OBJECTIVES: The study aimed to describe and assess the recommendations of published position statements regarding several aspects of biosimilars across specialties and determine whether these positions have changed with the emergence of new evidence.
METHODS: We systematically searched for published position statements of biosimilars in online databases and included statements written in English. The search was from the inception of the databases until May 2023. Two reviewers independently extracted the data. Only position statements that included recommendations to guide the use of biosimilars in clinical practice and were issued by health organisations and societies, including expert panels, were included. We synthesised recommendations on five aspects: prescribing practice, extrapolation of indication, interchangeability, treatment initiation with biosimilars in biologic-naïve patients, and pharmacovigilance.
RESULTS: The review included 25 papers involving eight specialties, 16 of which were from European countries, 1 from an international organisation representing 49 countries, and 6 from various countries. The papers were published between 2009 and 2020, with 19 published between 2015 and 2020. Of the five aspects of biosimilars assessed, nearly half (11 of 25) of the papers at the time they were published did not base their positions on a scientific or evidence-based approach. Only 4 of the 25 position papers were identified as revisions of their previous papers. With increasing experience in biosimilars and the emergence of new evidence, about 60% (16 of 25) of the papers contained outdated recommendations, particularly on two aspects. They were extrapolations of indications and interchangeability (including switching). The recommendations for most papers for three other aspects were still appropriate. These were prescribing biosimilars by their brand name and active ingredient, initiating treatment with biosimilars in biologic-naïve patients, and monitoring the long-term safety of biosimilars through pharmacovigilance. For four of the revised papers, their position evolved from opposing indication extrapolation for biosimilars to accepting it, while the position of two papers shifted from not recommending biosimilar switching to permitting the practice. Meanwhile, most papers were against automatic substitution by pharmacists because the evidence for this practice was still limited.
CONCLUSIONS: Across specialties, the variability among the position statements is seen for extrapolation of indications for biosimilars and interchangeability (including switching). This requires a revision, considering the latest evidence and growing experience with the use of biosimilars in extrapolated indications and with switching.
METHODS: From 2010 to 2014, men with HIV (N = 212) and opioid dependence before incarceration were enrolled in MMT within 6 months of release from Malaysia's largest prison and followed for 12-months post-release. As a prospective trial, allocation to MMT was at random and later by preference design (predictive nonetheless). MMT dosing was individually targeted to minimally achieve 80 mg/day. Time-to-event analyses were conducted to model linkage to MMT after release.
FINDINGS: Of the 212 participants allocated to MMT, 98 (46 %) were prescribed higher dosages (≥80 mg/day) before release. Linkage to MMT after release occurred in 77 (36 %) participants and significantly higher for those prescribed higher dosages (46% vs 28 %; p = 0.011). Factors associated with higher MMT dosages were being married, on antiretroviral therapy, longer incarceration periods, having higher levels of depression, and methadone preference compared to randomization. After controlling for other variables, being prescribed higher methadone dosage (aHR: 2.53, 95 %CI: 1.42-4.49) was the only independent predictor of linkage to methadone after release.
INTERPRETATION: Higher doses of methadone prescribed before release increased the likelihood of linkage to MMT after release. Methadone dosing should be introduced into international guidelines for treatment of opioid use disorder in prisons and further post-release benefits should be explored.
FUNDING: National Institute of Drug Abuse (NIDA).
OBJECTIVE: This study aims to test the feasibility and acceptability of an AI chatbot in promoting the uptake of HIV testing and pre-exposure prophylaxis (PrEP) in MSM.
METHODS: We conducted beta testing with 14 MSM from February to April 2022 using Zoom (Zoom Video Communications, Inc). Beta testing involved 3 steps: a 45-minute human-chatbot interaction using the think-aloud method, a 35-minute semistructured interview, and a 10-minute web-based survey. The first 2 steps were recorded, transcribed verbatim, and analyzed using the Unified Theory of Acceptance and Use of Technology. Emerging themes from the qualitative data were mapped on the 4 domains of the Unified Theory of Acceptance and Use of Technology: performance expectancy, effort expectancy, facilitating conditions, and social influence.
