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1.
PLoS One ; 19(4): e0302156, 2024.
Article in English | MEDLINE | ID: mdl-38635542

ABSTRACT

BACKGROUND: Acute myeloid leukemia (AML), a rapidly progressing cancer of the blood and bone marrow, is the most common and fatal type of adult leukemia. Therapeutic web portals have great potential to facilitate AML research advances and improve health outcomes by increasing the availability of data, the speed and reach of new knowledge, and the communication between researchers and clinicians in the field. However, there is a need for stakeholder research regarding their optimal features, utility, and implementation. METHODS: To better understand stakeholder perspectives regarding an ideal pan-Canadian web portal for AML research, semi-structured qualitative interviews were conducted with 17 clinicians, researchers, and clinician-researchers. Interview guides were inspired by De Laat's "fictive scripting", a method where experts are presented with scenarios about a future technology and asked questions about its implementation. Content analysis relied on an iterative process using themes extracted from both existing scientific literature and the data. RESULTS: Participants described potential benefits of an AML therapeutic portal including facilitating data-sharing, communication, and collaboration, and enhancing clinical trial matchmaking for patients, potentially based on their specific genomic profiles. There was enthusiasm about researcher, clinician, and clinician-researcher access, but some disagreement about the nature of potential patient access to the portal. Interviewees also discussed two key elements they believed to be vital to the uptake and thus success of a therapeutic AML web portal: credibility and user friendliness. Finally, sustainability, security and privacy concerns were also documented. CONCLUSIONS: This research adds to existing calls for digital platforms for researchers and clinicians to supplement extant modes of communication to streamline research and its dissemination, advance precision medicine, and ultimately improve patient prognosis and care. Findings are applicable to therapeutic web portals more generally, particularly in genomic and translational medicine, and will be of interest to portal end-users, developers, researchers, and policymakers.


Subject(s)
Communication , Leukemia, Myeloid, Acute , Adult , Humans , Canada , Patients , Information Dissemination , Leukemia, Myeloid, Acute/therapy
2.
Zhonghua Yi Xue Za Zhi ; 104(11): 843-849, 2024 Mar 19.
Article in Chinese | MEDLINE | ID: mdl-38462360

ABSTRACT

Objective: To investigate the effects of sirolimus combined with anti-CD20 monoclonal antibody desensitization on the prognosis of patients with haploidentical stem cell transplantation (haplo-SCT). Methods: Fifteen consecutive patients who received haplo-SCT and pre-transplant donor specific anti-human leukocyte antigen (HLA) antibody (DSA) positive [mean fluorescence intensity (MFI)≥2 000] in the Institute of Hematological Diseases from November 2021 to March 2023 were retrospectively recruited into the desensitized group. There were 4 males and 11 females, with a median age [M(Q1, Q3)] of 48 (37, 59) years. All patients were desensitized with sirolimus combined with anti-CD20 monoclonal antibody. The non-desensitized group included 29 patients with haplo-SCT who had not received desensitization treatment from August 2012 to June 2016. There were 12 males and 17 females with a median age of 42 (26, 50) years. Up to October 1, 2023, the median follow-up time was 13 (9, 18) months in the study group and 23 (14, 29) months in the control group. The changes of MFI before and after desensitization treatment and the prognosis of patients in the desensitized group were compared, including the incidence of primary implantation failure (pGF), neutrophil implantation time, platelet implantation time, grade Ⅱ-Ⅳ acute graft-versus-host disease (GVHD) and chronic GVHD incidence, non-recurrence related mortality, event-free survival rate, disease-free survival rate and overall survival rate. The survival curve was drawn by Kaplan-Meier method, and the survival rate between groups was compared with Log-rank test. Results: After desensitization treatment, the level of DSA MFI in the desensitized group decreased from 8 879 (7 544, 11 495) to 3 781 (1 638, 4 165) after desensitization treatment (P<0.01). All of the patients achieved hematopoietic recovery, and the median time for neutrophil and platelet engraftment were 14 (11, 15) and 20 (18, 25) days, respectively. The incidence of pGF in the desensitized group was 0, which was lower than that in the non-desensitized group (34.5%, 10/29) (P=0.011). The expected 1-year disease-free survival rate and overall survival rate in the desensitized group were 100% (15/15) and 100% (15/15) respectively, while those in the non-desensitized group were 75.9% (22/29) and 75.9% (22/29) respectively, the difference was not statistically significant (both P>0.05). The one-year event-free survival rate in the desensitized group was expected to be 100% (15/15), which was higher than that in the non-desensitized group (51.3%, 15/29) (P=0.002). Conclusion: Sirolimus combined with anti-CD20 monoclonal antibody desensitization therapy can reduce the DSA level of haplo-SCT recipients, promote hematopoietic engraftment after transplantation, and avoid the occurrence of pGF after transplantation.


