Conectar
To explore the attitudes of healthcare workers towards COVID-19 vaccines.
A qualitative descriptive design was used.
Five focus groups were conducted between October and November 2021, with a total of 30 nurses from different contexts in Northern Italy. Thematic analysis was used to analyse the transcripts.
Three main themes were identified: ‘favourable’, ‘unsure’ and ‘contrary to’ COVID-19 vaccines. The favourable position was underpinned by trust in science, research and vaccination; protection for themselves, their families, patients and the population; duty as professionals; necessity to set an example for others. Participants who were unsure had doubts about the composition, safety and efficacy of the vaccine and were sometimes afraid that media provided incomplete information. The main reason why nurses were against was the feeling that being forced to vaccinate perceived as blackmail. Favourable or unsure nurses struggled to deal with those who were against and developed a series of emotions that ranged from respect and attempt to rationalize, to frustration and defeat.
Identifying the areas of hesitation is essential to understand what affects the choices of acceptance, delay or refusal of vaccination. The issues that emerged regarding proper communication within the vaccination campaign highlights the key importance of adequate vaccination strategies.
Understanding attitudes towards vaccine and related motivations among healthcare workers could help develop more specific and targeted vaccination campaigns that can ensure proper vaccination coverage rates and avoid hesitancy or refusal.
Healthcare workers experiences of COVID-19 vaccines, their views and know how they feel during COVID-19 vaccinations. Healthcare workers had three different positions in COVID-19 vaccination. This research will guide and target future vaccination campaigns.
The study is reported using the Standards for Reporting Qualitative Research (SRQR).
No Patient or Public Contribution.
To analyse the qualitative evidence on the role of critical care nurses in rapid response teams.
Qualitative systematic review.
This qualitative systematic review employed Bettany-Saltikov and McSherry’s guidelines and is reported according to the Enhancing Transparency in Reporting the Synthesis of Qualitative Research checklist. Two pairs of blinded researchers screened the articles. The data were synthesised using a thematic analysis approach.
A systematic literature search was conducted using the CINAHL, Embase and MEDLINE databases.
Seven studies were included, and three main roles were identified: (1) balancing between confidence and fear in clinical encounters, (2) facilitating collaboration and (3) managing challenging power dynamics in decision-making.
Critical care nurses possess extensive knowledge and skills in providing critical care to patients experiencing deterioration on general wards. They play a vital role in facilitating collaboration between team members and ward staff. Furthermore, within the rapid response team, critical care nurses assume leadership responsibilities by overseeing the comprehensive coordination of patient care and actively engaging in the decision-making process concerning patient care.
Highlighting the central role of critical care nurses in rapid response teams as well such a team’s benefits in healthcare organisations can promote applications for funding to support further quality assurance of rapid response teams and thus enhance patient safety.
Health care organisations can assure the quality of rapid response team by providing economical resources and training. The education providers should facilitate and standardise curriculum for critical care nursing students to achieve necessary knowledge and skills as members in rapid response teams.
No patient or public contribution.
To examine the role of nurse–patient mutuality on three self-care behaviours in chronic illness patients.
A cross-sectional multi-centre study was conducted.
Mutuality was measured with the Nurse–Patient Mutuality in Chronic Illness scale which has the dimensions of developing and going beyond, being a point of reference and deciding and sharing care, and self-care was measured with the Self-care of Chronic Illness Inventory (SC-CII). Multivariable linear regression analyses were used to assess the contribution of three dimensions of mutuality on self-care maintenance, monitoring and management behaviours controlling for patient gender, age, education, number of medications, and presence of a family caregiver.
The sample included 465 inpatients and outpatients with at least one chronic illness. The three dimensions of mutuality had different roles in their influence on the three dimensions of self-care. Developing and going beyond was significantly associated with self-care maintenance and self-care monitoring behaviours. Point of reference was significantly associated with self-care maintenance behaviour. Deciding and sharing care was significantly associated with self-care monitoring and self-care management behaviours.
