Background
The Healthy China 2030 Plan [
1] outlines China’s 21st Century vision for healthcare and creates a favorable policy environment for mental health system reform of both national and global significance [
2,
3]. At its core, it acknowledges the symbiotic relationship between a healthy working population and economic success [
4]. It embodies key values of the United Nations’ Sustainability agenda [
2,
5] and aligns with the latest global thinking on “person-centered, integrated care” [
6‐
9]. Importantly, for a country with a sizable mental health treatment gap, where the vast majority of those with an identifiable mental health condition do not receive care [
10,
11], the plan prioritizes the need to improve mental health awareness and prevention along with ready access to mental health services [
12].
Shenzhen is a thriving metropolitan city located in Guangdong Province of China, just across the causeway from Hong Kong. Its population has rapidly expanded from 10.42 million people in 2010 to 17.56 million in 2020 with an average annual growth rate of 5.36% [
13]. It was one of China’s first special economic zones and is nationally renowned for its progressive socioeconomic reforms [
14,
15] which has transformed the region into a global commercial hub. Aware of increasing rates of mental disorders overall [
16‐
18] and above national levels of prevalence for depressive disorder in key working and vulnerable populations [
17,
19‐
23] (i.e. above 7.4%) [
24], the local health authority committed to improving the recognition and prevention of common mental disorders within its developing primary healthcare sector[
25]. Importantly, they invested in the upskilling of the GP workforce [
26‐
28] and sought to implement the service of at least one doctor with a mental health certification in each community health centre (CHC) by 2020 [
29]. Findings from qualitative research conducted with primary healthcare leaders in Shenzhen [
30], however, found that along with improved professional development, doctors at CHCs also needed better access to diagnostic guidelines and protocols for depression care.
Guidelines can be considered as a “synthesis of evidence” that have been shaped into “practice-oriented recommendations” and represent the “highest quality opportunity” for patient care [
31]. The sharing of guideline information, from one setting to another, avoids duplication of research efforts and optimizes on resource in underfunded settings [
32,
33] and, as such, has become a widely accepted approach for global progress in healthcare [
34]. One such guideline, the World Health Organization (WHO), Mental Health Gap Intervention Guide (mhGAP-IG) [
35] offers community health care centers in Shenzhen a rigorously developed and internationally approved resource [
36,
37] with which to train doctors on the assessment, management and follow-up of depression patients and other priority mental health conditions [
38,
39]. Now freely available in its second edition (although not in Mandarin Chinese), mhGAP-IG.v2 [
40] incorporates both evidence-based and financially affordable treatment options suitable for use in community and resource-poor settings.
mhGAP-IG.v2, however, is a generic tool and adoption needs to be accompanied by prior consideration of its context of use: “the physical, organizational, institutional and legislative structures that enable and constrain, resource and realize, people and procedures” [
41,
42]. Whilst a universal approach to the adaptation of mhGAP-IG is still evolving [
43], it is generally agreed upon that the consultation of end-users is integral for the appropriate adaptation and enhancement of future implementation [
38,
44,
45]. These pre-requisites are particularly relevant to China, where substantive organizational and operational change to the national healthcare system have produced a model of primary healthcare delivery unique to its developmental context.
For example, mhGAP-IG embodies aspirational global standards in mental health practice which have been shaped by an established acceptance and confidence for the close involvement of primary healthcare in the diagnosis and management of mental health conditions in upper income countries [
7,
46‐
48]. In contrast, primary healthcare doctors in China administer care without the legal authority to diagnose severe mental health conditions [
30,
49]. Neither do CHCs experience the operational autonomy of western clinics. Instead, they are tied into the management system of their district hospital which controls both their budget and drug formulary [
50]. Whilst Chinese psychiatrists were involved in the drafting of the initial mhGAP-IG, primary care representatives were not included in the consultation process and the guide may omit vital procedural or referral information in keeping with the realities of primary care prescribing practice.
Nor can the impact of culture on how different countries perceive, realise and respond to mental disorders at both a personal and system level, be ignored [
51]. Socio-political events in China’s past have conditioned current-day attitudes and behaviors that can act as barriers to the expression of, and health seeking for, depression [
52‐
54]. mhGAP-IG.v2 is closely aligned to international classification systems (e.g. ICD 10, DSM-IV) which were originally developed according to western presentation of disease in hospital settings and may not be sensitive enough to pick up cultural subtleties of disease presentation in community-based settings.
