Article Text

Original research
Evaluation of system based psychological first aid training on the mental health proficiency of emergency medical first responders to natural disasters in China: a cluster randomised controlled trial
  1. Min Peng1,2,3,
  2. Tao Xiao2,4,
  3. Ben Carter5,6,
  4. James Shearer1
  1. 1 King's Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
  2. 2 Psychological Rescue Branch, China Association for Disaster and Emergency Rescue Medicine, Beijing, People's Republic of China
  3. 3 Centre for Evaluation & Methods, Queen Mary University of London, London, UK
  4. 4 Social Affair Department, The Second Xiangya Hospital of Central South University, Changsha, People's Republic of China
  5. 5 Biostatistics & Health Informatics, Institute of Psychiatry Psychology & Neuroscience, King's College London, London, UK
  6. 6 King’s Clinical Trials Unit, Institute of Psychiatry Psychology & Neuroscience, King's College London, London, UK
  1. Correspondence to Dr James Shearer; james.shearer{at}kcl.ac.uk

Abstract

Objective To evaluate the effectiveness of a system based psychological first aid (PFA) training programme for emergency medical first responders in China.

Design Parallel-group, assessor-blinded, cluster randomised controlled trial.

Setting 42 clusters of health workers from various health facilities in China.

Participants 1399 health workers who provide emergency service for survivors of disasters.

Interventions One-day system based PFA training programme (PFA) or training as usual (TAU).

Primary and secondary outcome measures The primary outcome was the PFA skills, knowledge and attitude (SKA-PFA) score at 2 months postintervention. Secondary outcomes included post-traumatic growth, self-efficacy and professional quality of life.

Results The intervention group (n=690) had significantly higher SKA-PFA scores than the control group (n=709) at 2 months postintervention (adjusted mean difference=4.44; 95% CI 1.17 to 7.52; p=0.007; Cohen’s d=0.35). The intervention group also had higher scores on post-traumatic growth (p=0.113, d=0.24), self-efficacy (p=0.032, d=0.20) and professional quality of life (p=0.281, d=0.04).

Conclusions The system based PFA training programme was more effective than the TAU in enhancing the PFA knowledge and skills of the emergency medical first responders and in increasing their competence to provide emergency service for survivors in China.

Trial registration number ChiCTR2200060464.

  • randomized controlled trial
  • psychiatry
  • medical education & training
  • mental health

Data availability statement

Data are available on reasonable request. Deidentified individual participant data (including data dictionaries) will be made available, along with the study protocol and statistical analysis plan. The data will be available to researchers who provide a methodologically sound proposal for analyses that are approved by an independent review committee identified for this purpose. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third-party website (https://zenodo.org/).

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STRENGTHS AND LIMITATIONS OF THIS STUDY

  • This study was a parallel-group, assessor-blinded, cluster randomised controlled trial, which is a rigorous design to evaluate the effectiveness of an intervention.

  • This study involved a large sample of 1399 health workers from various health facilities in China, which enhances the generalisability of the findings.

  • This study used a validated measure of psychological first aid (PFA) knowledge, skills and attitude as the primary outcome and also assessed secondary outcomes related to post-traumatic growth, self-efficacy and professional quality of life.

  • This study found that the system based PFA training programme was more effective than the training as usual in improving the PFA competence and well-being of the emergency medical first responders.

  • The study has several limitations including the reliance on self-reported measures of psychological well-being proficiency and outcomes, which may be subject to social desirability bias or recall bias. We also could not ask participating hospitals to collect baseline data from participants prior to training mainly due to the prolonged burden on their services from the COVID-19 pandemic.

Introduction

Disasters are unexpected, and devastating events that harm people, property and society.1 They can be natural (eg, floods, earthquakes) or human-made (eg, wars, terrorism). Disasters affect the psychological well-being of survivors and others who witness or experience them2 causing serious psychological symptoms for 30%–40% of survivors.3 Disaster-related psychological symptoms are recognised as one of the most urgent public health challenges facing the world.4

Globally, in 2022, the number of people in need of humanitarian assistance owing to ongoing humanitarian crises and conflicts rose to 274 million.5 The cost of assisting 183 million people in 63 of the most vulnerable countries reached US$41 billion.6 The prevalence of severe mental disorders in conflict settings (schizophrenia, bipolar disorder, depression, anxiety and post-traumatic stress disorder (PTSD)) has been estimated at 22.1%, with an estimated 1 in 11 people (9%) exposed to conflict in the previous 10 years would develop a moderate or severe mental disorder.7 China is highly prone to natural disasters, especially seismic events.8 9 For example, the 2008 Sichuan earthquake and its aftershocks killed or displaced about 90 000 people and caused US$159 billion in direct economic losses.10 11 Similarly, the 2013 Ya’an earthquake and its aftershocks affected more than 1.5 million people and resulted in 196 deaths and 11 470 injuries.12

