Sedentary behaviour is associated with a variety of adverse health outcomes, including obesity, oestrogen metabolism and chronic inflammation, all of which are related to the pathogenesis of uterine fibroids (UFs). This study aimed to explore the relationship between leisure sedentary time (LST) and UFs.
Cross-sectional.
We conducted a cross-sectional analysis of data from patients from the Yunnan region in the China Multi-Ethnic Cohort Study.
A total of 6623 non-menopausal women aged 30–55 years old were recruited. Menstrual status was self-reported. Participants who lacked a unique national identity card, suffered from serious mental illness, did not have a clear diagnosis of UFs, or provided incomplete information were excluded.
UFs were diagnosed by abdominal B-ultrasound. Leisure sedentary behaviour was assessed by using a face-to-face questionnaire interview. Logistic regression and restricted cubic spline were employed to explore the relationship between LST and UFs.
A total of 562 participants had UFs, with a prevalence rate of 8.5% (7.8%, 9.2%). Multivariate adjusted logistic regression analysis showed that the risk of UFs in women with LST≥6 hour/day was 2.008 times that in women with LST0.05). According to the results of the stratified analysis for menstrual status and body mass index (BMI), there was a correlation between LST and the prevalence of UFs only in women with a BMI2 or perimenopause.
LST was independently associated with the prevalence of UFs, and a linear dose-response relationship was observed. Our study provides evidence on the factors influencing UFs, and further research is needed to propose feasible measures for UFs prevention.
Although the caesarean delivery (CD) rate has substantially increased, little is known about its impacts when performed in the first and second stages of labour on fetomaternal outcomes, especially among referred mothers. Thus, this study aimed to investigate the association between CDs performed during the first and second stages of labour and poor maternal and neonatal outcomes among mothers referred to tertiary centres.
This retrospective cohort study analysed medical records of mother–infant pairs from September 2020 to May 2023 in Southern Ethiopia.
We retrospectively collected data from 848 participants who underwent emergency CD on a referral basis during the study period.
The primary outcomes of interest were adverse maternal and neonatal outcomes. Data were analysed using descriptive and inferential statistics.
Of the 848 CDs, 722 (85.2%) and 126 (14.8%) were performed at the first and second stages of labour, respectively. Caesarean sections performed at the second stage were higher with nulliparity, increased maternal age, and birth weight. Compared with the first-stage CD, the second-stage CD was associated with a significantly increased risk of adverse maternal (OR 3.7, 95% CI 2.4 to 5.7) and neonatal outcomes (OR 2.0; 95% CI 1.3 to 2.9), including neonatal death.
Second-stage CDs have an increased risk of adverse maternal and neonatal outcomes. Strengthening and improving obstetric emergency surgical services and intensive neonatal care for those populations would help decrease the maternal and fetal negative consequences.
To assess diabetes knowledge and foot care practices among type 2 diabetes patients.
An institution-based cross-sectional study was undertaken from 1 January to 31 January 2021.
Eastern Ethiopia.
Randomly selected type 2 diabetes patients who were available during the data collection period were included.
Patients’ diabetes knowledge was assessed with the revised diabetes knowledge test questionnaire. Five items were used to evaluate foot self-care practices.
The study population comprised of 549 patients. About 52.5% of the patients had adequate diabetes knowledge (95% CI: 48.2% to 56.7%). Patients with an educational level of secondary school and above (adjusted OR (AOR): 2.04, 95% CI: 1.13 to 3.71), (AOR: 5.28, 95% CI: 2.28 to 12.22), and those with medium and above wealth status (AOR: 3.81, 95% CI: 2.24 to 6.47), (AOR: 3.46, 95% CI: 1.98 to 6.04), were found to have better odds of having adequate diabetes knowledge. However, those aged >55 years (AOR: 0.47, 95% CI: 0.22 to 0.99) were found to have lower odds of adequate diabetes knowledge.Of the total included patients, 20.2% (95% CI: 16.9% to 23.8%) had good foot care practices. Knowledge of the target fasting plasma glucose (AOR: 3.18, 95% CI: 1.94 to 5.22) and adequate diabetes knowledge (AOR: 3.40, 95% CI: 1.95 to 5.91) were significantly associated with good foot care practices.
