Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for a global pandemic with over 152 million cases and 3.19 million deaths reported by early May 2021. Understanding the serological response to SARS-CoV-2 is critical to determining the burden of infection and disease (coronavirus disease 2019 [COVID-19]) and transmission dynamics. We developed a capture IgM assay because it should have better sensitivity and specificity than the commonly used indirect assay. Here, we report the development and performance of a capture IgM enzyme-linked immunosorbent assay (ELISA) and a companion indirect IgG ELISA for the spike (S) and nucleocapsid (N) proteins and the receptor-binding domain (RBD) of S. We found that among the IgM ELISAs, the S ELISA was positive in 76% of 55 serum samples from SARS-CoV-2 PCR-positive patients, the RBD ELISA was positive in 55% of samples, and the N ELISA was positive in 15% of samples. The companion indirect IgG ELISAs were positive for S in 89% of the 55 serum samples, RBD in 78%, and N in 85%. While the specificities for IgM RBD, S, and N ELISAs and IgG S and RBD ELISAs were 97% to 100%, the specificity of the N IgG ELISA was lower (89%). RBD-specific IgM antibodies became undetectable by 3 to 6 months, and S IgM reached low levels at 6 months. The corresponding IgG S, RBD, and N antibodies persisted with some decreases in levels over this time period. These capture IgM ELISAs and the companion indirect IgG ELISAs should enhance serologic studies of SARS-CoV-2 infections.IMPORTANCE Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has inflicted tremendous loss of lives, overwhelmed health care systems, and disrupted all aspects of life worldwide since its emergence in Wuhan, China, in December 2019. Detecting current and past infection by PCR or serology is important to understanding and controlling SARS-CoV-2. With increasing prevalence of past infection or vaccination, IgG antibodies are less helpful in diagnosing a current infection. IgM antibodies indicate a more recent infection and can supplement PCR diagnosis. We report an alternative method, capture IgM, to detect serum IgM antibodies, which should be more sensitive and specific than most currently used methods. We describe this capture IgM assay and a companion indirect IgG assay for the SARS-CoV-2 spike (S), nucleocapsid (N), and receptor-binding domain (RBD) proteins. These assays can add value to diagnostic and serologic studies of coronavirus disease 2019 (COVID-19). Betacoronavirus genus and Coronaviridae family (–Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is member of the e family  that ince family , causes e family . SARS-Coe family –9.Critical to understanding SARS-CoV-2 infections and epidemiology is diagnosing acute and prior infection. Acute infection is most often detected with molecular detection of nucleic acid. Serologic studies for SARS-CoV-2 –13 antib–17–After optimizing assay conditions, we considered the value of including control antigen wells for each specimen in the IgM assay. We found considerable variations in the specimen-specific absorbance for control antigen (293F cell lysate), ranging from 0.18 to 1.2 absorbance units with all but one between 0.18 and 0.72 absorbance units. The P-N value (P is the absorbance against the test antigen and N is the absorbance against the control antigen) gave better separation between cases and controls with IgM and IgG enzyme-linked immunosorbent assays (ELISAs) . Consequ+ patients and 113 serum samples from control patients. The PCR+ patient serum samples were collected between 25 and 138 days post-symptom onset (PSO), with a mean of 54 days. The control serum samples were used to calculate cutoff values for the assays and to determine assay specificity. We considered specimens with P-N values greater than the mean plus 3 standard deviations of the P-N values of control specimens as positives. The cutoff P-N values for the IgM ELISAs were 0.101, 0.060, and 0.100 for S, RBD, and N, respectively. With these cutoffs, one control specimen was positive for S IgM and one was positive for RBD IgM, yielding a specificity of 112/113 (99%) for each; three specimens were positive for N IgM, giving a specificity of 110/113 (97%). Two of these three specimens were an acute-convalescent pair from a rhinovirus PCR+ patient with no significant change in P-N values between the paired specimens. Also, none of the IgM-positive specimens were IgG positive.We next determined the sensitivity and specificity of the three IgM and IgG assays  by testing their performance with 55 serum samples from PCR+ patients and one from an influenza A PCR+ patient). There were no significant differences in P-N values between these paired specimens. The other four serum specimens were from patients without detectable virus.Because previous studies have shown some persons who were never exposed to SARS-CoV-2 have IgG antibodies induced by other coronaviruses , we deciMoreover, the specificity of the different IgG ELISAs was 111/113 (98%), 113/113 (100%), and 101/113 (89%) for S, RBD, and N, respectively. Among the 55 serum samples from SARS-CoV-2 PCR-positive patients, 42 were positive for S IgM antibodies (sensitivity of 76%), 30 were positive for RBD IgM antibodies (sensitivity of 55%), and 8 were positive for N IgM antibodies (sensitivity of 15%). In comparison, we detected S IgG antibodies in 49 samples (sensitivity of 89%), RBD IgG antibodies in 43 samples (sensitivity of 78%), and N IgG antibodies in 47 samples (sensitivity of 85%)  and B. T+ patients, we observed a significant reduction in S- and RBD-specific IgM and N-specific IgG antibody levels with increasing time after symptom onset. In this analysis, our data show a rapid decline of RBD-specific IgM antibodies between 1 and 3 months, with many specimens reaching baseline levels at 3 months PSO (10 of 14 specimens became negative). The decline in S-specific IgM antibodies was slower, with many patients still having detectable antibody levels at 6 months (P = 0.02) , 17/23 (74%), and 6/23 (26%) of serum samples collected before 45 days PSO were positive, while 17/32 (53%), 13/32 (41%), and 3/32 (9%) of serum samples collected 45 or more days PSO were positive for S, RBD, and N IgM antibodies, respectively.A decrease in infection-induced SARS-CoV-2 serum antibody levels over time has been described previously –26. In o–6 months . The lev = 0.02) , 28. To In this study, we report an alternative antibody capture ELISA method for IgM antibodies in serum from COVID-19 patients. This IgM assay has proven reliable for a number of other infectious diseases, such as measles , Zika 3, dengue + patients (55) and the times at which these specimens were collected . The expected rapid decline in IgM antibodies, as illustrated in our data, results in a substantial decrease in the sensitivity of the IgM assay for the later collected specimens. Serum specimens collected earlier in the illness, including a larger set of serial specimens, would have provided a better indication of the sensitivity of the IgM ELISA.A limitation of these estimates of sensitivity and specificity is the number of serum specimens from PCRIn addition to the theoretical added sensitivity and specificity of the capture IgM, using a His tag on the protein to detect its capture by IgM antibodies makes it relatively easy to adapt this format to other antigens by replacing one His tag-labeled protein with another and optimizing conditions for this antigen. Note that since we did not compare this capture IgM ELISA to comparable indirect IgM ELISAs, we do not know if this theoretical advantage applies to this capture ELISA for COVID-19 IgM antibodies. Some disadvantages of the capture IgM ELISA include its greater complexity, the additional steps needed to run the assay, and the difficulty in adapting it to rapid testing.n = 14), our study did reveal features of IgM and IgG antibody kinetics consistent with other reports. The RBD- and S-specific IgM antibodies declined rapidly over time after symptom onset, with RBD-specific IgM antibodies at baseline at 8 to 10 weeks PSO (data not shown), and S-specific IgM antibodies were at low levels but still detectable at 6 months PSO  were collected from an acute and convalescent study of outpatients and inpatients with suspected SARS-CoV-2 infection identified between 17 April 2020 and 30 November 2020. Signed patient informed consent was obtained under an institutional review board (IRB)-approved protocol.Serum samples from 81 patients , respiratory syncytial virus (RSV), rhinovirus, human parainfluenza virus 1 to 4, human metapneumovirus (HMPV), or influenza virus A or B virus. The other 33 serum samples were acute-phase specimens from patients without PCR evidence of a respiratory virus infection.We also evaluated 113 serum specimens collected from 73 patients participating in a different IRB-approved study of adults hospitalized with an acute lower respiratory tract illness in 2018 and 2019 prior to the SARS-CoV-2 pandemic. These included 40 acute- and convalescent-phase serum pairs from patients that were BioFire-determined PCRRecombinant SARS-CoV-2 full-length spike and receptor-binding domain (RBD) proteins were produced as described elsewhere , 37. Proo-phenylenediamine dihydrochloride (OPD) substrate . The reaction was stopped by addition of 4 N H2SO4, and the absorbance was read at 490 nm using a Synergy H1 plate reader .All steps in the ELISA were performed at room temperature (RT). The wash solution, unless otherwise stated, was PBS + 0.05% Tween 20. The capture antibody, 2.5 μg/ml of mouse anti-human IgM antibody  diluted in PBS , was immobilized on a 96-well microtiter plate  overnight at 4°C. The plate was then washed twice with PBS, and blocking buffer  was added and incubated for 2 h. The plate was then washed twice, and serum specimens diluted 1:200 in dilution buffer (blocking buffer with 0.15% Tween 20) (BB-T) were added to the plate and incubated for 2 h. The plate was washed 5 times, and SARS-CoV-2 antigen  was added to the plate at 1 μg/ml in BB-T and incubated for 2 h. The plate was washed 5 times and incubated with Biotin-conjugated mouse anti-His antibody (0.5 μg/ml in BB-T) (SouthernBiotech) for 1.5 h. The plate was washed 5 times and incubated with horseradish peroxidase (HRP)-conjugated streptavidin at 100 ng/ml  diluted in BB-T and incubated for 1 h. The plate was washed 5 times, and color was developed with 2SO4, and absorbance was read at 490 nm.All steps in the ELISA were performed at RT. The wash solution, unless otherwise stated, was phosphate-buffered saline (PBS) + 0.05% Tween 20. Antigen  was diluted in PBS at 0.5 μg/ml (100 μl) and was coated in a 96-well microtiter plate overnight at 4°C. The plate was then washed twice with PBS, and blocking buffer was added and incubated for 2 h. The plate was then washed twice with washing buffer. Serum samples were diluted 1:200 with BB-T and incubated for 1 h 50 min at RT. The plate was then washed 5 times, and HRP-conjugated goat anti-human antibody diluted 1:5,000 in BB-T  was added and incubated for 1 h. Plates were washed 5 times, and the reaction was developed by OPD for 30 min. The reaction was stopped by addition of 4 N Ht test were used. P values of <0.05 were considered statistically significant.Analyses were calculated using Prism software (version 9.0). A Wilcoxon signed-rank test and Student’s


