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Participative research for individualised care in cardiovascular diseases (PRIC-CVD): study protocol for a non-interventional, multicentre mixed-methods study as part of iCARE4CVD

Por: Steiner · B. · Verket · M. · Baldewijns · K. · Murphy · M. · McNulty · A. · Schwertfeger · M. · Friedl · S. · Barrett · M. · Hill · L. · Brandts · J. · Romero · I. · Helms · T. M. · Brunner-La Rocca · H.-P. · Zippel-Schultz · B. · on behalf of the iCARE4CVD Consortium
Introduction

Cardiovascular disease (CVD) represents a public health burden, with high prevalence and significant morbidity and mortality. Although evidence-based interventions exist, there is a need for more individualised care. The European project Individualised care from early risk of cardiovascular disease to established heart failure (iCARE4CVD) aims to personalise CVD prevention and treatment. Participatory health research, which actively involves patients in the planning, implementation and evaluation of projects, plays a crucial role here. However, patient participation is often unsuccessful due to the lack of a representative patient sample who is involved throughout the project’s duration, has knowledge of the project and can contribute their experience.

Methods and analysis

Participative Research for Individualised Care in Cardiovascular Diseases is a non-interventional, non-randomised, multicentre mixed-methods study. The aim is to incorporate patients’ insights into several key activities within iCARE4CVD by establishing country-specific patient panels in Belgium, Germany, Ireland and the UK. The primary objective is to identify patients’ preferences, experiences, requirements and needs for better diagnosis, treatment and self-care of CVD. Therefore, 10–12 patients across the CVD spectrum, from early risk to established CVD and heart failure, will be included in each country (40–48 in total). Over 3.5 years, patient panel members are required to complete four tasks: (1) identification of meaningful Patient-Reported Outcome and Experiences Measures, (2) development of a motivational model to increase adherence, (3) feedback on CVD care processes and (4) usability testing of new digital tools developed within iCARE4CVD. These tasks comprise eight activities in the form of paper-based or digital exercises, telephone surveys, written surveys and in-person focus groups. The results will be continuously incorporated into iCARE4CVD.

Ethics and dissemination

This study received ethical approval by the Ethics Committee at the Faculty of Medicine of RWTH Aachen University (EK 24-172) and St. Vincent’s University Hospital (RS24-027), Research Ethics Committee. In Geel and Belfast, positive ethics approval is pending. All participants will provide written informed consent prior to enrolment in the study and participation in the first patient panel task. Results will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number

DRKS00034899.

Protocol version

V2.1, 6 June 2024.

Effectiveness of a Tailored Psychoeducational Intervention for Patients With Advanced Cancer in Indonesia: A Randomized Controlled Trial

ABSTRACT

Background

Patients with advanced cancer often face numerous physical, psychological, and practical challenges from their disease and treatments, yet interventions addressing their specific unmet needs remain limited.

Purpose

This study aimed to evaluate the effectiveness of a tailored psychoeducational intervention (PEI) on stress, anxiety, depression, coping, and fatigue among advanced cancer patients in Indonesia.

Design

A randomized controlled trial was conducted from August 2022 to March 2023 in Indonesia.

Methods

A total of 151 advanced cancer patients from a referral hospital in Indonesia were randomized into intervention and control (conventional management) groups. Participants were assessed using validated questionnaires including the Depression, Anxiety, and Stress Scale (DASS-21), Fatigue Severity Scale (FSS), and Brief COPE at three time points: baseline (T0, before intervention), after first intervention (T1), and after second intervention (T2). The PEI was delivered face-to-face with telephone follow-up calls. Generalized Estimating Equations (GEE) analysis was used to evaluate the intervention's effectiveness.

Results

The intervention was significantly associated with improved coping and reduced fatigue scores. Significant time effects were observed for depression, stress, coping, and fatigue scores. For anxiety, a significant impact was found at the second time point but not at the third, compared to the baseline. The difference-in-difference (DID) analysis revealed significant effects on coping and fatigue scores, while anxiety only showed significance at the second time point.

Conclusions

This study provides evidence for the potential effectiveness of PEI in improving coping strategies, relieving stress, anxiety, and depression, and reducing fatigue among advanced cancer patients in Indonesia.

Clinical Relevance

The tailored PEI, including follow-up phone calls, can be independently implemented by nurses. Focusing on patients' unmet needs and spirituality, this intervention can help manage mental health issues and strengthen coping mechanisms, potentially leading to positive effects on physical conditions such as fatigue.

