bluuebunny/crossref_metadata_2025_split huggingface dataset:
Study design of a stepped wedge cluster randomized controlled trial to evaluate the effect of a locally tailored approach for preconception care – the APROPOS-II study
Authors: Maas Veronique Y. F. , Koster Maria P. H. , Ista Erwin , Vanden Auweele Kim L. H. , de Bie Renate W. A. , de Smit Denhard J. , Visser Bianca C. , van Vliet-Lachotzki Elsbeth H. , Franx Arie , Poels Marjolein 
Published: February 2020

Abstract
Background
In a previous feasibility study (APROPOS) in a single municipality of the Netherlands, we showed that a locally tailored preconception care (PCC) approach has the potential to positively affect preconceptional lifestyle behaviours. Therefore, we designed a second study (APROPOS-II) to obtain a more robust body of evidence: a larger group of respondents, more municipalities, randomization, and a more comprehensive set of (clinical) outcomes. The aim of this study is to assess the effectiveness and the implementation process of a local PCC-approach on preconceptional lifestyle behaviours, health outcomes and the reach of PCC among prospective parents and healthcare providers.

Methods
This study is an effectiveness-implementation hybrid type 2 trial. This involves a stepped-wedge cluster randomized controlled trial design aiming to include over 2000 future parents from six municipalities in the Netherlands. The intervention has a dual-track approach, focusing on both the uptake of PCC among future parents and the provision of PCC by healthcare providers. The PCC-approach consists of 1) a social marketing strategy directed towards prospective parent(s) and 2) a local care pathway to improve interdisciplinary collaboration. Data will be collected before and after the introduction of the intervention through questionnaires and medical records in each of the participating municipalities. The primary outcome of this study is change in lifestyle behaviours (e.g. folic acid use, smoking and alcohol use). Secondary outcomes are pregnancy outcomes (e.g. miscarriage, preterm birth, gestational diabetes) and the uptake of PCC. Moreover, a process evaluation will be performed, providing information on the efficacy, feasibility, barriers and facilitators regarding the implementation of the intervention.

Discussion
The APROPOS-II study introduces a locally tailored PCC-approach in six municipalities in the Netherlands that will contribute to the body of evidence regarding the effectiveness of PCC and its implementation. If this intervention has a positive effect on lifestyle behaviour changes, leading to improved pregnancy outcomes and the future health of prospective parents and their offspring, it could subsequently be upscaled to (inter)national implementation.

Trial registration
Dutch Trial register: NL7784 (Registered June 6th, 2019).
Debate: Why should gender-affirming health care be included in health science curricula?
Authors: de Vries Elma , Kathard Harsha , Müller Alex 
Published: February 2020

Abstract
Background
Every person who seeks health care should be affirmed, respected, understood, and not judged. However, trans and gender diverse people have experienced significant marginalization and discrimination in health care settings. Health professionals are generally not adequately prepared by current curricula to provide appropriate healthcare to trans and gender diverse people. This strongly implies that health care students would benefit from curricula which facilitate learning about gender-affirming health care.

Main body
Trans and gender diverse people have been pathologized by the medical profession, through classifications of mental illness in the Diagnostic and Statistical Manual of Mental Disorders (DSM) and International Classification of Disease (ICD). Although this is changing in the new ICD-11, tension remains between depathologization discourses and access to gender-affirming health care.
Trans and gender diverse people experience significant health disparities and an increased burden of disease, specifically in the areas of mental health, Human Immunodeficiency Virus, violence and victimisation. Many of these health disparities originate from discrimination and systemic biases that decrease access to care, as well as from health professional ignorance.
This paper will outline gaps in health science curricula that have been described in different contexts, and specific educational interventions that have attempted to improve awareness, knowledge and skills related to gender-affirming health care. The education of primary care providers is critical, as in much of the world, specialist services for gender-affirming health care are not widely available. The ethics of the gatekeeping model, where service providers decide who can access care, will be discussed and contrasted with the informed-consent model that ﻿upholds autonomy by empowering patients to make their own health care decisions.

