Risultati per: Cardio-oncology: rivista open access

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This cross-sectional study characterizes the distribution of centers offering fertility preservation services in the US and quantifies the number of self-identified reproductive-age female individuals living outside of geographically accessible areas.

Objectives
Using the ‘Four Delay’ framework, our study aimed to identify and explore barriers to accessing quality injury care from the injured patients’, caregivers’ and community leaders’ perspectives.

Design
A qualitative study assessing barriers to trauma care comprising 20 in-depth semistructured interviews and 4 focus group discussions was conducted. The data were analysed thematically.

Setting
This qualitative study was conducted in Rwanda’s rural Burera District, located in the Northern Province, and in Kigali City, the country’s urban capital, to capture both the rural and urban population’s experiences of being injured.

Participants
Purposively selected participants were individuals from urban and rural communities who had accessed injury care in the previous 6 months or cared for the injured people, and community leaders. Fifty-one participants, 13 females and 38 males ranging from 21 to 68 years of age participated in interviews and focus group discussions. Thirty-six (71%) were former trauma patients with a wide range of injuries including fractured long bones (9, 45%), other fractures, head injury, polytrauma (3, 15% each), abdominal trauma (1, 5%), and lacerations (1, 5%), while the rest were caregivers and community leaders.

Results
Multiple barriers were identified cutting across all levels of the ‘Four Delays’ framework, including barriers to seeking, reaching, receiving and remaining in care. Key barriers mentioned by participants in both interviews and focus group discussions were: lack of community health insurance, limited access to ambulances, insufficient number of trauma care specialists and a high volume of trauma patients. The rigid referral process and lack of decentralised rehabilitation services were also identified as significant barriers to accessing quality care for injured patients.

Conclusions
Future interventions to improve access to injury care in Rwanda must be informed by the identified barriers along the spectrum of care, from the point of injury to receipt of care and rehabilitation.

Introduction
Psoriatic arthritis (PsA) affects around 150 000 people in the UK of whom around 50% require treatment with biologics. The most used biologics for PsA target tumour necrosis factor (TNF) or interleukin-17A (IL-17A). About 50% of patients respond to each, but it is not currently possible to predict response for individual patients, necessitating sequential treatment steps. A recent proof of concept study in PsA suggested that using peripheral immunophenotype to choose therapy could improve time to treatment response.
This study will test the hypothesis, within an open-label parallel-group biomarker-stratified multicentre randomised controlled trial, which the baseline proportion of CD4+T cells with an activated type 17 immunophenotype (Th17 levels) predicts response to IL-17A or TNF inhibitors in PsA. Additional analyses will identify if the model can be refined by combining additional clinical and immunophenotypic factors. Statistical modelling will be used to predict the likely effectiveness of these approaches compared with standard care.

Methods and analysis
Patients with PsA eligible to start their first biologic as part of standard care are recruited and baseline blood tests are taken for immunophenotyping. Participants are stratified equally by Th17 levels and randomised 1:1 to receive either TNF (adalimumab) or IL-17A (secukinumab) inhibitors. The primary analysis will establish the interaction between baseline immunophenotype and treatment on the primary outcome (achievement of minimal disease activity criteria at week 24). In secondary analysis, modelling will identify if this prediction model can be optimised further by incorporating clinical phenotypes and additional immunophenotyping techniques.

Ethics and dissemination
Ethical approval for the study was granted by the North West Preston Research Ethics Committee (ref 21/NW/0016). Dissemination will be via conference presentations and peer-reviewed publications, aiming to impact on treatment guidelines.

Trial registration number
ISRCTN17228602.

Introduction
On average, people with disabilities face many difficulties in accessing healthcare and experience worse health outcomes. Yet, evidence on how to overcome these barriers is lacking. Participatory approaches are gaining prominence as they can generate low-cost, appropriate and scalable solutions. This study protocol is for the pilot testing of the co-created Participatory Learning and Action for Disability (PLA-D) groups to assess feasibility.

Methods and analysis
We will pilot test PLA-D in five groups in Luuka district, Uganda during 2023. Each group will include approximately 20 members (people with disabilities, family members, carers) who will meet every 2–3 weeks over a 9–11 month period. The groups, guided by a trained facilitator, will identify issues about health and healthcare access and plan and implement locally generated solutions (eg, raising awareness of rights, advocacy and lobbying, establishing health savings and financing schemes). We will collect diverse sources of data to assess feasibility: (1) in-depth interviews and focus group discussions with group participants, non-participants and group facilitators; (2) monitoring of group activities; (3) direct observation of groups and (4) quantitative survey of group participants at baseline and endline. Data analyses will be undertaken to assess feasibility in terms of: acceptability, demand, implementation and practicality. We will develop and refine evaluation tools in preparation for a future trial.

