Hepatitis B virus (HBV) infection is an important public health issue. Hong Kong’s universal HBV immunisation programme for newborns began in 1988.1 This programme consists of administering hepatitis B immunoglobulin (HBIg) to infants born to hepatitis B surface antigen (HBsAg)–positive mothers, along with the first dose of the HBV vaccine at birth. The second and third doses of the vaccine are typically given in Maternal and Child Health Centres at 1 and 6 months, respectively. Notably, the proportion of HBsAg-positive pregnant women has steadily decreased in recent years, from 5.2% in 20162 to 2.4% in 2023 (unpublished data). Despite a 99.8% HBsAg screening rate among antenatal women, together with 99.5% coverage for both HBIg and HBV vaccinations in newborns of HBsAg-positive mothers,2 a local study3 of 641 HBsAg-positive pregnant women showed that the overall mother-to-child transmission (MTCT) rate remained 1.1%, indicating immunoprophylaxis failure. To align with the World Health Organization’s (WHO) goal of eliminating viral hepatitis as a public health threat by 2030,4 and specifically to achieve the WHO target of <0.1% HBsAg prevalence among 5-year-old children by that year, further reduction of MTCT of HBV has been targeted by the multidisciplinary Steering Committee on Prevention and Control of Viral Hepatitis, established in 2018 and chaired by the Director of Health and the Chief Executive of Hospital Authority.5 As an obstetrics representative on the Steering Committee, the first author had the opportunity to present a literature review for use in formulating the action plan. Three strategies were considered: (1) maintaining the current approach of administering HBIg and HBV vaccinations to newborns of HBsAg-positive mothers, (2) conducting another randomised controlled trial on the use of tenofovir in further prevention of MTCT of HBV, and (3) implementing a universal programme to use tenofovir for this purpose. Although two major randomised controlled trials,6 7 both published in The New England Journal of Medicine, appeared to reach conflicting conclusions, the MTCT of HBV rates were zero in both the Mainland China study6 (n=92, per-protocol) and the Thailand study7 (n=147). The safety of tenofovir in pregnancy has also been established. Rebound increases in alanine aminotransferase after tenofovir discontinuation were mild in most cases (acute hepatic exacerbation, defined as alanine aminotransferase elevation of >300 IU/L, occurred in 6% of the tenofovir group vs 3% of the control group7). The administration of antivirals to HBsAg-positive pregnant women with high HBV DNA levels has been recommended by the American Association for the Study of Liver Diseases, European Association for the Study of the Liver, Asian Pacific Association for the Study of the Liver, and Advisory Committee on Immunization Practices.5 Despite these recommendations, the WHO had not made any recommendations by 2018. The Steering Committee ultimately decided to proceed with option 3.5

All HBsAg-positive pregnant women with an HBV viral load >200 000 IU/mL will receive an early referral to the corresponding hepatology clinic under Hospital Authority to discuss starting tenofovir (tenofovir disoproxil fumarate; United States Food and Drug Administration pregnancy category B8) by 28 weeks of gestation to further reduce the risk of MTCT of HBV. This programme began as a pilot at Queen Mary Hospital and Prince of Wales Hospital in the first quarter of 2020; it was expanded to Pamela Youde Nethersole Eastern Hospital, Kwong Wah Hospital, Queen Elizabeth Hospital, Princess Margaret Hospital, United Christian Hospital, and Tuen Mun Hospital in the third quarter of 2020.5 In this issue of the Hong Kong Medical Journal, Cheung et al9 published the 2024 Hong Kong College of Obstetricians and Gynaecologists guideline on antenatal screening and management of hepatitis B to prevent MTCT, summarising current clinical practices in Hong Kong. This evidence-based guideline aligns with the core strategy of reducing MTCT risk in the Hong Kong Viral Hepatitis Action Plan 2020-2024.10 Additionally, the guideline addresses important issues such as immunoprophylaxis failure, antenatal management, and the indications for and duration of continued antiviral treatment after delivery. We strongly encourage our readers to incorporate the recommendations of the Hong Kong College of Obstetricians and Gynaecologists into their clinical practice.

Between September 2020 and December 2022, a total of 2151 HBsAg-positive pregnant women attended Hospital Authority antenatal clinics.11 Among them, 328 (15.2%) had a high viral load (HBV DNA >200 000 IU/mL) and were referred to hepatologists, and 314 (95.7%) of these pregnant women attended hepatology clinics. After consultation with hepatologists, most women (n=292, 93.0%) accepted tenofovir prophylaxis.11 Among those who refused tenofovir after consultation, common reasons included concerns about potential side-effects on the fetus and fears of hepatitis flare-ups after postpartum discontinuation of tenofovir.11

A key aspect of outcome assessment is post-vaccination serology testing, which will be performed in infants after they complete the full course of vaccination. Infants born to HBsAg-positive mothers will be recruited from Maternal and Child Health Centres and referred to the Hong Kong Children’s Hospital for blood tests. We anticipate favourable results, confirming the elimination of MTCT of HBV in Hong Kong by 2030!

Both authors contributed equally to the development of the manuscript. Both authors had full access to the data, contributed to the study, approved the final version for publication, and take responsibility for its accuracy and integrity.

Both authors have declared no conflicts of interest.

This editorial received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

1. Wong VC, Ip HM, Reesink HW, et al. Prevention of the HBsAg carrier state in newborn infants of mothers who are chronic carriers of HBsAg and HBeAg by administration of hepatitis-B vaccine and hepatitis-B immunoglobulin. Double-blind randomised placebo-controlled study. Lancet 1984;1:921-6. Crossref

2. Department of Health, Hong Kong SAR Government. Surveillance of Viral Hepatitis in Hong Kong: 2022 Report. 2023. Available from: https://www.hepatitis.gov.hk/english/health_professionals/files/hepsurv22.pdf. Accessed 8 Oct 2024.

3. Cheung KW, Seto MT, Kan AS, et al. Immunoprophylaxis failure of infants born to hepatitis B carrier mothers following routine vaccination. Clin Gastroenterol Hepatol 2018;16:144-5. Crossref

4. World Health Organization. Global Hepatitis Report 2017. Geneva: Global Hepatitis Programme; 2017. Available from: http://apps.who.int/iris/bitstream/10665/255016/1/9789241565455-eng.pdf?ua=1. Accessed 27 Sep 2024.

5. Leung WC. Use of tenofovir in further prevention of mother-to-child-transmission of hepatitis B virus. Hong Kong Med Diary 2020;25:11-5.

6. Pan CQ, Duan Z, Dai E, et al. Tenofovir to prevent hepatitis B transmission in mothers with high viral load. N Engl J Med 2016;374:2324-34. Crossref

7. Jourdain G, Ngo-Giang-Huong N, Harrison L, et al. Tenofovir versus placebo to prevent perinatal transmission of hepatitis B. N Engl J Med 2018;378:911-23. Crossref

8. United States Food and Drug Administration. Prescribing information: tenofovir disoproxil fumarate tablets, for oral use. Revised 2017. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/pepfar/078800PI.pdf. Accessed 9 Oct 2024.

9. Cheung KW, So PL, Mak LL, et al. 2024 Hong Kong College of Obstetricians and Gynaecologists guideline on antenatal screening and management of hepatitis B for prevention of mother-to-child transmission. Hong Kong Med J 2024;30:400-8. Crossref

10. Department of Health, Hong Kong SAR Government. Hong Kong Viral Hepatitis Action Plan 2020-2024. 2020. Available from: https://www.hepatitis.gov.hk/doc/action_plan/Action%20Plan_Full%20Version_PDF_en.pdf. Accessed 8 Oct 2024.

11. Tsui WM, Leung WC, Kung KN, Lai CH. Antiviral prophylaxis for the prevention of mother-to-child transmission of hepatitis B virus. Hospital Authority Convention 2024 poster presentation F3_3.34. Available from: https://d1j0dbg7fhovrj.cloudfront.net/assets/haconvention2024/filemanager/images/1712735576F_P3.34_TSUIWaiManVivien.jpg. Accessed 27 Sep 2024.

In Hong Kong, 50% to 60% of the population consulted traditional Chinese medicine (TCM) practitioners at least once in their lives notwithstanding the wide availability of services from Western medicine (WM).1 A study has shown the concomitant use of TCM and WM by 25.9% of patients in Hong Kong.2 There is a need for better integration clinically and legally, especially when both WM and TCM practitioners are uncertain of their liabilities if any medico-legal incidents arise during co-care. Application of various common-law elements of negligence (duty of care, standard of care, causation and foreseeability) would help to develop deeper insights into how liabilities would fall on different parties.