Subject(s)
Graft vs Host Disease , Hematopoietic Stem Cell Transplantation , Male , Female , Humans , Sirolimus/therapeutic use , Retrospective Studies , Hematopoietic Stem Cell Transplantation/adverse effects , Prognosis , Graft vs Host Disease/etiology , Antibodies, Monoclonal , Transplantation Conditioning/adverse effects , Transplantation Conditioning/methods
3.
Clin Oncol (R Coll Radiol) ; 36(5): 300-306, 2024 05.
Article in English | MEDLINE | ID: mdl-38388251

ABSTRACT

AIMS: Squamous cell carcinoma oral cavity cancers (SCCOCCs) have a higher reported incidence in South Asian countries. We sought to compare presenting stage and outcome by ethnicity in patients with SCCOCC treated with radical radiotherapy in a single centre in the UK. MATERIALS AND METHODS: All patients with SCCOCC treated with radical radiotherapy at an oncology department in Leicester (UK) between 2011 and 2017 were identified. Baseline demographic, clinical data and 2-year treatment outcomes were reported. RESULTS: Of the 109 patients included, 40 were South Asian and 59 were non-South Asian. South Asians had significantly poorer 2-year disease-free survival compared with non-South Asians (54.6% versus 73%, P = 0.01). CONCLUSION: Our analysis suggests that South Asians with SCCOCC have poorer outcomes despite a younger age and similar disease characteristics. Environmental, social factors and differing biology of disease may be responsible and further research is required to inform targeted interventions.


Subject(s)
Asian People , Mouth Neoplasms , Humans , Ethnicity , Treatment Outcome , Mouth Neoplasms/ethnology , United Kingdom
4.
Heliyon ; 10(4): e26144, 2024 Feb 29.
Article in English | MEDLINE | ID: mdl-38390105

ABSTRACT

Within various unstructured industrial environments, there is often the requirement to conduct remote engineering tasks, such as sampling the structure for analysis prior to decommissioning. Most existing tools are simply not dexterous enough to fulfil this task, and thus new technology is required. We describe here a simple, lightweight, and water-resistant collaborative dual-arm continuum robot system which can aid in this task. To improve the kinematic accuracy of the system, a class of flexible hinges have been combined with a conventional continuum robot configuration. The thickness and width of said flexible hinges can be adjusted to adapt to various tasks. Kinematic and stiffness models have further been developed, incorporating the influence of these flexible hinges. A set of experiments have been conducted to validate the proposed model and demonstrate the advantages of the platform. It was found that the kinematic accuracy of the continuum robot can be improved by a factor of around 10 with the aid of said hinges.

5.
Genes (Basel) ; 15(2)2024 Jan 25.
Article in English | MEDLINE | ID: mdl-38397146

ABSTRACT

The role of genetic counselors is evolving in response to health-related direct-to-consumer genetic tests (DTC-GT). While there is consensus in the literature that pre- and post-DTC-GT genetic counseling would benefit consumers, genetic counselors have reservations about DTC-GTs, and there is a paucity of research on providing DTC-GT counseling. This pilot quantitative survey is the first study to examine Canadian genetic counselors' views on DTC-GTs and how this disruptive biotechnology affects their role, and consumer informed consent and privacy. Canadian genetic counselors are cognizant of the harm to informed consent and privacy associated with DTC-GT, but are hesitant to engage directly, wary of misusing clinical time and resources. However, counselors are open to producing educational materials on DTC-GTs and collaborating with other stakeholders and the DTC-GT industry to support consumers. In this study, practical considerations for DTC-GT counseling sessions are discussed, including the unique needs of DTC-GT patients and the challenges posed by DTC-GTs to the genetic counseling duty to inform. This research benefits genetic counselors and physicians by examining how best to utilize genetic counselors' skills in the DTC-GT context, to minimize burdens on the healthcare system and support DTC-GT consumers.