Ethics and dissemination
Ethical approval for the study has been received by the London School of Hygiene & Tropical Medicine and the Uganda Virus Research Institute ethics committees. Informed consent will be obtained from all study participants, making adaptations for people with disabilities as necessary. We will reach different groups for our dissemination activities, including (1) people with disabilities (eg, community meetings); (2) policy and programme stakeholders in Uganda and international (eg, individual meetings, evidence briefs) and (3) academics (journal articles, conference/seminar presentations).

Introduction
Modern systemic treatment has reduced incidence of regional recurrences and improved survival in breast cancer (BC). It is thus questionable whether regional radiotherapy (RT) is still beneficial in patients with sentinel lymph node (SLN) macrometastasis. Postoperative regional RT is associated with an increased risk of arm morbidity, pneumonitis, cardiac disease and secondary cancer. Therefore, there is a need to individualise regional RT in relation to the risk of recurrence.

Methods and analysis
In this multicentre, prospective randomised trial, clinically node-negative patients with oestrogen receptor-positive, HER2-negative BC and 1-2 SLN macrometastases are eligible. Participants are randomly assigned to receive regional RT (standard arm) or not (intervention arm). Regional RT includes the axilla level I–III, the supraclavicular fossa and in selected patients the internal mammary nodes. Both groups receive RT to the remaining breast. Chest-wall RT after mastectomy is given in the standard arm, but in the intervention arm only in cases of widespread multifocality according to national guidelines. RT quality assurance is an integral part of the trial.
The trial aims to include 1350 patients between March 2023 and December 2028 in Sweden and Norway. Primary outcome is recurrence-free survival (RFS) at 5 years. Non-inferiority will be declared if outcome in the de-escalation arm is not >4.5 percentage units below that with regional RT, corresponding to an HR of 1.41 assuming 88% 5-year RFS with standard treatment. Secondary outcomes include locoregional recurrence, overall survival, patient-reported arm morbidity and health-related quality of life. Gene expression analysis and tumour tissue-based studies to identify prognostic and predictive markers for benefit of regional RT are included.

Ethics and dissemination
The trial protocol is approved by the Swedish Ethics Authority (Dnr-2022-02178-01, 2022-05093-02, 2023-00826-02, 2023-03035-02). Results will be presented at scientific conferences and in peer-reviewed journals.

Trial registration number
NCT05634889.

Circulation, Ahead of Print. Advances in cancer therapeutics have led to dramatic improvements in survival, now inclusive of nearly 20 million patients and rising. However, cardiovascular toxicities associated with specific cancer therapeutics adversely affect the outcomes of patients with cancer. Advances in cardiovascular imaging have solidified the critical role for robust methods for detecting, monitoring, and prognosticating cardiac risk among patients with cancer. However, decentralized evaluations have led to a lack of consensus on the optimal uses of imaging in contemporary cancer treatment (eg, immunotherapy, targeted, or biological therapy) settings. Similarly, available isolated preclinical and clinical studies have provided incomplete insights into the effectiveness of multiple modalities for cardiovascular imaging in cancer care. The aims of this scientific statement are to define the current state of evidence for cardiovascular imaging in the cancer treatment and survivorship settings and to propose novel methodological approaches to inform the optimal application of cardiovascular imaging in future clinical trials and registries. We also propose an evidence-based integrated approach to the use of cardiovascular imaging in routine clinical settings. This scientific statement summarizes and clarifies available evidence while providing guidance on the optimal uses of multimodality cardiovascular imaging in the era of emerging anticancer therapies.

Objective
The paper aimed to study the association between household access to water, sanitation and hygiene (WASH) services and the occurrence of diarrhoea and acute respiratory infection among children under 5 years in Benin.

Design
We performed secondary analyses using Benin’s Fifth Demographic and Health Survey datasets. The dependent variables were diarrhoea and acute respiratory infection (yes=1, no=0). Among the independent variables were the household access to individual WASH services, grouped as follows: ‘basic’, ‘limited’, ‘unimproved’ and ‘no service’. Multivariate logistic regression was used to determine the association between household access to WASH services and the occurrence of diarrhoea and acute respiratory infection. Results from the multivariate logistic regression were presented using adjusted Odds Ratios (aORs) with 95% Confidence Intervals (95% CIs).