The mutuality between nurse and patient may be a novel area of research to support and improve patient self-care behaviours with implications for clinical practice and education.
Mutuality between nurse and patient increases patient engagement, symptom recognition, decision-making process and patient-centred approach favouring the development of self-care behaviours.
Mutuality between nurse and patient is a new concept and its association with the patient outcomes could bring relevance to the nursing profession. Self-care behaviours are important in the management of chronic diseases, but are difficult to perform. Mutuality between nurse and patient influences the three different behaviours of self-care in chronic illness, for this reason it is important to increase the level of mutuality in this dyad.
STROBE checklist for cross-sectional studies was followed in this study.
Patients were involved in the sample of the study.
by Najam ul Hasan Abbasi, Ahmad Bilal, Khair Muhammad, Saba Riaz, Shakeela Altaf
The previous studies have found an association between Big Five personality traits and postpartum depression in women. The present study aimed to find out an association between Big Five personality traits and postpartum depression in a sample of Pakistani fathers. A total of 400 Pakistani fathers who had birth of a child in the past 1 month to 1 year period and had been living with their married partners were recruited purposively by using Google Form based survey from the major cities of Pakistan. The Urdu translated versions of Big Five Personality Inventory (BFI) and Edinburgh Postnatal Depression Scale (EPDS) were used as the main outcome measures to assess the relationship between personality traits and postpartum depression. The results found a significant negative and moderate association between Big Five personality traits and paternal postpartum depression except openness which had a weak association and neuroticism which had a positive and moderate association with PPPD (r(398) = .45). The multiple linear regression analysis found that Big Five personality traits significantly predicted paternal postpartum depression (F(5, 394) = 53.33, p = .001) except openness (B = .007, p = .98). The analysis of variance (ANOVA) found significant differences in paternal postpartum depression for age of father (F(2, 397) = 6.65, p = .001, ηp2 = .03), spouse age (F(2, 393) = 5.97, p = .003, ηp2 = .02), employment type (F(2, 395) = 9.69, p = .001, ηp2 = .04) and time spent at home (F(2, 397) = 6.23, p = .002, ηp2 = .03) while there were found no significant differences for education (F(2, 397) = 1.29, p = .27, ηp2 = .006), marital duration (F(2, 397) = 2.17, p = .11, ηp2 = .01), and birth number of recent child (F(2, 397) = 1.48, p = .22, ηp2 = .007). The study concluded that Big Five personality traits are significantly correlated with and predict paternal postpartum depression except openness which did not predict paternal postpartum depression. The occurrence of paternal postpartum depression varied significantly for age of father, age of spouse, type of employment and time spent at home.by Fatou Ndiaye, Abdoulaye Diop, Joseph Chabi, Katherine Sturm-Ramirez, Massila Senghor, El Hadji Diouf, Badara Samb, Seynabou Mocote Diedhiou, Omar Thiaw, Sarah Zohdy, Ellen Dotson, Doudou Sene, Mame Birame Diouf, Valerie Koscelnik, Lilia Gerberg, Abdoulaye Bangoura, Tiffany Clark, Ousmane Faye, Ibrahima Dia, Lassana Konate, El Hadji Amadou Niang
Urban malaria has become a challenge for most African countries due to urbanization, with increasing population sizes, overcrowding, and movement into cities from rural localities. The rapid expansion of cities with inappropriate water drainage systems, abundance of water storage habitats, coupled with recurrent flooding represents a concern for water-associated vector borne diseases, including malaria. This situation could threaten progress made towards malaria elimination in sub-Saharan countries, including Senegal, where urban malaria has presented as a threat to national elimination gains. To assess drivers of urban malaria in Senegal, a 5-month study was carried out from August to December 2019 in three major urban areas and hotspots for