According to this study, about half of individuals with type 2 diabetes have adequate levels of knowledge about the disease. In addition, only one out of every five patients has good foot care habits. Diabetes education should emphasise the significance of rigorous adherence to daily foot care practices.
The high incidences of both the developmental delay among young children and the mental health problems of their caregivers are major threats to public health in low-income and middle-income countries. Parental training interventions during early childhood have been shown to benefit early development, yet evidence on strategies to promote caregiver mental health remains limited. In addition, evidence on the optimal design of scalable interventions that integrate early child development and maternal mental health components is scarce.
We design a single-blind, factorial, cluster-randomised controlled, superiority trial that will be delivered and supervised by local agents of the All China Women’s Federation (ACWF), the nationwide, government-sponsored social protection organisation that aims to safeguard the rights and interests of women and children. We randomise 125 villages in rural China into four arms: (1) a parenting stimulation arm; (2) a caregiver mental health arm; (3) a combined parenting stimulation and caregiver mental health arm and (4) a pure control arm. Caregivers and their children (aged 6–24 months at the time of baseline data collection) are selected and invited to participate in the 12-month-long study. The parenting stimulation intervention consists of weekly, one-on-one training sessions that follow a loose adaptation of the Reach Up and Learn curriculum. The caregiver mental health intervention is comprised of fortnightly group activities based on an adaptation of the Thinking Healthy curriculum from the WHO. Primary outcomes include measures of child development and caregiver mental health. Secondary outcomes include a comprehensive set of physical, psychological and behavioural outcomes. This protocol describes the design and evaluation plan for this programme.
This study received approval from the Institutional Review Board of Stanford University (IRB Protocol #63680) and the Institutional Review Board of the Southwestern University of Finance and Economics in Chengdu, Sichuan, China. Informed oral consent will be obtained from all caregivers for their own and their child’s participation in the study. The full protocol will be publicly available in an open-access format. The study findings will be published in economics, medical and public health journals, as well as Chinese or English policy briefs.
AEA RCT Registry (AEARCTR-0010078) and ISRCTN registry (ISRCTN84864201).
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.
This review explored the literature on the use of social media in recruiting young people, aged 13–18 years, to mental health research. It aimed to identify barriers and facilitators to recruitment and strategies to improve participation in future research.
Scoping review.
Articles published between January 2011 and February 2023 were searched for on PubMed, Scopus, Medline (via EBSCOhost) and Cochrane Library databases.
Studies that outlined social media as a recruitment method and recruited participants aged 13–18 years.
Data was extracted by two reviewers independently and cross-checked by a third reviewer. Data on study design, aims, participants, recruitment methods and findings related specifically to social media as a recruitment tool were collected.
24 journal articles met the inclusion criteria. Studies were predominantly surveys (n=13) conducted in the USA (n=16) recruiting via Facebook (n=16) and/or Instagram (n=14). Only nine of the included articles provided a summary of success and reviewed the efficacy of social media recruitment for young people in mental health research. Type of advertisement, the language used, time of day and the use of keywords were all found to be factors that may influence the success of recruitment through social media; however, as these are based on findings from a small number of studies, such potential influences require further investigation.
Social media recruitment can be a successful method for recruiting young people to mental health research. Further research is needed into recruiting socioeconomically marginalised groups using this method, as well as the effectiveness of new social media platforms.
Open Science Framework Registry (https://osf.io/mak75/).
This qualitative study aims to identify patient-reported barriers to treatment for neovascular age-related macular degeneration (nAMD) and investigate their impact on quality of life.
Using a qualitative explorative design.
Semi-structured individual or dyadic interviews were conducted with patients and their relatives.
Twenty-one patients completed the interview, with four of them having a relative present.
Gadamer’s hermeneutics guided the epistemological approach, and maximum variation sampling was employed to capture diverse patient experiences. An advisory board consisting of patients, relatives and ophthalmologists ensured the relevance of the study. Thematic analysis was conducted using NVivo software.
