SupporTive Care At Home Research (STAHR) for patients with advanced cancer: Protocol for a cluster non-randomized controlled trial.

Advancements in the treatment and management of patients with cancer have extended their survival period. To honor such patients' desire to live in their own homes, home-based supportive care programs have become an important medical practice. This study aims to investigate the effects of a multidimensional and integrated home-based supportive care program on patients with advanced cancer. SupporTive Care At Home Research is a cluster non-randomized controlled trial for patients with advanced cancer. This study tests the effects of the home-based supportive care program we developed versus standard oncology care. The home-based supportive care program is based on a specialized home-based medical team approach that includes (1) initial assessment and education for patients and their family caregivers, (2) home visits by nurses, (3) biweekly regular check-ups/evaluation and management, (4) telephone communication via a daytime access line, and (5) monthly multidisciplinary team meetings. The primary outcome measure is unplanned hospitalization within 6 months following enrollment. Healthcare service use; quality of life; pain and symptom control; emotional status; satisfaction with services; end-of-life care; advance planning; family caregivers' quality of life, care burden, and preparedness for caregiving; and medical expenses will be surveyed. We plan to recruit a total of 396 patients with advanced cancer from six institutions. Patients recruited from three institutions will constitute the intervention group, whereas those recruited from the other three institutions will comprise the control group.

Autologous concentrated bone marrow injection for precollapse osteonecrosis of the femoral head concurrent with contralateral total hip arthroplasty: protocol for a clinical trial.

INTRODUCTION: The femoral head contralateral to the collapsed femoral head requiring total hip arthroplasty (THA) often manifests in the precollapse stage of osteonecrosis of the femoral head (ONFH). It is not yet demonstrated how autologous concentrated bone marrow injection may prevent collapse of the femoral head concurrent with contralateral THA. The primary objective is to evaluate the efficacy of autologous concentrated bone marrow injection for the contralateral, non-collapsed, femoral head in patients with bilateral ONFH, with the ipsilateral collapsed femoral head undergoing THA. METHODS AND ANALYSIS: This is a multicentre, prospective, non-randomised, historical-data controlled study. We will recruit patients with ONFH who are scheduled for THA and possess a non-collapsed contralateral femoral head. Autologous bone marrow will be collected using a point-of-care device. After concentration, the bone marrow will be injected into the non-collapsed femoral head following the completion of THA in the contralateral hip. The primary outcome is the percentage of femoral head collapse evaluated by an independent data monitoring committee using plain X-rays in two directions 2 years after autologous concentrated bone marrow injection. Postinjection safety, adverse events, pain and hip function will also be assessed. The patients will be evaluated preoperatively, and at 6 months, 1 year and 2 years postoperatively. ETHICS AND DISSEMINATION: This protocol has been approved by the Certified Committee for Regenerative Medicine of Tokyo Medical and Dental University and Japan's Ministry of Healthy, Labour and Welfare and will be performed as a class III regenerative medicine protocol, in accordance with Japan's Act on the Safety of Regenerative Medicine. The results of this study will be submitted to a peer-review journal for publication. The results of this study are expected to provide evidence to support the inclusion of autologous concentrated bone marrow injections in the non-collapsed femoral head in Japan's national insurance coverage. TRIAL REGISTRATION NUMBER: jRCTc032200229.

Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support.

BACKGROUND: An estimated one-quarter to one-half of people diagnosed with haematological malignancies experience anaemia. There are different strategies for red blood cell (RBC) transfusions to treat anaemia. A restrictive transfusion strategy permits a lower haemoglobin (Hb) level whereas a liberal transfusion strategy aims to maintain a higher Hb. The most effective and safest strategy is unknown. OBJECTIVES: To determine the efficacy and safety of restrictive versus liberal RBC transfusion strategies for people diagnosed with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without a haematopoietic stem cell transplant (HSCT). SEARCH METHODS: We searched for randomised controlled trials (RCTs) and non-randomised studies (NRS) in MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1982), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2023, Issue 2), and eight other databases (including three trial registries) to 21 March 2023. We also searched grey literature and contacted experts in transfusion for additional trials. There were no language, date or publication status restrictions. SELECTION CRITERIA: We included RCTs and prospective NRS that evaluated restrictive versus liberal RBC transfusion strategies in children or adults with malignant haematological disorders receiving intensive chemotherapy or radiotherapy, or both, with or without HSCT. DATA COLLECTION AND ANALYSIS: Two authors independently screened references, full-text reports of potentially relevant studies, extracted data from the studies, and assessed the risk of bias. Any disagreement was discussed and resolved with a third review author. Dichotomous outcomes were presented as a risk ratio (RR) with a 95% confidence interval (CI). Narrative syntheses were used for heterogeneous outcome measures. Review Manager Web was used to meta-analyse the data. Main outcomes of interest included: all-cause mortality at 31 to 100 days, quality of life, number of participants with any bleeding, number of participants with clinically significant bleeding, serious infections, length of hospital admission (days) and hospital readmission at 0 to 3 months. The certainty of the evidence was assessed using GRADE. MAIN RESULTS: Nine studies met eligibility; eight RCTs and one NRS. Six hundred and forty-four participants were included from six completed RCTs (n = 560) and one completed NRS (n = 84), with two ongoing RCTs consisting of 294 participants (260 adult and 34 paediatric) pending inclusion. Only one completed RCT included children receiving HSCT (n = 6); the other five RCTs only included adults: 239 with acute leukaemia receiving chemotherapy and 315 receiving HSCT (166 allogeneic and 149 autologous). The transfusion threshold ranged from 70 g/L to 80 g/L for restrictive and from 80 g/L to 120 g/L for liberal strategies. Effects were reported in the summary of findings tables only for the trials that included adults to reduce indirectness due to the limited evidence contributed by the prematurely terminated paediatric trial. Evidence from RCTs Overall, there may be little to no difference in the number of participants who die within 31 to 100 days using a restrictive compared to a liberal transfusion strategy, but the evidence is very uncertain (three studies; 451 participants; RR 1.00, 95% CI 0.27 to 3.70, P=0.99; very low-certainty evidence). There may be little to no difference in quality of life at 0 to 3 months using a restrictive compared to a liberal transfusion strategy, but the evidence is very uncertain (three studies; 431 participants; analysis unable to be completed due to heterogeneity; very low-certainty evidence). There may be little to no difference in the number of participants who suffer from any bleeding at 0 to 3 months using a restrictive compared to a liberal transfusion strategy (three studies; 448 participants; RR 0.91, 95% CI 0.78 to 1.06, P = 0.22; low-certainty evidence). There may be little to no difference in the number of participants who suffer from clinically significant bleeding at 0 to 3 months using a restrictive compared to a liberal transfusion strategy (four studies; 511 participants; RR: 0.94, 95% CI 0.74 to 1.19, P = 0.60; low-certainty evidence). There may be little to no difference in the number of participants who experience serious infections at 0 to 3 months using a restrictive compared to a liberal transfusion strategy (three studies, 451 participants; RR: 1.20, 95% CI 0.93 to 1.55, P = 0.17; low-certainty evidence). A restrictive transfusion strategy likely results in little to no difference in the length of hospital admission at 0 to 3 months compared to a liberal strategy (two studies; 388 participants; analysis unable to be completed due to heterogeneity in reporting; moderate-certainty evidence). There may be little to no difference between hospital readmission using a restrictive transfusion strategy compared to a liberal transfusion strategy (one study, 299 participants; RR: 0.89, 95% CI 0.52 to 1.50; P = 0.65; low-certainty evidence). Evidence from NRS The evidence is very uncertain whether a restrictive RBC transfusion strategy: reduces the risk of death within 100 days (one study, 84 participants, restrictive 1 death; liberal 1 death; very low-certainty evidence); or decreases the risk of clinically significant bleeding (one study, 84 participants, restrictive 3; liberal 8; very low-certainty evidence). No NRS reported on the other eligible outcomes. AUTHORS' CONCLUSIONS: Findings from this review were based on seven studies and 644 participants. Definite conclusions are challenging given the relatively few included studies, low number of included participants, heterogeneity of intervention and outcome reporting, and overall certainty of evidence. To increase the certainty of the true effect of a restrictive RBC transfusion strategy on clinical outcomes, there is a need for rigorously designed and executed studies. The evidence is largely based on two populations: adults with acute leukaemia receiving intensive chemotherapy and adults with haematologic malignancy requiring HSCT. Despite the addition of 405 participants from three RCTs to the previous review's results, there is still insufficient evidence to answer this review's primary outcome. If we assume a mortality rate of 3% within 100 days, we would need a total of 1492 participants to have an 80% chance of detecting, at a 5% level of significance, an increase in all-cause mortality from 3% to 6%. Further RCTs are needed overall, particularly in children.

