To assess the impact of tobacco control regulations and policy implementation on smoking cessation tendencies in cigarette users born between 1982 and 1991 in Chile.

Longitudinal cross-sectional study.

National level.

Data from the National Survey of Drug Consumption (Service of Prevention and Rehabilitation for Drug and Alcohol Consumption). A pseudo-cohort of smokers born between 1982 and 1991 (N=17 905) was tracked from 2002 to 2016.

Primary outcome was the tendency to cease smoking conceptualised as the report of using cigarettes 1 month or more ago relative to using cigarettes in the last 30 days. The main exposure variable was the Tobacco Policy Index—tracking tobacco policy changes over time. Logistic regression, controlling for various factors, was applied.

Models suggested a 14% increase in the smoking cessation tendency of individuals using cigarettes 1 month or more ago relative to those using cigarettes in the last 30 days (OR 1.14, CI 95% CI 1.10 to 1.19) for each point increment in the Tobacco Policy index.

Our study contributes to documenting a positive impact of the implementation of interventions considered in the MPOWER strategy in the progression of smoking cessation tendencies in smokers born between 1982 and 1991 in Chile.

To explore people’s views of recovery from total knee replacement (TKR) and which recovery domains they felt were important.

Semi-structured interviews exploring the views of individuals about to undergo or who have undergone TKR. A constant-comparative approach with thematic analysis was used to identify themes. The process of sampling, collecting data and analysis were continuous and iterative throughout the study, with interviews ceasing once thematic saturation was achieved.

Tertiary care centre.

A purposive sample was used to account for variables including pre, early or late postoperative status.

12 participants were interviewed, 4 who were preoperative, 4 early postoperative and 4 late postoperative. Themes of pain, function, fear of complications, awareness of the artificial knee joint and return to work were identified. Subthemes of balancing acute and chronic pain were identified.

The results of this interview-based study identify pain and function, in particular mobility, that were universally important to those undergoing TKR. Surgeons should consider exploring these domains when taking informed consent to enhance shared decision-making. Researchers should consider these recovery domains when designing interventional studies.

Based on the available evidence, cognitive stimulation is recommended as an intervention for people with dementia (PwD). Currently, cognitive stimulation is regularly offered as a group programme in care facilities. However, some residents, such as those who are bedridden, cannot participate. Furthermore, group programmes were not feasible during the pandemic. A concept that accompanies everyday life and enables cognitive stimulation in everyday communication (ie, ‘24/7’) has been missing. Therefore, this feasibility study aims to (1) assess the feasibility of a new continuous 24/7 cognitive stimulation programme (CogStim24) based on a process evaluation and (2) examine the possible effects of CogStim24 on the primary outcome of global cognition in PwD and further PwD-related and staff-related outcomes.

The complex CogStim24 programme is developed to be conducted as an everyday intervention during routine care including cognitively stimulating techniques, such as reminiscence therapy, multisensory stimulation and physical activity. In this unblinded single-arm study with pre-assessments and post-assessments, four nursing homes with a total of N=20 nursing and care staff will participate in an 11-week CogStim24 training programme. The intervention will be conducted to N=60 PwD. Neuropsychological assessments will be conducted pre-staff and post-staff training, as well as after a 6-week implementation phase. A process evaluation will be performed.

Ethics approval was obtained from the ethics committee of the Faculty of Medicine of the University of Cologne, Cologne, Germany. Although cognitive stimulation is known to be effective for enhancing global cognition and quality of life in PwD, it is currently undersupplied to PwD. Therefore, CogStim24 has the potential to reach many more PwD. This study has the potential to serve as a basis for a large multicentre cluster randomised controlled trial. An interdisciplinarity team and mixed-methods approach will help generate information on the practicality and mechanisms of impact of CogStim24. This is important for the further development of the intervention and for facilitating its implementation. The study results will be disseminated via presentations at scientific conferences and meetings for healthcare professionals and PwD and their relatives. Several manuscripts presenting results of the different study parts will be published in peer-reviewed journals.

DRKS00024381.

