bluuebunny/crossref_metadata_2025_split huggingface dataset:
Applying the consolidated framework for implementation research to evaluate the community rapid intervention service
Authors: Moult Alice , Baker Dereth , Twohig Helen , Missen Matthew , Iqbal Zafar , Duffy Helen , Paskins Zoe 
Published: August 2023

Abstract
Background
Developed in 2019, the Community Rapid Intervention Service (CRIS) is a community intervention service aiming to prevent hospital admissions. CRIS provides a response within two hours to patients with sub-acute medical needs in their usual place of residence. This evaluation aimed to identify challenges and facilitators to implementation of the service, with a view to informing future service development, optimising patient care and disseminating learning to other areas looking to implement similar services.

Methods
This study used the Consolidated Framework for Implementation Research (CFIR) as an evaluation framework. We conducted semi-structured interviews with local healthcare system leaders, clinicians that worked within the CRIS, and clinicians who interfaced with the CRIS. The CFIR was used to guide data collection and analysis. Two Community of Practice (CoP) meetings were held to gather stakeholders’ perspectives of the evaluation.

Results
Three key themes were identified from the analysis of 13 interviews: contextual factors influencing implementation, service identity and navigating complexity. Contextual factors such the influence of the Covid 19 pandemic upon health services and the expansion of the CRIS were discussed by participants. The adaptability of the service was deemed both a facilitator and challenge of implementation. Ways to build-on and improve the existing CRIS model were suggested.

Conclusion
This evaluation has shown that the CRIS may need to be redefined with clarity provided as to how the service interfaces with other urgent and planned care offered in acute, primary, community and social services. Structuring the evaluation around the CFIR was helpful in identifying facilitators and challenges that influenced the implementation of the CRIS.
Perturbations in gut microbiota composition in patients with polycystic ovary syndrome: a systematic review and meta-analysis
Authors: Li Pan , Shuai Ping , Shen Sj , Zheng Huimin , Sun Ping , Zhang Renfang , Lan Shanwei , Lan Zixin , Jayawardana Thisun , Yang Yumei , Zhao Jianhui , Liu Yuping , Chen Xia , El-Omar Emad M. , Wan Zhengwei 
Published: August 2023

Abstract
Background
The results of human observational studies on the correlation between gut microbiota perturbations and polycystic ovary syndrome (PCOS) have been contradictory. This study aimed to perform the first systematic review and meta-analysis to evaluate the specificity of the gut microbiota in PCOS patients compared to healthy women.

Methods
Literature through May 22, 2023, was searched on PubMed, Web of Science, Medline, Embase, Cochrane Library, and Wiley Online Library databases. Unreported data in diversity indices were filled by downloading and processing raw sequencing data. Systematic review inclusion: original studies were eligible if they applied an observational case-control design, performed gut microbiota analysis and reported diversity or abundance measures, sampled general pre-menopausal women with PCOS, and are longitudinal studies with baseline comparison between PCOS patients and healthy females. Systematic review exclusion: studies that conducted interventional or longitudinal comparisons in the absence of a control group. Two researchers made abstract, full-text, and data extraction decisions, independently. The Joanna Briggs Institute Critical Appraisal Checklist was used to assess the methodologic quality. Hedge’s g standardized mean difference (SMD), confidence intervals (CIs), and heterogeneity (I2) for alpha diversity were calculated. Qualitative syntheses of beta-diversity and microbe alterations were performed.

Results
Twenty-eight studies (n = 1022 patients, n = 928 control) that investigated gut microbiota by collecting stool samples were included, with 26 and 27 studies having provided alpha-diversity and beta-diversity results respectively. A significant decrease in microbial evenness and phylogenetic diversity was observed in PCOS patients when compared with control participants (Shannon index: SMD = − 0.27; 95% CI, − 0.37 to − 0.16; phylogenetic diversity: SMD = − 0.39; 95% CI, -− 0.74 to − 0.03). We also found that reported beta-diversity was inconsistent between studies. Despite heterogeneity in bacterial relative abundance, we observed depletion of Lachnospira and Prevotella and enrichment of Bacteroides, Parabacteroides, Lactobacillus, Fusobacterium, and Escherichia/Shigella in PCOS. Gut dysbiosis in PCOS, which might be characterized by the reduction of short-chain fatty acid (SCFA)-producing and bile-acid-metabolizing bacteria, suggests a shift in balance to favor pro-inflammatory rather than anti-inflammatory bacteria.