Impact evaluation of a cash-plus programme for children with disabilities in the Xiengkhouang Province in Lao PDR: study protocol for a non-randomised controlled trial.

INTRODUCTION: More than 170 countries have implemented disability-targeted social protection programmes, although few have been rigorously evaluated. Consequently, a non-randomised controlled trial is being conducted of a pilot 'cash-plus' programme implemented by UNICEF Laos and the Laos government for children with disabilities in the Xiengkhouang Province in Laos. The intervention combines a regular cash transfer with provision of assistive devices and access for caregivers to a family support programme. METHODS AND ANALYSIS: The non-randomised controlled trial will involve 350 children with disabilities across 3 districts identified by programme implementers as eligible for the programme (intervention arm). Implementers have also identified approximately 180 children with disabilities in neighbouring districts, who would otherwise meet eligibility criteria but do not live in the project areas (control arm). The trial will assess the impact of the programme on child well-being (primary outcome), as well as household poverty, caregiver quality of life and time use (secondary outcomes). Baseline data are being collected May-October 2023, with endline 24 months later. Analysis will be intention to treat. A complementary process evaluation will explore the implementation, acceptability of the programme, challenges and enablers to its delivery and mechanisms of impact. ETHICS AND DISSEMINATION: The study has received ethical approval from the London School of Hygiene and Tropical Medicine and the National Ethics Committee for Health Research in Laos. Informed consent and assent will be taken by trained data collectors. Data will be collected and stored on a secure, encrypted server and its use will follow a detailed data management plan. Findings will be disseminated in academic journals and in short briefs for policy and programmatic actors, and in online and in-person events. TRIAL REGISTRATION NUMBER: ISRCTN80603476.

Study protocol of a prospective, interventional non-randomised trial investigating the impact of asthma education on specific disease understanding, health literacy and therapy outcome in childhood.

INTRODUCTION: Childhood asthma is a highly prevalent chronic disease. A failure to implement patient education programmes may result in increased morbidity, despite the availability of distinct diagnostic and therapeutic approaches. Patients with lower socioeconomic status (SES) tend to have a higher asthma prevalence. Moreover, the progression of asthma is significantly influenced by factors such as health literacy and the children's specific knowledge about the condition. With this trial, the primary objective is to evaluate whether asthma education enhances specific disease understanding in children with asthma (primary outcome). Secondary objectives include evaluating training effects on health literacy, retention rates of information, 'Children Asthma Control Test' (C-ACT) score, frequency of emergency room and physician visits (secondary outcomes) and whether SES influences training effects. METHODS AND ANALYSIS: To address the research objectives, this study comprises two projects. The first subproject will investigate the influence of asthma training on the development of disease understanding and health literacy. The second subproject will analyse the influence of SES on the outcome of children participating in asthma training. This research is designed as a comparative, non-randomised study involving two paediatric groups between the ages of ≥7 and < 14 years. After being diagnosed with asthma, the intervention group undergoes standardised psychoeducational asthma training at a certified centre associated with paediatricians in private practice in Germany, following the recommendations of the 'Arbeitsgruppe Asthmaschulung im Kindes- und Jugendalter e.V.', a national association aiming to establish uniform and guideline-based standards for patient education in children and adolescents. The comparison group receives a significantly shorter period of education and instruction on the usage of asthma medication at outpatient clinics. Data will be collected from patients and their parents at three specific survey time points, based on standardised tools.To describe mean differences between the intervention and control group over time (subproject 1), a repeated-measures analysis of variance (ANOVA) will be conducted. In subproject 2, multivariate linear regression analysis will be used to analyse the variables determining the changes in specific disease understanding and health literacy, including SES. The sample size calculation is based on a mixed ANOVA model with two groups and two measurements resulting in a total of 126 participants. ETHICS AND DISSEMINATION: All protocols and a positive ethics approval were obtained from the Witten/Herdecke University, Germany (S-159, 2023; application submission: 24 June 2023, final vote: 10 July 2023). Furthermore, the study was registered at the German Clinical Trials Register (DRKS), DRKS00032423. The application submission was on 3 August 2023, and the final approval was on 4 August 2023. The results will be disseminated among experts and participants and will be published in peer-reviewed, international journal with open access. TRIAL REGISTRATION NUMBER: DRKS00032423.

