bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparison of antiangina therapies in patients with coronary heart disease in China: study protocol for a multicentre, retrospective, hospital system-based study
Authors: Li Ping , Chen Juan , Ke Zheng , Han Jing , Shen Lan , Zhou Ning 
Published: February 2021

IntroductionChina has the largest number of patients with coronary heart disease (CHD) in the world. Numerous pharmacological strategies are available for CHD in routine clinical practice. CHD-induced angina pectoris affects patients’ quality of life and is a key predictor of prognosis. This study will compare the effectiveness of different antiangina treatments, particularly ATP-sensitive potassium channel (KATP) activators, in the Central China District. This proposal underpins the first comparison of antiangina therapies in patients with CHD in China using a multicentre, retrospective, hospital system-based assessment.Methods and analysisThis retrospective real-world study will assess the largest hospital databases in Wuhan City in Central China to evaluate outcomes including mortality, revascularisation, myocardial infarction (MI), stroke and other cardio-cerebrovascular events in patients with CHD. Data will be consecutively collected between 1 April 2009 and 31 August 2019 through the hospital information system, laboratory information system and hospital imaging system. All data will be standardised by at least three independent technicians and statisticians using International Classification of Diseases Tenth Version, ISO15189 and Specification for Drafting of Basic Dataset of Electronic Medical Record (WS445). The data will include patient demographics, physical and laboratory examinations, imaging examinations, medical history, diagnosis, treatment options and payment information. We will compare KATPactivators with other antiangina drugs using propensity score matching. The primary outcome will be major adverse cardiovascular events, defined as a composite of death, MI, stroke and rehospitalisation due to angina.Ethics and disseminationThe current study is designed to translate research into improved care for patients. The institutional review board of Wuhan Tongji Hospital (Liao Jiazhi, Du Aiye, Chen Zhishui, Fang Feng, Yu Shiying, Liu Dong and Li Yaping) approved the study protocol (version 1.0, July 2019, approval number TJ-IRB201909112). Here we reported a protocol related to a pre-results. Data will be presented in peer-reviewed journals, social media and relevant conferences.Trial registration numberChiCTR1900027812; Pre-results.
Retrospective cohort study to investigate the 10-year trajectories of disease patterns in patients with hypertension and/or diabetes mellitus on subsequent cardiovascular outcomes and health service utilisation: a study protocol
Authors: WAN Eric Yuk Fai , Chin Weng Yee , Yu Esther Yee Tak , Chen Julie , Tse Emily Tsui Yee , Wong Carlos King Ho , Ha Tony King Hang , Chao David Vai Kiong , Tsui Wendy Wing Sze , Lam Cindy Lo Kuen 
Published: February 2021

IntroductionHypertension (HT) and diabetes mellitus (DM) and are major disease burdens in all healthcare systems. Given their high impact on morbidity, premature death and direct medical costs, we need to optimise effectiveness and cost-effectiveness of primary care for patients with HT/DM. This study aims to find out the association of trajectories in disease patterns and treatment of patients with HT/DM including multimorbidity and continuity of care with disease outcomes and service utilisation over 10 years in order to identify better approaches to delivering primary care services.Methods and analysisA 10-year retrospective cohort study on a population-based primary care cohort of Chinese patients with documented doctor-diagnosed HT and/or DM, managed in the Hong Kong Hospital Authority (HA) public primary care clinics from 1 January 2006 to 31 December 2019. Data will be extracted from the HA Clinical Management System to identify trajectory patterns of patients with HT/DM. Complications defined by ICPC-2/International Classification of Diseases-Ninth Revision, Clinical Modification diagnosis codes, all-cause mortality rates and public service utilisation rates are included as independent variables. Changes in clinical parameters will be investigated using a growth mixture modelling analysis with standard quadratic trajectories. Dependent variables including effects of multimorbidity, measured by (1) disease count and (2) Charlson’s Comorbidity Index, and continuity of care, measured by the Usual Provide Continuity Index, on patient outcomes and health service utilisation will be investigated. Multivariable Cox proportional hazards regression will be conducted to estimate the effect of multimorbidity and continuity of care after stratification of patients into groups according to respective definitions.Ethics and disseminationThis study was approved by the institutional review board of the University of Hong Kong—the HA Hong Kong West Cluster, reference no: UW 19–329. The study findings will be disseminated through peer-reviewed publications and international conferences.Trial registration numberNCT04302974.
Journey to facility birth in Zanzibar: a questionnaire-based cohort study of patients’ perspectives on preparedness, access and quality of care
Authors: Herklots Tanneke , D'haene Lara , Mbarouk Khairat Said , Rajhy Mubina , Couperus Simone , Meguid Tarek , Franx Arie , Koster Maria P H , Jacod Benoit 
Published: February 2021