Whilst over 90 countries have seen the uptake of mhGAP-IG [
39], publications focusing on its adaptation for country-specific needs are in short supply. The Programme for Improving Mental Health Care (PRIME) initiated investigations into the use, adaptation and integration of mhGAP-IG resources into the primary care systems across low and middle income countries [
55,
56]. Since then, researchers based in Africa [
38,
57‐
59] and Nepal [
45] have endeavored to either contextualize or provide a culturally sensitive translation [
59] of the guide. This was commonly achieved by engaging key stakeholders in a multi-stepped review, generally led by mental health specialists or a discrete research team [
38,
57,
58] and including Primary care representatives in at least one stage of the adaptation process (i.e. as participants of preliminary qualitative focus groups [
38,
57] for prototype testing of a training program [
58].
This research uses the Delphi Approach, an established consensus methodology (see methods section for more details), to adapt the depression component of the mhGAP-IG.v2 for use by doctors working in community healthcare centres in Shenzhen, to take into account local culture and health system structure and reform. It signifies the completion of three phases of research, all of which have been conducted “
with primary care, for primary care”: from its conception with primary care leaders to explore the current needs for the improved management of depressive disorder in CHCs [
30]; to immersive workshops with primary care leaders to compare the depression guidelines with current conceptualisations of depression and clinical practice (awaiting publication); through to this Delphi study with the broader primary care community in Shenzhen.
It is unique amongst these adaptation studies by its intentional focus on the depression component only (i.e. one chapter of the guide). With the exception of one study in Nepal [
45], which focused on dementia, other key studies in this field were directed at reviewing the whole guide [
38,
57‐
59]. The advantage of this depression-only approach is the breadth and depth of items, generated from highly focused preliminary research that can be put forward for consensus testing. As such, there is potential to obtain the systematic consensus on guideline adaptations across a range of topical mental health system, depression symptom presentation and other complex care-related concepts, which have not been previously explored in this way. Importantly, it seeks to support local and global aspirations of reducing the mental health treatment gap in China.
In summary, this study occupies a vital bridge between international guidance on best practice for depression care and making knowledge relevant and acceptable for the end-user of the guide. To the best of our knowledge, it is the only mhGAP-IG.v2 adaptation study initiated in China within the primary healthcare sector.
Results
Demographics
Panelist characteristics: Overall, doctors had an average of 6 + years of formal general practice experience. In Wave 1, 15% of panelists personally held a mental health certificate and 57% had access to another GP with mental health certification within their CHC. In Wave 2, more panelists either held a mental health certificate (24%) or had access to another GP with mental health certification (68%). A sub-analysis confirmed that, during the course of the study, several panelists received mental health training and achieved certification as part of their health center’s commitment to “one mental health GP per centre”.
CHC characteristics: In general, panelists worked in a clinical team with an average of 7 to 8 doctors, although clinic size ranged widely from 1 to 20 doctors. Panelists in Wave 2 had a significantly lower patient load per week than those in Wave 1 (Wave 2: 176.3 patients/week versus Wave 1: 275 patients/week). Similarly, Wave 2 panelists also recorded fewer depression diagnoses (Wave 2: 1.9/week versus Wave 1: 2.7/week). A sub-analysis and follow-up telephone calls with several panel members confirmed a temporal change in health seeking behavior during the one-year interim between survey waves, which coincided with the Covid-19 epidemic. During this time, people were advised not to visit the doctor (unless in emergency) and doctors focused their time on the vaccine rollout.
Consensus overview
Upon completion of research, Panelists “somewhat agreed” with 158/199 proposed adaptions to the mhGAP-IG (overall adjusted mean score: 4.26 up from 4.25 in Wave 1). The adjusted mean scores for each domain ranged from 4.05–4.65 with statements relating to “Developing a patient-centred guide” receiving the highest adjusted mean score and “Follow-up” the lowest. In Wave 1, domains for “Developing a patient-centred guide” and “Bipolar disorder” received 100% consensus on all items. Thus the 47 items put forward for Wave 2 came from eight domains only. Further consensus was limited, with only between 17–31% of items clustered within three domains receiving further agreement. The domain with the most intra-wave movement was “Follow-up” where the percentage consensus increased from 64 to 73% across the two waves of research. Finally, no items, from any domain, in either wave of research, were rejected outright (i.e. scored either 1 or 2 by 80% or more doctors). (See Table
1).
