bluuebunny/crossref_metadata_2025_split huggingface dataset:
Improving outcomes for hospitalised First Nations peoples through greater cultural safety and better communication: the Communicate Study Partnership study protocol
Authors: Ralph Anna P. , McGrath Stuart Yiwarr , Armstrong Emily , Herdman Rarrtjiwuy Melanie , Ginnivan Leah , Lowell Anne , Lee Bilawara , Gorham Gillian , Taylor Sean , Hefler Marita , Kerrigan Vicki 
Published: June 2023

Abstract

Background
The Communicate Study is a partnership project which aims to transform the culture of healthcare systems to achieve excellence in culturally safe care for First Nations people. It responds to the ongoing impact of colonisation which results in First Nations peoples experiencing adverse outcomes of hospitalisation in Australia’s Northern Territory. In this setting, the majority of healthcare users are First Nations peoples, but the majority of healthcare providers are not. Our hypotheses are that strategies to ensure cultural safety can be effectively taught, systems can become culturally safe and that the provision of culturally safe healthcare in first languages will improve experiences and outcomes of hospitalisation.

Methods
We will implement a multicomponent intervention at three hospitals over 4 years. The main intervention components are as follows: cultural safety training called ‘Ask the Specialist Plus’ which incorporates a locally developed, purpose-built podcast, developing a community of practice in cultural safety and improving access to and uptake of Aboriginal language interpreters. Intervention components are informed by the ‘behaviour change wheel’ and address a supply–demand model for interpreters. The philosophical underpinnings are critical race theory, Freirean pedagogy and cultural safety. There are co-primary qualitative and quantitative outcome measures: cultural safety, as experienced by First Nations peoples at participating hospitals, and proportion of admitted First Nations patients who self-discharge. Qualitative measures of patient and provider experience, and patient-provider interactions, will be examined through interviews and observational data. Quantitative outcomes (documentation of language, uptake of interpreters (booked and completed), proportion of admissions ending in self-discharge, unplanned readmission, hospital length of stay, costs and cost benefits of interpreter use) will be measured using time-series analysis. Continuous quality improvement will use data in a participatory way to motivate change. Programme evaluation will assess Reach, Effectiveness, Adoption, Implementation and Maintenance (‘RE-AIM’).

Discussion
The intervention components are innovative, sustainable and have been successfully piloted. Refinement and scale-up through this project have the potential to transform First Nations patients’ experiences of care and health outcomes.

Trial registration
Registered with ClinicalTrials.gov Protocol Record 2008644
Arthroscopic-assisted reduction and internal fixation for complex tibial plateau fracture: radiographic and clinical outcomes with 2- to 15-year follow-up
Authors: Cheng You-Hung , Yang Cheng-Pang , Chang Shih-Sheng , Weng Chun-Jui , Chiu Chih-Hao , Chan Yi-Sheng 
Published: June 2023

Abstract
Background
To investigate the radiologic and prognostic outcomes after using arthroscopic-assisted reduction and internal fixation (ARIF) in complex tibial plateau fractures with mid- to long-term follow-up.

Methods
This retrospective study reviewed complex tibial plateau fractures that underwent ARIF from 1999 to 2019. Radiologic outcomes, including tibial plateau angle (TPA), posterior slope angle (PSA), Kellgren–Lawrence classification and Rasmussen radiologic assessment, were measured and evaluated. The prognosis and complications were assessed by the Rasmussen clinical assessment with a minimum follow-up of 2 years.

Results
Ninety-two consecutive patients (mean age: 46.9 years) with a mean follow-up of 74.8 months (24–180) were included in our series. Using AO classification, there were 20 type C1 fractures, 21 type C2 fractures, and 51 type C3 fractures. All the fractures achieved solid union. TPA was maintained well on average at the last follow-up and showed no significant difference compared to postoperatively (p = 0.208). In the sagittal plane, the mean PSA increased from 9.3 ± 2.9° to 9.6 ± 3.1° (p = 0.092). A statistically significant increase in PSA was also noted in the C3 group (p = 0.044). Superficial or deep infection was noted in 4 cases (4.3%), and total knee arthroplasty (TKA) was performed in 2 cases (2.2%) due to grade 4 osteoarthritis (OA). Ninety (97.8%) and 89 (96.7%) patients had good or excellent results in the Rasmussen radiologic assessment and Rasmussen clinical assessment, respectively.

