Conectar
To identify barriers to hospital participation in controlled cluster trials of clinical decision support (CDS) and potential strategies for addressing barriers.
Qualitative descriptive design comprising semistructured interviews.
Five hospitals in New South Wales and one hospital in Queensland, Australia.
Senior hospital staff, including department directors, chief information officers and those working in health informatics teams.
20 senior hospital staff took part. Barriers to hospital-level recruitment primarily related to perceptions of risk associated with not implementing CDS as a control site. Perceived risks included reductions in patient safety, reputational risk and increased likelihood that benefits would not be achieved following electronic medical record (EMR) implementation without CDS alerts in place. Senior staff recommended clear communication of trial information to all relevant stakeholders as a key strategy for boosting hospital-level participation in trials.
Hospital participation in controlled cluster trials of CDS is hindered by perceptions that adopting an EMR without CDS is risky for both patients and organisations. The improvements in safety expected to follow CDS implementation makes it challenging and counterintuitive for hospitals to implement EMR without incorporating CDS alerts for the purposes of a research trial. To counteract these barriers, clear communication regarding the evidence base and rationale for a controlled trial is needed.
Pre-eclampsia affects ~5%–7% of pregnancies. Although improved obstetric care has significantly diminished its associated maternal mortality, it remains a leading cause of maternal morbidity and mortality in the world. Term pre-eclampsia accounts for 70% of all cases and a large proportion of maternal–fetal morbidity related to this condition. Unlike in preterm pre-eclampsia, the prediction and prevention of term pre-eclampsia remain unsolved. Previously proposed approaches are based on combined third-trimester screening and/or prophylactic drugs, but these policies are unlikely to be widely implementable in many world settings. Recent evidence shows that the soluble fms-like tyrosine kinase-1 (s-Flt-1) to placental growth factor (PlGF) ratio measured at 35–37 weeks’ gestation predicts term pre-eclampsia with an 80% detection rate. Likewise, recent studies demonstrate that induction of labour beyond 37 weeks is safe and well accepted by women. We hypothesise that a single-step universal screening for term pre-eclampsia based on sFlt1/PlGF ratio at 35–37 weeks followed by planned delivery beyond 37 weeks reduces the prevalence of term pre-eclampsia without increasing the caesarean section rates or worsening the neonatal outcomes.
We propose an open-label randomised clinical trial to evaluate the impact of a screening of term pre-eclampsia with the sFlt-1/PlGF ratio followed by planned delivery in asymptomatic nulliparous women at 35–37 weeks. Women will be assigned 1:1 to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cut-off of >90th centile is used to define the high risk of subsequent pre-eclampsia and offer planned delivery from 37 weeks. The efficacy variables will be analysed and compared between groups primarily following an intention-to-treat approach, by ORs and their 95% CI. This value will be computed using a Generalised Linear Mixed Model for binary response (study group as fixed effect and the centre as intercept random effect).
The study is conducted under the principles of Good Clinical Practice. This study was accepted by the Clinical Research Ethics Committee of Hospital Clinic Barcelona on 20 November 2020. Subsequent approval by individual ethical committees and competent authorities was granted. The study results will be published in peer-reviewed journals and disseminated at international conferences.
Evidence shows a high rate of unnecessary antibiotic prescriptions for respiratory tract infections (RTIs) in primary care. There is increasing evidence showing that shorter courses for RTIs are safe and help in reducing antimicrobial resistance (AMR). Stopping antibiotics earlier, as soon as patients feel better, rather than completing antibiotic courses, may help reduce unnecessary exposure to antibiotics and AMR.
The aim of this study was to explore the perceptions and views of primary care healthcare professionals about customising antibiotic duration for RTIs by asking patients to stop the antibiotic course when they feel better.
Qualitative research.
A total of 21 qualitative interviews with primary care professionals (experts and non-experts in AMR) were conducted from June to September 2023. Data were audiorecorded, transcribed and analysed thematically.
Overall, experts seemed more amenable to tailoring the antibiotic duration for RTIs when patients feel better. They also found the dogma of ‘completing the course’ to be obsolete, as evidence is changing and reducing the duration might lead to less AMR, but claimed that evidence that this strategy is as beneficial and safe as fixed courses was unambiguous. Non-experts, however, believed the dogma of completing the course. Clinicians expressed mixed views on what feeling better might mean, supporting a shared decision-making approach when appropriate. Participants claimed good communication to professionals and patients, but were sceptical about the risk of medicalisation when asking patients to contact clinicians again for a check-up visit.