Patient engagement and integrated knowledge translation (iKT) processes improve health outcomes and care experiences through meaningful partnerships in consensus-building initiatives and research. Consensus-building is essential for engaging a diverse group of experienced knowledge users in co-developing and supporting a solution where none readily exists or is less optimal. Patients and caregivers provide invaluable insights for building consensus in decision-making around healthcare, policy and research. However, despite emerging evidence, patient engagement remains sparse within consensus-building initiatives. Specifically, our research has identified a lack of opportunity for youth living with chronic health conditions and their caregivers to participate in developing consensus on indicators/benchmarks for transition into adult care. To bridge this gap and inform our consensus-building approach with youth/caregivers, this scoping review will synthesise the extent of the literature on patient and other knowledge user engagement in consensus-building healthcare initiatives.

Following the scoping review methodology from Joanna Briggs Institute, published literature will be searched in MEDLINE, EMBASE, CINAHL and PsycINFO databases from inception to July 2023. Grey literature will be hand-searched. Two independent reviewers will determine the eligibility of articles in a two-stage process, with disagreements resolved by a third reviewer. Included studies must be consensus-building studies within the healthcare context that involve patient engagement strategies. Data from eligible studies will be extracted and charted on a standardised form. Abstracted data will be analysed quantitatively and descriptively, according to specific consensus methodologies, and patient engagement models and/or strategies.

Ethics approval is not required for this scoping review protocol. The review process and findings will be shared with and informed by relevant knowledge users. Dissemination of findings will also include peer-reviewed publications and conference presentations. The results will offer new insights for supporting patient engagement in consensus-building healthcare initiatives.

https://osf.io/beqjr

The effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that the licensed meningococcal B (MenB) vaccine, 4CMenB is effective against gonococcal infections due to cross-reacting antibodies and 95% genetic homology between the two bacteria, Neisseria meningitidis and Neisseria gonorrhoeae, that cause the diseases. This project aims to undertake epidemiological and genomic surveillance to evaluate the long-term protection of the 4CMenB vaccine against gonococcal infections in the Northern Territory (NT) and South Australia (SA), and to determine the potential benefit of a booster vaccine doses to provide longer-term protection against gonococcal infections.

This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4–7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison.

The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.

Wildfires and deforestation potentially have direct effects on multiple health outcomes as well as indirect consequences for climate change. Tropical rainforest areas are characterised by high rainfall, humidity and temperature, and they are predominantly found in low-income and middle-income countries. This study aims to synthesise the methods, data and health outcomes reported in scientific papers on wildfires and deforestation in these locations.

We will carry out a scoping review according to the Joanna Briggs Institute’s (JBI) manual for scoping reviews and the framework proposed by Arksey and O’Malley, and Levac et al. The search for articles was performed on 18 August 2023, in 16 electronic databases using Medical Subject Headings terms and adaptations for each database from database inception. The search for local studies will be complemented by the manual search in the list of references of the studies selected to compose this review. We screened studies written in English, French, Portuguese and Spanish. We included quantitative studies assessing any human disease outcome, hospitalisation and vital statistics in regions of tropical rainforest. We exclude qualitative studies and quantitative studies whose outcomes do not cover those of interest. The text screening was done by two independent reviewers. Subsequently, we will tabulate the data by the origin of the data source used, the methods and the main findings on health impacts of the extracted data. The results will provide descriptive statistics, along with visual representations in diagrams and tables, complemented by narrative summaries as detailed in the JBI guidelines.

The study does not require an ethical review as it is meta-research and uses published, deidentified secondary data sources. The submission of results for publication in a peer-reviewed journal and presentation at scientific and policymakers’ conferences is expected.

Open Science Framework (https://osf.io/pnqc7/).

SARS-CoV-2 mainly infects respiratory endothelial cells, which is facilitated through its spike protein binding to heparan sulphate. Calcium dobesilate (CaD) is a well-established, widely available vasoactive and angioprotective drug interacting with heparan sulphate, with the potential to interfere with the uptake of SARS-CoV-2 by epithelial cells. The CADOVID trial aims to evaluate the efficacy and safety of CaD in reducing the SARS-CoV-2 viral load in non-hospitalised adult patients diagnosed with COVID-19, confirmed by a positive SARS-CoV-2 PCR, including its efficacy to reduce the impact of persistent COVID-19 symptoms.