RESULTS: Most participants (13/14, 93%) perceived the chatbot to be useful because it provided comprehensive information on HIV testing and PrEP (performance expectancy). All participants indicated that the chatbot was easy to use because of its simple, straightforward design and quick, friendly responses (effort expectancy). Moreover, 93% (13/14) of the participants rated the overall chatbot quality as high, and all participants perceived the chatbot as a helpful tool and would refer it to others. Approximately 79% (11/14) of the participants agreed they would continue using the chatbot. They suggested adding a local language (ie, Bahasa Malaysia) to customize the chatbot to the Malaysian context (facilitating condition) and suggested that the chatbot should also incorporate more information on mental health, HIV risk assessment, and consequences of HIV. In terms of social influence, all participants perceived the chatbot as helpful in avoiding stigma-inducing interactions and thus could increase the frequency of HIV testing and PrEP uptake among MSM.
CONCLUSIONS: The current AI chatbot is feasible and acceptable to promote the uptake of HIV testing and PrEP. To ensure the successful implementation and dissemination of AI chatbots in Malaysia, they should be customized to communicate in Bahasa Malaysia and upgraded to provide other HIV-related information to improve usability, such as mental health support, risk assessment for sexually transmitted infections, AIDS treatment, and the consequences of contracting HIV.
METHODS: A cross-sectional study was conducted between October 2022 and August 2023 using an online REDCap electronic data capture tool questionnaire. PACS was defined as new or persistent symptoms lasting more than 28 days after a positive SARS-CoV-2 polymerase chain reaction or rapid test kit antigen test. Multivariable logistic regression was performed to determine predictors associated with PACS.
RESULTS: Among 609 infected healthcare workers, they were predominantly female (71.8%), Malays (84.6%), and aged 18-39 years (70.1%). 50.7% of infected healthcare workers experienced PACS. The most common PACS symptoms experienced were fatigue (27.9%), cough (25.1%), decreased physical strength (20.5%), and musculoskeletal pain (19.2%). Those who are more likely to develop PACS were females, underlying asthma, and COVID-19 severity category 3. On the other hand, those who received booster vaccinations were less likely to develop PACS.
CONCLUSION: PACS is prevalent among healthcare workers with COVID-19 at the University Malaya Medical Centre. These findings emphasise the critical need for those with higher risk to receive regular health monitoring and checkups to detect any early signs of PACS. It underscores the need for continuous support and healthcare interventions to mitigate the impacts of PACS and ensure the physical and mental well-being of healthcare workers.
SOURCES OF DATA: Recent published literature.
AREAS OF AGREEMENT: Corticosteroids and immunomodulators that antagonize the interleukin-6 (IL-6) receptor have been shown to play a critical role in modulating inflammation and improving clinical outcomes in hospitalized patients. Inhaled budesonide reduces the time to recovery in older patients with mild-to-moderate COVID-19 managed in the community.
AREAS OF CONTROVERSY: The clinical benefit of remdesivir remains controversial with conflicting evidence from different trials. Remdesivir led to a reduction in time to clinical recovery in the ACTT-1 trial. However, the World Health Organization SOLIDARITY and DISCOVERY trial did not find a significant benefit on 28-day mortality and clinical recovery.
GROWING POINTS: Other treatments currently being investigated include antidiabetic drug empagliflozin, antimalarial drug artesunate, tyrosine kinase inhibitor imatinib, immunomodulatory drug infliximab, antiviral drug favipiravir, antiparasitic drug ivermectin and antidepressant drug fluvoxamine.
AREAS TIMELY FOR DEVELOPING RESEARCH: The timing of therapeutic interventions based on postulated mechanisms of action and the selection of clinically meaningful primary end points remain important considerations in the design and implementation of COVID-19 therapeutic trials.