Clinicians reported positive and negative views about individualising antibiotic courses for RTIs, but, in general, experts supported a customised antibiotic duration as soon as patients feel better. The information provided by this qualitative study will allow improving the performance of a large randomised clinical trial aimed at evaluating if this strategy is safe and beneficial.
Diabetes-related distress lowers the motivation for self-care, often leading to lowered physical and emotional well-being, poor diabetes control, poor medication adherence and increased mortality among individuals with diabetes.
To assess factors associated with diabetes-related distress among people living with type 2 diabetes in Southeast Ethiopia.
Institution-based cross-sectional study was conducted.
Six diabetic follow-up care units at public hospitals in Southeast Ethiopia.
All adult people living with type 2 diabetes from the diabetic follow-up clinic.
Diabetes Distress Scale-17 questionnaire was used to assess diabetes-related distress.
Out of the total 871 study participants intended, 856 participated in the study with a response rate of 98.3%. The findings showed that about 53.9% (95% CI 50.4% to 57.2%) of the patients have diabetes-related distress. Physical activity (adjusted OR, AOR 2.22; 95% CI 1.36 to 3.63), social support (AOR 4.41; 95% CI 1.62 to 12.03), glycaemic control (AOR 2.36; 95% CI 1.35 to 4.12) and other comorbidities (AOR 3.94; 95% CI 2.01 to 7.73) were factors that significantly associated with diabetes-related distress at p
This study demonstrated that more than half of the participants had diabetes-related distress. Therefore, the identified factors of diabetes-related distress need to be a concern for health institutions and clinicians in the management of people living with type 2 diabetes.
Bariatric surgery is an effective treatment for severe obesity that leads to significant physical health improvements. Few studies have prospectively described the short-term impact of surgery on mental health using standardised case-finding measures for anxiety or depressive disorders. This study describes the prevalence and short-term course of these conditions following surgery.
Prospective observational cohort study.
12 National Health Service centres in England.
Participants studied took part in the By-Band-Sleeve study, a multicentre randomised controlled trial evaluating the surgical management of severe obesity. We included participants who had undergone surgery (gastric bypass, gastric band or sleeve gastrectomy) within 6 months of randomisation.
Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline and 12 months post-randomisation. Sociodemographic variables collected at prerandomisation included body mass index, age, sex, ethnicity, marital status, tobacco use, employment status and income band.
In our sample of 758 participants, 94.5% (n 716) and 93.9% (n 712) had completed baseline anxiety (HADS-A) and depression (HADS-D) subscales. At pre-randomisation 46.1% (n 330/716, 95% CI 42.4% to 49.7%) met clinical case criteria for anxiety and 48.2% (n 343/712, 95% CI 44.5% to 51.8%) for depression. Among participants returning completed 12 months post-randomisation questionnaires (HADS-A n 503/716, HADS-D n 498/712), there was a significant reduction in the proportion of clinical cases with anxiety (–9.5%, 95% CI –14.3% to -4.8% p
Almost half of people undergoing bariatric surgery had underlying anxiety or depressive symptoms. In the short term, these symptoms appear to substantially improve. Future work must identify whether these effects are sustained beyond the first post-randomisation year.
While the factors commonly associated with an increased risk of child maltreatment (CM) were found to be increased during COVID-19, reports of actual maltreatment showed varying trends. Similarly, evidence regarding the impact of COVID-19 on CM within the European Cooperation on Science and Technology and Network Collaborative (COST) Action countries remains inconsistent. This scoping review aims to explore the extent and nature of evidence pertaining to CM within the countries affiliated with the Child Abuse and Neglect in Europe Action Network (Euro-CAN), funded by the COST.
Key electronic databases were searched to identify eligible papers, reports and other material published between January 2020 and April 2023: PubMed, EMBASE, PsycINFO, Social Policy and Practice, Scopus and Web of Science. To cover the breadth of evidence, a systematic and broad search strategy was applied using a combination of keywords and controlled vocabulary for four concepts: children, maltreatment, COVID-19 and Euro-CAN countries, without restrictions on study design or language. Grey literature was searched in OpenGrey and Google Scholar. Two reviewers will independently screen full-text publications for eligibility and undertake data extraction, using a customised grid. The screening criteria and data charting will be piloted by the research team.
The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) extension for scoping reviews will be followed to present the results. Results will be summarised in a tabular form and narratively.
This review will identify and summarise publicly available data, without requiring ethical approval. The findings will be disseminated to the Euro-CAN Network and reported to the COST Association. They will also be published in a peer-reviewed journal. This protocol is registered on Open Science Framework.