Background: Primary healthcare (PHC) in South Africa often experiences crucial challenges that lead to patients’ negative experiences regarding their care, compromising the significant role that PHC services could play in health promotion and disease prevention. The primary purpose of implementing the Ideal Clinic (IC) in South Africa was to improve patients’ care quality at the clinics. There seems to be a paucity of studies determining professional nurses’ experiences when implementing the IC. Purpose: This study aimed to explore and describe professional nurses’ experiences regarding implementing the IC at three selected clinics in the Makhado local area. Study method: A qualitative phenomenological research design was used to explore professional nurses’ experiences regarding IC implementation. Purposive sampling was used to select 15 professional nurses working at the three selected clinics. Data were collected using semi-structured one-on-one interviews. Interviews were conducted until saturation was reached. Trustworthiness was ensured by applying Lincoln and Guba’s four criteria, i.e., credibility, transferability, dependability, and confirmability. Ethical clearance was obtained from the University of Limpopo Turfloop Research and Ethics Committee, and permission to conduct the study was obtained from Limpopo Province Department of Health Research and Ethics Committee. Thematic analysis was used to analyze data. Results: The following themes emerged from the study findings: perceived benefits of the IC on the primary healthcare services provided to the community, challenges experienced by professional nurses when implementing the IC program, and challenges related to the supply of resources for implementing the IC. The study results revealed that, although the IC aimed to improve the overburdened PHC facilities in SA, the professional nurses still experienced some challenges when implementing the IC program. Some of the challenges faced were a lack of knowledge and training in the IC program, poor infrastructure and the shortage of equipment, and inadequate provision of support by line managers, all of which resulted in poor-quality patient care. Conclusion: This study revealed that the introduction and implementation of the IC can have potential benefits to the community and the primary healthcare system. However, it was not introduced and appropriately implemented, which resulted in professional nurses experiencing several challenges. The national department of health needs to strengthen the program’s implementation through proper training, consultation, and continuous support of the nurses. Provision of quality equipment and supplies is also recommended. According to the 2018 global joint report by the World Health Organization (WHO), Organization for Economic Cooperation and Development (OECD), and World Bank Group, globally, poor-quality health services are holding back progress on improving health in countries at all income levels . AdditioDifferent scholars have emphasized the importance of research in implementing policies in the health sector, more importantly, in African middle- and low-income countries with high inequality in healthcare services due to poverty and lack of resources ,8,9. TheIn South Africa (SA), the IC program was initiated in July 2013 to improve the quality of PHC facilities. The IC has work streams with different building blocks capable of rendering excellent health services. The workstreams include how the institutional structure is arranged regarding the waiting period for patients, appointment dates, availability of human resource materials and supplies, and financial and administrative management . More imAdditionally, the IC was designed to prevent a lack of quality patient care in PHC services. According to Fryatt and Hunter, South Africans are using clinics in increasing numbers, rising from 67 million in 1998 to 128 million in 2013 . SeveralThe IC target provides a community-based, comprehensive range of integrated diagnostic, acute, preventative, rehabilitative, and chronic services . The IC Meanwhile, the IC initiative was initiated to satisfy SA communities’ needs . AlthougThis study adopted a qualitative phenomenological design to explore and gain more understanding through a personal and participant expression of the lived experience of professional nurses regarding the implementation of the IC program. Through phenomenological design, the professional nurses working in the selected clinics were able to express their experiences about implementing the IC as subjectively lived. Moreover, this enabled the researchers to discover the new meanings and appreciations that can be developed to inform or reorient the IC implementation ,17.The study was conducted at three selected PHC facilities of Makhado Local Municipality. Makhado Local Municipality is located in Vhembe District, Limpopo Province. It is one of four municipalities in the district, comprising almost one-third of its geographical area. The Makhado Local Municipality is a predominately rural area with more than 200 villages and PHC facilities. Primary healthcare facility A delivers services to 4500 community members from 11 local villages monthly with 11 professional nurses who implement the IC. Primary healthcare facility B provides services to an average of 3500 community members from seven villages with 17 professional nurses. In comparison, clinic C delivers services to 2500 community members from nine villages with six professional nurses.The population consisted of 34 professional nurses working in the three selected primary healthcare facilities in Makhado Local Municipality. A total purposive sampling strategy was used to determine professional nurses implementing the IC program on the basis of their knowledge and experience . The samData were collected at the three selected PHC facilities through semi-structured open-ended one-on-one interviews. According to Jacobs and Furgerson, an open-ended inquiry exposes the human part of a story about participants’ experiences . The parAs described by Vaismoradi, Turunen, and Bondas, a thematic descriptive approach was applied to analyze data by examining descriptions of lived experiences . The priTrustworthiness was ensured by adhering to Guba’s four criteria: credibility, dependability, confirmability, and transferability. We ensured credibility by recording all the interview sessions and capturing the field notes as proof of the participants’ data collection. Transferability was ensured by the detailed description of the research methodology. Dependability was ensured by keeping safe all the voice recordings and field notes. To ensure confirmability, the researchers submitted the verbatim transcripts to the independent coder, and a meeting was set to discuss the themes and subthemes, which were reached independently .The findings are presented in themes and subthemes see , supportProfessional nurses perceived the IC as a program that benefits and improves the standard of the primary healthcare service. The benefits include, firstly, improved access to PHC services to the community members through facility reorganization. Facility reorganization is when the PHC facility is reorganized to eliminate congestion in the facility . AdditioProfessional nurses reported that, despite the benefits experienced, there were challenges during the IC implementation. These challenges were explained according to subthemes. Firstly, professional nurses expressed concerns regarding the maintenance of equipment for the effective implementation of the IC program. The maintenance of equipment, as well as the replacement of broken furniture and machinery, affected the implementation of the IC program. Secondly, professional nurses expressed concerns regarding an IC program that was implemented abruptly. Professional nurses implementing the IC program need to be trained and tested on their knowledge regarding the program’s content. Training should be done through long- and short-term courses on the implementation of an IC program, thus indicating the significance of the in-service training that could be conducted at PHC facilities to orientate all professional nurses . Lastly,Participants expressed concern with the provision of essential drugs and other resources to implement the IC. Two subthemes emerged. Firstly, professional nurses pledged that patients’ actual help would be their priority; however, with an inadequate supply of essential drugs during emergency care services, this became a dream. With the IC program, priority became the infrastructure, administration, and clinic cleanliness, causing further challenges with the supply of drugs. Secondly, there was a lack of provision of human and other resources to implement the IC program. When the IC program was introduced, there were some guidelines and specifications on how it should be implemented; however, participants reported that the resources for implementation were not provided.Despite the global commitment to strengthen the PHC systems as an essential step toward achieving universal health coverage, the actual implementation has not exceeded expectations . This stThis study revealed the good experiences of professional nurses regarding the implementation of the IC program as one of the programs which brought changes and benefits to the PHC system. These benefits included the reorganization of PHC facilities and integration of services, wherein the patients are managed in the same centralization of care. Additionally, with the IC program, the facilities were reorganized from the clinic entrance, whereby there is signage to guide the patients to the designated waiting area, and all the consulting rooms are labeled. These results concur with the literature IC program manual, which specifies that the facility must be reorganized with a designated consulting area and staffing for acute, chronic health conditions and preventative health services . The manProfessional nurses’ experiences revealed changes brought by the implementation of the IC program, such as changes in the booking system for all patients with chronic diseases and those seeking preventative services, as well as a reduction in workload. Professional nurses expressed that the booking system changes helped reduce the workload in the facility because patients came per appointment. In support of the results, the IC manual outlined that the booking system should operate as a function of date and time for patients to come and collect