Conclusion
There is an ethical imperative for health professionals to reduce health care disparities of trans and gender diverse people and practice within the health care values of social justice and cultural humility. As health science educators, we have an ethical duty to include gender-affirming health in health science curricula in order to prevent harm to the trans and gender diverse patients that our students will provide care for in the future.
Direct medical costs of end-stage kidney disease and renal replacement therapy: a cohort study in Guangzhou City, southern China
Authors: Zhang Hui , Zhang Chao , Zhu Sufen , Ye Hongjian , Zhang Donglan 
Published: February 2020

Abstract
Background
Renal replacement therapy was a lifesaving yet high-cost treatment for people with end-stage kidney disease (ESKD). This study aimed to estimate the direct medical costs per capita of ESKD by different treatment strategies: haemodialysis (HD); peritoneal dialysis (PD); kidney transplantation (KT) (in the first year); KT (in the second year), and by two urban health insurance schemes.

Methods
This was a retrospective observational cohort study. Data were obtained from outpatient and inpatient claims database of two urban health insurance from Guangzhou City, Southern China. Adult patients with HD (n = 3765; mean age 58 years), PD (n = 1237; 51 years), KT (first year) (n = 117; 37 years) and KT (second year) (n = 41; 39 years) were identified between 2010 and 2012. The primary outcome was the annual per patient medical costs in 2013 Chinese Yuan (CNY) incurred in the outpatient and inpatient sectors. Secondary outcomes were annual outpatient visits and inpatient admissions, length of stay per admission. Generalized linear regression and bootstrapping statistical methods were used for analysis.

Results
The estimated average annual medical costs for patients on HD were CNY 94,760.5 (US$15,066.0), 95% Confidence Interval (CI): CNY85,166.6–106,972.2, which was higher than those for patients on PD [CNY80,762.9 (US$12,840.5), 95% CI: CNY 76,249.8-85,498.9]. The estimated annual cost ratio of HD versus PD was 1.17 (95% CI: 1.12–1.25). Among the transplanted patients, the estimated average annual medical costs in the first year were CNY132,253.0 (US$21,026.9), 95%CI: CNY114,009.9–153,858.6, and in the second year were CNY93,155.3 (US$14,810.8), 95%CI: CNY61,120.6–101,989.1. The mean annual medical costs for dialysis patients under Urban Employee-based Basic Medical Insurance scheme were significantly higher than those for patients under Urban Resident-based Basic Medical Insurance scheme (P < 0.001).

Conclusions
The direct medical costs of ESKD patients were high and different by types of renal replacement therapy and insurance. The findings can be used to conduct cost-effectiveness research on different types of RRT for ESKD patients that provides economic evidence for health policy design in China.
Improving medicines management for people with dementia in primary care: a qualitative study of healthcare professionals to develop a theory-informed intervention
Authors: Barry Heather E. , Bedford Laura E. , McGrattan Máiréad , Ryan Cristín , Passmore A. Peter , Robinson A. Louise , Molloy Gerard J. , Darcy Carmel M. , Buchanan Hilary , Hughes Carmel M. 
Published: February 2020

Abstract
Background
People with dementia (PwD) face unique challenges with medicines management, yet little is known about these challenges from the perspectives of primary healthcare professionals, particularly general practitioners (GPs) and community pharmacists. Few medicines management interventions have been developed which are aimed at community-dwelling PwD. This study sought to develop an intervention to improve medicines management for PwD in primary care using a theory-informed approach.