This is a randomised, placebo-controlled, double-blind, monocentric phase II trial. Enrolment began in July 2022. A total of 74 adult patients will be randomly allocated to the CaD arm or the placebo group with a 1:1 ratio, respectively. Participants in the intervention arm will receive two capsules of CaD 500 mg two times per day and the placebo arm will receive two matching capsules of mannitol 312.5 mg two times per day, with a treatment period of 7 days for both arms, followed by a 77-day observational period without treatment administration. Participants will be asked to complete secured online questionnaires using their personal smartphone or other electronic device. These include a COVID-19 questionnaire (assessing symptoms, temperature measurement, reporting of concomitant medication and adverse events), a COVID-19 persistent symptoms’ questionnaire and the Short Form 12-Item (SF-12) survey. SARS-CoV-2 PCR testing will be performed on nasopharyngeal swabs collected on days 1, 4, 8 and 21. The primary endpoint is the reduction from baseline of SARS-CoV-2 viral load determined by RT-PCR at day 4.

This trial has received approval by the Geneva Regional Research Ethics Committee (2022-00613) and Swissmedic (701339). Dissemination of results will be through presentations at scientific conferences and publication in scientific journals.

NCT05305508; Clinicaltrials.gov; Swiss National Clinical Portal Registry (SNCTP 000004938).

To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline.

Systematic review.

We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020.

Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome.

4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials.

We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005).

Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials.

CRD42022282565.

After COVID-19, a global mental health crisis affects young people, with one in five youth experiencing mental health problems worldwide. Delivering mental health interventions via mobile devices is a promising strategy to address the treatment gap. Mental health apps are effective for adolescent and young adult samples, but face challenges such as low real-world reach and under-representation of minoritised youth. To increase digital health uptake, including among minoritised youth, there is a need for diversity, equity and inclusion (DEI) considerations in the development and evaluation of mental health apps. How well DEI is integrated into youth mental health apps has not been comprehensively assessed. This scoping review aims to examine to what extent DEI considerations are integrated into the design and evaluation of youth mental health apps and report on youth, caregiver and other stakeholder involvement.

We will identify studies published in English from 2009 to 29 September 2023 on apps for mental health in youth. We will use PubMed, Global Health, APA PsycINFO, SCOPUS, CINAHL PLUS and the Cochrane Database and will report according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review Extension guidelines. Papers eligible for inclusion must be peer-reviewed publications in English involving smartphone applications used by adolescents or young adults aged 10–25, with a focus on depression, anxiety or suicidal ideation. Two independent reviewers will review and extract articles using a template developed by the authors. We will analyse the data using narrative synthesis and descriptive statistics. This study will identify gaps in the literature and provide a roadmap for equitable and inclusive mental health apps for youth.

Ethics approval is not required. Findings will be disseminated through academic, industry, community networks and scientific publications.

HIV is a major public health issue affecting millions globally. Women and girls account for 46% of new HIV infections in 2022 and approximately 1.3 million females become pregnant every year. Vertical transmission of HIV from persons living with HIV (PLHIV) to infants may occur through different modalities, such as through breast/chest feeding. Notably, 82% of PLHIV who chose to breast/chest feed are on antiretroviral therapy (ART) when feeding their infants. Precise estimates of the risk of postpartum transmission to infants during breast/chest feeding at varying viral load levels remain a significant gap in the literature.

A rapid systematic search of electronic databases will be conducted from January 2005 to the present, including Medline, Embase and Global Health. The objective of this rapid review is to explore and assess the available evidence on the effect of varying viral load levels on the risk of HIV transmission to infants during breast/chest feeding when the birthing or gestational parent living with HIV is on ART. Study characteristics will be summarised and reported to support the narrative summary of the findings. The focus will be on the absolute risk of HIV transmission from birthing parent to infant during chest/breast feeding. The findings will also be stratified by month, including the risk of HIV transmission for 6 months and greater than 6 months postpartum. We will ascertain the risk of bias using A Measurement Tool to Assess Systematic Reviews 2, Quality of Prognosis Studies and Downs and Black checklist for the appropriate study type. A summary score will not be calculated, rather the strengths and limitations of the studies will be narratively described.