IntroductionTackling substandard maternity care in health facilities requires engaging women’s perspectives in strategies to improve outcomes. This study aims to provide insights in the perspectives of women with severe maternal morbidity on preparedness, access and quality of care in Zanzibar’s referral hospital.MethodsIn a prospective cohort from April 2017 to December 2018, we performed semistructured interviews with women who experienced maternal near-miss complications and matched controls. These focused on sociodemographic and obstetric characteristics, perceived accessibility to and quality of facility care with 15 domains, scored on a one-to-five scale. Participants’ comments and answers to open questions were employed to illustrate quantitative outcomes. Zanzibar’s Medical Research and Ethics Committee approved the study (ZAMREC/0002/JUN/17).ResultsWe included 174 cases and 151 controls. Compared with controls, patients with a near-miss had less formal education (p=0.049), perceived their wealth as poor (p=0.002) and had a stillbirth more often (p<0.001). Many experienced a delay in deciding to seek care. More than controls, near-miss patients experienced barriers in reaching care (p=0.049), often of financial nature (13.8% vs 4.0%). Quality of care was perceived as high, with means above 3 out of 5, in 14 out of 15 domains. One-fifth had an overall suboptimal experience, mostly regarding informed choice and supplies availability. Additional comments were expressed by a minority of participants.ConclusionMost patients promptly sought, accessed and received maternity care in Zanzibar’s referral hospital. A minority experienced barriers, mostly financial, in reaching care and more so among patients with near-miss complications. Quality of facility care was generally highly rated. However, some reported insightful critical perceptions. This study highlights the impact of sociodemographic differences on health, the value of involving patients in decisions regarding maternity care and the need to ensure availability of medical supplies, all which will contribute to improved maternal well-being.
Role of the total progressive motile sperm count (TPMSC) in different infertility factors in IUI: a retrospective cohort study
Authors: Lin Haiyan , Li Yu , Ou Songbang , Jiao Xuedan , Wang Wenjun , Humaidan Peter , Zhang Qingxue 
Published: February 2021

ObjectiveThe objective of this retrospective cohort study was to explore the optimal range of the total progressive motile sperm count (TPMSC) for live birth in couples with varying infertility diagnosis undergoing intrauterine insemination (IUI) in a university-affiliated teaching hospital.MethodsA total of 2647 couples and 5171 IUI cycles were included between January 2015 and December 2018. Of those, 1542 cycles were performed due to unexplained infertility, 1228 cycles due to anovulation, 1120 cycles due to mild male factor infertility and 122 cycles due to mild endometriosis. The primary outcome measure was live birth rate (LBR). The secondary outcome measure was clinical pregnancy rate (CPR).ResultsThe CPR and LBR were highest in patients with a diagnosis of anovulation compared with the other three groups of patients. The CPR and LBR in patients with unexplained, mild male factor and mild endometriosis were comparable. For the patients with mild male factor infertility, the CPR with prewash TPMSC of >75.0 M and postwash TPMSC of 65.10 M was above 10%, statistically significantly higher than other quartiles of TPMSC (p<0.05). The LBR with postwash TPMSC of >65.10 M was statistically significantly higher than other groups (p<0.05). However, in patients with unexplained infertility, the CPR and LBR were not statistically different in quartiles of TPMSC, being less than 10%. Overall, there was only one clinical pregnancy and no live birth in patients >40 years of age.ConclusionsIn conclusion, the infertility diagnosis plays a significant role for the patient undergoing IUI. Thus, the anovulatory patients benefitted most from IUI, irrespective of TPMSC. For patients with unexplained infertility, TPMSC does not affect the success rate of IUI. Overall,female patients more than 40 years old should not be referred to IUI.
A five-year trend in pre-eclampsia admission and factors associated with inpatient eclampsia: a retrospective study from a resource-limited hospital in northeast Ethiopia
Authors: Tlaye Kenean Getaneh , Endalifer Melese Linger , Getu Mikiyas Amare , Nigatu Addisu Getie , Kebede Eleni Tesfaye 
Published: February 2021