Setting
Benin.

Participants
Children under 5 years successfully surveyed during Benin’s Fifth Demographic and Health Survey.

Outcome measures
Diarrhoea and acute respiratory infection.

Results
In the current study, 12 034 children under 5 years met the selection criteria and were included in the analyses. The prevalence of diarrhoea and acute respiratory infection was 10.5% (95% CI=9.8% to 11.3%) and 2.9% (95% CI=2.5% to 3.4%), respectively. Children living in households without sanitation service, that is, practising open defecation (aOR=1.9, 95% CI=1.4 to 2.6), and with unimproved (aOR=1.9, 95% CI=1.3 to 2.7) and limited (aOR=1.5, 95% CI=1.1 to 2.2) services were more likely to have diarrhoea compared with children with basic sanitation services. Household access to WASH services was not associated with acute respiratory infection.

Conclusion
We suggest reinforcing household access to basic sanitation services to combat diarrhoea in children under 5 years. Further research is needed on the effects of WASH interventions on diarrhoea and acute respiratory infection in children under 5 years.

Objectives
The study estimated the shortages of oncology medicines in Pakistan, their causes, impacts, mitigation strategies, and possible interventions.

Design
Cross-sectional survey.

Setting
Oncology pharmacists working at 43 oncology settings (out of 80) from five regions of Pakistan (four provinces (Punjab, Sindh, Khyber Pakhtunkhwa and Baluchistan) and one federal territory (Islamabad)) were approached.

Participants
Oncology pharmacists with more than 1 year of experience were selected using stratified random sampling, and data were collected using a questionnaire from September 2021 to January 2022.

Primary and secondary outcome measures
To estimate the prevalence of oncology medicine shortages in Pakistan and establish recommendations to overcome them.

Results
Of 167 responded pharmacists, 87% experienced shortages in their practice. Most respondents (50%) experienced both oncology and support agent shortages. It was a current problem in hospitals (58%) and increased with time, but the situation varied across regions (p=0.007). Mainly shortages occur half-yearly (p=0.001) and last for

Objective
Recent studies have shown that motorised spiral enteroscopy (MSE) enables deeper and total small bowel evaluation compared with single-balloon enteroscopy (SBE) in suspected Crohn’s disease (CD) when analysed per procedure. However, no randomised controlled study has compared bidirectional MSE with bidirectional SBE in suspected CD.

Design
Patients with suspected CD requiring small bowel enteroscopy were randomly assigned to either SBE or MSE between May 2022 and September 2022 in a high volume tertiary centre. Bidirectional enteroscopy was done if intended lesion could not be reached on unidirectional study. Comparison was made with regard to technical success (ability to reach lesion), diagnostic yield, depth of maximal insertion (DMI), procedure time and total enteroscopy rates. Depth:time ratio was calculated to avoid confounding for the location of lesion.

Results
Among 125 suspected patients with CD (28% female, 18–65 years, median 41 years), 62 and 63 underwent MSE and SBE, respectively. The overall technical success (98.4 %: MSE, 90.5 %: SBE; p=0.11), diagnostic yield (95.2%: MSE; 87.3%: SBE, p=0.2) and procedure time were not significantly different. However, MSE appeared to have higher technical success (96.8% vs 80.7%, p=0.08) in deeper small bowel (distal jejunum/proximal ileum) with higher DMI, higher depth:time ratio and total enteroscopy rates when attempted (77.8% vs 11.1%, p=0.0007). Both the modalities were safe although minor adverse events were more common with MSE.

Conclusion
MSE and SBE have comparable technical success and diagnostic yield for small bowel evaluation in suspected CD. MSE scores over SBE with regard to deeper small bowel evaluation with complete small bowel coverage and higher depth of insertion in a shorter time.

Trial registration number
NCT05363930.

Introduction
Contrast-enhanced CT (CECT) is widely used for diagnostic purposes. The use of contrast medium carries a risk for postcontrast acute kidney injury (PC-AKI), especially in patients with AKI or chronic kidney disease (CKD). Current guidelines recommend prophylactic intravenous hydration to prevent PC-AKI in high-risk patients. Oral hydration is non-inferior to intravenous hydration in patients with moderate CKD, but it has not been evaluated in high-risk patients.