Conclusions
The complex tibial plateau fracture could be treated successfully using arthroscopy-assisted reduction and internal fixation. Most patients achieve excellent and good clinical outcomes with low complication rates. In our experience, a higher incidence of increased slope was noted, especially in type C3 fractures. Reduction of the posterior fragment should be done cautiously during the operation.

Levels of evidence
Level III.
Nutrition management of PKU with pegvaliase therapy: update of the web-based PKU nutrition management guideline recommendations
Authors: Cunningham Amy , Rohr Fran , Splett Patricia , Mofidi Shideh , Bausell Heather , Stembridge Adrya , Kenneson Aileen , Singh Rani H. 
Published: June 2023

Abstract
Background
The web-based GMDI/SERN PKU Nutrition Management Guideline, published before approval of pegvaliase pharmacotherapy, offers guidance for nutrition management of individuals with phenylketonuria (PKU) treated with dietary therapy and/or sapropterin. An update of this guideline aims to provide recommendations that improve clinical outcomes and promote consistency and best practice in the nutrition management of individuals with PKU receiving pegvaliase therapy. Methodology includes: formulation of a research question; review, critical appraisal, and abstraction of peer-reviewed studies and unpublished practice literature; expert input through Delphi surveys and a Nominal Group process; and external review by metabolic experts.

Results
Recommendations, summary statements, and strength of evidence are included for each of the following topics: (1) initiating a pegvaliase response trial, (2) monitoring therapy response and nutritional status, (3) managing pegvaliase treatment after response to therapy, (4) education and support for optimal nutrition with pegvaliase therapy, and (5) pegvaliase therapy during pregnancy, lactation, and adolescence. Findings, supported by evidence and consensus, provide guidance for nutrition management of individuals receiving pegvaliase therapy for PKU. Recommendations focus on nutrition management by clinicians, as well as the challenges for individuals with PKU as a result of therapy changes.

Conclusions
Successful pegvaliase therapy allows the possibility for individuals with PKU to consume an unrestricted diet while still maintaining the benefits of blood phenylalanine control. This necessitates a perspective change in education and support provided to individuals in order to achieve healthy nutrient intake that supports optimal nutritional status. The updated guideline, and companion Toolkit for practical implementation of recommendations, is web-based, allowing for utilization by health care providers, researchers, and collaborators who advocate and care for individuals with PKU. These guidelines are meant to be followed always taking into account the provider’s clinical judgement and considering the individual’s specific circumstances. Open access is available at the Genetic Metabolic Dietitians International (https://GMDI.org) and Southeast Regional Genetics Network (https://managementguidelines.net) websites.
Cryptosporidium parvum: an emerging occupational zoonosis in Finland
Authors: Enbom Tuulia , Suominen Kristiina , Laitinen Sirpa , Ollgren Jukka , Autio Tiina , Rimhanen-Finne Ruska 
Published: June 2023

Abstract
Background
Cryptosporidiosis has increased in recent years in Finland. We aimed to identify risk factors for human cryptosporidiosis and to determine the significance of Cryptosporidium parvum as a causative agent. Based on notifications to the Finnish Infectious Disease Register (FIDR), we conducted a case-control study and genotyped Cryptosporidium species from patient samples from July to December 2019. We also retrieved the occupational cryptosporidiosis cases from 2011 to 2019 from the Finnish Register of Occupational Diseases (FROD).

Results
Of 272 patient samples analyzed, 76% were C. parvum and 3% C. hominis. In the multivariable logistic regression analysis of 82 C. parvum cases and 218 controls, cryptosporidiosis was associated with cattle contact (OR 81, 95% confidence interval (CI) 26–251), having a family member with gastroenteritis (OR 34, 95% CI 6.2–186), and spending time at one’s own vacation home (OR 15, 95% CI 4.2–54). Of the cases, 65% had regular cattle contact. The most common gp60 subtypes identified were IIaA15G2R1 and IIaA13G2R1. In FROD, 68 recognized occupational cryptosporidiosis cases were registered in 2011–2019.