ObjectiveTo investigate the 5-year trend of pre-eclampsia admission, magnitude and factor associated with inpatient eclampsia among deliveries involving pre-eclampsia which have been attended at one of the resource-limited public hospitals in northeast Ethiopia.DesignRetrospective medical record review study.SettingWoldia General Hospital Medical archive, Woldia town, Ethiopia.ParticipantsAll antenatal admission and deliveries involving pre-eclampsia attended from 2011 to 2016 at the hospital were included in the review.Primary and secondary outcome measuresTrend of pre-eclampsia admission was determined using non-parametric Mann-Kendall correlation. Case management, clinical and patient-related factors were tested for possible association with the development of inpatient eclampsia using binary logistic regression. P value less than 0.05 considered significant.ResultAcross the 5-year period, there were 8764 deliveries attended at the hospital’s labour and delivery ward, of them 241 (2.76%) were co-diagnosed with pre-eclampsia. The trend showed marginal decrement through years (tau-b correlation coefficient (Tb)=−0.4, p=0.035) with the highest caseload (4.4%) observed on year 2013/2014. The rate of inpatient eclampsia was 19.6 per 10 000 births and the likelihood of its occurrence among pre-eclamptic women was 7.1% (95% CI 2.7% to 11.5%). In multivariate analysis, being multigravida (adjusted OR (AOR) 0.154, 95% CI 0.029 to 0.831) and spontaneous onset of labour (AOR 5.628, 95% CI 1.1247 to 9.401) were associated with inpatient eclampsia.ConclusionIn the study setting, the overall magnitude of pre-eclampsia admission was comparable with the global average, but its yearly trend showed marginal decrement from 2011 to 2016. High rate of inpatient eclampsia might indicate undertreatment which alarms further study and/or corrective measures. Waiting for spontaneous onset of labour could increase the risk of developing inpatient eclampsia whereas neither type of anticonvulsant nor duration of its usage has made significant association.
Neonatal Severe Hyperbilirubinemia Online Registry in Jiangsu Province: protocol for a multicentre, prospective, open, observational cohort study
Authors: Li Qianqian , Deng Xiaoyi , Yan Junmei , Sun Xiaofan , Dong Xiaoyue , Chen Xiaohui , Han Shuping , Huo Jie , Yu Zhangbin 
Published: February 2021

IntroductionSevere hyperbilirubinaemia in newborns can be easily complicated by acute bilirubin encephalopathy or even kernicterus, which could lead to neurological sequelae or death. However, there is no systematic study of the management of severe hyperbilirubinaemia in China. The Neonatal Severe Hyperbilirubinemia Online Registry study aims to investigate the management of jaundice before admission, risk factors and outcomes of severe hyperbilirubinaemia in a real-world setting in China.Methods and analysisThis is a prospective, multicentre, open, observational cohort study. From May 2020 to April 2023, more than 2000 patients with neonatal severe hyperbilirubinaemia from 13 tertiary hospitals in Jiangsu Province will join the study. Demographic data and treatment information will be collected from their clinical data. Management measures for jaundice before admission will be collected by the WeChat applet (called ‘Follow-up of jaundice’) after being provided by the patient’s guardian using a mobile phone. Follow-up data will include cranial MRI examination results, brainstem auditory-evoked potential or automatic auditory brainstem response, physical examination results and Griffiths Development Scales-Chinese at the corrected ages of 3–6 months and 1 and 2 years. Results and conclusions will be recorded using ‘Follow-up of jaundice.’ In-hospital outcomes, including severity of hyperbilirubinaemia (severe, extreme, hazardous), acute bilirubin encephalopathy (mild, moderate, severe) and survival status (death or survival), will be collected at discharge. Follow-up outcomes will include loss to follow-up, survival status and kernicterus (yes or no) at 2 years. The research will enhance our comprehensive knowledge of jaundice management before admission, risk factors and outcomes of severe hyperbilirubinaemia in China, which will ultimately help to reduce the incidence of neonatal severe hyperbilirubinaemia.Ethics and disseminationOur protocol has been approved by the Medical Ethics Committee of Nanjing Maternity and Child Health Care Hospital. We will present our findings at national conferences and peer-reviewed paediatrics journals.Trial registration numberNCT04251286.
Development and psychometric evaluation of a Positive Health measurement scale: a factor analysis study based on a Dutch population
Authors: Van Vliet Marja , Doornenbal Brian M , Boerema Simone , van den Akker-van Marle Elske M 
Published: February 2021