METHODS: A retrospective study cohort was conducted at the University Malaya Medical Centre (UMMC) on cases of MRSA bacteremia from 2012 to 2016. Patient demographic and clinical data were collected for risk factors analyses.
RESULTS: New cases of MRSA bacteremia showed a trend of increase from 0.12 to 100 admissions in 2012 to 0.17 per 100 admissions in 2016 but a drop was observed in 2014 (0.07 per 100 admissions). Out of the 275 patients with MRSA bacteremia, 139 (50.5%) patients were aged ≥ 65 years old. Co-morbidities and severity at presentation were significantly higher among older adults, including diabetes mellitus (p = 0.035), hypertension (p = 0.001), and ischemic heart disease (p
METHODS: We searched 6 electronic databases to identify randomised controlled trials assessing the impact of using technology in vaccine safety communication. The Cochrane Collaboration's tool for assessing risk of bias was used to evaluate each study.
RESULTS: We included 22 studies involving 27,109 participants from 8 countries; 15 studies assessed the use of videos and 7 examined innovative technologies. Using videos significantly improved knowledge (n = 3) and participant engagement (n = 2) compared to printed material. Among the innovative technologies, the use of virtual reality, and smartphone applications incorporating social networking or gamification significantly increased vaccination knowledge, confidence, and engagement. The studies showed that narrative messaging increased perceived disease severity (n = 2) and vaccination intention (n = 2).
CONCLUSIONS: While the use of innovative technologies is increasing, videos currently remain the most popular technology for vaccine safety communication. Communication technology, particularly with narrative messaging, improves patient engagement and comprehension.
PRACTICE IMPLICATIONS: Health authorities should increase focus on using videos and smartphone applications for vaccine safety communication. Collaboration among stakeholders is essential to develop guidelines on effective message content to complement the technology.
OBJECTIVE: We developed an innovative, clinic-integrated smartphone app called JomPrEP, which provides a virtual platform for Malaysian MSM to engage in HIV prevention services. In collaboration with the local clinics in Malaysia, JomPrEP offers a range of HIV prevention (ie, HIV testing and pre-exposure prophylaxis [PrEP]) and other support services (eg, referral to mental health support) without having to interface face to face with clinicians. This study evaluated the usability and acceptability of JomPrEP to deliver HIV prevention services for MSM in Malaysia.
METHODS: In total, 50 PrEP-naive MSM without HIV in Greater Kuala Lumpur, Malaysia, were recruited between March and April 2022. Participants used JomPrEP for a month and completed a postuse survey. The usability of the app and its features were assessed using self-report and objective measures (eg, app analytics, clinic dashboard). Acceptability was evaluated using the System Usability Scale (SUS).
RESULTS: The participants' mean age was 27.9 (SD 5.3) years. Participants used JomPrEP for an average of 8 (SD 5.0) times during 30 days of testing, with each session lasting an average of 28 (SD 38.9) minutes. Of the 50 participants, 42 (84%) ordered an HIV self-testing (HIVST) kit using the app, of whom 18 (42%) ordered an HIVST more than once. Almost all participants (46/50, 92%) initiated PrEP using the app (same-day PrEP initiation: 30/46, 65%); of these, 16/46 (35%) participants chose PrEP e-consultation via the app (vs in-person consultation). Regarding PrEP dispensing, 18/46 (39%) participants chose to receive their PrEP via mail delivery (vs pharmacy pickup). The app was rated as having high acceptability with a mean score of 73.8 (SD 10.1) on the SUS.
CONCLUSIONS: JomPrEP was found to be a highly feasible and acceptable tool for MSM in Malaysia to access HIV prevention services quickly and conveniently. A broader, randomized controlled trial is warranted to evaluate its efficacy on HIV prevention outcomes among MSM in Malaysia.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05052411; https://clinicaltrials.gov/ct2/show/NCT05052411.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/43318.