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Effectiveness of an anti-inflammatory diet versus low-fat diet for knee osteoarthritis: the FEAST randomised controlled trial protocol

Por: Law · L. · Heerey · J. L. · Devlin · B. L. · Brukner · P. · Kemp · J. L. · Attanayake · A. · Hulett · M. D. · De Livera · A. · Mosler · A. B. · Morris · H. G. · White · N. P. · Culvenor · A. G.
Introduction

Chronic inflammation plays a key role in knee osteoarthritis pathophysiology and increases risk of comorbidities, yet most interventions do not typically target inflammation. Our study will investigate if an anti-inflammatory dietary programme is superior to a standard care low-fat dietary programme for improving knee pain, function and quality-of-life in people with knee osteoarthritis.

Methods and analysis

The eFEct of an Anti-inflammatory diet for knee oSTeoarthritis study is a parallel-group, assessor-blinded, superiority randomised controlled trial. Following baseline assessment, 144 participants aged 45–85 years with symptomatic knee osteoarthritis will be randomly allocated to one of two treatment groups (1:1 ratio). Participants randomised to the anti-inflammatory dietary programme will receive six dietary consultations over 12 weeks (two in-person and four phone/videoconference) and additional educational and behaviour change resources. The consultations and resources emphasise nutrient-dense minimally processed anti-inflammatory foods and discourage proinflammatory processed foods. Participants randomised to the standard care low-fat dietary programme will receive three dietary consultations over 12 weeks (two in-person and one phone/videoconference) consisting of healthy eating advice and education based on the Australian Dietary Guidelines, reflecting usual care in Australia. Adherence will be assessed with 3-day food diaries. Outcomes are assessed at 12 weeks and 6 months. The primary outcome will be change from baseline to 12 weeks in the mean score on four Knee injury and Osteoarthritis Outcome Score (KOOS4) subscales: knee pain, symptoms, function in daily activities and knee-related quality of life. Secondary outcomes include change in individual KOOS subscale scores, patient-perceived improvement, health-related quality of life, body mass and composition using dual-energy X-ray absorptiometry, inflammatory (high-sensitivity C reactive protein, interleukins, tumour necrosis factor-α) and metabolic blood biomarkers (glucose, glycated haemoglobin (HbA1c), insulin, liver function, lipids), lower-limb function and physical activity.

Ethics and dissemination

The study has received ethics approval from La Trobe University Human Ethics Committee. Results will be presented in peer-reviewed journals and at international conferences.

Trial registration number

ACTRN12622000440729.

Association between breast feeding and food consumption according to the degree of processing in Brazil: a cohort study

Background

The benefits of breast feeding may be associated with better formation of eating habits beyond childhood. This study was designed to verify the association between breast feeding and food consumption according to the degree of processing in four Brazilian birth cohorts.

Methods

The duration of exclusive, predominant and total breast feeding was evaluated. The analysis of the energy contribution of fresh or minimally processed foods (FMPF) and ultra-processed foods (UPF) in the diet was evaluated during childhood (13–36 months), adolescence (11–18 years) and adulthood (22, 23 and 30 years).

Results

Those who were predominantly breastfed for less than 4 months had a higher UPF consumption (β 3.14, 95% CI 0.82 to 5.47) and a lower FMPF consumption (β –3.47, 95% CI –5.91 to –1.02) at age 22 years in the 1993 cohort. Exclusive breast feeding (EBF) for less than 6 months was associated with increased UPF consumption (β 1.75, 95% CI 0.25 to 3.24) and reduced FMPF consumption (β –1.49, 95% CI –2.93 to –0.04) at age 11 years in the 2004 cohort. In this same cohort, total breast feeding for less than 12 months was associated with increased UPF consumption (β 1.12, 95% CI 0.24 to 2.19) and decreased FMPF consumption (β –1.13, 95% CI –2 .07 to –0.19). Children who did not receive EBF for 6 months showed an increase in the energy contribution of UPF (β 2.36, 95% CI 0.53 to 4.18) and a decrease in FMPF (β –2.33, 95% CI –4 .19 to –0.48) in the diet at 13–36 months in the 2010 cohort. In this cohort, children who were breastfed for less than 12 months in total had higher UPF consumption (β 2.16, 95% CI 0.81 to 3.51) and lower FMPF consumption (β –1.79, 95% CI –3.09 to –0.48).

Conclusion

Exposure to breast feeding is associated with lower UPF consumption and higher FMPF consumption in childhood, adolescence and adulthood.

Coutilisation of oral rehydration solution and zinc for treating diarrhoea and its associated factors among under-five children in East Africa: a multilevel robust Poisson regression

Por: Legesse · B. T. · Wondie · W. T. · Gedefaw · G. D. · Workineh · Y. T. · Seifu · B. L.
Objective

This study aimed to assess the coutilisation of oral rehydration solution (ORS) and zinc for treating diarrhoea and its associated factors among under-5 children in East Africa.