Conclusions
C. parvum is the most common Cryptosporidium species found in humans in Finland and poses a moderate to high risk of occupational infection for people working with cattle. The number of occupational notifications of cryptosporidiosis increased between 2011 and 2019. Cryptosporidiosis should be recognized as an important occupational disease among persons working with livestock in Finland, criteria to identify occupational cryptosporidiosis need to be created, and occupational safety in cattle-related work should be improved.
A survey for antibodies against Fasciola hepatica in cattle and sheep in Finland indicates a low level of exposure
Authors: Gröning Heini , Oksanen Antti , Skrzypczak Teresa , Autio Tiina 
Published: June 2023

Abstract
Background
Fasciolosis is a parasitic infection caused by the liver fluke Fasciola hepatica that can have a major economic impact on livestock industry. The prevalence of the disease has recently been increasing in many North European countries. The objective of this study was to determine the prevalence of antibody against F. hepatica in Finnish cattle herds and sheep flocks during 2019 by using a commercial enzyme-linked immunosorbent assay (ELISA). Randomly selected bulk tank milk samples were obtained from 660 dairy herds. Blood samples were collected at slaughterhouses from 1944 suckler cows from 309 herds and from 1120 sheep from 95 flocks.

Results
Antibodies against F. hepatica were found in 0.45% (95% confidence interval (CI): 0.15–1.33) of the dairy herds and 0.97% (95% CI: 0.33–2.82) of the suckler cow herds. The seropositive herds were located in eastern and central Finland. None of the sampled sheep flocks tested had antibodies against F. hepatica (95% CI: 0–3.89). The results of the assays were compared with meat inspection data received from the slaughterhouses. All positive herds also had liver condemnations due to F. hepatica based on the meat inspection reports.

Conclusions
Compared to other North European countries, the prevalence of fasciolosis in Finland can be considered low, and according to meat inspection reports, there are no indications of the prevalence increasing in Finland.
Small RNA modifications: regulatory molecules and potential applications
Authors: Xiong Qunli , Zhang Yaguang 
Published: June 2023

AbstractSmall RNAs (also referred to as small noncoding RNAs, sncRNA) are defined as polymeric ribonucleic acid molecules that are less than 200 nucleotides in length and serve a variety of essential functions within cells. Small RNA species include microRNA (miRNA), PIWI-interacting RNA (piRNA), small interfering RNA (siRNA), tRNA-derived small RNA (tsRNA), etc. Current evidence suggest that small RNAs can also have diverse modifications to their nucleotide composition that affect their stability as well as their capacity for nuclear export, and these modifications are relevant to their capacity to drive molecular signaling processes relevant to biogenesis, cell proliferation and differentiation. In this review, we highlight the molecular characteristics and cellular functions of small RNA and their modifications, as well as current techniques for their reliable detection. We also discuss how small RNA modifications may be relevant to the clinical applications for the diagnosis and treatment of human health conditions such as cancer.
Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2): protocol for a multi-centre randomised controlled trial
Authors: Mackenzie Scott C. , Stephen Jacqueline , Williams Linda , Daniels Jane , Norrie John , Becker Christian M. , Byrne Dominic , Cheong Ying , Clark T. Justin , Cooper Kevin G. , Cox Emma , Doust Ann M. , Fernandez Priscilla , Hawe Jeremy , Holland Tom , Hummelshoj Lone , Jackson Louise J. , King Kathleen , Maheshwari Abha , Martin Dan C. , Sutherland Lauren , Thornton Jim , Vincent Katy , Vyas Sanjay , Horne Andrew W. , Whitaker Lucy H. R. 
Published: June 2023

Abstract
Background
Endometriosis affects 190 million women and those assigned female at birth worldwide. For some, it is associated with debilitating chronic pelvic pain. Diagnosis of endometriosis is often achieved through diagnostic laparoscopy. However, when isolated superficial peritoneal endometriosis (SPE), the most common endometriosis subtype, is identified during laparoscopy, limited evidence exists to support the common decision to surgically remove it via excision or ablation. Improved understanding of the impact of surgical removal of isolated SPE for the management of chronic pelvic pain in women is required. Here, we describe our protocol for a multi-centre trial to determine the effectiveness of surgical removal of isolated SPE for the management of endometriosis-associated pain.