Subject(s)
Counselors , Humans , Canada , Genetic Testing , Genetic Counseling , Professional Role
6.
JMIR Res Protoc ; 13: e54668, 2024 Feb 13.
Article in English | MEDLINE | ID: mdl-38349734

ABSTRACT

BACKGROUND: Artificial intelligence (AI)-based chatbots could help address some of the challenges patients face in acquiring information essential to their self-health management, including unreliable sources and overburdened health care professionals. Research to ensure the proper design, implementation, and uptake of chatbots is imperative. Inclusive digital health research and responsible AI integration into health care require active and sustained patient and stakeholder engagement, yet corresponding activities and guidance are limited for this purpose. OBJECTIVE: In response, this manuscript presents a master protocol for the development, testing, and implementation of a chatbot family in partnership with stakeholders. This protocol aims to help efficiently translate an initial chatbot intervention (MARVIN) to multiple health domains and populations. METHODS: The MARVIN chatbots study has an adaptive platform trial design consisting of multiple parallel individual chatbot substudies with four common objectives: (1) co-construct a tailored AI chatbot for a specific health care setting, (2) assess its usability with a small sample of participants, (3) measure implementation outcomes (usability, acceptability, appropriateness, adoption, and fidelity) within a large sample, and (4) evaluate the impact of patient and stakeholder partnerships on chatbot development. For objective 1, a needs assessment will be conducted within the setting, involving four 2-hour focus groups with 5 participants each. Then, a co-construction design committee will be formed with patient partners, health care professionals, and researchers who will participate in 6 workshops for chatbot development, testing, and improvement. For objective 2, a total of 30 participants will interact with the prototype for 3 weeks and assess its usability through a survey and 3 focus groups. Positive usability outcomes will lead to the initiation of objective 3, whereby the public will be able to access the chatbot for a 12-month real-world implementation study using web-based questionnaires to measure usability, acceptability, and appropriateness for 150 participants and meta-use data to inform adoption and fidelity. After each objective, for objective 4, focus groups will be conducted with the design committee to better understand their perspectives on the engagement process. RESULTS: From July 2022 to October 2023, this master protocol led to four substudies conducted at the McGill University Health Centre or the Centre hospitalier de l'Université de Montréal (both in Montreal, Quebec, Canada): (1) MARVIN for HIV (large-scale implementation expected in mid-2024), (2) MARVIN-Pharma for community pharmacists providing HIV care (usability study planned for mid-2024), (3) MARVINA for breast cancer, and (4) MARVIN-CHAMP for pediatric infectious conditions (both in preparation, with development to begin in early 2024). CONCLUSIONS: This master protocol offers an approach to chatbot development in partnership with patients and health care professionals that includes a comprehensive assessment of implementation outcomes. It also contributes to best practice recommendations for patient and stakeholder engagement in digital health research. TRIAL REGISTRATION: ClinicalTrials.gov NCT05789901; https://classic.clinicaltrials.gov/ct2/show/NCT05789901. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54668.

7.
Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi ; 41(11): 808-813, 2023 Nov 20.
Article in Chinese | MEDLINE | ID: mdl-38073206

ABSTRACT

Objective: To explore the effect of nerve injury in rats by neurobehavioral experiments, in order to provide a model and idea for further clarification of the traumatic brain injury mechanism under explosion exposure. Methods: From May 2021 to August 2022, 160 SPF male rats were randomly divided into four groups, including control group, 60 kPa group (low intensity group), 90 kPa group (medium intensity group) and 120 kPa group (high intensity group). The blast induced traumatic brain injury (bTBI) model of rats was established by using the shock tube platform to simulate the shock wave parameters of the explosion overpressure of 60 kPa, 90 kPa and 120 kPa. Acute observation was carried out after 24 h and 7 d of explosive exposure, and chronic recovery observation was carried out after 28 d and 90 d. The time effect of shock wave brain injury in different situations was discussed by open field, light dark test, active avoidance test. Finally, the results of brain injury in rats were detected by pathological tissue staining. Results: After 24 h explosion exposure, compared with the control group, the rest time of rats in low and high intensity groups increased, the total movement distance decreased, and the number of visits to the camera obscura decreased, with statistical significance (P<0.05). After 7 days of exposure, compared with the control group, the rest time of rats in high intensity group increased, and the number of visits to the obscura decreased, with statistical significance (P<0.05). After 28 and 90 days of exposure, compared with the control group, there were no significant differences in rest time, total exercise distance and times of visiting the camera obscura in all intensity groups (P>0.05). After 24 h of explosive exposure, compared with the control group, the cell morphology of rats in each intensity group was normal, and no inflammatory cell infiltration was observed. Conclusion: In the acute phase (24 h) of blast exposure, rats have no desire to explore the outside world, and shock wave exposure may damage the neurological function of rats.