When a patient comes to consult a practitioner, WM or TCM, a doctor-patient relationship is arguably already established. If a patient is under the co-care with prescriptions of both TCM and WM, who owes the duty of care to the patient? A three-pronged test can be used to determine the duty of care3:

the proximity (sufficient close) in the relationship between the claimant (patient) and the defendant (practitioner);

damage being reasonably foreseeable; and

whether the court considers it fair, just and reasonable to impose a duty of the given scope upon the defendant practitioner.

Who has the closest relationship with the patient claimant for a particular management? For instance, a patient consulted a WM doctor for back pain with no significant abnormalities detected, and the patient was advised bed rest, with sick leave certification and analgesia if needed. The patient then consulted a TCM practitioner and was prescribed some herbal medicine to take regularly. The patient also took analgesia, and s/he developed an allergic reaction. Who should owe a greater duty of care? Likewise, a patient consulted TCM for health maintenance with a prescription of TCM supplements. The patient then had a bad cough and was diagnosed with bronchitis by a WM doctor, who prescribed a course of antibiotics. The patient developed severe diarrhoea. Which practitioner owed a greater duty of care?

It is the submission of the authors that in the back pain case, the TCM practitioner may have had a closer relationship with the patient claimant upon initiation of regular treatments. The TCM practitioner should ask firstly whether the patient has been prescribed any medication. In the bronchitis case, the WM doctor may have had a closer relationship and should enquire about any concurrent medication including supplements. The patient claimant then bears the burden of proof with respect to whether the medication is likely to cause damage (causation). The defendant practitioner could defend against the claimant’s allegations with scientific evidence. If the best available evidence has not revealed any significant adverse drug interaction, the court may not see it “fair, just and reasonable” to impose a duty on the defendant practitioner (reasonable standard of care).

In WM, the Bolam test is applied, where a doctor is “not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”.4 Traditional Chinese medicine practitioners hold themselves as practitioners specialised in treatment of certain health conditions, and they might use methods not in perfect line with WM practices, and patients look for TCM because they prefer not to receive WM, should the Bolam test also apply, or should TCM follow its own specific standard of care?5 Let us consider three cases to provide some insights.

In the United Kingdom, Abdur Shakoor was treated by Situ, an herbalist (TCM practitioner) with 5 years’ experience in China possessing both a traditional “medicine” and “modern” medical qualifications, but no British professional medical qualifications. Situ prescribed a course of Chinese herbal remedies for Shakoor’s lipoma.6 Shakoor got very ill and died of liver failure. Post-mortem examination found that his liver contained Bai Xian Pi (白蘚皮), or Dictamnus dasycarpus, which could be hepatotoxic as published in western journals. The judge concluded that as long as the herbalist has complied with the United Kingdom’s laws, not prescribing substances prohibited or regulated by statutes, and taking steps to keep abreast of pertinent information in TCM textbooks and periodicals, this would fulfil the standard of care of a reasonable herbalist.6

In Singapore, Lim Poh Eng,7 a TCM practitioner, was charged criminally negligence in having caused grievous harm to a patient by prescribing colonic washouts without proper training in the procedure and use of equipment, and without any understanding of the risks and complications involved. Lim was convicted after trial and failed on appeal to argue that the standard of negligence in criminal cases should be higher than the civil standard. The High Court ruled that a TCM practitioner embanking on management without prior knowledge and training can be found negligent.

Practitioners providing TCM or complementary and alternative medicine for management should provide evidence to create a hypothetical standard of care, otherwise the same standard will apply as WM. A United States case, Gonzalez,8 provides a legal reference. Dr Gonzalez (defendant doctor) initiated a cancer treatment including pancreatic enzymes, specific diets, vitamin and mineral supplements, animal organs extracts, and coffee enemas. Such departure from good and accepted medical practice was a proximate cause of the claimant’s injuries. If the treatment risks and the alternatives had been appropriately given, a reasonably prudent person in the claimant’s position would not have agreed.

The Bolam4 test can still be applied to TCM/complementary and alternative medicine, in accordance with the standard of care provided by responsible TCM practitioners skilled in that particular field. This is particularly important for the ‘but for’ test to prove causation: “but for the defendant’s negligence, would the claimant suffer injuries?” In a claim, the claimant bears the burden of proof, and the defendant doctor can adduce expert opinions to rebut. In the United Kingdom case Wilsher v Essex,9 a junior doctor mistakenly inserted a catheter into a vein instead of an artery in a preterm baby for oxygen monitoring and excess oxygen was given, which may be a possible cause of blindness but not a definite cause. So, the claim failed in causation. The damage must not be too remote or unforeseeable as in Goodwill,10 where a doctor did not owe a duty of care for contraceptive advice to the person having sexual relationship in future after vasectomy.

Healthcare practitioners can refer to the basic doctrine of bio-medical ethics to avoid medical mishaps.11 Identification of the ‘material risk’ in adopting ‘patient-centred’ care, particularly after the leading judgement of Montgomery12 in the United Kingdom Supreme Court, would enable both WM and TCM practitioners to understand why patients seek alternative treatments in line with the principles of autonomy and also justice and fidelity,13 acting for the best interests for patients. However, patients should understand the limitations that practitioners of TCM and WM might not fully comprehend the practices on other side. They can only advise on the benefits of treatment of their own specialities as well as the potential harmful effects (beneficence and non-malfeasance). It is the authors’ submission that it is not fair, just and reasonable to ask WM doctors to be liable for any harmful effects of treatment under TCM and vice versa.

There is also concern of liability of referring patients from each side. The basic principle is whether the alternative therapeutic options are generally accepted within the medical community and a referral to a medical specialist usually does not attract malpractice liability, so referring doctors ought to know, through reasonable inquiry, the credentials of the practitioner to whom they refer.14 Another concern is vicarious liability if the TCM practitioners are employed by or affiliated with an institution. A key factor is the degree of control that Chief Medical Executives, usually WM doctors, have over TCM practitioners. United Kingdom court cases provide good references. In Barclays Bank, the Supreme Court held that the bank was not vicariously liable by having referred its employees to doctors for pre-employment check if an employee was subsequently sexually harassed by a doctor referred.15 In Christian Brothers, the Supreme Court discussed the test of control that “[m]any employees apply a skill or expertise that is not susceptible to direction by anyone else in the company that employs them. Thus, the significance of control today is that the employer can direct what the employee does, not how he does it.” (para 36).16 Chief Medical Executives can only control that their TCM practitioners comply with law and regulations, but not how those practitioners consult with patients. This is particularly important when a complaint is filed against a Chief Medical Executive regarding the performance of a TCM practitioner.

When patient is under co-care of a TCM practitioner and a WM doctor, there should be clear delineation of the duties and standard of care in those particular circumstances. Regulatory bodies should examine causation under co-care to determine issues of liability. If a WM/TCM practitioner embanks on management under other’s domain, the standard of care required is that of an ordinary skilled person exercising and professing to have the special skill as in Lim7 and Wilsher9 (the House of Lords held that a junior doctor owes the same duty of care and standard of care as a qualified doctor). Structured inter-professional education and research can drive integration with better understanding of the clinical science of each other.17 18 With the integrated Chinese-Western Medicine Programme executed by the Hospital Authority for cancer care, stroke, and low back pain since 2014, an integrated healthcare framework should be shared among the key stakeholders to ensure patient safety for definition of clear professional boundaries and roles.

All authors have contributed to the concept, review and analysis of literature and critical revision of the manuscript for important intellectual content. A Lee is responsible for the first draft. All authors had full access to the data, contributed to the study, approved the final version for publication, and take responsibility for its accuracy and integrity.

All authors have disclosed no conflicts of interest.

Content in this presentation is intended solely to provide general discussion concerning medico-legal perspective of Integrated Chinese and Western Medicine. It is not intended as legal or medical advice. Legal or medical advice should be obtained from qualified legal counsel or other professionals to address specific facts and circumstances and to ensure compliance with applicable laws and standards. This paper is written in personal capacity of the authors and the opinions expressed therein do not represent the organisations which they work for or affiliated with.