Comprehensive care programmes for children with medical complexity.

BACKGROUND: Children with medical complexity (CMC) represent a small, but growing, proportion of all children. Regardless of their underlying diagnosis, by definition, all CMC have similar functional limitations and high healthcare needs. It has been suggested that improving aspects of healthcare delivery for CMC improves health- and quality of life-related outcomes for children and their families and reduces healthcare-related expenditure. As a result, dedicated comprehensive care programmes have been established at many hospitals to meet the needs of CMC; however, it is unclear if such programmes are effective. OBJECTIVES: Our main objective was to assess the effectiveness of comprehensive care programmes that aim to improve care coordination and other aspects of health care for CMC and to assess whether the effectiveness of such programmes differs according to the programme setting and structure. We aimed to assess their effectiveness in relation to child and parent health, functioning, and quality of life, quality of care, number of healthcare encounters, unmet healthcare needs, and total healthcare-related costs. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and CINAHL in May 2023. We also searched reference lists, trial registries, and the grey literature. SELECTION CRITERIA: Randomised and non-randomised trials, controlled before-after studies, and interrupted time series studies were included. Studies that compared enrolment in a comprehensive care programme with non-enrolment in such a programme/treatment as usual were included. Participants were children that met the criteria for the definition of CMC, which is: having (i) a chronic condition, (ii) functional limitations, (iii) increased health and other service needs, and (iv) increased healthcare costs. Studies that included the following types of outcomes were included: health; quality of care; utilisation, coverage and access; resource use and costs; equity; and adverse outcomes. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data, assessed the risk of bias in each included study, and evaluated the certainty of evidence according to GRADE criteria. Where possible, data were represented in forest plots and pooled. We were unable to undertake a meta-analysis for comparisons and outcomes, so we used a structured synthesis approach. MAIN RESULTS: We included four studies with a total of 912 CMC as participants. All included studies were randomised controlled trials conducted in hospitals in the USA or Canada. Participants varied across the included studies; however, all four studies included children with complex and chronic illness and high healthcare needs. While the primary aim of the intervention was similar across all four studies, the components of the interventions differed: in the four studies, the intervention involved some element of care coordination; in two of the studies, it involved the child receiving care from a multidisciplinary team, while in one study, the intervention was primarily centred on access to an advanced practice nurse care coordinator and another study involved nurse a practitioner-paediatrician dyad partnering with families. The risk of bias in the four studies varied across domains, with issues primarily relating to the lack of blinding of participants, personnel, and outcome assessors, inadequate allocation concealment, and incomplete outcome data. Comprehensive care for CMC compared to usual care may make little to no difference to child health, functioning, and quality of life at 12 or 24 months (three studies with 404 participants) and we assessed the evidence for the outcomes in this category (child health-related quality of life and functional status) as being of low certainty. For CMC, comprehensive care probably makes little or no difference to parent health, functioning, and quality of life compared to usual care at 12 months (one study with 117 participants) and we assessed the evidence for this outcome as being of moderate certainty. Comprehensive care for CMC compared to usual care may slightly improve child and family satisfaction with, and perceptions of, care and service delivery at 12 months (three studies with 453 participants); however, we assessed the evidence for these outcomes as being of low certainty. For CMC, comprehensive care probably makes little or no difference to the number of healthcare encounters (emergency department visits) and the number of hospitalised days (hospital admissions) compared to usual care at 12 months (three studies with 668 participants), and we assessed the evidence for these outcomes as being of moderate certainty. Three of the included studies (668 participants) reported cost outcomes and had conflicting results, with one study reporting significantly lower healthcare costs at 12 months in the intervention group compared to the control group, one reporting no differences between groups, and the other study reporting a greater increase in total healthcare costs in the intervention group compared to the control group. Overall, comprehensive care may make little or no difference to overall healthcare costs in CMC; however, the methods used to measure total healthcare costs varied across studies and the certainty of the evidence relating to this outcome is low. No studies assessed the costs to the family. AUTHORS' CONCLUSIONS: The findings of this review should be treated with caution due to the limited amount and quality of the published research that was available to be included. Overall, the certainty of the evidence for the effectiveness of comprehensive care for CMC ranged from low to moderate across outcomes and there is currently insufficient evidence on which to draw strong conclusions. There is a need for more high-quality randomised trials with consistency of the target population and intervention components, methods of reporting outcomes, and follow-up periods, as well as full cost analyses, taking into account both costs to the family and costs to the healthcare system.

Problematic meta-analyses: Bayesian and frequentist perspectives on combining randomized controlled trials and non-randomized studies.

PURPOSE: In the literature, the propriety of the meta-analytic treatment-effect produced by combining randomized controlled trials (RCT) and non-randomized studies (NRS) is questioned, given the inherent confounding in NRS that may bias the meta-analysis. The current study compared an implicitly principled pooled Bayesian meta-analytic treatment-effect with that of frequentist pooling of RCT and NRS to determine how well each approach handled the NRS bias. MATERIALS & METHODS: Binary outcome Critical-Care meta-analyses, reflecting the importance of such outcomes in Critical-Care practice, combining RCT and NRS were identified electronically. Bayesian pooled treatment-effect and 95% credible-intervals (BCrI), posterior model probabilities indicating model plausibility and Bayes-factors (BF) were estimated using an informative heavy-tailed heterogeneity prior (half-Cauchy). Preference for pooling of RCT and NRS was indicated for Bayes-factors > 3 or < 0.333 for the converse. All pooled frequentist treatment-effects and 95% confidence intervals (FCI) were re-estimated using the popular DerSimonian-Laird (DSL) random effects model. RESULTS: Fifty meta-analyses were identified (2009-2021), reporting pooled estimates in 44; 29 were pharmaceutical-therapeutic and 21 were non-pharmaceutical therapeutic. Re-computed pooled DSL FCI excluded the null (OR or RR = 1) in 86% (43/50). In 18 meta-analyses there was an agreement between FCI and BCrI in excluding the null. In 23 meta-analyses where FCI excluded the null, BCrI embraced the null. BF supported a pooled model in 27 meta-analyses and separate models in 4. The highest density of the posterior model probabilities for 0.333 < Bayes factor < 1 was 0.8. CONCLUSIONS: In the current meta-analytic cohort, an integrated and multifaceted Bayesian approach gave support to including NRS in a pooled-estimate model. Conversely, caution should attend the reporting of naïve frequentist pooled, RCT and NRS, meta-analytic treatment effects.