Table 1
Wave 1 & 2 Delphi Survey Consensus by Thematic Domains
Overall Consensus | 199 | 76 | 4.25 | 47 | 13 | 3.66 | 79 | 4.26 |
1. Developing a Patient-Centred Guide | 18 | 100 | 4.65 | 0 | Na | Na | 100 | 4.65 |
2. Symptom Presentation of Depression | 28 | 64 | 4.07 | 10 | 0 | 3.50 | 64 | 4.06 |
3. Improving Access/Usage to Diagnostic Tools | 11 | 64 | 4.13 | 4 | 25 | 3.80 | 73 | 4.24 |
4. Healthcare and Community Interconnectivity | 28 | 79 | 4.23 | 6 | 17 | 3.75 | 82 | 4.26 |
5. Considering Pharmacological Interventions | 18 | 78 | 4.20 | 4 | 0 | 3.51 | 78 | 4.19 |
6. Considering Mania and Depressive Episode in Bipolar Disorder | 4 | 100 | 4.59 | 0 | Na | Na | 100 | 4.59 |
7. Communicating Depression to Patients and the Community | 29 | 90 | 4.36 | 3 | 0 | 3.77 | 90 | 4.36 |
8. Follow-Up | 33 | 61 | 4.03 | 13 | 31 | 3.64 | 73 | 4.05 |
9. Managing Patient Information | 11 | 82 | 4.20 | 2 | 0 | 3.73 | 82 | 4.20 |
10. Overall Structure of an Adapted Guide | 19 | 74 | 4.06 | 5 | 0 | 3.61 | 74 | 4.06 |
Domain specific results
Table
2 outlines panelists’ recommendations for adaptations to mhGAP-IG.v2 based on statements that received consensus after two waves of Delphi survey. It is grouped by domain (ten in total) and listed according to decreasing mean score for overall domain agreement. Full listings of items, with and without consensus, are available as Additional file
1: Tables S3 and S4.
Table 2
Primary care recommendations for an adapted mhGAP-IG.v2
Rank ordered by mean score | Based on all items receiving consensus after two waves of Delphi survey (Wave 1: 75 CHC doctors; Wave 2: 59 CHC doctors) |
Developing a patient-centered guide | 1.1 Not just patient-centred but person-centred Ensure patient privacy Sensitive to events in patients life (i.e. grief) Accommodate for patient diversity 1.2 Provide a personalised patient management plan (PMP) developed in partnership with the patient flexible to evolve over time to suit patient needs outlines several strategies to elicit positive behaviour change 1.3 PMP to incorporate doctor, patient and administrative outcomes:- Doctor review of treatment progress (e.g. drug side effects, treatment changes) patient’s treatment evaluation (e.g. treatment experience and engagement with therapy) administrative tracker (e.g. consultation appointments and potential referral options) 1.4 Doctor with mental health certification to develop PMP template 1.5Address contextual differences Consider suicide risk as a priority Highlight family involvement in every stage of care Provide specific examples of patient success stories from Shenzhen |
Depressive episodes in bipolar disorder | 2.1 Differentiate between treatment practice for (uncomplicated) depression and depressive episode in bipolar disorder mood stabilizer required as an adjunct to antidepressant treatment 2.2 Check for symptoms of mania with the patient or with family members |
Communicating depression to patients and the community | 3.1 Doctors to play a role in improving community awareness and health literacy 3.2 Stronger emphasis of the role of family in patient support 3.3 Include strategies for CHC to monitor patients at risk of suicide 3.4 Expand content of patient psychoeducation include approaches to develop patient trust (e.g. listening with empathy) address any misconceptions about the disease provide treatment success stories prepare patients for community stigma discuss the importance of treatment adherence provide advice on engagement with activities encourage attendance of follow-up appointments with CHC/specialists agree to a management/healthcare plan provide advice on self-care Consider implementing an appointment system |
Healthcare interconnectivity | 4.1 Highlight community involvement with monitoring patients at risk of suicide 4.2 Clarify referral pathways and the division of professional responsibilities 4.3 Highlight opportunities for medical and non-medical intersectorial care* 4.4 Reference involvement of family as a component of intersectorial care 4.5 Include a reminder to keep the patient central to all discussions |
Access/usage to depression questionnaires | 5.1 Recommend questionnaire usage during management and/or/both follow-up 5.2 Questionnaires conducted in a private consultation room 5.3 Doctors & nurses can administer questionnaire (assuming training provided) 5.4 Clarify scope for tools (i.e. multiple times? non-clinic settings?) |
Managing patient information | 6.1 Review a patient’s history before consultation and update patient records 6.2 Supplement information from patient management system if necessary 6.3 Validate patients’ treatment with specialists, other treating doctors, family members or by sighting medication 6.4 Hold regular in-clinic meetings to discuss difficult cases with other doctors |
Considering pharmacological interventions for depression | 7.1 Address Dr’s role with regards to monitoring and changing drug dose 7.2 Include indication and side effect profiles for each drug group 7.3 Include drug availability & reimbursement status for each drug group 7.4 Include adherence advice for each drug group 7.5 Provide details of latest generation of drugs 7.6 Provide Chinese brand names 7.7 Add information for Benzodiazepines |
