University Research Ethics Committee Research Articles

What are the effects of teaching Evidence-Based Health Care (EBHC) at different levels of health professions education? An updated overview of systematic reviews.

Evidence-based healthcare (EBHC) knowledge and skills are recognised as core competencies of healthcare professionals worldwide, and teaching EBHC has been widely recommended as an integral part of their training. The objective of this overview of systematic reviews (SR) was to update evidence and assess the effects of various approaches for teaching evidence-based health care (EBHC) at undergraduate (UG) and postgraduate (PG) medical education (ME) level on changes in knowledge, skills, attitudes and behaviour. This is an update of an overview that was published in 2014. The process followed standard procedures specified for the previous version of the overview, with a modified search. Searches were conducted in Epistemonikos for SRs published from 1 January 2013 to 27 October 2020 with no language restrictions. We checked additional sources for ongoing and unpublished SRs. Eligibility criteria included: SRs which evaluated educational interventions for teaching EBHC compared to no intervention or a different strategy were eligible. Two reviewers independently selected SRs, extracted data and evaluated quality using standardised instrument (AMSTAR2). The effects of strategies to teach EBHC were synthesized using a narrative approach. Previously published version of this overview included 16 SR, while the updated search identified six additional SRs. We therefore included a total of 22 SRs (with a total of 141 primary studies) in this updated overview. The SRs evaluated different educational interventions of varying duration, frequency, and format to teach various components of EBHC at different levels of ME (UG, PG, mixed). Most SRs assessed a range of EBHC related outcomes using a variety of assessment tools. Two SRs included randomised controlled trials (RCTs) only, while 20 reviews included RCTs and various types of non-RCTs. Diversity of study designs and teaching activities as well as aggregated findings at the SR level prevented comparisons of the effects of different techniques. In general, knowledge was improved across all ME levels for interventions compared to no intervention or pre-test scores. Skills improved in UGs, but less so in PGs and were less consistent in mixed populations. There were positive changes in behaviour among UGs and PGs, but not in mixed populations, with no consistent improvement in attitudes in any of the studied groups. One SR showed improved patient outcomes (based on non-randomised studies). Main limitations included: poor quality and reporting of SRs, heterogeneity of interventions and outcome measures, and short-term follow up. Teaching EBHC consistently improved EBHC knowledge and skills at all levels of ME and behaviour in UGs and PGs, but with no consistent improvement in attitudes towards EBHC, and little evidence of the long term influence on processes of care and patient outcomes. EBHC teaching and learning should be interactive, multifaceted, integrated into clinical practice, and should include assessments. The protocol for the original overview was developed and approved by Stellenbosch University Research Ethics Committee S12/10/262. Young T, Rohwer A, Volmink J, Clarke M. What are the effects of teaching evidence-based health care (EBHC)? Overview of systematic reviews. PLoS One. 2014;9(1):e86706. doi: 10.1371/journal.pone.0086706.

Towards a culture of care for ethical review: connections and frictions in institutional and individual practices of social research ethics

ABSTRACT As researchers, institution-wide regulatory and organisational cultures guide our work. Over the past two decades, University Research Ethics Committees have been formally established across social science disciplines. However, the functioning of these committees has not been without critique. It is often argued that established ethical procedures informed by the medical sciences do not fit well with the more iterative epistemologies and unpredictable practices of doing social fieldwork. In this paper, I contribute to these discussions by considering what a further framework, a ‘culture of care’, might offer to university research ethics. A culture of care has evolved in contexts like the National Health Service (NHS) and animal research, and makes central claims around support, openness, collaboration and relationships. Bringing this to research ethics, I explore experiences of care through moments of friction in doing fieldwork with people living with Motor Neurone Disease. Identifying gaps between the institutional, personal and relational, I tentatively suggest some key features that a culture of care for research ethics might seek to develop. These discussions are also timely. Wider conversations emerging around reimagining research cultures in higher education provide an opportune moment to consider what a reimagined research ethics might look like and offer too.

Impacts of perioperative warming on vital findings and blood parameters of patients having cholecystectomy

This study was carried out to determine the effects of preoperative, preoperative, and postoperative warming on vital signs and blood parameters in patients undergoing laparoscopic cholecystectomy. This study was carried out in operating room A of a research and practice hospital. Necessary permissi-ons were obtained from the university research ethics committee, hospital, and patients. Eighty patients who had undergone medical operations in the hospital in the last six months were included in the sampling method. Body temperatures and physiological findings of the patients and room temperature were also given as percen-tages. Repeated measurements of variance and t-test evaluated postoperative physiological results of each patient. The average body temperature of the patients was 36.36+ 2.81°C, and the average body temperature after the operation was 36.33+ 2.80°C (p >0.05). The mean arterial pressure (MAP) of the patients before the operation was 102.64+11.529 mm Hg. The mean arterial pressure of the patients in the recovery room after the operation was 98.55+ 9.940. During the operation, the MAP was between 96 and 98 Hg. There was a significant difference in terms of the mean arterial pressure of the patients (p <0.05). The average hemoglobin, lymphocyte, platelet counts, activated partial thromboplastin time levels, and values were within the normal range, and there was a significant difference in terms of importance and levels before and after the operation (p < 0.05). The average preoperative, preoperative and postoperative blood urea nitrogen (BUN) values of the patients were 13.79+ 6.126, 13.70+6.752, and 13.52+7.637, respectively. They were within the normal range, and there was no statistical difference (p >0.05). As a result, it can be said that keeping the preoperative, preoperative, and postoperative body tempera-tures of the patients positively affects blood pressure, respiration, and oxygenation and help to normalize these values. In addition, it keeps erythrocyte, hemoglobin, leukocytes, lymphocytes, thrombocyte, APTT, BUN, AST, ALT values within the normal range. It contributes positively to the healing process of the wound. In order to increase the accuracy of this study, it is recommended to conduct studies that include more control and experi-mental groups.