Cost-effectiveness analysis of the Assessment of Burden of Chronic Conditions (ABCC) tool in primary care in the Netherlands

Por: Peters · L. H. · Joore · M. A. · Gidding-Slok · A. H. · Keijsers · L. C. · Twellaar · M. · Boudewijns · E. A. · van Schayck · O. C. · Muris · J. W. · Kimman · M. L.
Objectives

The increasing prevalence of chronic conditions and multimorbidity places a significant burden on patients and leads to increasing challenges for healthcare systems, especially in primary care. Recognising the multifaceted nature of chronic conditions, the Assessment of Burden of Chronic Conditions (ABCC) tool was developed to support person-centred care, by facilitating shared decision-making and self-management. This study aims to evaluate the cost-effectiveness of the ABCC tool in primary care.

Design and setting

This cost-effectiveness analysis was conducted over 18 months alongside a clustered, two-arm quasi-experimental study in primary care in the Netherlands.

Participants

The study included 231 participants diagnosed with chronic obstructive pulmonary disease (COPD), asthma, type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF). Of these, 173 were assigned to the intervention group and 58 to the control group.

Interventions

The intervention group was intended to incorporate the ABCC tool into routine consultations, while the control group had to continue care as usual.

Outcome measures

Outcomes were assessed from a societal perspective, including quality-adjusted life years (QALYs) derived via the EuroQol-5D-5L (EQ-5D-5L) questionnaire. Costs were measured using adapted versions of the Productivity Costs Questionnaire (PCQ) and Medical Consumption Questionnaire (MCQ). Sensitivity analyses (SAs) included a healthcare perspective, per-protocol analysis (to account for disruptions caused by COVID-19) and exclusion of home care costs (to address extreme outliers). Moreover, all analyses were performed for well-being-adjusted life years (WALYs), derived from the ICEpop CAPability measure for Adults (ICECAP-A) questionnaire.

Results

The ABCC tool was more expensive and effective than usual care, with an incremental cost-effectiveness ratio (ICER) of 64 525 per QALY and a 29% probability of cost-effectiveness. With the exception of the healthcare perspective, the SAs yielded more favourable outcomes in terms of cost-effectiveness, with ICERs (probability of cost-effectiveness) of 41 484 (31%), 8683 (58%) and 23 905 (48%) for a healthcare perspective, per-protocol analysis and exclusion of home care costs, respectively. Outcomes for QALY and WALY were comparable.

Conclusion

While the primary analysis suggested a relatively low probability of cost-effectiveness, the SAs showed higher probabilities. The per-protocol analysis suggested that the ABCC tool can be cost-effective when actually used.

Trial registration number

NCT04127383.

Low-dose versus high-dose intravenous nitroglycerin in the treatment of sympathetic crashing acute pulmonary oedema: a systematic review and meta-analysis focusing on efficacy, safety and outcomes

Por: Pramudyo · M. · Kamarullah · W. · Pranata · R. · Prameswari · H. S. · Iqbal · M. · Dewi · T. I. · Hidayat · S. · Akbar · M. R.
Objectives

Sympathetic crashing acute pulmonary oedema (SCAPE) is a menacing medical emergency and a severe form of acute heart failure that requires urgent intervention. Nitroglycerin (NTG) is commonly used in SCAPE management, but the optimal dosing remains uncertain. This meta-analysis compared the efficacy and safety of high-dose vs low-dose NTG in SCAPE patients, assessing mechanical ventilation need, symptom resolution, hospital stay and major adverse cardiovascular events (MACE).

Design

Systematic review and meta-analysis conducted per Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, registered in Prospective Register of Systematic Reviews (CRD42024527486).

Data sources

A comprehensive search in PubMed, Europe PMC and ScienceDirect up to November 2024. Reference lists of included studies were also reviewed.

Eligibility criteria

Randomised controlled trials (RCTs) and observational studies comparing high-dose NTG (≥100 mcg/min) with low-dose NTG (

Data extraction and synthesis

Two authors independently screened the titles and abstracts of identified studies for eligibility. Full texts of potentially relevant articles were then reviewed. Any discordance or disagreements were resolved through discussion, with final decisions made by consensus. Risk of bias was assessed using the Newcastle–Ottawa Scale. Meta-analysis was performed using STATA 17.0 and Review Manager 5.4. The Mantel–Haenszel method was applied for dichotomous outcomes, and the inverse variance approach for continuous outcomes. Heterogeneity was assessed via I-squared (I)2, with a random-effects model applied when needed.