This editorial received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

1. Wong W, Lam CL, Bian XZ, Zhang ZJ, Ng ST, Tung S. Morbidity pattern of traditional Chinese medicine primary care in the Hong Kong population. Sci Rep 2017;7:7513. Crossref

2. Leung GK, Wong SW, Ng GK, Hung KN. Concomitant use of Western and Chinese medicine treatments in neurosurgical patients in Hong Kong. Chin J Integr Med 2011 Jul 30. Crossref

3. Caparo Industries plc v Dickman [1990] UKHL 2 (House of Lords).

4. Bolam v Friern Health Management Committee [1957] 1 WLR 582 (Queen’s Bench).

5. Raposo VL. Complementary and alternative medicine, medical liability and the proper standard of care. Complement Ther Clin Pract 2019;35:183-8. Crossref

6. Estate of Shakoor (deceased) v Situ (t/a Eternal Health Co) [2001] 1 WLR 410; All ER 181 (Queen’s Bench).

7. Lim Poh Eng v Public Prosecutor [1999] 1 SLR(R) 428 (High Court).

8. Charell v Gonzalez [1997] 173 Misc.2d 227; 660 N.Y.S. 2d 665 (N.Y. Sup.Ct.1997) (Supreme Court of New York).

9. Wilsher v Essex [1988]. AC 1074 (House of Lords).

10. Goodwill v British Pregnancy Advice Service [1996] 7 Med LR 129 (Court of Appeal).

11. Beauchamp TL, Childress JF. Principles of biomedical ethics. Oxford (Great Britain): Oxford University Press; 1989.

12. Lee A. ‘Bolam’ to ‘Montgomery’ is result of evolutionary change of medical practice towards ‘patient-centered care’. Postgrad Med J 2017;93:46-50. Crossref

13. Tarvydas VM, Cottone RR. The Code of Ethics for Professional Rehabilitation Counselors: what we have and what we need. Rehabil Couns Bull 2000;43:188-96. Crossref

14. Cohen MH. Legal and ethical issues in complimentary medicine: a United States perspective. Med J Aust 2004;181:168-9. Crossref

15. Barclays Bank plc v Various Claimants [2020] UKSC 13 (Supreme Court).

16. The Catholic Child Welfare Society and others v Various Claimants (FC) and The Institute of the Brothers of the Christian Schools and others [2012] UKSC 56 (Supreme Court), UK (“Christian Brothers”).

17. Chiu SW, Sze TO. Revival or innovation? Chinese medicine at the crossroads of professionalization in Hong Kong. SSM–Qualitative Research in Health 2021;1:100004. Crossref

18. Perharic-Walton L, Murray V. Toxicity of Chinese herbal remedies. Lancet 1992;340:674. Crossref

At least 1 in 10 people worldwide is living with a kidney disease.1 According to the Global Burden of Disease study, >3.1 million deaths were attributed to kidney dysfunction in 2019, making it the seventh leading risk factor for mortality worldwide (Fig 1 and online supplementary Fig).2 However, global mortality from all kidney diseases may actually range from 5 to 11 million per year if the mortality rate also includes estimated lives lost from acute kidney injury and lack of access to renal replacement therapy for kidney failure (KF), especially in lower-resource settings.3 These high global mortality rates reflect disparities in prevention, early detection, diagnosis, and treatment of chronic kidney disease (CKD).4 Mortality rates from CKD are especially high in some regions, particularly Central Latin America and Oceania (islands of the South Pacific Ocean), highlighting the need for urgent action.5

Chronic kidney disease also represents a substantial global economic burden, with exponentially increasing costs as CKD progresses, due to the costs of dialysis and transplantation, as well as multiple co-morbidities and complications that accumulate over time.6 7 In the United States, Medicare fee-for-service spending for all beneficiaries with CKD was US$86.1 billion in 2021 (22.6% of total expenditures).8 Data from many lower-resource settings, where most healthcare spending comprises out-of-pocket costs, are absent. A recent study in Vietnam showed that the perpatient cost of CKD was higher than the gross domestic product per capita.7 In Australia, it has been estimated that early diagnosis and prevention of CKD could save the health system AU$10.2 billion over 20 years.9

Although there is regional variation in the causes of CKD, the risk factors with the highest population-attributable factors for age-standardised CKD-related disease-adjusted life years are hypertension (51.4%), a high fasting plasma glucose level (30.9%), and a high body mass index (26.5%).10 These risk factors are also leading risk factors for mortality worldwide (Fig 1). Only 40% and 60% of people with hypertension and diabetes, respectively, are aware of their diagnosis; considerably smaller proportions of these individuals are receiving treatment and reaching therapeutic targets.11 12 Moreover, at least 1 in 5 people with hypertension and 1 in 3 people with diabetes also have CKD.13

Most cases of CKD can be prevented through healthy lifestyles, prevention and management of risk factors, avoidance of acute kidney injury, optimisation of maternal and child health, mitigation of climate change, and efforts to address social and structural determinants of health.3 Nevertheless, the benefits of some of these measures may only be evident in future generations. Until then, early diagnosis and risk stratification create opportunities to introduce therapies that can slow, halt, or even reverse CKD.14 It is concerning that CKD awareness is particularly low among individuals with kidney dysfunction, such that approximately 80% to 95% of such patients worldwide are unaware of their diagnosis (Fig 2).15 16 17 18 19 20 Therefore, people are dying because of missed opportunities to detect CKD early and deliver optimal care.

Furthermore, CKD is a major risk factor for cardiovascular disease; during kidney disease progression, cardiovascular death and KF become competing risks.21 Indeed, data from the 2019 Global Burden of Disease Study showed that more deaths were caused by kidney dysfunction–related cardiovascular disease (1.7 million deaths) than by CKD itself (1.4 million deaths).2 Therefore, cardiovascular disease management should also be prioritised for people with CKD.

Strategies to prevent and treat CKD have been established on the basis of strong evidence collected over the past three decades (Fig 3).19 22 Clinical practice guidelines for CKD are clear; however, adherence to these guidelines is suboptimal (Fig 2).15 19 20

Regardless of aetiology, management of major risk factors, particularly diabetes and hypertension, forms the basis of optimal care for people with CKD.19 23 In addition to lifestyle changes and risk factor control, the earliest pharmacological agents to demonstrate kidney protection were renin-angiotensin-aldosterone system inhibitors in the form of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers.14 19 Despite decades of knowledge that these medications have substantial protective effects on renal and cardiovascular function in people with CKD, real-world data from electronic health records show that their use remains low (Fig 2). For example, in the United States, ACEI and angiotensin receptor blocker utilisation rates ranging from 20% to 40% were reported ≥15 years after the most recent approval of these agents for patients with CKD and/or type 2 diabetes.24 Although more recent data show that prescribing rates in this population have improved to 70%, only 40% of such patients continue taking an ACEI or angiotensin receptor blocker for at least 90 days.20 These data indicate gaps in prescribing nephroprotective medication and continuity of care over time, potentially related to cost, lack of patient education, polypharmacy, and adverse effects.25

Although the initial enthusiasm for sodium-glucose cotransporter 2 (SGLT2) inhibitors focused on their benefits for diabetes and cardiovascular disease, unprecedented therapeutic benefits have also been observed regarding CKD. Relative risk reduction levels with SGLT2 inhibitors approach 40% for substantial decreases in estimated glomerular filtration rate, KF, and mortality among populations with several types of CKD, heart failure, or elevated cardiovascular disease risk.26 27 These decreases were observed in addition to benefits from standard-of-care risk factor management and renin-angiotensin-aldosterone system inhibitors. The risks of heart failure, cardiovascular death, and all-cause mortality were also reduced in patients with CKD during SGLT2 inhibitor treatment.26 The addition of SGLT2 inhibitors to renin-angiotensin-aldosterone system inhibitor–based treatment was able to delay the need for renal replacement therapy by several years, depending on the initial timing of combined treatment.28 Moreover, for every 1000 patients with CKD who received an SGLT2 inhibitor in addition to standard therapy, 83 deaths, 19 heart failure–related hospitalisations, 51 instances of dialysis initiation, and 39 episodes of acute renal function worsening were prevented.29

The persistent underuse of these and other guideline-recommended therapies involving SGLT2 inhibitors is concerning (Fig 2).20 24 In the CURE-CKD (Center for Kidney Disease Research, Education and Hope–CKD) Registry, only 5% and 6.3% of eligible patients with CKD and diabetes, respectively, continued to receive SGLT2 inhibitor and glucagon-like peptide-1 receptor agonist therapy at 90 days.18 Notably, a lack of commercial health insurance and the receipt of treatment in community-based (versus academic) institutions were associated with lower likelihoods of SGLT2 inhibitor, ACEI, or angiotensin receptor blocker prescriptions among patients with CKD and diabetes.20 In low- or middle-income countries (LMICs), the gap between evidence and implementation is even wider, considering the high cost and inconsistent availability of these medications, although generics are available.30 Such gaps in delivering optimal care for CKD are unacceptable.

