Antimicrobial resistance (AMR) has caused significant mortality and morbidity globally, and Hong Kong is no exception. It has been estimated that from 2020 to 2030, AMR-related infections in Hong Kong will result in 18 433 excess deaths with a total economic cost of US$4.3 billion.1 Antimicrobial resistance is not only a problem of resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), carbapenem-resistant Acinetobacter, vancomycin-resistant Enterococcus and carbapenemase-producing Enterobacterales in hospitals; rising resistance to commonly used antibiotics has narrowed prescribing options, leading to treatment failure in community-acquired infections. The latest community laboratory surveillance, conducted in 2024 by the Centre for Health Protection (CHP) of the Department of Health, revealed that the urinary pathogen Escherichia coli was commonly resistant to ampicillin (67.2%), co-trimoxazole (32.2%), and levofloxacin (36.9%), with 16.9% of specimens testing positive for extended-spectrum beta-lactamase.2 The same surveillance programme indicated that isolates of Streptococcus pneumoniae were resistant to erythromycin (75.0%) and penicillin (29.2%).2 The local threat of AMR highlights the need for robust antibiotic stewardship. In a local study involving 19 primary care clinicians and 321 patients that investigated help-seeking behaviour and antibiotic prescribing for acute cough, there was a significant difference in antibiotic prescribing rates between private and public primary care clinicians (17.4% vs 1.6%).3 In another local study of primary care physicians on the management of uncomplicated urinary tract infections, the proportion of E coli isolates matched (sensitive) to the prescribed antibiotic (amoxicillin, ampicillin, ciprofloxacin, co-trimoxazole, gentamicin, or nitrofurantoin) was 90.7% in the public sector and 59.2% in the private sector, indicating that there is room for improvement in the latter.4

The CHP has been tracking antimicrobial supply as a proxy for consumption through surveillance data collected from licensed wholesale traders. Over the past decade, about half of the antimicrobials prescribed each year have been prescribed by private doctors in the community (Fig 1). Interestingly, a significant 27.2% reduction in the overall defined daily dose per 1000 inhabitants per day was observed during the three pandemic years (2020-2022) compared with the pre–COVID-19 baseline, probably due to reduced respiratory infections.5 Nevertheless, a rebound in defined daily dose was noted at the start of 2023, particularly in the private sector following the resumption of normalcy.5 Antimicrobial consumption can be grouped according to the World Health Organization (WHO)’s AWaRe classification—Access, Watch and Reserve—based on resistance risk and medical importance, with the aim of improving appropriate antibiotic use.6 According to the WHO, ‘Access’ antibiotics can be used freely, ‘Watch’ antibiotics require caution, and ‘Reserve’ antibiotics are reserved for last-resort cases. The WHO has advocated increasing the use of ‘Access’ antibiotics to at least 60% of total antibiotic consumption, while preserving ‘Watch’ and ‘Reserve’ antibiotics for conditions in which they are truly indicated.6 In Hong Kong, since 2020, the proportion of antimicrobial use within the ‘Access’ group has met the WHO target of 60% of total consumption (Fig 2). It is noteworthy that the proportion of ‘Access’ antibiotics prescribed is the lowest among private doctors in the community compared with other sectors, such as the Hospital Authority and private hospitals (Fig 3). Overuse of broad-spectrum antibiotics is one of the main drivers of AMR and calls for coordinated efforts to address the resistance problem.

The second Hong Kong Strategy and Action Plan on Antimicrobial Resistance (2023-2027) was launched in 2022 to address the issue of AMR under a One Health approach.7 Among the six key areas, optimising the use of antimicrobials in humans is one of the main strategic actions. In 2017 and 2018, the CHP issued guidance notes on the use of antimicrobials for seven common conditions in a community setting, under the leadership of an Advisory Group on Antibiotic Guidance Notes in Primary Care, covering acute rhinosinusitis (ARS), acute pharyngitis, acute otitis media (AOM), acute uncomplicated cystitis in women, community-acquired pneumonia (CAP), acute exacerbations of chronic obstructive pulmonary disease (COPD), and simple (uncomplicated) skin and soft tissue infections. With the changing epidemiology of infectious diseases, evolving bacterial resistance patterns, and the latest scientific evidence for the management of different conditions, the Advisory Group has recently reviewed and updated its guidance notes. The Advisory Group has also been renamed the Advisory Group on Antibiotic Guidance Notes in Community Setting and includes new representatives from the Hong Kong College of Paediatricians, the Hong Kong College of Physicians, the Hong Kong College of Otorhinolaryngologists, and the Hong Kong Chinese Medical Association. Similar to the previous group, the Advisory Group also includes members from the Hong Kong Medical Association, Hong Kong Academy of Medicine, private medical groups, The Hong Kong Society for Infectious Diseases, Hong Kong Doctors Union, a representative from the Coordinating Committee in Family Medicine of the Hospital Authority, Chief Pharmacist’s Office of the Hospital Authority, The Hong Kong Private Hospitals Association, and representatives of the CHP. Five meetings were held to deliberate on the content, from July 2024 to August 2025. In this latest edition, the Advisory Group has revised the content of the guidance notes with reference to international guidelines, up-to-date scientific research, local disease epidemiology, the latest susceptibility data from the local surveillance network, and the availability of antibiotics in the local market. These notes serve as a key reference to optimise the use of antibiotics in the treatment of infections across both public and private sectors in the community. We have extracted the relevant content on aetiology, clinical features, and the latest recommendations on antibiotic use for these seven conditions. The recommended choice of antibiotics, including first- and second-line drugs for each condition, can be found in the online supplementary Tables 1-11. The full version of the guidance notes is available on the CHP website: https://www.chp.gov.hk/en/features/49811.html.

Rhinosinusitis refers to inflammation of the mucosal lining of the nasal cavity, nasopharynx, and paranasal sinuses. Acute rhinosinusitis is clinically defined as lasting fewer than 12 weeks, whereas rhinosinusitis that persists for 12 weeks or longer without complete resolution of symptoms is defined as chronic rhinosinusitis.8 Acute rhinosinusitis is caused predominantly by viral infection, termed acute viral rhinosinusitis or the common cold. Adults experience approximately two to five episodes per year, and schoolchildren seven to ten.8 When secondary bacterial infection occurs, acute bacterial rhinosinusitis (ABRS) develops. It is more frequent in children than in adults.9 10 11 The majority of ARS cases are caused by viral infection, with only about 2% complicated by bacterial infection.12 13 Streptococcus pneumoniae, Haemophilus influenzae (non-typeable), and Moraxella catarrhalis are the main causes of ABRS.14 Staphylococcus aureus, streptococcal species, and anaerobes (from odontogenic infections) may occasionally be found.15

Clinical features of rhinosinusitis include cough, nasal symptoms, fever, halitosis, headache, facial pain, and swelling. Cough is worse at night due to postnasal drip. The appearance of nasal discharge ranges from watery to purulent and cannot reliably distinguish between bacterial and viral infection. Fever usually resolves within 48 hours. Facial tenderness may occur when the upper molars are percussed or the cheekbones are pressed; this is less common in children than in adults. Acute viral rhinosinusitis is mostly self-limiting, typically lasting no longer than 7 to 10 days.8 16

Most ARS symptoms start to improve after 5 days, and the majority of uncomplicated ARS cases resolve within 2 to 3 weeks. Antibiotics are generally not needed. Symptomatic management, such as paracetamol, nonsteroidal anti-inflammatory drugs, nasal decongestants, intranasal normal saline irrigation and intranasal corticosteroids, can be considered where appropriate.8 12 17 18 19 20 Antibiotic treatment for ABRS is only slightly beneficial. A Cochrane review found that, out of 100 patients treated with antibiotics, only five experienced faster cure between days 7 and 14.20 The number needed to benefit is 18, while the number needed to harm is about eight.18 Antibiotic treatment causes more adverse effects than placebo in the treatment of ABRS.19 In addition, the use of antibiotics does not prevent complications.21 For uncomplicated ABRS cases, watchful waiting can be considered after shared decision making and education about when to return for follow-up or initiate antibiotics (eg, if symptoms do not improve within the next 3 days or worsen rapidly or significantly at any time).12 22 Antibiotic treatment should be reserved for cases with features suggestive of ABRS; however, careful patient selection is recommended to avoid unnecessary antibiotic use and potential side-effects. 8 12

The recommended antibiotics for the treatment of ABRS in adults and paediatric patients are detailed in online supplementary Tables 1 and 2, respectively. The first-line antibiotic is usually amoxicillin or amoxicillin-clavulanate. The latter is a beta-lactam/beta-lactamase inhibitor combination and is therefore active against beta-lactamase-producing bacteria, including most H influenzae, M catarrhalis and methicillin-sensitive S aureus. It has no added advantage against S pneumoniae, whose beta-lactam resistance does not rely on enzyme production. For patients with type I hypersensitivity to penicillin, antibiotics from a completely different class should be used, such as doxycycline or macrolides. If macrolides (eg, clarithromycin, erythromycin) are prescribed, follow-up after the initial course of treatment is recommended because of the relatively high rate of antibiotic resistance. A 7-day course of antibiotics is sufficient to treat acute sinusitis in both adults and children. This takes into account the overall evidence on efficacy and safety, as well as the risk of AMR.12 A meta-analysis comparing short-course treatment (3-7 days) with long-course treatment (6-10 days) found no significant difference in cure rate or symptom improvement.23