No human subjects will be involved in the research. The findings of this rapid review will inform a future systematic review and will be disseminated through peer-reviewed publications, presentations and conferences.

CRD42024499393.

Fatigue is an important and distressing symptom for many people living with chronic musculoskeletal (MSK) conditions. Many non-pharmacological interventions have been investigated in recent years and some have been demonstrated to be effective in reducing fatigue and fatigue impact, however, there is limited guidance for clinicians to follow regarding the most appropriate management options. The objective of this scoping review is to understand and map the extent of evidence in relation to the factors that relate to the outcome of non-pharmacological interventions on MSK condition-related fatigue across the lifespan.

This scoping review will include evidence relating to people of all ages living with chronic MSK conditions who have been offered a non-pharmacological intervention with either the intention or effect of reducing fatigue and its impact. Databases including AMED, PsycINFO, CINAHLPlus, MEDLINE, EMBASE and Scopus will be searched for peer-reviewed primary research studies published after 1 January 2007 in English language. These findings will be used to identify factors associated with successful interventions and to map gaps in knowledge.

Ethical approval was not required for this review. Findings will be disseminated by journal publications, conference presentations and by communicating with relevant healthcare and charity organisations.

To investigate the status of the midwifery workforce and childbirth services in China and to identify the association between midwife staffing and childbirth outcomes.

A descriptive, multicentre cross-sectional survey.

Maternity hospitals from the eastern, central and western regions of China.

Stratified sampling of maternity hospitals between 1 July and 31 December 2021.

The sample hospitals received a package of questionnaires, and the head midwives from the participating hospitals were invited to fill in the questionnaires.

A total of 180 hospitals were selected and investigated, staffed with 4159 midwives, 412 obstetric nurses and 1007 obstetricians at the labour and delivery units. The average efficiency index of annual midwifery services was 272 deliveries per midwife. In the sample hospitals, 44.9% of women had a caesarean delivery and 21.4% had an episiotomy. Improved midwife staffing was associated with reduced rates of instrumental vaginal delivery (adjusted β –0.032, 95% CI –0.115 to –0.012, p

The rates of childbirth interventions including the overall caesarean section in China and the episiotomy rate, especially in the central region, remain relatively high. Improved midwife staffing was associated with reduced rates of instrumental vaginal delivery and episiotomy, indicating that further investments in the midwifery workforce could produce better childbirth outcomes.

Chronic diseases have a high prevalence worldwide, and patients with chronic diseases often suffer from depression, leading to a poor prognosis and a low quality of life. Metacognitive therapy is a transdiagnostic psychotherapy intervention focused on thinking patterns, with the advantages of reliable implementation effect, short intervention period and low cost. It can help patients change negative metacognition, alleviate depression symptoms, and has a higher implementation value compared with other cognitive interventions. Therefore, metacognitive therapy may be an effective way to improve the mental health of patients with chronic diseases.

CNKI, Wanfang Database, VIP Database for Chinese Technical Periodicals, Sinomed, PubMed, SCOPUS, Embase, The Cochrane Library, Web of Science and PsycINFO will be used to select the eligible studies. As a supplement, websites (eg, the Chinese Clinical Registry, ClinicalTrials.gov) will be searched and grey literature will be included. The heterogeneity and methodological quality of the eligible studies will be independently screened and extracted by two experienced reviewers. All the data synthesis and analysis (drawing forest plots, subgroup analysis and sensitive analysis) will be conducted using RevMan 5.4.1.

This article is a literature review that does not include patients’ identifiable information. Therefore, ethical approval is not required in this protocol. The findings of this systematic review and meta-analysis will be published in a peer-reviewed journal as well as presentations at relevant conferences.

CRD42023411105.