SARS-CoV-2 has impacted globally the care of chronic diseases. However, direct evidence from certain vulnerable communities, such as Indigenous communities in Latin America, is missing. We use observational data from a health district that primarily serves people of Maya K’iche’ ethnicity to examine the care of type 2 diabetes in Guatemala during the pandemic.
We used a parallel convergent mixed methods design. Quantitative data (n=142 individuals with diabetes) included glycated haemoglobin (HbA1c), blood pressure, body mass index and questionnaires on diabetes knowledge, self-care and diabetes distress. Quantitative data was collected at two points, at baseline and after COVID restrictions were lifted. For quantitative outcomes, we constructed multilevel mixed effects models with multiple imputation for missing data. Qualitative data included interviews with providers, supervisors and individuals living with diabetes (n=20). We conducted thematic framework analysis using an inductive approach.
Quantitative data was collected between June 2019 and February 2021, with a median of 487 days between data collection points. HbA1c worsened +0.54% (95% CI, 0.14 to 0.94) and knowledge about diabetes decreased –3.54 points (95% CI, –4.56 to –2.51). Qualitatively, the most important impact of the pandemic was interruption of the regular timing of home visits and peer group meetings which were the standard of care.
The deterioration of diabetes care was primarily attributed to the loss of regular contact with healthcare workers. The results emphasize the vulnerability of rural and Indigenous populations in Latin America to the suspension of chronic disease care.
There is burgeoning evidence for the potential of nature-based interventions to improve wellbeing. However, the role of nature in enhancing maternal mental health, child development and early relationships remains relatively unexplored. This study aimed to develop a co-designed nature-based intervention to improve postnatal mothers’ and infants’ wellbeing.
Person-based and co-design approaches informed the planning and design of the postnatal nature-based intervention. In stage 1, a multidisciplinary team was formed to agree research questions and appropriate methodology, and a scoping review was conducted. Six qualitative focus groups were then held with 30 mothers and 15 professional stakeholders. In stage 2, intervention guiding principles and a logic model were developed, and a stakeholder consensus meeting was convened to finalise the prototype intervention. The research was conducted in Bristol, UK, across voluntary, educational and community-based healthcare settings.
Stakeholder consultation indicated significant enthusiasm for a postnatal nature-based intervention. A scoping review identified little existing research in this area. Focus group data are reported according to four broad themes: (1) perceived benefits of a group postnatal nature-based intervention, (2) potential drawbacks and barriers to access, (3) supporting attendance and implementation, and (4) ideas for intervention content. The developed intervention was tailored for mothers experiencing, or at risk of, postnatal mental health difficulties. It was identified that the intervention should facilitate engagement with the natural world through the senses, while taking into account a broad range of postnatal-specific practical and psychological needs.
To our knowledge, this is the first reported use of person-based and co-design approaches to develop a postnatal nature-based intervention. The resulting intervention was perceived by target users to address their needs and preferences. Further research is needed to determine the feasibility, clinical and cost-effectiveness of this approach.
Glial brain tumours are highly mortal and are noted as major neurosurgical challenges due to frequent recurrence or progression. Despite standard-of-care treatment for gliomas, the prognosis of patients with higher-grade glial tumours is still poor, and hence empowering antitumour immunity against glioma is a potential future oncological prospect. This review is designed to improve our understanding of the efficacy of cell-based immunotherapies for glioma.
This systematic review will be performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A comprehensive search of main electronic databases: PubMed/MEDLINE, Scopus, ISI Web of Science EMBASE and ProQuest will be done on original articles, followed by a manual review of review articles. Only records in English and only clinical trials will be encountered for full-text review. All the appropriate studies that encountered the inclusion criteria will be screened, selected and then will undergo data extraction step by two independent authors. For meta-analyses, data heterogeneity for each parameter will be first evaluated by Cochran’s Q and I2 statistics. In case of possible heterogeneity, a random-effects meta-analysis will be performed and for homogenous data, fixed-effects models will be selected for reporting the results of the proportional meta-analysis. Bias risk will be assessed through Begg’s and Egger’s tests and will also be visualised by Funnel plots.
As this study will be a systematic review without human participants’ involvement, no ethical registration is required and meta-analysis will be presented at a peer-reviewed journal.
CRD42022373297
Daily calcium supplements are recommended for pregnant women from 20 weeks’ gestation to prevent pre-eclampsia in populations with low dietary calcium intake. We aimed to improve understanding of barriers and facilitators for calcium supplement intake during pregnancy to prevent pre-eclampsia.