ObjectivesThe My Positive Health (MPH) dialogue tool is increasingly adopted by healthcare professionals in the Netherlands as well as abroad to support people in their health. Given this trend, the need arises to measure effects of interventions on the Positive Health dimensions. However, the dialogue tool was not developed for this purpose. Therefore, this study aims to work towards a suitable measurement scale using the MPH dialogue tool as starting point.DesignA cross-sectional study design.Participants and settingsA total of 708 respondents, who were all members of the municipal health service panel in the eastern part of the Netherlands, completed the MPH dialogue tool.MethodsThe factor structure of the MPH dialogue tool was explored through exploratory factor analysis using maximum likelihood extraction. Next, the fit of the extracted factor structure was tested through confirmatory factor analysis. Reliability and discriminant validity of both a new model and the MPH scales were assessed through Cronbach’s alpha tests.ResultsSimilar to the MPH dialogue tool, the extracted 17-item model has a six-factor structure but named differently, comprising the factors physical fitness, mental functions, future perspectives, contentment, social relations and health management. The reliability tests suggest good to very good reliability of the aimed measurement tool and MPH model (Cronbach’s alpha values ranging from, respectively, 0.820 to 0.920 and 0.882 to 0.933). The measurement model shows acceptable discriminant validity, whereas the MPH model suggests overlap between domains.ConclusionThe results suggest that the current MPH dialogue tool seems reliable as a dialogue, but it is not suitable as a measurement scale. We therefore propose a 17-item model with improved, acceptable psychometric properties which can serve as a basis for further development of a measurement scale.
Comparative efficacy and safety of different regimens of ranibizumab for neovascular age-related macular degeneration: a network meta-analysis of randomised controlled trials
Authors: Zhao Xinyu , Meng Lihui , Chen Youxin 
Published: February 2021

ObjectiveTo give a comprehensive efficacy and safety ranking of different therapeutic regimens of ranibizumab for neovascular age-related macular degeneration (nAMD).DesignA systematic review and network meta-analysis.MethodsThe PubMed, Embase, Cochrane Central Register of Controlled Trials, and other clinical trial registries were searched up to 1 October 2019 to identify related randomised controlled trials (RCT) of different regimens of ranibizumab for nAMD. The primary efficacy outcome was the changes of best-corrected visual acuity (BCVA) at 1 year, the primary safety outcome was the incidence of severe ocular adverse events. Secondary outcomes such as changes of central retinal thickness (CRT) were evaluated. We estimated the standardised mean difference (SMD), ORs, 95% CIs, the surface under the cumulative ranking curves and the mean ranks for each outcome using network meta-analyses with random effects by Stata 14.0.ResultsWe identified 26 RCTs involving 10 821 patients with nAMD randomly assigned to 21 different therapeutic regimens of ranibizumab or sham treatment. Ranibizumab 0.5 mg (treat and extend, T&E) is most effective in terms of changes of BCVA (letters, SMD=21.41, 95% CI 19.86 to 22.95) and three or more lines of BCVA improvement (OR=2.83, 95% CI 1.27 to 4.38). However, it could not significantly reduce retreatment times compared with monthly injection (SMD=−0.94, 95% CI −2.26 to 0.39). Ranibizumab 0.5 mg (3+pro re nata)+non-steroidal anti-inflammatory drugs (NSAIDs) is most effective in reducing CRT and port delivery system of ranibizumab (100 mg/mL) could reduce the number of retreatment most significantly. All regimes have no more risk of severe ocular complications (including vitreous haemorrhage, rhegmatogenous retinal detachment, endophthalmitis, retinal tear and retinal pigment epithelium tear) or cardiocerebral vascular complications.ConclusionsRanibizumab 0.5 mg (T&E) is most effective in improving the visual outcome. The administration of topical NSAIDs could achieve additional efficacy in CRT reduction and visual improvement. Both interventions had acceptable risks of adverse events.
Symptom appraisal, help-seeking and perceived barriers to healthcare seeking in Uganda: an exploratory study among women with potential symptoms of breast and cervical cancer
Authors: Mwaka Amos Deogratius , Walter Fiona M , Scott Suzanne , Harries Jane , Wabinga Henry , Moodley Jennifer 
Published: February 2021