Methods
We plan to undertake a multi-centre participant-blind parallel-group randomised controlled clinical and cost-effectiveness trial with internal pilot. We plan to randomise 400 participants from up to 70 National Health Service Hospitals in the UK. Participants with chronic pelvic pain awaiting diagnostic laparoscopy for suspected endometriosis will be consented by the clinical research team. If isolated SPE is identified at laparoscopy, and deep or ovarian endometriosis is not seen, participants will be randomised intraoperatively (1:1) to surgical removal (by excision or ablation or both, according to surgeons’ preference) versus diagnostic laparoscopy alone. Randomisation with block-stratification will be used. Participants will be given a diagnosis but will not be informed of the procedure they received until 12 months post-randomisation, unless required. Post-operative medical treatment will be according to participants’ preference. Participants will be asked to complete validated pain and quality of life questionnaires at 3, 6 and 12 months after randomisation. Our primary outcome is the pain domain of the Endometriosis Health Profile-30 (EHP-30), via a between randomised group comparison of adjusted means at 12 months. Assuming a standard deviation of 22 points around the pain score, 90% power, 5% significance and 20% missing data, 400 participants are required to be randomised to detect an 8-point pain score difference.

Discussion
This trial aims to provide high quality evidence of the clinical and cost-effectiveness of surgical removal of isolated SPE.

Trial registration
ISRCTN registry ISRCTN27244948. Registered 6 April 2021.
Non-COVID-19 UK clinical trials and the COVID-19 pandemic: impact, challenges and possible solutions
Authors: Lorenc Ava , Rooshenas Leila , Conefrey Carmel , Wade Julia , Farrar Nicola , Mills Nicola , Paramasivan Sangeetha , Realpe Alba , Jepson Marcus 
Published: June 2023

Abstract
Introduction
The COVID-19 pandemic impacted the operationalisation of non-COVID-19 clinical trials globally, particularly site and participant recruitment and trial success/stoppage. Trials which anticipate recruitment challenges may embed methods such as the QuinteT Recruitment Intervention (QRI) to help identify and understand the sources of challenges. Such interventions can help shed light on pandemic-related challenges. This paper reports our experience of the impact of the COVID-19 pandemic on conducting clinical trials with an embedded QRI, highlighting how the QRI aided in identifying challenges and potential solutions, particularly related to the site set-up and participant recruitment.

Main body
We report on 13 UK clinical trials which included a QRI. Information is from QRI data and researchers’ experience and reflections. In most trials, recruitment was lower than even the lowest anticipated rates. The flexibility of the QRI facilitated rapid data collection to understand and document, and in some instances respond to, operational challenges. Challenges were mostly logistical, pandemic-related and beyond the control of the site or central trial teams. Specifically: disrupted and variable site opening timelines —often due to local research and development (R&D) delays— shortages of staff to recruit patients; fewer eligible patients or limited access to patients; and intervention-related factors. Almost all trials were affected by pandemic-related staffing issues including redeployment, prioritisation of COVID-19 care and research, and COVID-19-related staff illness and absence. Trials of elective procedures were particularly impacted by the pandemic, which caused changes to care/recruitment pathways, deprioritisation of services, reduced clinical and surgical capacity and longer waiting lists. Attempted solutions included extra engagement with staff and R&D departments, trial protocol changes (primarily moving online) and seeking additional resourcing.

Conclusion
We have highlighted wide-ranging, extensive and consistent pandemic-related challenges faced by UK clinical trials, which the QRI helped to identify and, in some cases, address. Many challenges were insurmountable at individual trials or trials unit level. This overview highlights the need to streamline trial regulatory processes, address staffing crises, improve recognition of NHS research staff and for clearer, more nuanced central guidance on the prioritisation of studies and how to deal with the backlog. Pre-emptively embedding qualitative work and stakeholder consultation into trials with anticipated difficulties, moving some processes online, and flexible trial protocols may improve the resilience of trials in the current challenging context.
Evaluating the completeness of the reporting of abstracts since the publication of the CONSORT extension for abstracts: an evaluation of randomized controlled trial in ten nursing journals
Authors: He Yan , Zhang Rong , Shan Wenjing , Yin Yuhuan , Zhang Xiaoli , Zhang Yiyin , Wang Xiaoping 
Published: June 2023

