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Elements of organisation of integrated maternity care and their associations with outcomes: a scoping review protocol

Por: Liebregts · J. · Goodarzi · B. · Valentijn · P. P. · Downe · S. · Erwich · J. J. · Burchell · G. · Batenburg · R. · de Vries · E. F. · de Jonge · A. · Verhoeven · C. J. M. · VOICE study group · Graaf · Heemstra · Rippen · Struijs · Zuidhof · Boesveld · Kaiser · Fransen · Berks · Haga
Introduction

Integrated care is seen as an enabling strategy in organising healthcare to improve quality, finances, personnel and sustainability. Developments in the organisation of maternity care follow this trend. The way care is organised should support the general aims and outcomes of healthcare systems. Organisation itself consists of a variety of smaller ‘elements of organisation’. Various elements of organisation are implemented in different organisations and networks. We will examine which elements of integrated maternity care are associated with maternal and neonatal health outcomes, experiences of women and professionals, healthcare spending and care processes.

Methods and analysis

We will conduct this review using the JBI methodology for scoping reviews and the reporting guideline PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews). We will undertake a systematic search in the databases PubMed, Scopus, Cochrane and PsycINFO. A machine learning tool, ASReview, will be used to select relevant papers. These papers will be analysed and classified thematically using the framework of the Rainbow Model of Integrated Care (RMIC). The Population Concept Context framework for scoping reviews will be used in which ‘Population’ is defined as elements of the organisation of integrated maternity care, ‘Context’ as high-income countries and ‘Concepts’ as outcomes stated in the objective of this review. We will include papers from 2012 onwards, in Dutch or English language, which describe both ‘how the care is organised’ (elements) and ‘outcomes’.

Ethics and dissemination

Since this is a scoping review of previously published summary data, ethical approval for this study is not needed. Findings will be published in a peer-reviewed international journal, discussed in a webinar and presented at (inter)national conferences and meetings of professional associations.

The findings of this scoping review will give insight into the nature and effectiveness of elements of integrated care and will generate hypotheses for further research.

Initial prescriptions and medication switches of biological products: an analysis of prescription pathways and determinants in the Swiss healthcare setting

Por: Wirth · K. · Boes · S. · Näpflin · M. · Huber · C. · Blozik · E.
Objectives

Biological products have contributed to extraordinary advances in disease treatments over the last decade. However, the cost-saving potential of imitator products, so-called biosimilars, is still under-researched in Switzerland. This study aims to assess biosimilars’ prescriptions at treatment initiation and their determinants, as well as biological therapy switches.

Design

The study included all patients who had at least one biosimilar available on the market at the time when they were prescribed a biological product. We analysed longitudinal data for biosimilar prescriptions in Switzerland using descriptive statistics and logistic regression to quantify the associations with individual, pharmaceutical and provider-related variables.

Setting

The analysis is based on de-identified claims data of patients with mandatory health insurance at Helsana, one of the Swiss health insurance companies with a substantial enrollee base in mandatory health insurance.

Participants

Overall, 18 953 patients receiving at least one biological product between 2016 and 2021 were identified.

Outcome measures

We differentiated between initial prescriptions and follow-up prescriptions. Our regression focused on initial prescriptions due to evidence indicating that patients tend to follow the medication prescribed at therapy initiation.

Results

Although biosimilars’ market share was low (28.6%), the number of prescriptions has increased (from 1016 in 2016 to 6976 in 2021). Few patients with medication switches (n=1492, 8.5%) were detected. Increased relative price difference (difference in the price of available biosimilars relative to price of corresponding reference product) was associated with decreased probability of biosimilar prescriptions, whereas male sex, an increase of available imitator drugs on the market, larger packaging sizes, and prescriptions from specialists or physicians in outpatient settings were associated with increased biosimilar use.

Conclusion

The low number of biosimilar prescriptions, despite the proliferating biosimilar market, indicates a high potential for biosimilar diffusion. The findings indicate that patients typically adhere to the therapy options initially chosen and are less inclined to make changes following the initiation of treatment. Our research highlights the need for awareness initiatives to improve understanding among patients and physicians, enabling informed, shared decision-making about biosimilar prescriptions.

Danish Prostate Cancer Consortium Study 1 (DPCC-1) protocol: Multicentre prospective validation of the urine-based three-microRNA biomarker model uCaP

Por: Fredsoe · J. · Glud · E. · Boesen · L. · Logager · V. · Poulsen · M. H. · Pedersen · B. G. · Borre · M. · Sorensen · K. D.
Introduction

The primary objective of the Danish Prostate Cancer Consortium Study 1 (DPCC-1) is to provide validation for a novel urine-based microRNA biomarker, called uCaP, for a diagnosis of prostate cancer.

Methods and analysis

Eligible participants are biopsy naïve men aged ≥18 years with prostate-specific antigen (PSA) levels ≥3 ng/mL, who are referred to prostate MRI due to suspicion of PC at one of the following three major urology/uroradiology centers: Aarhus University Hospital, Herlev & Gentofte University Hospital, or Odense University Hospital, where MRI and targeted biopsy are implemented in clinical use. Exclusion criteria include previous diagnosis of urogenital cancer, contraindication to MRI, gender reassignment treatment or PSA level >20 ng/mL. The participants will be asked to donate a urine sample in connection with their MRI. The study is observational, uses a diagnostic accuracy testing setup and will integrate into the current diagnostic pathway.

We will measure the levels of the three microRNAs in the uCaP model (miR-222–3 p, miR-24–3 p and miR-30c-5p) in extracellular vesicle-enriched cell-free urine samples, to assess if uCaP can improve specificity and retain sensitivity for International Society of Urological Pathology Grade Group ≥2 PC, when used as a reflex test to PSA ≥3 ng/mL. We hypothesise that uCaP can improve selection for prostate MRI and reduce the number of unnecessary scans and biopsies.

Ethics and dissemination

This study is approved by the Central Denmark Region Committee on Health Research Ethics (reference number: 1-10-72-85-22). All participants will provide written informed consent. Study results will be published in peer-reviewed journals and presented in scientific meetings.

Trial registration number

NCT05767307 at clinicaltrials.gov.

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