To examine outcomes from respiratory pathogens containment strategies focused on international travellers.
We developed a compartmental model generalisable to respiratory infectious diseases, in which international travellers interact with each other and airline/airport workers during transit. We used SARS-CoV-2 Omicron surge data (basic reproduction number (R0): 9.5) as a case example and performed sensitivity and scenario analyses, including varying the R0 for different respiratory pathogens.
A US high-volume airport.
Simulated international travellers and airline/airport workers.
Projection of new and imported SARS-CoV-2 infections without intervention (No Intervention); pre-travel screening for travellers who intend to travel (intended travellers) with PCR (Pre-travel PCR); or antigen testing (Pre-travel Ag); mask-wearing guidance for travellers and workers (Mask-wearing); and a Combined strategy (Pre-travel PCR & Mask-wearing).
The number of new and imported respiratory disease infections over the 90-day simulation period.
Over the 90-day simulation, the number of infected travellers entering the USA would be: 1 155 580 (27.2% of 4.2 million (M) intended travellers) with No Intervention; 709 560/4.2M (16.7%) with Pre-travel PCR; 862 330/4.2M (20.3%) with Pre-travel Ag; 1033 820/4.2M (24.4%) with Mask-wearing; and 650 480/4.2M (15.3%) with Combined. The number of new infections among airline/airport workers would be: 25 670 (73.3% of 35 000 workers) with No Intervention; 25 260 (72.2%) in Pre-travel PCR; 25 590 (73.1%) in Pre-travel Ag; 24 630 (70.4%) in Mask-wearing; and 18 770 (53.6%) in Combined. In scenario analyses, the most impactful parameters were R0 of the respiratory pathogen and population immunity level.
A Combined strategy of pre-travel PCR testing and mask-wearing would most effectively reduce respiratory infection among international travellers and airline/airport workers, but would still allow a substantial number of infections to enter the USA, especially when the pathogen is highly transmissible.
Human papillomavirus (HPV) vaccines have been introduced in the Chinese market since 2016. However, the HPV vaccine coverage is still remarkably low among adolescent girls in China. This study will employ discrete choice experiments (DCEs) to elicit the preferences of Chinese caregivers for HPV vaccine-related profile characteristics and service delivery methods for adolescent girls.
Two DCEs will be conducted with caregivers of girls aged 9–18 in China. The first DCE will focus on caregivers’ preferences regarding the HPV vaccine-related profile for girls aged 9–18, with potential attributes including level of protection against cervical cancer, level of protection against genital warts, risk of severe side effects, number of dose(s), place of manufacture, waiting time and cost for one dose. The second DCE will assess Chinese caregivers’ preferences for vaccination service delivery methods, with the potential attributes including source of recommendation, information channel, message framing, how to make an appointment, location for receiving the vaccine and incentives. A total of 300 participants will be recruited to complete the DCEs. We will summarise the key socio-demographic characteristics of participants and use latent class and mixed logit models to assess preferences and preference heterogeneity in HPV vaccination services.
Ethical approval was obtained from the Research and Ethics Committee at Nanjing Medical University. Findings from this study will be disseminated widely to relevant stakeholders via scheduled meetings, webinars, presentations at conferences and in peer-reviewed journal manuscripts.
To characterise the reporting practices of sequential multiple assignment randomised trials (SMARTs) in human health research.
Scoping review of protocol and primary analysis papers describing SMARTs published between January 2009 and February 2024.
SMARTs are innovative trial designs that allow for multiple stages of randomisation to treatment, with randomization potentially based on a patient’s response(s) to previous treatment(s). They are uniquely designed to develop sequential adaptive interventions (dynamic treatment regimes (DTRs)) to support personalized clinical decision-making over time. Previous reviews have identified inconsistencies in how the design, implementation and results of SMARTs have been reported in published studies. A comprehensive assessment of SMART reporting practices is lacking and necessary for developing standardised SMART-specific reporting guidelines.