Acute pharyngitis, or acute sore throat, is a mostly self-limiting disease and usually lasts for around 1 week. Although its aetiology can be viral or bacterial, most cases are viral and antibiotics are inappropriate. Viral pharyngitis can be caused by enterovirus, rhinovirus, influenza or parainfluenza virus, coronavirus (including severe acute respiratory syndrome coronavirus 2), adenovirus, respiratory syncytial virus, Epstein–Barr virus, herpes simplex virus, metapneumovirus, cytomegalovirus, and human immunodeficiency virus. Patients with acute sore throat and associated signs and symptoms such as conjunctivitis, coryza, cough, diarrhoea, hoarseness, discrete ulcerative stomatitis and/or viral exanthema are more likely to have a viral illness.24 25 Conversely, symptoms such as sudden-onset sore throat, fever, and/or pain on swallowing, and physical examination findings such as pharyngeal and tonsillar erythema, an erythematous sandpaper-like rash, tonsillar hypertrophy with or without exudates, palatal petechiae, and/or anterior cervical lymphadenopathy are more suggestive of a bacterial cause.25 26 Group A streptococcus (GAS) is the most common bacterial cause of acute pharyngitis, accounting for about 80% of bacterial cases, with the remainder usually caused by group C or group G streptococci. Group A streptococcus is responsible for 5% to 15% of sore throat consultations in adults and 20% to 30% in children.27 28 29 Although symptoms of GAS pharyngitis resolve without antibiotic treatment, complications can arise and may be suppurative (eg, cervical lymphadenitis, peritonsillar abscess, mastoiditis, and retropharyngeal abscess) or non-suppurative (eg, scarlet fever, acute rheumatic fever, and post-streptococcal glomerulonephritis).25

Although GAS pharyngitis is mostly self-limiting, antibiotics are prescribed to relieve acute symptoms, prevention of acute and subacute complications, and reduce transmission. Antibiotic treatment can prevent suppurative complications and acute rheumatic fever, and may offer protection against the subsequent development of post-infectious glomerulonephritis.30 Group A streptococcus is generally sensitive to penicillin and other members of the beta-lactam group of antibiotics, but shows high resistance (42.3% to 60.0% from 2016 to 2020) to erythromycin locally.31

Penicillin V or amoxicillin is the recommended drug of choice for patients who are not allergic to these agents (online supplementary Tables 3 and 4). Group A streptococcus resistant to penicillins and other beta-lactams has not been reported. All Streptococcus pyogenes isolates tested by the CHP from 2008 to 2020 were sensitive to penicillin.31 First-generation cephalosporins (eg, cephalexin) are the first-line agents for penicillin-allergic individuals (ie, those without anaphylactic reactions). Other cephalosporins (eg, cefaclor, cefuroxime) are alternatives but are not favoured as first-line agents because of their broader spectrum of activity. As GAS resistance to macrolides (eg, erythromycin, azithromycin, and clarithromycin) is known to be common in Hong Kong, macrolides are not an appropriate first-choice antibiotic treatment.31 Regarding the duration of antibiotics, a 10-day course is recommended by the Infectious Diseases Society of America and the United States Centers for Disease Control and Prevention to achieve maximal eradication of GAS from the pharynx for the primary prevention of acute rheumatic fever.25 The National Institute for Health and Care Excellence guideline recommends treatment for 5 to 10 days but recognises that microbiological cure may be better with a 10-day course of phenoxymethylpenicillin compared with a 5- or 7-day course, although there were no differences in relapse or recurrence.32 Since routine rapid antigen detection testing for GAS is not recommended and microbiological cure is the goal, a 10-day course is recommended to maximise treatment effectiveness.

Acute otitis media is the acute inflammation of the middle ear. It is a common paediatric condition with peak prevalence at 6 to 18 months, while AOM in adults is rare.33 It has been reported that 27% of infants and 37% of children with upper respiratory tract infections develop AOM.34 35 After the introduction of pneumococcal vaccination, overseas studies showed that the incidence of AOM decreased significantly.36 37 Acute otitis media can be caused by viruses or bacteria, but it is often difficult to distinguish between them as both can co-exist. Viruses that cause upper respiratory tract infections (eg, respiratory syncytial virus, adenovirus and influenza viruses) are present in up to two-thirds of cases.38 The average global distribution of causative bacterial pathogens of AOM is as follows: S pneumoniae (30%), H influenzae (non-typeable) [23%], and M catarrhalis (5%).39 The remaining cases are caused by other bacteria (eg, GAS). There is usually a single bacterial cause, but coinfection with other pathogens is known to occur.40 Typical symptoms of AOM include otalgia that interferes with normal activity or sleep, new-onset ear discharge, fever, loss of appetite and difficulty hearing. It may present as ear tugging or irritability in infants and young children.

Viral AOM is a mostly self-limiting infection, with symptoms (ie, otalgia) typically lasting about 3 to 7 days.41 Most children and young people recover within 3 days without antibiotics. In a Cochrane review, 60% of children not treated with antibiotics showed improvement in symptoms within 24 hours, and over 80% had symptoms that resolved spontaneously within 3 days.42 When determining whether to prescribe antibiotics, healthcare providers should consider the patient’s general health, the severity of the disease, the risk of complications, and the expected benefits of antibiotic therapy:

If the patient is not improving within 48 to 72 hours and has acute, worsening symptoms; is systemically very unwell; has signs and symptoms of a more serious illness or condition; or is at high risk of complications, clinicians should offer immediate antibiotics. The patient should be referred to hospital if there is severe systemic infection or complication (eg, mastoiditis, meningitis, or facial nerve paralysis).

Red flag signs and symptoms include a fever of 39°C or above, drowsiness, rapid breathing, rapid heart rate, severe ear pain, and signs or symptoms of intracranial complications (eg, neck stiffness, altered mental status, seizures, or focal neurological deficits).

Children under 2 years of age with bilateral AOM, and children and young people with AOM and otorrhoea, are more likely to benefit from antibiotics.41

Antibiotic treatment has no early effect on pain, a slight effect over the following days, and only a modest effect on the number of children with tympanic perforations, contralateral otitis episodes and abnormal tympanometry findings in subsequent weeks, with no difference in the rare occurrence of severe complications.42 A Cochrane review found that for patients with respiratory infections (including AOM) in whom clinicians considered it safe not to prescribe antibiotics immediately, a non-prescribing approach with advice to return if symptoms did not resolve (delayed antibiotics) resulted in the least antibiotic use, while maintaining similar patient satisfaction and clinical outcomes compared with immediate antibiotics.43 The recommended choice of antibiotic regimen is detailed in online supplementary Table 5. Regardless of whether antibiotics are prescribed, patients and caregivers should be informed about red flag symptoms and advised to seek medical attention if symptoms worsen rapidly.

Community-acquired pneumonia refers to an acute infection of the lung parenchyma in a patient who has acquired the infection outside a healthcare setting and has developed symptoms and signs in the community. Community-acquired pneumonia can be caused by a variety of pathogens, including viruses and bacteria. There is increasing recognition of viral pathogens in CAP4 of which the most common include influenza virus, rhinovirus and parainfluenza virus. The most frequently detected bacterial pathogens are S pneumoniae, H influenzae, S aureus, and Mycoplasma pneumoniae.44 45 46 47 Group A streptococcus and S aureus may cause secondary bacterial pneumonia following influenza virus infection. Common clinical features of CAP include cough, fever, pleuritic chest pain, dyspnoea, and sputum production. On physical examination, many patients are febrile, although this finding is frequently absent in older patients. Tachypnoea and tachycardia are also common. Chest examination may reveal audible crackles. Signs of consolidation, such as decreased or bronchial breath sounds and dullness to percussion, may be present.

Antibiotic therapy should be started as soon as CAP is suspected or established48 49 50 51 52 53 (online supplementary Tables 6 and 7). When considering the choice of antibiotic, clinicians are advised to take into account the severity of the infection and the risk of developing complications (eg, co-morbidities such as severe lung disease or immunosuppression), local AMR patterns and prevalence, as well as any recent antibiotic use and microbiological results, if available.54

Streptococcus pneumoniae is one of the most common pathogens identified in local CAP.44 In Hong Kong, there is reduced susceptibility of S pneumoniae to penicillin (23% to 51% resistance) and to macrolides (82% resistance to erythromycin) in the community.55 56 Risk factors include age over 65 years, beta-lactam therapy within the last 3 months, alcoholism, multiple medical co-morbidities, and exposure to a child in a day-care centre. Amoxicillin-clavulanate is therefore recommended as the first-line empirical treatment. Doxycycline can be added if macrolide-resistant M pneumoniae infection is suspected. For patients with co-morbidities or those at risk of Legionella pneumonia, a macrolide can be added. Due to poor intrinsic activity against S pneumoniae and/or low oral bioavailability, certain oral cephalosporins (first-generation agents, cefaclor, cefuroxime, ceftibuten, cefixime and loracarbef) are not recommended.