In addition to SGLT2 inhibitors, nonsteroidal mineralocorticoid receptor antagonists have been demonstrated to reduce the risks of CKD progression, KF, cardiovascular events, and mortality, when used in addition to standard-of-care treatment involving renin-angiotensin-aldosterone system inhibitors, among people with type 2 diabetes.31 There is a growing portfolio of promising therapeutic options, including glucagon-like peptide-1 receptor agonists (NCT03819153, NCT04865770), aldosterone synthase inhibitors (NCT05182840), and dual-to-triple incretins (online supplementary Table 1).26 32 Furthermore, there is clear evidence that in patients with CKD and/or type 2 diabetes, glucagon-like peptide-1 receptor agonists reduce cardiovascular events, constitute safe and effective glucose-lowering therapies, and aid in weight loss.32

Historically, it has taken an average of 17 years for new treatments to move from clinical evidence to routine practice.33 Considering that millions of people with CKD die each year, this waiting period is far too long.

Since the launch of the World Health Organization Global Action Plan for the prevention and control of non-communicable diseases (NCDs) in 2013, there has been global progress in the proportion of countries with a national NCD action plan and dedicated NCD units.34 However, CKD is incorporated into NCD strategies in approximately one-half of countries.4 Policies are required to integrate kidney care within essential health packages under universal health coverage (Fig 4).30 Multisectoral policies must also address social determinants of health, which are major amplifiers of CKD risk and severity that limit people’s opportunities to improve their health.3 A lack of investment in kidney health promotion, along with primary and secondary prevention of kidney diseases, hinders progress.14

Two major goals of universal health coverage are to achieve coverage for essential health services and to reduce financial hardship imposed by healthcare. However, universal health coverage alone is insufficient to ensure adequate access to kidney care.3 Health systems must be strengthened, and quality of care must be prioritised, because poor quality care contributes to more deaths than lack of access in low-resource settings.35 Quality care requires a well-trained healthcare workforce, sustainable availability of accurate diagnostics, reliable infrastructure, and medication supplies; it should be monitored through a continuous quality improvement process (Fig 4). Medication quality, especially in LMICs, may be an additional barrier to successful management of CKD.36 Regulation and monitoring of drug manufacturing and quality standards are important to ensure safe and effective therapies. Strategies to support regulation and quality assurance should be developed according to local circumstances and guidelines, as outlined elsewhere.37

The establishment of a credible case for CKD detection and management based on real-world data regarding risks, interventions, outcomes, and costs will help translate theoretical cost-effectiveness (currently established primarily in high-income countries with minimal data from other countries) into economic reality.30 38 Screening should include evaluation of risk factors for CKD; identification of family history; recognition of potential symptoms (usually advanced, such as fatigue, poor appetite, oedema, and itching); and measurements of blood pressure, serum creatinine, urine components (ie, urinalysis), and urine albumin/protein to creatinine ratio, as outlined in established guidelines.19 39 Early identification of CKD in primary care is expected to lower costs over time by reducing CKD complications and KF. Medications required for kidney care are already included in the World Health Organization Model List of Essential Medicines (Table 1). These medications should be provided at the national level under universal health coverage.40 Additionally, pharmaceutical companies should provide these medications at affordable prices.

The shortage of primary care professionals is exacerbated by inconsistent access to specialists and allied health professionals in both high-income countries and LMICs. It is essential to define roles and responsibilities for kidney care. Solutions may include multidisciplinary team care (primary care physicians, pharmacists, specialists, nurses, therapists, educators, nutritionists, and mental health professionals), well-established mechanisms for collaboration among all elements, and rapid communication technologies (both within health systems and among health professionals) to support care and decision-making.41 42 Brain drain in low-resource settings is a complex issue that must be addressed.

The mobilisation of community health workers yields cost-savings in infectious disease programmes within LMICs; it may facilitate early detection, diagnosis, and management of NCDs.43 Protocolised CKD management, possibly assisted by electronic decision-support systems, may be appropriate for interventions at the community level, with the integration of primary care physicians and aid from nephrologists and other professionals.44 45 For example, in some settings, pharmacists could identify people with diabetes or hypertension exhibiting CKD risk, based on their prescriptions, then offer on-site testing and referral as needed.46 Pharmacists could also provide medication reconciliation and advice regarding safety, effectiveness, and adherence. Social workers and pharmacists can help patients with medications to access suitable programmes.46

Clinical ‘inertia’, commonly regarded as a causative factor in low prescribing rates, has many facets (Fig 4).47 Many knowledge gaps regarding CKD exist among primary care physicians.48 Such gaps can be remedied with focused public and professional education. Additional factors include fear of adverse effects from medication, misaligned incentives within the health system, excessive workload, formulary restrictions, and clinician burnout.47 Furthermore, inconsistent recommendations in guidelines from different professional organisations may enhance confusion. A major barrier to optimal care is the time constraints imposed on individual clinicians. A typical primary care physician in the United States would require approximately 26.7 hours per day to implement guideline-recommended care for a panel of 2500 patients.49 Innovation is required to support guideline implementation, especially for primary care physicians who must follow multiple guidelines to meet the diverse needs of their patients. Electronic health records, reminders, team-based nudges, and decision-support tools offer potentially valuable assistance for quality kidney care in busy clinical practices.50 However, the additional time and effort involved in negotiating pre-authorisations or completing medication assistance programme requests, as well as the need for frequent monitoring of multiple medications, also hinder appropriate prescribing.25 Many primary care physicians only have a few minutes allocated for each patient because of institutional pressure or patient volume. The term ‘inertia’ can hardly be applied to clinicians working at this pace. The number of health professionals worldwide must increase.

Visits for patients with CKD are complex because multimorbidity is common. Such patients are often managed by multiple specialists, leading to fragmentation of care, lack of holistic oversight, and diffusion of responsibility for treatment. Single and combined outcomes analyses have shown that multidisciplinary care improves transition to renal replacement therapy and reduces mortality.51 Novel ‘combined clinic’ models with on-site collaboration and joint participation (eg, with nephrologists, cardiologists, and endocrinologists) may provide substantial benefits for patients in terms of reduced fragmentation of care, logistics, and cost savings.

Self-management is the most important aspect of kidney care. A patient’s ability to understand his/her health needs, make healthy choices, feel safe and respected in the health system, and obtain psychosocial support are important for promoting health decision-making (Fig 4). Good communication should begin with quality information and confirmation of ‘understanding’ by the patient (and family members, as applicable). Electronic apps and reminders can serve as useful tools that support patients by improving disease knowledge, promoting patient empowerment, and improving self-efficacy; however, a one-size-fits-all approach is unlikely to be successful.52 Important barriers include a lack of patient health information, poor communication, and mistrust, especially in the marginalised and minoritised communities where CKD is common.30 Patients may also be confused by contradictory recommendations among healthcare professionals, as well as conflicting messages in mainstream media. Innovative platforms that improve CKD-related communication between patients and clinicians represent a promising approach to promote optimal prescribing and adherence.53 54

Patient perspectives are essential when designing and testing health strategies to overcome barriers and promote equity. Collaborative care models must include patients, families, and community groups, as well as various types of healthcare professionals, health systems, government agencies, and payers.38 Advocacy organisations, local community groups, and peer navigators with trusted voices and relationships can serve as conduits for education while providing input regarding the development of patient tools and outreach programmes.55 Most importantly, patients must be the focus of their own care.

In high-income countries, people without health insurance and people with high copays paradoxically pay the highest amounts for essential and non-essential nonessential medications.38 Across LMICs, kidney diseases represent the leading cause of catastrophic health expenditures due to reliance on out-of-pocket payments.56 In 18 countries, four cardiovascular disease medications frequently indicated in CKD (statins, ACEIs, aspirin, and β-blockers) had greater availability in private settings than in public settings; they were mostly unavailable in rural communities, and they were unaffordable for 25% of people in upper middle-income countries and 60% of people in low-income countries.57 Newer therapies may be prohibitively expensive worldwide, especially where generics are not yet available. In the United States, the retail price for a 1-month supply of an SGLT2 inhibitor or finerenone is approximately US$500 to $700; for glucagon-like peptide-1 receptor agonists, the retail price is approximately US$800 to $1200 per month.38 This reliance on out-of-pocket payments for vital, life-saving essential medications is unacceptable (Fig 4).

Not all kidney diseases are equal. Much of what has been discussed here applies to the most common forms of CKD (eg, diabetes-related and hypertension-related). Some incompletely understood forms of CKD have different risk profiles, including environmental exposures, genetic predisposition, and autoimmune or other systemic disorders. Highly specialised therapies may be required. Pharmaceutical companies should be responsible for ensuring that research studies include disease-representative participants with appropriate representation (eg, race, ethnicity, sex, and gender), that effective drugs are made available after studies, and that the balance between profits and prices is fair and transparent. Many novel therapies are offering new hope for various kidney diseases; once these therapies are approved, there must be no delay in extending benefits to all affected patients (online supplementary Table 1).