malaria incidence (Diourbel, Touba, and Kaolack) including the rainy season (August-October) and partly dry season (November–December). The aim was to characterize malaria vector larval habitats, vector dynamics across both seasons, and to identify the primary eco- environmental entomological factors contributing to observed urban malaria transmission. A total of 145 Anopheles larval habitats were found, mapped, and monitored monthly. This included 32 in Diourbel, 83 in Touba, and 30 in Kaolack. The number of larval habitats fluctuated seasonally, with a decrease during the dry season. In Diourbel, 22 of the 32 monitored larval habitats (68.75%) were dried out by December and considered temporary, while the remaining 10 (31.25%) were classified as permanent. In the city of Touba 28 (33.73%) were temporary habitats, and of those 57%, 71% and 100% dried up respectively by October, November, and December. However, 55 (66.27%) habitats were permanent water storage basins which persisted throughout the study. In Kaolack, 12 (40%) permanent and 18 (60%) temporary Anopheles larval habitats were found and monitored during the study. Three malaria vectors (An. arabiensis, An. pharoensis and An. funestus s.l.) were found across the surveyed larval habitats, and An. arabiensis was found in all three cities and was the only species found in the city of Diourbel, while An. arabiensis, An. pharoensis, and An. funestus s.l. were detected in the cities of Touba and Kaolack. The spatiotemporal observations of immature malaria vectors in Senegal provide evidence of permanent productive malaria vector larval habitats year-round in three major urban centers in Senegal, which may be driving high urban malaria incidence. This study aimed to assess the presence and type of anopheline larvae habitats in urban areas. The preliminary data will better inform subsequent detailed additional studies and seasonally appropriate, cost-effective, and sustainable larval source management (LSM) strategies by the National Malaria Control Programme (NMCP).by Siting Chen, Corey L. Nagel, Ruotong Liu, Anda Botoseneanu, Heather G. Allore, Jason T. Newsom, Stephen Thielke, Jeffrey Kaye, Ana R. Quiñones
IntroductionMultimorbidity may confer higher risk for cognitive decline than any single constituent disease. This study aims to identify distinct trajectories of cognitive impairment probability among middle-aged and older adults, and to assess the effect of changes in mental-somatic multimorbidity on these distinct trajectories.
MethodsData from the Health and Retirement Study (1998–2016) were employed to estimate group-based trajectory models identifying distinct trajectories of cognitive impairment probability. Four time-varying mental-somatic multimorbidity combinations (somatic, stroke, depressive, stroke and depressive) were examined for their association with observed trajectories of cognitive impairment probability with age. Multinomial logistic regression analysis was conducted to quantify the association of sociodemographic and health-related factors with trajectory group membership.
ResultsRespondents (N = 20,070) had a mean age of 61.0 years (SD = 8.7) at baseline. Three distinct cognitive trajectories were identified using group-based trajectory modelling: (1) Low risk with late-life increase (62.6%), (2) Low initial risk with rapid increase (25.7%), and (3) High risk (11.7%). For adults following along Low risk with late-life increase, the odds of cognitive impairment for stroke and depressive multimorbidity (OR:3.92, 95%CI:2.91,5.28) were nearly two times higher than either stroke multimorbidity (OR:2.06, 95%CI:1.75,2.43) or depressive multimorbidity (OR:2.03, 95%CI:1.71,2.41). The odds of cognitive impairment for stroke and depressive multimorbidity in Low initial risk with rapid increase or High risk (OR:4.31, 95%CI:3.50,5.31; OR:3.43, 95%CI:2.07,5.66, respectively) were moderately higher than stroke multimorbidity (OR:2.71, 95%CI:2.35, 3.13; OR: 3.23, 95%CI:2.16, 4.81, respectively). In the multinomial logistic regression model, non-Hispanic Black and Hispanic respondents had higher odds of being in Low initial risk with rapid increase and High risk relative to non-Hispanic White adults.