their treatment . The facThe study findings revealed that professional nurses experienced challenges regarding implementing the IC program since the program requires early identification, reporting, and recording of broken equipment. Professional nurses expressed concerns regarding delays in reporting broken equipment and machines, as well as the long period taken to have them fixed. This finding concurs with the study by Kredo, Cooper, Abrams, et al., conducted in four provinces in South Africa, which suggested an urgent need for the National Department of Health (NDoH) to prioritize the existing challenges in the healthcare system in accessing and using medical supplies, which impacted adherence to guidelines . SteinhoProfessional nurses expressed concerns regarding an IC program that was implemented abruptly with unclear descriptions of professional nurses’ roles . The parIn line with the existing study by Kredo, Cooper, Abrams, et al., a lack of professional nurses’ involvement (who are the end-users in implementing the IC program) was revealed, which resulted in a lack of interest and negative attitude and behavior . DiffereChallenges related to the availability of treatment and resources were reported as barriers to effectively implementing the IC clinic. Such challenges were inadequate supply of essential drugs during emergency care services, shortage of stationery, and staff shortage. The program has different streams, whereby, in each consulting room, there should be a professional nurse. This was one of the participants’ significant concerns as there was inadequate staffing to achieve this. This finding concurs with Muthathi, Laetitia, and Rispel’s study that revealed a shortage of human resources and equipment as a major challenge. It is recommended for the Department of Health, SA, to provide healthcare workers and adequate resources in the PHC facilities to properly implement the IC program .The IC program in SA was introduced into PHC facilities as part of the preparation for the implementation of National Health Insurance (NHI). The NHI aims to ensure that universal healthcare for all in South Africa is provided. On the other hand, the IC program aims to improve the quality of patient care.The current study suggests that the implementation of the IC program remains a challenge in the PHC facilities; thus, the provision of quality patient care cannot be achieved. The study recommends that, to improve the identified gaps in the implementation of the IC program, the National Department of Health (NDoH) in SA should consult with the end-users before and during the implementation to improve the quality of patient care. It is worth mentioning that professional nurses can effectively implement the IC program if they are well trained, continually supported, and provided with adequate staff, supplies, and quality equipment.This study was conducted at only three PHC facilities in the Makhado Local Area of the Vhembe District. Therefore, the results of the study cannot be generalized to other local areas. The IC program is still new and has only been implemented in South Africa and Malaysia; therefore, data from international and African studies are limited.According to the study results and the description of how the IC should be implemented, “the IC is a clinic with good infrastructure, adequate staff, adequate medicine and supplies, good administrative processes, and sufficient bulk supplies, which uses applicable clinical policies, protocols, guidelines, and partner and stakeholder support to ensure the provision of quality health services to the community” . The stu


Medical training program and hospital response to the COVID-19 pandemic has varied greatly and has impacted trainee well-being. Which factors have specifically related to trainee wellness, however, has not yet been examined in depth. The aim of the study was to understand trainee perspectives on the individual psychiatry trainee programs’ hospitals’ objective COVID-19 preparedness management. We also sought and to gauge how program changes, and general pandemic-related concerns, have been associated with trainee satisfaction and burnout.A cross-sectional survey study of psychiatric trainees was distributed electronically throughout the country via various psychiatry residency program listservs in April 2020. Statistical analyses were performed utilizing simple linear regression.From 352 respondents , the most frequent program changes were “decreased number of rotations requiring in-person patient care” and “increased call hours or duties.” Of pandemic-related concerns surveyed, the two greatest were “spreading COVID-19 to family/friends” and “co-residents’ burnout and anxiety.” A positive relationship was found between trainee satisfaction with perceived COVID-19 departmental response and comfort level of residents/fellows in expressing concerns with attending clinicians and department leadership.Since the start of the COVID-19 pandemic, trainees have experienced a variety of changes to trainee program policies and guidelines. Overall, poor communication and trainee dissatisfaction with departmental response correlated with concern of infection and anxiety/burnout. Insights garnered from this study could provide scaffolding for the best practices to reduce trainee physician anxiety/burnout for the current and future pandemics of this variety and magnitude.The online version contains supplementary material available at 10.1186/s12909-022-03286-x. The global spread of SARS-CoV-2 (the virus causing COVID-19) has resulted in significant morbidity and mortality, requiring hospital systems around the world to quickly and frequently implement changes in preparation and management of disease proliferation . Among hDespite rapidly evolving changes in response to the pandemic, little attention has been paid to how psychiatric practice, training programs, and trainees have been impacted. The delay in investigation is particularly impermissible considering that lower physician satisfaction has consistently been found to lead to poorer quality of care, as well as an increase in safety incidents . In prev”7. Concerns and fears varied, including contracting the illness, PPE shortages, the ability to adhere to rapidly changing guidelines, and feeling as though trainees are not being prioritized regarding receiving PPE7. Furthermore, the perceived pressure to avoid relinquishing duty and placing burden on colleagues has been exacerbated  clinical care and we have been excluded from many important clinical communications.” Others were concerned about the timeliness of response, stating “The slow response of my department has been extremely disheartening and made me question very heavily if I will be staying with this department upon residency completion.” In the most extreme examples, psychiatric care was no longer prioritized due to redeployment to other healthcare services, for example “I have been also deployed to Medicine Floors which have [sic] severely impacted my ability to do patient care with my outpatient psychiatry patients.”Subjectively mixed responses to question 16 included themes of discordance between how different authorities were addressing their concerns. For example, “While I’m very satisfied with my program director’s individual response, our department leaders have hand [sic] difficulty taking unified, swift action.” Others noted positive changes over time, “I was initially not very satisfied with the response. However, we have a very vocal group of residents and are lucky to have a department willing to take our feedback.”As the COVID-19 pandemic endures, so must clinicians. Given the established relationship with frequency of patient contact during pandemics with secondary post-traumatic stress and other psychological distress, trainees are particularly vulnerable . The finProgram responses varied across respondents. However, the most frequent perceived changes were decreased rotations requiring in-person patient care and extended call hours or duties. This could suggest efforts to reduce contact redundancy , a shift of resident specialty responsibilities during the pandemic, or contrasting approaches. It is unclear from this study whether program changes have impacted resident training, which must be weighed against trainee safety and public health interests. However, with the growing presence and proven efficacy of virtual-based psychiatric care –32, it aTrainees expressed concern across all domains questioned. Notably the most extreme levels of concern (“extremely” and “moderately” concerned) were dominated by concern for others, with fear of co-resident burnout, spreading COVID-19 to loved ones, and transmission to patients being the most frequently reported. This again lends credence to previous claims on the importance of providing necessary materials (PPE) and proper education on how to best reduce transmission , 12. FurAmong the relationships examined, trainee burnout negatively correlated with level of comfort communicating concerns to leadership and overall level of satisfaction with program response. Additional studies have noted similar findings in other specialty training programs. This suggests that similar principles may be applicable across medical training , 35. SimThe method of distribution in electronically distributing surveys to both program coordinators and directors for them to forward to their trainees was felt to be the best means to widely distribute the survey in a responsible way. However, to assure anonymity and further protect the respondent, we did not request trainees to report to which training program they belong. Thus, there is no way of knowing how many trainees received the survey, and no response rate can be calculated. Other limitations include inability of respondents to identify their region from the available choices, as they were not provided with AADPRT region definitions. While great efforts were made to promote anonymity and comfort, the inherent nature of a study requesting feedback on one’s employer entails a social desirability bias. Specific program/institution names were not requested to ensure the security of the respondents. Therefore, in addition to the known national limitations in testing and differences in testing policies, survey data collected cannot be accurately correlated to local disease prevalence , 37. SomOur study found a significant positive relationship between trainee comfort communicating with the program leadership and trainee satisfaction with program response. We also found a negative correlation between resident perceived risk of infection or burnout with satisfaction of department response and comfort communicating with the department. These findings highlight not only the importance of mitigating concerns of trainees through institutional modifications and good communication, but also the importance of an individualized approach with trainee concerns.Additional file 1.