To investigate patient-reported barriers to the recommended treatment for nAMD and impact on quality of life.
The study included 21 patients with nAMD, with a median age of 79 years. Five themes emerged: (1) good compliance with intravitreal treatment, (2) the dual role of relatives, (3) treatment commute, (4) hospital barriers, (5) preventive health literacy.
This study highlights the resilience and adherence of patients with nAMD in Denmark to their treatment despite various barriers. While the therapy may have negative effects on their well-being, patients do not opt out of treatment. These findings underscore the importance of personalised treatment plans that provide, for example, convenient access to care and clear future agreements at the hospital. By adopting more patient-centred approaches, healthcare providers can enhance patient satisfaction and improve treatment adherence, ultimately leading to better patient outcomes and quality of life.
To compare the efficacy of a traditional cock-up splint, which supports the wrist only, with a modified splint that supports the wrist and the metacarpophalangeal (MCP) joints of the medial four digits in the treatment of carpal tunnel syndrome (CTS).
An assessor-blind randomised controlled trial.
Hospital-based hand therapy clinics.
Fifty-nine adults with mild-to-moderate CTS were randomly assigned to wear a wrist splint (control group) or an MCP splint (intervention group) for 6 weeks.
The standardised outcome measures used included grip and pinch strength, the static two-point discrimination test, Phalen’s manoeuvre test, Tinel’s sign and the Boston CTS Questionnaire.
Both groups improved significantly from splint use in some clinical features. The wrist splint and the MCP splint groups had significant improvements in lateral pinch strength (p=0.032 and p=0.002, respectively), two-point discrimination of the thumb (p=0.003 and p=0.041, respectively), two-point discrimination of the index (p=0.035 and p=0.023, respectively) and the Phalen’s manoeuvre symptoms (p=0.025 and p=0.002, respectively). The MCP splint group had additional improvements over the wrist splint group in tip pinch (p=0.012) and Palmar pinch (p=0.011) strength.
Splinting is a practical and effective intervention option for improving the symptoms of CTS. A wrist splint that incorporates the MCP joints is more effective than the traditional wrist-only splint, with long-lasting improvements that remained consistent after 6 months of the splint intervention. Using the more effective MCP splint may consequently reduce disability, facilitate return to work and lower the associated costs.
Stroke remains the second leading cause of death worldwide, a common cause of which is intracranial atherosclerotic stenosis (ICAS). Medical treatment is recommended as first-line therapy for treating ICAS, but the recurrence rate remains high. Drug-coated balloon (DCB) angioplasty has been designed to lower the risk of recurrent stenosis, holding therapeutic promise in the treatment of ICAS. However, the benefits of DCB require further evaluation.
The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols was followed to develop this protocol. We will systematically search online databases including Cochrane Central Register of Controlled Trials, PubMed, Web of Science, EMBASE, China Biological Medicine Database, ClinicalTrials.gov and WHO ICTRP from 1 January 2011 to the date of search. This will be supplemented by a manual search of unpublished and ongoing trials to manually select articles for inclusion. Inclusion criteria are randomised or quasi-randomised clinical trials and observational studies that investigated DCB or medical treatment for patients with a symptomatic ICAS of 50%–99%. The primary outcome is short-term composite safety including death of any cause, or non-fatal stroke. Secondary outcomes include long-term death or stroke, restenosis, neurological rehabilitation, quality of life and other complications. The available data will be analysed using meta-analysis, if appropriate. The evaluation of heterogeneity and biases will be guided by the Cochrane Handbook for Systematic Reviews of Interventions.
This systematic review does not require ethical approval as all available data from eligible studies will be anonymous with no concerns regarding privacy. Our findings will be disseminated through international conferences and peer-reviewed publications. Additional data from the study are available on request to corresponding authors via email.
CRD42022341607.
