Risultati per: Studio REDUCE-IT e appropriatezza prescrittiva degli acidi grassi omega-3

Objectives
To assess the feasibility of conducting a randomised placebo-controlled trial of corticosteroids prior to planned caesarean section from 35+0 to 39+6 weeks.

Design
A triple-blind, placebo-controlled, parallel, trial randomised at the participant level (1:1 ratio). Additional feasibility data obtained by questionnaires from trial participants and women who declined trial participation, and focus groups with local site researchers and clinicians.

Setting
Three obstetric units in New Zealand including tertiary and secondary care; public and private care, and research active and non-active units.

Participants
Women undergoing a planned caesarean section from 35+0 to 39+6 weeks; local site researchers and clinicians.

Interventions
Two doses of 11.4 mg betamethasone or saline placebo. Questionnaires and focus group meetings.

Primary and secondary outcome measures
Primary outcome: trial recruitment rate of eligible women. Secondary outcomes: trial recruitment by gestational age, site and delivery indication; proportion of babies who completed measurements of blood glucose concentrations as per protocol; overall incidence neonatal respiratory distress requiring >60 min of respiratory support; overall incidence of neonatal hypoglycaemia, and barriers and enablers to trial participation by participants, researchers and clinicians.

Results
The recruitment rate was 8.9% (88/987) overall and 11.2% (88/789) for those approached about the trial. Neonatal blood glucose concentrations were measured as per protocol in 87/92 (94.6%) babies. For potential participants, key enablers to participation were contributing to research, a feeling of relevance and a good understanding; key barriers were a lack of understanding and concerns over safety. For researchers and clinicians, themes representing enablers and barriers included relevance, communication and awareness, influences on women’s decision-making, resource challenges and trial process practicalities.

Conclusions
Some women are willing to participate in a randomised placebo-controlled trial of corticosteroids prior to a planned caesarean section birth at late preterm and term gestations. Participation in such a trial can be enhanced.

Introduction
The aim of this randomised feasibility trial is to determine the feasibility of conducting an adequately powered randomised controlled trial (RCT) investigating the efficacy of prefabricated contoured foot orthoses in people with hip osteoarthritis (OA). The secondary aims of the trial are to compare the effect of prefabricated contoured foot orthoses to a flat shoe insert comparator on outcomes of hip-related pain, physical activity and quality of life. We hypothesise that the demand, implementation, acceptability and practicality of foot orthoses as a treatment option for people with hip OA will be deemed feasible, informing the development of an adequately powered RCT to evaluate the efficacy and long term outcomes.

Methods and analysis
We will recruit 28 people with hip OA who will be randomised to receive either prefabricated contoured foot orthoses or flat shoe inserts to use for a 6-week period. Both groups will receive standardised education on hip OA and physical activity. The study’s primary outcome is the feasibility domains of demand, implementation, acceptability and practicality. The secondary outcomes include the change in Hip Osteoarthritis Outcome Score-12, Patient Health Questionnaire-9, Brief Fear of Movement Scale for OA, Physical activity accelerometry and the Physical Activity Questionnaire-short form. Descriptive statistics will be used to describe feasibility outcomes with limited efficacy analysis used for the secondary outcomes. Linear mixed models will be used to analyse between-group differences at 6 weeks, with baseline values used as covariates, treatment allocation as a fixed factor and participant as a random factor.

Ethics and dissemination
This trial has been approved by the La Trobe University Human Research Ethics Committee (HEC20427), St. Vincent’s Hospital Melbourne, Human Research Ethics Committee (HREC 266/20) and Northern Health Research Governance (NH-2021-292862). The results will be disseminated via a peer-reviewed journal and presented at international conferences.

Trial registration number
NCT05138380.