Methods
Semi-structured interviews were conducted with GPs (n = 15) and community pharmacists (n = 15) to explore participants’ views and experiences of medicines management for PwD, and their perceptions of barriers and facilitators to successful medicines management for PwD. The 14-domain Theoretical Domains Framework was the underpinning theoretical guide, allowing key theoretical domains to be identified and mapped to behaviour change techniques (BCTs) which are considered the ‘active ingredients’ of an intervention. Draft interventions were developed to operationalise selected BCTs and were presented to GPs and community pharmacists during task groups. Final selection of an intervention for feasibility testing was guided by feedback provided during these task groups and through application of the APEASE (Affordability, Practicability, Effectiveness/cost-effectiveness, Acceptability, Side-effects/safety, Equity) criteria.

Results
Participants expressed a number of concerns about medicines management for PwD, particularly monitoring adherence to medication regimens and conducting medication review. Two draft interventions comprising selected BCTs (‘Modelling or demonstration of behaviour’; ‘Salience of consequences’; ‘Health consequences’; ‘Social and environmental consequences’; ‘Action planning’; Social support or encouragement’, ‘Self-monitoring of behaviour’) were developed, each targeting GPs and community pharmacists. Following the task groups and discussions within the research team, the community pharmacy-based intervention was selected for future feasibility testing. The intervention will target community pharmacists to conduct a medication review (incorporating an adherence check) with a PwD, delivered as an online video demonstrating key behaviours. The video will include feedback emphasising positive outcomes of performing the behaviours. Action planning and a quick reference guide will be used as complementary intervention components.

Conclusions
A community pharmacist-based intervention has been developed targeting medicines management for PwD in primary care using a systematic, theory-informed approach. Future work will determine the usability and acceptability of implementing this intervention in clinical practice.
A cluster-randomized field trial to reduce cesarean section rates with a multifaceted intervention in Shanghai, China
Authors: Zhang Lulu , Zhang Lin , Li Meng , Xi Jie , Zhang Xiaohua , Meng Zhenni , Wang Ying , Li Huaping , Liu Xiaohua , Ju Feihua , Lu Yuping , Tang Huijun , Qin Xianju , Ming Yanhong , Huang Rong , Li Guohong , Dai Hongying , Zhang Rong , Qin Min , Zhu Liping , Zhang Jun 
Published: February 2020

Abstract
Background
Cesarean section (CS) rate has risen dramatically and stayed at a very high level in China over the past two to three decades. Given the short- and long-term adverse effects of CS, effective strategies are needed to reduce unnecessary CS. We aimed to evaluate whether a multifaceted intervention would decrease the CS rate in China.

Methods
We carried out a cluster-randomized field trial with a multifaceted intervention in Shanghai, China, from 2015 to 2017. A total of 20 hospitals were randomly allocated into an intervention or a control group. The intervention consisted of more targeted health education to pregnant women, improved hospital CS policy, and training of midwives/doulas for 8 months. The study included a baseline survey, the intervention, and an evaluation survey. The primary outcome was the changes of overall CS rate from the pre-intervention to the post-intervention period. A subgroup analysis stratified by the Robson classification was also conducted to examine the CS change among women with various obstetric characteristics.

Results
A total of 10,752 deliveries were randomly selected from the pre-intervention period and 10,521 from the post-intervention period. The baseline CS rates were 42.5% and 41.5% in the intervention and control groups, respectively, while the post-intervention CS rates were 43.4% and 42.4%, respectively. Compared with the control group, the intervention did not significantly reduce the CS rate (adjusted OR = 0.92; 95% CI 0.73, 1.15). Similar results were obtained in subgroup analyses stratified by the risk level of pregnancy, maternal age, number of previous CS, or parity. Scarred uterus and maternal request remained the primary reasons for CS after the interventions in both groups. The intervention did not alter the perinatal outcomes (adjusted change of risk score = − 0.06; 95%CI − 0.43, 0.31).

Conclusions
A multifaceted intervention including more targeted prenatal health education, improved hospital CS policy, and training of midwives/doulas, did not significantly reduce the CS rate in Shanghai, China. However, our experience in implementing a multifaceted intervention may provide useful information to other similar areas with high CS use.

