclusion: Collectively, our study demonstrates that hBMSCs-derived exosomes with miR-205 alleviate prostate cancer by regulating RHPN2, which provides a potential treatment biomarker for prostate cancer. Funding Statement: This work is supported by the National Natural Science Foundation of China (No. 81001146) and the Science and Technology Planning Project of Guangdong Province, China (No. 2017A020215168). Declaration of Interests: The authors report no conflict of interest. Ethics Approval Statement: All patients enrolled in the study signed informed consent documentation. This study was approved by the Ethics Committee of the First Affiliated Hospital, Sun Yat-Sen University. All procedures of animal experiments were in line with the Guide for Care and Use of Laboratory Animals.

Mesenchymal Stem Cells-Derived Exosomal H19 Promotes Trophoblast Cell Invasion and Migration by Down-Regulating Let-7b in Preeclampsia

Aberrant expression of long non-coding RNAs (lncRNAs) was associated with tumorigenesis and other diseases. As transport carriers, cells-derived exosomes were released into the extracellular space and regulated multiple functions of target cells. The present study aimed to investigate the clinical significance and biological function of mesenchymal stem cells (MSCs)-derived exosomal H19 in preeclampsia (PE). The expression of let-7b and FOXO1 in PE placental tissues was measured by RNA quantification and Western blot assay. Interaction between FOXO1 and let-7b, as well as let-7b and H19 was identified by dual luciferase reporter gene assay, and further confirmed by RNA-pull down and RNA immunoprecipitation assays. The roles of let7b and FOXO1 in trophoblast cells were tested by gain- or loss-of-function experiments. Exosomes derived from MSCs were isolated and co-cultured with HTR-8/SVNEO cells, and the invasion, migration, and apoptosis of trophoblast cells were measured in response to overexpression or silence of H19. The expression of let-7b was increased and FOXO1 was decreased in placental tissues of PE patients. H19 competitive bound to let-7b by acting as a competitive endogenous RNA (ceRNA), and FOXO1 was a target gene of let-7b. Then, H19 was delivered to HTR-8/SVNEO cells by MSCs-secreted exosomes. MSCs-derived exosomes overexpressing H19 up-regulated FOXO1 and activated AKT signaling pathway by silence of let-7b, thus to promote invasion, migration and suppress apoptosis of trophoblast cells in PE. Collectively, the key findings of the present study provided an evidence that functional up-regulation of MSCs-derived exosomes containing H19 enhanced invasion, migration and suppressed apoptosis of trophoblast cells in PE. Funding Statement: This study was supported by the Department of Science and Technology of Jilin Province (20170204045SF). Declaration of Interests: The authors declare no competing interests. Ethical Approval Statement: The study was conducted under the approval of the Ethics Committee of The Second Hospital of Jilin University. All participating patients signed informed consent documentation. All experiments were conducted in strict accordance with the Helsinki Declaration.