Design

Cross-sectional study design. Multilevel Poisson regression analysis with robust variance was fitted to identify predictors of zinc and ORS coutilisation. An adjusted prevalence ratio (aPR) with a 95% CI was reported to declare the statistical significance.

Setting

Twelve East African countries.

Participants

16 850 under-5 children who had diarrhoea were included in the study.

Result

In East African nations, the coutilisation of ORS and zinc for the treatment of diarrhoea in children under 5 was 53.27% with a 95% CI (52.54% to 54.01%). Children of mothers with primary education (aPR 1.15, 95% CI 1.09 to 1.20), secondary education (aPR 1.08, 95% CI 1.02 to 1.14), higer education (aPR 1.19, 95% CI 1.10 to 1.29), those from maternal age category of 20–24 (aPR 1.14, 95% CI 1.07 to 1.21), age category of 25–29 (aPR 1.13, 95% CI 1.06 to 1.21), age category of 30–34 (aPR 1.09, 95% CI 1.02 to 1.16), those from wealthy households (aPR 1.04, 95% CI 1.01 to 1.09) and those who have a media exposure (aPR 1.04, 95% CI 1.01 to 1.08) were more likely to receive combination.

Conclusion

Only half of the under-5 children with diarrhoea in East Africa were treated with a combination of ORS and zinc. To increase the use of the suggested combination therapy of ORS with zinc, it is important to empower women through education and prevent teen pregnancy.

Double burden of malnutrition and associated factors among women of reproductive age in sub-Saharan Africa: a multilevel multinomial logistic regression analysis

Por: Seifu · B. L. · Mare · K. U. · Legesse · B. T. · Tebeje · T. M.
Background

Globally, malnutrition among women of reproductive age is on the rise and significantly contributing to non-communicable disease, deaths and disability. Even though the double burden of malnutrition (DBM) is a common problem among women in sub-Saharan Africa (SSA), there are limited studies examining the factors contributing to underweight, overweight, and obesity at the SSA level.

Objective

To determine the factors associated with the DBM, and their relative magnitude, among women of reproductive age in SSA.

Design

Cross-sectional study design.

Setting

33 SSA countries.

Participants

240 414 women of reproductive age.

Primary and secondary outcome measures

A multilevel multinomial logistic regression model was applied to identify factors associated with malnutrition. The adjusted relative risk ratio with 95% CI was used to declare the statistical significance of the association.

Results

The pooled prevalence of underweight, overweight and obesity among women in SSA were 8.87%, 16.47% and 6.10%, respectively. Women who are from rural residence and smoke cigarettes were more likely to be underweight. Conversely, women between the age of 24–34 and 35–49, who have higher education, belong to a middle and rich household, are ever married, have high parity, use contraceptives, have media exposure and smoke cigarettes were more likely to be overweight and/or obese.

Conclusion

The findings of our study suggest that certain factors such as residence, education status, wealth, marital status, occupation, cigarette smoking, and contraceptive use have a significant assocation with malnutrition among women. Therefore, it is important for public health programs aimed at preventing the double burden of malnutrition to focus on these factors through comprehensive public awareness and cost-effective operational health interventions.

Evaluation of an outreach programme for patients with COVID-19 in an integrated healthcare delivery system: a retrospective cohort study

Por: Myers · L. C. · Lawson · B. L. · Escobar · G. J. · Daly · K. A. · Chen · Y.-f. I. · Dlott · R. · Lee · C. · Liu · V.
Objectives

In the first year of the COVID-19 pandemic, health systems implemented programmes to manage outpatients with COVID-19. The goal was to expedite patients’ referral to acute care and prevent overcrowding of medical centres. We sought to evaluate the impact of such a programme, the COVID-19 Home Care Team (CHCT) programme.

Design

Retrospective cohort.

Setting

Kaiser Permanente Northern California.

Participants

Adult members before COVID-19 vaccine availability (1 February 2020–31 January 2021) with positive SARS-CoV-2 tests.

Intervention

Virtual programme to track and treat patients with ‘CHCT programme’.

Outcomes

The outcomes were (1) COVID-19-related emergency department visit, (2) COVID-19-related hospitalisation and (3) inpatient mortality or 30-day hospice referral.

Measures

We estimated the average effect comparing patients who were and were not treated by CHCT. We estimated propensity scores using an ensemble super learner (random forest, XGBoost, generalised additive model and multivariate adaptive regression splines) and augmented inverse probability weighting.