Assessment of health-related quality of life in patients with inflammatory bowel disease in occupied Palestinian territory: a correlation cross-sectional study

BackgroundDisease activity is suggested to be an important indicator for quality of life (QoL) in patients with inflammatory bowel disease (IBD). Few studies of the association between adherence to medication and QoL in patients with IBD are available, and their findings are conflicting. We examined associations between disease activity, medication adherence, and QoL in patients with IBD in occupied Palestinian territory. MethodsThis correlation cross-sectional study was done from July 1, 2017, to Feb 30, 2018. We used convenience sampling to recruit patients from three major hospitals in southern and northern regions of occupied Palestinian territory. The disease-specific inflammatory bowel disease questionnaire (IBDQ) was used to examine QoL. Medication adherence was measured with the modified Morisky adherence scale. Associations were assessed by regression analysis. Results were analysed with SPSS version 20. The study was approved by the Al-Quds University Research Ethics Committee. Informed verbal consent was obtained from the participants before the start of the study. Interpretation132 patients were enrolled. The mean age was 34 years (SD 13) and 77 (58%) patients were men. Active disease in the previous 6 months was reported in 81 participants (61%). Low adherence to medication (score <6) was reported in 52 (39%) of participants. The average IBDQ score was low (150·72 [SD 30·08]), with the emotional and bowel domains being most affected. Active disease was the most significant factor associated with patients’ QoL overall (p<0·001). No significant association was found between medication adherence and QoL. Regression analysis revealed significant independent associations between QoL and disease remission (p<0·001), high educational status (p=0·009), and using azathioprine (p=0·034). InterpretationOur results provides baseline data about Palestinian IBD patients’ QoL and medication use and adherence, and might help health-care providers to identify patients with IBD at risk of low QoL, especially those with relapse and active symptoms. Attention should be given by health-care providers and strategists to increasing knowledge about IBD. The importance of treatment adherence should be explored further. Some limitations were encountered during the study period; it was conducted in only three hospitals and the results might not be generalisable. The cross-sectional type of this study might prevent the identification of any cause-and-effect relationships, especially between medication and post-treatment improvements in QoL. FundingNone.

Using Photovoice as A Student-Centred Teaching Method among Graduate Nursing Students: A Mixed Method Study

Photovoice is used commonly for community action research. Evidence shows that when used appropriately in the classroom, it can effectively engage students and enhance learning. Use in the nursing classroom is however limited. The aim of the study was to assess perception and experiences of postgraduate students, as well as the effectiveness of photovoice teaching strategy on acquisition of skills in critical thinking, communication, self directed learning, and problem-based learning. This mixed method study used photovoice pedagogy to teach the course “Health Systems Management” to twenty postgraduate students of Nursing Science at a University in Nigeria. Ethical clearance was obtained from the University Research Ethics Committee. Evaluation of students’ understanding of the teaching method and learning content involved obtaining photographs supporting both the positive and negative aspects of assigned topics, and presenting them as photovoice seminar. Data collection was through a validated 40-items questionnaire (for quantitative data) and Focus Group Discussion and in-depth interview (for exploratory data). Descriptive and inferential data analysis was on SPSS 18.0, while qualitative data were thematically analysed on NVivo 7.0. Results showed that photovoice methodology helped students develop critical thinking skills (p = 0.01), promoted self-directed learning (p = 0.001), strengthened communication skills (p = 0.01) and ensured problem-based learning (p = 0.02). Participants reported benefits of the method as empowerment of students for more effective involvement/participation in the teaching-learning process (100%), creation of powerful visual facts of topics (95.0%), effective engagement of students (90.0%), and enhanced appreciation of different points of view (85.0%). Qualitative data analysis yielded three themes “Transformation of the teaching-learning process”, “Critical group dialogue”, and “Engagement of students”. In conclusion, photovoice enhanced critical reflection, critical thinking, social communication, and self-directed learning skills and increased engagement of students. It can serve as an effective instructional method in nursing education.

The Development of “Friend from Heart” Application based on LINE System to Promote Well-Being of Undergraduate Students of Faculty of Education, Kasetsart University

Depression and suicide rates among youths tended to increase. From reviews, many applications and online counseling could reduce depression and anxiety to promote well-being of youths and university students effectively. This study was conducted to develop &amp;quot;Friend from heart&amp;quot; application based on LINE system to promote well-being for undergraduate students of faculty of education, Kasetsart University. The research method included the survey of basic data for developing the application and evaluation of the application by specialists. A total of 72 voluntary students were invited to join an online survey. It was found that most of the students (81.94%) wanted applications that provide physical health information such as exercise, eating healthy food, and health care. However, about 16.66% of students needed an application that can speak or listen problems with video calls. Then, researchers took the services that students were interested more than 50% to develop the applications. It worked through the application, consisting of chatbot, physical health, mental health, and appointment with counselor. The index of item-objective congruence was 0.66-1.00 with additional specialists commenting that the application had an interesting design with good structure to help students. For ethical approval, it was obtained from the Kasetsart University Research Ethics Committee.