Trial registration
This trial was registered at the Chinese Clinical Trial Registry (www.chictr.org.cn) (ChiCTR-IOR-16009041) on 17 August 2016.
Health-related quality of life and extent of self-care practice among heart failure patients in Ethiopia
Authors: Seid Mohammed Assen 
Published: February 2020

Abstract
Background
Heart Failure (HF) results in an immense impact on the patients’ Health-related quality of life (HRQOL). Heart failure patients HRQOL is dependent on the patients’ level of engagement in self-care behaviors. Therefore this study aimed to determine HF patients’ health-related quality of life and its relationship with self-care behaviors.

Methods
An institutional-based study was conducted on 284 heart failure patients at the University of Gondar referral hospital. The data were collected using a structured questionnaire-based interview. The data were analyzed using SPSS version 20. Both descriptive and analytical statistical tests were utilized. A multinomial logistic regression analysis was done to determine the association between HRQOL and different independent variables. Variables with a p-value< 0.05 were considered as a significant predictor of the outcome variable.

Results
The finding of this study showed that more than sixty-six percent of the study population were females. The overall mean score of HF patients’ quality of life was 46.4 ± 22.4 and the physical and emotional subscale mean score was 20.2 ± 9.8 and 10.5 ± 6.8 respectively. The majority of the study participants 147(51.8%) had poor quality of life. The multinomial logistic regression analysis result showed that rural residence (odds ratio 2.41, 95% CI, 1.23 to 4.71) and inadequate level of self-care practice (odds ratio 2.61, 95% CI, 1.43 to 4.78) were independent predictors of poor HRQOL. The correlation analysis also showed that there was a significant negative relationship between HF patients’ HRQOL score and Self-care practice score (r = − 0.127, P = 0.032).

Conclusion
Overall, the majority of HF patients had poor HRQOL. Heart failure patients’ HRQOL was significantly associated with place of residence and patients’ level of self-care practice. Therefore, patients with HF are required to learn the benefit of self-care behaviors to improve their quality of life and to decrease the disease progression. Furthermore, HF patients who come from rural areas need special emphasis in each follow-up evaluation.
Patterns and predictors of exercise behavior during 24 months of follow-up after a supervised exercise program during breast cancer chemotherapy
Authors: An Ki-Yong , Kang Dong-Woo , Morielli Andria R. , Friedenreich Christine M. , Reid Robert D. , McKenzie Donald C. , Gelmon Karen , Mackey John R. , Courneya Kerry S. 
Published: February 2020

Abstract
Background
Understanding the longer-term exercise behavior of patients with breast cancer after chemotherapy is important to promote sustained exercise. The purpose of the current study was to report the longer-term patterns and predictors of exercise behavior in patients with breast cancer who exercised during chemotherapy.

Methods
In the Combined Aerobic and Resistance Exercise (CARE) Trial, 301 patients with breast cancer were randomized to three different exercise prescriptions during chemotherapy. Exercise behaviors after chemotherapy were self-reported at 6-, 12-, and 24-month follow-up. Exercise patterns were identified by categorizing patients according to which exercise guideline they were meeting (neither, aerobic only, resistance only, or combined) at each of the three follow-up timepoints (64 possible patterns). Predictors of longer-term exercise behavior included physical fitness, patient-reported outcomes, and motivational variables from the theory of planned behavior assessed at postintervention (postchemotherapy). Univariate and multivariate stepwise multinomial logistic regression and linear regression were used for statistical analyses.