Results

There were 98 585 patients with COVID-19. The majority were followed by CHCT (n=80 067, 81.2%). Patients followed by CHCT were older (mean age 43.9 vs 41.6 years, p

Conclusions

Despite CHCT following older patients with higher comorbidity burden, there appeared to be a protective effect. Patients followed by CHCT were more likely to present to acute care and less likely to die inpatient.

Characteristics of patients attached to near-retirement family physicians: a population-based serial cross-sectional study in Ontario, Canada

Por: Premji · K. · Green · M. E. · Glazier · R. H. · Khan · S. · Schultz · S. E. · Mathews · M. · Nastos · S. · Frymire · E. · Ryan · B. L.
Objectives

Population ageing is a global phenomenon. Resultant healthcare workforce shortages are anticipated. To ensure access to comprehensive primary care, which correlates with improved health outcomes, equity and costs, data to inform workforce planning are urgently needed. We examined the medical and social characteristics of patients attached to near-retirement comprehensive primary care physicians over time and explored the early-career and mid-career workforce’s capacity to absorb these patients.

Design

A serial cross-sectional population-based analysis using health administrative data.

Setting

Ontario, Canada, where most comprehensive primary care is delivered by family physicians (FPs) under universal insurance.

Participants

All insured Ontario residents at three time points: 2008 (12 936 360), 2013 (13 447 365) and 2019 (14 388 566) and all Ontario physicians who billed primary care services (2008: 11 566; 2013: 12 693; 2019: 15 054).

Outcome measures

The number, proportion and health and social characteristics of patients attached to near-retirement age comprehensive FPs over time; the number, proportion and characteristics of near-retirement age comprehensive FPs over time. Secondary outcome measures: The characteristics of patients and their early-career and mid-career comprehensive FPs.

Results

Patient attachment to comprehensive FPs increased over time. The overall FP workforce grew, but the proportion practicing comprehensiveness declined (2008: 77.2%, 2019: 70.7%). Over time, an increasing proportion of the comprehensive FP workforce was near retirement age. Correspondingly, an increasing proportion of patients were attached to near-retirement physicians. By 2019, 13.9% of comprehensive FPs were 65 years or older, corresponding to 1 695 126 (14.8%) patients. Mean patient age increased, and all physicians served markedly increasing numbers of medically and socially complex patients.

Conclusions

The primary care sector faces capacity challenges as both patients and physicians age and fewer physicians practice comprehensiveness. Nearly 15% (1.7 million) of Ontarians may lose their comprehensive FP to retirement between 2019 and 2025. To serve a growing, increasingly complex population, innovative solutions are needed.

Optimising scale-up for public health impact: a multimethod implementation science research protocol to improve infant health outcomes in Ethiopia

Por: Hakizimana · D. · Shitu · K. · Rankin · K. C. · Alemie · G. A. · Walson · J. · Guthrie · B. L. · Means · A. R.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Protocol of a randomised trial of teriparatide followed by zoledronic acid to reduce fracture risk in adults with osteogenesis imperfecta

Por: Hald · J. D. · Keerie · C. · Weir · C. J. · Javaid · M. K. · Lam · W. · Osborne · P. · Walsh · J. · Langdahl · B. L. · Ralston · S. H.
Introduction

Osteogenesis imperfecta (OI) is a rare genetic disease associated with multiple fractures throughout life. It is often treated with osteoporosis medications but their effectiveness at preventing fractures is unknown. The Treatment of Osteogenesis Imperfecta with Parathyroid Hormone and Zoledronic Acid trial will determine if therapy with teriparatide (TPTD) followed by zoledronic acid (ZA) can reduce the risk of clinical fractures in OI.

Methods and analysis

Individuals aged ≥18 years with a clinical diagnosis of OI are eligible to take part. At baseline, participants will undergo a spine X-ray, and have bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA) at the spine and hip. Information on previous fractures and previous bone targeted treatments will be collected. Questionnaires will be completed to assess pain and other aspects of health-related quality of life (HRQoL). Participants will be randomised to receive a 2-year course of TPTD injections 20 µg daily followed by a single intravenous infusion of 5 mg ZA, or to receive standard care, which will exclude the use of bone anabolic drugs. Participants will be followed up annually, have a repeat DXA at 2 years and at the end of study. Spine X-rays will be repeated at the end of study. The duration of follow-up will range between 2 and 8 years. The primary endpoint will be new clinical fractures confirmed by X-ray or other imaging. Secondary endpoints will include participant reported fractures, BMD and changes in pain and HRQoL.

Ethics and dissemination

The study received ethical approval in December 2016. Following completion of the trial, a manuscript will be submitted to a peer-reviewed journal. The results will inform clinical practice by determining if TPTD/ZA can reduce the risk of fractures in OI compared with standard care.

Trial registration number

ISRCTN15313991.

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