Subject(s)
Blast Injuries , Brain Injuries, Traumatic , Brain Injuries , Rats , Male , Animals , Explosions , Blast Injuries/pathology , Brain Injuries/pathology , Disease Models, Animal
8.
Zhonghua Liu Xing Bing Xue Za Zhi ; 44(10): 1537-1544, 2023 Oct 10.
Article in Chinese | MEDLINE | ID: mdl-37875439

ABSTRACT

Objective: To describe the prevalence of psychological distress and to analyze its influencing factors among Chinese children and adolescents aged 9-18 years in 2019. Methods: Data was from the 2019 Chinese National Survey on Students' Constitution and Health, and 148 892 children and adolescents were included. Psychological distress was measured using the Kessler Psychological Distress Scale (K10): scores ≤19 were defined as no psychological distress, scores between 20-24 were defined as mild psychological distress, scores between 25-29 were defined as moderate psychological distress, and scores ≥30 were defined as severe psychological distress (moderate to severe psychological distress were defined as high psychological distress). The ANOVA, t test, and χ2 test were used to compare the differences in K10 scores and high psychological distress rates among children and adolescents with different characteristics. The ANOVA and trend χ2 test were used to analyze the trends. Modified-Poisson regression models were used to determine influencing factors of high psychological distress. Results: The K10 scores for Chinese children and adolescents aged 9-18 years in 2019 was 21.5±9.2, and their rate of high psychological distress was 31.6%. The rates of high psychological distress among children and adolescents aged 9-12, 13-15, and 16-18 years were 22.3%, 35.9%, and 38.8%. K10 scores and rates of high psychological distress showed an increasing trend as age increased (trends test all P<0.001). K10 scores and rates of high psychological distress were higher among children and adolescents who were older, female, rural, in areas with medium to low GDP per capita level, and with lower parental education (all P<0.001). Multifactorial modified-Poisson regression analysis showed that children and adolescents aged 13-15 years, 16-18 years, female, rural, and in areas with low to moderate GDP per capita level were at higher risk of high psychological distress (all P<0.05), with aOR (95%CI) of 1.55 (1.52-1.58), 1.66 (1.63-1.69), 1.07 (1.05-1.09), 1.02 (1.01-1.04), 1.10 (1.07-1.12). Children and adolescents in areas with medium to high GDP per capita level, whose father had a secondary or high school degree, whose father had a college degree or above, whose mother had a secondary or high school degree, and whose mother had a college degree or above were at lower risk of high psychological distress (all P<0.05), with aOR (95%CI) of 0.96 (0.94-0.98), 0.92 (0.90-0.93), 0.84 (0.82-0.86), 0.95 (0.93-0.97), 0.86 (0.83-0.88). Conclusions: The prevalence of psychological distress was high among Chinese children and adolescents aged 9-18 years in 2019, which is a vital problem. Mental health interventions need to be implemented among children and adolescents that were older, girls, rural, live in areas with lower economic levels, and whose parents have a lower education level.


Subject(s)
Mothers , Parents , Humans , Female , Adolescent , Child , Prevalence , Regression Analysis , Mental Health , Stress, Psychological/epidemiology
10.
Digit Health ; 9: 20552076231204428, 2023.
Article in English | MEDLINE | ID: mdl-37799497

ABSTRACT

The use of smartphones has greatly increased in the last decade and has revolutionized the way that health data are being collected and shared. Mobile applications leverage the ubiquity and technological sophistication of modern smartphones to record and process a variety of metrics relevant to human health, including behavioral measures, clinical data, and disease symptoms. Information processed by mobile applications may have significant utility for increasing biomedical knowledge, both through conventional research and emerging discovery paradigms such as citizen science. However, the ways in which smartphone-collected data may be used in nontraditional modes of biomedical discovery are not well understood, such as using data to train artificially intelligent algorithms and for product development purposes. This paper argues that the use of mobile health data for algorithm training and product development is (a) likely to become a prominent fixture in medicine, (b) likely to raise significant ethical and legal challenges, and (c) warrants immediate scrutiny by policymakers and scholars. We introduce the concept of "smartphone-crowdsourced medical data," or SCMD, and set out a broad research agenda for addressing concerns associated with this new and potentially momentous practice. We conclude that SCMD for algorithm training raises a number of ethical and legal issues which require further scholarly attention to ensure that individual interests are protected and that emerging health information sources can be used in ways that maximally, and safely, promote medical innovation.