Conclusions
Gut dysbiosis in PCOS is associated with decreased diversity and alterations in bacteria involved in microbiota-host crosstalk.

Trial registration
PROSPERO registration: CRD42021285206, May 22, 2023.
Pyrotinib plus capecitabine for trastuzumab-resistant, HER2-positive advanced breast cancer (PICTURE): a single-arm, multicenter phase 2 trial
Authors: Cao Jun , Teng Yuee , Li Huiping , Zhang Lili , Ouyang Quchang , Xie Weimin , Pan Yueyin , Song Zhenchuan , Ling Xiaoling , Wu Xiaohong , Xu Jingwei , Li Li , Ren Liping , Wang Hong , Zhou Dongxian , Luo Jing , Hu Xichun 
Published: August 2023

Abstract
Background
Patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer and primary resistance to trastuzumab have a poor clinical outcome and lack good evidence to inform clinical decision. This study investigated the efficacy and safety of pyrotinib plus capecitabine in this population.

Methods
This phase 2 trial was conducted at 16 sites in China. Patients received oral pyrotinib 400 mg once daily and capecitabine 1000 mg/m2 twice a day on days 1–14 of each 21-day cycle until disease progression or intolerable toxicity. The primary endpoint was investigator-assessed progression-free survival (PFS).

Results
Between June 2019 and September 2021, 100 patients were enrolled with a median age of 51 years (range, 24–69). All patients had been treated with trastuzumab and 21 (21.0%) patients had prior use of pertuzumab. As of August 31, 2022, the median follow-up duration was 20.1 months (range, 1.3–38.2). The median PFS was 11.8 months (95% confidence interval [CI], 8.4–15.1), which crossed the pre-specified efficacy boundary of 8.0 months. The objective response rate was 70.0% (70/100), with a median duration of response of 13.8 months (95% CI, 10.2–19.3). The disease control rate was 87.0% (87/100). The median overall survival was not reached. The most common grade ≥ 3 treatment-emergent adverse event was diarrhea (24 [24.0%]). No treatment-related deaths occurred.

Conclusions
Pyrotinib plus capecitabine can be considered to be a treatment option in HER2-positive advanced breast cancer patients who have shown primary resistance to trastuzumab. Even in the era of modern anti-HER2 treatments, this clinical setting warrants more investigations to meet unmet needs.

Trial registration
ClinicalTrials.gov, NCT04001621. Retrospectively registered on June 28, 2019.
Education and clinical pharmacist-led management strategies for the risk and prophylaxis of venous thromboembolism in general surgery
Authors: Kiracı Zeynep Karaburç , Yalçın Nadir , Cennet Ömer , Demirkan Kutay , Yorgancı Kaya 
Published: August 2023

Abstract
Background
Despite the risks of venous thromboembolism (VTE) in surgical patients are well defined, primary thromboprophylaxis (TP) can be neglected. The aim of this study was to evaluate the risk of VTE and appropriateness of TP and to assess the effects of education and clinical pharmacy (CP) services.

Methods
This study was conducted in a total of 3 periods (n = 800): pre-education (n = 340), post-education (n = 269) and CP intervention period (n = 191) and the risk of VTE and the appropriateness of TP were evaluated. At the end of pre-education period, patients were re-evaluated after education was given about the guidelines on TP and an educative poster was posted in the services (post-education period). During the CP intervention period, the CP made recommendations in terms of optimal TP use to the physicians in charge.

Results
While there was no significant difference in the optimal TP rate administered to the patients before and after education (138/340, 40.6% vs. 122/269, 45.4%; p = 0.238); this rate was increased to 113/191 (59.2%) in the CP intervention period (p = 0.004). High-risk patients who received one type of TP constituted the majority of patients who did not receive optimal TP. While the ratio of high-risk patients undergoing a single type of TP in the pre- and post-education periods (104/340, 30.6% vs. 83/269, 30.9%), was similar (p = 0.819); with the CP interventions, this rate was reduced to 35/191 (18.3%) (p = 0.001).