Patient Partnership Tools to Support Medication Safety in Community-Dwelling Older Adults: Protocol for a Nonrandomized Stepped Wedge Clinical Trial.

BACKGROUND: Preventable harms from medications are significant threats to patient safety in community settings, especially among ambulatory older adults on multiple prescription medications. Patients may partner with primary care professionals by taking on active roles in decisions, learning the basics of medication self-management, and working with community resources. OBJECTIVE: This study aims to assess the impact of a set of patient partnership tools that redesign primary care encounters to encourage and empower patients to make more effective use of those encounters to improve medication safety. METHODS: The study is a nonrandomized, cross-sectional stepped wedge cluster-controlled trial with 1 private family medicine clinic and 2 public safety-net primary care clinics each composing their own cluster. There are 2 intervention sequences with 1 cluster per sequence and 1 control sequence with 1 cluster. Cross-sectional surveys will be taken immediately at the conclusion of visits to the clinics during 6 time periods of 6 weeks each, with a transition period of no data collection during intervention implementation. The number of visits to be surveyed will vary by period and cluster. We plan to recruit patients and professionals for surveys during 405 visits. In the experimental periods, visits will be conducted with two partnership tools and associated clinic process changes: (1) a 1-page visit preparation guide given to relevant patients by clinic staff before seeing the provider, with the intention to improve communication and shared decision-making, and (2) a library of short educational videos that clinic staff encourage patients to watch on medication safety. In the control periods, visits will be conducted with usual care. The primary outcome will be patients' self-efficacy in medication use. The secondary outcomes are medication-related issues such as duplicate therapies identified by primary care providers and assessment of collaborative work during visits. RESULTS: The study was funded in September 2019. Data collection started in April 2023 and ended in December 2023. Data was collected for 405 primary care encounters during that period. As of February 15, 2024, initial descriptive statistics were calculated. Full data analysis is expected to be completed and published in the summer of 2024. CONCLUSIONS: This study will assess the impact of patient partnership tools and associated process changes in primary care on medication use self-efficacy and medication-related issues. The study is powered to identify types of patients who may benefit most from patient engagement tools in primary care visits. TRIAL REGISTRATION: ClinicalTrials.gov NCT05880368; https://clinicaltrials.gov/study/NCT05880368. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57878.

Single-arm phase 3 designs: An oxymoron?

BACKGROUND: Since the 1950s, randomized clinical trials (RCTs) have served as the gold standard for confirming the benefits of a new drug. Accordingly, phase 3 trials, the last steps in the evaluation process for a new drug, have been recommended to all be RCTs. Nevertheless, single-arm phase 3 trials still appear to be in use. METHODS: We performed a PubMed search to identify the use of a single-arm design in phase 3 trials, excluding only non-English articles. Three categories were distinguished: past use of an RCT, of any other trial design, or no previous trial; and according to diagnosis (oncology, infection, others). RESULTS: A total of 176 single-arm phase 3 trials (19 oncology, 43 infections and 114 others) were identified by the search, with exponential growth since 1994, in parallel with that of RCTs. Among them, 64 (36%) were preceded by an RCT, 58 (33%) by a non-randomized trial, and 54 (31%) had no previous trial, with no main influence of the diagnosis setting. Justification of the design was reported in 30 (18%) of those trials, with ethical concerns comprising one-third of those justifications. This was similar in the 14 single-arm phase 2-3 trials, with about one-third in each group, and 17% justification of a non-comparative design. CONCLUSION: The use of a single-arm phase 3 trial is heterogeneous, ranging from first trials up to confirmatory trials after a previously conducted RCT. Justification for these single-arm designs as confirmatory evidence should be more clearly reported, along with potential sources of bias.

Effectiveness and cost-effectiveness of a collaborative deprescribing intervention of proton-pump-inhibitors on community-dwelling older adults: Protocol for the C-SENIoR, a pragmatic non-randomized controlled trial.

INTRODUCTION: Worldwide, demographic ageing is a major social, economic and health challenge. Despite the increase in life expectancy, elderly often live with multiple chronic conditions, exposing them to multiple medications. Concerns have been raised about the growing issue of inappropriate long-term usage of proton-pump inhibitors (PPI), which have been associated with adverse outcomes and increased healthcare costs. Deprescribing is a recommended intervention to reduce or withdraw medicines that might be causing harm or might no longer be of benefit. This protocol details a trial to assess the effectiveness and cost-effectiveness of a collaborative deprescribing intervention of PPI among community-dwelling elderly, involving community pharmacists and general practitioners. METHODS AND ANALYSIS: A pragmatic, multicentre, two-arm, non-randomised controlled trial of a structured PPI collaborative deprescribing intervention in the primary care setting with a 6-month follow-up will be conducted. Patients must be 65 years old or older, live in the community and have been using PPI for more than 8 weeks. We hypothesize that the intervention will reduce the PPI usage in the intervention group compared to the control group. The primary outcome is the successful discontinuation or dose decrease of any PPI, defined as a statistically significant absolute 20% reduction in medication use between the intervention and control groups at 3- and 6-month follow-ups. An economic evaluation will be conducted alongside the trial. This study was approved by the Ethics Research Committee of Nova Medical School, NOVA University of Lisbon and by the Ethics Committee from the Local Health Unit Alto Minho, Portugal. DISCUSSION: This pragmatic trial will provide evidence on the effectiveness and cost-effectiveness of a patient-centred collaborative deprescribing intervention in the community setting in Portugal. It will also inform improvements for the development of future multi-faceted interventions that aim to optimise medication for the community-dwelling elderly. CLINICAL TRIAL REGISTRATION: ISRCTN 49637686.