An important but often overlooked group consists of children with kidney diseases. This group is especially vulnerable in LMICs, where nephrology services and resources are limited; families must often decide whether to pay for one child’s treatment or support the rest of the family.58 Children with CKD also have a high risk of cardiovascular disease, even in high-income settings, and they require more attention to control risk factors and achieve treatment targets.59

Considering that rigorous evidence-based treatments for CKD have been established, implementation must be optimised.60 Implementation research aims to identify effective solutions by understanding how evidence-based practices, often developed in high-income countries, can be integrated into care pathways in lower-resource settings. The management of CKD is suitable for implementation research: optimal therapeutic strategies are known, outcomes are easily measurable, and essential diagnostics and medications already are in place. Crucial components of such research are the identification of local patient preferences and elucidation of challenges. Ministries of health should commit to overcoming identified barriers and scaling up successful and sustainable programmes.

Polypills are attractive on multiple levels: fixed doses of several guideline-recommended medications are present within a single tablet (Table 1), the price is low, the pill burden is reduced, and the regimen is simple.61 Polypills can prevent cardiovascular disease and are cost-effective for patients with CKD.62 More studies are needed, but considering the alternatives of costly renal replacement therapy or premature death, it is likely that polypills will be a cost-effective approach for reducing CKD progression.

The integration of telehealth and other types of remotely delivered care can improve efficiency and reduce costs.63 Electronic health records and registries can support monitoring of quality of care and identify gaps to guide implementation and improve outcomes within an evolving health system that is capable of learning. Artificial intelligence may also be harnessed to stratify risk, personalise medication prescribing, and facilitate adherence.64 The use of telenephrology for communication between primary care physicians and specialists may also be beneficial for patient care.65

Multiple methods can support the identification of patient preferences for CKD care, including interviews, focus groups, surveys, discrete choice experiments, structured tools, and simple conversations.66 67 Many of these methods are currently in the research phase. Clinical translation will require contextualisation and assessments of local and individual acceptability.

The journey of each person living with CKD is unique; however, common challenges and barriers exist. As examples of lived experiences, comments collected from patients about their medications and care are detailed in online supplementary Table 2. These voices must be heard and acknowledged to close gaps and improve the quality of kidney care worldwide.

The current lack of progress in kidney care has been tolerated for far too long. New therapeutic advances offer real hope that many people with CKD can survive without developing KF. The evidence for clinical benefit is overwhelming and unequivocal. These patients cannot wait another 17 years for this evidence to be translated into clinical practice.33 It is time to ensure that all who are eligible for CKD treatment receive this care in an equitable manner.

Known barriers and global disparities in access to diagnosis and treatment must be urgently addressed (Fig 4). To achieve health equity for people with kidney diseases and those at risk of developing kidney diseases, we must raise awareness among policy makers, patients, and the general population; harness innovative strategies to support all cadres of healthcare workers; and balance profits with reasonable prices (Table 2). If we narrow the gap between what we know and what we do, kidney health will become a reality worldwide.

All authors contributed equally to the conception, preparation, and drafting of the manuscript.

VA Luyckx is chair of the Advocacy Working Group of the International Society of Nephrology and has no financial disclosures. KR Tuttle has received research grants from the National Institutes of Health (National Institute of Diabetes and Digestive and Kidney Diseases, National Heart, Lung, and Blood Institute, National Center for Advancing Translational Sciences, National Institute on Minority Health and Health Disparities, director’s office), the United States Centers for Disease Control and Prevention, and Travere Therapeutics; and consultancy fees from AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. She is also chair of the Diabetic Kidney Disease Collaborative for the American Society of Nephrology. R Correa-Rotter is a member of the Steering Committee for World Kidney Day, a member of the Diabetes Committee of the Latin American Society of Nephrology and Hypertension, and a member of the Latin American Regional Board of the International Society of Nephrology. He is also a member of the Steering Committees for the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial (AstraZeneca), the Study Of diabetic Nephropathy with AtRasentan (SONAR) [AbbVie], A Non-interventional Study Providing Insights Into the Use of Finerenone in a Routine Clinical Setting (FINE-REAL) [Bayer], and CKD-ASI (Boehringer Ingelheim). He has received research grants from AstraZeneca, GlaxoSmithKline, Roche, Boehringer Ingelheim, and Novo Nordisk, as well as speaker honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, and Amgen. All other authors have declared no competing interests.

This editorial received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

This article was published in Kidney International (Luyckx VA, Tuttle KR, Abdellatif D, et al. Mind the gap in kidney care: translating what we know into what we do. Kidney Int 2024;105:406-17. https://doi.org/10.1016/j.kint.2023.12.003), and was reprinted concurrently in several journals. The articles cover identical concepts and wording, but vary in minor stylistic and spelling changes, detail, and length of manuscript in keeping with each journal’s style. Any of these versions may be used in citing this article.

The supplementary material was provided by the authors and some information may not have been peer-reviewed. Accepted supplementary material will be published as submitted by the authors, without any editing or formatting. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by the Hong Kong Academy of Medicine and the Hong Kong Medical Association. The Hong Kong Academy of Medicine and the Hong Kong Medical Association disclaim all liability and responsibility arising from any reliance placed on the content.

1. Jager KJ, Kovesdy C, Langham R, Rosenberg M, Jha V, Zoccali C. A single number for advocacy and communication-worldwide more than 850 million individuals have kidney diseases. Kidney Int 2019;96:1048-50. Crossref

2. Institute for Health Metrics and Evaluation (IHME). GBD compare data visualization. Available from: http://vizhub.healthdata.org/gbd-compare. Accessed 18 Nov 2023.

3. Luyckx VA, Tonelli M, Stanifer JW. The global burden of kidney disease and the sustainable development goals. Bull World Health Organ 2018;96:414-22D. Crossref

4. International Society of Nephrology. ISN Global Kidney Health Atlas, 3rd ed. Available from: https://www.theisn.org/initiatives/global-kidney-health-atlas/. Accessed 18 Nov 2023.

5. GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 2020;395:709-33. Crossref

6. Vanholder R, Annemans L, Brown E, et al. Reducing the costs of chronic kidney disease while delivering quality health care: a call to action. Nat Rev Nephrol 2017;13:393-409. Crossref

7. Nguyen-Thi HY, Le-Phuoc TN, Tri Phat N, et al. The economic burden of chronic kidney disease in Vietnam. Health Serv Insights 2021;14:11786329211036011. Crossref

8. United States Renal Data System. Healthcare expenditures for persons with CKD. Available from: https://usrds-adr.niddk.nih.gov/2023/chronic-kidney-disease/6-healthcare-expenditures- for-persons-with-ckd. Accessed 18 Nov 2023.

9. Kidney Health Australia. Changing the chronic kidney disease landscape: the economic benefits of early detection and treatment. Available from: https://kidney.org.au/uploads/resources/Changing-the-CKD-landscape-Economic-benefits-of-early-detection-and-treatment.pdf. Accessed 16 Jan 2024.

10. Ke C, Liang J, Liu M, Liu S, Wang C. Burden of chronic kidney disease and its risk-attributable burden in 137 low-and middle-income countries, 1990-2019: results from the Global Burden of Disease Study 2019. BMC Nephrol 2022;23:17. Crossref

11. Gregg EW, Buckley J, Ali MK, et al. Improving health outcomes of people with diabetes: target setting for the WHO Global Diabetes Compact. Lancet 2023;401:1302-12. Crossref

12. Geldsetzer P, Manne-Goehler J, Marcus ME, et al. The state of hypertension care in 44 low-income and middle-income countries: a cross-sectional study of nationally representative individual-level data from 1.1 million adults. Lancet 2019;394:652-62. Crossref

13. Chu L, Bhogal SK, Lin P, et al. AWAREness of diagnosis and treatment of chronic kidney disease in adults with type 2 diabetes (AWARE-CKD in T2D). Can J Diabetes 2022;46:464-72. Crossref

14. Levin A, Tonelli M, Bonventre J, et al. Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy. Lancet 2017;390:1888-917. Crossref

15. Stengel B, Muenz D, Tu C, et al. Adherence to the Kidney Disease: Improving Global Outcomes CKD guideline in nephrology practice across countries. Kidney Int Rep 2020;6:437-48. Crossref

16. Chu CD, Chen MH, McCulloch CE, et al. Patient awareness of CKD: a systematic review and meta-analysis of patient-oriented questions and study setting. Kidney Med 2021;3:576-85.e1. Crossref

17. Ene-Iordache B, Perico N, Bikbov B, et al. Chronic kidney disease and cardiovascular risk in six regions of the world (ISN-KDDC): a cross-sectional study. Lancet Glob Health 2016;4:e307-19. Crossref

18. Gummidi B, John O, Ghosh A, et al. A systematic study of the prevalence and risk factors of CKD in Uddanam, India. Kidney Int Rep 2020;5:2246-55. Crossref

19. Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int 2022;102(5S):S1-127. Crossref