Conclusion
Even though education has positive influence on surgeons, the implementation of CP practices is more effective especially in terms of maintaining optimal TP.
Consequences of using poly-ether-ether-ketone versus traditional implant on tibial cement penetration and short-term clinical outcomes during total knee arthroplasty: a randomized controlled trial
Authors: Zhao Guanghui , Yao Shuxin , Sun Xiangxiang , Ma Jianbing , Wang Jianpeng 
Published: August 2023

Abstract
Background
The use of poly-ether-ether-ketone (PEEK) prosthesis during total knee arthroplasty (TKA) is a relatively new concept. Several studies have suggested that the thickness of cement penetration during TKA may affect the stability of the implants. The present study aimed to compare the cement penetration and clinical performance between PEEK and traditional cobalt chromium molybdenum (CoCrMo) prosthesis during TKA.

Methods
This study was a randomized controlled trial with level I of evidence. A total of 48 patients were randomly assigned to either the PEEK group (n = 24) or the CoCrMo group (n = 24). Mean bone cement penetration under the tibial baseplate was assessed radiographically in four zones in the anteroposterior view and two zones in the lateral view, in accordance with the Knee Society Scoring System. Furthermore, parameters such as the Knee Society Score (KSS), visual analogue scale (VAS) scores, complications and survivorship at 1 year postoperatively were also compared.

Results
According to the results of this study, the mean bone cement penetration exhibited no significant difference between PEEK and CoCrMo groups (2.49 ± 0.61 mm vs. 2.53 ± 0.68 mm, p = 0.85). Additionally, there were no remarkable differences in the KSS clinical score, functional score, and VAS score between the two groups. Moreover, complications and survivorship were also statistically compared between the groups and presented no significant differences.

Conclusions
Based on the current findings, it can be concluded that PEEK implant present similar bone cement penetration, short-term clinical outcomes, and survivorship with traditional CoCrMo implant in TKA without added complications.
Trial registration Chinese Clinical Trial Registry (ChiCTR2100047563).
Different neuroprognostication thresholds of neuron-specific enolase in shockable and non-shockable out-of-hospital cardiac arrest: a prospective multicenter observational study in Korea (the KORHN-PRO registry)
Authors: Kim Youn-Jung , Kim Yong Hwan , Youn Chun Song , Cho In Soo , Kim Su Jin , Wee Jung Hee , Park Yoo Seok , Oh Joo Suk , Lee Byung Kook , Kim Won Young 
Published: August 2023

Abstract

Background
Serum neuron-specific enolase (NSE) is the only recommended biomarker for multimodal prognostication in postcardiac arrest patients, but low sensitivity of absolute NSE threshold limits its utility. This study aimed to evaluate the prognostic performance of serum NSE for poor neurologic outcome in out-of-hospital cardiac arrest (OHCA) survivors based on their initial rhythm and to determine the NSE cutoff values with false positive rate (FPR) < 1% for each group.

Methods
This study included OHCA survivors who received targeted temperature management (TTM) and had serum NSE levels measured at 48 h after return of spontaneous circulation in the Korean Hypothermia Network, a prospective multicenter registry from 22 university-affiliated teaching hospitals in South Korea between October 2015 and December 2018. The primary outcome was poor outcome at 6 month, defined as a cerebral performance category of 3–5.

Results
Of 623 patients who underwent TTM with NSE measured 48 h after the return of spontaneous circulation, 245 had an initial shockable rhythm. Median NSE level was significantly higher in the non-shockable group than in the shockable group (104.6 [40.6–228.4] vs. 25.9 [16.7–53.4] ng/mL, P < 0.001). Prognostic performance of NSE assessed by area under the receiver operating characteristic curve to predict poor outcome was significantly higher in the non-shockable group than in the shockable group (0.92 vs 0.86). NSE cutoff values with an FPR < 1% in the non-shockable and shockable groups were 69.3 ng/mL (sensitivity of 76.0%) and 102.7 ng/mL (sensitivity of 42.1%), respectively.

Conclusion
NSE prognostic performance and its cutoff values with FPR < 1% for predicting poor outcome in OHCA survivors who underwent TTM differed between shockable and non-shockable rhythms, suggesting postcardiac arrest survivor heterogeneity.