An Integrated Care Pathway for depression in adolescents: protocol for a Type 1 Hybrid Effectiveness-implementation, Non-randomized, Cluster Controlled Trial.

INTRODUCTION: Our group developed an Integrated Care Pathway to facilitate the delivery of evidence-based care for adolescents experiencing depression called CARIBOU-2 (Care for Adolescents who Receive Information 'Bout OUtcomes, 2nd iteration). The core pathway components are assessment, psychoeducation, psychotherapy options, medication options, caregiver support, measurement-based care team reviews and graduation. We aim to test the clinical and implementation effectiveness of the CARIBOU-2 pathway relative to treatment-as-usual (TAU) in community mental health settings. METHODS AND ANALYSIS: We will use a Type 1 Hybrid Effectiveness-Implementation, Non-randomized Cluster Controlled Trial Design. Primary participants will be adolescents (planned n = 300, aged 13-18 years) with depressive symptoms, presenting to one of six community mental health agencies. All sites will begin in the TAU condition and transition to the CARIBOU-2 intervention after enrolling 25 adolescents. The primary clinical outcome is the rate of change of depressive symptoms from baseline to the 24-week endpoint using the Childhood Depression Rating Scale-Revised (CDRS-R). Generalized mixed effects modelling will be conducted to compare this outcome between intervention types. Our primary hypothesis is that there will be a greater rate of reduction in depressive symptoms in the group receiving the CARIBOU-2 intervention relative to TAU over 24 weeks as per the CDRS-R. Implementation outcomes will also be examined, including clinician fidelity to the pathway and its components, and cost-effectiveness. ETHICS AND DISSEMINATION: Research ethics board approvals have been obtained. Should our results support our hypotheses, systematic implementation of the CARIBOU-2 intervention in other community mental health agencies would be indicated.

Transdiagnostic Unified Protocol for Women with Breast Cancer: A Preliminary Study

This article aimed to explore the feasibility and clinical utility of the online Unified Protocol to improve emotional regulation with women diagnosed with breast cancer. Method. Research with a quantitative, exploratory, descriptive, and interactive approach, with a quasi-experimental design, pre-posttest for paired samples. Nine women with an average age of 53 years (SD= 9.5; range from 41 to 71) participated in a psychological intervention of 12 weekly 90-minute sessions. A statistically significant change (p < 0.05) between pre and post-test measurements in Anxiety (t= 2.777; p=.024), Quality of life (Z= -2.670; p=.008), Optimism (t= -2.785; p= .024) and Positive Affect (t= -3.834; p=.005) were found. The size of the effect was moderate in Optimism and big in Anxiety, Quality of life and Positive Affect. High levels of treatment satisfaction were found. The intervention was useful to improve the emotional regulation of women with a medical condition in a pandemic context. (AU)

Efectividad de la formación teórico-práctica en soporte vital básico a monitoras de comedores escolares desde Atención Primaria / Effectiveness of theoretical-practical training in basic life support for school canteen monitors from Primary Care

Introducción: las enfermedades cardiovasculares constituyen un problema de salud pública a nivel mundial y dentro de ellas destaca la parada cardiorrespiratoria (PCR). Los comedores escolares son espacios con potencial riesgo de presenciar una PCR. Materiales y métodos: estudio analítico cuasiexperimental de intervención. Las participantes recibieron formación mediante una plataforma virtual interactiva y una sesión de simulación clínica presencial sobre maniobra de Heimlich, reanimación cardiopulmonar (RCP) básica y uso del desfibrilador externo semiautomático (DESA). Se realizó un análisis descriptivo de la población a estudio y un análisis estadístico comparativo entre el resultado obtenido en un test previo y otro posterior a la formación virtual. Se creó una variable restando la puntuación obtenida antes de la formación a la obtenida después de la misma. Se analizó mediante observación directa la simulación clínica. Se definió la significación estadística con una p <0,05. Análisis estadístico con SPSS versión 19.0. Se siguieron los principios de la Declaración de Helsinki y las directrices sobre buenas prácticas clínicas. Resultados: la totalidad de la muestra eran mujeres con edad mediana de 48,50 años. La nota mediana del test previo fue de 6,7/10 y el test posterior tuvo un resultado constante de 10/10. La diferencia entre el test posterior y el previo tuvo una mediana de 3,3 (p 0,01) y se constató en la simulación que el aprendizaje fue óptimo. Conclusiones: la formación en RCP es una estrategia de impacto social, relacionada con una mejora en la respuesta ante un caso de PCR, disminuyendo la morbimortalidad que esta implica. (AU)

Introduction: cardiovascular diseases constitute a public health problem worldwide, among which cardiopumonary arrest (CPA) stands out. School canteens are spaces where there is a possibility of witnessing CPA. Materials and methods: quasi-experimental interventional and analytical study. Participants received training through an interactive virtual platform and a face-to-face clinical simulation session on the Heimlich manoeuvre, basic cardiopulmonary resuscitation (CPR) and the use of the semiautomatic external defibrillator (SAED). We carried out a descriptive analysis of the study population and a comparative statistical analysis of the results obtained in the tests conducted before and after the virtual training. We created variable corresponding to the subtraction of the pre-training score from the post-training score. Clinical simulation was analysed by direct observation. Statistical significance was defined as p < 0.05. The statistical analysis was carried out with SPSS version 19.0. The study adhered to the principles of the Declaration of Helsinki and the guidelines on good clinical practice. Results: the entire sample consisted of women with a median age of 48.50 years. The median score in the pre-test was 6.7/10, and the score in the post-test was uniformly 10/10. The median difference between the pre- and post-training tests was of 3.3 points (p 0.01) and the simulation evinced that the learning was optimal. Conclusions: training in CPR is a strategy that has social impact in terms of the improvement in the response to a CPA events, achieving a reduction in the associated morbidity and mortality. (AU)

The effectiveness of a blended-learning training methodology on the dialysis nurse’s perception of competence. Quasi-experimental study / Efetividade de um programa de formação b-learning na perceção de competência do enfermeiro de diálise. Estudo quase-experimental

