bluuebunny/crossref_metadata_2025_split huggingface dataset:
Examining the complementarity between the ERIC compilation of implementation strategies and the behaviour change technique taxonomy: a qualitative analysis
Authors: McHugh Sheena , Presseau Justin , Luecking Courtney T. , Powell Byron J. 
Published: August 2022

Abstract
Background
Efforts to generate evidence for implementation strategies are frustrated by insufficient description. The Expert Recommendations for Implementing Change (ERIC) compilation names and defines implementation strategies; however, further work is needed to describe the actions involved. One potentially complementary taxonomy is the behaviour change techniques (BCT) taxonomy. We aimed to examine the extent and nature of the overlap between these taxonomies.

Methods
Definitions and descriptions of 73 strategies in the ERIC compilation were analysed. First, each description was deductively coded using the BCT taxonomy. Second, a typology was developed to categorise the extent of overlap between ERIC strategies and BCTs. Third, three implementation scientists independently rated their level of agreement with the categorisation and BCT coding. Finally, discrepancies were settled through online consensus discussions. Additional patterns of complementarity between ERIC strategies and BCTs were labelled thematically. Descriptive statistics summarise the frequency of coded BCTs and the number of strategies mapped to each of the categories of the typology.

Results
Across the 73 strategies, 41/93 BCTs (44%) were coded, with ‘restructuring the social environment’ as the most frequently coded (n=18 strategies, 25%). There was direct overlap between one strategy (change physical structure and equipment) and one BCT (‘restructuring physical environment’). Most strategy descriptions (n=64) had BCTs that were clearly indicated (n=18), and others where BCTs were probable but not explicitly described (n=31) or indicated multiple types of overlap (n=15). For some strategies, the presence of additional BCTs was dependent on the form of delivery. Some strategies served as examples of broad BCTs operationalised for implementation. For eight strategies, there were no BCTs indicated, or they did not appear to focus on changing behaviour. These strategies reflected preparatory stages and targeted collective cognition at the system level rather than behaviour change at the service delivery level.

Conclusions
This study demonstrates how the ERIC compilation and BCT taxonomy can be integrated to specify active ingredients, providing an opportunity to better understand mechanisms of action. Our results highlight complementarity rather than redundancy. More efforts to integrate these or other taxonomies will aid strategy developers and build links between existing silos in implementation science.
Telehealth service delivery in an Australian regional mental health service during COVID-19: a mixed methods analysis
Authors: Chatterton Mary Lou , Marangu Elijah , Clancy Elizabeth M. , Mackay Matthew , Gu Eve , Moylan Steve , Langbein Amy , O’Shea Melissa 
Published: August 2022

Abstract
Background
COVID-19 required mental health services to quickly switch from face-to-face service delivery to telehealth (telephone and videoconferencing). This evaluation explored implementation of a telehealth mental health response in a regional public mental health provider.

Methods
A mixed methods approach, combining service use data, brief satisfaction surveys, and qualitative interviews/focus groups was undertaken. Number and types of contacts from de-identified mental health service data were compared between April–May 2020 and April–May 2019. Mental health consumers and providers completed brief online satisfaction surveys after videoconferencing sessions. Attitudes and perspectives on the implementation of telehealth were further explored by applying a descriptive qualitative framework to the analysis of interview and focus group data supplied by consumers and providers. Template thematic analysis was used to elucidate key themes relating to the barriers and enablers of telehealth uptake and future implementation recommendations.

Results
Total contacts decreased by 13% from 2019 to 2020. Face-to-face contacts decreased from 55% of total in 2019 to 24% in 2020. In 2019, 45% of contacts were by telephone, increasing to 70% in 2020. Only four videoconferencing contacts were made in 2019; increasing to 886 in 2020. Consumer surveys (n = 26) rated videoconferencing as good or excellent for technical quality (92%), overall experience (86%), and satisfaction with personal comfort (82%). Provider surveys (n = 88) rated technical quality as good or excellent (68%) and 86% could achieve assessment/treatment goals with videoconferencing. Provider focus groups/interviews (n = 32) identified that videoconferencing was well-suited to some clinical tasks. Consumers interviewed (n = 6) endorsed the ongoing availability of telehealth within a blended approach to service delivery. Both groups reflected on videoconferencing limitations due to infrastructure (laptops, phones, internet access), cumbersome platform and privacy concerns, with many reverting to telephone use.