Abstract
Background
As a practice-oriented discipline, strict adherence to reporting guidelines is particularly important in randomized controlled trial (RCT) abstracts of the nursing area. However, whether abstract reports after 2010 have complied with the Consolidated Standards of Reporting Trials for Abstracts (CONSORT-A) guideline is unclear. This study aimed to evaluate whether the publication of CONSORT-A has improved abstract reporting in nursing and explores the factors associated with better adherence to the guidelines.

Methods
We searched the Web of Science for 200 RCTs randomly selected from ten nursing journals. We used a data extraction form based on CONSORT-A, including 16 items, to analyze the reporting adherence to the guidelines, and the reporting rate of each item and the total score for each abstract were used to indicate adherence and overall quality score (OQS, range 0–16). A comparison of the total mean score between the two periods was made, and affecting factors were analyzed.

Results
In the studies we included, 48 abstracts were published pre-CONSORT-A whereas 152 post-CONSORT-A. The overall mean score for reporting adherence to 16 items was 7.41 ± 2.78 and 9.16 ± 2.76 for pre- and post-CONSORT-A, respectively (total score: 16). The most poorly reported items are “harms (0%),” “outcomes in method (8.5%),” “randomization (25%),” and “blinding (6.5%).” Items including the year of publication, impact factor, multiple center trial, word count, and structured abstract are significantly associated with higher adherence.

Conclusions
The adherence to abstract reporting in nursing literature has improved since the CONSORT-A era, but the overall completeness of RCT abstracts remained low. A joint effort by authors, editors, and journals is necessary to improve reporting quality of RCT abstracts.
Pregabalin as an effective treatment for acute postoperative pain following spinal surgery without major side effects: protocol for a prospective, randomized controlled, double-blinded trial
Authors: Park Ki-Hoon , Chung Nam-Su , Chung Hee-Woong , Kim Tae Young , Lee Han-Dong 
Published: June 2023

Abstract
Background
Patients experience considerable postoperative pain after spinal surgery. As the spine is located at the centre of the body and supports body weight, severe postoperative pain hinders upper body elevation and gait which can lead to various complications, including pulmonary deterioration and pressure sores. It is important to effectively control postoperative pain to prevent such complications. Gabapentinoids are widely used as preemptive multimodal analgesia, but their effects and side effects are dose-dependent. This study was designed to examine the efficacy and side effects of varying doses of postoperative pregabalin for the treatment of postoperative pain after spinal surgery.

Methods
This is a prospective, randomized controlled, double-blind study. A total of 132 participants will be randomly assigned to the placebo (n = 33) group or to the pregabalin 25 mg (n = 33), 50 mg (n = 33), or 75 mg (n = 33) groups. Each participant will be administered placebo or pregabalin once prior to surgery and every 12 h after surgery for 72 h. The primary outcome will be the visual analogue scale pain score, total dose of administered intravenous patient-controlled analgesia, and frequency of rescue analgesic administered for 72 h from arrival to the general ward after surgery, subdivided into four periods: 1–6 h, 6–24 h, 24–48 h, and 48–72 h. The secondary outcomes will be the incidence and frequency of nausea and vomiting due to intravenous patient-controlled analgesia. Safety will be assessed by monitoring the occurrence of side effects such as sedation, dizziness, headache, visual disturbance, and swelling.

Discussion
Pregabalin is already widely used as preemptive analgesia and, unlike nonsteroidal anti-inflammatory drugs, is not associated with a risk of nonunion after spinal surgery. A recent meta-analysis demonstrated the analgesic efficacy and opioid-sparing effect of gabapentinoids with significantly decreased risks of nausea, vomiting, and pruritus. This study will provide evidence for the optimal dosage of pregabalin for the treatment of postoperative pain after spinal surgery.

Trial registration
ClinicalTrials.gov NCT05478382. Registered on 26 July 2022.