Methods and analysis
The ENRICH trial will enrol 254 patients with estimated glomerular filtration rate ≤30 mL/min/1.73 m2 undergoing intravenous CECT, who are block randomised (2-4-2) with stratification for CKD stage, diabetes status, and indication for referral to prophylactic treatment with oral or intravenous hydration. PC-AKI is defined as an absolute increase in SCr of >0.3 mg/dL or >1.5 from baseline at 2–5 days. Renal function will also be evaluated

Background
Chronic non-cancer pain (CNCP) treatment’s primary goal is to maintain physical and mental functioning while improving quality of life. Opioid use in CNCP patients has increased in recent years, and non-pharmacological interventions such as music listening have been proposed to counter it. Unlike other auditive stimuli, music can activate emotional-regulating and reward-regulating circuits, making it a potential tool to modulate attentional processes and regulate mood. This study’s primary objective is to provide the first evidence on the distinct (separate) effects of music listening as a coadjuvant maintenance analgesic treatment in CNCP patients undergoing opioid analgesia.

Methods and analysis
This will be a single-centre, phase II, open-label, parallel-group, proof-of-concept randomised clinical trial with CNCP patients under a minimum 4-week regular opioid treatment. We plan to include 70 consecutive patients, which will be randomised (1:1) to either the experimental group (active music listening) or the control group (active audiobooks listening). During 28 days, both groups will listen daily (for at least 30 min and up to 1 hour) to preset playlists tailored to individual preferences.
Pain intensity scores at each visit, the changes (differences) from baseline and the proportions of responders according to various definitions based on pain intensity differences will be described and compared between study arms. We will apply longitudinal data assessment methods (mixed generalised linear models) taking the patient as a cluster to assess and compare the endpoints’ evolution. We will also use the mediation analysis framework to adjust for the effects of additional therapeutic measures and obtain estimates of effect with a causal interpretation.

Ethics and dissemination
The study protocol has been reviewed, and ethics approval has been obtained from the Bellvitge University Hospital Institutional Review Board, L’Hospitalet de Llobregat, Barcelona, Spain. The results from this study will be actively disseminated through manuscript publications and conference presentations.

Trial registration number
NCT05726266.

Objectives
The emergence of the COVID-19 pandemic led to multiple preventive actions as primary interventions to contain the spread of the virus. Globally, countries are facing enormous challenges with consequences for use of social, economic and health services. The Democratic Republic of Congo (DRC) was among the African countries implementing strict lockdown at the start of the pandemic, resulting in shortages and decreased access to services. The adverse effects of the pandemic had unpleasant consequences for the country. This study aimed to examine the association between COVID-19 pandemic-related factors, sociodemographic factors, and the need to visit healthcare facilities, including family planning services, among women aged 15–49 years in the DRC.

Methods
We conducted a secondary analysis of a performance monitoring for action (PMA) cross-sectional COVID-19 phone survey in Kinshasa, DRC, which had a response rate of 74.7%. In total, 1325 randomly selected women aged 15–49 years from the Kinshasa province who had previously participated in the PMA baseline survey participated in the survey. Bivariate and multivariate logistic regressions were used to assess associations.

Results
The COVID-19 pandemic and related factors affected 92% of women in the Kinshasa province socioeconomically. A majority were highly economically dependent on their partner or some other sources for their basic needs to be met, and even more worried about the future impact of the pandemic on their household finances. Over 50% of women did not attempt visiting a health service, with some of the top reasons being fear of being infected with COVID-19 and not being able to afford services. We found a significant association between age groups and contraceptive use. The need for and use of contraceptives was higher among women aged 25–34 years than those aged 15–24 or 35–49 years.

Conclusion
Effective social/economic support to women and girls during pandemics and in crises is essential as it can have lasting beneficial effects on many domains of their lives, including their ability to access health services and the contraceptives of their choice.

Introduction
Enterococcus spp is responsible for 8%–15% of total bacteraemias with an associated global mortality around 23%–30%. Regarding the clinical management of enterococcal bacteraemia, the evidence on the duration of antibiotic treatment is scarce and the studies do not discriminate between complicated and uncomplicated bacteraemia.

Methods
The INTENSE study is a multicentre, open-label, randomised, pragmatic, phase-IV clinical trial to demonstrate the non-inferiority of a 7-day vs 14-day course for the treatment of uncomplicated enterococcal bacteraemia and incorporating the early switching to oral antibiotics when feasible. The primary efficacy endpoint is the clinical cure at day 30±2 after the end of the treatment. Secondary endpoints will include the rate of relapse or infective endocarditis, length of stay, duration of intravenous therapy, Clostridioides difficile infection and the evaluation of the safety of both treatment arms through the recording and analysis of adverse events. For a 6% non-inferiority margin and considering a 5% withdrawal rate, 284 patients will be included.