The objective was to evaluate the accuracy of a single determination of IgM antibodies for hepatitis E virus (HEV) diagnosis in patients with acute hepatitis. A prospective study included patients with suspicion of HEV infection, defined as individuals with acute hepatitis showing negative results for serological and molecular markers of other hepatitis viruses. All patients were evaluated for hepatitis E virus infection, including both IgM antibodies and viral RNA determinations. Hepatitis E virus infection was defined as positivity for any of these markers. A total of 182 patients were included in the study, of whom 68 (37.4%) were diagnosed with HEV infection. Of these, 29 (42.6%) were positive for both IgM and HEV RNA, 25 (36.8%) were positive only for IgM antibodies, and 14 (20.6%) were positive only for HEV RNA. Considering only those individuals who were positive for IgM antibodies, 54 of the 68 total cases (79.4%) could be identified, showing a percentage of false-negative individuals of 20.6%. The diagnostic algorithm of hepatitis E virus infection in patients with acute hepatitis should include the determination of both IgM antibodies and HEV RNA because single sampling for IgM antibody determination led to an important proportion of misdiagnosed cases.IMPORTANCE In immunocompetent patients with a suspicion of hepatitis E virus (HEV) infection, single IgM antibody testing is typically applied. In this prospective study, we aimed to evaluate the accuracy of three different HEV screening approaches in patients with acute hepatitis, including approaches based on IgM determination, HEV RNA detection, and the combination of both. Our study shows that any diagnostic algorithm for HEV infection in patients with acute hepatitis should be based on the determination of both markers (IgM antibodies and HEV RNA) because single sampling for IgM antibodies results in an unacceptable number of false-negative results (20%). According to our results, the determination of HEV RNA should not be limited to immunosuppressed individuals because a high proportion of cases could be misdiagnosed. Hepatitis E virus (HEV) is recognized as a major cause of acute hepatitis in Europe and worldwide , 2. Durin = 46; 67.6%), and the median age was 47 years . The baseline characteristics of patients are shown in + cell counts of >200 cells/ml.During the study period, 182 patients with suspected HEV infection were included in the study. Of them, 94 (51.6%) were male, and the median age was 49 years . A total of 68  patients were diagnosed with HEV infection. Of them, the majority were male (MN628559), another classified as genotype 3m (GenBank accession number MT250083), and two cases in which a subtype could not be assigned (GenBank accession numbers MT776550 and MT250081).Forty-three (63.2%) patients showed detectable HEV loads, and their strains were sequenced. All strains were consistent with genotype 3, and most of them were classified as genotype 3f (90.6%). Only four sequences were consistent with other subtypes, including one classified as genotype 3e  were positive for IgM. Of them, 29 (42.6%) were positive for both IgM and HEV RNA, and 25 (36.8%) were positive only for IgM. Finally, 14 (20.6%) patients with detectable HEV RNA exhibited negativity for IgM antibodies. The accuracy of hepatitis E virus diagnosis based on the single consideration of IgM antibodies or HEV RNA at the same time point is shown in Regarding IgG antibodies, 38 out 54 (70.3%) patients with positivity for IgM antibodies also exhibited positivity for IgG antibodies. None of the patients with detectable HEV RNA were positive for IgG antibodies.The European Centers for Disease Control (ECDC) considers the determination of HEV RNA in acute cases optional because PCR testing might not be available in all laboratories and settings . Thus, iThe sensitivity and accuracy of a screening approach based on single sampling for IgM antibody determination will depend on the assay employed . In our Our study presents several limitations. First, only patients with acute hepatitis were included. HEV infection can result in extrahepatic manifestations, even in the absence of liver damage . ConsequIn conclusion, our study provides evidence that in the diagnostic algorithm of HEV infection in patients with acute hepatitis, the determination of both IgM antibodies and HEV RNA is necessary. The single use of one of these markers could lead to an important proportion of misdiagnosed cases.A prospective study was conducted in 6 reference hospitals in Andalusia (South Spain) between February 2016 and November 2020, including patients with suspicion of HEV infection. These patients were diagnosed with acute hepatitis and were negative for other hepatitis viruses, including serological and molecular markers for hepatitis A virus (IgM antibodies), hepatitis B virus , hepatitis C virus , cytomegalovirus (IgM antibodies), and Epstein-Barr virus (IgM antibodies).https://www.rivm.nl/mpf/typingtool/hev/) and confirmed by BLAST analysis  with an automated procedure , and positivity was confirmed by immunoblotting . Additionally, in all patients, IgG antibodies were determined using the specific Wantai kit , also confirming positive results by immunoblotting. For HEV molecular analysis, RNA was extracted from 400 μl of serum using the QIAamp Mini Elute virus spin kit  by an automated procedure . The purified RNA was eluted in a 50-μl volume. For reverse transcription-quantitative PCR (RT-qPCR), the Qiagen one-step PCR kit  was used for 25 μl of the template (50-μl reaction volume) following a pangenotypic in-house protocol targeting the open reading frame 3 (ORF3) region developed and validated by our group, with the detection limit set at 21 IU/ml . Samplesanalysis .Hepatitis E virus infection was considered positive in an individual exhibiting positivity for IgM antibodies and/or detectable HEV RNA according to the definitions of clinical guidelines , 3. The This study was designed and conducted in accordance with the Declaration of Helsinki. The Ethics and Clinical Trials Committee (CEIC) of Andalusia approved the study protocol, obtaining informed consent from each patient (reference number 4535). The SSPA Biobank coordinated the collection, processing, handling, and assignment of the biological samples used in this study according to standard procedures established for this purpose (agreement number S2100110).MN628557 to MN628567, MT250081, MT250082, MT250083, MN537838, MN914126, MN914127, MT776550 to MT776554, MT854329, and MW143072).All data generated or analyzed during the study are included in the article. The data sets used and/or analyzed during the present research project are available from the corresponding author upon reasonable request. All sequences were submitted to GenBank (accession numbers


Using patient audio recordings of medical visits to provide clinicians with feedback on their attention to patient life context in care planning can improve health care delivery and outcomes, and reduce costs. However, such an initiative can raise concerns across stakeholders about surveillance, intrusiveness and merit. This study examined the perspectives of patients, physicians and other clinical staff, and facility leaders over 3 years at six sites during the implementation of a patient-collected audio quality improvement program designed to improve patient-centered care in a non-threatening manner and with minimal effort required of patients and clinicians.Patients were invited during the first and third year to complete exit surveys when they returned their audio recorders following visits, and clinicians to complete surveys annually. Clinicians were invited to participate in focus groups in the first and third years. Facility leaders were interviewed individually during the last 6 months of the study.p = .008), more likely to agree that leadership supports continuous improvement of patient care and gives feedback on outcomes (p = .02), and at a time that is convenient (p = .04). Patients who volunteered sometimes expressed concerns they were “spying” on their doctors, but most saw it as an opportunity to improve care. Leaders were supportive of the program but not yet prepared to commit to funding it exclusively with facility resources.There were a total of 12 focus groups with 89 participants, and 30 leadership interviews. Two hundred fourteen clinicians and 800 patients completed surveys. In a qualitative analysis of focus group data employing NVivo, clinicians initially expressed concerns that the program could be disruptive and/or burdensome, but these diminished with program exposure and were substantially replaced by an appreciation for the value of low stakes constructive feedback. They were also significantly more confident in the value of the intervention in the final year (A patient-collected audio program can be implemented when it is perceived as safe, not disruptive or burdensome, and as contributing to better health care.The online version contains supplementary material available at 10.1186/s12913-021-06921-3. Measures of health care provider performance generally rely on information collected from the electronic medical record, claims data, and from patient surveys . These qContextual errors are common , adverseOnce collected, the recordings are 4C coded to generate de-identified examples of both contextualized care and contextual error, which are then shared by a peer – designated as a clinical champion -- with all participating clinicians at standing meetings for the purpose of helping them improve their care, a process known as “audit & feedback.”  RecentlyIn this report we present findings of the study’s investigation of the implementation process. The program successfully reached 666 clinicians, with patients recording 4496 visits, and proved effective , 13. TheThe two sites at which the QI program was first introduced had previously participated in a multi-year study of the methodology . Hence tIn light of the benefits of a patient-collected audio program for improving care and even health care outcomes, there is value in understanding stakeholder perspectives on such an intrusive approach to data collection. Prior studies on the implementation of audio recording at the point of care are predominantly of programs for providing recordings for patients rather that for quality improvement teams . At leasBased on these studies, along with lessons-learned during the initial research phase when the program was first developed, the Contextualizing Care Program (CCP), as it is named, was designed around three principles applicable to clinicians, patients, and the facility leadership who control resources : first tHence, each component of the program was designed around these three principles. For example, to optimize security, data are collected on encrypted devices and uploaded to a server accessible only to the coding team and that meets VA standards for the storage of protected health information. To minimize disruption, clinicians simply provide usual care, with no role in the audio recording process, and aggregate feedback occurs during standing meetings. To demonstrate value, feedback incorporates a range of practical examples from audio recordings illustrating the direct link from the physician’s attention to patient life context to patient health care outcomes extracted from the medical record of patients at 4–6 months post recorded and coded encounter. In addition, physicians receive Maintenance of Certification (MOC) credit from the American Board of Internal Medicine for participation, another tangible value. These three principles for the adoption of a patient-collected audio-recording program are further detailed in an earlier publication . Here weWe utilized mixed methods to gather data for a deductive thematic analysis of stakeholder perceptions of the safety, level of disruption or burden, and value of the patient-collected audio program. Data collection consisted of surveys, focus groups, and structured interviews. In addition, we conducted an inductive thematic analysis of unstructured data collected in the focus groups, the open response components of the survey and the leadership interviews. Subjects consisted of three groups: (a) patients recording their visits, (b) clinicians and other staff whose patient interactions were recorded, and (c) employees with leadership responsibility either within the participating clinics or at the organizational level. This study was approved by the VA Central Institutional Review Board.The setting consisted of six hospital based ambulatory care clinics within the Department of Veterans Affairs, the United States’ largest integrated healthcare system. Patients were invited to complete a brief anonymous exit survey when they returned their audio-recorder, administered in the third quarter of the first year and the second quarter of the third year. They were asked to respond to three questions -- pertaining to safety, level of disruption or burden, and value -- using a Likert scale: “I felt comfortable recording my visit with my primary care doctor,” “Participation in this project was not disruptive to my interactions today with VA staff,” and “The potential benefits of this project are clear to me.” They were also asked to document anything they liked and disliked about participating and to share any additional comments.Clinicians were invited to complete an anonymous survey annually, in the third quarter, and to participate in a focus group in the third quarter of the first and third years, the latter to include clinical pharmacists, nurses, and medical assistants who were also occasionally recorded. The survey, which was distributed both in paper form at standing meetings and online via email, included the Organizational Readiness to Change Assessment (ORCA) items, followed by three items with Likert scales assessing perceived safety, level of disruption or burden, and value of participation, and a fourth item measuring self-efficacy  from the study team trained the clinical champion by phone on how to facilitate the session. They reviewed a guide designed for the study that included an opening script, the use of grounded prompts designed to draw out participants’ responses on various topics, and specific questions to elicit participant perspective on the principles of safety, disruption or burden, and perceived value of the program  who led the focus group training and provided supervision. They were planned as 20–30-min semi-structured phone interviews for which an interview guide was prepared, including an opening script , clinicians (survey and focus groups), patients (surveys), and facility leaders (structured interviews).Veterans and clinicians endorsed the safety of the program. Veteran responses to the safety item “I feel comfortable recording my visit with my doctor” appear in the top panel of Fig. Clinician responses to the safety items are shown in the top panel of Fig. In the clinician focus groups, a number of participants reported feeling initial concern about being audio recorded that resolved once they came to see first-hand how the data were utilized. One participant characteristically said, in the first round of interviews, “I think, initially, I was nervous, thinking, ‘Oh, my gosh. What are they going to be doing?’ and everything.” Another expressed a common concern that they “were being graded,” and could be judged if things they said were taken out of context: “I think the hardest part was how honest could I be in a conversation. I had already built up a rapport with most of these patients to be able to talk very frankly with them, and the recorder made it seem like I have to watch what I say.” In the second round of focus groups, comments such as this one were more typical: “I think that I forget that people have recorders. When I’m speaking with patients, it’s usually, I think, how I would normally talk to patients. I don’t think it really changed how I interact, I guess, with patients,” and “I don’t think I’m aware of it until on rare occasion I have a patient bring it up and say, “Oh, I was asked to wear this recorder. Once that happens, I am a little aware of it for a few minutes, but there’s just so much to do and so much to cover that it just quickly goes out of my brain.”Some providers also expressed concerns about whether patients might be uncomfortable participating even if they volunteered to do so. One put it this way: “The patients don’t fully understand it sometimes, and they feel sometimes -- they feel on the defensive. They feel like the government is recording on their doctor who they like. I think that’s the biggest fear from the patients is they don’t understand it’s voluntary and it’s not punitive, and it’s all for performance improvement.” Others, in contrast, saw the program as an opportunity for patients to feel like they were helping to improve care: “I did have a couple patients who told me they were recording, and they actually seemed to think it was kind of neat. The way that they talked about it was, like, they felt they were in on helping the VA, and they were contributing.”Leaders, including supervisors and managers, were aware of distrust among some participants, especially early on, who suspected that the program was evaluating them in some way even though they had been told it was not. As one interviewee put it, “I think some of the hesitancy, sometimes by staff, and reluctance, especially in the beginning, was that you’re being recorded … And even though this is not supposed to be punitive, there’s always that concern and kind of defense that goes up that this is gonna be used against you in some way.” One perceived that the distrust was greater among nurses: “I hear no concerns from the physicians. I have heard concerns from nursing staff … They don’t come out and say it directly … I think they -- I think they’re afraid it might be used against them, and could be used in a disciplinary matter.” Another, however, commented that it waned with exposure: “I think once the staff [nurses] started getting those results and they can see that there’s nothing in there that’s personalized or anything like that, it’s very objective, very generalized and everything, … , the way it was presented was really for educational purposes. I think they were feeling more comfortable in doing it.”Veterans and clinicians also endorsed the lack of disruption involved in participation .Overall, 12% of clinicians felt the program could be disruptive, but with the number diminishing over time: The percentage who agreed with the statement that “Feedback reports on my performance were provided at a time that is convenient for me” increased from 2017 to 2019, the only change that was significant . They also rated senior leadership and clinical management more highly in 2019 compared to 2017 for overall commitment to quality improvement, based on their responses to 5 ORCA context items, including “provide effective management for continuous improvement of patient care,” and “provide staff members with feedback/data on effects of clinical decisions” (p = .02).Surveyed clinicians agreed that they were confident in their ability to contextualize care in each year Fig. . CliniciI think we’ve been participants in the program long enough and getting feedback about it that it’s become habituated in our practices. That being said, if there were no more reminders of this program, would behaviors extinguish over time without that nurturing and cultivation? I don’t know. I think it’s possible. But for now, I think it’s been so long that it’s built into my practice much like learning any other clinical skill. Once you do it enough over time, it becomes pretty routine for you.Focus group participants commented on whether the program should continue. A common theme was that if the program were discontinued, its benefits could wane. One participant commented that “I have developed the habit [of contextualizing care] already, and that’s a good thing, but reminders help to keep that happening, and not slipping back into bad habits, old habits.” Another participant felt the program might have lasting benefits even if ended:Similarly, leaders often articulated that they thought the benefits of the program would be lost if it were not sustained. One interviewee said, “What is monitored tends to get improved. And then once you stop monitoring and you stop observing a practice, it tends to regress back to the mean. So, I do think there would be some value to continuing the project definitely.” Another suggested it should be required, suggesting that they could “make it sort of a condition of employment that you’ll participate and get this feedback as part of helping you professionally develop.”Nevertheless, despite an appreciation for the value of the program, few felt they could self-fund the initiative if it fell upon their facilities to do so. As one medical center leader put it, “It’s a question of do we have the staff availability, and do we have the resources to have staff manning the desk. It’s resource intensive and money intensive. So, as long as it’s being provided, we probably likely will continue. But if it were to stop and if we were asked to implement, I don’t know we’ll have the funds or the staff to implement it and continue going.” And another indicated they’d like to see further evidence of the value of the program: “We live in a resource-constrained environment, and any resources that are put towards things that are ineffective are wasted resources. So, if this doesn’t improve, I would assume, reduction of contextual errors, then putting resources towards continuing it would not be a good use of resources.”like about participating in the intervention?”, 165 to “What did you dislike about participating in the intervention?”, and 70 to “Do you have any additional comments about your participation in the project?” Broadly speaking, the responses supported the ratings of safety, lack of disruption or burden, and value, but also included several other notable opinions.In their survey, Veterans were also invited to respond to three open-ended questions. There were 425 responses to “What did you The most common response to the first question could be described as altruistic, as in “I appreciate helping to improve care,” or “Just like the fact that my doctor will have feedback.” Many perceived that their doctor was more thorough when aware the visit was being recorded, as in “my doctor was more on her toes.” Finally, quite a few commented on ease of participation, as in “Frankly, I was not thinking about it . I hit play and it didn’t cross my mind.” For the second item, responses were largely assertions that there was “nothing to dislike” about participating. All but 11 fell into this category. Among these 11 were concerns about surveillance, as in “Even though it’s not spying, still feels like it is,” concerns about privacy, as in “Felt nervous talking about sex,” and concerns about impacting the interaction, as in “Felt that it could possibly interfere with doctor-patient communication.” For the third item – additional comments – most responded simply that they had “none” or wrote “all good.” Others were affirmations of support for the program, as in “If this program improves things for other vets as well, it is well worth it,” and “I am glad the VA cares so much about quality care to have a survey like this.” A few had suggestions about the process, sometimes with opposing perspectives, including “I think the doctor should be told who is recording them and who is not” and “I wonder if this program would be more valuable if doctors didn’t know they were being recorded.”Inviting patients to audio record their visits for the purpose of collecting data to improve care is generally accepted and even embraced if the process is regarded as safe, not disruptive or burdensome, and worthwhile. For physicians and other health care staff, a program feels safe when they trust that their audio recorded interactions will not be used punitively and, furthermore, that they won’t be shared with identifiers with anyone other than themselves; for patients, it’s when they are confident that their privacy is not compromised and, in addition, that they are not unwittingly enlisting in surveillance of their physicians. Not disruptive or burdensome means that participating clinicians are not required to do additional paperwork or attend additional activities as a result of the program, and that it is left up to them to decide how and whether to alter their care, with no consequences if they don’t; for patients, it’s that participating doesn’t distract them from their visit. And, finally, worthwhile  means that clinicians see first-hand that the feedback they obtain is eye-opening, convincing, and practical. Receiving needed credits towards board re-certification and/or maintaining licensure is also a value. For patients, valuing the program entails understanding enough about it to appreciate that they may be improving health care by participating.Based on data collected from the focus groups and leadership interviews, it appears that perceptions about the program’s safety increased over the course of the study as participants came to see and trust that the data were only used for its intended purpose. That a respected peer served as clinical champion may have been a reassuring signal that the initiative was credible as well as worthwhile. Notably, however, the physician survey did not identify any measurable increase in perceptions that the program was safe, although it did document a relatively highly level of baseline level of comfort with having visits recorded. That participation in the survey was entirely voluntary and, hence, non-representative, and that those who participated in the second round were not necessarily the same as those who participated at the start of the study, may account for inconsistencies between the quantitative and qualitative findings.Perceptions that the program is disruptive or burdensome were uncommon, with just 12% of clinicians surveyed and 3% of patients expressing this concern. Furthermore, there was a significant increase among the former with regard to finding the feedback process “convenient.” Perceptions that the program is valuable also increased among clinicians significantly, as reflected in their increased confidence that it was based on strong evidence. And over 90% of patients reported that “the potential benefits of this project are clear to me.”Finally, facility leaders were supportive of the program, mirroring the perceptions of providers. Few saw it as an impediment to health care delivery. Some even regarded it as a morale booster and a stand-out from other quality improvement initiatives because it appeals to clinicians’ and other staffs’ self-motivation to improve based on low-stakes feedback rather than employing a carrot or stick. Most also saw the program as inherently valuable, although a few raised questions about the evidence that the feedback would change clinician practice. Despite appreciating the program, however, few indicated they would or could fund the program with local resources exclusively.A limitation is that the findings may not generalize to settings outside the Veterans Health Administration. Also, participants in focus groups and surveys may not be representative; they could be either more or less likely to feel positively about the program. Finally, we do not yet know the extent to which the program will be maintained – only that it garnered the support of key stakeholders. Sustaining it will require long term investment for an initiative that is not mandated. The fact that a program that requires audio-recording medical encounters is seen as safe, not disruptive or burdensome, and worthwhile may be necessary but not sufficient to sustain it. At the time of the study’s conclusion, support for the program varied by site. It had received funding at one new site, and at least one existing site had committed to continued funding of the program. All activity ceased with the onset of the COVID-19 pandemic.A patient-collected audio program that adheres to principles of safety, avoidance of work disruption or burden, and for which there is a demonstrated evidence base can be effectively introduced in a health care setting with the support of clinical staff, patients, and facility leaders. Although this study examined the implementation of a program to improve the attention of physicians and other health professional to patient life context in care planning, it may provide generalizable information about how to implement patient-collected audio recording for other quality improvement purposes. The physician-patient encounter has been called an impenetrable “black box” as physician and patient interact behind closed doors, with assessments relying entirely on secondary data from the medical record or reports by patients of the experience . PatientAdditional file 1: Appendix A: Provider Survey with ORCA Questions. Appendix B: Focus Group Leader Facilitation Guide. Appendix C: Leadership Interview Guide.