Health Care Policy

Racial and ethnic disparities in kidney disease care are well documented. These inequities are particularly stark for Black individuals, who have a 2-fold to 4-fold higher prevalence of kidney failure, less access to predialysis nephrology care and kidney transplants, and higher risk of kidney disease–related death than White individuals. Adding to this research, Butler et al examined racial differences in “unmet existential and supportive care needs” in a cross-sectional survey of 948 Asian American or Native Hawaiian or Pacific Islander, Black or African American, and White individuals who were receiving dialysis at 31 facilities in Seattle, Washington, and Nashville, Tennessee, between 2015 and 2018. In adjusted analyses, compared with White individuals, Asian American or Native Hawaiian or Pacific Islander and Black individuals were more likely to want to learn what to do about pain and symptoms of kidney disease and to want someone to talk to about the meaning of life. Black individuals were also more likely to want to talk about care plans, treatments, and future treatment options.

Introduction
Stillbirth continues to be a public health concern in high-income countries, and with mixed results from several stillbirth prevention interventions worldwide the need for an effective prevention method is ever present. The Safer Baby Bundle (SBB) proposes five evidence-based care packages shown to reduce stillbirth when implemented individually, and therefore are anticipated to produce significantly better outcomes if grouped together. This protocol describes the planned economic evaluation of the SBB quality improvement initiative in Australia.

Methods and analysis
The implementation of the SBB will occur over three state-based health jurisdictions in Australia—New South Wales, Queensland and Victoria, from July 2019 onwards. The intervention is being applied at the state level, with sites opting to participate or not, and no individual woman recruitment. The economic evaluation will be based on a whole-of-population linked administrative dataset, which will include the data of all mothers, and their resultant children, who gave birth between 1 January 2016 and 31 December 2023 in these states, covering the preimplementation and postimplementation time period. The primary health outcome for this economic evaluation is late gestation stillbirths, with the secondary outcomes including but not limited to neonatal death, gestation at birth, mode of birth, admission to special care nursery and neonatal intensive care unit, and physical and mental health conditions for mother and child. Costs associated with all healthcare use from birth to 5 years post partum will be included for all women and children. A cost-effectiveness analysis will be undertaken using a difference-in-difference analysis approach to compare the primary outcome (late gestation stillbirth) and total costs for women before and after the implementation of the bundle.

Ethics and dissemination
Ethics approval for the SBB project was provided by the Royal Brisbane & Women’s Hospital Human Research Ethics Committee (approval number: HREC/2019/QRBW/47709). Approval for the extraction of data to be used for the economic evaluation was granted by the New South Wales Population and Health Services Research Ethics Committee (approval number: 2020/ETH00684/2020.11), Australian Institute of Health and Welfare Human Research Ethics Committee (approval number: EO2020/4/1167), and Public Health Approval (approval number: PHA 20.00684) was also granted. Dissemination will occur via publication in peer reviewed journals, presentation at clinical and policy-focused conferences and meetings, and through the authors’ clinical and policy networks.
This study will provide evidence around the cost effectiveness of a quality improvement initiative to prevent stillbirth, identifying the impact on health service use during pregnancy and long-term health service use of children.

Introduction
Research on public health interventions to improve hypertension care and control in low-income and middle-income countries remains scarce. This study aims to evaluate the effectiveness and assess the process and fidelity of implementation of a multi-component intervention to reduce the gaps in hypertension care and control at a population level in low-income communes of Medellin, Colombia.

Methods and analysis
A multi-component intervention was designed based on international guidelines, cross-sectional population survey results and consultation with the community and institutional stakeholders. Three main intervention components integrate activities related to (1) health services redesign, (2) clinical staff training and (3) patient and community engagement. The effectiveness of the intervention will be evaluated in a controlled before-after quasi-experimental study, with two deprived communes of the city selected as intervention and control arms. We will conduct a baseline and an endline survey 2 years after the start of the intervention. The primary outcomes will be the gaps in hypertension diagnosis, treatment, follow-up and control. Effectiveness will be evaluated with the difference-in-difference measures. Generalised estimation equation models will be fitted considering the clustered nature of data and adjusting for potential confounding variables. The implementation process will be studied with mixed methods. Implementation fidelity will be documented to assess to which degree the intervention components were implemented as intended.

