Annals of Internal Medicine, Ahead of Print.
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Reaffirming the JAMA Network Commitment to the Health of Patients and the Public
In the first month of the new administration responsible for leading the US, the executive branch has issued a flurry of orders, including ones associated with the dismissal or resignation of tens of thousands of federal employees. Many of these have substantial consequences for science, medicine, and public health. Amidst the dizzying array of actions, it is difficult to know where to focus and how best to respond. However, the silencing of science and health-related communications through suppression or erasure of information, and the corresponding silence by many in the fields of biomedicine and public health, deserve special consideration.
A New Language Equity Framework for Health Technology
This Medical News article is an interview with Pilar Ortega, MD, MGM, about the need for interventions to improve health care quality and access for patients with non-English language preference, and why equitable design is essential for new AI-driven health technologies and digital advancements.
Impact of Parental Crohn’s Disease on Offspring’s Gut Health and Disease Vulnerability
Evaluation of the psychometric properties of patient-reported outcome measures of health-related quality of life across the European cancer continuum: a systematic review protocol using COSMIN methodology
Introduction
Over the past decades, there has been increasing recognition that assessing patients with cancer’s health-related quality of life (HRQoL) is pivotal to delivering optimal patient-centred healthcare. However, with the increasing number of patient-reported outcome measures (PROMs) available, it becomes more and more challenging to identify the most appropriate PROM to capture HRQoL. Therefore, the aim of this systematic review is to (1) identify all available PROMs assessing HRQoL across the European cancer continuum and (2) critically appraise, compare and summarise the psychometric properties of the identified PROMs.
Methods and analysis
Bibliographic databases MEDLINE and PubMed Central (through PubMed) and EMBASE (through Scopus) will be comprehensively searched from database inception until March 2024. Studies reporting on the measurement properties of PROMs assessing HRQoL throughout the European cancer continuum will be included. The evaluation of the psychometric properties, data extraction and data synthesis will be conducted according to the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology. Two reviewers will independently assess the methodological quality using the COSMIN risk of bias checklist and the COSMIN criteria for good measurement properties. Subsequently, findings will be qualitatively summarised. The Grading of Recommendations Assessment, Development and Evaluations (GRADE) guidelines will be used to grade and summarise the quality of the evidence.
Ethics and dissemination
Ethical clearance for this research is not required, as the systematic review will only use information from previously published research. The results of this review will be submitted for publication in a peer-reviewed journal and will be used to provide a set of evidence-based recommendations for a European project (EUonQOL), which aims at developing a new PROM (EUonQOL toolkit) to assess HRQoL across the European cancer continuum. Moreover, findings will be disseminated to a clinical audience and policymakers through conferences, supporting researchers and clinicians in choosing the best measure to evaluate HRQoL in patients with cancer and survivors in Europe.
PROSPERO registration number
CRD42023418616.
Trends and inequalities in womens use of quality antenatal care, intrapartum care, and immediate postnatal care services in Ethiopia: multivariate decomposition, secondary data analyses of four demographic and health surveys over two decades (2001-2019)
Objective
This study aimed to examine the trends and inequalities in women’s use of quality antenatal care (ANC), quality intrapartum care and immediate postnatal care (PNC) services, and the determinants that contributed to changes in receiving these services from 2001 to 2019 in Ethiopia using the Ethiopia Demographic and Health Surveys (EDHSs) data.
Design, outcomes, setting and analysis
Secondary data analyses of four waves of nationally representative EDHSs from 2005 to 2019 were conducted. We defined quality ANC as having blood pressure measurement, blood and urine tests, iron supplementation and being informed of pregnancy-related complications during ANC visits; quality intrapartum care as having health facility birth, birth assisted by skilled personnel and newborn put to the breast within 1 hour of birth and immediate PNC as having maternal and newborn PNC within 24 hours of birth. We used control charts, multivariate logistic regression decomposition analyses and equiplots to measure and analyse trends and inequalities over two decades using data from EDHSs 2005–2019.
Results
Over the period 2001–2019, there were increases in the percentage of quality ANC (3.7%–39.6%), intrapartum care (3.9%–43.3%) and immediate PNC (2.6%22.1%) services received. However, there were widening inequalities between these services received by women, favouring those from advantageous socioeconomic backgrounds. From 2001–2019, the largest significant increases in the percentage of women receiving quality ANC and immediate PNC services were due to changes in the distribution of sociodemographic and maternal care characteristics, while the largest significant increase in the percentage of women receiving quality intrapartum care was due to changes in the effects of these characteristics.