Trial registration KORHN-PRO, NCT02827422. Registered 11 September 2016—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02827422
LAST-seq: single-cell RNA sequencing by direct amplification of single-stranded RNA without prior reverse transcription and second-strand synthesis
Authors: Lyu Jun , Chen Chongyi 
Published: August 2023

AbstractExisting single-cell RNA sequencing (scRNA-seq) methods rely on reverse transcription (RT) and second-strand synthesis (SSS) to convert single-stranded RNA into double-stranded DNA prior to amplification, with the limited RT/SSS efficiency compromising RNA detectability. Here, we develop a new scRNA-seq method, Linearly Amplified Single-stranded-RNA-derived Transcriptome sequencing (LAST-seq), which directly amplifies the original single-stranded RNA molecules without prior RT/SSS. LAST-seq offers a high single-molecule capture efficiency and a low level of technical noise for single-cell transcriptome analyses. Using LAST-seq, we characterize transcriptional bursting kinetics in human cells, revealing a role of topologically associating domains in transcription regulation.
A randomized controlled trial on using predictive algorithm to adapt level of psychological care for community college students: STAND triaging and adapting to level of care study protocol
Authors: Wen Alainna , Wolitzky-Taylor Kate , Gibbons Robert D. , Craske Michelle 
Published: August 2023

AbstractBackgroundThere is growing interest in using personalized mental health care to treat disorders like depression and anxiety to improve treatment engagement and efficacy. This randomized controlled trial will compare a traditional symptom severity decision-making algorithm to a novel multivariate decision-making algorithm for triage to and adaptation of mental health care. The stratified levels of care include a self-guided online wellness program, coach-guided online cognitive behavioral therapy, and clinician-delivered psychotherapy with or without pharmacotherapy. The novel multivariate algorithm will be comprised of baseline (for triage and adaptation) and time-varying variables (for adaptation) in four areas: social determinants of mental health, early adversity and life stressors, predisposing, enabling, and need influences on health service use, and comprehensive mental health status. The overarching goal is to evaluate whether the multivariate algorithm improves adherence to treatment, symptoms, and functioning above and beyond the symptom-based algorithm.Methods/designThis trial will recruit a total of 1000 participants over the course of 5 years in the greater Los Angeles Metropolitan Area. Participants will be recruited from a highly diverse sample of community college students. For the symptom severity approach, initial triaging to level of care will be based on symptom severity, whereas for the multivariate approach, the triaging will be based on a comprehensive set of baseline measures. After the initial triaging, level of care will be adapted throughout the duration of the treatment, utilizing either symptom severity or multivariate statistical approaches. Participants will complete computerized assessments and self-report questionnaires at baseline and up to 40 weeks. The multivariate decision-making algorithm will be updated annually to improve predictive outcomes.DiscussionResults will provide a comparison on the traditional symptom severity decision-making and the novel multivariate decision-making with respect to treatment adherence, symptom improvement, and functional recovery. Moreover, the developed multivariate decision-making algorithms may be used as a template in other community college settings. Ultimately, findings will inform the practice of level of care triage and adaptation in psychological treatments, as well as the use of personalized mental health care broadly.Trial registrationClinicalTrials.gov NCT05591937, submitted August 2022, published October 2022.
Goals for Adherence with Low-cost Incentives (GOALS): a protocol for a randomized controlled trial evaluating the impact of small airtime incentives on ART adherence among young people living with HIV in Kampala, Uganda
Authors: Linnemayr Sebastian , Huang Haijing Crystal , Wagner Zachary , Onkundi Faith Kemunto , Mukasa Barbara , Odiit Mary 
Published: August 2023

Abstract
Background
Treatment outcomes of HIV-positive individuals are threatened by low antiretroviral therapy (ART) adherence, a problem that is particularly acute among youth. Incentives are a promising tool to support ART adherence, but traditional incentive designs rewarding uniformly high levels of the desired health behavior may demotivate those with low levels of the behavior. In this study, we investigate the effectiveness of alternative approaches to target-setting for incentive eligibility using subgoals (i.e., individual-specific, interim targets leading up to the optimal target).