Results
A total of 264 (88%) participants completed all three follow-up exercise behavior assessments and exhibited 50 different exercise patterns. Postintervention aerobic fitness was the most consistent predictor of longer-term exercise behavior at all three timepoints. For example, higher aerobic fitness (per 1 ml/kg/min) predicted better adherence to the “aerobic only” (OR = 1.09; p = 0.005) and “combined” (OR = 1.12; p < 0.001) guidelines compared to “neither” guideline at 6-month follow-up. Additionally, higher postintervention muscular strength (per 1 kg) was associated with better adherence to the “resistance only” (OR = 1.07; p = 0.025) and “combined” (OR = 1.08; p < 0.001) guidelines compared to “neither” guideline at 24-month follow-up. Finally, lower perceived difficulty (per 1 scale point) was associated with better adherence to the “combined” (OR = 0.62; p = 0.010) and “aerobic only” (OR = 0.58; p = 0.002) guideline compared to the “neither” guideline at the 24-month follow-up.

Conclusions
Our study is the first to show that the longer-term exercise patterns of patients with breast cancer who exercised during chemotherapy are diverse and predicted by physical fitness and motivational variables after chemotherapy. Our novel implications are that improving physical fitness during chemotherapy and applying motivational counseling after chemotherapy may improve longer-term exercise behavior in patients with breast cancer.

Trial registration
(NCT00249015).
Concerns and educational needs of Iranian parents regarding the sexual health of their male adolescents: a qualitative study
Authors: Babayanzad Ahari Shahnaz , Behboodi Moghadam Zahra , Azin Seyed Ali , Maasoumi Raziyeh 
Published: February 2020

Abstract
Background
Parents play an important role in promoting the sexual health of their adolescents. However, many parents experience several challenges. The purpose of this study was to explore the concerns and educational needs of Iranian parents regarding the sexual health of their male adolescents.

Methods
This qualitative study was designed based on the conventional content analysis approach. Semi-structured and in-depth interviews were conducted with 16 parents of male adolescents aged 12–18 years. All interviews were audio recorded and transcribed verbatim. The data were collected through purposeful sampling and continued until data saturation. Finally, the Graneheim and Landman strategies were used to analyze data.

Results
According to the participants’ comments, four main categories were extracted as follows: fear of emotional and sexual harms, quality of parent-child relationships, effect of media and cyberspace, and necessity of sexuality health education.

Conclusions
The findings highlighted the need for sexuality health education through cooperation with schools for offering appropriate education to the students, parents, and school staffs.
The results showed that parents required training to enhance their knowledge and skills to improve their communication with their adolescents about sexuality issues. Therefore, it is necessary to design, implement, and evaluate culture-appropriate educational programs to address the parents’ concerns regarding adolescents’ sexual health.
Should compression bandage be performed after total knee arthroplasty? A meta-analysis of randomized controlled trials
Authors: Liu Pei , Mu Xiaohong , Zhang Qidong , Liu Zhaohui , Wang Weiguo , Guo Wanshou 
Published: February 2020

Abstract
Background
Compression bandage often is used after total knee arthroplasty (TKA) to alleviate pain, ameliorate swelling, and reduce bleeding. However, there is controversy about its application due to conflicting clinical outcomes and potential compression-related complications. This meta-analysis aimed to answer the question of if compression bandage should be implemented routinely after TKA.

Methods
Relevant randomized controlled trials (RCTs) on compression bandage were comprehensively retrieved utilizing search engines such as PubMed, EMBASE, Web of Science, and the Cochrane Library, up to September 2019. Studies included in the meta-analysis were those that compared post-operative pain score, swelling, total blood loss, pre- and post-operative hematocrit levels differences, range of motion (ROM), and complications, using Review Manager 5.3.0.

Results
Included were seven RCTs, which reported on 511 knees. The pooled results showed the compression bandage group was associated with a greater post-operative pain score during ambulation at 48 h (WMD = 0.70, 95% CI 0.07 to 1.34, P = 0.03), compared with the non-compression bandage group. No statistically significant differences were found between the groups in post-operative pain scores at the other times, swelling, blood loss, ROM, or other complications (P > 0.05).

Conclusions
The current evidence is unable to conclude that compression bandage is necessary after primary TKA. Surgeons routinely undertaking compression bandage should deliberate whether there is enough clinical evidence.