ObjectiveWe assessed the process of recognising abnormal bodily changes, interpretations and attributions, and help-seeking behaviour among community-based Ugandan women with possible symptoms of breast and cervical cancer, in order to inform health interventions aiming to promote timely detection and diagnosis of cancer.DesignQualitative in-depth interviews.SettingRural and urban communities in Uganda.ParticipantsWomen who participated in the African Women Awareness of CANcer cross-sectional survey who disclosed potential breast and cervical cancer symptoms were eligible; recruitment was purposive. Interviews were conducted in women’s homes, lasted between 40 and 90 min, were audio-recorded, transcribed verbatim and translated to English. Thematic analysis was used to identify themes and subthemes, underpinned by the conceptual framework of the Model of Pathways to Treatment.Results23 women were interviewed: 10 had potential symptoms of breast cancer and 13 of cervical cancer. Themes regarding symptom appraisal and help-seeking included the: (1) detection and interpretation of abnormal bodily sensations; (2) lay consultations regarding bodily changes; (3) iterative process of inferring and attributing illnesses to the bodily changes; (4) restricted disclosure of symptoms to lay people due to concerns about privacy and fear of stigmatisation; (5) help-seeking from multiple sources including both traditional and biomedical health practitioners, and (6) multiple perceived barriers to help-seeking including long waiting times, lack of medicines, absenteeism of healthcare professionals, and lack of money for transport and medical bills.ConclusionWomen with potential symptoms of breast and cervical cancer undergo complex processes of symptom interpretation, attributing symptoms or inferring illness, and lay consultations before undertaking help-seeking and management. Increasing community understanding of breast and cervical cancer symptoms, and tackling perceived barriers to health-seeking, could lead to prompt and appropriate symptom appraisal and help-seeking, and contribute to improving cancer outcomes.
Protocol for assessing whether cognition of preterm infants <29 weeks’ gestation can be improved by an intervention with the omega-3 long-chain polyunsaturated fatty acid docosahexaenoic acid (DHA): a follow-up of a randomised controlled trial
Authors: Gould Jacqueline F , Makrides Maria , Sullivan Thomas R , Anderson Peter J , Gibson Robert A , Best Karen P , McPhee Andrew J , Doyle Lex William , Opie Gillian , Travadi Javeed , Cheong Jeanie , Davis Peter G , Sharp Mary , Simmer Karen , Collins Carmel T 
Published: February 2021

IntroductionDocosahexaenoic acid (DHA) is an omega-3 (n-3) fatty acid that accumulates into neural tissue during the last trimester of pregnancy, as the fetal brain is undergoing a growth spurt. Infants born <29 weeks’ gestation are deprived the normal in utero supply of DHA during this period of rapid brain development. Insufficient dietary DHA postnatally may contribute to the cognitive impairments common among this population. This follow-up of the N-3 fatty acids for improvement in respiratory outcomes (N3RO) randomised controlled trial aims to determine if enteral DHA supplementation in infants born <29 weeks’ gestation during the first months of life improves cognitive development at 5 years of age corrected for prematurity.Methods and analysisN3RO was a randomised controlled trial of enteral DHA supplementation (60 mg/kg/day) or a control emulsion (without DHA) in 1273 infants born <29 weeks’ gestation to determine the effect on bronchopulmonary dysplasia (BPD). We showed that DHA supplementation did not reduce the risk of BPD and may have increased the risk.In this follow-up at 5 years’ corrected age, a predefined subset (n=655) of children from five Australian sites will be invited to attend a cognitive assessment with a psychologist. Children will be administered the Wechsler Preschool and Primary Scale of Intelligence (fourth edition) and a measure of inhibitory control (fruit stroop), while height, weight and head circumference will be measured.The primary outcome is full-scale IQ. To ensure 90% power, a minimum of 592 children are needed to detect a four-point difference in IQ between the groups.Research personnel and families remain blinded to group assignment.Ethics and disseminationThe Women’s and Children Health Network Human Research Ethics Committee reviewed and approved the study (HREC/17/WCHN/187). Caregivers will give informed consent prior to taking part in this follow-up study. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberACTRN12612000503820.