308 A Qualitative Study Evaluating the Uses, Benefits and Barriers of Tele-Consultations in The Pre-Operative Pathway for Elective Orthopaedic Surgery at A Major London Teaching Hospital

Abstract Introduction Digital healthcare technology is becoming a prodigious tool in healthcare management, supporting efforts for effective demand management and personalised, user-centred care. One example is tele-consultations, clinical consultations conducted remotely using technology such as telephones or videos. However, there is slow adoption of such technology and lack of literature supporting its use, particularly within the pre-operative surgical pathway, where communication, patient education and planning is vital to post-surgical outcomes. This study aimed to evaluate the uses, benefits and barriers of tele-consultations in the pre-operative pathway for elective hip and knee arthroplasty, at Imperial College Healthcare NHS Trust, from the perspective of key clinical stakeholders. Method 16 Semi Structured Interviews were conducted with Healthcare professionals (HCPs) along the preoperative pathway before conducting a thematic analysis. Ethical approval was received from Imperial College Research Ethics Committee on 05/02/2019. Results HCPs suggested use-cases for tele-consultation use in pre-assessment consultations with lower risk patients, information delivery, physiotherapy, and occupational therapy pre-assessment. Benefits cited were reduced overall costs and time, increased workflow efficiency with barriers noted as accessibility challenges, lack of holistic examination of patient and digital illiteracy. Conclusions Future studies should be conducted in other NHS trusts to identify greater uses within the entire surgical pathway.

Unintended consequences of technology-enabled work activities experienced by healthcare professionals in tertiary hospitals of sub-Saharan Africa

The unintended consequences experienced by healthcare professionals while using health ICTs at points-of-care are disruptive to their work activities. Failure to address these consequences inhibits efforts to support the delivery of quality healthcare services in hospital settings. Hence, the aim of this paper is to identify how unintended consequences disrupt technology-enabled work activities of healthcare professionals in hospital settings. An interpretive stance was adopted to investigate healthcare professionals’ experiences with the use of health ICTs for their work activities through open-ended interview questions, to acquire in-depth information about unintended consequences events. A total of 19 participants were selected using a purposive sampling technique to identify healthcare professionals from two tertiary hospitals with varying levels of technology implementation. The participants included doctors and nurses in clinical departments that use health ICTs for medical imaging, referrals and reporting. Ethics clearance for data collection were granted by the University research ethics committee and the hospitals. Thematic analysis was adopted to identify and interpret patterns that emerged from participants’ responses. Findings indicated that the unintended consequences experienced by healthcare professionals are protracted time to complete tasks; interruption of tasks and workarounds at points-of-care. The unintended consequences are caused by contradictions that result from tensions between contextual conditions that inhibit perceived usefulness, and a lack of fit between tasks of work activities and health ICTs. Hospital managers and health technology vendors should actively consider the likely undesirable experiences or disruptions from feedback recorded during the pilot implementation phase within use contexts.

Effectiveness of a Parenting Programme Delivered Within a Conditional Cash Transfer System to Reduce Violence Against Children in the Philippines: Results From a Randomised Controlled Trial With 1-Year Follow-Up

Background: Parenting interventions and conditional cash transfer (CCT) programmes are promising strategies to reduce the risk of violence against children, but evidence of the effectiveness of combining such programmes is lacking for families in low- and middle-income countries with children over 2 years of age. This study examined the effectiveness of a locally-adapted parenting programme delivered as part of a government CCT system to low-income families with children aged 2 to 6 years in Metro Manila, Philippines. Methods: Participants were randomly assigned (1:1) to either a 12-session group-based parenting programme or a control group receiving usual family services ( N = 120). Participation in either service was required among the conditions for receiving cash grants. Baseline assessments were conducted in July 2017 with 1-month post-intervention assessments in January 2018 and 12-month follow-up in January 2019. Findings: One-month post-intervention assessments indicated moderate intervention effects for primary outcomes of reduced overall child maltreatment (d = -0·50 [-0·86, -0·13]), emotional abuse (d = -0·59 [-0·95; -0·22]), physical abuse (IRR = 0·51 [0·27; 0·74]), and neglect (IRR = 0·52 [0·18; 0·85]). There were also significant effects for reduced dysfunctional parenting, child behaviour problems, and intimate partner violence, and increased parental efficacy and positive parenting. Reduced overall maltreatment, emotional abuse, and neglect effects were sustained at 1-year follow-up. Interpretation: Findings suggest that a culturally-adapted parenting intervention delivered as part of a CCT programme may be effective in sustaining reductions in violence against children in low- and middle-income countries. Clinical Trial Registration Details: All assessments were parent-report (ClinicalTrials.gov: NCT03205449). Funding Information: This research was supported by UBS Optimus Foundation and UNICEF Philippines, and by the Complexity and Relationships in Health Improvement Programmes of the Medical Research Council MRC UK and Chief Scientist Office (Grant: MC_UU_12017/14 and CSO SPHSUU14, MC_UU_1201711 and CSO SPHSU11). Declaration of Interests: Dr. Ward reports grants from UBS Optimus Foundation, grants from UNICEF Philippines, during the conduct of the study; Dr. Hutchings reports I received grant funding to contribute to the design of the trial and supervision of group leaders; Lachman is the co-developer of a non-profit parenting program with the World Health Organization ‘Parenting for Lifelong Health’, under a creative commons license, and receives fees as a trainer for this; Dr. Alampay reports that she led the team that culturally-adapted the parenting program that is being evaluated in the study; Dr. GARDNER reports grants from WHO VIOLENCE PREVENTION, grants from UNICEF Thailand, grants from UBS Optimus Foundation, outside the submitted work; and I am a co developer of the programme, PLH, tested in the trial. PLH material are open access, under a creative commons licence, and I receive no fees, royalties or other compensation as a result of its testing or implementation; all other authors have nothing to disclose. Ethics Approval Statement: Ethical procedures were approved by the University of Oxford Central University Research Ethics Committee (Reference: R43041/RE001), the Ateneo de Manila University Research Ethics Committee (Reference: AdMUREC_16_014PA), and the University of Cape Town Department of Psychology Research Ethics Committee (Reference: PSY2016-041).