Exploring the experiences and perspectives of healthcare professionals, patients and caregivers toward serious illness conversations based on the Serious Illness Care Program is vital for improving communication with patients who are seriously ill, as has been shown in previous studies. However, few studies have carried out a systematic review to examine common themes, strengthen conclusions and identify gaps in the literature, the findings of which could help steer further research, policies and practice to improve more timely and person-centred conversations about the values and priorities of patients with serious illnesses. The objective of this qualitative meta-synthesis is to explore how healthcare professionals, patients and caregivers described their own experiences of the processes of serious illness communication through a secondary analysis of published qualitative data.
Meta-aggregation will be used to conduct a systematic review of qualitative studies. We conducted an initial search on 10 October 2023; papers published in English will be searched using electronic databases, including PubMed (MEDLINE), Web of Science, Embase, Ovid and CINAHL. Studies that satisfy the eligibility criteria will be evaluated for methodological quality using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research. The meta-aggregative review will consist of the following: (1) extraction of findings of all included studies; (2) categorisation of the findings, with at least two findings per category; and (3) synthesis of one or more findings from at least two categories. Study eligibility screening, data extraction, analysis and JBI Critical Appraisal Checklist and Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research assessments will be undertaken independently by two authors.
Secondary data analysis of published literature does not require ethical approval. The results will be disseminated in peer-reviewed journals and presented in conference papers and elsewhere.
CRD42022330859.
To compare the modified strategy for the right-sided double-lumen tube (R-DLT) placement using a combination of CT measurements and flexible video bronchoscopy guidance with traditional bronchoscopy technique.
Double-blind, parallel randomised control trial at a tertiary care medical centre in China. 100 patients undergoing video-assisted thoracoscopic surgery and requiring R-DLT were randomly allocated to the control group and the intervention group.
The control group used the traditional bronchoscopy-guided technique. In the intervention group, the length and anteroposterior diameter of the right main bronchus (RMB) were measured on CT images to select the side and size of the Rüsch tube, and then a black depth marker was placed on the tube according to the difference between the length of the RMB and the bronchial cuff. Under the guidance of bronchoscopy, the depth marker should be placed parallel to the tracheal carina and a characteristic white line on the tube should be parallel to the midline of the tracheal carina.
The primary endpoint was the positioning of right upper lobe (RUL) ventilatory slot and RUL bronchial orifice. The secondary endpoints included intubation data and perioperative adverse events.
Compared with the control group, our modified strategy significantly increased the optimal and acceptable position rate (76% vs 98%, respectively; p
This study demonstrates the superiority of our strategy and provides a new viable method for R-DLT placement.
Chinese Clinical Trial Registry (ChiCTR1900021676).
Tuberculosis (TB) is a main concern of health care workers in sub-Saharan Africa. Healthcare workers have the potential to have contact with TB patients and are the main stakeholders in healthcare settings to implement TB infection control, and the poor practice of TB infection control may increase the risk of transmission of TB in healthcare settings. However, there is no consistent conclusion on the TB infection control practice among healthcare workers in Ethiopia. Thus, this study aimed to determine the pooled magnitude of TB infection control practice and associated factors among healthcare workers in Ethiopia.
This systematic review and meta-analysis will be done by following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline. The following databases will be used to search for articles: PubMed, Cochrane Library, Google Scholar and grey literatures. The quality of studies will be assessed using the Joanna Briggs Institute (JBI) critical appraisal checklist. The data from included studies will be extracted using Microsoft Excel V.2016, and the extracted data will be analysed using STATA V.16. Forest plot and I2 statistics will be done for heterogeneity. A funnel plot and Egger’s regression test will be conducted to check for publication bias. Potential sources of bias will be identified by subgroup analysis and meta-regression. Any type of study design conducted in Ethiopia and in English language will be included.
Ethics approval is not required, and the findings will be published in peer-reviewed journal.
CRD42023393580.