Analysis
The difference in proportions with one-sided 95% CIs will be calculated for the clinical cure rate using the control group as reference. For secondary categorical endpoints, a similar analysis will be performed and Mann-Whitney U-test will be used to compare median values of quantitative variables. A superiority analysis applying the response adjusted for days of antibiotic risk will be performed if there were incidents in recruitment; will allow obtaining results with 194 patients recruited.

Ethics and dissemination
The study has obtained the authorisation from the Spanish Regulatory Authority, the approval of the ethics committee and the agreement of the directors of each centre. Data will be published in peer-reviewed journals.

Trial registration number
NCT05394298.

Objective
An increasing number of studies have explored the clinical effects of antiglaucoma surgical procedures; however, economic evidence was scarce. We aimed to compare the cost-effectiveness between maximal medical treatment (MMT) and commonly used surgical procedures (trabeculectomy, Ahmed glaucoma valve implantation, gonioscopy-assisted transluminal trabeculotomy and ab interno canaloplasty).

Design and setting
A Markov model study.

Participants
A hypothetical cohort of 100 000 patients with mild-to-moderate primary open-angle glaucoma (POAG).

Outcomes
Data were obtained from public sources. The main outcomes were incremental cost–utility ratios (ICURs) using quality-adjusted life-years (QALYs). Sensitivity analyses were conducted to verify the robustness and sensitivity of base-case results.

Main results
Both cumulative costs and QALYs gained from surgical procedures (US$6045–US$13 598, 3.33–6.05 QALYs) were higher than those from MMT (US$3117–US$6458, 3.14–5.66 QALYs). Compared with MMT, all surgical procedures satisfied the cost-effectiveness threshold (lower than US$30 501 and US$41 568 per QALY gained in rural and urban settings, respectively). During the 5-year period, trabeculectomy produced the lowest ICUR (US$21 462 and US$15 242 per QALY gained in rural and urban settings, respectively). During the 10-year-follow-up, trabeculectomy still produced the lowest ICUR (US$13 379 per QALY gained) in urban setting; however, gonioscopy-assisted transluminal trabeculotomy (US$19 619 per QALY gained) and ab interno canaloplasty (US$18 003 per QALY gained) produced lower ICURs than trabeculectomy (US$19 675 per QALY gained) in rural areas. Base-case results were most sensitive to the utilities and costs of initial treatment and maintenance.

Conclusions
The long-term cost-effectiveness of commonly used surgical procedures could be better than the short-term cost-effectiveness for mild-to-moderate POAG patients in China. Health economic studies, supported by more rigorous structured real-world data, are needed to assess their everyday cost-effectiveness.

Introduction
Incorrect penicillin allergy records are recognised as an important barrier to the safe treatment of infection and affect an estimated 2.7 million people in England. Penicillin allergy records are associated with worse health outcome and antimicrobial resistance. The ALlergy AntiBiotics And Microbial resistAnce (ALABAMA) trial aims to determine if an intervention package, centred around a penicillin allergy assessment pathway (PAAP) initiated in primary care, is safe and effective in improving patient health outcomes and antibiotic prescribing.

Methods and analysis
The ALABAMA trial is a multicentre, parallel-arm, open-label, randomised pragmatic trial with a nested pilot study. Adults (≥18 years) with a penicillin allergy record and who have received antibiotics in the previous 24 months will be eligible for participation. Between 1592 and 2090 participants will be recruited from participating National Health Service general practices in England. Participants will be randomised to either usual care or intervention to undergo a pre-emptive PAAP using a 1:1 allocation ratio. The primary outcome measure is the percentage of treatment response failures within 28 days of an index prescription. 2090 and 1592 participants are estimated to provide 90% and 80% power, respectively, to detect a clinically important absolute difference of 7.9% in primary outcome at 1 year between groups. The trial includes a mixed-methods process evaluation and cost-effectiveness evaluation.

Ethics and dissemination
This trial has been approved by London Bridge Research Ethics Committee (ref: 19/LO/0176). It will be conducted in compliance with Good Clinical Practice guidelines according to the Declaration of Helsinki. Informed consent will be obtained from all subjects involved in the study. The primary trial results will be submitted for publication to an international, peer-reviewed journal.

Trial registration
ISRCTN20579216.