Ethics and dissemination
The study protocol has been approved by the Ethics Research Committee of Metrosalud in Colombia (reference 1400/5.2), the Medical Ethics Committee of the Antwerp University Hospital (reference 18/40/424) and the Institutional Review Board of the Antwerp Institute of Tropical Medicine (reference 1294/19). We will share and discuss the study results with the community, institutional stakeholders and national health policymakers. We will publish them in national and international peer-reviewed scientific journals.

Trial registration number
NCT05011838.

Introduction
Family caregivers play a key role in providing ongoing long-term care and assistance to their loved ones during cancer treatment. However, family caregivers of patients with lung cancer are frequently unprepared for their roles and they may undergo psychological distress, thus reducing their own quality of life while affecting patients’ health outcomes. Interventions that specifically target this population are lacking. This study aims to evaluate the effectiveness of a perioperative support programme on family caregivers of patients with early-stage lung cancer.

Methods and analysis
This study is guided by the Stress-Coping Model. Family caregivers of patients diagnosed with early-stage lung cancer and those who are scheduled for lung resection treatment will be invited to participate. Participants will be randomised to groups that either receive the perioperative support programme or usual care. The intervention consists of four face-to-face intervention sessions during the hospital stay and two weekly telephone follow-up sessions after discharge. Primary and secondary outcomes will be assessed at baseline and at 4 and 12 weeks after the intervention. Primary outcomes will include psychological distress and secondary outcomes will include caregiving burden, quality of life, coping style and social support. Generalised estimation equation model will be used to analyse the intervention effects.

Ethics and dissemination
The study was approved by the Ethics Committee of the Second Xiangya Hospital of Central South University (LYG2022003). The authors will disseminate the study’s findings by publishing them in international scientific journals.

Trial registration number
ChiCTR2200058280.

Background
The minimum clinically effective dose, and whether this is received in randomised controlled trials (RCTs) of complex self-management interventions in long-term conditions (LTCs), can be unclear. The Template for Intervention Description and Replication (TIDieR) checklist states that dose should be clearly reported to ensure validity and reliable implementation.

Objectives
To identify whether the expected minimum clinically effective dose, and the dose participants received is reported within research articles and if reporting has improved since the TIDieR checklist was published.

Methods
Four databases were systematically searched (MEDLINE, PsycINFO, AMED and CINAHL) to identify published reports between 2008 and 2022 for RCTs investigating complex self-management interventions in LTCs. Data on reporting of dose were extracted and synthesised from the eligible articles.

Results
94 articles covering various LTCs including diabetes, stroke and arthritis were included. Most complex interventions involved behaviour change combined with education and/or exercise. The maximum dose was usually reported (n=90; 97.8%), but the expected minimum clinically effective dose and the dose received were reported in only 28 (30.4%) and 62 (67.4%) articles, respectively. Reporting of the expected minimum clinically effective dose and the dose participants received did not improve following the publication of the TIDieR checklist in 2014.

Conclusions
Interpreting results and implementing effective complex self-management interventions is difficult when researchers’ reporting of dose is not in line with guidelines. If trial findings indicate benefit from the intervention, clear reporting of dose ensures reliable implementation to standard care. If the results are non-significant, detailed reporting enables better interpretation of results, that is, differentiating between poor implementation and lack of effectiveness. This ensures quality of interventions and validity and generalisability of trial findings. Therefore, wider adoption of reporting the TIDieR checklist dose aspects is strongly recommended. Alternatively, customised guidelines for reporting dose in complex self-management interventions could be developed.

PROSPERO registration number
CRD42020180988.

A commercially available online decision aid appeared to reduce conflict and improve knowledge about driving.

Objectives
To explore patients’ experiences of getting a diagnosis of eye disease, the psychological impact of this and how this could be improved.

Design
An exploratory qualitative interview study using a narrative approach and inductive methods.