11.
Front Genet ; 14: 1190421, 2023.
Article in English | MEDLINE | ID: mdl-37576562

ABSTRACT

Genetic counseling is a fast-growing profession worldwide, with genetic counselors taking on increasingly comprehensive and autonomous roles in the healthcare sector. However, the absence of appropriate legal frameworks could potentially create risks of harm to the public. Legal recognition serves to protect the public from risk of harm by regulating the safe and competent practice of healthcare professionals. Genetic counseling is not legally recognized in most world jurisdictions. Examination of the legal status of genetic counseling in different jurisdictions and whether existing legal mechanisms are adequate to address potential risks of harm is therefore timely. This paper examines the different roles of genetic counselors in the Canadian province of Quebec and the state of Qatar, the authors' respective jurisdictions. It considers the types of harms that may be created where appropriate legal mechanisms are lacking, considering the socio-political and legal differences between the two jurisdictions. Moreover, it examines the legal status of genetic counseling in Quebec and Qatar to determine whether these statuses appropriately address the identified risks of harm. The authors argue that existing legal frameworks are inadequate to address these risks and recommend that additional regulatory mechanisms be implemented to properly protect the public from risks of harm.

12.
Beijing Da Xue Xue Bao Yi Xue Ban ; 55(4): 593-599, 2023 Aug 18.
Article in Chinese | MEDLINE | ID: mdl-37534637

ABSTRACT

OBJECTIVE: To evaluate the change of prevalence of malnutrition among Chinese primary and secondary school students and to analyze the policy effect during the period of the Program for the Development of Chinese Children 2011-2020 (PDCC 2011-2020). METHODS: The data of Chinese students aged 7 to 18 years were extracted from 8 successive cross-sectional surveys of the Chinese National Survey on Students ' Constitution and Health (CNSSCH) from 1985 to 2019. Malnutrition of students was evaluated according to the screening standard for malnutrition of school-age children and adolescents. The changes of prevalence of malnutrition among primary and secondary school students were described by gender, urban and rural areas, age group and province, from 2010 to 2019. The Joinpoint regression model was used to analyze the trajectory of the prevalence of malnutrition among students aged 7 to 18 years from 1985 to 2019, so as to evaluate the policy effect of the PDCC 2011-2020. RESULTS: The prevalence of malnutrition among primary and secondary school students in China decreased from 12.7% in 2010 to 8.5% in 2019. The prevalence of malnutrition among boys and girls, urban and rural students, and students of all age groups showed a continuous downward trend (Ptrend < 0.001) from 2010 to 2019. From 2010 to 2019, 27 of the 31 provinces (autonomous regions and municipalities) saw a significant decrease in the prevalence of malnutrition among primary and secondary school students. Joinpoint regression model showed that the prevalence of malnutrition among Chinese primary and secondary school students continued to decline from 1985 to 2019, but 2010 was the turning point in the downward trend. From 1985 to 2010, the prevalence of malnutrition among primary and secondary school students decreased by an average of 2.4% per year (95%CI: 1.9%-2.8%, P < 0.001), and the downward trend accelerated after 2010, with an average annual decline of 4.3% (95%CI: 2.4%-6.2%, P < 0.001). CONCLUSION: The prevalence of malnutrition among primary and secondary school students in China continued to decline from 2010 to 2019, achieving the goal of controlling the prevalence of malnutrition among primary and secondary school students in the PDCC 2011-2020. The PDCC 2011-2020 may have played an important role in improving the malnutrition among primary and secondary school students. However, the problem of malnutrition among primary and secondary school students still exists, and it is still necessary to adhere to the coverage and financial support of the nutrition improvement plan in areas with high incidence of malnutrition.