We systematically searched multiple databases for SMART-related protocol and primary analysis papers published between January 2009 and February 2024. Title, abstract and full-text screenings were performed by pairs of reviewers, with disagreements resolved by consensus. Data extraction included study characteristics, design elements and analytical approaches for embedded or tailored DTRs. Results were synthesised qualitatively and presented descriptively.
From 5486 screened studies, 103 (59 protocol papers, 16 primary analysis papers, 14 protocol papers with corresponding primary analysis papers) met the inclusion criteria. Most studies targeted adults (62.7% protocols, 62.5% primary analyses, 42.9% protocol+primary analyses) and were primarily conducted in the USA. Behavioural and mental health constituted the most frequent therapeutic domain. While intervention descriptions and re-randomisation criteria were consistently reported, operational characteristics such as blinding (protocols: 64.4%, primary analyses: 62.5%, protocols+primary analyses: 71.4%) and randomisation details (protocols: 55.9%, primary analyses: 37.5%, protocols+primary analyses: 50.0%) were inconsistently documented. Only 46.7% of primary analyses evaluated embedded DTRs, and none explored deeply tailored DTRs.
Despite the increased adoption of SMART designs, substantial reporting variability persists. Most primary analyses underuse the capability of SMARTs to generate data for developing DTRs. SMART-specific standardised reporting guidelines can help accelerate the scientific and clinical impact of SMARTs.
For people whose stroke risk would be reduced by taking a long-term oral anticoagulant (OAC), it is important to implement effective strategies to support medication initiation, adherence and persistence. To do this, a better understanding of the factors associated with implementation of interventions to optimise OAC management is needed.
This scoping review aimed to summarise the evidence-based characteristics associated with implementing interventions designed to optimise long-term OAC adherence.
Primary research (published post-2000) evaluating any intervention designed to optimise implementation of long-term OAC for stroke prevention by way of change in OAC services, staff or patient behaviour.
Five databases (MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo, Cochrane Library) were searched from 1 January 2000 to 4 August 2023 using a combination of terms relating to population, intervention and study design.
Titles/abstracts were screened by at least one reviewer. Data from each full text were abstracted (with 20% double-checked for accuracy) and its implementation content reviewed, guided by the Expert Recommendations for Implementing Change strategies.
216 studies were included, with varying descriptive reporting of implementation strategies, and only 61 (28%) self-identifying as an implementation study. The median number of implementation strategies used was three, with recently published studies (2015 onwards), those including patients receiving either direct OACs (DOACs) or vitamin K antagonists (VKAs) and those including multiple intervention targets (service, staff or patients) associated with using more implementation strategies. ‘Train and educate stakeholders’ strategies were the most commonly used, and ‘Adapt and tailor to the context’ strategies were the least used by included studies. Conversely, self-defined implementation studies were less likely to use ‘Train and educate stakeholders’ strategies, although they were positively associated with use of ‘Adapt and tailor to the context’. ‘Use evaluative & iterative’ strategies were used more frequently in studies where patients used either VKAs or DOACs, or were published more recently.
Studies need to self-define as implementation studies, improve implementation strategy reporting and be transparently registered, alongside conducting process evaluations or more richly describing implementation processes. Future research could explore why some implementation strategies are used more than others and whether aligning strategy clusters with intervention targets results in clinically significant differences in patient care.
To explore patients’ experiences and perspectives on using a direct-to-consumer smartwatch with single-lead electrocardiography (1L-ECG) for ambulatory rhythm diagnostics in primary care.
Qualitative study using semi-structured interviews and thematic analysis.
Primary care patients referred for ambulatory rhythm monitoring in a diagnostic centre.
Eighteen adults with paroxysmal palpitations, of whom nine were female patients (50%), aged 32–85 (median 66) years.
Participants simultaneously wore a smartwatch with 1L-ECG capability (Withings ScanWatch) and a conventional Holter monitor for 7 days.
Patient experiences and perceived barriers and facilitators to smartwatch use for rhythm monitoring, reported after the monitoring period.