Background: Schools are a key setting for student well-being promotion. Various school-based mental health programs have been implemented worldwide, with greater emphasis placed on psychological and social aspects. The bio-psycho-social model provides a holistic and integrated view of mental health based on theory and research evidence. Given the importance of considering all three dimensions in mental health promotion, this study explored reasons for the relative neglect of this approach by studying the early phase of school well-being program development and implementation.Method: In total, 77 Hong Kong government-funded student well-being programs implemented in 2000–2009 were reviewed for the use of biological, psychological, and social interventions. Questionnaires and interviews were conducted to explore program leaders' usage and views regarding theoretical frameworks and evidence-based practice and program evaluation. Challenges encountered in the initial stage of school well-being program development and implementation were identified and analyzed.Results: Of the 77 programs reviewed, only 5 addressed all three bio-psycho-social factors of mental health. A significantly greater number of programs addressed psychological (n = 63) and social (n = 40) factors compared to those that covered biological factors of mental health (n = 13). Of 24 program implementers who responded to the online survey, 75% claimed to have studied or applied a theoretical framework yet only 41.7% considered evidence-based practices to be important. The majority of interviewed participants valued their own practical experience over theory and research evidence. Many programs lacked rigorous evaluation of clear objectives and measurable outcomes, thus the mechanisms of change and program effectiveness were uncertain. Perceived barriers to program adoption and continuation were identified.Conclusion: This study highlighted a neglect of the biological contribution to mental health in school well-being promotion initiatives, possibly due to lack of theoretical knowledge and evidence-based practice among program leaders and implementers in the early phase of school mental health promotion. The bio-psycho-social model should therefore be recommended for student well-being programs as a holistic and integrated theory of mental health underpinning program objectives, mechanisms of change, and measurable outcomes. To develop effective practices in student well-being promotion, more thorough documentation, a rigorous evaluation framework, and support for frontline educators to evaluate their practices were recommended. Suicide is a leading cause of death among youths globally, claiming close to 800,000 lives annually . In HongSchools are a key setting for mental health promotion and suicide prevention among children and youth. Universal interventions in the school context refer to those delivered to the whole student population . School The bio-psycho-social (BPS) model is a holistic and integrated framework of mental health. Although this is important for mental health promotion and has immense potential for school application, reviews of existing school programs worldwide show that it has yet to be well-integrated into school interventions.This study is a historical review of the initiation of school-based well-being programs in Hong Kong. Alarmed by a sharp rise of suicide rate in Hong Kong from 1997 to 2003 in the general population and, in children aged 15 or below, a rise from 0.5 to 1 per 100,000 in 1997–2000 , childreThe bio-psycho-social model is a holistic approach that considers the interaction of biological, psychological and social factors in contributing to health and well-being. It was conceptualised in response to the biomedical model of illness, under which the significant influence of psychosocial factors in physical health would often be overlooked . In the According to the model, each of the three factors do not operate in isolation, but both affect and are affected by each other. In one of the largest meta-analyses of suicide risk factors, Franklin et al. found that the evidence for singular risk factors considered individually  was relatively weak, and instead, they must be considered in complex additive and interactive relationships with other multi-domain factors to explain suicide risk  . PsycholTherefore, an effective BPS approach to universal whole-school mental health promotion would consider how biological, psychological, and social factors interact and contribute to student mental health and well-being. With a deeper understanding of students' bio-psycho-social needs, risk and protective factors within the school setting, and the underlying mechanisms that link them to mental health, schools can then design more effective and relevant programs and activities to promote students' well-being.Schools and education authorities around the world have designed and implemented various mental health promotion programs. A review of existing research literature as well as national guidelines on whole school mental health programs reveal a wide range of theoretical underpinnings . WorldwiOther approaches may focus more on biological factors alone. For instance, the WHO's Health Promoting Schools program has been shown to benefit student health behaviours  worldwide. However, while mental health is mentioned in the model, in practice, the appearance of psychosocial interventions is limited . Other pGovernment-published guidelines such as Personal, Social, Health, and Economic education (PSHE) in the UK and the Whole School, Whole Community, Whole Child Model (WSCC) from the US have indeed incorporated all three bio-psycho-social elements into their frameworks. However, beyond general guidelines, there is variability in the program practice and implementation quality. In PSHE, the factors of BPS are clearly outlined, though these categories are more separate and distinct and it is unclear whether there is emphasis on discussing the interaction of the three components. In the case of WSCC and its holistic BPS consideration, there is not much documentation or empirical research literature to date on its implementation practices and evaluation . Before Other challenges in BPS school program implementation include evaluation practices and research quality. Reviews of school program evaluation literature have cited the need for higher research quality in conducting rigorous evaluation, including the use of control groups and clearer documentation of program protocol and implementation . RecommeInformed by theory and empirical evidence, we propose that a bio-psycho-social model of student mental health would consider all three components and their interdependence, systematically addressing the multi-modal and intertwined needs of the child in an integrated, evidence-based manner. Applying this theoretical model of mental health in schools and gathering empirical evidence on its effectiveness across different settings would be key to building a strong universal level of suicide intervention among children and youth.Given international research has suggested that school interventions have tended to approach mental health promotion in a compartmentalised topic-based manner  with a bThis study reviewed 77 school-based programs on student well-being that were funded by the government under the theme “developing students' positive attitudes and values” and implemented between 2000 and 2009. Under the funding scheme, schools were expected to implement a 1-year program on life, moral, value, and/or sex education. This was the first territory-wide initiative for enriching student learning  theoretical model, to identify challenges and obstacles, and to evaluate the quality of the programs. Lessons learnt from a successful case in implementing the BPS framework in school well-being promotion in Hong Kong were discussed.The main review of the 77 programs was performed by assessing their corresponding proposals, final reports and deliverables including program manuals, pamphlets, and booklets. Program information and data extracted included objectives, target population, contents, evaluation, challenges, and outcomes.One key objective of this study was to investigate the application of the BPS framework in school-based well-being programs in Hong Kong, and how each component of the BPS model related to such programs. By examining the program materials and coding them for their use of biological, psychological, and social interventions in the school-based programs, we aimed to illustrate historically the focus of programs with respect to the BPS model.A set of criteria for assessing program quality was developed by the research team  to indicAn online questionnaire survey was designed to collect general views and opinions from program leaders/implementers involved in the 77 programs. Most of the program implementers were school teachers while others were social workers. Qualitative data was collected from open-ended questions about the implementers' views on (1) the meaning of developing students' positive attitudes and values, (2) how they evaluated the effectiveness of programs, and (3) difficulties encountered. Analysis of qualitative data was performed by documenting all responses to each question and identifying key categories or themes. A multiple-choice question was included to identify if the program design was based on a theoretical framework, evidence-based practice, teacher or social worker's experience, and/or expert opinion. Participants were also asked to indicate if their program would continue. Due to turnover of personnel over the years, only implementers of 24 programs responded to the online survey.Program implementers were interviewed to further explore the details of program design, implementation, and impacts on students. Most of the program implementers were school teachers while others were social workers. Guidelines for the interview were designed to investigate for each program the theoretical origin and objectives, its implementation process, the evaluation methods employed, the program outcomes, the obstacles and challenges encountered as well as the intention to continue vs. discontinue the program. Examples of interview questions include “What does a theoretical framework mean to you?”, “Did you design the programs based on any theoretical framework, and if yes, what framework is it?”, “What does evidence-based practice mean to you?”, “Why and how did you choose your target population?”, and “How did you evaluate the effectiveness of the program?”