Subject(s)
Malnutrition , Male , Adolescent , Female , Humans , Child , Prevalence , Cross-Sectional Studies , Malnutrition/epidemiology , Malnutrition/prevention & control , Students , China/epidemiology , Rural Population , Schools
13.
Nan Fang Yi Ke Da Xue Xue Bao ; 43(7): 1204-1213, 2023 Jul 20.
Article in Chinese | MEDLINE | ID: mdl-37488803

ABSTRACT

OBJECTIVE: To assess the value of Improved Mayo Endoscopic Score (IMES) for evaluation of treatment efficacy for active ulcerative colitis (UC). METHODS: We retrospectively analyzed the clinical and endoscopic data of 103 patients diagnosed with active UC in Beijing Tsinghua Changgung Hospital from January, 2015 to December, 2020. The severity of endoscopic lesions was determined by Mayo Endoscopic Score and the Ulcerative Colitis Endoscopic Index of Severity (UCEIS), and the area of the endoscopic lesions was evaluated based on the Montreal classification system. The IMES was established by combining the MES with the Montreal classification. RESULTS: Univariate analysis suggested that young patients (<40 years old), patients with extensive disease type (E3), patients with high endoscopic scores (MES=3, UCEIS>4, and IMES>4), and patients receiving advanced drug therapy (with systemic hormones, immunosuppressants, immunomodulators, and biological agents, etc.) had lower clinical and endoscopic remission rates. COX survival analysis showed that IMES≤4 was an independent risk factor for clinical and endoscopic remission. ROC curve indicated that the predictive value of IMSE≤4 for clinical and endoscopic remission (AUC=0.7793 and 0.7095, respectively; P<0.01) was better than that of Montreal (AUC=0.7357 and 0.6847, respectively; P<0.01), MES=2 (AUC=0.6671 and 0.5929, respectively; P<0.01), and UCEIS≤4 (AUC=0.6823 and 0.6459, respectively; P<0.01); IMES=5 had a better predictive value for patients with active UC undergoing colectomy tham E3 and MES=3. CONCLUSION: IMES has good value in evaluating treatment efficacy for active UC.


Subject(s)
Colitis, Ulcerative , Humans , Adult , Retrospective Studies , Endoscopy , Immunosuppressive Agents , Treatment Outcome
14.
Hum Genet ; 142(7): 981-994, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37365297

ABSTRACT

Risk prediction models hold great promise to reduce the impact of cancer in society through advanced warning of risk and improved preventative modalities. These models are evolving and becoming more complex, increasingly integrating genetic screening data and polygenic risk scores as well as calculating risk for multiple types of a disease. However, unclear regulatory compliance requirements applicable to these models raise significant legal uncertainty and new questions about the regulation of medical devices. This paper aims to address these novel regulatory questions by presenting an initial assessment of the legal status likely applicable to risk prediction models in Canada, using the CanRisk tool for breast and ovarian cancer as an exemplar. Legal analysis is supplemented with qualitative perspectives from expert stakeholders regarding the accessibility and compliance challenges of the Canadian regulatory framework. While the paper focuses on the Canadian context, it also refers to European and U.S. regulations in this domain to contrast them. Legal analysis and stakeholder perspectives highlight the need to clarify and update the Canadian regulatory framework for Software as a Medical Device as it applies to risk prediction models. Findings demonstrate how normative guidance perceived as convoluted, contradictory or overly burdensome can discourage innovation, compliance, and ultimately, implementation. This contribution aims to initiate discussion about a more optimal legal framework for risk prediction models as they continue to evolve and are increasingly integrated into landscape for public health.


Subject(s)
Ovarian Neoplasms , Software , Female , Humans , Canada , Risk , Genetic Testing
15.
Biopreserv Biobank ; 21(3): 267-274, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37192471