Evaluating the Utilisation of a Service Designed to Enhance Care with Medicines Following Acute Hospital Discharge: A Retrospective Study

Abstract Introduction Medication safety challenges are common after hospital discharge and an important global health care improvement target [1,2]. ‘Transfers of Care Around Medicines’ (TCAM) services have been suggested as an intervention that may help address this problem, and are designed to enable the referral of patients on discharge from the hospital to a named community pharmacy in the surrounding Clinical Commissioning Group (CCG). A TCAM service was launched by a large NHS Trust in England in February 2019 to enhance medicines communication and optimisation between primary and secondary care following hospital discharge. The TCAM service is delivered through the PharmOutcomes™ platform, and the initial focus of the service was to support patients with new or existing Monitored Dosage Systems (MDS). Aim To evaluate the utilisation of the TCAM service in the host NHS Trust and surrounding CCG through the examination of the nature and outcome of referrals made to community pharmacy. Method Anonymised service delivery data of patients referred from the TCAM service via the PharmOutcomes™ platform between March 2019 – February 2020 were retrospectively examined. The data comprised important variables, including patient demographics, status and time of referrals, and referral outcomes including problems/errors identified with medications and services provided by the community pharmacy such as medicines reconciliation. Study approvals were obtained from the host NHS Trust and the Health Research Authority (HRA); the study was exempt from the University Research Ethics Committee (UREC) approval [2019-7048-10983]. Results A total of 3,033 TCAM referrals to 67 community pharmacies were analysed. Most referrals were for patients aged 70 and above (72%, n=2,195) and 56% (n=1,713/3,033) of the referrals were for female patients. The number of referrals varied between 215 and 310 per month (median 246, Inter quartile range [IQR] 234 - 268). Most referrals (67%, 2,038/3,033) were marked as ‘completed’ by the community pharmacies, with 32.8% (n=995) left uncompleted. The rate of referral completion varied between 59 and 80% per month (median 66.4, IQR 64.5 - 70). Five (0.2%) patients were identified by community pharmacies that had adverse drug reactions (ADRs) from the cohort of 2,038 patients with completed referrals, with 45 (2%, n=45/2,038) identified as having issues that necessitated referral to the general practitioner (GP). The most common reason for referral to GP was medication changes identified from hospital, incorrect repeat prescriptions following discharge, to request a new prescription or weekly MDS, and to inform the GP that the patient has stopped taking their medication. The most common services carried out in community pharmacies following referral were reported as medicines reconciliation (47%, n=954/2,038), followed by review of information (46.7%, n=952/2,038), home delivery of medication (39%, n=798/2,038), review MDS arrangements (23.6%, n=482/2,038), commence MDS (18.6%, n=380/2,038), and pharmacy managed repeat service (12%, n=254/2,038). The main strength of this study is the inclusion of referral data that occurred over a one-year period, while the data were limited in generalisability due to inclusion of one geographical region and only patients using MDS. Conclusion The findings of this study may inform the ongoing development of electronic pharmacy referral systems for use at hospital discharge.

A framework of ethical issues to consider when conducting internet-based research

Background: The Internet has changed the way that academia access information for teaching and research purposes. ‘Internet-based research’ refers to studies where data are collected from the internet, often social media sites. However, there are no definitive ethical guidelines for researchers on how to collect, analyse and use the data collected from internet-based research. Objective: The objective of the article was to develop a framework that can be used by researchers to consider ethical issues in internet-based research. Methods: The framework was developed from an in-depth literature review that examined recent research that investigated ethical dilemmas in internet-based research and existing guidelines that are available from universities across the globe to guide research ethics committees on how to evaluate such research. Results: The framework that was developed consisted of five focus areas: the study population, legal issues, privacy expectations of users, data considerations and data storage. For each of these focus areas, several subareas were identified and discussed in detail to ensure that data were collected in a responsible and ethical manner. Conclusion: The recommendation from the study is that both researchers and university research ethics committees should use the framework that was developed to guide their ethical decision-making process when collecting data from the Internet.