Conclusions
While videoconferencing increased, technical and other issues led to telephone being the preferred contact method. Satisfaction surveys indicated improvement opportunities in videoconferencing. Investment in user-friendly platforms, telehealth infrastructure and organisational guidelines are needed for successful integration of videoconferencing in public mental health systems.
Effect of perioperative magnesium sulfate and labetalol infusion on peripheral perfusion and postoperative pain in nasal surgery: a randomized controlled trial
Authors: Kamel Alshaimaa Abdel Fattah , Medhat Marwa Mohamed , Salem Dina Abdelhameed Elsadek , Naby Sara Mohamed Abdel 
Published: August 2022

AbstractBackgroundMaintenance of adequate peripheral perfusion during controlled hypotension is necessary for patient safety and improved surgical outcomes during controlled hypotension in nasal surgery. The hypothesis of this study was to investigate the effect of perioperative magnesium sulfate and labetalol infusion on peripheral perfusion and postoperative pain in patients undergoing nasal surgery.MethodsA total of 50 patients were randomly assigned into two equal groups in this double-blind clinical study: the magnesium sulfate group; received 40 mg/kg loading dose of intravenous (IV) magnesium sulfate followed by 10–15 mg/kg/h continuous IV infusion and the labetalol group; received 0.25 mg/kg loading dose of IV labetalol followed by 0.5–1 mg/kg/h continuous IV infusion to achieve a mean arterial blood pressure (MABP) of = 55–65 mmHg. The primary outcome was to compare the effect of perioperative magnesium sulfate and labetalol infusion on peripheral perfusion during nasal surgery. The secondary outcomes were the assessment of serum lactate, postoperative pain, time to the first call for pethidine (rescue analgesic) and total pethidine consumption.ResultsPPI was comparable between the groups at baseline, intubation, and 5 min. In contrast, magnesium sulfate group had a significantly higher PPI than the labetalol group. The magnesium sulfate group had a significantly higher MABP and heart rate compared to labetalol group. The time to reach the target MABP was significantly prolonged in magnesium sulfate than the labetalol group [21.6 ± 1.7 vs 6.9 ± 1.5] min. VAS scores were significantly lower for 2 hs postoperatively in the magnesium sulfate group than the labetalol group. The time to first call of pethidine was significantly prolonged in the magnesium sulfate group compared to the labetalol group [113.1 ± 5.2 vs 28.2 ± 1.5] min.ConclusionsMagnesium sulfate maintains wider PPI and offers better postoperative pain relief compared to labetalol during induced hypotension in nasal surgery.Trial registrationInstitutional review board approval (ref: 6601/20–12-2020).Clinicaltrial.gov (ref:NCT04688203, date of registration: 29 -12–2020).
False-positives and false-negatives in non-invasive prenatal testing (NIPT): what can we learn from a meta-analyses on > 750,000 tests?
Authors: Liehr Thomas 
Published: August 2022

AbstractBackgroundNon-invasive prenatal testing (NIPT) has had an incomparable triumph in prenatal diagnostics in the last decade. Over 1400 research articles have been published, predominantly praising the advantages of this test.MethodsThe present study identified among the 1400 papers 24 original and one review paper, which were suited to re-evaluate the efficacy of > 750,000 published NIPT-results. Special attention was given to false-positive and false-negative result-rates. Those were discussed under different aspects—mainly from a patient-perspective.ResultsA 27: 1 rate of false-positive compared to false-negative NIPT results was found. Besides, according to all reported, real-positive, chromosomally aberrant NIPT cases, 90% of those would have been aborted spontaneously before birth. These findings are here discussed under aspects like (i) How efficient is NIPT compared to first trimester screening? (ii) What are the differences in expectations towards NIPT from specialists and the public? and (iii) There should also be children born suffering from not by NIPT tested chromosomal aberrations; why are those never reported in all available NIPT studies?ConclusionsEven though much research has been published on NIPT, unbiased figures concerning NIPT and first trimester screening efficacy are yet not available. While false positive rates of different NIPT tests maybe halfway accurate, reported false-negative rates are most likely too low. The latter is as NIPT-cases with negative results for tested conditions are yet not in detail followed up for cases with other genetic or teratogenic caused disorders. This promotes an image in public, that NIPT is suited to replace all invasive tests, and also to solve the problem of inborn errors in humans, if not now then in near future. Overall, it is worth discussing the usefulness of NIPT in practical clinical application. Particularly, asking for unbiased figures concerning the efficacy of first trimester-screening compared to NIPT, and for really comprehensive data on false-positive and false-negative NIPT results.
Diversity of adenosine deaminase in children with EBV-related diseases
Authors: Shi Ting , Shen Yu , Zhang Wei , Qian Meiying , Chen Xiuli , Huang Linlin , Tian Jianmei 
Published: August 2022