Mixed-method systematic review, with confidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations-Confidence in the Evidence from Reviews of Qualitative research approach.
MEDLINE and EMBASE (via Ovid), CINAHL and Global Health (via EBSCO) and grey literature databases were searched up to 17 September 2022.
We included primary qualitative, quantitative and mixed-methods studies reporting implementation or use of calcium supplements during pregnancy, excluding calcium fortification and non-primary studies. No restrictions were imposed on settings, language or publication date.
Two independent reviewers extracted data and assessed risk of bias. We analysed the qualitative data using thematic synthesis, and quantitative findings were thematically mapped to qualitative findings. We then mapped the results to behavioural change frameworks to identify barriers and facilitators.
Eighteen reports from nine studies were included in this review. Women reported barriers to consuming calcium supplements included limited knowledge about calcium supplements and pre-eclampsia, fears and experiences of side effects, varying preferences for tablets, dosing, working schedules, being away from home and taking other supplements. Receiving information regarding pre-eclampsia and safety of calcium supplement use from reliable sources, alternative dosing options, supplement reminders, early antenatal care, free supplements and support from families and communities were reported as facilitators. Healthcare providers felt that consistent messaging about benefits and risks of calcium, training, and ensuring adequate staffing and calcium supply is available would be able to help them in promoting calcium.
Relevant stakeholders should consider the identified barriers and facilitators when formulating interventions and policies on calcium supplement use. These review findings can inform implementation to ensure effective and equitable provision and scale-up of calcium interventions.
CRD42021239143.
Metabolic disturbances are of major health concerns in the world. In addition to their high prevalence, these disorders have substantial roles in developing other physical and mental diseases. Diet could have a considerable influence on managing the progression of these conditions and their consequent health-related effects. The aim of the ‘Diet in relation to Metabolic, sleep and psychological health Status’ Project is to explore the association of nutrition with metabolic, sleep and mental health, considering potential mediators including brain-derived neurotrophic factor (BDNF) and adropin.
This cross-sectional study will be conducted on adults (20–65 years) working in schools of Isfahan, Iran. A multistage cluster random sampling method will be used to select participants. Anthropometric, body composition and biochemical values including fasting blood glucose, lipid profile, 25-hydroxy vitamin D, insulin, BDNF, adropin, malondialdehyde, superoxide dismutase, glutathione peroxidase, uric acid, creatinine and C reactive protein will be measured for each participant. National Cholesterol Education Program and Adult Treatment Panel III will be considered to define metabolic syndrome. Diet will be assessed through a validated Food Frequency Questionnaire. Furthermore, sleep status, mental health, quality of life, physical activity and demographic status of individuals will be assessed by validated questionnaires. The collected data will be analysed using appropriate statistical methods.
The study protocol was approved by the local Ethics Committee of Isfahan University of Medical Sciences. All participants will provide written informed consent. Dissemination will be through conference presentations and publications in peer-reviewed journals.
Over 40 million people in low-income and middle-income countries (LMICs) experience serious health-related suffering (SHS) annually and require palliative care. Patient and caregiver experiences of SHS in LMICs are understudied despite their importance in guiding palliative care provision. Diabetes and cancer are the second-leading and third-leading causes of death in Mexico, causing a significant SHS burden on patients, families and health systems. This study examines SHS and palliative care from the point of view of patients with cancer and diabetes and their caregivers.
A qualitative descriptive study based on in-depth telephone interviews was conducted between August 2021 and February 2022. Data were analysed through inductive thematic analysis.
Overall, 20 patients with end-stage cancer, 13 patients with diabetes and 35 family caregivers were interviewed individually.
Participants were recruited from two family medicine clinics and a pain clinic in Mexico City.
Seven themes emerged: (1) suffering as a multifaceted phenomenon, (2) diversity in perceptions of suffering, (3) different coping strategies, (4) need and perceived importance of relief from suffering, (5) barriers to accessing services to relieve suffering, (6) demand for the health sector’s active and humane role in addressing suffering and (7) preferences and need for comprehensive care for relief from suffering. The primary coping strategies included family companionship, protective buffering and faith-based support. Participants lacked knowledge of palliative care. They expressed the importance of relief from suffering, viewing it as the health sector’s responsibility and requesting more humane, personalised care and access to medicines and pain clinics.