Effects of Cognitive-Behavioral Therapy on Pain Intensity and Stress Coping Styles in Patients With Gastric Wound

Background and Aim: Patients with the symptoms of gastrointestinal diseases and ulcers constitute a large number of patients referring to general and internal clinics. Furthermore, preliminary studies on gastric ulcers highlighted the role of psychological factors in the development of a susceptible gastric ulcer. The current study aimed to determine the effects of Cognitive-Behavioral Therapy (CBT) on pain intensity and stress coping styles in patients with gastric ulcers. Methods &amp; Materials: This was an experimental study with a pretest-posttest-follow-up and a control group design. The statistical population included all patients with a gastric ulcer who were referred to public health centers in Tehran City, Iran, in the winter of 2018. Among the volunteers participating in the study, 30 patients with gastric ulcers were selected by the convenience sampling method. Next, they were randomly assigned to the experimental and control groups (n=15/group). Measurement tools included the McGill Pain Questionnaire (MPQ) and the Coping Inventory for Stressful Situations (CISS; Endler &amp; Parker, 1990). The experimental group subjects participated in eight 90-minute sessions of CBT. However, the controls received no psychological treatment in this period. For data analysis, repeated-measures Analysis of Variance (ANOVA) and post-hoc tests were applied. Ethical Considerations: This study was approved by the Research Ethics Committee of the Islamic Azad University, Karaj Branch (Code: IR.IAU.K.REC.1397.85). Results: The present research results signified that CBT improved problem-oriented coping styles (P&lt;0.01) and decreased emotion-focused coping styles (P&lt;0.01) and avoidance (P&lt;0.01) in the test group. Besides, the mean scores of pain intensity decreased in the experimental group, compared to the controls (P&lt;0.01). Conclusion: The provided CBT was effective on pain intensity and stress coping styles in patients with gastric ulcers.

Validation of ESM1 Related to Ovarian Cancer and the Biological Function and Prognostic Significance by Bioinformatics Analysis and Experimental Verification

Background: Ovarian cancer (OC), a serious gynecological malignant disease, remains an enormous challenge in early diagnosis and medical treatment. Based on GEO and TCGA database by R language, Endothelial cell-specific molecule 1 (ESM1) were confirmed separately on the tool of bioinformatic analysis. ESM1 has been demonstrated that up-regulated in multiple cancer types, but the oncogenetic mechanism of ESM1 in promoting OC is still largely unknown. Methods: In the study, we used WGCNA network and Random survival forest variable screening to filtered out ESM1 in OC differentially expressed genes (DEGs). Next, we confirmed the mRNA and protein levels of ESM1 in OC samples via PCR and IHC. The correlation between ESM1 level and clinical data of OC patients were further confirmed, including FIGO stage, lymph node metastasis, and recurrence. The role of ESM1 in OC development were explored by several functional experimentations in vivo and in vitro. Then, the molecular mechanisms of ESM1 was further elucidated by bioinformatic end experimental analysis. Results: ESM1 was significantly up-regulated in OC, which positively with PFS but negatively with OS. ESM1 knockdown inhibited cell proliferation, apoptosis escaping, cell cycle, angiogenesis migration and invasion via multiple experiments. Moreover, GSVA analysis found that ESM1 was associated with the Akt pathway, and our results also supported the prediction. Conclusion: ESM1 was closely correlated with OC development and progression, and it could be considered a novel biomarker and therapeutic target for OC patients. Funding Statement: None. Declaration of Interests: The authors declare no conflict of interest. Ethics Approval Statement: The study protocol was in line with the ethical guidelines of the 1975 Declaration of Helsinki and was approved by the research ethics committee of University of South China and the research ethics committee of Shenzhen University. Informed consent to participate in the study. was obtained from each patient that was recruited

An Online Cultural Experience for Mental Health in People Aged 16-24 Compared to a Typical Museum Website: A Randomised Controlled Trial