Bronchiolitis is an acute viral infection of the lower respiratory tract. It is most commonly caused by respiratory syncytial virus. Being a common reason for hospitalisation, it affects 13–17% of all hospitalised children younger than 2 years. Only supportive therapy, including suctioning nasal secretions, water–electrolyte balance maintenance and oxygen supplementation when needed, is recommended. However, non-evidence-based diagnostic and therapeutic approaches, including the use of inhaled bronchodilators, nebulised epinephrine, and nebulised and systemic steroids, are common. The inhalation of 3% hypertonic saline is not recommended in bronchiolitis management. However, a recently published meta-analysis revealed that the inhalation of hypertonic saline can reduce the risk of hospitalisation for outpatients with bronchiolitis, while resulting in a shorter length of hospital stay and reduced severity of respiratory distress for inpatients, although the evidence is of low certainty. We aim to assess the efficacy of nebulised hypertonic saline for the treatment of children hospitalised with bronchiolitis.
This will be a randomised, double-blinded, parallel-group, controlled trial. Children younger than 2 years who are hospitalised due to bronchiolitis will be recruited from at least three paediatric departments in Poland. Bronchiolitis is defined as an apparent viral respiratory tract infection associated with airway obstruction that is manifested by at least one of following symptoms: tachypnoea, increased respiratory effort, crackles and/or wheezing. A total of 140 children will be randomised (1:1) to receive either hypertonic saline nebulisation (5 mL, three times a day) or normal saline at the same dose. The primary outcome measure will be the duration of hospitalisation.
The Bioethics Committee of the Lower Silesia Medical Chamber in Wroclaw approved the study protocol (4/PNDR/2023). Caregivers will receive oral and written information about the study and written informed consent will be obtained by the study physicians. The findings of the study will be submitted to a peer-reviewed journal, and abstracts will be submitted to relevant national and international conferences.
ClinicalTrials.gov Registry (NCT06069336).
Paediatric intensive care units (PICUs) survivors and their families often experience widespread morbidity and psychosocial consequences after discharge, known as post-intensive care syndrome in paediatrics (PICS-p). In Switzerland, more than 5000 children are admitted to PICUs each year, and despite the high survival rate, there are no data on post-PICU recovery. This study aims to investigate PICS in children and families and identify its associated factors.
This is a national, multicentre, longitudinal, observational study that includes PICU survivors, main family caregivers and siblings (n=1300) recruited from the eight Swiss accredited PICUs with follow-up at discharge, 1, 3 and 6 months after discharge from the PICU. Data will be collected on the domains of physical, emotional, social and cognitive health, as well as factors affecting the outcome related to demographics, clinical specification, PICU and family environment, as well as community and social resources. Structural equation models and growth mixture models will analyse the outcomes, and the heterogeneity of recovery that shed light on the diverse recovery experiences of children and their families. The study identifies risk and protective factors with a focus on the influence of social and familial resources. It will also explore the mutual impact of the child’s recovery and parent/sibling psychosocial health.
The protocol is approved by the CER-VD ethics committee. Participants will be provided with verbal and written explanations of the study, and their privacy and anonymity will be protected throughout the process. The results will be presented at local and international conferences.
Swiss ethics committees ID: 2022-02128, representing the eight cantons for both French and German-speaking parts of Switzerland.
Compensatory mouth breathing, caused by nasopharyngeal obstructive diseases, is the main cause of hyperdivergent mandibular retrognathia in children. Such deformities require effective growth guidance before pubertal growth peaks. The traditional mandibular advancement device, twin block (TB), can guide the forward development of the mandible. However, the side effect of increasing the vertical dimension of the lower facial third, worsens the facial profile of children with divergent growth trends. To solve this problem, a modified TB (LLTB) appliance was designed to control the vertical dimension by intruding incisors and inhibiting the elongation of posterior teeth during the advancement of the mandible, which could avoid the side effects of traditional appliances and effectively guide the growth of the mandible in a normal direction.
The study was designed as a single-centre, single-blind, randomised, parallel controlled trial. We aim to enrol 60 children aged 9–14 years with hyperdivergent skeletal class II malocclusion, using a 1:1 allocation ratio. The participants were will be randomly assigned to receive either the TB or LLTB treatment. The primary outcome will be a change in the angle of the mandibular plane relative to the anterior cranial base. The secondary outcomes will include changes in the sagittal maxillomandibular relation, occlusal plane, facial height, morphology of the mandible and upper airway width. Safety endpoints will also be evaluated.