Mycoplasma pneumoniae is common in children and is also seen in adults in Hong Kong.44 57 The infection is often self-limiting without specific antibiotic therapy. Initial empirical therapy covering M pneumoniae is considered optional for outpatients with mild CAP. It may be indicated if the first-line agent has failed, if outpatients have severe CAP, or if the patient is a child aged over 5 years or an adolescent. Up to 40% of CAP in children aged 5 years or above has been attributed to M pneumoniae.57 In Hong Kong, the macrolide resistance rate among M pneumoniae is high in the community, with an increasing trend from 28.2% in 2018 to 61.3% in 2024.58 Doxycycline is recommended for the treatment of macrolide-resistant M pneumoniae–associated CAP in adults and children (regardless of age or duration of therapy).59

Fluoroquinolones may be considered in the treatment of CAP when the first-line agent has failed, when an outpatient is allergic to first-line agents, or when there is documented infection with S pneumoniae with a penicillin minimum inhibitory concentration (MIC) of 4 μg/mL or above (intermediate susceptibility to penicillin). Nonetheless, excessive use of respiratory fluoroquinolones in CAP may lead to delayed diagnosis of tuberculosis and increased fluoroquinolone resistance in Mycobacterium tuberculosis. Fluoroquinolones should be reserved for use in outpatients who have no other treatment options. Patients should be warned of the risk of severe adverse effects, including aortic dissection or rupture of an aortic aneurysm, significant decreases in blood sugar, and disabling side-effects involving the tendons, muscles, joints, nerves, central nervous system, and mental health.60 61 62

Most outpatients with CAP will show an adequate clinical response within 72 hours. For most patients, appropriately chosen initial antibiotic therapy should not be changed within the first 72 hours unless there is marked clinical deterioration. Clinical judgement is required when determining the duration of antibiotic therapy. Factors to consider include the patient’s clinical response, severity of infection, causative pathogen, in vitro susceptibility of the pathogen, and the presence of complications and side-effects. In adults and children, a 5-day course of antibiotics (except for doxycycline) is usually effective for mild CAP in the outpatient setting.54 63 64 65 66 Clinicians may consider stopping treatment after 5 days unless the patient fails to improve clinically or the microbiological results suggest the need for a longer course.67

Chronic obstructive pulmonary disease is a heterogeneous lung condition characterised by chronic respiratory symptoms due to airway and/or alveolar abnormalities. It is caused by a combination of environmental (eg, passive smoking, outdoor and indoor air pollution, occupational exposure to airborne pollutants) and host factors (eg, smoking and advancing age).68 69 In Hong Kong, the prevalence of COPD is 0.5% among individuals aged 15 years or above.70 It is most common among those aged 75 to 84 years (2.2%), with a male predominance.70 The most common respiratory symptoms include dyspnoea, cough, and/or sputum production. Chronic obstructive pulmonary disease is diagnosed by spirometry demonstrating a postbronchodilator ratio of FEV₁/FVC (forced expiratory volume in 1 second to forced vital capacity) of <0.7. The disease is associated with co-morbidities such as cardiovascular disease, hypertension, and lung cancer.71 72 73 It may be punctuated by acute exacerbations, defined as acute episodes of worsening respiratory symptoms within 14 days that may be accompanied by tachypnoea and/or tachycardia, and are often associated with local and systemic inflammation.74 Acute exacerbations of COPD are mainly triggered by respiratory viral infection (eg, influenza A and rhinovirus), although bacterial infection and air pollution can also precipitate these events.74 75 76 77 Common bacterial isolates in patients hospitalised with a COPD exacerbation include H influenzae, S pneumoniae, Pseudomonas aeruginosa, and M catarrhalis.76 78 79 80

Appropriately prescribed antibiotics may shorten recovery time and reduce the risk of early relapse, treatment failure, and duration of hospitalisation. Antibiotics can be prescribed when there are clinical signs of bacterial infection. Evidence suggests that sputum colour and purulence can predict the presence of bacterial infection. In a pooled analysis, green or yellow sputum showed a sensitivity of 94.7% and a specificity of 15% for the presence of bacteria.81 Studies have also shown that a positive bacterial culture was obtained in 77% to 84% of patients with purulent sputum.82 83 According to the 2024 Global Strategy for Prevention, Diagnosis and Management of COPD report, antibiotics should be given to patients in the community if they: (a) have three cardinal symptoms, namely increased dyspnoea, increased sputum volume, and increased sputum purulence; (b) have increased sputum purulence and one other cardinal symptom; or (c) require mechanical ventilation.74

Empirical antibiotic therapy (online supplementary Table 8) targets likely bacterial pathogens responsible for acute exacerbations of COPD and takes into account local patterns of antibiotic resistance.56 Pseudomonas aeruginosa and/or Enterobacterales infection may occur in outpatients with advanced COPD. Risk factors for P aeruginosa infection include chronic colonisation or previous isolation of P aeruginosa from sputum, very severe COPD (forced expiratory volume in 1 second <30% predicted), bronchiectasis on chest imaging, broad-spectrum antibiotic use within the past 3 months, and chronic systemic glucocorticoid use.84 85 86 87 Amoxicillin and macrolides are not recommended because of the high resistance rates in Hong Kong. Local community data show reduced susceptibility of S pneumoniae to penicillin (23%-51% resistance) and to macrolides (82% resistance to erythromycin).55 56 In addition, 50% of H influenzae isolates were resistant to ampicillin, and nearly all (99%) M catarrhalis isolates produced beta-lactamase.56 Amoxicillin-clavulanate or a respiratory fluoroquinolone (eg, levofloxacin) is recommended. In patients for whom amoxicillin-clavulanate is contraindicated because of non-type I penicillin allergy, a cephalosporin such as cefpodoxime or cefuroxime may be considered. Fluoroquinolones should be reserved for outpatients who have no other treatment options for acute bacterial exacerbation of chronic bronchitis because of the risk of severe adverse effects, including aortic dissection or rupture of an aortic aneurysm, significant decreases in blood sugar, or disabling side-effects involving the tendons, muscles, joints, nerves, central nervous system and mental health.60 61 62 Regarding treatment duration, a systematic review of outpatients with COPD exacerbations indicated that short-course antibiotic treatment (≤5 days) did not differ significantly from long-course treatment (≥6 days) in terms of clinical cure or bacterial eradication.88 These results concurred with those of another systematic review and meta-analysis comparing short-course (<6 days) with long-course antibiotics (>7 days).89 In addition, there were significantly fewer adverse events with short-course antibiotics.88 89 90 Based on the evidence, a 5-day course of antibiotics will generally be adequate to treat a mild-to-moderate acute exacerbation of COPD due to bacterial infection.

Acute uncomplicated cystitis is characterised by local bladder signs and symptoms such as dysuria, urgency, frequency and suprapubic pain. There should be no signs or symptoms suggestive of infection spreading beyond the bladder (eg, fever, chills, rigors, unstable vital signs, flank pain or costovertebral angle tenderness). Individuals with urinary catheters are excluded from this definition.91 92 93 94 95 96 97 Cystitis usually occurs when bacteria from the gastrointestinal tract enter the urethra and ascend to the bladder.98 Escherichia coli is the most commonly isolated pathogen (~52%) in midstream urine samples collected in the outpatient setting of the Hospital Authority, followed by Klebsiella pneumoniae (~9%), Proteus mirabilis (~5%), and Streptococcus agalactiae (~3%) [unpublished data from CHP].

Given the very high probability of urinary tract infection based on typical symptoms, clinicians can consider empirical treatment without urine culture or dipstick urinalysis. The choice of antibiotics should take into account the symptoms, potential complications, previous urine culture results, and local antibiotic susceptibility patterns.98 Among the E coli isolated from urine samples in outpatient settings of the Department of Health56 and Hospital Authority (unpublished data), 64% to 67% were resistant to ampicillin, 36% to 46% to levofloxacin, 20% to cefpodoxime, 39% to cefuroxime, 31% to 32% to co-trimoxazole, 6% to 16% to amoxicillin-clavulanate, 2% to fosfomycin and 1% to 2% to nitrofurantoin. In the same settings, 99% to 100% of Klebsiella pneumoniae were resistant to ampicillin, 23% to 42% to nitrofurantoin, 12% to cefpodoxime, 35% to cefuroxime, 15% to 20% to co-trimoxazole, 10% to 17% to levofloxacin, and 8% to 14% to amoxicillin-clavulanate.56 Judicious use of antibiotics is recommended to minimise potential collateral damage (ecological adverse effects of antimicrobial therapy, such as colonisation or infection with multidrug-resistant organisms), particularly with broad-spectrum cephalosporins and fluoroquinolones.97

For the choice of antibiotic therapy (online supplementary Table 9), nitrofurantoin is appropriate because of the low local resistance rate and is less likely to select for drug-resistant organisms (the preserved in vitro susceptibility of E coli to nitrofurantoin over many years of use suggests that it causes only minor collateral damage). Beta-lactam agents, including amoxicillin-clavulanate, are appropriate choices for therapy even in cases of intermediate susceptibility because they achieve high urinary concentrations. In view of disabling and potentially long-lasting or irreversible side-effects, fluoroquinolones should be used only when other commonly prescribed antibiotics are considered inappropriate. Co-trimoxazole is not recommended as a first-line agent given the high local resistance.56 Antibiotic treatment is not required for asymptomatic bacteriuria except during pregnancy or prior to urological procedures associated with mucosal trauma.91 95 99 100

The term ‘skin and soft-tissue infections (SSTIs)’ describes a wide variety of clinical conditions. Simple, or uncomplicated, SSTIs refer to superficial infections such as cellulitis, simple abscesses, impetigo and furuncles, and require antibiotics or surgical incision and drainage. Complicated SSTIs include deep soft-tissue infections (eg, deep abscesses and necrotising fasciitis) that require significant surgical intervention. When classifying patients with SSTIs, the necrotising or non-necrotising nature of the infection, the anatomical extent, the characteristics of the infection (purulent or non-purulent), and the clinical condition of the patient should always be assessed independently.101 102 Simple SSTIs usually present with localised clinical findings such as erythema, warmth, oedema and pain over the affected site. They are not associated with systemic signs or symptoms that indicate spread (eg, fever, tachycardia, diaphoresis, fatigue, anorexia and vomiting) or uncontrolled co-morbidities that may complicate treatment. Simple SSTIs are usually monomicrobial, mainly caused by S aureus and beta-haemolytic streptococci such as S pyogenes. In diabetic foot infection, polymicrobial infection is more likely. Vibrio vulnificus infection is associated with injuries related to seawater or seafood exposure. Impetigo is usually caused by S aureus, whereas cellulitis is usually caused by beta-haemolytic streptococci. Nonetheless, both pathogens may occur in combination in simple SSTIs.