Background: The mental health of young people is a major public health concern that has been exacerbated during the COVID-19 pandemic. There is growing interest in cultural assets such as museums to improve mental health. However, there is a dearth of experimental research regarding the impact of cultural assets on common mental disorders in young adults, and in online experiences, which may improve accessibility.Methods/design: The O-ACE POP (Online Active Community Engagement Proof of Principle) study is a randomised controlled trial of a co-produced online museum experience named Ways of Being (WoB) compared with the Ashmolean Website (Ash) on negative affect, positive affect and symptoms of anxiety and depression (K10) over a 3-day intervention phase followed by a 6-week follow up assessment.Findings: 463 people aged 16-24 were randomised: 231 to WoB and 232 to Ash and 349 (74%) completed to 6 weeks. Negative affect was lower over the intervention phase in those allocated to WoB than Ash (WoB-Ash n=448, NA -0.158, p=0·010). For males (179, 39%), those aged 18-24 (422, 91%), non-white ethnic groups (88, 19%), regular users of online culture (238, 51%), those not on antidepressants (363, 78%), and individuals without probable moderate-severe mental health problems (327, 71%) at baseline, negative affect was significantly lower in those allocated to WoB compared to the Ash. Mean K10 reduced over the trial period, from 27·1 (95% CI= 26·6-27·7) to 23·3 (95% CI= 22·5-24·1), as did negative affect whereas positive affect remained relatively stable. Trial recruitment was rapid and feedback positive with broad geographical, occupational and ethnic diversity.Interpretation: Cultural interventions may improve MH outcomes in a measurable way. Populations that are underserved, both clinically and in research such as non-white ethnic groups, non-students and males and were reached in this study. This demonstrates the importance of measuring psychometric outcomes and the potential for co-produced community cultural resources to support mental health.Trial Registration: Trial Registration: NCT04663594Funding: This study is sponsored by the University of Oxford COVID-19 Research Response Fundand supported by the NIHR Oxford Health Biomedical Research Centre, The WestminsterFoundation and the Huo Family FoundationDeclaration of Interest: AKP and MV were supported by a grant provided by the Huo Family Foundation. All other authors have nothing to declare. Ethical Approval: The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. All procedures involving human subjects were approved by the University of Oxford Central University Research Ethics Committee (CUREC), approval reference number R70187/RE007.

Rasch Modeling and Multilevel Confirmatory Factor Analysis for the Usability of the Impact of Event Scale-Revised (IES-R) During the COVID-19 Pandemic

Background: Several instruments are currently used to assess the Coronavirus Disease 2019 (COVID-19) induced psychological distress, including the 22-Items Impact of Event Scale-Revised (IES-R). The IES-R is a self-administered scale to assess posttraumatic stress symptomology after a traumatic event, measuring the symptoms of intrusion, avoidance, and hyperarousal as experienced in the past seven days.Objectives: The current study aimed to examine the construct validity of the IES-R based on the Rasch Model with COVID-19 related data as well as to test multilevel construct validity of IES-R within countries and between countries during the pandemic crisis.Methods: A multi-country web-based cross-sectional survey was conducted utilizing the 22-Items IES-R. A total of 1020 participants have enrolled in our survey, of whom 999 were included in the analyses. Data were analyzed using Rasch modeling and Multilevel Confirmatory Factor Analysis (MCFA).Results: The Rasch model’s confirmatory criteria of construct validity for IES-R revealed that the IES-R is a satisfactory instrument from the five-point Likert scale, asserting that its 22 items are significant contributors to assess the uni-dimensionality of the IES-R. The MCFA confirmed that 22-Items IES-R with its three factors including intrusion, avoidance, hyperarousal is characterized by a construct validity within and between country-level.Conclusion: The results suggested that 22-Items IES-R is a reliable screening instrument for measuring traumatic distress related to the global pandemic of COVID-19 and can be utilized to provide timely psychological health support when needed based on the screening results.Funding: None to declare. Declaration of Interest: None to declare. Ethical Approval: This study was approved by Taiz University Research Ethics Committee on 26March 2020 with reference number Taiz/RSCGS/2020/03/26/0236.

The 2021 WHO Catalogue of &lt;i&gt;Mycobacterium Tuberculosis&lt;/i&gt; Complex Mutations Associated with Drug Resistance: A New Global Standard for Molecular Diagnostics