Symptom presentation of depression | 8.1 Guide should “reflect a real-life consultation” consider whether a patient had had a previous episode of depression ascertain details of relationship problems (including grief) assess patient’s risk of suicide early in consultation consider physical symptoms first 8.2 Include triggers and risk factors for depression 8.3 Diagnosis based on “a symptom spectrum rather than core symptoms alone” merge both the core and additional symptoms into one listing include loss of libido in symptom listing order the list by good predictors of depression/commonly seen symptoms provide additional details of symptom profile changes over time 8.4 Structural clarity to differentiate between physical and mental symptoms 8.5 Additional symptom information required for children 8.6 Careful quantifications/translations required for “sleeping too much” “talking and moving more slowly than usual” |
Overall structure | 9.1 Some or major restructuring needed to better reflect the context of use 9.2 Emphasise intersectorial involvement including family/community network 9.3 Highlight differences between depression and a depressive episode in bipolar disorder 9.4 Integrate follow-up and management into one continuous section 9.5 Commence assessment with consideration of patients at high risk of suicide 9.6 Place the patient at the centre of the guide |
Follow-up | 10.1 Define follow-up and explain why it is necessary to determine a patient’s treatment status to establish previous therapy/treatments received to monitor current treatment side effects & assess for improvement 10.2 Explain how to assess for improvement:- i.e. itemise signs of improvement 10.3 Highlight key CHC outcomes to be achieved from follow-up consultation options for basic psychotherapy at CHC level referral options for either psychological interventions/drug treatment 10.4 Itemise modes of follow-up contact (face-to-face, telephone, electronic) 10.5 Recommend preferred mode of consultation contact ideally, face-to-face follow-up for all patients at least, face-to-face for all those with serious conditions patient’s preference for non-emergency cases 10.6 Frequency and duration of contact determined by depression severity, risk of self harm and treatment compliance |
Of highest approval was developing a patient-centred guide. Panelists consented to an “in principal” person-centred approach to care with additional emphasis given to patient privacy, sensitivity towards patient diversity and personal events of significance. To achieve this, they supported the provision of a patient-led management plan and agreed it should include both patient-led outcomes, doctors’ clinical feedback and administrative milestones. As this is not current practice in Shenzhen, they allocated responsibility for template development to be held by the CHC doctor with mental health certification. They also universally agreed that guidelines should emphasize suicide as a priority concern in primary care and the active involvement of family in care. These two elements reflect unique differences between “norms” in China’s primary care health system and mhGAP-IG.v2.
Panelists unanimously consented to incorporating all information in mhGAP-IG.v2 relating to differential needs for the treatment of a depressive episode in bipolar disorder. Again, they highlighted the importance of involving family in the guidelines for care by actively asking for their input regarding mania symptoms.
To be more relevant for the Shenzhen context, panelists wanted to expand the mhGAP-IG.v2 scope to approve doctors’ role to educate patients, family and community members about depression as an important step to improving overall health literacy. Furthermore, they endorsed CHC doctors playing a leading role with monitoring suicide in the community supported by the inclusion of additional strategies. They consented to updating the section on psycho-education to further contextualise it for use in Shenzhen, with a particular need to address establishing patient trust. Panelists saw fit to use the guide to promote using an appointment system as a practical solution to improve access to doctor time.
Two key changes to mhGAP-IG.v2 were agreed upon to enhance healthcare interconnectivity and demonstrate a context-specific commitment to intersectorial care. Firstly, the flowcharts relating to referral options should encompass a wide range of medical and non-medical services (e.g. schools; police; social services; work-place support groups; voluntary organisations; other mental health support services; disabled persons federation). Secondly, family members need to be incorporated as key components of intersectorial care. Importantly, the schema of the guide should also project a sense of keeping the patient central to decision-making.