20. Nicholas SB, Daratha KB, Alicic RZ, et al. Prescription of guideline-directed medical therapies in patients with diabetes and chronic kidney disease from the CURE-CKD Registry, 2019-2020. Diabetes Obes Metab 2023;25:2970-9. Crossref

21. Grams ME, Yang W, Rebholz CM, et al. Risks of adverse events in advanced CKD: the Chronic Renal Insufficiency Cohort (CRIC) study. Am J Kidney Dis 2017;70:337-46. Crossref

22. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int 2024;105(4S):S117-314. Crossref

23. Kidney Disease: Improving Global Outcomes (KDIGO) Blood Pressure Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease. Kidney Int 2021;99(3S):S1-87. Crossref

24. Tuttle KR, Alicic RZ, Duru OK, et al. Clinical characteristics of and risk factors for chronic kidney disease among adults and children: an analysis of the CURE-CKD Registry. JAMA Netw Open 2019;2:e1918169. Crossref

25. Ismail WW, Witry MJ, Urmie JM. The association between cost sharing, prior authorization, and specialty drug utilization: a systematic review. J Manag Care Spec Pharm 2023;29:449-63. Crossref

26. Heerspink HJ, Vart P, Jongs N, et al. Estimated lifetime benefit of novel pharmacological therapies in patients with type 2 diabetes and chronic kidney disease: a joint analysis of randomized controlled clinical trials. Diabetes Obes Metab 2023;25:3327-36. Crossref

27. Nuffield Department of Population Health Renal Studies Group; SGLT2 inhibitor Meta-Analysis Cardio-Renal Trialists' Consortium. Impact of diabetes on the effects of sodium glucose co-transporter-2 inhibitors on kidney outcomes: collaborative meta-analysis of large placebo-controlled trials. Lancet 2022;400:1788-801. Crossref

28. Fernández-Fernandez B, Sarafidis P, Soler MJ, Ortiz A. EMPA-KIDNEY: expanding the range of kidney protection by SGLT2 inhibitors. Clin Kidney J 2023;16:1187-98. Crossref

29. McEwan P, Boyce R, Sanchez JJ, et al. Extrapolated longer-term effects of the DAPA-CKD trial: a modelling analysis. Nephrol Dial Transplant 2023;38:1260-70. Crossref

30. Vanholder R, Annemans L, Braks M, et al. Inequities in kidney health and kidney care. Nat Rev Nephrol 2023;19:694-708. Crossref

31. Agarwal R, Filippatos G, Pitt B, et al. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. Eur Heart J 2022;43:474-84. Crossref

32. Tuttle KR, Bosch-Traberg H, Cherney DZ, et al. Post hoc analysis of SUSTAIN 6 and PIONEER 6 trials suggests that people with type 2 diabetes at high cardiovascular risk treated with semaglutide experience more stable kidney function compared with placebo. Kidney Int 2023;103:772-81. Crossref

33. Rubin R. It takes an average of 17 years for evidence to change practice—the burgeoning field of implementation science seeks to speed things up. JAMA 2023;329:1333-6. Crossref

34. World Health Organization. Mid-point evaluation of the implementation of the WHO global action plan for the prevention and control of noncommunicable diseases 2013-2020 (NCD-GAP). Volume 1: Report. 2020. Available from: https://cdn.who.int/media/docs/default-source/documents/about-us/evaluation/ncd-gap-final-report.pdf?sfvrsn=55b22b89_5&download=true. Accessed 18 Nov 2023.

35. Kruk ME, Gage AD, Joseph NT, Danaei G, García-Saisó S, Salomon JA. Mortality due to low-quality health systems in the universal health coverage era: a systematic analysis of amenable deaths in 137 countries. Lancet 2018;392:2203-12. Crossref

36. Kingori P, Peeters Grietens K, Abimbola S, Ravinetto R. Uncertainties about the quality of medical products globally: lessons from multidisciplinary research. BMJ Glob Health 2023;6(Suppl 3):e012902. Crossref

37. Pan American Health Organization. Quality control of medicines. Available from: https://www.paho.org/en/topics/quality-control-medicines. Accessed 18 Nov 2023.

38. Tuttle KR, Wong L, St Peter W, et al. Moving from evidence to implementation of breakthrough therapies for diabetic kidney disease. Clin J Am Soc Nephrol 2022;17:1092-103. Crossref

39. Kalyesubula R, Conroy AL, Calice-Silva V, et al. Screening for kidney disease in low- and middle-income countries. Semin Nephrol 2022;42:151315. Crossref

40. Francis A, Abdul Hafidz MI, Ekrikpo UE, et al. Barriers to accessing essential medicines for kidney disease in low- and lower middle-income countries. Kidney Int 2022;102:969-73. Crossref

41. Rangaswami J, Tuttle K, Vaduganathan M. Cardio-renal-metabolic care models: toward achieving effective interdisciplinary care. Circ Cardiovasc Qual Outcomes 2020;13:e007264. Crossref

42. Neumiller JJ, Alicic RZ, Tuttle KR. Overcoming barriers to implementing new therapies for diabetic kidney disease: lessons learned. Adv Chronic Kidney Dis 2021;28:318-27. Crossref

43. Mishra SR, Neupane D, Preen D, Kallestrup P, Perry HB. Mitigation of non-communicable diseases in developing countries with community health workers. Global Health 2015;11:43. Crossref

44. Joshi R, John O, Jha V. The potential impact of public health interventions in preventing kidney disease. Semin Nephrol 2017;37:234-44. Crossref

45. Patel A, Praveen D, Maharani A, et al. Association of multifaceted mobile technology-enabled primary care intervention with cardiovascular disease risk management in rural Indonesia. JAMA Cardiol 2019;4:978-86. Crossref

46. Ardavani A, Curtis F, Khunti K, Wilkinson TJ. The effect of pharmacist-led interventions on the management and outcomes in chronic kidney disease (CKD): a systematic review and meta-analysis protocol. Health Sci Rep 2023;6:e1064. Crossref

47. Sherrod CF, Farr SL, Sauer AJ. Overcoming treatment inertia for patients with heart failure: how do we build systems that move us from rest to motion? Eur Heart J 2023;44:1970-2. Crossref

48. Ramakrishnan C, Tan NC, Yoon S, et al. Healthcare professionals’ perspectives on facilitators of and barriers to CKD management in primary care: a qualitative study in Singapore clinics. BMC Health Serv Res 2022;22:560. Crossref

49. Porter J, Boyd C, Skandari MR, Laiteerapong N. Revisiting the time needed to provide adult primary care. J Gen Intern Med 2023;38:147-55. Crossref

50. Peralta CA, Livaudais-Toman J, Stebbins M, et al. Electronic decision support for management of CKD in primary care: a pragmatic randomized trial. Am J Kidney Dis 2020;76:636-44. Crossref

51. Rios P, Sola L, Ferreiro A, et al. Adherence to multidisciplinary care in a prospective chronic kidney disease cohort is associated with better outcomes. PLoS One 2022;17:e0266617. Crossref

52. Stevenson JK, Campbell ZC, Webster AC, et al. eHealth interventions for people with chronic kidney disease. Cochrane Database Syst Rev 2019;8:CD012379. Crossref

53. Tuot DS, Crowley ST, Katz LA, et al. Usability testing of the kidney score platform to enhance communication about kidney disease in primary care settings: qualitative think-aloud study. JMIR Form Res 2022;6:e40001. Crossref

54. Verberne WR, Stiggelbout AM, Bos WJ, van Delden JJ. Asking the right questions: towards a person-centered conception of shared decision-making regarding treatment of advanced chronic kidney disease in older patients. BMC Med Ethics 2022;23:47. Crossref

55. Taha A, Iman Y, Hingwala J, et al. Patient navigators for CKD and kidney failure: a systematic review. Kidney Med 2022;4:100540. Crossref

56. Essue BM, Laba TL, Knaul F, et al. Economic burden of chronic ill health and injuries for households in low- and middle-income countries. In: Jamison DT, Gelband H, Horton S, et al, editors. Disease Control Priorities: Improving Health and Reducing Poverty. 3rd ed. The International Bank for Reconstruction and Development/The World Bank; 2017: 121-43. Crossref

57. Khatib R, McKee M, Shannon H, et al. Availability and affordability of cardiovascular disease medicines and their effect on use in high-income, middle-income, and low-income countries: an analysis of the PURE study data. Lancet 2016;387:61-9. Crossref

58. Kamath N, Iyengar AA. Chronic kidney disease (CKD): an observational study of etiology, severity and burden of comorbidities. Indian J Pediatr 2017;84:822-5. Crossref

59. Cirillo L, Ravaglia F, Errichiello C, Anders HJ, Romagnani P, Becherucci F. Expectations in children with glomerular diseases from SGLT2 inhibitors. Pediatr Nephrol 2022;37:2997-3008. Crossref

60. Donohue JF, Elborn JS, Lansberg P, et al. Bridging the “know-do” gaps in five non-communicable diseases using a common framework driven by implementation science. J Healthc Leadersh 2023;15:103-19. Crossref

61. Population Health Research Institute. Polypills added to WHO essential medicines list. 2023. Available from: https://www.phri.ca/eml/". Accessed 18 Nov 2023.