Ethical approval was obtained from the ethics committee of Shanghai Stomatological Hospital. Both participants and their guardians will be fully informed of the study and sign an informed consent form before participating in the trial. The results will be publicly available in peer-reviewed scientific journals.
ChiCTR2000035882.
Child mortality rates remain high in sub-Saharan Africa, including Ethiopia. We are conducting a cluster randomised control trial in the Gondar zone of the Amhara region to determine the impact of pairing Orthodox priests with community health workers, known locally as the Health Development Army (HDA), on newborns’ nutritional status, early illness identification and treatment, and vaccination completeness.
Ensuring intervention efficacy with scientific rigour is essential, but there are often delays in adopting evidence into policy and programmes. Here, we present a protocol for conducting parallel implementation research alongside an efficacy study to understand intervention implementability and scalability. This will help develop a scale-up strategy for effective elements of the intervention to ensure rapid implementation at scale.
We will conduct a stakeholder analysis of key implementation stakeholders and readiness surveys to assess their readiness to scale up the intervention. We will conduct semistructured interviews and focus group discussions with stakeholders, including HDA members, health workers, Orthodox priests, and caregivers, to determine the core intervention elements that need to be scaled, barriers and facilitators to scaling up the intervention in diverse sociocultural settings, as well as the human and technical requirements for national and regional implementation. Finally, to determine the financial resources necessary for sustaining and scaling the intervention, we will conduct activity-based costing to estimate implementation costs from the provider’s perspective.
The study received approval from the University of Gondar Institutional Review Board (approval no: VP/RTT/05/1030/2022) and the University of Washington Human Subjects Division (approval no: STUDY00015369). Participants will consent to participate. Results will be disseminated through workshops with stakeholders, local community meetings, presentations at local and international conferences, and journal publications. The study will provide evidence for factors to consider in developing a scale-up strategy to integrate the intervention into routine health system practices.
The Gastric Alimetry platform offers a multimodal assessment of gastric function through body surface gastric mapping (BSGM) and concurrent symptom-tracking via a validated App. We aim to perform a longitudinal cohort study to examine the impact of Gastric Alimetry, and changes in clinical management on patient symptoms, quality of life and psychological health.
This is a prospective multicentre longitudinal observational cohort study of participants with chronic gastroduodenal symptoms. Consecutive participants undergoing Gastric Alimetry will be invited to participate. Quality of life will be assessed via EuroQol-5D and the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life score. Gastrointestinal symptoms will be assessed via the Patient Assessment of Upper Gastrointestinal Symptom Severity index, and the Gastroparesis Cardinal Symptom Index. Psychometrics will be assessed, including anxiety via the General Anxiety Disorder-7, perceived stress using the Perceived Stress Scale 4, and depression via the Patient Health Questionnaire 9. Clinical parameters including diagnoses, investigations and treatments (medication and procedures) will also be captured. Assessments will be made the week after the BSGM test, at 30 days, 90 days, 180 days and 360 days thereafter. The primary outcome is feasibility of longitudinal follow-up of a cohort that have undergone Gastric Alimetry testing; from which patients’ continuum of care can be characterised. Secondary outcomes include changes in patient-reported symptoms, quality of life and psychometrics (anxiety, stress and depression). Inferential causal analyses will be performed at the within patient level to explore causal associations between treatment changes and clinical outcomes. The impact of Gastric Alimetry on clinical management will also be captured.
The protocol has been approved in Aotearoa New Zealand by the Auckland Health Research Ethics Committee. Results will be submitted for conference presentation and peer-reviewed publication.
Dietary sodium intake represents a risk factor for cardiovascular disease and mortality. The study sought to analyse the sodium content of effervescent dietary supplements and drugs in Germany and the USA.
Comparative cross-sectional study.
The sodium content of 39 dietary supplement effervescent tablets available in Germany was measured in May and June 2022 using optical emission spectrometry with inductively coupled argon plasma. The sodium content of 33 common pharmacy-only effervescent tablets (over-the-counter (OTC) drugs) in Germany was obtained from the summary of product characteristics. We compared the sodium content of the measured German dietary supplement effervescent tablets to that of 51 dietary supplement effervescent tablets available in the USA (data: National Institutes of Health’s Dietary Supplement Label Database).