ConclusionsThese findings show that depressive and stroke multimorbidity combinations have the greatest association with rapid cognitive declines and their prevention may postpone these declines, especially in socially disadvantaged and minoritized groups.
by Yusuf Ari Mashuri, Vitri Widyaningsih, Alimah Premanawasti, Jaap Koot, Zinzi Pardoel, Jeanet Landsman-Dijkstra, Maarten Postma, Ari Probandari
BackgroundA high prevalence of hypertension is found in Low- and Middle-income Countries (LMICs) including in Indonesia. However, hypertension awareness, treatment, and control are relativity poor. A community-based program to screen and educate people on non-communicable disease prevention (POSBINDU) was launched by the Indonesian government. However, the association between participation in the POSBINDU program with increasing knowledge, attitude, and practice of hypertension has not been widely assessed. In this study, we compared the knowledge, attitudes, and practices among people who accessed the POSBINDU and those who did not access the POSBINDU program. Subsequently, factors associated with the knowledge, attitudes, and practices among people who accessed the POSBINDU and those who did not access the POSBINDU were explored.
MethodsThis was an observational study with a cross-sectional design measuring the knowledge, attitudes, and practices for hypertension control in four districts in Indonesia from October 2019 to January 2020. A total of 1,988 respondents were included in this study. A questionnaire was used to assess the knowledge, attitudes, and practices of hypertension. Simple logistic regression was used to investigate the correlation between the characteristics of respondents and knowledge, attitudes, and practice status. Multiple logistic regression tests were conducted to investigate factors associated with knowledge, attitudes, and practice status.
ResultsWe found that people who accessed POSBINDU had higher odds of having better knowledge (aOR:1.4; 95%CI:1.2–1.8), however, accessed to POSBINDU was associated with lower attitudes (aOR:0.6; 85%CI: 0.5–0.7) and had no association with hypertension-related practice.
ConclusionPeople who accessed POSBINDU have an association with good knowledge, but the association with good attitude and practice was less clear. Therefore, an improvement in the POSBINDU program is needed to increase the attitudes and practices of hypertension.
To clarify the concept of fear of childbirth among pregnant women and to examine its current measure tools.
Fear of childbirth is a psychological symptom, prevalent among pregnant women, which negatively impacts women's health and well-being. It has become an increasingly concerning issue in perinatal mental health. However, due to its poor conceptualization, it presents difficulty in conducting reliable assessments and identifying risk factors.
The Walker and Avant approach to concept analysis guided this review. Six bibliographic databases were systematically searched for published research from their inception date to May 2023. Additional records were identified by manually searching the reference lists of relevant studies. Quantitative and qualitative studies investigating fear of childbirth in pregnant women were included.
Three critical attributes have been identified: cognitive impairments, affective disorders and somatic symptoms. Antecedents include perceived a real or anticipated threat of pregnancy or its outcomes, low perceived self-coping ability and unmet social support needs. Consequences include processing and avoiding behaviours. This study also identified the dimensions of fear of childbirth, including 6 primary categories and 14 subcategories. The content of five scales was analysed and none covered all domains.
The current analysis provides healthcare providers with a more comprehensive framework to assess and identify fear of childbirth. Further research is needed to develop a suitable instrument that covers all the attributes and dimensions of this concept and assesses its severity.
This conceptual analysis provides a comprehensive insight into the phenomenon of fear of childbirth. This will help family members, healthcare providers and policymakers to identify the psychological needs of pregnant women and improve the quality of antenatal care.
Not applicable as no new data were generated.
To analyse whether the harmful effect of job demands on recovery can be alleviated by healthy lifestyle, psychological recovery experiences and job resources. We also describe their prevalence among employees in different types of eldercare service and in the health and social services sector in general.
Cross-sectional study.
The data were collected using a self-report survey in 2020 in the health and social services sector organizations (n = 4478). Employees were classified as the following service types: general health and social services (N = 3225), home care (N = 452), service housing (N = 550) and outpatient and ward care (N = 202). The data were analysed using percentages, cross-tabulations and logistic regression analysis.
Poor recovery, high job demands, low appreciation and low autonomy in terms of worktime and breaks were more prevalent in eldercare. Employers could alleviate the risk of high job demands by offering job resources—appreciation, autonomy in terms of worktimes and breaks—and motivating employees to maintain healthy lifestyle habits and use recovery experiences such as relaxation.