Setting
This study was conducted with patients who had attended ophthalmic appointments in primary and secondary care and in opticians located in the South of England.

Participants
18 people diagnosed with eye disease in England.

Results
Four themes were identified: the convoluted process of being diagnosed, the impact of clinicians’ words, the search for information and reflections on what could be improved. The prolonged wait for a definitive diagnosis was a source of frustration and anxiety for many patients. Professionals’ words and tone when delivering a diagnosis sometimes affected a patient’s view of their diagnosis and their later ability to come to terms with it. Patients were desperate for information, but many felt they were not provided with sufficient information at the time of diagnosis and did not know whether to trust information found online. Participants felt the provision of a hospital liaison service and/or counselling could mitigate the impact on patients and families.

Conclusions
Interactions with clinicians can have a lasting impact on how a diagnosis is experienced and how well the patient is able to come to terms with their visual impairment. Receiving little or no information left patients feeling lost and unsupported. This led them to search for information from less reliable sources. Clinicians should consider how they communicate a diagnosis to patients, how and when they offer information about diagnosis and prognosis and where possible signpost patients to additional support systems and counselling services as early as possible.

Objective
Over 160 000 participants per year complete the 12-item Oxford Hip and Knee Scores (OHS/OKS) as part of the NHS England Patient-Reported Outcome Measures (PROMs) programme. We used a modern computational approach, known as computerised adaptive testing (CAT), to simulate individually tailored OHS and OKS assessment, with the goal of reducing the number of questions a patient must complete without compromising measurement accuracy.

Methods
We fit the 2018/2019 PROMs data to an item response theory (IRT) model. We assessed IRT model assumptions alongside reliability. We used parameters from the IRT model with data from 2017/2018 to simulate CAT assessments. Two simulations were run until a prespecified SE of measurement was met (SE=0.32 and SE=0.45). We compared the number of questions required to meet each cut-off and assessed the correlation between the full-length and CAT administration.

Results
We conducted IRT analysis using 40 432 OHS and 44 714 OKS observations. The OHS and OKS were both unidimensional (root mean square error of approximation 0.08 and 0.07, respectively) and marginal reliability 0.91 and 0.90. The CAT, with a precision limit of SE=0.32 and SE=0.45, required a median of four items (IQR 1) and two items (IQR 1), respectively, for the OHS, and median of four items (IQR 2) and two items (IQR 0) for the OKS. This represents a potential 82% reduction in PROM length. In the context of 160 000 yearly assessments, these methodologies could result in the omission of some 1 280 000 redundant questions per year, which equates to 40 000 hours of patient time.

Conclusion
The application of IRT to the OHS and OKS produces an efficient and substantially reduced CAT. We have demonstrated a path to reduce the burden and potentially increase the compliance for these ubiquitous outcome measures without compromising measurement accuracy.

Objective
There is an abundance of evidence illuminating the factors that contribute to disrespectful maternity care in sub-Saharan Africa. However, there is limited documented evidence on how some of the key influences on the mistreatment of women could be addressed. We aimed to document the perspectives of nurses and other healthcare workers on existing and potential strategies embedded at the health facility level to promote respectful delivery of healthcare for women during delivery and on what interventions are needed to promote respectful and equitable treatment of women receiving maternity care in rural Kenya.

Design, setting and participants
We analysed relevant data from a qualitative study based on in-depth interviews with 24 healthcare workers conducted between January and March 2020, at health facilities in rural Kilifi and Kisii counties, Kenya. The facilities had participated in a project (AQCESS) to reduce maternal and child mortality and morbidity by improving the availability and the use of essential reproductive maternal and neonatal child health services. The participants were mostly nurses but included five non-nurse healthcare workers. We analysed data using NVivo V.12, guided by a reflective thematic analysis approach.

Results
Healthcare workers identified four interconnected areas that were associated with improving respectful delivery of care to women and their newborns. These include continuous training on the components of respectful maternity care through mentorships, seminars and organised training; gender-responsive services and workspaces; improved staffing levels; and adequate equipment and supplies for care.