Simple SSTIs are amenable to outpatient management with topical or oral antibiotics. When choosing an empirical antibiotic (online supplementary Tables 10 and 11), clinicians should consider the severity of symptoms, site of infection, risk of uncommon pathogens, previous microbiological results, MRSA status, and local resistance patterns.103 In mild and localised impetigo, topical antibiotics are adequate treatment.104 105 In other cases of simple SSTIs, oral antibiotics are indicated. Based on data from outpatient settings of the Hospital Authority, resistance of S pyogenes to penicillins and other beta-lactams has not been reported in Hong Kong; nonetheless, 37% of isolates were resistant to erythromycin (unpublished data from CHP). Coverage for community-associated MRSA (CA-MRSA) should be considered if risk factors are present (eg, history of direct contact with CA-MRSA–infected wounds, discharge or soiled areas, close contact with carriers, presence of skin lesions, poor personal hygiene, and sharing of personal items), or if the patient does not respond to first-line treatment.106 107 Co-trimoxazole, doxycycline/minocycline, and clindamycin can be considered if CA-MRSA is suspected or confirmed. Locally, 24% to 26% of S aureus isolates are MRSA.56 In addition, patients with CA-MRSA and their close contacts should receive topical decolonisation therapy.107

Superficial and small abscesses usually respond well to incision and drainage and seldom require antibiotics, except when they are associated with systemic signs of infection, extensive cellulitis, rapid progression or poor response to initial drainage; involve sites that are difficult to drain (eg, face, hands, and genitalia); or occur in children, older adults, or those with significant co-morbid illness or immunosuppression.102 A 5- to 7-day course of antibiotic treatment is recommended for simple SSTIs, but this may be extended to up to 10 days at the clinician’s discretion if the infection does not improve after completion of the initial course.103 106 108 109 110 111 Since the skin requires time to return to its normal condition, full resolution should not be expected within 5 to 7 days.103

Rational prescription of antimicrobials is vital to curb the rise of resistant pathogens. At the 79th United Nations General Assembly High-Level Meeting on AMR held in September 2024, global leaders approved a political declaration committing to a clear set of targets and actions, including a 10% reduction in the estimated 4.95 million annual human deaths associated with bacterial AMR by 2030.112 The declaration also aims for at least 70% of antibiotics used in human health worldwide to belong to the WHO Access group.112 A territory-wide survey was conducted in 2023 to examine the awareness and practices of the general public regarding AMR in Hong Kong.113 The results showed that when a doctor’s initial assessment indicated that antibiotics were not needed, the vast majority of respondents (94.7%) accepted the doctor’s advice to observe for a few more days or to wait for diagnostic test results before deciding whether to prescribe antibiotics.113 In addition, about half (49.5%) of respondents wanted doctors to share decision making with them regarding antibiotic prescriptions.113 We urge all doctors in both the public and private sectors to prescribe antibiotics only when clinically indicated and to refer to clinical guidelines and the current guidance notes when selecting an appropriate agent. Whenever possible, narrow-spectrum antibiotics should be used at optimal doses and for the shortest effective duration.

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

ESK Ma and MCS Wong are members of the Hong Kong Medical Journal Editorial Board and internal review of this editorial was independently conducted by a senior editor. Other 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.

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 or 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.

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7. Ma ES. Combating antimicrobial resistance in Hong Kong: where are we and where should we go? Hong Kong Med J 2022;28:424-6. Crossref

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11. Marom T, Alvarez-Fernandez PE, Jennings K, Patel JA, McCormick DP, Chonmaitree T. Acute bacterial sinusitis complicating viral upper respiratory tract infection in young children. Pediatr Infect Dis J 2014;33:803-8. Crossref

12. National Institute for Health and Care Excellence. Sinusitis (acute): antimicrobial prescribing. 2017 October 27. Available from: https://www.nice.org.uk/guidance/ng79. Accessed 25 Mar 2025.

13. Gwaltney JM Jr, Wiesinger BA, Patrie JT. Acute community-acquired bacterial sinusitis: the value of antimicrobial treatment and the natural history. Clin Infect Dis 2004;38:227-33. Crossref

14. Chow AW, Benninger MS, Brook I, et al. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis 2012;54:e72-112. Crossref

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91. SA Health, Government of South Australia. Urinary Tract Infections (adult): Empirical Treatment Clinical Guideline. September 2023. Available from: https://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/about+us/governance/policy+governance/policies/urinary+tract+infections+adult+empirical+treatment+clinical+guideline. Accessed 26 May 2025.

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Hong Kong, China is undergoing a transformative shift in its approach to medical product regulation, driven by the convergence of artificial intelligence (AI), biomedical advancements, and a strategic goal to position itself as an international hub for medical innovation.1 For over two decades, the Medical Device Administrative Control System (MDACS) of the Department of Health (DH) has served as a cornerstone in safeguarding public health in relation to medical devices (MDs). Building on this foundation, the DH is progressing towards a comprehensive statutory framework aimed at upholding the highest standards of safety and quality, while fostering an environment that supports medical innovation.

At present, Hong Kong, China has yet to establish an overarching piece of legislation to govern the full lifecycle of MDs, including their manufacture and supply. Depending on their characteristics, certain MDs may fall within the scope of existing laws, such as the Pharmacy and Poisons Ordinance (Cap 138), the Radiation Ordinance (Cap 303), the Trade Descriptions Ordinance (Cap 362), the Consumer Goods Safety Ordinance (Cap 456), and so forth.

The DH introduced the voluntary MDACS in 2004 as a transitional arrangement to safeguard safety, quality, and performance, as well as to enhance public awareness of MD safety. Implemented by the DH, this initiative was designed as a pragmatic, phased approach to prepare the industry for a future statutory framework.

Consistent with best practices adopted globally, MDACS operates through a two-pronged approach covering pre-market control and post-market surveillance. At its core lies a risk-based device classification framework aligned with international standards established by the International Medical Device Regulators Forum,2 formerly the Global Harmonization Task Force. This system categorises MDs according to factors such as level of invasiveness, duration of contact with the body, and potential for harm in the event of malfunction. General MDs are classified into four classes, from Class I (lowest risk) to Class IV (highest risk),3 while In Vitro Diagnostic MDs are categorised from Class A (lowest risk) to Class D (highest risk).4

Under the voluntary MDACS, only medium-to high-risk devices—namely Class II and above General MDs, and Class B and above In Vitro Diagnostic MDs—are eligible for listing, establishing a form of pre-market control with regulatory oversight proportionate to the potential risks posed to public health. Complementing this, the system incorporates an adverse event reporting mechanism for all MD classes under the post-market surveillance, through which manufacturers, importers, and users can report incidents, thereby supporting timely risk identification, recurrence prevention, and harm mitigation.

The MDACS also covers the listing of traders, including importers, distributors, and local manufacturers, who are key players in the MD supply chain. The framework places emphasis on the role of Local Responsible Persons, who serve as the primary link between the DH and MD manufacturers. They play a pivotal role in post-market activities such as incident reporting, recalls, and corrective actions, ensuring robust and effective oversight.

With its internationalised background, Hong Kong, China has traditionally enjoyed access to a wide range of medical technologies from around the world and has spearheaded numerous medical innovations. Throughout its phased implementation, MDACS has placed high importance on regulatory harmonisation and convergence with international standards. In addition to the evaluation of MDs by Conformity Assessment Bodies recognised by the DH, which are accredited organisations that independently assess and certify MDs to ensure compliance with safety, quality, and performance standards set out under the MDACS, marketing approvals from eight reference regulatory jurisdictions are also accepted. As of the end of October 2025, more than 8300 MDs have been listed under MDACS, encompassing both locally manufactured and imported devices.

The phased development of Hong Kong’s MD regulatory system has been underpinned by close collaboration with diverse stakeholders. Ongoing engagement with industry, academia, and research institutions has been instrumental in refining MDACS. Timely updates of guidance documents on emerging MD technologies, risk management, and post-market surveillance have supported a practical and efficient regulatory pathway for new devices, benefiting both innovators and patients.

Collaboration also extends into the Greater Bay Area (GBA), which is a key strategic priority. The DH has actively engaged with the Guangdong–Hong Kong–Macao Greater Bay Area Center for Medical Device Evaluation and Inspection of the National Medical Products Administration. Joint activities, including seminars and training, have supported the local industry in navigating the Chinese Mainland’s regulatory and registration processes, thereby fostering healthcare innovation and regional cooperation.

A related policy, the “special measure of using Hong Kong registered drugs and MDs used in Hong Kong public hospitals in the GBA” (港澳藥械通), established in 2021, allows designated GBA healthcare institutions to use MDs that are in use in Hong Kong public hospitals and deemed urgently needed for clinical purposes, subject to approval by Guangdong Province regulatory authorities. As of October 2025, this measure has enabled the use of 73 MDs across 45 designated institutions.5 Through this approach, state-of-the-art and innovative MDs of clinical and health benefits can gain expedited access to the Chinese Mainland and enhance the health of Chinese Mainland residents. These initiatives form part of a broader plan to promote regulatory innovation for medical products in the GBA, aligning with Hong Kong’s unique position as a super-connector in the region. Guided by co-operation agreements and Memorandum of Understanding, the Government has worked closely with the National Medical Products Administration and relevant authorities to create greater synergy in the cross-boundary regulatory oversight of medical products, including MDs.6 7

On the international front, the DH contributes actively as a member of the Global Harmonization Working Party, where it has led a Work Group on post-market surveillance.8 Participation in such platforms enables Hong Kong to help shape harmonised documents and ensure its regulatory framework aligns with global best practices.

In August 2025, the DH signed a Memorandum of Understanding with Singapore’s Health Sciences Authority,9 covering regulatory cooperation on MDs. These collaborations underscore Hong Kong’s commitment to building strong international partnerships and advancing a more interconnected, resilient, and innovation-friendly regulatory ecosystem.

The DH is systematically advancing MDACS towards a comprehensive statutory framework through key supporting measures. A significant driver has been the Government’s policy of procuring MDACS-listed devices in the public healthcare sector, including those procured by the DH and the Hospital Authority. This has incentivised the industry to list their products, resulting in increased listings and readiness for a smooth transition to mandatory regulation.

In parallel, the DH has proactively addressed challenges arising from novel technologies. New guidance documents and technical references have been developed for complex domains such as software as a MD, cybersecurity, AI-enabled MDs, and personalised MDs.10 These initiatives provide the industry with clearer expectations, helping innovators and entrepreneurs bring advanced technologies to market responsibly and efficiently.