China has made progress in the hospital treatment of mental disorders that require intensive care, such as schizophrenia and bipolar disorder. However, there is still a lack of attention and resources for more prevalent mental disorders, such as depression and anxiety, which affect millions of people in China.13 Despite the global prevalence and impact of psychological symptoms, which constitute 14% of the global disease burden,14 only 1% of health aid has been allocated to psychological well-being support. Moreover, the available resources for psychological well-being support are scarce, unevenly distributed and inefficiently used.15 This results in a large and persistent ‘mental health service gap’.16 In China, this is evidenced by having 1.55 psychiatrists per 100 000 people, compared with the global average of 3.96 psychiatrists per 100 000 people.17 Without effective and accessible interventions, psychological well-being outcomes will deteriorate, especially for those with pre-existing mental disorders who are more vulnerable in emergencies.18 19

Early psychological symptoms intervention can prevent adverse mental health outcomes for people in emergencies.20 21 Front-line health workers, as the first responders, can provide immediate and effective psychological symptoms intervention along with physical healthcare to the affected population.22 Interventions should be brief, evidence-based, culturally appropriate and cost-effective, such as self-help manuals, to suit disaster and public emergency situations.23 Despite the progress in developing evidence-based psychological symptom interventions for disaster-affected people, their long-term sustainability and scalability in resource-limited contexts remain a challenge.

Previous studies have shown that psychological first aid (PFA) reduces stress reactions by providing immediate emotional and practical support to people who have experienced acute stress.24 PFA is a technique designed to reduce the occurrence of PTSD and other negative psychological outcomes in people who have experienced a traumatic event. PFA is not a form of therapy, but rather a humane, supportive and practical assistance that respects the dignity, culture and abilities of the affected individuals. PFA aims to help people feel safe, connected, calm, and hopeful, and to facilitate access to physical, emotional and social support, as well as coping strategies and collaborative services. PFA is endorsed by the WHO and other mental health experts as an effective early intervention for disaster survivors.25 It is not a psychiatric or professional-led therapy, but a universal intervention method2 that is non-intrusive and feasible in various contexts. System based PFA training programme is ‘Culturally appropriate’ which means that the PFA training programme was adapted to the Chinese context by incorporating local examples, case studies and role plays, as well as addressing the cultural beliefs and values of the Chinese population to illustrate the application of PFA in different scenarios, such as natural disasters, accidents, violence and pandemics. For example, the PFA principles were aligned with Chinese values and practices, and the PFA action cards were modified to include culturally relevant examples and scenarios.

The training programme was based on the WHO guidelines for PFA, which emphasise the importance of respecting the culture and dignity of the affected individuals and communities, and providing support that is consistent with their needs and preferences.26 PFA also helps to refer those who need more intensive psychological care.27 As disaster relief response, PFA helps people cope with the immediate aftermath of a crisis, such as the London bombing in 2005. PFA can improve psychological outcomes for people who may not receive other forms of treatment, by reducing their stress, connecting them with resources and offering them hope.28 PFA is a technique for non-specialists to improve their psychological support competence in disasters.29 30 PFA has also been found to be suitable, acceptable and increased proficiency for paraprofessionals to conduct simple psychological intervention and referral in disaster settings.31

The aim of this study is to compare the effectiveness of a system based training programme versus training as usual (TAU) for emergency medical first responders who provide PFA to disaster survivors in China. The term ‘emergency medical first responders’ refers to individuals in the healthcare field who provide immediate care to patients with life-threatening conditions. System based PFA training is a specific approach to PFA training that has been developed and evaluated by a team of researchers in CADERM (China’s Association for Disaster and Emergency Rescue Medicine). System based training is based on the systems based approach to medical education,32 33 which aims to give medical emergency first responders an awareness of and responsiveness to the wider social, policy and ethical context of the mental healthcare system, and the skills and competencies to effectively use specialist resources in the mental health system to provide the best mental healthcare. The primary outcome of this study is the PFA skills, knowledge and attitude (PFA-SKA) score, which measures the knowledge, skills and proficiency of the health workers in delivering PFA. The hypothesis of this study is that emergency medical first responders who receive system based training will have higher PFA-SKA scores than those who receive the TAU.