Patients found the smartwatch more user-friendly and feasible than the Holter monitor. Difficulties included uncertainty about when to initiate recordings, challenges capturing brief episodes and anxiety triggered by automated algorithm outputs. Participants emphasised the importance of accessible healthcare support for interpretation and reassurance.
This study shows that smartwatch-based 1L-ECG monitoring is feasible and acceptable for ambulatory rhythm diagnostics in primary care. Prior to routine implementation, it is crucial to address the identified challenges: particularly anxiety related to algorithm results, uncertainty about when to record and accessible clinician support.
Since 2018, WHO has endorsed the use of whole-genome sequencing (WGS) of Mycobacterium tuberculosis complex isolates to detect drug-resistant tuberculosis (DR-TB). This endorsement was based on the assumption that a faster and more detailed description of the resistance profile would improve treatment prescription for DR-TB by healthcare providers, and hence the treatment outcomes of patients. Nonetheless, this assumption has not been tested in routine clinical practice and different scenarios. In Brazil, WGS is not routinely used for the diagnosis of DR-TB, having been carried out in only a few centres for research purposes. With this trial, we will evaluate whether a WGS-based drug-resistance report improves treatment adequacy in patients with pulmonary DR-TB, compared with the current standard-of-care diagnostic methods used in the state of São Paulo, Brazil.
We will conduct a non-randomised controlled clinical trial with two arms to compare the intervention group (ie, individuals receiving a WGS-based report) with a historical control group (i.e., individuals who received resistance diagnostics based on the standard of care of conventional genotyping and phenotyping techniques). The primary outcome will be the proportion of patients whose treatment scheme was adequate based on complete resistance profile determined by WGS and/or phenotypic drug-susceptibility testing (pDST). Other secondary outcomes will also be considered. The target sample size is 88 eligible patients per group. The intervention group will be prospectively recruited over 18 months and the control group will be composed of patients diagnosed with pulmonary DR-TB up to 2 years before the start of the trial. To ensure comparability, isolates from the control group will undergo WGS retrospectively, and pDST will be performed retrospectively in both groups. This clinical trial will take place in six medical centres for the treatment of DR-TB in the state of São Paulo. This study is intended to support the implementation of the WGS in the routine diagnosis of DR-TB in the state of São Paulo.
Ethical approval was obtained from the Human Research Committee of the Institute of Biomedical Sciences, University of São Paulo, Brazil (CAAE: 79497924.1.1001.5467). Study results will be published in peer-reviewed journals and disseminated to policymakers and stakeholders.
U1111-1308-4669.
Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.
A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p
The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.
This study aims at documenting the frequency of reported abuse, stigma and discrimination and exploring the perspectives for improving the quality of maternal-newborn care (QMNC) of migrant mothers’ reporting abuse, stigma or discrimination.
Mixed methods multicentre cross-sectional study.
All maternal facilities (tertiary and secondary levels of care, n=9) from Friuli-Venezia Giulia region, Northeast Italy, between November 2019 and January 2022 in Northeast Italy.
874 migrant and 3968 non-migrant women answering a validated WHO Standard-based questionnaire after birth.
Frequency of reported abuse, stigma and discrimination during facility-based childbirth was calculated and compared with those of non-migrant mothers. Thematic analysis was conducted on eight open questions, using WHO Standards as a framework for the analysis.
Among migrant women, 84 (9.6%) reported some type of abuse, stigma and discrimination, a frequency similar to non-migrant women (9.8%, p=0.880). The most frequently reported was verbal abuse (87.7%), followed by stigma and discrimination (15.1%). Most women (86.9%) provided at least one comment, with a frequency comparable to non-migrant women (p=0.076). Among a total of 327 comments, 104 (31.8%) were practical suggestions for improving QMNC. Experience of care was the domain with the highest frequency both of negative (64.9% of negative comments) and positive comments (51.7% of positive comments) and with the highest frequency of suggestions for improving QMNC (52.9% of suggestions). Overall, suggestions mainly focused on strengthening healthcare professionals’ communication skills, allowing companionship during childbirth, increasing healthcare professionals’ availability and timely support.