To further enhance regulatory efficiency, the DH fully digitalised the listing process by launching the Medical Device Information System in 2024.11 This one-stop e-service platform enables online applications and post-market surveillance management, improving public service delivery and internal operations. Building on this, the DH will leverage emerging technologies—such as AI—to streamline evaluations, accelerate approvals, and strengthen data-driven regulatory oversight.

In line with international trends, the Government is advancing preparatory work for legislation, targeting the introduction of a legislative proposal into the Legislative Council in 2026.

This is a key component of a broader initiative to establish the Hong Kong Centre for Medical Products Regulation (CMPR) in 2026 under the DH.12 13 Planned since June 2024 by its Preparatory Office, the CMPR will consolidate regulation of Western and Chinese medicines, as well as MDs, under a single statutory framework. It will institutionalise mechanisms for pre-market approval, conformity assessment, and post-market surveillance.

The unified regime is designed to safeguard public health while remaining responsive to rapid scientific and technological advances. Capacity-building initiatives are underway to augment regulatory capabilities. With legislation empowering the CMPR and the Government’s commitment to become a “leading, internationally renowned medical products regulatory authority, driving excellence and innovation”, Hong Kong, China is laying the foundation for a regulatory system that protects patients and promotes the research, development, and commercialisation of cutting-edge medical products.14

Wider Government initiatives to foster a fertile health R&D ecosystem provide important synergies. The Hetao Shenzhen–Hong Kong Science and Technology Innovation Co-operation Zone is being developed as a world class research hub and catalyst for GBA growth, covering life and health technology and AI.15 Complementing this, infrastructure such as the GBA International Clinical Trial Institute,16 located within Hetao, will provide one-stop platforms to support clinical trials and accelerate the translation of scientific research into tangible patient benefits. A Real-World Study and Application Centre will also be established, alongside development of clinical databases and biobanks, to position Hong Kong as a leading global hub for real-world studies.17 18

The DH is committed to creating a regulatory framework that balances stringent safety controls with the necessary flexibility to encourage innovation. This includes proactive engagement with innovators and timely guidance for next-generation technologies—such as AI-enabled MDs and precision medicines—while actively monitoring global best practices.

Realising this vision requires close collaboration among innovators, manufacturers, healthcare professionals, and researchers, whose involvement in research, commercialisation, and regulatory dialogue is essential to transforming technological advances into better health outcomes. By reinforcing its safety framework and cultivating an innovation-friendly ecosystem, Hong Kong, China is pursuing a proactive strategy to build global leadership in healthcare technology and advance towards a safer, healthier future.

All authors contributed equally to the conception, preparation, and editing of the manuscript. All authors approved the final version for publication and take responsibility for its accuracy and integrity.

All authors have disclosed no conflicts of interest.

1. Hong Kong SAR Government. The Chief Executive’s 2023 Policy Address: Develop into a Health and Medical Innovation Hub—Establish a Drug Approval Authority based on "Primary Evaluation" in the Long Run. 25 Oct 2023. Available from: https://www.policyaddress.gov.hk/2023/en/p139a.html. Accessed 17 Aug 2025.

2. International Medical Device Regulators Forum. About IMDRF. Available from: https://www.imdrf.org. Accessed 17 Aug 2025.

3. Medical Device Division, Department of Health, Hong Kong SAR Government. Medical Device Administrative Control System: Classification of General Medical Devices. Available from: https://www.mdd.gov.hk/filemanager/common/mdacs/TR003E.pdf. Accessed 20 Nov 2025.

4. Medical Device Division, Department of Health, Hong Kong SAR Government. Medical Device Administrative Control System: Classification of In Vitro Diagnostic Medical Devices. Available from: https://www.mdd.gov.hk/filemanager/common/mdacs/TR006E.pdf. Accessed 20 Nov 2025.

5. Medical Device Division, Department of Health, Hong Kong SAR Government. Measure of using HK registered drugs and medical devices used in HK public hospitals in Guangdong–Hong Kong–Macao Greater Bay Area. Available from: https://www.mdd.gov.hk/en/whats-new/measure-of-using-hk-registered-drugs/index.html. Accessed 19 Nov 2025.

6. Hong Kong SAR Government. Secretary for Health meets Commissioner of National Medical Products Administration and renews Co-operation Agreements (with photos) [press release]. 8 May 2024. Available from: https://www.info.gov.hk/gia/general/202405/08/P2024050800443.htm. Accessed 10 Oct 2025.

7. Hong Kong SAR Government. S for Health meets Guangdong Provincial Medical Products Administration delegation (with photos) [press release]. 27 Mar 2023. Available from: https://www.info.gov.hk/gia/general/202303/27/P2023032700690.htm. Accessed 13 Oct 2025.

8. Global Harmonization Working Party. WG4 Post-Market. Available from: https://www.ghwp.org/members/technical-committee/wg-4-post-market. Accessed 17 Aug 2025.

9. Hong Kong SAR Government. Secretary for Health continues visit to Singapore (with photos) [press release]. 13 Aug 2025. Available from: https://www.info.gov.hk/gia/general/202508/13/P2025081300574.htm. Accessed 17 Aug 2025.

10. Medical Device Division, Department of Health, Hong Kong SAR Government. Medical Device Administrative Control System: Technical References. Available from: https://www.mdd.gov.hk/en/mdacs/issued-documents/technical-references/index.html. Accessed 17 Aug 2025.

11. Medical Device Division, Department of Health, Hong Kong SAR Government. Medical Device Administrative Control System: Medical Device Information System. Available from: https://www.mdd.gov.hk/en/mdacs/mdis/index.html. Accessed 17 Aug 2025.

12. Department of Health, Hong Kong SAR Government. Preparatory Office for the Hong Kong Centre for Medical Products Regulation. Available from: https://www.dh.gov.hk/english/main/main_pocmpr/main_pocmpr.html. Accessed 20 Aug 2025.

13. Hong Kong SAR Government. The Chief Executive’s 2025 Policy Address: Chapter IV Industry Development and Reform, Paragraph 63. 25 Sep 2025. Available from: https://www.policyaddress.gov.hk/2025/public/pdf/policy/policy-full_en.pdf. Accessed 25 Sep 2025.

14. Hong Kong SAR Government. DH announces timetable for establishing CMPR and roadmap towards phased implementation of “primary evaluation” (with photo/video) [press release]. 26 Jun 2025. Available from: https://www.info.gov.hk/gia/general/202506/26/P2025062600281.htm. Accessed 17 Aug 2025.

15. Hong Kong SAR Government. LCQ12: Hetao Shenzhen–Hong Kong Science and Technology Innovation Co-operation Zone [press release]. 11 Dec 2024. Available from: https://www.info.gov.hk/gia/general/202412/11/P2024121100302.htm. Accessed 20 Nov 2025.

16. Hong Kong SAR Government. Greater Bay Area International Clinical Trial Institute officially opened in Hong Kong Park of Hetao Shenzhen–Hong Kong Science and Technology Innovation Cooperation Zone (with photos) [press release]. 21 Nov 2024. Available from: https://www.info.gov.hk/gia/general/202411/21/P2024112100163.htm. Accessed 17 Aug 2025.

17. Hong Kong SAR Government. Under Secretary for Health chairs third meeting of Steering Committee on Health and Medical Innovation Development (with photos) [press release]. 12 Jun 2025. Available from: https://www.info.gov.hk/gia/general/202506/12/P2025061200317.htm. Accessed 10 Oct 2025.

18. Hong Kong SAR Government. Government delegation attends Guangdong–Hong Kong–Macao Greater Bay Area Clinical Trial Collaboration meeting in Shenzhen (with photos) [press release]. 29 Jul 2025. Available from: https://www.info.gov.hk/gia/general/202507/29/P2025072900830.htm. Accessed 10 Oct 2025.

In a recent position paper,1 the Hong Kong Academy of Medicine (HKAM) recommended that both HKAM and its Colleges establish mechanisms to evaluate faculty development programmes using both quantitative and qualitative methods. This recommendation underscores the importance of mixed methods approaches in evaluating educational activities within postgraduate medical education (PGME). This editorial builds on our study of the impact of the conjoint workplace-based assessment (WBA) workshop, published in this issue of the Hong Kong Medical Journal,2 to illustrate the effective application of mixed methods approaches.

Mixed methods combine quantitative and qualitative approaches to provide a comprehensive evaluation.3 In healthcare, experimental research utilising quantitative methods is more familiar; these methods are equally relevant in medical education. Quantitative studies rely on measurable data and statistical analyses to assess the effectiveness of interventions in numerical terms, such as the number of trainees achieving a specific competency level or improvements in assessment scores. This approach addresses questions such as ‘How effective was the workshop in enhancing feedback skills among trainers?’ or ‘What proportion of trainees demonstrated improved competency after implementing WBA?’ Quantitative methods are particularly valuable for investigating cause-and-effect relationships.4

For descriptive questions about ongoing events or explanatory questions about how or why something occurred, qualitative studies are often the most suitable approach.4 These studies enhance understanding by exploring experiences, behaviours, and attitudes, providing insights that cannot be captured through numerical data alone. This approach is particularly valuable for examining complex interventions where contextual factors exert substantial influence. In such situations, adoption of the CMO model (Context + Mechanism = Outcome) can be highly effective.5 Qualitative methods (eg, interviews, focus groups, and observations) enable the exploration of participants’ perspectives—what they value in an educational intervention, the challenges they encounter, and areas requiring improvement. For example, within the context of the conjoint WBA workshop, qualitative research can reveal how trainers and trainees perceive WBA and feedback, their emotional responses, the barriers they face in effectively integrating WBA into daily practice, and the factors that facilitate learning during the workshop.2 Despite the subjective nature of qualitative research, quality criteria have been established to ensure its rigour.6

Quantitative and qualitative studies address distinct research purposes and questions. They also differ in aspects such as ontology, sampling methods, and analysis, as summarised in the Table.7 8 Mixed methods studies combine the strengths of both approaches, compensating for the limitations of each. Quantitative data reveal patterns, whereas qualitative insights provide essential context and depth, enabling a more comprehensive understanding. This combination is particularly important in PGME, where reliance on quantitative measures alone risks neglecting key nuances of learner experiences, while qualitative approaches may lack generalisability. By integrating both methods, evaluations become more robust and better suited to inform faculty development, curriculum enhancement, and improvements to the clinical learning environment.