Conclusions
The healthcare system in Ethiopia should expand access to all the recommended maternal healthcare interventions to disadvantaged population subgroups. Universal coverage of quality maternal and newborn healthcare across the continuum is needed. There is also a need to promote ≥4 ANC, early initiation of ANC, girls’ and women’s education and enabling women’s economic empowerment.
[Articles] Enhancing health equity considerations in guidelines: health equity extension of the GIN-McMaster Guideline Development Checklist
The GIN-McMaster health equity extension provides guidance for the streamlined integration of health equity considerations throughout the guideline development process. Using this tool alongside the original GIN-McMaster GDC may lead to more equitable and impactful guidelines.
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Test clinici la promuovono. L’esperto: ‘Mai come sostitutivo del medico’
Protective role of health insurance coverage in reducing under-five mortality in Ethiopia: Gompertz inverse-Gaussian shared frailty modelling
Objective
To determine the association between health insurance coverage and under-five mortality in Ethiopia using data from the 2016 Ethiopia Demographic and Health Survey (EDHS).
Methods
The current study used a total of 10 641 under-five children from the 2016 EDHS. To identify the predictors, the Gompertz inverse-Gaussian shared frailty model was fitted. The theta value, Akaike Information Criteria and Bayesian Information Criteria were applied for model evaluation, and variables with p values less than 0.2 were included in the multivariable analysis. The strength and statistical significance of the associations were demonstrated by reporting the adjusted HR (AHR) with a 95% CI in the multivariable Gompertz inverse-Gaussian shared frailty model.
Results
According to the study’s findings, 96.46% of the children were born to mothers not covered by health insurance. The study found that health insurance coverage was significantly associated with a lower risk of under-five mortality (not covered: AHR=0.13; 95% CI 0.02, 0.95). Other factors that showed significant associations with under-five mortality include place of residency, family size, twin status, place of delivery and preceding birth interval.
Conclusion
The findings indicate that health insurance coverage in Ethiopia is significantly associated with a lower risk of mortality among children under five. However, coverage remains low among mothers of these children, highlighting an urgent need for policies and interventions aimed at expanding health insurance coverage and addressing key determinants of child health to reduce under-five mortality and improve child survival outcomes. Addressing gaps in health insurance and other contributing factors is vital for creating effective strategies to lower under-five mortality rates.
Embedding equity, diversity and inclusion processes within clinical trials and health and social care research
The lack of diverse and inclusive clinical research populations fuels health inequalities in the UK, and there is an urgent need to reverse this. This communication provides a practical framework for positive action to integrate equity, diversity and inclusion (EDI) processes into clinical research design, protocols and implementation and to establish accountable clinical research systems that are trustworthy to the public and accessible to diverse communities.
This framework is a consensus-based guide developed by the Equality, Diversity and Inclusion working group of the National Institute for Health and Care Research’s (NIHR’s) Clinical Research Network in North West London. This work involved analysing challenges to integrating EDI within the clinical research process, such as clinical trial protocols as directed by industry sponsors and National Health Service investigator teams. It aligns with the UK government’s clinical research strategy and NIHR’s INCLUDE project.
It advises an interconnected approach to embedding EDI throughout the clinical research lifecycle. By following this framework, we aspire to guide clinical research towards a more equitable, inclusive and representative model that better serves the needs of all populations.
Protective role of health insurance coverage in reducing under-five mortality in Ethiopia: Gompertz inverse-Gaussian shared frailty modelling
Objective
To determine the association between health insurance coverage and under-five mortality in Ethiopia using data from the 2016 Ethiopia Demographic and Health Survey (EDHS).
Methods
The current study used a total of 10 641 under-five children from the 2016 EDHS. To identify the predictors, the Gompertz inverse-Gaussian shared frailty model was fitted. The theta value, Akaike Information Criteria and Bayesian Information Criteria were applied for model evaluation, and variables with p values less than 0.2 were included in the multivariable analysis. The strength and statistical significance of the associations were demonstrated by reporting the adjusted HR (AHR) with a 95% CI in the multivariable Gompertz inverse-Gaussian shared frailty model.