62. Sepanlou SG, Mann JF, Joseph P, et al. Fixed-dose combination therapy for prevention of cardiovascular diseases in CKD: an individual participant data meta-analysis. Clin J Am Soc Nephrol 2023;18:1408-15. Crossref

63. Dev V, Mittal A, Joshi V, et al. Cost analysis of telemedicine use in paediatric nephrology–the LMIC perspective. Pediatr Nephrol 2024;39:193-201. Crossref

64. Musacchio N, Zilich R, Ponzani P, et al. Transparent machine learning suggests a key driver in the decision to start insulin therapy in individuals with type 2 diabetes. J Diabetes 2023;15:224-36. Crossref

65. Zuniga C, Riquelme C, Muller H, Vergara G, Astorga C, Espinoza M. Using telenephrology to improve access to nephrologist and global kidney management of CKD primary care patients. Kidney Int Rep 2020;5:920-3. Crossref

66. van der Horst DE, Hofstra N, van Uden-Kraan CF, et al. Shared decision making in health care visits for CKD: patients' decisional role preferences and experiences. Am J Kidney Dis 2023;82:677-86. Crossref

67. Hole B, Scanlon M, Tomson C. Shared decision making: a personal view from two kidney doctors and a patient. Clin Kidney J 2023;16(Suppl 1):i12-9. Crossref

Many doctors have become concerned and unsure about the standard of care required of them in obtaining informed consent following the United Kingdom Supreme Court decision in Montgomery v Lanarkshire Health Board ('Montgomery').1 This article aims to provide an update on the relevant common law positions, clarified helpfully by the same court in McCulloch v Forth Valley Health Board ('McCulloch') in July 2023.2

The case of Montgomery established that a doctor must 'take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.' It rejected the previous paternalistic approach to medical consent and introduced a legal standard that emphasises respect for a patient’s right to self-determination. The decision also gave rise to uncertainties about the meaning of 'reasonable alternative treatment' and the role of professional clinical judgement in determining it.3

In McCulloch, a 39-year-old man was hospitalised with chest pain and suspected pericarditis. Echocardiogram findings were inconclusive. A cardiologist who subsequently saw the patient decided not to prescribe non-steroidal anti-inflammatory drugs (NSAIDs) because the patient was by then pain-free, and she did not discuss that treatment option with the patient. The patient died of cardiac tamponade secondary to idiopathic pericarditis and pericardial effusion a few days later.

The patient’s widow brought a claim, alleging that had the patient been informed of the option of NSAID, he would have taken it and would not have died. The cardiologist explained that she did not, in her professional judgement, regard NSAIDs as necessary or appropriate treatment when she assessed him; had he been in pain, she would have prescribed the medication. Expert witnesses agreed that NSAID could reduce pericardial effusion, but opinions were divided regarding its use in the absence of chest pain. The case eventually went to the Supreme Court, which found for the defendant cardiologist based on expert opinions in support of her practice, and took the opportunity to clarify that:

whether a treatment is a reasonable alternative is determined by applying the 'professional practice test', ie, whether the doctor has acted in accordance with a practice accepted as proper by a responsible body of medical opinion4;

a doctor is not negligent in failing to discuss a treatment option if the doctor’s opinion that the treatment is not reasonable is supported by a reasonable body of medical opinion;

the doctor is also not negligent in this regard even if the doctor is aware (or ought to be aware) that another reasonable body of opinion would consider that treatment option to be reasonable (and therefore warranting discussion with the patient);

once the doctor has applied the professional practice test and decided on a range of reasonable treatment options, the patient should be informed of all of those options; the doctor cannot simply discuss only the option(s) that the doctor prefers; and

the doctor must inform the patient of the respective advantages, disadvantages, and material risks associated with the treatment option(s) which the doctor considers reasonable.

McCulloch thus affirmed the pre-eminent role of professional clinical judgement in determining the reasonable treatment options for each patient, as well as the principle that the role of the court is not to substitute clinical expertise but to impose a duty of care to inform. The decision is consistent with Montgomery in that patients remain entitled to be adequately advised, albeit not on all possible alternative treatments, but on all reasonable ones in accordance with reasonable and responsible medical practice. This narrowing-down approach has the merits of reducing the risk of doctors bombarding patients with information and reducing the risk of putting doctors in a position of conflict by requiring them to discuss treatments which they do not find clinically appropriate. It is a significant clarification of the laws which should bring some relief to our professional peers.

The adoption of the 'professional practice test' means that a doctor can defend an omission to discuss certain treatment options only if his or her practice is supported by expert witness opinion (it will be recalled that the doctor’s omission to discuss the option of caesarean section in Montgomery was not supported by any reasonable body of medical opinion). Where expert opinions are divided, the court cannot prefer one opinion to another (and hence the ruling in McCulloch).4 However, the court may on rare occasions reject an opinion if it does not have a logical basis.5 The importance of quality expert witness opinion and proper training for expert witnesses cannot be overemphasised.

Another caveat is the continued and resolute requirement for doctors to discuss the material risks of medical treatment, defined in Montgomery as 'risks to which a reasonable person in the patient’s position would be likely to attach significance, or risks to which the doctor is or should reasonably be aware that the particular patient would be likely to attach significance.' Factors pointing to materiality may include: the odds and nature of the risk, the effect of its occurrence on the life of the patient, the importance to the patient of the benefits sought through the treatment, and the alternatives available and the risks associated with those alternatives.1

The broad definition of material risks can pose challenges to the doctor concerned as it necessitates an appreciation of the particular patient’s subjective values, beliefs, occupational needs, or even lifestyle and hobbies. It arguably opens up unforeseeable possibilities to support a claim, as suggested by a four-fold increase in consent-based claims in the United Kingdom during the post-Montgomery era.6 Doctors should therefore be mindful that obtaining informed consent is not a mere tick-box exercise, but a shared decision-making process involving personalised and bi-directional discussions.

Lastly, it is important to mention that McCulloch and Montgomery, both post-1997 Supreme Court decisions, are persuasive or highly persuasive, but not binding, in Hong Kong. Although Montgomery had already been applied in a local dental case, it is unclear whether McCulloch will receive the same judicial response.7 Similarly, the Medical Council of Hong Kong has incorporated the principles espoused in Montgomery into its professional guidance on medical consent.8 Whether McCulloch will be so treated remains to be seen; there is little doubt that it be welcome.

The author is solely responsible for drafting of the manuscript, approved the final version for publication, and takes responsibility for its accuracy and integrity.

The author has declared no conflict of interest.

This editorial received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

1. Montgomery v Lanarkshire Health Board [2015] UKSC 11

2. McCulloch v Forth Valley Health Board [2023] UKSC 26

3. Devaney S, Purshouse C, Cave E, Heywood R, Miola J, Reinach N. The far-reaching implications of Montgomery for risk disclosure in practice. J Patient Saf Risk Manag 2019;24:25-9. Crossref

4. Bolam v Friern Hospital Management Committee (1957) 1 WLR 582

5. Bolitho v City and Hackney Health Authority [1998] AC 232

6. Wald DS, Bestwick JP, Kelly P. The effect of the Montgomery judgment on settled claims against the National Health Service due to failure to inform before giving consent to treatment. QJM 2020;113:721-5. Crossref

7. Chan Siu Yim v Dr Cheung Sheung Kin [2017] DCPI 2358/2013

8. The Medical Council of Hong Kong. Newsletter: Implications of “Montgomery (Appellant) v Lanarkshire Health Board (Respondent)(Scotland)”. 2015;22. Available from: https://www.mchk.org.hk/files/newsletter22.pdf. Accessed 8 Mar 2024.