. When selecting programs for the in-depth interview, a good representation was sought, reaching out to the full range of grantee sectors including pre-primary, primary, secondary, and special schools, tertiary institutes and non-government organizations (NGOs). Due to high personnel turnover, only implementers from 19 programs agreed to participate in the interview. Each interview lasted for about one hour and was audio taped and transcribed.The distribution of programs across target student populations was calculated to give an overview of the targeted groups. Of the 77 well-being programs, 33 (42.8%) were developed and delivered to secondary school students only and 22 programs (28.6%) targeted primary school students only. An additional 9 programs (11.7%) served both primary and secondary schools. Pre-primary sector only accounted for 11 (14.3%) programs and the least number of programs served special school students, with only 2 (2.6%) programs available for review.The use of BPS interventions was coded for each well-being program and the composition of programs by their adoption of a single-, dual-, or multi-component approach was analyzed . Out of n = 29; 37.7%) outnumbered those focusing on social  or biological factors . Among the 29 programs adopting a dual-component approach, the majority  focused on psychological and social aspects of student well-being, whereas only a handful adopted the combination of psychological and biological elements . No program selected the pairing of social and biological components, but they did appear together in the five (6.5%) programs that covered all three components.Among the 43 programs adopting a single-component approach, the ones with a sole focus on psychological components  had objectives set to facilitate the psychological development of children and adolescents  aimed to strengthen students' communication skills and social relations  were implemented in pre-primary and primary sectors, targeting the youngest students.Social development was the second-most focused facet in the school well-being programs. Over half of the programs , followed by observation of students' performance and learning progress. Some programs simply conducted post-program interviews with participants without pre-program assessment or interview to compare them with. Remarkably, only very few programs adopted rigorous research designs such as controlled experiments and quasi-experimental approach, leaving the majority without any systematic methodology to evaluate program effectiveness. Key performance indicators and measurable outcomes were often lacking and at most, participants' satisfaction levels of programs were acquired instead.From the results of coding for the use of biological, psychological, and social interventions in the school-based programs, it appeared that a holistic and integrated approach of the BPS theoretical framework for promoting well-being was overlooked, whereas much emphasis was placed on the psychological and social dimensions alone. An online questionnaire survey was then conducted to explore how the conceptualisation of the program first came about. In-depth interviews of program implementers were conducted to further explore the rationale for designing the mental health programs and any other issues of design and implementation. Due to turnover of personnel over the years, implementers of only 24 programs responded to the online survey, giving a response rate of 31.2%. For the interview, implementers from a range of organizations that developed and delivered the programs participated. These included staff members of one special school, two primary schools, three secondary schools, six tertiary institutions, and seven NGOs.Qualitative responses were collected from the online survey using open-ended questions; feedback from the 24 program implementers provided insight into how frontline educators in Hong Kong perceived the objectives of implementing school-based well-being programs. In their opinion, helping school children develop positive attitudes and values, i.e., the major theme of the government-funded scheme, was to teach them to be responsible, motivated, proactive, optimistic, resilient, and hopeful. To this end, it was meant to equip students with skills and knowledge such that psychologically, they become capable of coping with challenges in life and managing negative emotions while socially, they learn to care for and respect one another. Their pre-existing concept of nurturing students' positive attitudes and values may explain why almost all well-being programs disproportionately addressed the psychological and social development of students while some placed much emphasis on building moral characters. Incidentally, implementers went on to elaborate that in the process of program design, schools were often prompted by specific current social and societal issues such as juvenile violence incidents in the community or perceived deficiency in children's moral character building. Current issues thus played a role in the conceptualisation stage, shaping the program objectives, as described by interviewees:“Unlike researchers, their start point was to cater for the needs of the target population such as students and teachers after assessing what they really needed and reviewing what was and was not effective based on literature reviews.”Quantitative data from the online survey summarized the rationale behind designing the well-being programs. From the 24 program implementers who responded, 75% claimed to have designed their programs based on a theoretical framework; similarly, 75% of implementers relied on past experiences of teachers or social workers when designing program contents and activities. More than half of them (58.3%) consulted other professionals or organizations on program design. However, only 41.7% took into consideration evidence-based practice in their program design.practical knowledge is more important than theory.” Some interviewees considered observation as a type of evaluation as well. They observed the students' performance in class, tracked the students' learning process and communicated with them to understand their needs and evaluate their progress. Some teachers required the participants to write a brief reflection after each activity. They had designed corresponding worksheets with questions asking about the students' feelings. They also considered the briefing and debriefing sessions before and after their project activities.Contrary to the quantitative data collected from the online survey, interview data revealed that most of the 19 implementers did not design their programs based on any theoretical framework. Some interviewees claimed that they made reference to theories relevant to development of positive attitudes and values in children and young people but they did not completely put the theories into practice. Some interviewees developed their own framework based on past experience. These interviewees, who were either social workers or teachers, explained that as frontline professionals, they were accustomed to drawing on relevant experience from the past when designing activities and programs for students. Specifically, the experience of interacting with students was adopted by social workers, teachers, and school principals as the key reference, a finding in line with the online survey responses. Most interviewees claimed that, for school-based well-being programs, “For most interviewees who worked in schools and NGOs, evidence-based practice meant “practical knowledge” which is built through conducting pilot trials, class observations, having conversations with the target population, and refining the execution plan before launching the programs. Based on such practical knowledge, some interviewees developed their own frameworks for designing well-being programs. In contrast to programs initiated by tertiary institutions, which in general demonstrated evidence-based practice supported by comprehensible theoretical frameworks and rigorous methodology, many interviewees either did not fully understand what theoretical framework and evidence-based practices are or did not have their programs clearly documented, resulting in limited information available for developing evidence-based practice.Among the 24 schools that responded to the online survey, just over half (54.2%) continued the well-being programs after the funding period. Both the online survey and interviews revealed that shortage of manpower and time constraint were top challenges to most implementers in executing the well-being programs. While regular curricula had already been scheduled and lessons were tightly packed, well-being program activities often led to extra working hours and additional tasks for teaching staff including administrative works, program planning and design, teacher training, as well as documentation and evaluation. Another challenge cited by program implementers was related to human resources:“For projects that were carried out by school teachers, the main obstacles were to find external professionals to help with the projects. The frequent transfer of personnel, which caused inconsistency of the projects, was another problem.”For programs initiated by NGOs, school recruitment and student dropout were the main obstacles. The reluctance of schools joining their programs was due to the very same reasons of tight teaching schedules and limited human resources available for cooperating with the NGO even when the latter was the service provider. In one program that incorporated the biological components, physical health-related activities were restricted because of the lack of space and sports facilities in school and the community.It is worth noting that recruitment of students to a school-based well-being promotion program was also challenging due to two main reasons. The first was found to be a fear of being stigmatised by association with any mental health issue, and the second was low motivation to engage in such activities. The latter could be due to the high demands put on students to demonstrate academic achievement first and foremost in Hong Kong. For schools that were determined to prioritize student well-being, perceived difficulty in applying for government funding posed another major obstacle to initiating and sustaining school-based well-being-promoting programs. The administrative cost of following the complicated funding application procedures was cited by implementers as a significant deterrent.health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.”  provided a good demonstration of consideration of a theoretical framework and application of the BPS principles in an integrative manner. The Comprehensive Health Program for Young Children Development targeting pre-school children was implemented by the BGCAHK in 2006 for 1 year. With reference to the longstanding concept of health as defined by the World Health Organization, that is “irmity.” , BGCAHK On top of a nutrition and healthy eating curriculum, getting children interested in exercise and to build a fitness habit formed part of their program objectives that addressed the biological component. A joint-school parent-child sports event and mini Olympic Games were organized with the focus on exercising for fun, team spirit, and engaging children and their parents together, thereby integrating the biological with the social components in a natural context. Besides physical health, the cognitive development of young children was also recognized to be an important biological factor in mental health. Supported by developmental theories on the crucial role of play in young children's cognitive development, the program also included a range of game activities, quiet and interactive, for children to acquire and exercise problem solving skills on their own or together with others.To strengthen protective factors of mental health in the psychological and social domains, the program taught pre-schoolers to recognize, manage, and express their emotions appropriately through interaction with fellow students and family members. From the program, children learned to listen to and understand others' feelings and were guided to put them into practice in the classroom setting; the concept of gratitude was introduced to pre-schoolers by creating a culture of appreciation at home and at school. Empathy, a complementary character of gratitude, was also taught experientially, for example, by accompanying children on a visit to an elderly centre to learn about other people's lives. Through experiential learning, children developed virtues of love and care in the contexts of classroom, family, and community.It is worth noting the program did not only target and benefit pre-school children but also their parents and teachers. Several workshops for parents were delivered by physiotherapists, psychologists, and social workers, and these aimed at increasing their knowledge around bio/psycho/social topics of children's physical and mental wellness. Parent workshops also included the sharing of well-designed exercise and game ideas for parents and children and training in parenting and communication skills. Teachers gained understanding in the concept of holistic health and hands-on experience in developing and running well-being programs suitable to their kindergarten. Evaluation in the form of pre- and post-program questionnaire surveys were administered to teachers, which recorded improvements (higher mean scores) of children's physical health, self-managing ability, emotion control, problem solving, social skills, and empathy, according to teachers' observation.To summarize, this program is a representation of a good and effective school-based program for promoting well-being