The study emphasizes the importance of appreciation in the health and social services sector context. Even with moderate levels of appreciation employers can protect employees from poor recovery from work in the demanding health and social services work environment.
Eldercare employees face continuous and accumulating work strain at the same time as the sector struggles against a labour shortage. One way to prevent the harmful consequences of strain is to enhance recovery from work.
Employers could alleviate the risk of high job demands and poor recovery by showing appreciation and giving employees more autonomy in terms of work time and breaks during the workday. This could also motivate employees to keep up healthy lifestyle habits and use their recovery experiences. Results are important especially in the daily management of HSS work.
Managers in the health and social services sector and eldercare can use these findings to promote recovery from work.
STROBE checklist.
No patient or public contribution.
More than 170 countries have implemented disability-targeted social protection programmes, although few have been rigorously evaluated. Consequently, a non-randomised controlled trial is being conducted of a pilot ‘cash-plus’ programme implemented by UNICEF Laos and the Laos government for children with disabilities in the Xiengkhouang Province in Laos. The intervention combines a regular cash transfer with provision of assistive devices and access for caregivers to a family support programme.
The non-randomised controlled trial will involve 350 children with disabilities across 3 districts identified by programme implementers as eligible for the programme (intervention arm). Implementers have also identified approximately 180 children with disabilities in neighbouring districts, who would otherwise meet eligibility criteria but do not live in the project areas (control arm). The trial will assess the impact of the programme on child well-being (primary outcome), as well as household poverty, caregiver quality of life and time use (secondary outcomes). Baseline data are being collected May–October 2023, with endline 24 months later. Analysis will be intention to treat. A complementary process evaluation will explore the implementation, acceptability of the programme, challenges and enablers to its delivery and mechanisms of impact.
The study has received ethical approval from the London School of Hygiene and Tropical Medicine and the National Ethics Committee for Health Research in Laos. Informed consent and assent will be taken by trained data collectors. Data will be collected and stored on a secure, encrypted server and its use will follow a detailed data management plan. Findings will be disseminated in academic journals and in short briefs for policy and programmatic actors, and in online and in-person events.
Childhood obesity rates in the UK are high. The early years of childhood are critical for establishing healthy behaviours and offer interventional opportunities. We aimed to identify studies evaluating the impact of UK-based obesity interventions in early childhood.
Systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Nine databases were searched in March 2023. Eligibility criteria: We included UK-based obesity intervention studies delivered to children aged 6 months to 5 years that had diet and/or physical activity components and reported anthropometric outcomes. The primary outcome of interest was z-score Body Mass Index (zBMI) change (within and between subjects). Studies evaluating the effects of breastfeeding interventions were not included as obesity prevention interventions, given that best-practice formula feeding is also likely to encourage healthy growth. The publication date for studies was limited to the previous 12 years (2011–23), as earlier reviews found few evaluations of interventions in the UK.
The reviewers worked independently using standardised approach to search, screen and code the included studies. Risk of bias was assessed using Cochrane tools (ROB 2 or ROBINS-I).
Six trials (five studies) were identified, including two randomised controlled trials (RCT), one cluster randomised trial (CRT), two feasibility CRTs and one impact assessment. The total number of participants was 566. Three trials focused on disadvantaged families and two included high-risk children categorised as having overweight or obesity. Compared with baseline, five interventions reported reductions in zBMI, three of which were statistically significant (p
UK evidence was limited but some interventions showed promising results in promoting healthy growth. As part of a programme of policies, interventions in the early years may have an important role in reducing the risk of childhood obesity.
CRD42021290676
In the end of life context, patients are often seen as somewhat passive recipients of care provided by health professionals and relatives, with little opportunity to be perceived as autonomous and active agents. Since studies show a very high prevalence of altruistic dispositions in palliative care patients, we strive to investigate the concept of patient altruism in a set of six interdisciplinary studies by considering three settings: (1) in the general palliative context—by studying to what extent patient altruism is associated with essential psychological outcomes of palliative care (subproject 1a), how altruism is understood by patients (subproject 1b) and how altruism expressed by patients is experienced by palliative care nurses (subproject 1c); (2) in two concrete decision-making contexts—advance care planning (subproject 2a) and assisted suicide (subproject 2b); and (3) through verbal and non-verbal patient communication in palliative care settings (subproject 3).