Abstract
Background
Adenosine deaminase (ADA) is an enzyme involved in purine metabolism with an important role in cellular immunity. Thus, this study investigated the association between ADA and Epstein–Barr virus (EBV)-related diseases.

Methods
We retrospectively collected data from all children admitted to the Children’s Hospital of Soochow University, Suzhou, China, between May 1, 2018, and March 31, 2019, who underwent plasma EBV-DNA polymerase chain reaction, alanine aminotransferase (ALT), and ADA testing.

Results
Of 6868 children, 1877 had an elevated level of ADA, and 4991 had a level within the normal range. Multivariate logistic regression analysis indicated that ALT (adjusted odds radio [aOR] = 1.001, 95% confidence interval [CI]: 1.001–1.002), EBV infection (aOR = 8.486, 95% CI: 6.753–10.663), inflammatory disease (aOR = 3.915, 95% CI: 3.198–4.794), autoimmune disease (aOR = 2.307, 95% CI: 1.823–2.920), and malignant disease (aOR = 1.381; 95% CI: 1.101–1.734) were risk factors for an elevated ADA level. Furthermore, the ADA levels among EBV-related diseases significantly differed, including infectious mononucleosis, atypical EBV infection, respiratory infection, malignant disease, and other diseases (P < 0.05). In addition, the ADA level positively correlated with the Epstein–Barr viral load (r = 0.501, P < 0.05).

Conclusions
This large, retrospective study identified a correlation between ADA and EBV-related diseases, which may help clinicians detect these diseases earlier based on the plasma ADA concentration.
BRCA1/2 variants and copy number alterations status in non familial triple negative breast cancer and high grade serous ovarian cancer
Authors: El Ansari Fatima Zahra , Jouali Farah , Fekkak Rim , Bakkach Joaira , Ghailani Nourouti Naima , Barakat Amina , Bennani Mechita Mohcine , Fekkak Jamal 
Published: August 2022

Abstract
Background
While the role of BRCA1/2 genes in familial breast and ovarian cancer is well established, their implication in the sporadic form of both cancers is still controversial. With the development of poly (ADP-ribose) polymerase (PARP) inhibitors, the exact relationship between BRCA1/2 genes and sporadic triple negative breast cancer/high grade serous carcinoma (TNBC/HGSC) needs to be further investigated. Therefore, we conducted a study in which we analyze BRCA1/2 point mutations and copy number alterations in Moroccan patients suffering from TNBC/HGSC.

Methods
To achieve our goal, we analyzed BRCA1/2 genes in the FFPE tissue blocks and blood samples of 65 TNBC/HGSC selected patients, using next generation sequencing technology.

Results
From the 65 successfully sequenced patients in our cohort, we detected five-point variants in six different patients, four variants were classified as pathogenic and one of unknown significance. Regarding copy number alterations we detected one copy number loss in BRCA1 gene and one copy number gain in BRCA2 gene. The genetic screening of BRCA1/2 genes using these patients’ genomic DNA indicated that five harbored a germline genetic alteration. While three harbored a somatic genetic alteration. To the best of our knowledge, three-point variants detected in our study have never been reported before.