Introdução:Os enfermeiros que prestam cuidados à pessoa com doença renal crónica em hemodiálise devem ter formação específica em técnicas dialíticas. Assim, os Enfermeiros de Diálise deverão desenvolver competências específicas e diferenciadas ao longo do seu percurso profissional. O b-learning desempenha um papel fundamental na modernização do ensino, tornando-o mais acessível, flexível e adaptado às necessidades dos enfermeiros. Oferece oportunidades para melhorar a quali-dade da aprendizagem e promover a colaboração e a inovação no processo educativo.Objetivos:Os objetivos do estudo foram: avaliar a influência das variáveis sociodemográficas (idade e habilitações literárias) e da formação adquirida (frequência e duração) no perfil de competências e avaliar a eficácia de um programa de formação em técnicas de HD, na perceção de competência do Enfermeiro de Diálise. Material e Métodos:Estudo quase-experimental, pré e pós-teste, sem grupo controle. Resultados:A idade, a frequência e a duração da formação influenciam a perceção de competência do enfermeiro de diálise. Os participantes apresentaram uma melhoria significativa em alguns domínios da perceção de competência do Enfermeiro de Diálise após a implementação de um programa de formação em técnicas de HD. Conclusões:A existência de um programa de formação para Enfermeiros de Diálise, devidamente estruturado e padronizado, é uma mais-valia na aquisição, consolidação e atualização de conhecimentos. (AU)

Introduction: Nurses providing care to individuals with chronic kidney disease undergoing hemodialysis must have specific training in dialysis techniques. Therefore, Dialysis Nurses should develop specific and differentiated competencies throughout their professional career. Blended learning plays a fundamental role in modernizing education, making it more accessible, flexible, and tailored to the needs of nurses. It offers opportunities to improve the quality of learning and promote collaboration and innovation in the educational process. Objectives: The study’s objectives were to assess the influence of sociodemographic variables (age and education) and acquired training (frequency and duration) on the competence profile and to evaluate the effectiveness of a training program in HD techniques on the perception of competence of Dialysis Nurses. Material and Methods: Quasi-experimental, pre and post-test study without a control group. Results: Age, frequency, and duration of training influence dialysis nurses’ perceptions of competence. Participants showed a significant improvement in some domains of dialysis nurses’ perceptions of competence after the implementation of a training program in HD techniques. Conclusions: A properly structured and standardized training program for dialysis nurses is an asset in acquiring, consolidating, and updating knowledge. (AU)

Impacto de la implementación de un método de traspaso de información estandarizada interdisciplinar en sala de partos y unidad de cuidados obstétricos intermedios / Impact of the implementation of a standardised interdisciplinary information transfer method in the Delivery room and Intermediate Obstetric Care Unit

Objetivo Este estudio tiene como objetivo describir la implementación de la metodología estandarizada en la transferencia de información en sala de partos y unidad de cuidados obstétricos intermedios en un hospital de tercer nivel de Barcelona e identificar el impacto de esta implementación en los factores que actúan como facilitadores y barreras en el procedimiento. Método Estudio cuasiexperimental tipo pretest-postest sin grupo control en la unidad de cuidados obstétricos intermedios y sala de partos del servicio de Medicina Maternofetal de un hospital de tercer nivel de Barcelona. El personal sanitario autocumplimentó un cuestionario ad hoc antes y después de implementar la metodología estandarizada IDEAS en el servicio durante 2019 y 2020. Se evaluó la autopercepción personal en el procedimiento de transferencia de información. El test de Wilcoxon por pares se utilizó para la comparación antes y después. Resultados El uso de una metodología estandarizada ha mostrado un impacto en la mejora de la transmisión de la información. Se detectaron diferencias significativas antes y después de la intervención en las siguientes dimensiones: ubicación, personas implicadas, periodo de tiempo del procedimiento, estructurada ordenada y clara y tiempo suficiente para preguntas (p<0,001); mientras que no se observaron diferencias en transmisión al profesional referente, actuaciones bien definidas y realización de un resumen. Conclusiones Existen factores, como aspectos estructurales, organizativos y falta de tiempo, que dificultan la comunicación efectiva, por tanto, actúan como barreras en la transferencia de información. La implementación de una metodología con las personas implicadas, el tiempo y el espacio adecuado permite mejorar aspectos en la comunicación en el equipo multiprofesional y, por tanto, la seguridad del paciente. (AU)

Aim This study aims to describe the implementation of the standard methodology for information transfer in the labour ward and Intermediate Obstetric Care Unit and to identify the impact of this implementation on the factors that act as facilitators and barriers in the procedure. Method Quasi-experimental pretest-posttest study without a control group in an Intermediate Obstetric Care Unit and delivery room of the Maternal-Fetal Medicine Service of a tertiary hospital in Barcelona. Healthcare staff self-completed an ad hoc questionnaire before and after implementing the standardised IDEAS methodology in the service during 2019 and 2020. Personal self-perception in the information transfer procedure was assessed. The Wilcoxon pairwise test was used for comparison before and after. Results The use of a standardised methodology has shown an impact on improving the transmission of information. Significant differences were detected before and after the intervention in the following dimensions: location, people involved, time period of the procedure, structured, orderly and clear, and sufficient time for questions (p<0.001); while no differences were observed in: transmission to the referring professional, well-defined actions, and completion of a summary. Conclusions There are factors such as structural and organisational aspects and lack of time that hinder effective communication and therefore act as barriers to the transfer of information. The implementation of a methodology with the health professionals involved, the time and the appropriate space allows for the improvement of communication aspects in the multiprofessional team and, therefore, patient safety. (AU)

Eficacia y seguridad de un compuesto de ácidos grasos hiperoxigenados en la mejora de la microcirculación de la púrpura fulminante en pacientes pediátricos con sepsis: estudio piloto / Efficacy and safety of a hyperoxygenated fatty acid compound in improving the microcirculation of purpura fulminans in paediatric patients with sepsis: a pilot study