Materials and methods

This study has been reported using the Consolidated Standards of Reporting Trials (CONSORT) for cluster randomised trials, which is an extension of the standard CONSORT statement that includes additional items relevant to cluster trials.34

Study design

This was a parallel-group, single-blinded (outcome assessors), cluster randomised controlled trial (cRCT), to evaluate the effect of PFA compared with usual care (1:1) on knowledge, skills and attitudes of PFA. The trial protocol has been previously published.35

Interventions

System based PFA training

The system based PFA training model was adopted by National Health Commission of China. A pilot of the training intervention found it to be feasible and acceptable for emergency medical first responders. The PFA training course was culturally tailored and localised based on a PFA training of trainers (ToT) manual, which includes elements of mental health awareness along with PFA training based on the Johns Hopkins University PFA guideline.30 The system based PFA Training model has six modules mainly including core conception, knowledge and practice (see online supplemental table S1).

Supplemental material

Training as usual

The participants in the TAU (control arm) received training delivered from the same training staff based on the Mental Health Gap Action Programme (mhGAP) Intervention Guide (IG) in non-specialised health settings. The mhGAP intervention is a WHO initiative that aims to improve the access and quality of mental healthcare in low-income and middle-income countries. It consists of evidence-based guidelines, training materials and tools for the assessment and management of priority mental, neurological and substance use disorders in non-specialised health settings. The mhGAP-IG is the main tool for implementing the mhGAP approach. It is designed for use by doctors, nurses and other health workers who are not mental health specialists.36 The efficacy of mhGAP intervention was already well established in the literature.37

The primary and secondary outcomes were measured at 1 day, 1 month and 2 months after the intervention.

Sample size calculations

The total sample size of 1399 healthcare workers was estimated with a power=0.80 and an alpha=0.05, using PASS software based on d=0.4329 and an intraclass correlation coefficient (ICC)=0.2 estimated in a similar study conducted in Nepal.38 The total minimum required sample size was 21 clusters per arm with 30 participants with an additional 10% inflation for drop-out in each cluster to show a 20% difference in mean competency score on the SKA-PFA39 between the intervention group and control group.

Randomisation

A random sequence was created by the study statistician using a varying permuted block design in a 1:1 ratio with stratification by hospital type (tertiary and secondary). The random sequence was concealed and allocated by an independent administrator at CADERM not associated with the study. The health workers within each hospital followed the same group assignment as their hospital. The outcome assessors and data analysts were blinded to the groups. The hospital and individual data were anonymised.

Participants

The study population consisted of emergency medical first responders who were involved in disaster and emergency response in clinical settings. These included doctors and nurses working in emergency departments, infectious disease departments, orthopaedics departments, emergency units, etc. The eligible participants were those who did not have specialised training or experience in psychological well-being care. The participants provided electronic informed consent after receiving information about the study’s purpose, procedures and potential risks. We recruited 1399 participants from 42 hospitals across 6 provinces in China, covering rural and urban areas in southern, western, southeast, northern and central south regions. The enrolment period was from March to July 2022.

Primary outcome measure

The primary outcome measure was the PFA-SKA, a self-administered questionnaire measuring PFA knowledge, skills and attitudes, at 2 months after the intervention. The secondary outcomes were post-traumatic growth, perceived self-efficacy and professional quality of life (ProQOL), measured by validated scales. We analysed all participants who were randomised (intention to treat) and those who attended the training and completed the follow-up assessments.

PFA skills, knowledge and attitude

The primary outcome of the training was to facilitate emergency medical first responders with the necessary knowledge, skills and motivation to provide emergency psychological interventions. PFA-SKA is a self-report measure that evaluates the knowledge, skills and attitudes of emergency medical first responders who provide emergency psychological interventions. It was developed by CADERM in Changsha by licensed psychologists and was based on the main factors that influence PFA and conversations with mental health professionals.40 The items of PFA-SKA were characterised in three domains: (1) how well the participants understood of the elements of PFA which is the system-based PFA training and their understanding of knowledge of PFA content (40 points); (2) demonstrate skills related to the psychological intervention (including competence to perform PFA intervention, proficiency and self-assessment of relevant skills for the implementation of PFA) (30 points) and (3) attitudes including perception of barriers, as well as personal judgement about the value of emergency psychological intervention (30 points). Post-test questions for PFA knowledge and skills and professional attitude were assessed with a 20-item questionnaire with a score from 1 to 5. Each item is rated on a 5-point Likert scale ranging from (‘very much so’ (5 points) to ‘not at all’ (1 point) and the total score ranges from 20 to 100. The higher the score, the more positive the gained capacity. Cronbach’s α was 0.92 in Yun and Choi’s41 study with a sample size of 24, and 0.94 in Kang and Choi’s study with a sample size of 30.42 A pilot was conducted to evaluate the reliability and validity coefficients. The PFA-SKA was validated in a pilot with a sample of 18 Chinese health workers and showed good internal consistency (Cronbach’s alpha=0.881).