This study shows that both migrant and non-migrant mothers are exposed to abuse, stigma and discrimination during childbirth, and that both are willing to provide practical suggestions, which should be used for planning actions to improve QMNC.
This study aimed to analyse the number of myocardial infarction (MI) admissions during the COVID-19 lockdown periods of 2020 and 2021 (March 15th to June 15th) and compare them with corresponding pre-pandemic period in 2019. The study also evaluated changes in critical treatment intervals: onset to door (O2D), door to balloon (D2B) and door to needle (D2N) and assessed 30-day clinical outcomes. This study examined MI care trends in India during the COVID-19 lockdown period, irrespective of patients’ COVID-19 infection status.
Multicentre retrospective cohort study
Twenty-three public and private hospitals across multiple Indian states, all with 24/7 interventional cardiology facilities.
All adults (>18 years) admitted with acute myocardial infarction between March 15 and June 15 in 2019 (pre-pandemic), 2020 (first lockdown) and 2021 (second lockdown). A total of 3614 cases were analysed after excluding duplicates and incomplete data.
Number of MI admissions, median O2D, D2B and D2N times.
30-day outcomes including death, reinfarction and revascularisation.
MI admissions dropped from 4470 in year 2019 to 2131 (2020) and 1483 (2021). The median O2D increased from 200 min (IQR 115–428) pre-COVID-19 to 390 min (IQR 165–796) in 2020 and 304 min (IQR 135–780) in 2021. The median D2B time reduced from 225 min (IQR 120–420) in 2019 to 100 min (IQR 53–510) in 2020 and 130 min (IQR 60–704) in 2021. Similarly, D2N time decreased from 240 min (IQR 120–840) to 35 min (IQR 25–69) and 45 min (IQR 24–75), respectively. The 30-day outcome of death, reinfarction and revascularisation was 4.25% in 2020 and 5.1% in 2021, comparable to 5.8% reported in the Acute Coronary Syndrome Quality Improvement in Kerala study.
Despite the expansion of catheterisation facilities across India, the country continues to fall short of achieving international benchmarks for optimal MI care.
European cardiovascular guidelines recommend systematic atrial fibrillation (AF) screening in community-dwelling high-risk patients. However, little is known about the impact of abnormal screening findings, including AF and non-AF incidental findings on the target population. This gap highlights the need to assess both the benefits and potential harms from patients’ perspectives to fully understand the impact of AF screening. Therefore, the aim of this study is to explore patients’ experiences with AF screening among those who received abnormal findings from ambulatory ECG monitoring.
We conducted a qualitative study using semistructured interviews, analysed thematically. Participants in the PATCH-AF trial, based in Amsterdam primary care, were purposively sampled based on their screening results (AF or non-AF incidental findings), sex and socioeconomic status.
We achieved data saturation after conducting 16 interviews (6 with interviewees diagnosed with AF and 10 with non-AF incidental findings). Participants had a median age of 76 (73–79) years, and 56% were male. Their experiences, whether positive or negative, fluctuated throughout the screening process and depended on their initial motivations for participation in AF screening (seeking extra health checks, finding explanations for pre-existing symptoms or contributing to medical research), expectations and perceived benefits from clarification, diagnostic workup or treatment. Influencing factors included the type of finding (AF or non-AF incidental finding), healthcare provider communication and individual characteristics such as age, socioeconomic status and medical history.
This qualitative study highlights both positive and negative AF screening experiences from the patients’ perspective. It underscores how patients’ motivations and expectations for participation, the type of ambulatory ECG finding and communication and follow-up by healthcare providers shape their overall experiences. Healthcare providers should be aware of these factors to optimise screening consultations. Clear guidelines on communicating abnormal ambulatory ECG findings, especially incidental findings, are warranted.
The Netherlands Trial Register (NTR) number NL9656.