Panelists took the opportunity to expand the guidelines to provide advice on the potential use of depression screening tools to support a depression diagnosis (i.e. by whom; at what stage of care; how often; in what settings). Practical measures to improve the management of patient information were also approved, such as validating patient treatments directly with patient and/or treating doctors. Additionally, they endorsed the practice of case sharing with other doctors within the same clinic.
With regards to adapting the table of pharmacological treatments for depression, experts concurred that drug listings should provide Chinese brand names and include the latest generation products. As well as standard product indications and side effect profile information contained within the current guide, CHC doctors had additional information needs to cover product availability (CHC versus hospital), reimbursement status and compliance advice. Contrary to the current focus on antidepressants only, panelists conceded to introducing information on Benzodiazepines. Importantly, they agreed that drug information should be preceded with a clarification of the CHC doctor’s role in monitoring and changing antidepressant treatment.
Whilst Panelists struggled to come to agreement on all of the items relating to depression presentation, they consented to a conceptual change to diagnostic practice such that diagnosis should be based on a spectrum of symptoms rather than core symptoms alone. They endorsed a key structural change to the assessment section (i.e. merging core and additional symptoms into one listing). Whilst they did not concede to expanding the content of the merged listing to include anxiety and a range of depression-related behavioral symptoms (e.g.. weeping) (See additional files for non-consensus items), other agreements portrayed a preference to reflect a real life consultation and the use of risk factors to support recognition of depression. It was agreed that children would need additional information.
Several structural changes to the overall guide were recommended, particularly relating to the algorithms for follow-up practice, which do not currently resemble the CHC reality. Panelists approved statements to merge the management and follow-up sections of the current guide. Additional educational elements would need to be added to the new section: to define the purpose of follow-up; to explain how to assess for improvement; and to provide outcome measures such as context-specific referral options to care. Details relating to frequency, duration, and appropriate mode of follow-up contact were also needed. Panelists reinforced the need to bring suicide to the forefront of the guide and embed family as part of the cycle of care. Furthermore, any changes are not to deflect from the intrinsic principle of keeping patients central.
Limitations
Several limitations of this study are closely related to the COVID-19 pandemic, which spanned the duration of research and directly impacted research feasibility. Wave 1 research coincided with the national call to action for GP panelists to conduct COVID testing and contact tracing of approximately 1 million people who had travelled between Wuhan (the geographic source of the epidemic) and Shenzhen prior to Wuhan’s lockdown [
92‐
95]. Throughout 2020 healthcare services were heavily in demand (to administer care and support vaccine roll-out) and international relations between China and Australia deteriorated [
96‐
99] with the following consequences:
(i)
It was not practically feasible, nor ethically appropriate, to initiate the second wave of the survey during much of 2020. This delay, from a pre-planned interval of one month to nearly one year, potentiated a drift in doctors’ perspectives on depression (i.e. confounding) and saw health system changes (e.g. increase in doctor mental health certifications; changes within CHC leadership) which are hard to adjust for in the analysis.
(ii)
A loss in panel retention by 21%, although the rate of attrition remained higher than in many panel-based studies conducted in Western countries. Fortunately, the study design over-recruited to allow for a potential loss to follow-up, thus the final number of participants [
59] was of sufficient magnitude and included a good spread of panelists from across geographic areas to substantiate findings. This remained well above the recommended minimum panel size (e.g. 10–18) [
61] and number for panel stability (e.g. 23) [
60] for a Delphi Study.
(iii)
A pragmatic decision was taken to terminate the study after two waves of on-line survey with the result that 21% of items remained without further consensus. Whilst many Delphi studies continue to a third wave to fulfil the methodological principle of consensus testing [
63], it is not unusual to conduct an adapted, two-wave Delphi study in the mental health research sector [
100,
101] due to the cost to benefit ratio of successive waves of research. In this case, two waves of research produced only a tiny change in consensus (1%) and it could be argued that any further research would generate smaller or near negligible changes in viewpoint. Additionally, the body of information produced by the 76% of statements achieving consensus provides abundant, specific and detailed direction for the commencement of guideline adaptation.
This research was designed to obtain the perspectives of primary care physicians only. However, depression care cannot be provided in isolation and further development of the guide would ideally seek advice from multiple stakeholders including the specialist team that receive the referrals, the local services which strive to rehabilitate patients back into the community and, most importantly, persons who live with the day-to-day reality of the condition.
Finally, translation of some concepts/items from the source workshops may have been difficult for primary care doctors to understand. To minimise translation concerns, however, all items were back-translated by an experienced translator and tested prior to fieldwork by two bilingual doctors, working in CHCs in Shenzhen.
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