Secondary outcome measures

Post-traumatic Growth Index

The Post-traumatic Growth Index (PTGI) is a self-report measure that assesses the positive changes experienced by individuals as a result of coping with traumatic events. It is based on the theory that trauma can lead to personal growth in five domains: new possibilities, relating to others, personal strength, spiritual change and appreciation of life. The PTGI consists of 21 items, each rated on a 6-point Likert scale ranging from 0 (I did not experience this change as a result of my crisis) to 5 (I experienced this change to a very great degree as a result of my crisis). For example, one item is ‘I have a greater sense of closeness with others’. The total score of the PTGI ranges from 0 to 105, with higher scores indicating higher levels of post-traumatic growth. The PTGI has good psychometric properties, with high internal consistency (Cronbach’s alpha=0.90),43 and good convergent and discriminant validity (correlated with positive affect, optimism, and social support, and negatively correlated with depression, anxiety, and post-traumatic stress). The PTGI was validated in different cultural contexts, such as Jordan44 and Turkey (M=49.11, SD=29.11), and showed similar mean scores to the original study (M=55.94, SD=23.81).45

General Self-Efficacy Scale

The General Self-Efficacy (GSE) Scale is a self-report measure that evaluates the optimistic self-beliefs to cope with difficulties in life. It is based on the concept of self-efficacy, which refers to the belief that one’s actions are responsible for successful outcomes. The GSE consists of 10 items, each rated on a 4-point Likert scale ranging from 1 (not at all true) to 4 (exactly true). For example, one item is ‘I can always manage to solve difficult problems if I try hard enough’. The total score of the GSE ranges from 10 to 40, with higher scores indicating higher perceived GSE. The GSE has good psychometric properties, with high internal consistency (Cronbach’s alpha=0.86), and good criterion and predictive validity (correlated with coping behaviour, academic achievement and health outcomes). The GSE was validated in different languages and cultures, such as German, Chinese and Arabic and showed similar factor structure and reliability coefficients.46

Professional quality of life

ProQOL-5 is a self-report measure that assesses the quality of life of professionals who work in helping fields, such as healthcare, social work and education. It is based on the idea that helping others can have both positive and negative effects on one’s well-being and satisfaction.47 The ProQOL-5 consists of three subscales: compassion satisfaction, compassion fatigue and burn-out. Compassion satisfaction refers to the positive feelings derived from helping others, such as joy, fulfilment and gratitude. Compassion fatigue refers to the negative feelings caused by exposure to the suffering of others, such as sadness, anger and guilt. Burn-out refers to the negative feelings caused by the demands and stress of the work, such as exhaustion, frustration and cynicism. The ProQOL-5 has 30 items, each rated on a 5-point Likert scale ranging from 1 (never) to 5 (very often). For example, one item is ‘I feel invigorated after working with those I help’. The total score of each subscale ranges from 10 to 50, with higher scores indicating higher levels of compassion satisfaction, reduced compassion fatigue and lower level of burn-out. The ProQOL-5 has good psychometric properties, with acceptable internal consistency (Cronbach’s alpha=0.72 for compassion satisfaction, 0.80 for compassion fatigue and 0.75 for burn-out),47 and good construct and criterion validity (correlated with job satisfaction, turnover intention and psychological distress). The ProQOL-5 was validated in different settings and populations, such as nurses, teachers and disaster workers, and showed similar reliability and validity coefficients. With a low ProQOL, health workers may manifest a loss of self‐worth and diminished productivity, and staff turnover can be affected.48

Statistical analysis

A linear mixed effects model was used to analyse the primary and secondary outcome measures adjusting for the fixed effect of: hospital location (rural or urban); hospital type (tertiary or secondary hospital); number of hospital beds; teaching hospital, number of departments; gender, work experience (years of clinical working), time and time-by-treatment group. We accounted for the clustering of health workers within hospitals by including a random intercept for the hospital effect in our regression models. The adjusted mean difference (aMD) will be presented alongside the 95%CI, p value and ICC. According to the guidelines proposed by Cohen,49 d=0.2, 0.5 and 0.8 represent small, medium and large effect sizes, respectively. Based on these criteria, we interpreted Cohen’s d=0.35 as a moderate improvement, which falls between small and medium effect sizes.