ABSTRACT

Background: Scientific research is becoming an increasingly collaborative and global venture. The Healthy Life Trajectories Initiative (HeLTI), for instance, is an international Developmental Origins of Health and Disease research collaboration developed to address the increasing burden of noncommunicable diseases around the world. It comprises four separate but harmonized cohort trials in Canada, China, India, and South Africa. These cohorts will generate rich data and biosample sets that can be shared both within the HeLTI Consortium and with other researchers from around the world. Methods: To ensure the coordination and operation of these types of collaborative research initiatives, a standardized and harmonized governance model is required to regulate the processes and interactions between all involved actors. To develop the governance models, frameworks and related policies from other longitudinal cohort studies and biobanks were used, as were guidance documents on biobank and database governance and relevant literature on data and biobank governance. Results: This article outlines the key components of the governance model for the HeLTI Consortium, including management of the cohorts' respective databases and biobanks, access to data and biosamples, and considerations related to intellectual property and publications. Conclusion: Governance within international collaborative research ventures is critical to ensure the operations and benefits of these types of research apparatuses. Although this article focuses on the HeLTI Consortium as a model, it may nonetheless serve as a model for both current and future collaborative consortium-based research initiatives. Clinical Trial Registration Numbers: Canada, ISRCTN13308752; China, ChiCTR1800017773; India, ISRCTN20161479; South Africa, PACTR201903750173871.


Subject(s)
Biological Specimen Banks , Policy , Humans , Longitudinal Studies , Cohort Studies , Databases, Factual
16.
J Pediatr ; 260: 113524, 2023 09.
Article in English | MEDLINE | ID: mdl-37245625

ABSTRACT

OBJECTIVE: To assess the comparability of international ethics principles and practices used in regulating pediatric research as a first step in determining whether reciprocal deference for international ethics review is feasible. Prior studies by the authors focused on other aspects of international health research, such as biobanks and direct-to-participant genomic research. The unique nature of pediatric research and its distinctive regulation by many countries warranted a separate study. STUDY DESIGN: A representative sample of 21 countries was selected, with geographical, ethnic, cultural, political, and economic diversity. A leading expert on pediatric research ethics and law was selected to summarize the ethics review of pediatric research in each country. To ensure the comparability of the responses, a 5-part summary of pediatric research ethics principles in the US was developed by the investigators and distributed to all country representatives. The international experts were asked to assess and describe whether principles in their country and the US were congruent. Results were obtained and compiled in the spring and summer of 2022. RESULTS: Some of the countries varied in their conceptualization or description of one or more ethical principles for pediatric research, but overall, the countries in the study demonstrated a fundamental concordance. CONCLUSIONS: Similar regulation of pediatric research in 21 countries suggests that international reciprocity is a viable strategy.


Subject(s)
Biological Specimen Banks , Ethics, Research , Child , Humans , Research Personnel , Informed Consent
17.
Zhonghua Yu Fang Yi Xue Za Zhi ; 57(4): 486-491, 2023 Apr 06.
Article in Chinese | MEDLINE | ID: mdl-37032159

ABSTRACT

Objective: To analyze the trends of the age of menarche among Chinese Han girls aged 9 to 18 years from 2010 to 2019. Methods: Data were extracted from the Chinese National Surveys on Students' Constitution and Health in 2010, 2014 and 2019. A total of 253 037 Han girls aged 9 to 18 years with complete data on menarche were selected in this study. They were asked one-on-one about their menstrual status, age and residence information. The median age of menarche was estimated by probability regression. U tests were used to compare the difference in median age at menarche in different years. Results: The median age at menarche (95%CI) among Chinese Han girls was 12.47 (12.09-12.83) years in 2010, 12.17 (11.95-12.38) years in 2014 and 12.05 (10.82-13.08) years in 2019, respectively. Compared with that in 2010, the median age at menarche in 2019 decreased by 0.42 years (U=-77.27, P<0.001). The annual average changes were -0.076 years from 2010 to 2014 (U=-57.19, P<0.001) and -0.023 years from 2014 to 2019 (U=-21.41, P<0.001), respectively. The average annual changes in urban areas in the periods of 2010 to 2014 and 2014 to 2019 were -0.071 years and 0.006 years, respectively, while those in rural areas were -0.082 years and -0.053 years, respectively. The average annual changes in the regions of north, northeast, east, south central, southwest and northwest were -0.064, -0.099, -0.091, -0.080, -0.096 and -0.041 years in the period of 2010 to 2014 and 0.001, -0.040, -0.002, -0.005, -0.043 and -0.081 years in the period of 2014 to 2019. Conclusion: The age of menarche among Chinese Han girls aged 9 to 18 years shows an advanced trend from 2010 to 2019, and the trends in urban and rural areas and different regions have different characteristics.