According to the World Health Organization (WHO) global statistics as of early January 2024, >774 million confirmed cases of coronavirus disease 2019 (COVID-19) and >7 million deaths have been reported worldwide during the COVID-19 pandemic.1 At a global level, the COVID-19 pandemic has now evolved into a steady state of low-level transmission, with low numbers of reported COVID-19 cases and deaths. The trend has been maintained over the past 12 months, despite a slight increase in the number of reported cases during the most recent available 28-day period.1 Since the declaration of the Public Health Emergency of International Concern by the WHO in January 2020, the global pandemic has caused widespread and devastating economic and social turmoil, along with extensive disruptions and backlogs affecting health services in overburdened healthcare systems. In the early months of the pandemic, global attention focused on COVID-19 emergency response and control efforts, such as case identification, contact tracing, rapid diagnostic tests, and acute treatment. As understanding has improved regarding the COVID-19 pandemic and its effects, including post-acute sequelae of COVID-19 (ie, long COVID), on all aspects of healthcare,2 3 many countries have shifted their focus to the establishment of longer-term, dynamic, and sustained frameworks for health emergency preparedness, response, and resilience at national, regional, and global levels.

In the WHO Strategic Preparedness and Response Plan for 2023-2025,4 a new strategy consisting of five core components—(a) emergency coordination; (b) collaborative surveillance; (c) community protection; (d) safe and scalable care; and (e) access to countermeasures—has been proposed with a strong emphasis on the mobilisation of multisectoral partnerships for coordination, planning, financing, monitoring, and evaluation. Considering the potential for surges of new variants with greater severity or transmissibility,5 the updated WHO framework has been designed and positioned to maintain sufficient capacity, operational readiness, and system flexibility to scale up clinical care services and multidisciplinary team support. This approach builds on the response-driven pillars outlined between 2020 and 2022 to address the complex interactions of COVID-19 with an expanding range of emerging long-term conditions and circumstances.

Extensive research has been conducted regarding the effects of public health measures intended to reduce the risk of COVID-19 transmission.6 The COVID-19–driven changes and innovations in health practice have also been captured in past issues of the Hong Kong Medical Journal.7 In the Greater Bay Area, collaborative efforts between mainland medical staff and their Hospital Authority counterparts in a community treatment facility and large makeshift hospital to combat the fifth wave of the pandemic have highlighted the potential for cross-border connectivity and healthcare integration to benefit residents of Hong Kong and Macau.7 In addition to government- and provider-level support for the expansion of community-oriented and patient-centred healthcare services, there have been dramatic increases in the use and application of digital health technologies during the COVID-19 pandemic. Such innovations have also substantially impacted the manners in which clinical competencies are enhanced, patient education is delivered, performance parameters are evaluated, resilience-building environments are created, and health practices are strengthened. Studies have shown satisfactory perception and acceptance of telemedicine consultations among adults in Hong Kong; telemedicine users reported positive experiences regarding physician diagnosis, disease management, and resolution of barriers to healthcare delivery.8 9 Transformative health practices empowered by digital technologies, including (but not limited to) computerised decision support tools and clinical management systems, may help to address clinical inertia and workload-related factors, thereby facilitating efforts to improve physician motivation and satisfaction in the post-pandemic era.

The digital technology innovations also contributed to the understanding of the dynamic associations between regions with low average number of daily COVID-19 cases and early public awareness of WHO-recommended multiple preventive measures. This has been shown in an infodemiology study based on Google Trends data.10

The use of publicly available and aggregated data retrieved from internet searches could offer valuable insights into population-level behaviours and their links to the spread of COVID-19 across different time periods; these insights may support risk communications, community engagement, and response coordination.11 Post-pandemic cancer care delivery should be tailored to accommodate the diverse unmet needs of patient groups with different psychological phenotypes, as suggested by Hong Kong researchers who reported the use of psychometric analysis as a tool to identify patients with high risks of decline in physical, psychological, and dietary wellness.12

In parallel with the explosive spread of COVID-19 and the persistence of long COVID symptoms over the past 4 years, the development of artificial intelligence (AI) technology has advanced at an unprecedented pace worldwide. In preventive ophthalmology, there is evidence that community-based diabetic retinopathy screening via teleophthalmology, based on imaging examinations with low-cost devices and remote interpretation, can serve as an accurate and cost-effective alternative to conventional face-to-face examinations; it achieves similar clinical outcomes, broader population coverage, and timely referral to ophthalmologists, while maintaining high satisfaction rates.13 This approach could substantially enhance workflow efficiency across clinical settings and support clinical decision-making by determining triage thresholds and tailoring interventions using predictive analytics.

The use of telemedicine and AI has also received increasing attention; in particular, the integration of clinical, biological, and genetic data with long-term health outcomes will help to elucidate the bi-directional relationship between COVID-19 and the cardiovascular system.14 The 2023 updated position paper from the Italian Society of Cardiology and Working Group on Telecardiology and Informatics has highlighted the considerable potential of AI-assisted clinical prediction models in terms of enhancing cardiovascular illness screening, diagnosis, monitoring, and adverse event prevention.15 In both ambulatory and inpatient settings, health practice innovations such as telemedical care, mobile health applications, and personalised wearable biosensors play key roles in efforts to improve clinical decision-making, avoid unnecessary hospital admission, reduce time to treatment during cardiac emergencies, rationalise healthcare services, and promote home care.15

The evolution of COVID-19 demands sustained global commitment to building a well-prepared, responsive, and resilient future. This evolution also highlights the urgent need for research that addresses the legal, regulatory, ethical, and reliability challenges involved in transforming ‘big data’ and AI into innovative services that can be implemented in clinical and real-world settings. Important and open questions concerning the management of COVID-19—particularly in relation to its complex pathophysiology, risk factors, and effective treatments, as well as long-term vaccine safety and efficacy (and related issues)—continue to require multi-channel collection of standardised data supported by diverse, coordinated, and collaborative efforts from biomedical and research communities to inform practice and policy in the new digital era.

All authors contributed to the editorial, approved the final version for publication, and take responsibility for its accuracy and integrity.

The authors have declared no conflicts of interest.

1. World Health Organization. COVID-19 epidemiological update—19 January 2024. Available from: https://www.who.int/publications/m/item/covid-19-epidemiological-update---19-january-2024. Accessed 5 Feb 2024.

2. Arsenault C, Gage A, Kim MK, et al. COVID-19 and resilience of healthcare systems in ten countries. Nat Med 2022;28:1314-24. Crossref

3. The Lancet Respiratory Medicine. Long COVID: confronting a growing public health crisis. Lancet Respir Med 2023;11:663. Crossref

4. World Health Organization. From Emergency Response to Long-Term COVID-19 Disease Management: Sustaining Gains Made during the COVID-19 Pandemic. Geneva: World Health Organization; 2023.

5. Jacobs JL, Haidar G, Mellors JW. COVID-19: challenges of viral variants. Annu Rev Med 2023;74:31-53. Crossref

6. Ayouni I, Maatoug J, Dhouib W, et al. Effective public health measures to mitigate the spread of COVID-19: a systematic review. BMC Public Health 2021;21:1015. Crossref

7. Pai PM, Fan JK, Wong WC, Deng XF, Xu XP, Lo CM. Promoting integrated healthcare for Hong Kong and Macau residents in the Greater Bay Area during the COVID-19 pandemic. Hong Kong Med J 2023;29:268-72. Crossref

8. Hung KK, Chan EY, Lo ES, Huang Z, Wu JC, Graham CA. User perceptions of COVID-19 telemedicine testing services, disease risk, and pandemic preparedness: findings from a private clinic in Hong Kong. Hong Kong Med J 2023;29:404-11. Crossref

9. Choi MC, Chu SH, Siu LL, et al. Telemedicine acceptance by older adults in Hong Kong during a hypothetical severe outbreak and after the COVID-19 pandemic: a cross-sectional cohort survey. Hong Kong Med J 2023;29:412-20. Crossref

10. Mok A, Mui OO, Tang KP, et al. Public awareness of preventive measures against COVID-19: an infodemiology study. Hong Kong Med J 2023;29:214-23. Crossref

11. Wang HH, Li YT, Wong MC. Leveraging the power of health communication: messaging matters not only in clinical practice but also in public health. Hong Kong Med J 2022;28:103-5. Crossref

12. Bao KK, Cheung KM, Chow JC, Leung CW, Wong KH. The real-world impact of the COVID-19 pandemic on patients with cancer: a multidisciplinary cross-sectional survey. Hong Kong Med J 2023;29:132-41. Crossref

13. Vujosevic S, Limoli C, Luzi L, Nucci P. Digital innovations for retinal care in diabetic retinopathy. Acta Diabetol 2022;59:1521-30. Crossref

14. Lo YS, Jok C, Tse HF. Cardiovascular complications of COVID-19. Hong Kong Med J 2022;28:249-56. Crossref

15. Brunetti ND, Curcio A, Nodari S, et al; Working Group on Telecardiology, Informatics of the Italian Society of Cardiology. The Italian Society of Cardiology and Working Group on Telecardiology and Informatics 2023 updated position paper on telemedicine and artificial intelligence in cardiovascular disease. J Cardiovasc Med (Hagerstown) 2023;24(Suppl 2):e168-77. Crossref