Results
According to the study’s findings, 96.46% of the children were born to mothers not covered by health insurance. The study found that health insurance coverage was significantly associated with a lower risk of under-five mortality (not covered: AHR=0.13; 95% CI 0.02, 0.95). Other factors that showed significant associations with under-five mortality include place of residency, family size, twin status, place of delivery and preceding birth interval.
Conclusion
The findings indicate that health insurance coverage in Ethiopia is significantly associated with a lower risk of mortality among children under five. However, coverage remains low among mothers of these children, highlighting an urgent need for policies and interventions aimed at expanding health insurance coverage and addressing key determinants of child health to reduce under-five mortality and improve child survival outcomes. Addressing gaps in health insurance and other contributing factors is vital for creating effective strategies to lower under-five mortality rates.
Embedding equity, diversity and inclusion processes within clinical trials and health and social care research
The lack of diverse and inclusive clinical research populations fuels health inequalities in the UK, and there is an urgent need to reverse this. This communication provides a practical framework for positive action to integrate equity, diversity and inclusion (EDI) processes into clinical research design, protocols and implementation and to establish accountable clinical research systems that are trustworthy to the public and accessible to diverse communities.
This framework is a consensus-based guide developed by the Equality, Diversity and Inclusion working group of the National Institute for Health and Care Research’s (NIHR’s) Clinical Research Network in North West London. This work involved analysing challenges to integrating EDI within the clinical research process, such as clinical trial protocols as directed by industry sponsors and National Health Service investigator teams. It aligns with the UK government’s clinical research strategy and NIHR’s INCLUDE project.
It advises an interconnected approach to embedding EDI throughout the clinical research lifecycle. By following this framework, we aspire to guide clinical research towards a more equitable, inclusive and representative model that better serves the needs of all populations.
Factors associated with health literacy in older adults aged 65 and over: a secondary data analysis of the 2021 Korea Health Panel applying the Andersen behavioural model
Objectives
Using the Korea Health Panel 2021 survey data, we identify factors associated with health literacy (HL) among older adults aged 65 years and older.
Design
A secondary data analysis of the 2021 Korea Health Panel survey.
Setting
Korea Health Panel survey.
Participants
Data were from 3410 older adults greater double equals65 years of age, drawn from the 2016 registration census of the Korea Health Panel 2021 survey, with a stratified selection approach for participants.
Outcome measure
To explore the factors associated with HL within the framework of the Andersen behavioural model, considering predisposing factors (age, gender, region and spouse), enabling factors (National Basic Livelihood Security recipient, education level, economic activity, usual source of care) and need factors (subjective health status, usual activities, depression/anxiety and chronic disease).
Analysis
Stepwise multiple regression analysis was employed to examine the factors associated with HL among the study participants within the framework of the Andersen behavioural model.
Results
Statistically significant associations with HL were found for predisposition factors (age, gender and residential area), enabling factors (National Basic Livelihood Security recipient, educational background and usual source of care) and need factors (subjective health status, usual activities and the presence of chronic diseases). While the National Basic Livelihood Security recipient was significant in model 2 (p=0.011), it became nonsignificant in model 3 after adding need factors (p=0.093). Adding enabling factors to model 1 significantly increased the explanatory power (R2=0.084, p
Factors associated with health literacy in older adults aged 65 and over: a secondary data analysis of the 2021 Korea Health Panel applying the Andersen behavioural model
Objectives
Using the Korea Health Panel 2021 survey data, we identify factors associated with health literacy (HL) among older adults aged 65 years and older.
Design
A secondary data analysis of the 2021 Korea Health Panel survey.
Setting
Korea Health Panel survey.
Participants
Data were from 3410 older adults greater double equals65 years of age, drawn from the 2016 registration census of the Korea Health Panel 2021 survey, with a stratified selection approach for participants.
Outcome measure
To explore the factors associated with HL within the framework of the Andersen behavioural model, considering predisposing factors (age, gender, region and spouse), enabling factors (National Basic Livelihood Security recipient, education level, economic activity, usual source of care) and need factors (subjective health status, usual activities, depression/anxiety and chronic disease).
Analysis
Stepwise multiple regression analysis was employed to examine the factors associated with HL among the study participants within the framework of the Andersen behavioural model.