Subproject 1a: a cross-sectional study using validated and standardised questionnaires. Subprojects 1b and 1c: a constructivist grounded theory method aiming at developing a novel theory from semistructured interviews in both patients and nurses. Subproject 2a: a thematic analysis based on (1) audio-recordings of advance care planning encounters and (2) follow-up semidirective interviews with patients and their relatives. Subproject 2b: a qualitative study based on thematic analysis of interviews with patients actively pursuing assisted suicide and one of their relatives.Subproject 3: a conversation analysis based on audio and video-recorded interactions in two settings: (1) palliative inpatient unit and (2) advance care planning discussions.
The study project was approved by the Ethics Committees of the Canton of Vaud, Bern and Ticino (no: 2023-00088). In addition to participation in national and international conferences, each project will be the subject of two scientific publications in peer-reviewed journals. Additional publications will be realised according to result triangulation between projects. A symposium opened to professionals, patients and the public will be organised in Switzerland at the end of the project.
Inappropriate antibiotic prescribing is a major cause of antimicrobial resistance (AMR). The aim of this study was to explore paediatric general practitioners’ (GP Peds) antibiotic prescription practice in suspected respiratory tract infections (RTIs), using the capability–opportunity–motivation–behaviour framework.
The design is a qualitative study based on individual, semistructured telephone or virtual interviews.
Paediatric general practice in Hungary. We applied stratified maximum variation sampling to cover the categories of age, sex and geographical location of participants.
We interviewed 22 GP Peds. Nine were male and 13 were female: 2 of them were less than 40 years old, 14 were between 40 and 60 years, and 6 were above 60 years. 10 worked in low-antibiotic prescription areas, 5 in areas with medium levels of antibiotic prescription, 3 in high-antibiotic prescription areas, and 4 in and around the capital city.
Study participants had varying antibiotic prescription preferences. Personal experience and physical examination play a central role in GP Peds’ diagnostic and treatment practice. Participants emphasised the need to treat children in their entirety, taking their personal medical record, social background and sometimes parents’ preferences into account, besides the acute clinical manifestation of RTI. Most respondents were confident they apply the most effective therapy even if, in some cases, this meant prescribing medicines with a higher chance of contributing to the development of AMR. Some participants felt antibiotic prescription frequency has decreased in recent years.
Our findings suggest that a more prudent attitude toward antibiotic prescribing may have become more common but also highlight relevant gaps in both physicians’ and public knowledge of antibiotics and AMR. To reinforce awareness and close remaining gaps, Hungary should adopt its national AMR National Action Plan and further increase its efforts towards active professional communication and feedback for primary care physicians.
Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.
We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at
This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.
ClinicalTrials.gov, NCT05968794.
Emerging developments in applications of artificial intelligence (AI) in healthcare offer the opportunity to improve diagnostic capabilities in obstetrics and gynaecology (O&G), ensuring early detection of pathology, optimal management and improving survival. Consensus on a robust AI healthcare framework is crucial for standardising protocols that promote data privacy and transparency, minimise bias, and ensure patient safety. Here, we describe the study protocol for a systematic review and meta-analysis to evaluate current applications of AI in O&G diagnostics with consideration of reporting standards used and their ethical implications. This protocol is written following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 checklist.
The study objective is to explore the current application of AI in O&G diagnostics and assess the reporting standards used in these studies. Electronic bibliographic databases MEDLINE, EMBASE and Cochrane will be searched. Study selection, data extraction and subsequent narrative synthesis and meta-analyses will be carried out following the PRISMA-P guidelines. Included papers will be English-language full-text articles from May 2015 to March 2024, which provide original data, as AI has been redefined in recent literature. Papers must use AI as the predictive method, focusing on improving O&G diagnostic outcomes.