Four basic designs for mixed methods studies are commonly used9:

1. Exploratory sequential design: Qualitative research is conducted first to explore a topic, guiding a subsequent quantitative study, often for instrument development.
2. Explanatory sequential design: Quantitative data are collected first, followed by qualitative research to explain or provide context to the results.
3. Triangulation or convergent design: Qualitative and quantitative data are simultaneously collected to compare and contrast findings.
4. Longitudinal transformation: Data are collected at multiple points, typically from different populations and using various methods; analysis and integration occur throughout the project.

In the evaluation of the conjoint WBA workshop, both triangulation and explanatory approaches were utilised.2 Quantitative outcomes demonstrated the success of the intervention. Qualitative findings not only supported these results but also explained why specific outcomes were achieved, guiding future refinements.

However, many clinicians are unfamiliar with qualitative research methods, which limits their ability to fully engage with mixed methods evaluations. To address this limitation, the HKAM position paper also recommended that training in qualitative evaluation methods be provided to Fellows responsible for quality assurance.1 The Research Subcommittee of the Jockey Club Institute for Medical Education and Development has collaborated with the Scientific Committee of the Hong Kong College of Anaesthesiologists to develop a research course that includes both quantitative and qualitative methods. This course is now in progress and may subsequently be offered to other Colleges, thereby enhancing capacity for quality assurance across specialties.

As PGME increasingly shifts towards competency-based approaches, evaluations must evolve to reflect these changes. Mixed methods offer a practical means of achieving this evolution, providing a comprehensive understanding of learner progress and the contextual factors influencing outcomes.

The integration of mixed methods into educational evaluations aligns with HKAM’s vision of a continuous, evidence-based improvement cycle in PGME. By uncovering both the ‘what’ and the ‘why’ behind educational outcomes, educators become better equipped to make informed decisions that enhance the learning experience and ultimately improve the quality of care delivered by future specialists.

All authors have contributed equally to the concept, development, and critical revision of the manuscript. 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.

HY So and AKM Chan are co-authors of the article by So et al (Reference 2), published in the same issue. Other 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. So HY, Li PK, Lai PB, et al. Hong Kong Academy of Medicine position paper on postgraduate medical education 2023. Hong Kong Med J 2023;29:448-52. Crossref

2. So HY, Wong EW, Chan AK, et al. Improving efficiency and effectiveness of workplace-based assessment workshop in postgraduate medical education using a conjoint design. Hong Kong Med J 2025;31:445-52. Crossref

3. Maudsley G. Mixing it but not mixed up: mixed methods research in medical education (a critical narrative review). Med Teach 2011;33:e92-104. Crossref

4. Eisenhart M. Qualitative science in experimental time. Int J Qual Stud Educ 2006;19:697-707. Crossref

5. Berwick DM. The science of improvement. JAMA 2008;299:1182-4. Crossref

6. Frambach JM, van der Vleuten CP, Durning SJ. AM last page. Quality criteria in qualitative and quantitative research. Acad Med 2013;88:552. Crossref

7. Mehrad A, Zangeneh MH. Comparison between qualitative and quantitative research approaches: social sciences. Int J Res Educ Stud 2019;5:1-7.

8. Braun V, Clarke V. Successful Qualitative Research: A Practical Guide for Beginners. Los Angeles: Sage; 2013.

9. Schifferdecker KE, Reed VA. Using mixed methods research in medical education: basic guidelines for researchers. Med Educ 2009;43:637-44. Crossref

Expert witnesses serve important functions in the administration of justice. Their opinions have a significant impact on the outcomes of proceedings and represent a respectable source of information to parties seeking explanation, understanding, and closure in a dispute.1 However, there have been cases where expert witnesses have presented incorrect expert evidence to the courts. An oft-quoted example is the UK case of R v Sally Clark, where Professor Sir Roy Meadow, a prosecution expert witness, gave evidence relating to probabilities of sudden infant death syndrome.2 It later transpired that he had misunderstood and misinterpreted statistical data, leading to legal battles between him and the General Medical Council.3

Expert witnesses are expected to conduct research on legislation, codes of conduct, or practice guidelines issued by professional bodies, and to cite authorities from textbooks and published articles. Materials which have been utilised to support their opinions must be specified in their reports.4 This was emphasised by the Court of Appeal of New Zealand: “We have noted that Mr Keys [the witness] cited no professional literature or other material to verify his “elemental” methodology… These methodological difficulties sufficiently justify the Judge’s conclusion that Mr Keys’ evidence was neither helpful nor reliable”.5 Furthermore, the courts and tribunals need to be satisfied that the opinion and conclusions in the expert reports they receive are reliable.

The emergence of artificial intelligence (AI) is impacting not only the legal sector but every aspect of society around the world at lightning speed, giving rise to many challenges as well as opportunities.6 In the UK, it was reported that at the end of 2022, three-quarters of the largest solicitors’ firms were using AI; over 60% of the large law firms and a third of the small firms were at least exploring the potential of the new generative AI systems.7

In 2023, Lord Justice Birss, a Court of Appeal judge in the UK, used ChatGPT to provide a summary of an area of law. He is the first British judge known to use an AI chatbot to write part of a judgement.8 This shows that, when used with caution, AI can be a useful tool as an assistant to expert witnesses and is acceptable to the courts.

That same year, the Courts and Tribunals Judiciary in the UK published online guidance for Judicial Office Holders on the use of AI.9 It acknowledges that AI tools are capable of summarising large bodies of text although, as with any summary, care needs to be taken to ensure accuracy. In contrast, AI tools are a poor way of conducting research to find new information one cannot verify independently. While they may be useful in identifying materials that one would recognise as correct, the current public AI chatbots do not produce convincing analysis or reasoning.10

There is evidence that some expert witnesses in Hong Kong are already using or are considering using AI to write their reports. In a Workshop on Expert Witness Report Writing organised by the Hong Kong Academy of Medicine in August 2025, there were 32 participants from different specialties. They were given a fictitious case of a civil claim against a general practitioner, based on which they were asked to write expert reports on behalf of the defendant doctor and comment on his management. Some of them had written expert witness reports before. Of the 24 participants who replied to a survey on the use of AI tools in their preparations, nine indicated that they did use AI tools for various purposes, such as searching for references, summarising the literature, analysing the case based on updated medical standards in the practice of that specialty (family medicine), listing out all the favourable and unfavourable evidence/findings, organisation, editing, formatting, improving grammar and sentence structure, changing the wording to layman’s terms, and proofreading. Of the AI tools used, DeepSeek was the most popular (n=3), followed by ChatGPT (n=2) and Perplexity (n=2). Each of the following tools was used only once by the participants: Copilot, English Editor, Gemini, Poe, Grok and AI Genesis by Hospital Authority. Some participants have used more than one AI tool for their reports.11

The limitations of AI in the context of legal research have already been recognised. Since 2023, a number of non-existent judicial opinions with fake quotes and citations created by AI tools have been presented to the courts in the United States and the UK.12 Users may not know that AI tools have “inborn errors”. Artificial intelligence language models such as ChatGPT can be more prone to a mistake known as ‘hallucination’, where a system produces highly plausible but incorrect results. This is because they work by anticipating the text that should follow the input they are given, but they do not have a concept of ‘reality’.7

The currently available large language models are trained on materials published on the internet, and the quality of answers generated depends on the quality of the underlying datasets, as well as how one engages with the relevant AI tool, including the nature of the prompts entered. Erroneous output from AI tools may arise from misinformation (whether deliberate or otherwise), data selection bias, and/or data which are not up to date. Even with the best prompts, the information provided may be inaccurate, incomplete, misleading, or biased. Artificial intelligence tools may make up fictitious legal cases, citations, or quotes, or refer to legislation, articles, or legal texts that do not exist, yielding incorrect or misleading information regarding the law or how it might apply. Therefore, one should always have regard to this possibility, and the accuracy of any information provided by AI tools must be checked before it is relied upon and used in an expert opinion report.10

Even experts on generative AI may commit these mistakes. In a recent case in the United States, it was discovered that Professor Jeff Hancock had included citations to two non-existent academic articles and incorrectly cited the authors of a third article. He admitted that he had used GPT-4o to assist him in drafting his declaration but, in reviewing the declaration, he failed to discern that GPT-4o had generated fake citations to academic articles. The irony is that Professor Hancock, a credentialled expert on the dangers of AI and misinformation, had fallen victim to the siren call of relying too heavily on AI in a case that revolved around the dangers of AI.13

Expert evidence is absolutely fundamental to the rule of law. The Code of Conduct for Expert Witnesses applies to an expert who has been instructed to give or prepare evidence for the purpose of proceedings in the Court. It specifies that an expert witness has an overriding duty to help the Court impartially and independently on matters relevant to the expert’s area of expertise.4 Flawed evidence can lead to a court, acting in good faith, reaching an unsound decision, miscarriages of justice and, in turn, a lack of confidence in justice and a degradation of the rule of law.14

All legal representatives are responsible for the materials they put before the court/tribunal and have a professional obligation to ensure they are accurate and appropriate. They must confirm that they have independently verified the accuracy of any research or citations that have been generated with the assistance of an AI chatbot.10 Because expert witnesses also have a duty to the Court, it is crucial for them to verify the accuracy of any research or case citations that have been generated with the assistance of AI tools in the reports they submit to the persons who instruct them and/or the courts/tribunals.