Background: Molecular diagnostics are considered the most promising route to achieving rapid, universal drug susceptibility testing for Mycobacterium tuberculosis . There is currently no WHO endorsed catalogue of mutations to serve as a global standard for interpreting molecular information for drug resistance prediction. Methods: A candidate gene approach was used to identify mutations as associated with resistance, or consistent with susceptibility, for 13 WHO endorsed anti-tuberculosis drugs. 38,215 M. tuberculosis isolates with paired whole-genome sequencing and phenotypic drug susceptibility data were amassed from 41 countries. Mutations were graded according to their odds ratio and associated false discovery rate corrected p-value, and their positive predictive value for phenotypic resistance. A series of expert rules were applied for final confidence grading of each mutation. Findings: 15,667 associations were computed for 13,211 unique mutations linked to one or more drugs. 1,149/15,667 (7·3%) mutations were classified as associated with phenotypic resistance and 107/15,667 (0·7%) were deemed consistent with susceptibility. For rifampicin, isoniazid, ethambutol, fluoroquinolones, and streptomycin, the mutations’ pooled sensitivity was >80%. Specificity was over 95% for all drugs except ethionamide (91·4%), moxifloxacin (91·6%) and ethambutol (93·3%). Only two resistance mutations were classified for bedaquiline, delamanid, clofazimine, and linezolid as prevalence of phenotypic resistance was low for these drugs. Interpretation: This first WHO endorsed catalogue of molecular targets for M. tuberculosis drug susceptibility testing provides a global standard for resistance interpretation. It will be expanded as data emerge on phenotypically resistant isolates, including for new and repurposed drugs. Funding: UNITAID, Wellcome, MRC, BMGF. Declaration of Interest: C.U.K. is a consultant Becton Dickinson, the Foundation for Innovative New Diagnostics and the TB Alliance. C.U.K. is collaborating with PZA Innovation and Thermo Fisher Scientific. C.U.K. worked as a consultant for QuantuMDx, the Stop TB Partnership, the World Health Organization (WHO) Global TB Programme and the WHO Regional Office for Europe. C.U.K. gave a paid educational talk for Oxford Immunotec. Hain Lifescience covered C.U.K.’s and accommodation to present at a meeting. C.U.K. is an unpaid advisor to BioVersys and GenoScreen. E.R. is employed by Public Health England and holds an honorary contract with Imperial College London. I.F.L. is Director of the Scottish Mycobacteria Reference Laboratory. S.N. receives funding from German Center for Infection Research, Excellenz Cluster Precision Medicine in Chronic Inflammation, Leibniz Science Campus Evolutionary Medicine of the LUNG (EvoLUNG)tion EXC 2167. P.S. is a consultant at Genoscreen. T.R. is funded by NIH and DoD and receives salary support from the non-profit organization FIND. T.R. is a cofounder, board member and shareholder of Verus Diagnostics Inc, a company that was founded with the intent of developing diagnostic assays. Verus Diagnostics was not involved in any way with data collection, analysis or publication of the results. T.R. has not received any financial support from Verus Diagnostics. UCSD Conflict of Interest office has reviewed and approved T.R.’s role in Verus Diagnostics Inc. T.R. is a co-inventor of a provisional patent for a TB diagnostic assay (provisional patent #: 63/048.989). T.R. is a co-inventor on a patent associated with the processing of TB sequencing data (European Patent Application No. 14840432.0 & USSN 14/912,918). T.R. has agreed to “donate all present and future interest in and rights to royalties from this patent” to UCSD to ensure that he does not receive any financial benefits from this patent. S.S. is working and holding ESOPs at HaystackAnalytics Pvt. Ltd. (Product: Using whole genome sequencing for drug susceptibility testing for Mycobacterium tuberculosis). G.F.G. is listed as an inventor on patent applications for RBDdimer- based CoV vaccines. No other authors declare a conflict of interest. Ethical Approval: Approval for CRyPTIC study was obtained by Taiwan Centers for Disease Control IRB No. 106209, University of KwaZulu Natal Biomedical Research Ethics Committee (UKZN BREC) (reference BE022/13) and University of Liverpool Central University Research Ethics Committees (reference 2286), Institutional Research Ethics Committee (IREC) of The Foundation for Medical Research, Mumbai (Ref nos. FMR/IEC/TB/01a/2015 and FMR/IEC/TB/01b/2015), Institutional Review Board of P.D. Hinduja Hospital and Medical Research Centre, Mumbai (Ref no. 915-15-CR [MRC]), scientific committee of the Adolfo Lutz Institute (CTC-IAL 47-J / 2017) and in the Ethics Committee (CAAE: 81452517.1.0000.0059) and Ethics Committee review by Universidad Peruana Cayetano Heredia (Lima, Peru) and LSHTM (London, UK).

Level of Compassionate Health Care Service Provision and Its Associated Factors Among Health Professionals Working in Public Hospitals of Addis Ababa: Health Professional's Perspective

Background: Compassionate health care service is important for good clinical outcomes and patient satisfaction. However, complaints of non-compassionate care became very familiar and popular grievance of the community over the health care system. The aim of this study was to assess the level of compassionate health care service provision and its associated factors among health professionals working in public hospitals of Addis Ababa, Ethiopia. Methods: A facility based cross sectional study was conducted among six public hospitals of Addis Ababa, Ethiopia. Simple random sampling and systematic sampling methods were applied to select hospitals and each study participants respectively. Data were collected from 400 respondents using a self-administered structured questionnaire. The mean of compassionate health care was taken as the cut point to label respondent as good and poor compassionate health care service provider. Multivariate logistic regressions were done to determine the associated factors for compassionate care provision. Variables with p values <0.05 at the multivariable analysis were considered as significantly associated with compassionate care provision. Results: A total of 400 health professionals from 6 hospitals were participated in this study. Only 48.0% of health care professionals provided good compassionate care. Learn to be compassionate (AOR=5.083; CI 95% 2.69, 9.58); patient and their family realistic expectation (AOR= 2.24; CI 95% 1.07, 4.66) were found to be significantly associated with good compassionate health care provision. Conclusions and recommendations: Good compassionate health care service provision in Addis Ababa hospitals was very low. Teaching health science and medical students to be compassionate and ensuring health care clients to have realistic expectation is important to farther improve compassionate health care service provision. Funding Information: Debre-Berhan University covered the funding for this study. Declaration of Interests: The authors declare that they have no any competing interests to publication. Ethics Approval Statement: Ethical clearance was obtained from Collage of Health Science Debreberhan University research ethics committee in a letter Ref DBUMF05-009. Permission letter was obtained from the selected hospitals. Informed and written consent was obtained from each study participants.