Introducción La púrpura fulminante (PF) es una complicación grave de la sepsis resultado de un conjunto de alteraciones caracterizadas por el desarrollo de lesiones hemorrágicas equimóticas y necrosis de la piel. Objetivo Analizar la eficacia y la seguridad de la aplicación tópica de un compuesto de ácidos grasos hiperoxigenados (AGHO) en la microcirculación de la PF en pacientes pediátricos afectados de sepsis. Material y métodos Se llevó a cabo un estudio prospectivo cuasiexperimental pretest-posttest de un solo grupo en una Unidad de Cuidados Intensivos Pediátrica (UCIP). Se incluyeron en el estudio pacientes con PF de 0 a 18 años. Para evaluar la efectividad del producto objeto de evaluación en la microcirculación de las lesiones por PF se determinaron los valores de oximetría somática antes y después de la aplicación de AGHO cada 4h durante los 3 primeros días de ingreso de los pacientes. Resultados Se reclutaron 4 pacientes, con una mediana de edad de 98 meses. Las lesiones purpúricas que se midieron estaban ubicadas, sobre todo, en ambos pies y manos y, en 2 pacientes, también en los maléolos laterales y gemelos de ambas extremidades inferiores. Se obtuvieron un total de 225 mediciones, observando unas puntuaciones medias preintervención de 71,17±15,65% versus los 73,68±14,83% postintervención. Se objetivó significación estadística (p<0,001) al comparar las mediciones pre- y postintervención. Conclusiones La aplicación precoz y continuada de AGHO en el manejo de la PF por sepsis es una práctica eficaz y segura en los casos de población pediátrica analizada. En más de la mitad de los episodios analizados se objetivó un aumento de microcirculación tisular tras la aplicación de los AGHO, sin eventos adversos. (AU)

Introduction Purpura fulminans (PF) is a serious complication of sepsis resulting from a set of alterations characterised by the development of ecchymotic haemorrhagic lesions and skin necrosis. Aim To analyse the efficacy and safety of the topical application of HOFA compound, in the cutaneous microcirculation of PF lesions in paediatric patients affected by sepsis. Material and methods A prospective quasi-experimental pre-test/post-test single-group conducted in a Paediatric Intensive Care Unit of a third level hospital was performed. Paediatric patients aged 0-18 years with sepsis were included. Somatic oximetry values were measured before and after application of HOFAs every 4hours over the first three days of the patients’ hospitalisation. Patient's socio-demographic and clinical variables and somatic oximetry by placing a sensor for measuring tissue perfusion on the area with PF were determined. Results Four patients were recruited, with a median age of 98 months. The purpuric lesions measured were mainly located on both feet and hands and, in two patients, also on the lateral malleoli and calves of both lower extremities. A total of 225 measurements were obtained, with mean pre-intervention scores of 71.17±15.65% versus 73.68±14.83% post-intervention. Statistical significance (p<0.001) was observed upon comparison of the pre- and post-intervention measurements. Conclusions Early and continued application of HOFAs in the management of sepsis-induced PF is an effective and safe practice in the cases analysed. In more than half of the episodes analysed, an increase in tissue microcirculation was observed after the application of HOFAs, with no adverse events. (AU)

Impacto de la implementación de un método de traspaso de información estandarizada interdisciplinar en sala de partos y unidad de cuidados obstétricos intermedios / Impact of the implementation of a standardised interdisciplinary information transfer method in the Delivery room and Intermediate Obstetric Care Unit

Objetivo Este estudio tiene como objetivo describir la implementación de la metodología estandarizada en la transferencia de información en sala de partos y unidad de cuidados obstétricos intermedios en un hospital de tercer nivel de Barcelona e identificar el impacto de esta implementación en los factores que actúan como facilitadores y barreras en el procedimiento. Método Estudio cuasiexperimental tipo pretest-postest sin grupo control en la unidad de cuidados obstétricos intermedios y sala de partos del servicio de Medicina Maternofetal de un hospital de tercer nivel de Barcelona. El personal sanitario autocumplimentó un cuestionario ad hoc antes y después de implementar la metodología estandarizada IDEAS en el servicio durante 2019 y 2020. Se evaluó la autopercepción personal en el procedimiento de transferencia de información. El test de Wilcoxon por pares se utilizó para la comparación antes y después. Resultados El uso de una metodología estandarizada ha mostrado un impacto en la mejora de la transmisión de la información. Se detectaron diferencias significativas antes y después de la intervención en las siguientes dimensiones: ubicación, personas implicadas, periodo de tiempo del procedimiento, estructurada ordenada y clara y tiempo suficiente para preguntas (p<0,001); mientras que no se observaron diferencias en transmisión al profesional referente, actuaciones bien definidas y realización de un resumen. Conclusiones Existen factores, como aspectos estructurales, organizativos y falta de tiempo, que dificultan la comunicación efectiva, por tanto, actúan como barreras en la transferencia de información. La implementación de una metodología con las personas implicadas, el tiempo y el espacio adecuado permite mejorar aspectos en la comunicación en el equipo multiprofesional y, por tanto, la seguridad del paciente. (AU)

Aim This study aims to describe the implementation of the standard methodology for information transfer in the labour ward and Intermediate Obstetric Care Unit and to identify the impact of this implementation on the factors that act as facilitators and barriers in the procedure. Method Quasi-experimental pretest-posttest study without a control group in an Intermediate Obstetric Care Unit and delivery room of the Maternal-Fetal Medicine Service of a tertiary hospital in Barcelona. Healthcare staff self-completed an ad hoc questionnaire before and after implementing the standardised IDEAS methodology in the service during 2019 and 2020. Personal self-perception in the information transfer procedure was assessed. The Wilcoxon pairwise test was used for comparison before and after. Results The use of a standardised methodology has shown an impact on improving the transmission of information. Significant differences were detected before and after the intervention in the following dimensions: location, people involved, time period of the procedure, structured, orderly and clear, and sufficient time for questions (p<0.001); while no differences were observed in: transmission to the referring professional, well-defined actions, and completion of a summary. Conclusions There are factors such as structural and organisational aspects and lack of time that hinder effective communication and therefore act as barriers to the transfer of information. The implementation of a methodology with the health professionals involved, the time and the appropriate space allows for the improvement of communication aspects in the multiprofessional team and, therefore, patient safety. (AU)

Eficacia y seguridad de un compuesto de ácidos grasos hiperoxigenados en la mejora de la microcirculación de la púrpura fulminante en pacientes pediátricos con sepsis: estudio piloto / Efficacy and safety of a hyperoxygenated fatty acid compound in improving the microcirculation of purpura fulminans in paediatric patients with sepsis: a pilot study