The current publicly available AI platforms remember every prompt and any other information entered into them, which may then be used to respond to queries from other users. As a result, anything entered into an AI platform could, in principle, become publicly known. Therefore, one should be mindful of the importance of protecting data privacy and avoid entering any information into a public AI chatbot that is not already in the public domain, and which is private and confidential. To maintain data security, one should use workplace computer devices to access AI tools and one’s work email address (rather than personal ones).10 The Office of the Privacy Commissioner for Personal Data has also provided some tips for users of AI chatbots such as ChatGPT in protecting personal data privacy.15

Expert witnesses may be liable to professional disciplinary proceedings for professional misconduct3 and there may even be legal consequences.16 The Code of Conduct for Expert Witnesses makes it clear that, “Proceedings for contempt of court may be brought against a person if he makes, or causes to be made, a false declaration or a false statement in a document verified by a statement of truth without an honest belief in its truth”.4 Therefore, it is pertinent for expert witnesses to bear the following rules in mind:
- learn the basic knowledge of what AI tools can and cannot do before using them;
- check and verify the accuracy and appropriateness of any information provided by an AI tool when it is used or relied on;
- be prepared to correct any errors and bias in the information generated by AI tools; and
- protect the data privacy of the parties.

As with any other information available on the internet in general, while AI tools may be useful to find material one would recognise as correct but do not have to hand, they are a poor way of conducting research to find new information one cannot verify. Public AI chatbots might not provide accurate answers derived from authoritative databases. They generate new text using an algorithm based on the prompts they receive and the data they have been trained upon. Their output is based on what the model predicts to be the most likely combination of words (based on the documents and data that it holds as source information) and is not necessarily the most accurate answer.10 Expert witnesses must be vigilant when they conduct research on legislation, codes of conduct, or practice guidelines issued by professional bodies and cite authorities from textbooks and published articles in their expert witness reports. Moreover, when they use AI tools as aids, they must check that the information provided is accurate and appropriate before it is used or relied upon. They must also ensure confidentiality is maintained and that the personal data and privacy of the parties are protected.

Although this article is written with medical expert witnesses in mind, it applies equally to expert witnesses of other professions.

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

Both authors have disclosed no conflicts of interest.

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

1. Hong Kong Academy of Medicine Professionalism and Ethics Committee, Task Force on Laws for Healthcare Practitioners. Foreword. In: Best Practice Guidelines for Expert Witnesses. 2nd ed. Hong Kong: Hong Kong Academy of Medicine; 2025: 1.

2. R v Sally Clark [2003] EWCA Crim 1020

3. The General Medical Council v Professor Sir Roy Meadow [2006] EWCA Civ 1390

4. Cap 4A The Rules of the High Court, Appendix D: Code of conduct for expert witnesses. Available from: https://www.elegislation.gov.hk/hk/cap4A@2018-02-01T00:00:00. Accessed 4 Sep 2025.

5. Prattley Enterprises Limited v Vero Insurance New Zealand Limited [2016] NZCA 67 Para 105 and 109

6. The Law Society of Hong Kong. The impact of artificial intelligence on the legal profession. Position paper of the Law Society of Hong Kong. January 2024. Available from: https://www.hklawsoc.org.hk/-/media/HKLS/Home/News/2024/LSHK-Position-Paper_AI_EN.pdf?rev=77bf900208614367b9cbb15fd10aaa58. Accessed 4 Sep 2025.

7. Solicitors Regulation Authority, United Kingdom. Risk Outlook report: the use of artificial intelligence in the legal market. 20 November 2023. Available from: https://www.sra.org.uk/sra/research-publications/artificial-intelligence-legal-market/. Accessed 4 Sep 2025.

8. Farah H. Court of appeal judge praises ‘jolly useful’ ChatGPT after asking it for legal summary. The Guardian. 23 September 2023. Available from: https://www.theguardian.com/technology/2023/sep/15/court-of-appeal-judge-praises-jolly-useful-chatgpt-after-asking-it-for-legal-summary. Accessed 4 Sep 2025.

9. Courts and Tribunals Judiciary, United Kingdom. Artificial intelligence (AI): guidance for judicial office holders. 12 December 2023. Available from: https://www.judiciary.uk/wp-content/uploads/2023/12/AI-Judicial-Guidance.pdf. Accessed 4 Sep 2025.

10. Courts and Tribunals Judiciary, United Kingdom. Artificial intelligence (AI): guidance for judicial office holders. Updated 14 April 2025. Available from: https://www.judiciary.uk/wp-content/uploads/2025/04/Refreshed-AI-Guidance-published-version.pdf. Accessed 4 Sep 2025.

11. Hong Kong Academy of Medicine. Event report of HKAM Workshop on Expert Witness Report Writing [unpublished internal document]. Hong Kong: Hong Kong Academy of Medicine; 2025.

12. Roberto Mata v Avianca, Inc 22-cv-1461 (PKC) and Felicity Harber v The Commissioner for His Majesty’s Revenue and Customs [2023] UKFIY 1007 (TC)

13. Kohls v Ellison, Case No. 24-cv-3754 (LMP/DLM)

14. McMullin B. The expert. Law Society Ireland Gazette. 28 February 2024. Available from: https://www.lawsociety.ie/gazette/in-depth/2024/february/the-expert/. Accessed 4 Sep 2025.

15. Office of the Privacy Commissioner for Personal Data, Hong Kong. 10 Tips for users of AI chatbots. September 2023. Available from: https://www.pcpd.org.hk/english/resources_centre/publications/files/ai_chatbot_leaflet.pdf. Accessed 4 Sep 2025.

16. Jones v Kaney [2011] UKSC 13

Respiratory syncytial virus (RSV) is a common cause of respiratory infections globally and in Hong Kong.1 2 It is the leading cause of hospitalisation due to respiratory viral infections among infants and young children, and it is increasingly recognised as a substantial threat to older adults.1 2 3 4 Although hospitalised at lower rates than infants and young children, older people are more likely to experience severe outcomes, including cognitive decline, infection-triggered acute myocardial infarction, stroke, or even death.1 2 3 4 Contemporary data suggest that the spread and consequences of RSV, particularly in older adults, have consistently been underestimated.1 2 4 In older adults, the clinical outcomes of RSV infection are comparable to, or even more severe than, those of influenza.2 3 In Hong Kong, large-scale epidemiological data on RSV are currently unavailable.

Both upper respiratory tract and lower respiratory tract (LRT) specimens may be used to test for RSV. In a previous local study reviewing multiplex polymerase chain reaction (PCR) results from 20 127 respiratory specimens tested in a hospital across all age-groups between 2014 and 2023, RSV was detected in 2.03% of LRT specimens (including sputa and endotracheal/tracheal/bronchial aspirates) and in 7.93% of upper respiratory tract specimens (combined nasal/nasopharyngeal and throat swabs).5 In a multicentre, prospective study recruiting adult patients with chronic obstructive pulmonary disease and infective exacerbations, a higher RSV positivity rate by quantitative PCR was observed in sputum samples compared with nasopharyngeal swabs (7.69% vs 2.02%, respectively).6 Given that there is no single RSV test in adults with acceptable diagnostic accuracy, these figures may represent underestimates.6 In this study, 59% of RSV-associated exacerbations were PCR-negative, despite sample collection within 5 days of symptom onset.6

Local studies have demonstrated substantial morbidity and mortality associated with RSV infections among older adults. A small study found that, of 71 older adults (median age: 75 years; 74% with co-morbidities) hospitalised with RSV, 61% required supplemental oxygen, and 18% had severe disease requiring non-invasive ventilation or intensive care, or resulting in death within 30 days.7 Furthermore, in a retrospective study of adults admitted between 2009 and 2011 to three acute care general hospitals in Hong Kong serving a population of over 1.5 million, 607 patients (mean age: 75 years) had virologically confirmed RSV infection; 30-and 60-day mortality rates were 9.1% and 11.9%, respectively.3 Finally, in a study of hospitalised patients with laboratory-confirmed respiratory virus infections between 1998 and 2012, the incidence of hospitalisation due to RSV was 2.09 per 10 000 population in both men and women aged 65 to 74 years. The mean annual mortality in this age-group was 17.44 per 1 000 000 population for men and 11.02 per 1 000 000 population for women.1

A disruption in the population genetic diversity and seasonality of RSV as a consequence of the COVID-19 pandemic has been observed.8 9 10 Australian data demonstrated that many historically detected RSV lineages were no longer circulating after 2021, having been superseded by two novel RSV-A lineages, which may become dominant due to their greater resilience, fitness, infectivity, or a combination of these factors.8 Additionally, the RSV Hospitalization Surveillance Network in the US has shown that COVID-19 affected RSV seasonality, with a shorter but more intense season of infection in 2022-2023, though with at least a trend towards pre-COVID norms in the 2023-2024 season.9

Although surveillance for RSV in Hong Kong is comparatively less extensive, data from the local health authority suggest that the post-COVID pattern of RSV has also changed; it may now comprise a single infective season peaking between April and October.10 Moreover, a recent local paediatric study showed significantly increased odds of RSV infection in children aged 3 years or above after the COVID-19 lockdown, although the full impact remains to be determined.11

In addition to the evolving pathogenicity of RSV infection following the COVID-19 pandemic, it is important to note the increasingly ageing population and, consequently, a growing vulnerable population in regions such as Hong Kong, which will inevitably contribute to a heavier RSV disease burden.12 Accordingly, it is crucial to conduct adequate surveillance to monitor the changing epidemiology and to inform appropriate risk mitigation strategies.

Along with increased surveillance, the recent introduction of vaccines against RSV (from 2023 onwards) has created a new opportunity to manage the risk of infection and its consequences.13 Internationally, vaccination against RSV has been recommended by national or supranational organisations in multiple locations; older age is recognised as an independent risk factor, alongside various cardiopulmonary, metabolic, and immune conditions (Table).2 13 Understanding the extent of risk for the local population in Hong Kong, as well as the effectiveness of targeted interventions (eg, vaccine rollout), will rely on analyses of epidemiological data.