Conclusions
These findings demonstrate some of the solutions, from the perspectives of healthcare workers, that could be implemented to improve the care that women receive during pregnancy, labour and delivery. The issues raised by healthcare workers are common in sub-Saharan African countries, indicating the need to create awareness at the policy level to highlight the challenges identified, potential solutions, and application or implementation in different contexts.

Objective
To perform an economic evaluation of tranexamic acid (TXA) versus no-TXA, in addition to current clinical practice, for acute gastrointestinal bleeding, using the results of the HALT-IT trial (NCT01658124), a large randomised controlled trial which included 11 937 patients.

Design
A cost-effectiveness modelling analysis, performed over a lifetime time horizon.

Setting
The analysis was performed from a UK health service perspective.

Participants
The model includes adults with acute gastrointestinal bleeding.

Outcomes measures
The model reports costs in Great British pounds in 2021 and outcomes as life years (LYs) and quality-adjusted life years (QALYs). Cost-effectiveness was evaluated using incremental cost-effectiveness ratios (ICERs), reported as the cost per QALY gained.

Methods
A Markov model was developed to calculate the overall costs and health outcomes of TXA administration versus no-TXA. The model used data of the treatment effectiveness from the HALT-IT trial, which showed that TXA administration for acute gastrointestinal bleeding did not reduce all-cause mortality (risk ratio 1.03, 95% CI 0.92 to 1.16) compared with no-TXA. Data on health-related quality of life, costs and long-term mortality risks were derived from the literature. Costs and effects are discounted at 3.5% per annum.

Results
TXA was associated with marginally fewer LYs and QALYs, and lower costs, than treatment without TXA. The ICER associated with no-TXA was £1576 per LY gained and £2209 per QALY gained. No-TXA was 64% likely to be cost-effective at a £20 000 willingness-to-pay threshold, while TXA was 36% likely to be cost-effective.

Conclusion
Though inexpensive, TXA administration for patients with acute gastrointestinal bleeding is unlikely to be cost-effective.

Objectives
Patients with inflammatory arthritis report that fatigue is challenging to manage. We developed a manualised, one-to-one, cognitive–behavioural intervention, delivered by rheumatology health professionals (RHPs). The Fatigue – Reducing its Effects through individualised support Episodes in Inflammatory Arthritis (FREE-IA) study tested the feasibility of RHP training, intervention delivery and outcome collection ahead of a potential trial of clinical and cost-effectiveness.

Methods
In this single-arm feasibility study, eligible patients were ≥18 years, had a clinician-confirmed diagnosis of an inflammatory arthritis and scored ≥6/10 on the Bristol Rheumatoid Arthritis Fatigue (BRAF) Numerical Rating Scale (NRS) Fatigue Effect. Following training, RHPs delivered two to four sessions to participants. Baseline data were collected before the first session (T0) and outcomes at 6 weeks (T1) and 6 months (T2). The proposed primary outcome was fatigue impact (BRAF NRS Fatigue Effect). Secondary outcomes included fatigue severity and coping, disease impact and disability, and measures of therapeutic mechanism (self-efficacy and confidence to manage health).

Results
Eight RHPs at five hospitals delivered 113 sessions to 46 participants. Of a potential 138 primary and secondary outcome responses at T0, T1 and T2, there were 13 (9.4%) and 27 (19.6%) missing primary and secondary outcome responses, respectively. Results indicated improvements in all measures except disability, at either T1 or T2, or both.

Conclusions
This study showed it was feasible to deliver the intervention, including training RHPs, and recruit and follow-up participants with high retention. While there was no control group, observed within-group improvements suggest potential promise of the intervention and support for a definitive trial to test effectiveness.

Objectives
To evaluate digital, multimedia information (MMI) for its effects on trial recruitment, retention, decisions about participation and acceptability by patients, compared with printed information.