Conclusion
According to the results found in the present study, in a population without a family history of cancer, the possibility of a BRCA1/2 somatic pathogenic variant in high grade serous carcinoma is 7%. While for Triple negative breast cancer somatic point variants and copy number alterations seems to be a very rare genetic event.
Evaluation of an adaptive, multimodal intervention to reduce postoperative infections following cesarean delivery in Ethiopia: study protocol of the CLEAN-CS cluster-randomized stepped wedge interventional trial
Authors: Mammo Tihitena Negussie , Feyssa Mekdes Daba , Haile Sara Taye , Fikre Tesfaneh , Shiferaw Matiyas Asrat , Woldeamanuel Habtamu , Temesgen Fikremelekot , Gebeyehu Natnael , Starr Nichole , Fernandez Katie , Henrich Natalie , Alemu Senait Bitew , Miller Kate , Weiser Thomas G. 
Published: August 2022

AbstractBackgroundWe previously developed and pilot tested Clean Cut, a program to prevent postoperative infections by improving compliance with the WHO Surgical Safety Checklist (SSC) and strengthening adherence to infection control practices. This protocol describes theCheckListExpansion forAntisepsis and iNfection Control inCesareanSection (CLEAN–CS) trial evaluating our program’s ability to reduce infections following CS and other obstetric and gynecological operations in Ethiopia.Methods/designCLEAN-CS is a cluster-randomized stepped wedge interventional trial with five clusters (two hospitals per cluster). It aims to assess the impact of Clean Cut on six critical perioperative infection prevention standards including antiseptic practices, antibiotic administration, and routine SCC use. The trial involves baseline data collection followed by Clean Cut training and implementation in each cluster in randomized order. The intervention consists of (1) modifying and implementing the SSC to fit local practices, (2) process mapping each standard, (3) coupling data and processes with site-specific action plans for improvement, and (4) targeted training focused on process gaps. The primary outcome is 30-day CS infection rates; secondary outcomes include other patient-level complications and compliance with standards. Assuming baseline SSI incidence of 12%, an effect size of 25% absolute reduction, and the ability to recruit 80–90 patients per cluster per month, we require a sample of 8100 patients for significance. We will report our study according to CONSORT.DiscussionA cluster-randomized stepped wedge design is well-suited for evaluating this type of surgical safety program. The targeted standards are not in doubt, yet compliance is frequently difficult. Solutions are available and may be recognized by individuals, but teams dedicated to improvement are often lacking. Clean Cut was successfully piloted but requires a more rigorous methodological assessment. We seek to understand the qualities, characteristics, and resources needed to implement the program, the magnitude of effect on processes and outcomes, and to what degree it can enhance compliance with care standards. Challenges include a fraught social and political environment, pandemic travel restrictions, and a limited budget.Trial registrationClinicalTrials.govNCT04812522(registered on March 23, 2021); Pan-African Clinical Trials RegistryPACTR202108717887402(registered on August 24, 2021).
Principles and recommendations for incorporating estimands into clinical study protocol templates
Authors: Lynggaard Helle , Bell James , Lösch Christian , Besseghir Amel , Rantell Khadija , Schoder Volker , Lanius Vivian 
Published: August 2022

AbstractClinical study protocols are the foundation of good clinical studies. Prospective and multidisciplinary collaboration that pays attention to the design of all components of the study protocol can ensure that a clinical study will answer the research questions posed in a reliable manner that is meaningful for decision-makers and patients. The ICH E9(R1) addendum on estimands and sensitivity analysis in clinical trials provides a framework for clinical study planning to ensure alignment between study objectives, design, conduct, and analysis. The estimand or clinical question posed can be regarded as the backbone of the study and the clinical study protocol should reflect estimands accordingly. In practice, stakeholders are still learning how to embrace the estimand framework and how it impacts studies and study documents. In this paper, we anticipate that a protocol structure centred around estimands, or objectives rather than endpoints alone will prevail for all types of studies. To assist sponsors during this paradigm shift, this paper provides discussion and guidance for implementing the estimand framework in protocol templates.
Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial
Authors: Martyn-Nemeth Pamela , Duffecy Jennifer , Quinn Laurie , Reutrakul Sirimon , Steffen Alana D. , Burke Larisa , Clark Withington Margaret H. , Irsheed Ghada Abu , Perez Rose , Park Minsun , Saleh Adam , Mihailescu Dan , Baron Kelly Glazer 
Published: August 2022