The measured sodium content in the German dietary supplements was 283.9±122.6 mg sodium/tablet, equivalent to 14±6% of the maximum recommended daily sodium intake (MRDSI). Vitamin products had the highest (378.3±112.8 mg, 19±6% of MRDSI), and calcium products had the lowest mean sodium content (170.4±113.2 mg, 9±6% of MRDSI). Vitamin products contained significantly more sodium than magnesium (378.3 mg vs 232.7 mg; p=0.004), calcium (378.3 mg vs 170.4 mg; p=0.006) and mineral products (378.3 mg vs 191.6 mg; p=0.048). The sodium content measured in products available in Germany was higher when compared with the declared sodium content on the label of the products sold in the USA (283.9 mg vs 190.0 mg; p
Effervescent tablets of nutritional supplements and OTC drugs contain high amounts of sodium, which often is not disclosed.
Attributing musculoskeletal (MSK) pain to normal and commonly occurring imaging findings, such as tendon, cartilage and spinal disc degeneration, has been shown to increase people’s fear of movement, reduce their optimism about recovery and increase healthcare costs. Interventions seeking to reduce the negative effects of MSK imaging reporting have had little effect. To understand the ineffectiveness of these interventions, this study seeks to scope their behavioural targets, intended mechanisms of action and theoretical underpinnings. This information alongside known barriers to helpful reporting can enable researchers to refine or create new more targeted interventions.
The scoping review will be conducted in accordance with the JBI methodology for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Search terms will be devised by the research team. Searches of MEDLINE, EMBASE, CINAHL, AMED and PsycINFO from inception to current day will be performed. The review will include studies, which have developed or evaluated interventions targeting the reporting of MSK imaging. Studies targeting the diagnosis of serious causes of MSK pain will be excluded. Two independent authors will extract study participant data using predefined extraction templates and intervention details using the Template for Intervention Description and Replication checklist. Interventions will be coded and mapped to the technique, mechanism of action and behavioural target according to the Capability, Opportunity, Motivation-Behaviour (COM-B) model categories. Any explicit models or theories used to inform the selection of interventions will be extracted and coded. The study characteristics, behaviour change techniques identified, behavioural targets according to the COM-B and context specific theories within the studies will be presented in narrative and table form.
The information from this review will be used to inform an intervention design process seeking to improve the communication of imaging results. The results will also be disseminated through a peer-reviewed publication, conference presentations and stakeholder events.
A head and neck cancer (HNC) diagnosis significantly impacts a patient’s quality of life (QOL). Palliative care potentially improves their QOL. We will conduct a scoping review to identify existing knowledge about palliative care interventions for patients with HNC.
This scoping review was designed in accordance with the JBI Manual for Evidence Synthesis: Scoping Reviews and will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Our eligibility criteria follow the Population, Intervention, Comparison or Control, Outcomes and Study characteristics framework. The population is adult patients with locally advanced, metastatic, unresectable and/or recurrent HNC. We include peer-reviewed journal articles and articles in the press, in English, reporting on palliative care interventions with at least two of the eight National Consensus Project on Clinical Practice Guidelines for Quality Palliative Care domains; studies with and without comparators will be included. The outcomes are patient QOL (primary) and symptom severity, patients’ satisfaction with care, patients’ mood, advance care planning and place of death (secondary). We developed a search strategy across ten databases, to be searched from the inception to 11 September 2023: Medline ALL (Medline and EPub Ahead of Print and In-Process, In-Data-Review & Other Non-Indexed Citations), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase Classic+Embase, Emcare and PsycINFO all from the OvidSP platform; CINAHL from EBSCOhost, Scopus from Elsevier, Web of Science from Clarivate and Global Index Medicus from WHO. We will extract data using a piloted data form and analyse the data through descriptive statistics and thematic analysis.
Ethics approval is not needed for a scoping review. We will disseminate the findings to healthcare providers and policy-makers by publishing the results in a scientific journal.