at a young age. The program drew on developmental and educational theories for its content and activity design; its activities covered all three components of the BPS model while integrating them at times as well. The objective of supporting children to achieve healthy states biologically, psychologically, and socially were clearly defined and achievement was demonstrated by the documentation of changes in the students before and after the program. A whole-school approach that increased teachers' and parents' mental health literacy and involvement also served to increase the school's overall awareness and capacity of promoting holistic health and well-being among young children as an important school priority.This study revealed that, similar to global trends, the majority of the reviewed school-based well-being programs from the period between 2000 and 2009 in Hong Kong did not follow the holistic approach of the BPS model. Three further observations are highlighted here. Firstly, the psychological domain was without a doubt perceived as the single most important area of well-being, according to their appearances in programs. Secondly, the psychosocial dual-component programs were also popular, suggesting a tendency among program developers to see them as closely-related domains and highly relevant to student well-being. Thirdly, whether on its own or in combination with another component of the BPS model, biological interventions were by far the least selected component across the 77 programs. The absence of programs that combined it with the social component also suggests that the pair were possibly perceived as least related. These findings point to the general lack of regard for the interrelationship between all three components and their function in student mental health.Considering these findings in the local context, we identified some explanations for the imbalanced coverage of BPS. At the knowledge level, insufficient understanding of the BPS theoretical underpinnings and knowledge about its evidence-based practice was apparent, despite many implementers claiming to have adopted a theoretical framework. Implementers also frequently drew on personal experience, practical knowledge, and their understanding of current social issues to develop programs, while few considered evidence-based theoretical frameworks to be essential. This may be related to the general lack of mental health training received by school teachers and social workers working with school children and youth. Without a good understanding of how the bio-, psycho-, and social components of mental health are interrelated, it was not surprising to find that most programs employed a single or dual, instead of multiple, integrated approach to promoting student well-being. The lack of rigorous evaluation also meant that there was little objective evidence to highlight the importance of a multi-faceted, integrated approach. As a result, frontline implementers would either turn to personal experience first, consider practical concerns as more important, or follow popular local and global trends, focusing on psychosocial factors to the neglect of the biological domain.Sociocultural factors also came into play. In Hong Kong, the positive attitudes and values promotion programs were government-funded with an aim to promote student well-being, initially focusing on four major areas, namely, life, moral, value, and/or sex education. On the one hand, traditional Asian education philosophy emphasises morality and virtues when conceptualising whole-person development, which may have resulted in fewer attempts by program developers to integrate the biological domain into their design of well-being programs. On the other hand, the imbalance of BPS components may equally reflect a bias or lack of consideration on the part of policymakers when they defined the remit of this territory-wide funding scheme. Finally, the lack of common discourse about mental health in the education sector could be a limiting factor on the program's content development. This was reflected in students' fear of being stigmatised by participating in a program on mental health.Although there was extensive effort made to assess the quality of the programs, the assessment was constrained, evidenced by the limited information available in the program final reports. A full picture of program details was rarely captured by program implementers with the aim to produce reliable evidence. Our findings revealed at least two major factors that accounted for the overall lack in documenting and evaluating effective practices.per se rather than clearly defined and measurable outcomes, the indicators of whether or not the program was effective in promoting student well-being. These findings suggest that implementers lacked true understanding of the purpose of evaluation, perhaps with the tendency to see it as a demonstration of program accountability more than a key method to verify and document intervention effectiveness for continued application.Firstly, knowledge and understanding played an important part. Much of the focus of evaluation was on participants' satisfaction with the program activities Secondly, findings suggest that even if implementers did understand what was required in evaluation to measure program effectiveness, they perceived the costs to be too high. Conducting a comprehensive and rigorous evaluation would require a high level of resource, effort, and expert knowledge, and in turn the corresponding incentive needed for the school and program implementers to invest themselves would also be high. Overall, implementers may have faced obstacles of having sufficient theoretical knowledge, skills or incentive to conduct rigorous documentation and evaluation of their practices.This study also sheds light on several other barriers that prevented successful program adoption and implementation. At the practical level, insufficient training and support for the delivery of well-being programs in schools were highlighted. The shortage of manpower and time constraint appeared to have contributed to a high dropout rate. As one of the most common reasons for the discontinuation of school-based mental health programs around the world, it is worth investigating the underlying factors in each local context. For example, in our study, teachers cited their tight subject teaching schedule as a barrier to implementing the well-being program. Students also showed low incentives to participate. Subsequently, we consider the lack of time and motivation for well-being programs to be related to a lower priority given to teaching and learning about mental health topics compared to academic subjects. At a deeper level, it may also reflect a system not yet prepared to put student well-being at the centre of their school vision. Therefore, an education system that prioritises student well-being and shows determination to help schools overcome practical challenges is fundamental to the success of any suicide prevention attempts to bring in change and sustain it for long-term impact.In the past decade, after the initial stage of mental health programs was introduced, some critical events at large have influenced the development of well-being initiatives in schools. Firstly, following a surge in suicides among school-aged children and youth in 2016, Hong Kong educators have become very sensitive to news of students suffering from mental health issues. The widespread assumption that academic pressure is one of the most prominent risk factors contributing to suicide among the Hong Kong student population has made school leaders wary and actively looking for solutions.Secondly, the social unrest that took place in Hong Kong during 2014-20 was unprecedented in its recent history. Coinciding with the escalated social conflicts was the start of Covid-19, which together have critically impacted the well-being of school-aged children and youth as well as schools' effort to promote it. A research study on the effects that perpetual traumatic experiences from these critical events can have on the population's mental health showed that depression and PTSD symptoms were significantly greater among young people (aged 24 and under) compared to older groups . It contributed to a more comprehensive understanding of the initiation stage of local mental health promotion programs in a range of sectors including pre-primary, primary, secondary, and special schools, tertiary institutes, and NGOs. In terms of methodology, a range of quantitative and qualitative methods were used to achieve a thorough and in-depth evaluation of programs to review their coverage of the bio-psycho-social components, and of designers' and implementers' views in order to understand their design rationale and challenges in practice when initiating well-being programs in school.One limitation is that the programs were designed and implemented over a decade ago. While this historical review captures the process and challenges of initiating school mental health programs, as mentioned there have been changes in mental health awareness and trends that have grown beyond the initiation stage. Furthermore, societal events that have influenced mental health promotion programs have taken place since, highlighting the need to review the effectiveness and refine the ongoing territory-wide school mental health initiative on a regular basis so as to adapt to the ever-changing conditions of students.Mental health education and promotion in schools is one of the most important initiatives of suicide prevention among children and youth. By systematically reviewing programs developed as part of Hong Kong's first territory-wide mental health initiative, common experiences, challenges, and recommendations were identified. Firstly, the review has reflected a need to increase program providers' theoretical understanding of the bio-psycho-social model and the importance of addressing all three in an integrated manner as a key part of improving school mental health interventions for suicide prevention.Secondly, having examined intervention gaps and challenges in the local context, the review highlighted program evaluation as a key issue to resolve in order to strengthen school mental health programs. Evaluation is key to advancing the theoretical understanding of a holistic, integrated BPS approach to mental health, thereby constituting a fundamental step forward in suicide prevention among children and youth. The evidence generated from rigorous evaluation will also provide valuable directions for improving intervention and implementation effectiveness and demonstrate the program's worthiness for continued support and investment.Following the review, the local government and educators have been advised on specific components that contribute to optimum school-based mental health interventions. As such, the review has facilitated their strategic selection of areas to focus on in terms of promoting mental health in schools. Although the context of this review was specific to Hong Kong, we believe that it has demonstrated universal experiences and struggles echoed by program developers and implementers in other parts of the world and therefore contributed knowledge to the larger landscape of mental health and suicide prevention initiatives.sfpyip@hku.hk.The datasets presented in this article are not readily available because the data analyzed in this study was obtained from the Quality Education Fund (QEF) and access to data requires permission from the QEF. Requests to access the datasets should be directed to Prof. Paul Yip, The studies involving human participants were reviewed and approved by Human Research Ethics Committee, The University of Hong Kong. The patients/participants provided their written informed consent to participate in this study.PY conceptualised and designed the study. AS and EL organized the database and performed the analysis. AW, IC, and CT wrote the draft of the manuscript. PY and AC critically reviewed the manuscript. All authors contributed to manuscript revision, read, and approved the submitted version.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.