Introducción La púrpura fulminante (PF) es una complicación grave de la sepsis resultado de un conjunto de alteraciones caracterizadas por el desarrollo de lesiones hemorrágicas equimóticas y necrosis de la piel. Objetivo Analizar la eficacia y la seguridad de la aplicación tópica de un compuesto de ácidos grasos hiperoxigenados (AGHO) en la microcirculación de la PF en pacientes pediátricos afectados de sepsis. Material y métodos Se llevó a cabo un estudio prospectivo cuasiexperimental pretest-posttest de un solo grupo en una Unidad de Cuidados Intensivos Pediátrica (UCIP). Se incluyeron en el estudio pacientes con PF de 0 a 18 años. Para evaluar la efectividad del producto objeto de evaluación en la microcirculación de las lesiones por PF se determinaron los valores de oximetría somática antes y después de la aplicación de AGHO cada 4h durante los 3 primeros días de ingreso de los pacientes. Resultados Se reclutaron 4 pacientes, con una mediana de edad de 98 meses. Las lesiones purpúricas que se midieron estaban ubicadas, sobre todo, en ambos pies y manos y, en 2 pacientes, también en los maléolos laterales y gemelos de ambas extremidades inferiores. Se obtuvieron un total de 225 mediciones, observando unas puntuaciones medias preintervención de 71,17±15,65% versus los 73,68±14,83% postintervención. Se objetivó significación estadística (p<0,001) al comparar las mediciones pre- y postintervención. Conclusiones La aplicación precoz y continuada de AGHO en el manejo de la PF por sepsis es una práctica eficaz y segura en los casos de población pediátrica analizada. En más de la mitad de los episodios analizados se objetivó un aumento de microcirculación tisular tras la aplicación de los AGHO, sin eventos adversos. (AU)

Introduction Purpura fulminans (PF) is a serious complication of sepsis resulting from a set of alterations characterised by the development of ecchymotic haemorrhagic lesions and skin necrosis. Aim To analyse the efficacy and safety of the topical application of HOFA compound, in the cutaneous microcirculation of PF lesions in paediatric patients affected by sepsis. Material and methods A prospective quasi-experimental pre-test/post-test single-group conducted in a Paediatric Intensive Care Unit of a third level hospital was performed. Paediatric patients aged 0-18 years with sepsis were included. Somatic oximetry values were measured before and after application of HOFAs every 4hours over the first three days of the patients’ hospitalisation. Patient's socio-demographic and clinical variables and somatic oximetry by placing a sensor for measuring tissue perfusion on the area with PF were determined. Results Four patients were recruited, with a median age of 98 months. The purpuric lesions measured were mainly located on both feet and hands and, in two patients, also on the lateral malleoli and calves of both lower extremities. A total of 225 measurements were obtained, with mean pre-intervention scores of 71.17±15.65% versus 73.68±14.83% post-intervention. Statistical significance (p<0.001) was observed upon comparison of the pre- and post-intervention measurements. Conclusions Early and continued application of HOFAs in the management of sepsis-induced PF is an effective and safe practice in the cases analysed. In more than half of the episodes analysed, an increase in tissue microcirculation was observed after the application of HOFAs, with no adverse events. (AU)

Effectiveness of hybrid digital breast tomosynthesis/digital mammography compared to digital mammography in women presenting for routine screening at Maroondah BreastScreen: Study protocol for a co-designed, non-randomised prospective trial.

BACKGROUND: Digital breast tomosynthesis (DBT) for breast cancer screening has been shown in international trials to increase cancer detection compared with mammography; however, results have varied across screening settings, and currently there is limited and conflicting evidence on interval cancer rates (a surrogate for screening effectiveness). Australian pilot data also indicated substantially longer screen-reading time for DBT posing a barrier for adoption. There is a critical need for evidence on DBT to inform its role in Australia, including evaluation of potentially more feasible models of implementation, and quantification of screening outcomes by breast density which has global relevance. METHODS: This study is a prospective trial embedded in population-based Australian screening services (Maroondah BreastScreen, Eastern Health, Victoria) comparing hybrid screening comprising DBT (mediolateral oblique view) and digital mammography (cranio-caudal view) with standard mammography screening in a concurrent group attending another screening site. All eligible women aged ≥40 years attending the Maroondah service for routine screening will be enrolled (unless they do not provide verbal consent and opt-out of hybrid screening; are unable to provide consent; or where a 'pushback' image on hybrid DBT cannot be obtained). Each arm will enrol 20,000 women. The primary outcomes are cancer detection rate (per 1000 screens) and recall rate (percentage). Secondary outcomes include 'opt-out' rate; cohort characteristics; cancer characteristics; assessment outcomes; screen-reading time; and interval cancer rate at 24-month follow-up. Automated volumetric breast density will be measured to allow stratification of outcomes by mammographic density. Stratification by age and screening round will also be undertaken. An interim analysis will be undertaken after the first 5000 screens in the intervention group. DISCUSSION: This is the first Australian prospective trial comparing hybrid DBT/mammography with standard mammography screening that is powered to show differences in cancer detection. Findings will inform future implementation of DBT in screening programs world-wide and provide evidence on whether DBT should be adopted in the broader BreastScreen program in Australia or in subgroups of screening participants. TRIAL REGISTRATION: The trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR, ACTRN12623001144606, https://www.anzctr.org.au/). Registration will be updated to reflect trial progress and protocol amendments.

Study Protocol for a Controlled Trial of Nutrition Education Intervention about Celiac Disease in Primary School: ZELIAKIDE Project.

The only treatment for celiac disease (CD) is a strict and lifelong gluten-free diet (GFD), which must be safe and nutritionally balanced. Avoiding gluten brings difficulties with following the diet and can affect the social life of people with CD. The Zeliakide Project is a nutrition education program aimed at increasing the knowledge of the general population about healthy diets, CD and GFD, and, therefore, to improve the social inclusion and quality of life of people with CD. It is a one-month intervention program, two-armed cluster, non-randomised and controlled trial, conducted among 10-12-year-old children. Pre- and post-intervention evaluation and 1 month follow-up will be carried out to assess the effectiveness of the program. It is based on competencies and their respective learning outcomes. The teaching methodology chosen is a STEAM methodology: inquiry-based learning (IBL). A teaching unit has been created to develop the project, which, in the future, will be useful for the self-application of the program. This study will provide a valid and useful tool to achieve changes in the diet at the school level and will help to promote the social inclusion of people with CD. Moreover, it will enforce the STEAM competences of children.