Missing data

The number of participants with missing data for each outcome was summarised by arm and at each time point. Where there were two or more outcome time points, missing postrandomisation assessments were dealt with by fitting linear mixed models to all the available data using maximum likelihood methods.

Results

Between March 2022 and July 2022, from the 1399 participants in 42 hospital clusters who were recruited to the study, 42 hospitals were randomly assigned to system based PFA (n=21) or TAU (n=21) (figure 1). 33 hospitals withdrew before randomisation due to COVID-19 restrictions and related staffing problems. The CONSORT guidelines were followed for reporting cluster randomised trials.

Figure 1

CONSORT flow diagram: cluster randomised trial (adapted from CONSORT for cluster reporting guidance). The allocation ratio of 1:1 was achieved by using a computer-generated randomisation sequence. However, due to the over recruitment of 19 participants, the final number of participants in each group was slightly different. This did not affect the validity of the results or the statistical analysis. CONSORT, Consolidated Standards of Reporting Trials; PFA, psychological first aid.

Characteristics of the study hospital clusters and individuals are presented in table 1. The individual participants were mainly female, accounting for more than 80% of the total. They had an average of 7.68 years of clinical work experience, with most of them working in tertiary level, urban and teaching hospitals. Tertiary hospitals and secondary hospitals are two types of hospitals in China that are classified according to their level of care, size and function. Tertiary hospitals are the largest and most advanced, providing specialist, educational and research services. Secondary hospitals are smaller and offer general health, educational and regional research services. The participants work in various hospital departments, such as gastro surgery, functional neurosurgery, clinical lab, childcare and paediatrics, general internal medicine, orthopaedics and others. The characteristics of the participants were similar between the intervention group and the control group.

Table 1

Characteristics of the hospital clusters and their participants

Table 1 summarises the baseline characteristics of the participants by group and by follow-up status. There were no significant differences between the groups or between those who were followed up and those who were not followed up at baseline (see online supplemental table S2). The intervention group had 666 participants (96.52% of those recruited) who completed the training, compared with 707 participants (99.72%) in the control group. At the 2-month follow-up, data were missing for 118 participants (17.1%) in the intervention group and 184 participants (26.0%) in the control group (see online supplemental table S3).

Primary outcome

There was a moderate improvement in PFA-SKA at 2 months postintervention compared with TAU (aMD=4.347; 95%CI 1.17 to 7.52, p=0.007; Cohen’s d=0.35). This means that the intervention had a moderate impact on improving the PFA proficiency of the emergency medical first responders (see table 2).

Table 2

The primary outcome- PFA-SKA at 2 months

A predictive margins graph of PFA-SKA (figure 2) shows the temporal effect each level of time-by-group interaction and their CIs. The graph shows that the PFA arm had a better PFA-SKA gain than the TAU arm after 2 months. The graph also shows that the probability of PFA-SKA score increases with time for PFA group (intervention group). The CIs do not overlap for the values of 2 month follow-up, indicating that the effect is statistically significant.

Figure 2

Temporal effect of the PFA proficiency (PFA -SKA) outcome intervention group mean, per time point with associated 95% CIs for the intention-to-treat population (n=1399). PFA, psychological first aid; SKA, skills, knowledge and attitude; TAU, training as usual.

Secondary outcomes

There were small improvements in GSE (aMD=0.845, (95% CI 0.0716 to 1.618), p=0.032; Cohen’s d=0.20) at 2 months postintervention compared with TAU. There was no significant difference in PTGI (aMD=2.114, (95% CI −0.500 to 4.728), p=0.113; Cohen’s d=0.24) and ProQOL (aMD=1.509, (95% CI −1.233 to 4.252) which means the intervention did not have a positive or negative impact on the ProQOL of the participants (see table 3). Furthermore, an ICC estimation was conducted, and the residual ICC value for the hospital clusters is 0.099, with a very small SE, which measures how much of the variance in an outcome can be attributed to differences between clusters.

