Romanian National Guideline on Translating Fecal Microbiota Transplantation Applications related to Clostridioides difficile Infections into the Local Clinical Practice

Gîlcă-Blanariu, Georgiana Emmanuela; Ştefănescu, Gabriela; Gîrleanu, Irina; Iqbal, Tariq; Segal, Jonathan; Mullish, Benjamin H.; Quraishi, Mohammed Nabil; Keller, Josbert J.; Molnár, Tamás; Mégraud, Françis; Dumitraşcu, Dan L.; Manuc, Mircea; Iancu, Luminiţa Smaranda; Marica, Cristina; Gheorghe, Cristian; Manzoor, Susan; Trifan, Anca

doi:10.15403/jgld-3297

Cited by 3 publications

(6 citation statements)

References 126 publications

(204 reference statements)

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“…MWP (N=185) across 17 countries, India (93), UK (29), EU (24), Japan (11), US (9), Canada (6), and others (13), responded to the survey. Respondents were highly qualified with 87% having an MS/PhD/equivalent degree and MWF experience of 0-5 (26%), >5-10 (29%), >10-15 (24%), and >15 years (21%).…”

Section: Resultsmentioning

confidence: 99%

“…Clarification of document distinctions is provided in Table 1. [2][3][4]12,13,[24][25][26][27] As an example of the differences in readability and target reading ages between lay summaries and PLS, selected excerpts 28,29 showed the readability consensus was 12-14 years old for the lay summaries and 18-19 years old for the PLS (Figure 1, 28 Figure 2 29 ).…”

Section: Document Distinctions and Example Readability Comparisonsmentioning

confidence: 99%

“…Australia, Austria, Canada, Czechia, Denmark, Poland, Romania, South Korea, and the United Kingdom). [18][19][20][21][22][23][24][25][26] How ever, these guidelines are mostly an expert consensus of medical societies without the point of view of relevant regulatory authorities.…”

Section: Physicians' Approvalmentioning

confidence: 99%

“…The FAIR principles are domain-agnostic, and can be applied to many types of data including clinical trial and healthcare data. 24 As medical writers have key roles in communicating research findings, and preparing data to be shared, they are well placed to influence data sharing best practice in publications and promote FAIR data sharing efforts where possible.…”

Section: Introductionmentioning

confidence: 99%

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bench to the bedside. The logical next step is understandability in its broadest sense -ensuring that research findings are published in a way that can be understood as widely as possible.In our second article, Shalini Dwivedi and Vidhi Vashisht describe open access initiatives from a range of stakeholders and review the growing importance of plain language summaries (PLSs) in improving the transparency of medical research.The growing importance of com muni cating research in widely understandable language is reflected in the development of different document types for different purposes. Sarah Griffiths and colleagues review the varied terminology used to describe the three main types of document communicating in accessible language and chnage to make a case for harmonisation.Even with immediate open access to research results in understandable language, people with disabilities face unique barriers to information access. The author Jeffry Ricker, who is completely blind, explains how he faces obstacles every day owing, in part, to electronic documents designed primarily for those with vision. He also provides practical tips and resources for medical writers on writing for people with disabilities.Data sharing is an important principle of open science that has powerful potential to increase trust in published research. For medical research, ethical considerations place important constraints on the sharing of patient data, and Eniola Awodiya and Joana Osório evaluate how pharma ceutical companies are seeking to strike the right balance between patient privacy and transparency.Being free to access is of no value if content is not discoverable. The term grey literature is used to describe a wide range of different information that is produced outside traditional publishing and distribution channels. Typically, a lack of indexing or tagging with uniform metadata means that the grey literature is not easily discoverable. In our fifth article, Toby Green delivers a call to action to medical writers and communicators to engage with these rich and diverse sources of information.

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Section: Resultsmentioning

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Section: Document Distinctions and Example Readability Comparisonsmentioning

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Section: Physicians' Approvalmentioning

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Section: Introductionmentioning

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“All that is gold does not glitter”: Faecal microbiota transplantation

Kubátová¹

2022

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The management of Clostridioides difficile infection: from empirism to evidence

Deac,

Ofrim,

Fărcaș

et al. 2023

Medicine and Pharmacy Reports

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Clostridioides difficile infection (CDI) in clinical practice represents a challenge for its management and also prevention of recurrence. Even though there are updated guidelines for infection prevention, control and treatment, CDI remains a leading cause of healthcare acquired diarrhea with increasing incidence in the community. We present here a synthesis of the most recent international guidelines on the management of CDI. In 2021 updated guidelines on the treatment of CDI in adults were published by the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA), American College of Gastroenterology (ACG) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). These guidelines focused on CDI management in adults, including new data on the clinical efficacy of Fidaxomicin (FDX) and Bezlotoxumab. The 2017 publication of IDSA and SHEA - Clinical Practice Guidelines for Clostridium difficile infection also included pediatric treatment recommendations that are not a part of the 2021 update. Vancomycin (VAN) treatment for an initial CDI episode remains an acceptable alternative to FDX, considering the monetary and logistical challenge of acquiring FDX. There is growing literature on fecal microbiota transplantation (FMT) and the 2021 guidelines describe its role in severe complicated refractory CDI cases and for which surgical management is not feasible. Moreover, there are new data on the secondary prophylaxis with VAN in refractory CDI in patients with risk factors who receive broad spectrum antibiotics.

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Romanian National Guideline on Translating Fecal Microbiota Transplantation Applications related to Clostridioides difficile Infections into the Local Clinical Practice

Cited by 3 publications

References 126 publications

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“All that is gold does not glitter”: Faecal microbiota transplantation

The management of Clostridioides difficile infection: from empirism to evidence

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