Globally, approaches to RSV surveillance vary considerably. In Australia and South Korea, RSV is actively monitored as a notifiable disease, and healthcare professionals (HCPs) are mandated to report all confirmed cases to a central source.14 15 Active surveillance promotes testing for RSV, while its status as a notifiable disease facilitates systematic data collection, which, upon analysis, can effectively support the formulation of health strategies, their implementation, and informed health policy decision making.

Given that RSV is not a notifiable disease, its surveillance in Hong Kong is primarily conducted through sentinel clinics and a limited number of public and private hospitals. Sentinel systems generally require relatively low resource consumption but may not cover a sufficiently large population to provide accurate estimates of virus circulation. The impetus to test for RSV may also be limited in patients presenting with non-severe respiratory illnesses, which are common, exhibit non-specific symptoms, and are typically managed in a similar manner regardless of aetiology.15 Thus, where most sentinel activity occurs in primary care or community settings, the true burden may be underrepresented and skewed towards less severe cases. In contrast, sentinel systems in hospital settings can yield more detailed information on severe cases and outcome data concerning the most serious consequences of infection.15 In Hong Kong, RSV is likely underdiagnosed, partly due to low testing rates in adults, and partly due to skewed reporting by the existing sentinel system.

To enhance the RSV testing rate, educational campaigns for HCPs should be implemented to increase clinical suspicion of RSV in adults and to raise awareness of its potential consequences in older adults and other high-risk populations (eg, those with chronic respiratory, cardiac, endocrine, or renal diseases, as well as those with immunodeficiency).12 13 Targeted surveillance in these patient groups may offer cost savings. Testing sites can also be prioritised in areas of greatest risk, assessing the penetration and spread of RSV among populations such as older adults residing in higher-density settings, including long-term care facilities.

To mitigate the resource and workload implications of increased testing, European and other international guidelines have recommended incorporating RSV into existing surveillance systems for respiratory infections.15 16 Furthermore, it is important to standardise the testing method5 12 15; PCR remains the preferred tool for confirming RSV cases, given the risk of false-negative results with current rapid antigen tests. Hospital-based surveillance, covering nasopharyngeal specimens and beyond, may be considered, particularly to address the potential underdiagnosis of severe RSV cases.

Practical considerations for enhancing RSV surveillance in Hong Kong may include integration with broader respiratory pathogen surveillance and diagnostic systems, such as those for COVID-19 and influenza.15 Moreover, it is essential to centralise procedures, standardise case definitions, and expand laboratory capacity to streamline the implementation of territory-wide surveillance.15

At present, the management of severe RSV infection is non-specific and largely supportive.2 Although this approach may discourage testing or screening in patients presenting with symptomatic infections, increased quantity and quality of surveillance data could be used to optimise an RSV vaccination campaign. For example, such optimisation could involve prioritisation of high-risk groups, setting an appropriate age threshold for vaccination, and determining the overall cost-benefit ratio for reducing healthcare resource utilisation under various vaccination coverage scenarios.

To date, two of the three internationally licensed RSV vaccines are available in Hong Kong: the adjuvanted RSVPreF3 OA (Arexvy, GSK) and RSVpreF (Abrysvo, Pfizer) [Table].17 18 19 20 These vaccines have been evaluated using similar study designs, although variations exist in the trial centres’ coverage of RSV ‘season’ periods and in the case definitions used for acute respiratory illness, LRT illness, and severe LRT illness across at least two RSV seasons.18 19 20 Both trials have shown high efficacy and safety of the respective vaccines against symptomatic infection and severe outcomes (Table).18 20 However, head-to-head comparisons between the vaccines are not yet available.

Recent data from the US Centers for Disease Control and Prevention support the real-world effectiveness of both RSV vaccines.21 Based on findings from the VISION multi-site network of electronic health records (between 1 October 2023 and 31 March 2024), the effectiveness of the adjuvanted RSVPreF3 OA vaccine against RSV-associated emergency department visits and hospitalisations was 77% and 83%, respectively, among adults aged 60 years or above (Table).21 Similarly, RSVpreF demonstrated effectiveness of 79% against emergency department visits and 73% against hospitalisations.21

The primary concerns regarding RSV vaccination are similar to those associated with other vaccines: how to enhance uptake, raise awareness, address misconceptions, and identify which populations should be prioritised for free or subsidised vaccination through public health programmes.12 15 Unresolved scientific questions—such as the duration of protection and the appropriate age for vaccine administration—continue to be investigated and can be informed by local data. The US Centers for Disease Control and Prevention recommends RSV vaccination for adults aged 75 years or above, and for those aged 60 to 74 years with certain chronic medical conditions or other risk factors (eg, communal living) for severe RSV infection (Table).22 On 16 April 2025, the Advisory Committee on Immunization Practices extended this recommendation to adults aged 50 to 59 years who are at increased risk of severe RSV infection, following the US Food and Drug Administration’s licensure of the vaccine for this population group (Table).23

Although RSV vaccines are generally well tolerated, there have been reports of Guillain—Barré syndrome (GBS) and acute disseminated encephalomyelitis following vaccination.24 25 Assessment of GBS risk after vaccination with RSVpreF and adjuvanted RSVPreF3 OA was conducted in a self-controlled case series analysis, using risk windows defined as 1 to 42 days post-vaccination and control windows as 43 to 90 days post-vaccination.25 The analysis of all GBS cases from this study suggests an increased risk within the first 42 days post-vaccination, equating to seven excess cases per million doses of adjuvanted RSVPreF3 OA and nine excess cases per million doses of RSVpreF, in adults aged 65 years or above.24 25 While the findings indicate an increased GBS risk, they are not sufficient to establish a causal relationship.25 In the RENOIR study, one case each of GBS and Miller Fisher syndrome (a GBS variant) was reported after RSVpreF vaccination,19 whereas no cases of GBS have been reported to date in the AReSVi-006 study investigating the adjuvanted RSVPreF3 OA vaccine.17 Nonetheless, both vaccines are required to include a GBS warning, as mandated by the US Food and Drug Administration.25

Collectively, international experience suggests that the commercial availability of RSV vaccines will deliver clinical and public health benefits by reducing severe infections and the utilisation of healthcare resources.

In Hong Kong, the adjuvanted RSVPreF3 OA vaccine is indicated for active immunisation to prevent LRT disease caused by RSV in adults aged 60 years or above, as well as in adults aged 50 to 59 years who are at increased risk of RSV disease. RSVpreF is indicated for active immunisation in individuals aged 60 years or above to prevent LRT disease caused by RSV. To promote uptake of privately purchased (self-paid) vaccines, health education initiatives and advertising campaigns highlighting the importance of RSV vaccination should be encouraged.

As of January 2025, due to the lack of cost-benefit studies in older adults, the Hong Kong Scientific Committee on Vaccine Preventable Diseases does not universally recommend RSV vaccination. Instead, the Committee has advised that vaccination should be considered, particularly for individuals aged 75 years or above and those residing in nursing homes.24 Given that hospitalised patients with RSV infection frequently present with co-morbidities (>70% based on available local data),3 7 it is suggested that vaccination be prioritised for all adults aged 75 years or above, immunocompromised individuals, adults aged 60 years or above with relevant co-morbid conditions (eg, chronic obstructive pulmonary disease, asthma, congestive heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, chronic kidney disease, or frailty), and those living in community housing or residential care settings—concordant with recommendations from the Advisory Committee on Immunization Practices.13 Vaccination subsidies should be considered for at-risk groups who are economically disadvantaged. The precise target groups, as well as the potential health and cost savings from a targeted vaccine rollout, will depend on local epidemiological data. However, the development of formal recommendations should be prioritised by the government and relevant medical societies involved in the care of at-risk populations.

Respiratory syncytial virus infection is not only a childhood disease; it also poses a major health risk to older adults, especially those with underlying morbidities who require targeted prevention and treatment. The ageing population in Hong Kong further exacerbates this challenge. The recent development of effective vaccines (Table)17 18 19 20 26 underscores the urgent need to develop up-to-date recommendations and policies to guide the rational use of vaccination, both to prevent severe RSV infection and to reduce the associated healthcare utilisation and societal costs. The precise determination of target groups should be informed by local epidemiological data, which can be generated through dedicated studies and enhanced RSV surveillance, particularly in hospital settings. In the interim, HCPs are encouraged to proactively raise awareness of RSV among both medical peers and the public, and to consider extending vaccination to at-risk groups in line with international guidance and published literature. These combined efforts will promote a coherent policy of systematic vaccination, achieving the greatest benefit for patients and the broader community. Future studies should address the cost-effectiveness of RSV vaccination across various at-risk populations.12 27

Concept or design: JCK Chan.
Acquisition of data: JCK Chan, MYW Kwan.
Analysis or interpretation of data: All authors.
Drafting of the manuscript: JCK Chan.
Critical revision of the manuscript for important intellectual content: All authors.

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.

MCS Wong is an advisory committee member of Pfizer; an external expert of GlaxoSmithKline Limited; a member of the advisory board of AstraZeneca and has been paid consultancy fees for providing advice on research. Other authors did not receive an honorarium for participating in the preceding advisory board meeting as declared in the submitted ICMJE disclosure forms.

This editorial incorporates insights from an advisory board meeting held on 15 July 2024 in Hong Kong, with contributions from private practitioners Dr Aaron Lai, Dr Leung-cheung Goh, and Dr Mary Cheng.

Medical writing, editorial, and publication coordination support were independently funded by GSK in accordance with the Good Publication Practice (GPP3) guidelines. Editorial and medical writing support were provided by MediPaper Medical Communications Ltd. The funders had no role in study design, data collection, analysis, interpretation, or manuscript preparation. Ultimate responsibility for the opinions, interpretation, and conclusions lies with the authors.

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