Osteopathic Manual Treatment vs Kaltenborn-Evjenth Orthopedic Manual Therapy for Chronic Low Back Pain: A Proposal for a Protocol for Randomized Trials

Introduction: Numerous modalities of conservative therapeutic interventions are available to achieve the best health benefits in people with Low Back Pain (LBP), e.g., kinesiotherapy, physical therapy, behavior therapy. People with LBP continue to experience pain and disability despite receiving the best evidence based therapy. Osteopathic Manual Therapy (OMT) and Kaltenborn-Evjenth Ortopedic Manual Therapy (KEOMT) are the other options, although their effectiveness remains controversial. The aim of this study is a proposal for a protocol for randomized trials to compare the effectiveness of OMT vs. KEOMT on pain and disability in people suffering from LBP. Methods and analysis: It’s a randomized study with two-arms parallel, designed with concealed allocation, the assessor’s blinding with intention to-treat analysis. It will include 34 people a group with severe disability ranged from 41 to 60% in Oswestry Disability Index (ODI). There will be two groups: a treatment group (OMT) and a comparison group (KEOMT). All the patients in both groups will receive 2 treatments a week for 5 weeks. Each session in both groups will not exceed 30 minutes. During each session OMT and KEOMT techniques will be repeated 3 times. A baseline assessment will be performed pre and post intervention, two days later. The following parameters will be assessed during the evaluations: Numeric Pain Rating Scale – NPRS, ODI. Ethics and dissemination: The trial was approved by the Scientific Research Ethics Committee of University of Warmia and Mazury, Olsztyn, Poland. Registration approval number: 9/2018. Trial registration: The study protocol was prospectively registered in the Chinese Clinical Trial Registry on December 28, 2019 (registration ID: ChiCTR1900028580). Strengths and Limitations of this Study The participants’ random allocation to the experimental and the control groups. The same experienced physiotherapist, blind to the outcome measures, provides the interventions. The same assistant, blind to the group allocation, administrates the outcomes. The same number of the interventions, the compared contact time with the physiotherapist providing the interventions. A short follow-up period and/or a rather small sample size.

Prescribing laughter to ameliorate mental health, sleep, and wellbeing in university students: A protocol for a feasibility study of a randomised controlled trial

ObjectivesThis research is the first study to investigate the potential effects of a laughter prescription on both psychological health and objective sleep parameters in university students. The primary objective is to evaluate the feasibility of prescribing laughter to inform a larger randomised controlled trial. Secondary objectives are to assess if a two-week laughter prescription improves subjective and objective sleep outcomes, wellbeing, and/or psychological health outcomes. Trial designTo assess the feasibility of a randomised controlled trial for laughter prescription in relation to sleep, psychological health, and wellbeing. Forty university students will be recruited and randomised to one of two conditions (control/experimental). MethodsWrist actigraphy and sleep diaries will be used to estimate sleep outcomes during a one-week baseline testing phase and across the two-week intervention. The experimental group will be shown how to record a Laughie (a 1-min recording of their joyful laughter on their smartphone) and prescribed to laugh with it three times daily for 14 days (the control group will only track sleep). All participants will complete the WHO (Five) Well-being Index, and Hospital Anxiety and Depression Scale pre- and post-intervention. The CONSORT checklist, and the Feasibility, Reach-out, Acceptability, Maintenance, Efficacy, Implementation, and Tailorabilty (FRAME-IT) framework will guide intervention planning and evaluation. Participant interviews will be analysed using Differential Qualitative Analysis (DQA). ResultsThe feasibility of a two-week laughter prescription in university students and its impact on sleep, wellbeing, and/or psychological health outcomes will be assessed. ConclusionsZayed University Research Ethics Committee approved the study in July 2019. The research will be completed following protocol publication. Trial registrationClinicalTrials.gov. ID: NCT04171245. Date of registration: 18 October 2019.

Cardiopulmonary resuscitation training in secondary education: A prospective cross-sectional survey of 110 Hong Kong secondary schools

Background: Hong Kong rates of bystander cardiopulmonary resuscitation are very low by international standards. Several Hong Kong secondary schools have begun incorporating cardiopulmonary resuscitation training into their curriculums for teachers and students. Objective: This study aimed to explore secondary school cardiopulmonary resuscitation programs and better understand school principals’ attitudes toward cardiopulmonary resuscitation training. Methods: A cross-sectional survey was sent to all Hong Kong secondary school principals (public and private, except for special education schools) between December 2017 and March 2018. A self-administered questionnaire of 20 items focusing on school characteristics, details of any in-school cardiopulmonary resuscitation materials or training, attitudes toward teaching cardiopulmonary resuscitation, and any barriers or ways to promote school cardiopulmonary resuscitation training was given to all school principals in the territory. This study was approved by the Survey and Behavioural Research Ethics committee of the Chinese University of Hong Kong on September 13, 2017. Results: Out of the 506 schools contacted, 110 completed surveys were returned (21.7%). Cardiopulmonary resuscitation training was offered in 33.6% (37/110), while 92.7% (102/110) had an automatic external defibrillator. A majority (69.1% (76/110)) agreed or strongly agreed that cardiopulmonary resuscitation training should be compulsory for secondary school students. In schools where cardiopulmonary resuscitation was taught, most cardiopulmonary resuscitation students were aged 15–17 years, and most courses ran for &lt; 5 h. Increased funding could encourage more schools to offer cardiopulmonary resuscitation training to students in the future. Conclusion: One-third (33.6%) of Hong Kong secondary schools offer cardiopulmonary resuscitation training. Increased funding may support school-based cardiopulmonary resuscitation instruction and improve rates of bystander cardiopulmonary resuscitation in the future.