We will evaluate the reporting standards including the risk of bias, lack of transparency and consider the ethical implications and potential harm to patients. Outcome measures will involve assessing the included studies against gold-standard criteria for robustness of model development (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis, model predictive performance, model risk of bias and applicability (Prediction model Risk Of Bias Assessment Tool and study reporting (Consolidated Standards of Reporting Trials-AI) guidance.
Ethical approval is not required for this systematic review. Findings will be shared through peer-reviewed publications.There will be no patient or public involvement in this study.
CRD42022357024.
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.
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).
Even when total knee arthroplasty (TKA) is an extended treatment, most patients experience a suboptimal evolution after TKA. The objectives of this study are the following: (1) to determine the effectiveness of two different prosthesis stabilisation systems on the functionality in activities of daily life, and (2) to determine prognostic biomarkers of knee prosthesis function based on radiological information, quantification of cytokines, intra-articular markers and biomechanical functional evaluation to predict successful evolution.
The PROKnee trial was designed as a randomised controlled patient-blinded trial with two parallel groups that are currently ongoing. The initial recruitment will be 99 patients scheduled for their first TKA, without previous prosthesis interventions in lower limbs, who will be randomly divided into two groups that differed in the stabilisation methodology incorporated in the knee prosthesis: the MEDIAL-pivot group and the CENTRAL-pivot group. The maximum walking speed will be reported as the primary outcome, and the secondary results will be patient-reported questionnaires related to physical status, cognitive and mental state, radiological test, laboratory analysis and biomechanical instrumented functional performance, such as the 6-minute walking test, timed up-and-go test, gait, sit-to-stand, step-over, and ability to step up and down stairs. All the results will be measured 1 week before TKA and at 1.5, 3, 6 and 12 months after surgery.
All procedures were approved by the Ethical Committee for Research with Medicines of the University Clinical Hospital of Valencia on 8 October 2020 (order no. 2020/181). Participants are required to provide informed consent for the study and for the surgical procedure. All the data collected will be treated confidentially since they will be blinded and encrypted. The results from the trial will be published in international peer-reviewed scientific journals, regardless of whether these results are negative or inconclusive.
ClinicalTrials.gov Registry (NCT04850300).
To (1) pilot a study of behavioural characterisation based on risk and time preferences in clinically well-characterised individuals, (2) assess the distribution of preferences in this population and (3) explore differences in preferences between individuals with ‘lifestyle-related’ (LS) and ‘non-lifestyle-related’ (NLS) cardiovascular diseases.
Cross-sectional study with an economic online experiment to collect risk and time preferences, a detailed clinical characterisation and a sociodemographic and lifestyle survey. A definition of LS and NLS groups was developed.
Specialist outpatient clinics of the clinic for cardiology and pneumology of the University Hospital Düsseldorf and patients from a cardiology practice in Düsseldorf.
A total of 74 individuals with cardiovascular diseases.
Risk and time preferences.
The implementation of the study process, including participant recruitment and data collection, ran smoothly. The medical checklist, the survey and the time preference instrument were well received. However, the conceptual understanding of the risk preference instrument resulted in inconsistent choices for many participants (47%). The remaining individuals were more risk averse (27%) than risk seeking (16%) and risk neutral (10%). Individuals in our sample were also more impatient (49%) than patient (42%). The participant classification showed that 65% belonged to the LS group, 19% to the NLS group and 16% could not be assigned (unclear allocation to lifestyle (ULS) group). Excluding the ULS group, we show that individuals in the LS group were more risk seeking, and unexpectedly, more patient than those in the NLS group.
The process of the pilot study and its results can be used as a basis for the design of the main study. The differences in risk and time preferences between the LS and NLS groups provide us with a novel hypothesis for unhealthy behaviours: individuals never give up a bad habit, they simply postpone the latter, which can be tested alongside other additional research questions.
FreshRSS 