Methods / design
We will enroll 628 HIV-positive youth between ages 15 and 30 into a 3-year randomized controlled trial. Participants will be randomized 1:1:1:1 to a control arm or one of three intervention arms (n = 157 each) that allow them to enter a prize drawing for small incentives if their ART adherence meets the given goal. In the first arm (T1, assigned subgoal), goals will be externally assigned and adapted to their initial adherence level. In the second arm (T2, participatory subgoal), participants can set their own interim goals. In the third arm (T3, fixed goal), all participants must reach the same target goal of 90% adherence. T1 and T2 participants are required to reach 90% adherence by month 12 to participate in a larger prize drawing. The control group receives the usual standard of care. All four groups will receive weekly motivational messages; the three treatment groups will additionally receive reminders of their upcoming prize drawing. Adherence will be measured continuously throughout the intervention period using electronic devices and for 12 months post-intervention. Surveys will be conducted at baseline and every 6 months. Viral loads will be measured annually. The primary outcome is Wisepill-measured adherence and a binary measure for whether the person took at least 90% of their pills. The secondary outcome is the log-transformed viral load as a continuous measure.

Discussion
Our study is one of the first to apply insights about the psychology and behavioral economics of goal-setting to the design of incentives, by testing whether conditioning the eligibility threshold for incentives on subgoals (interim goals leading up to the ultimate, high goal) improves motivation and adherence more than setting a uniformly highly goal, and a comparison group.

Trial registration
ClinicalTrials.gov NCT05378607. Date of registration: May 18, 2022.
A community-based intervention to improve screening, referral and follow-up of non-communicable diseases and anaemia amongst pregnant and postpartum women in rural India: study protocol for a cluster randomised trial
Authors: Hirst Jane Elizabeth , Votruba Nicole , Billot Laurent , Arora Varun , Rajan Eldho , Thout Sudhir Raj , Peiris David , Patel Anushka , Norton Robyn , Mullins Edward , Sharma Ankita , Kennedy Stephen , Jha Vivekanand , Praveen Devarsetty 
Published: August 2023

Abstract
Background
Medical complications during pregnancy, including anaemia, gestational diabetes mellitus and hypertensive disorders of pregnancy place women are at higher risk of long-term complications. Scalable and low-cost strategies to integrate non-communicable disease screening into pregnancy care are needed. We aim to determine the effectiveness and implementation components of a community-based, digitally enabled approach, “SMARThealth Pregnancy,” to improve health during pregnancy and the first year after birth.

Methods
A pragmatic, parallel-group, cluster randomised, type 2 hybrid effectiveness-implementation trial of a community-based, complex intervention in rural India to decrease anaemia (primary outcome, defined as haemoglobin < 12g/dL) and increase testing for haemoglobin, glucose and blood pressure (secondary outcomes) in the first year after birth. Primary Health Centres (PHCs) are the unit of randomisation. PHCs are eligible with (1) > 1 medical officer and > 2 community health workers; and (2) capability to administer intravenous iron sucrose. Thirty PHCs in Telangana and Haryana will be randomised 1:1 using a matched-pair design accounting for cluster size and distance from the regional centre. The intervention comprises (i) an education programme for community health workers and PHC doctors; (ii) the SMARThealth Pregnancy app for health workers to support community-based screening, referral and follow-up of high-risk cases; (iii) a dashboard for PHC doctors to monitor high-risk women in the community; (iv) supply chain monitoring for consumables and medications and (v) stakeholder engagement to co-develop implementation and sustainability pathways. The comparator is usual care with additional health worker education. Secondary outcomes include implementation outcomes assessed by the RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance), clinical endpoints (anaemia, diabetes, hypertension), clinical service delivery indicators (quality of care score), mental health and lactation practice (PHQ9, GAD7, EuroQoL-5D, WHO IYCF questionnaire).

Discussion
Engaging women with screening after a high-risk pregnancy is a challenge and has been highlighted as a missed opportunity for the prevention of non-communicable diseases. The SMARThealth Pregnancy trial is powered for the primary outcome and will address gaps in the evidence around how pregnancy can be used as an opportunity to improve women’s lifelong health. If successful, this approach could improve the health of women living in resource-limited settings around the world.

Trial registration
ClinicalTrials.gov NCT05752955. Date of registration 3 March 2023.