Results

Four studies (one RCT, three observational) with 185 SCAPE patients met inclusion criteria. High-dose NTG reduced mechanical ventilation need (RR=0.31, 95% CI: 0.10 to 0.96; p=0.04, I2=0%, high certainty) and increased symptom resolution within 6 hours (RR=3.88, 95% CI: 1.95 to 7.71; p2=27%, moderate certainty). Hospital stay was shorter (MD=–47.49 hours, 95% CI: –93.76 to –1.21; p=0.04, I2=78%, low certainty). No significant difference was found in MACE risk (RR=0.41, 95% CI: 0.06 to 2.68; p=0.35, I2=72%, very low certainty). Hypotension incidence was 0% in both groups.

Conclusions

High-dose NTG improved clinical outcomes in SCAPE, reducing mechanical ventilation need, symptom duration and hospital stay without increased adverse events. These findings suggest high-dose NTG as a promising treatment strategy. Further large-scale studies are needed to optimise dosing protocols.

Post-market quality assessment of antibiotics: findings from a cross-sectional study using standardised patients in Tabalong and Bekasi districts, Indonesia

Por: Mashuri · Y. A. · Hasanah · M. · Rahayu · I. D. · Liverani · M. · Probandari · A. · Batura · N. · Schierhout · G. · Ferdiana · A. · Wulandari · L. P. L. · Dewi · B. K. · Jan · S. · Yeung · S. · Wiseman · V. · Day · R. · Wibawa · T.
Objectives

In Indonesia, antibiotics are often purchased without a prescription at community pharmacies, contrary to current regulations. This practice may increase the risk of out-of-specification (OOS) medicines being dispensed, potentially contributing to treatment failure and antibiotic resistance. To address this concern, we assessed the quality of antibiotics purchased without a prescription at private drug retail outlets (PDROs) in Indonesia.

Design and setting

We conducted a cross-sectional study in Tabalong and Bekasi, Indonesia, using standardised patients (SPs) who purchased antibiotics without a prescription for three clinical scenarios: upper respiratory tract infection (URTI), tuberculosis (TB) and child diarrhoea. The pharmacies and drug stores were randomly selected from each subdistrict based on the probability proportional method. We measured the active pharmaceutical ingredient (API) content of the antibiotic samples using high-performance liquid chromatography (HPLC).

Samples and analysis

The quality of 183 antibiotics including amoxicillin tablets (148/183, 80.9%, 95% CI 74.7% to 86.1%), amoxicillin dry syrup (12/183, 6.6%, 95% CI 3.6% to 10.8%), ampicillin tablets (5/183, 2.7%, 95% CI 1.1% to 5.9%) and ciprofloxacin tablets (18/183, 9.8%, 95% CI 6.2% to 14.8%) obtained from 117/166 (70.5%, 95% CI 62.8 to 77.2) PDROs were tested. Descriptive statistics were used to describe the characteristics of the purchased antibiotics, and the API content of each antibiotic was compared against the United States Pharmacopeia 43-National Formulary 38 (USP 43-NF 38) standards in absolute values and percentages.

Results

Almost all samples produced in Indonesia (182/183, 99.5%, 95% CI 97.5% to 99.9%) were unbranded (123/183, 67.2%, 95% CI 60.2% to 73.7%) or branded generic (60/183, 32.8%, 95% CI 26.3% to 39.8%) and packaged in strips (165/183, 90.2%, 95% CI 85.2% to 93.8%). Around 12/183 (6.6%, 95% CI 3.6% to 10.8%) antibiotics were found to be OOS; these were mostly amoxicillin 125 mg dry syrup (6/12, 50%, 95% CI 24.3% to 75.7%) and ciprofloxacin 500 mg tablet (5/18, 27.8%, 95% CI 11.5% to 50.6%). Around 33% (4/12, 95% CI 12.5% to 61.2%) of amoxicillin 125 mg dry syrup samples had an API content above the label claim, the highest being 187%, whereas 16.7% (2/12, 95% CI 3.6% to 43.6%) were below the label claim, the lowest being 64%. About 27.8% (5/18, 95% CI 11.5% to 50.6%) of ciprofloxacin samples tested had an API content above the label claim; the highest was 120%.

Conclusion

While the proportion of OOS antibiotics identified was relatively small, at a population level, it represents a significant proportion of sub-optimally treated infections.

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