The multifaceted nature of SHS highlights the health system’s responsibility to provide high-quality palliative care. Policies to enhance access to palliative care should integrate it into primary care, redesigning services towards patient and caregiver biopsychosocial and spiritual needs and ensuring access to medicines and competent health personnel.
Many Canadians struggle to access the primary care they need while at the same time primary care providers report record levels of stress and overwork. There is an urgent need to understand factors contributing to the gap between a growing per-capita supply of primary care providers and declines in the availability of primary care services. The assumption of responsibility by primary care teams for services previously delivered on an in-patient basis, along with a rise in administrative responsibilities may be factors influencing reduced access to care.
In this mixed-methods study, our first objective is to determine how the volume of services requiring primary care coordination has changed over time in the Canadian provinces of Nova Scotia and New Brunswick. We will collect quantitative administrative data to investigate how services have shifted in ways that may impact administrative workload in primary care. Our second objective is to use qualitative interviews with family physicians, nurse practitioners and administrative team members providing primary care to understand how administrative workload has changed over time. We will then identify priority issues and practical response strategies using two deliberative dialogue events convened with primary care providers, clinical and system leaders, and policy-makers.
We will analyse changes in service use data between 2001/2002 and 2021/2022 using annual total counts, rates per capita, rates per primary care provider and per primary care service. We will conduct reflexive thematic analysis to develop themes and to compare and contrast participant responses reflecting differences across disciplines, payment and practice models, and practice settings. Areas of concern and potential solutions raised during interviews will inform deliberative dialogue events.
We received research ethics approval from Nova Scotia Health (#1028815). Knowledge translation will occur through dialogue events, academic papers and presentations at national and international conferences.
To determine the feasibility of a definitive trial of metformin to prevent type 2 diabetes in the postnatal period in women with gestational diabetes.
A multicentre, placebo-controlled, double-blind randomised feasibility trial with qualitative evaluation.
Three inner-city UK National Health Service hospitals in London.
Pregnant women with gestational diabetes treated with medication.
2 g of metformin (intervention) or placebo (control) from delivery until 1 year postnatally.
Rates of recruitment, randomisation, follow-up, attrition and adherence to the intervention.
Preliminary estimates of glycaemic effects, qualitative exploration, acceptability of the intervention and costs.
Out of 302 eligible women, 57.9% (175/302) were recruited. We randomised 82.3% (144/175) of those recruited, with 71 women in the metformin group and 73 women in the placebo group. Of the participants remaining in the study and providing any adherence information, 54.1% (59/109) took at least 75% of the target intervention dose; the overall mean adherence was 64% (SD 33.6). Study procedures were found to be acceptable to women and healthcare professionals. An increased perceived risk of developing type 2 diabetes, or a positive experience of taking metformin during pregnancy, encouraged participation and adherence to the intervention. Barriers to adherence included disruption to the medication schedule caused by the washout periods ahead of each study visit or having insufficient daily reminders.
It is feasible to run a full-scale definitive trial on the effectiveness of metformin to prevent type 2 diabetes in women with gestational diabetes, during the early postnatal period. Adherence and engagement with the study could be improved with more regular reminders and potentially the addition of ongoing educational or peer support to reinforce messages around type 2 diabetes prevention.
Persistent human papillomavirus (HPV) infection is a known cause of a subset of head and neck cancers (HNCs). In the last two decades, the proportion of HNCs attributable to HPV infection has increased worldwide, notably the oropharyngeal cancers. However, the trend of HPV-related HNC burden is not clearly understood yet in China. Thus, the absolute
BROADEN-China is a nationwide, multisite, cross-sectional study. A stratified, multistage, non-randomised cluster sampling method will be used to select 2601 patients with HNC from 14 hospitals across seven regions, based on population density in China. Patients with formalin-fixed paraffin-embedded tissue samples collected prior to treatment induction during three time periods will be included, and factors (eg, smoking status, alcohol consumption, betel nut chewing, Epstein-Barr virus, teeth loss, etc) associated with HNC will be assessed. HPV testing (HPV-DNA, HPV-mRNA and p16INK4a immunohistochemistry) and histological diagnosis of the tissue samples will be conducted at a central laboratory.
The study protocol and all required documents have been submitted for review and approval to the Independent Ethics Committees of all the participating sites. The informed consent was waived for all participants and all the recorded data will be treated as confidential.
We have included 14 hospitals as our participating sites, of which Henan Cancer Hospital is the leading site. The study has been approved by the independent ethics committees of the leading site on 3 December 2020. The other 13 participating site names of ethics committee and IRB that have approved this study.
FreshRSS 