Abstract
Background
Despite improvements in treatment regimens and technology, less than 20% of adults with type 1 diabetes (T1D) achieve glycemic targets. Sleep is increasingly recognized as a potentially modifiable target for improving glycemic control. Diabetes distress, poor self-management behaviors, and reduced quality of life have also been linked to sleep variability and insufficient sleep duration. A significant gap of knowledge exists regarding interventions to improve sleep and the effects of sleep optimization on glycemic control in T1D. The purpose of this study is to determine the efficacy of a T1D-specific sleep optimization intervention (Sleep-Opt) on the primary outcomes of sleep variability, sleep duration, and glycemic control (A1C); other glycemic parameters (glycemic variability, time-in-range [TIR]); diabetes distress; self-management behaviors; quality of life; and other patient-reported outcomes in adults with T1D and habitual increased sleep variability or short sleep duration.

Methods
A randomized controlled parallel-arm study will be employed in 120 adults (aged 18 to 65 years) with T1D. Participants will be screened for habitual sleep variability (> 1 h/week) or insufficient sleep duration (< 6.5 h per night). Eligible subjects will be randomized to the Sleep-Opt intervention group or healthy living attention control group for 12 weeks. A 1-week run-in period is planned, with baseline measures of sleep by actigraphy (sleep variability and duration), glycemia (A1C and related glycemic measures: glycemic variability and TIR using continuous glucose monitoring), and other secondary outcomes: diabetes distress, self-management behaviors, quality of life, and additional patient-reported outcomes. Sleep-Opt is a technology-assisted behavioral sleep intervention that we recently developed that leverages the rapidly increasing public interest in sleep tracking. Our behavioral intervention employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. The attention control group will participate in a healthy living information program. Baseline measures will be repeated at midpoint, program completion, and post-program (weeks 6, 12, and 24, respectively) to determine differences between the two groups and sustainability of the intervention.

Discussion
A better understanding of strategies to improve sleep in persons with T1D has the potential to be an important component of diabetes.

Trial registration
Clinical Trial Registration: NCT04506151.
Early essential newborn care for cesarean section newborns in China: study protocol for a multi-centered randomized controlled trial
Authors: Wang Xueyin , Zhang Xiaosong , Sobel Howard Lawrence , Li Zhao , Juan Juan , Yang Huixia 
Published: August 2022

Abstract
Background
Early essential newborn care (EENC) is a package of evidence-based and cost-effective interventions delivered around birth mainly including delayed cord clamping, immediate and sustained skin-to-skin contact, and early initiation of exclusive breastfeeding. EENC is proven effective in promoting breastfeeding and improving women’s and newborns’ health. However, there is little evidence on implementation of EENC on newborns born by cesarean section in China. Therefore, the objective of this study is to assess the effectiveness of EENC intervention on rates of exclusive breastfeeding and early initiation of breastfeeding for cesarean section newborns in China.

Methods
This is a multi-centered, randomized controlled trial conducted in 4 tertiary hospitals in China. A total of 720 eligible women who will receive cesarean section are being randomized into four groups: control group (n=180), intervention group 1 (skin-to-skin contact for 30 min, n=180), intervention group 2 (skin-to-skin contact for 60 min, n=180), and intervention group 3 (skin-to-skin contact for 90 min, n=180). The control group will receive routine care, whereas the intervention groups will receive EENC with different duration of skin-to-skin contact. Demographic characteristics, clinical information, and breastfeeding outcomes will be collected. The primary outcome is rates of exclusive breastfeeding and early initiation of breastfeeding, and the secondary outcomes include maternal and neonatal morbidity and admissions.

Discussion
This study will provide evidence of the impact of EENC on improvement of breastfeeding outcomes and maternal and neonatal health for cesarean section newborns in China, and evidence-based recommendation to inform optimal duration of skin-to-skin contact for cesarean deliveries. The results of this study have potential to inform national-level guidelines and policy-making for optimizing EENC implementation for cesarean section newborns.

Trial registration
Chinese Clinical Trial Registry ChiCTR2100048997. Retrospectively registered on 19 July 2021