Design
Study Within A Trial using random cluster allocation within the Forearm Fracture Recovery in Children Evaluation (FORCE) study.

Setting
Emergency departments in 23 UK hospitals.

Participants
1409 children aged 4–16 years attending with a torus (buckle) fracture, and their parents/guardian. Children’s mean age was 9.2 years, 41.0% were female, 77.4% were ethnically White and 90.0% spoke English as a first language.

Interventions
Participants and their parents/guardian received trial information either via multimedia, including animated videos, talking head videos and text (revised for readability and age appropriateness when needed) on tablet computer (MMI group; n=681), or printed participant information sheet (PIS group; n=728).

Outcome measures
Primary outcome was recruitment rate to FORCE. Secondary outcomes were Decision-Making Questionnaire (nine Likert items, analysed summatively and individually), three ‘free text’ questions (deriving subjective evaluations) and trial retention.

Results
MMI produced a small, not statistically significant increase in recruitment: 475 (69.8%) participants were recruited from the MMI group; 484 (66.5%) from the PIS group (OR=1.35; 95% CI 0.76 to 2.40, p=0.31). A total of 324 (23.0%) questionnaires were returned and analysed. There was no difference in total Decision-Making Questionnaire scores: adjusted mean difference 0.05 (95% CI –1.23 to 1.32, p=0.94). The MMI group was more likely to report the information ‘very easy’ to understand (89; 57.8% vs 67; 39.4%; Z=2.60, p=0.01) and identify information that was explained well (96; 62.3% vs 71; 41.8%). Almost all FORCE recruits were retained at the 6 weeks’ timepoint and there was no difference in retention rate between the information groups: MMI (473; 99.6%); PIS (481; 99.4%).

Conclusions
MMI did not increase recruitment or retention in the FORCE trial, but participants rated multimedia as easier to understand and were more likely to evaluate it positively.

Trial registration number
ISRCTN73136092 and ISRCTN13955395.

Objective
There are numerous studies reporting a disproportionally high prevalence of thrombophilia in women with a history of recurrent miscarriage (RM), which has led to overdiagnosis and treatment without an improvement in clinical outcomes. The objective of our study was to assess the prevalence of inherited and acquired thrombophilia in a large cohort of women with a history of early RM using internationally agreed diagnostic criteria and inclusion parameters and compare it to the meta-analysis results of existing literature.

Methods

Design
Retrospective cohort study and systematic review of literature.

Setting
This is a retrospective cohort study set-up in two dedicated tertiary centres for women with RM in Southwest London and Surrey. We reviewed all the available literature related to causes of RMs. We ascertained the prevalence of thrombophilia in the study population and compared it with historical and published prevalence in the general population.

Participants
1155 women between 2012 and 2017. All patients had three or more first trimester miscarriages and a full thrombophilia screen.

Results
The overall prevalence of thrombophilia in our study population is 9.2% (106/1155) with 8.1% (94/1155) of cases positive for inherited thrombophilia, which is similar to the general population; Factor V Leiden (4.9%; 57/1155) and prothrombin gene mutation (2.9%; 34/1155) were the most common inherited thrombophilias, while only 1% (12/1155) tested positive for acquired thrombophilia. Persistent positive lupus anticoagulant (LA) was found in 0.5% (6/1155) and persistent positive anticardiolipin (ACL) antibodies with a value ≥40 U/mL was found in 0.5% (6/1155) of patients. Tests for LA/ACL were performed a minimum of 12 weeks apart thus meeting the revised Sapporo criteria for a diagnosis of antiphospholipid syndrome.

Conclusion
The findings of our study demonstrate that the prevalence of inherited thrombophilia is similar in women with RM to that in the general population. Similarly, the prevalence of acquired thrombophilia, using the revised Sapporo criteria, in the cohort of RMs is similar to that in the general population. Therefore, we do not recommend investigation or treatment of inherited or acquired thrombophilia in women with RM.

PROSPERO registration number
CRD42020223554.