Subject(s)
East Asian People , Menarche , Female , Humans , Probability , Child , Adolescent
19.
Zhonghua Liu Xing Bing Xue Za Zhi ; 44(3): 422-429, 2023 Mar 10.
Article in Chinese | MEDLINE | ID: mdl-36942337

ABSTRACT

Objective: To analyze the perceived exercise benefits and barriers and their association with physical activity time in Chinese Han children and adolescents aged 9-18 years. Methods: Data were extracted from the 2019 Chinese National Survey on Students' Constitution and Health and a total of 163 656 children and adolescents aged 9-18 years in Han ethnic group were included in the analysis. Mann-Whitney U test and Kruskal-Wallis test were used to compare the perceived exercise benefits score, perceived exercise barriers score and perceived exercise benefits to barriers ratio in the children and adolescents with different demographic characteristics and physical activity time. The differences in physical activity time in subgroups were compared with χ2 tests. log-binomial regression model was used to evaluate the association between physical activity time and perceived exercise benefits and barriers. Results: The M (Q1,Q3) of the perceived exercise benefits score, perceived exercise barriers score, and perceived exercise benefits to barriers ratio in the children and adolescents were 4.11 (3.78, 4.78), 2.70 (2.10, 3.20) and 1.55 (1.22, 2.07), respectively. Children and adolescents living in urban area, boys, those at younger age and those with physical activity time ≥1 hour had higher perceived exercise benefits score and perceived exercise benefits to barriers ratio, but lower perceived exercise barriers score (all P<0.001). The prevalence of physical activity time ≥1 hour was 41.4% in the children and adolescents. In the log-binomial model with two variables of perceived exercise benefits score and perceived exercise barriers score, for each 1-point increase in the perceived exercise benefits, the possibility of physical activity time ≥1 hour increased by 11% (OR=1.11, 95%CI: 1.10-1.12), and for each 1-point increase in the perceived exercise barriers, the possibility of physical activity time ≥1 hour decreased by 15% (OR=0.85, 95%CI: 0.84-0.85). In the log-binomial model with variable of perceived exercise benefits to barriers ratio, for each 1-point increase in the perceived exercise benefits to barriers ratio, the possibility of physical activity time ≥1 hour increased by 12% (OR=1.12, 95%CI: 1.11-1.12). Conclusion: The perceived exercise benefits and barriers are significantly associated with physical activity time in children and adolescents in China.


Subject(s)
Asian People , Exercise , Adolescent , Child , Humans , Male , China , Ethnicity , Students , Female
20.
Eur Rev Med Pharmacol Sci ; 27(3): 1007-1015, 2023 02.
Article in English | MEDLINE | ID: mdl-36808346

ABSTRACT

OBJECTIVE: The current management of subarachnoid hemorrhage (SAH) in the urban Chinese population remains unclear and the relevant literature is still lacking. Therefore, this work aimed to investigate the recent clinical practice in the management of spontaneous SAH in an urban population-based setting. PATIENTS AND METHODS: From 2009 to 2011, the China Epidemiology Research In Subarachnoid Hemorrhage (CHERISH) project, which was a two-year prospective, multi-center, population-based, case-control study, was performed in the northern urban Chinese population. SAH cases were described in terms of their features, clinical management, and in-hospital outcomes. RESULTS: Totally of 226 cases were enrolled with a final diagnosis of primary spontaneous SAH (65% of females; mean age, 58.5±13.2 years; range, 20-87 years). Among them, 92% of these patients received nimodipine, while 93% took mannitol. Meanwhile, 40% of them received traditional Chinese medicine (TCM), while 43% took neuroprotective agents. Endovascular coiling was applied in 26% of 98 angiography-confirmed intracranial aneurysms (IA) cases, while neurosurgical clipping was in 5% of them. CONCLUSIONS: Our findings on the management of SAH in the northern metropolitan Chinese population reveal that nimodipine is an effective medical therapy with a high rate of use. There is also a high utilization rate of alternative medical interventions. Endovascular coiling occlusion is more common than neurosurgical clipping. Therefore, regionally traditional therapy may be a key factor for the difference in the treatment of SAH between northern and southern China.


Subject(s)
Aneurysm, Ruptured , Intracranial Aneurysm , Subarachnoid Hemorrhage , Female , Humans , Middle Aged , Aged , Nimodipine , Urban Population , Case-Control Studies , Prospective Studies , Treatment Outcome , Intracranial Aneurysm/surgery , Aneurysm, Ruptured/surgery
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