Results
Statistically significant associations with HL were found for predisposition factors (age, gender and residential area), enabling factors (National Basic Livelihood Security recipient, educational background and usual source of care) and need factors (subjective health status, usual activities and the presence of chronic diseases). While the National Basic Livelihood Security recipient was significant in model 2 (p=0.011), it became nonsignificant in model 3 after adding need factors (p=0.093). Adding enabling factors to model 1 significantly increased the explanatory power (R2=0.084, p
Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D): a decentralised feasibility randomised controlled trial delivered across the UK and Canada
Objectives
Assess the feasibility of a mobile health (mHealth)-supported home-delivered physical activity (PA) intervention (MOTIVATE-T2D) in people with recently diagnosed type 2 diabetes (T2D).
Design
Feasibility multicentre, parallel group, randomised controlled trial (RCT).
Setting
Participants were recruited from England and Canada using a decentralised design.
Participants
Adults (40–75 years) recently diagnosed with T2D (5–24 months).
Interventions
Participants were randomised 1:1 to intervention (MOTIVATE-T2D) or active control groups. Participants codesigned 6month- home-delivered, personalised, progressive PA programmes supported by virtual behavioural counselling. MOTIVATE-T2D used biofeedback from wearable technologies to support the programme. The active control group received the same intervention without wearables.
Outcomes
The primary outcomes were recruitment rate, retention and adherence to purposeful exercise. Clinical data on effectiveness were collected as exploratory outcomes at baseline, 6 and 12 months, with HbA1c and systolic blood pressure (BP) proposed as primary outcomes for a future full RCT.
Results
n=135 eligible participants expressed an interest in the trial, resulting in 125 participants randomised (age 55±9 years, 48% female, 81% white), a recruitment rate of 93%. Retention at 12 months was 82%. MOTIVATE-T2D participants were more likely to start (OR 10.4, CI 3.4 to 32.1) and maintain purposeful exercise at 6 (OR 7.1, CI 3.2 to 15.7) and 12 months (OR 2.9, CI 1.2 to 7.4). Exploratory clinical outcomes showed a potential effect in favour of MOTIVATE-T2D, including proposed primary outcomes HbA1c and systolic BP (between-group mean differences: HbA1c: 6 months: –5% change from baseline, CI –10 to 2: 12 months: –2% change from baseline, CI –8 to –4; systolic BP: 6 months: –1 mm Hg, CI –5 to 3: 12 months: –4 mm Hg, CI –8 to 1).
Conclusions
Our findings support the feasibility of delivering the MOTIVATE-T2D mHealth-supported PA intervention for people with recently diagnosed T2D and progression to a full RCT to examine its clinical and cost-effectiveness.
Trial registration number
ISRCTN: 14335124; ClinicalTrials.gov: NCT0465353.
What are the broader impacts and value from a randomised controlled trial conducted in six public hospital antenatal clinics in Australia? An impact assessment using the Framework to Assess the Impact from Translational health research
Objectives
The Breathing for Life Trial (BLT) was a multicentre randomised controlled trial testing the hypothesis that a fractional exhaled nitric oxide-based intervention to guide asthma therapy in pregnancy improves perinatal outcomes. While BLT was negative based on selected outcomes, the conduct of the trial over 7 years showed potential for assessing the broader research impacts and returns on investment in BLT. The aim of this study was to retrospectively assess and report on the impact and value of BLT to show accountability for the research investment in what was deemed a ‘negative’ trial.
Methods
The Framework to Assess the Impact from Translational health research (FAIT) was selected as the preferred method. FAIT combines three validated methods, including a modified Payback framework, an economic analysis of return on investment and a narrative account of the impact generated from the research. Data collection was done via document analysis of BLT administrative and research records and review of relevant websites/databases.
Results
BLT delivered a return on investment of $6.7 million in leveraged grants, fellowships and consultancies and conservatively returned $2.44 for every dollar invested. The research trained and upskilled 18 midwives and obstetricians in evidence-based asthma management in pregnancy and improved research capability of six PhD students. Specialised equipment purchased by BLT is now being repurposed to undertake other research in regional Australia, saving further research investment. Of the 1200 mothers who were part of BLT, 508 now have written asthma plans, 268 had a clinically significant improvement in their asthma control score and the proportion who improved their asthma plan knowledge increased by 58 percentage points from 12 to 70%.
Conclusion
This case example in the developing field of impact assessment illustrates how researchers can use evidence to demonstrate and report more broadly on the impact of and returns on research investment in a clinical trial.
Trial registration number
ACTRN12613000202763; Post results.