Table 3

The secondary outcomes-PTGI, GSE, ProQOL

Discussion

This cRCT found moderate but statistically significant improved PFA-SKA in the system based PFA group compared with the TAU group. These results indicate that the system based training programme was more effective than the TAU in improving the psychological well-being proficiency of emergency medical first responders in disaster and emergency settings.

The system based PFA group also had higher scores than the TAU group on post-traumatic growth or coping, perceived self-efficacy and ProQOL. This finding is consistent with previous studies that have shown the effectiveness of PFA training for various populations, such as paraprofessionals,31 humanitarian workers29 and school staff.30 However, this study is the first to evaluate the impact of a system based PFA training programme developed as part of national guidelines in China for emergency medical first responders.

This study adds to the healthcare workforce literature as this study measured not only the scores in PFA knowledge, skills and attitudes, but also the outcomes in self-efficacy, resilience and ProQOL of the participants, which are important outcomes for their well-being and performance in disaster and emergency settings. However, we acknowledge that our study focused on individual-level measures and did not assess the community-level impact of the intervention. Therefore, we cannot draw any conclusions about the effectiveness of the intervention on the broader population or the health system. This is a limitation of our study that needs to be addressed in future research. This finding also has significant policy implications, as it highlights the need for integrating psychological well-being and psychosocial support into community-based health services and disaster response plans. China has a developing network of community-based psychological well-being services that offer various functions, such as psychological support for individuals and families.50 However, these services require coordination with other sectors to ensure comprehensive and holistic care for people with psychological well-being needs.

The study has several limitations including the reliance on self-reported measures of psychological well-being proficiency and outcomes, which may be subject to social desirability bias or recall bias. There were understandable administrative challenges in undertaking this research during the COVID-19 pandemic. Most were overcome by the goodwill and dedication of the participating hospitals, however, one of the limitations of this study was the missing data due to incomplete follow-up questionnaires. Participants in some hospitals were not instructed to complete the follow-up questionnaires, which resulted in a lower response rate and reduced statistical power. We also could not ask participating hospitals to collect baseline data from participants prior to training mainly due to the prolonged burden on their services from the COVID-19 pandemic. Finally, it was not logistically possible to test the population impact of improved psychological well-being capacity by including survivors of natural disasters and public health emergencies. Instead, we will use an economic modelling approach to estimate the long-term resource use, cost and health outcomes based on the trial results and other sources. An ongoing economic modelling analysis will evaluate the long-term costs and benefits of the intervention for survivors of disasters and emergencies based on previously reported trial intervention costs.35

Conclusions/recommendations

The study demonstrated that the system based training programme was an impactful intervention that could strengthen the psychological well-being capacity and resilience of communities in China in disaster and emergency settings. The study also provided policy recommendations for integrating psychological well-being and psychosocial support into non-specialist health services and disaster response plans, based on the evidence from the evaluation.

Data availability statement

Data are available on reasonable request. Deidentified individual participant data (including data dictionaries) will be made available, along with the study protocol and statistical analysis plan. The data will be available to researchers who provide a methodologically sound proposal for analyses that are approved by an independent review committee identified for this purpose. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third-party website (https://zenodo.org/).

Ethics statements

Patient consent for publication

Ethics approval

Our research guaranteed the confidentiality and safety of participants. We did not share personal information to any third parties, such as agents or employers without their consent. The researcher provided information about the study and its aims to the participants before obtaining their informed consent. Participants provided oral consent before the study begins. This study protocol was approved by the Second Xiangya Hospital, Central South University Clinical Research Ethics Committee (2021) Ethical Review (Clinical Research) #067), and the trial protocol was registered with the China Clinical Trials Registry: ChiCTR2200060464 (URL: https://www.chictr.org.cn). Participants were able to withdraw from the study at any time and for any reason without prejudice.

References

Supplementary materials

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Footnotes

  • X @minpeng, @drbencarter

  • Contributors MP and JS contributed to the conception and design of the work, data acquisition, drafting the manuscript, final approval of the manuscript, and accountability for the work. BC contributed to the conception and design of the work, data analysis and interpretation, critical revision of the manuscript, final approval of the manuscript. TX contributed to data acquisition, and ethical approval, critical revision of the manuscript, final approval of the manuscript, and accountability for the work. TX contributed as a guarantor to accept full responsibility for the conduct of the study, had access to the data, and controlled the decision to publish.

  • Funding N/A

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.