bluuebunny/crossref_metadata_2025_split huggingface dataset:
Association between 7-day serum β-hCG levels after frozen–thawed embryo transfer and pregnancy outcomes: a single-centre retrospective study from China
Authors: Yuan Lihua , Yu Lingyu , Sun Zhengao , Song Jingyan , Xiao Jimei , Jiang Huaying , Sa Yuanhong 
Published: October 2020

ObjectiveEarly monitoring of plasma human chorionic gonadotropin (β-hCG) level is vital in predicting pregnancy outcome. This study investigated the predictive value of serum β-hCG level on the seventh day after frozen–thawed embryo transfer (FET) for ongoing pregnancy (OP) and adverse pregnancy (AP).DesignRetrospective study.SettingThe Reproductive and Genetic Center of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, China.Participants1061 pregnant women who underwent FET between January 2014 and January 2017.Primary and secondary outcome measuresPregnancy outcome.ResultsSerum β-hCG levels on the seventh day after FET were higher in the single OP group compared with the biochemical pregnancy group (p<0.001). Besides, the serum β-hCG cut-off level at 4.34 mIU/mL on the seventh day showed high predictive value (area under the curve (AUC)=0.852). Serum β-hCG levels on the seventh day after FET were higher in the twin OP group compared with the single OP group (p<0.001). Also, the serum β-hCG cut-off level at 17.95 mIU/mL on the seventh day showed high predictive value (AUC=0.903). Serum β-hCG levels on the seventh day after FET were lower in the ectopic pregnancy group compared with the single OP group (p<0.001) whereas, serum β-hCG cut-off level at 4.53 mIU/mL on the seventh day exhibited a high predictive value (AUC=0.860). Further, the serum β-hCG levels on the seventh day after FET were lower in the single early spontaneous abortion group compared with the single OP group (p<0.001) while the serum β-hCG cut-off level at 5.34 mIU/mL on the seventh day exhibited high predictive value (AUC=0.738).ConclusionSerum β-hCG on the seventh day after FET has good clinical significance for the prediction of OP and AP.
Cost-effectiveness of new MDR-TB regimens: study protocol for the TB-PRACTECAL economic evaluation substudy
Authors: Sweeney Sedona , Gomez Gabriela , Kitson Nichola , Sinha Animesh , Yatskevich Natalia , Staples Suzanne , Moodliar Ronelle , Motlhako Sharon , Maloma Matshepo , Rassool Mohammed , Ngubane Nosipho , Ndlovu Ella , Nyang'wa Bern-Thomas 
Published: October 2020

IntroductionCurrent treatment regimens for multidrug-resistant tuberculosis (MDR-TB) are long, poorly tolerated and have poor outcomes. Furthermore, the costs of treating MDR-TB are much greater than those for treating drug-susceptible TB, both for health service and patient-incurred costs. Urgent action is needed to identify short, effective, tolerable and cheaper treatments for people with both quinolone-susceptible and quinolone-resistant MDR-TB. We present the protocol for an economic evaluation (PRACTECAL-EE substudy) alongside an ongoing clinical trial (TB-PRACTECAL) aiming to assess the costs to patients and providers of new regimens, as well as their cost-effectiveness and impact on participant poverty levels. This substudy is based on data from the three countries participating in the main trial.Methods and analysisPrimary cost data will be collected from the provider and patient perspectives, following economic best practice. We will estimate the probability that new MDR-TB regimens containing bedaquiline, pretomanid and linezolid are cost-effective from a societal perspective as compared with the standard of care for MDR-TB patients in Uzbekistan, South Africa and Belarus. Analysis uses a Markov model populated with primary cost and outcome data collected at each study site. We will also estimate the impact of new regimens on prevalence of catastrophic patient costs due to TB.Ethics and disseminationEthical approval has been obtained from the London School of Hygiene & Tropical Medicine and Médecins Sans Frontières. Local ethical approval will be sought in each study site. The results of the economic evaluation will be shared with the country health authorities and published in a peer-reviewed journal.Trial registration numberClinicalTrials.gov Registry (NCT04207112); Pre-results.
Barriers to uptake of reproductive information and contraceptives in rural Tanzania: an intersectionality informed qualitative enquiry
Authors: Carroll Allison , Kapilashrami Anuj 
Published: October 2020

ObjectivesAccess to reproductive information and contraception (RIC) continues to be a critical unmet need in Tanzania and impedes the realisation of reproductive health rights. This study examined key sources of RIC and the factors influencing their uptake by women in Mbeya region of Tanzania.SettingThis qualitative study was undertaken in a rural ward in a district in the south of the Mbeya regionParticipantsIn-depth interviews were undertaken with 48 women users and 2 nurses working in a public health facility, and focus group discussions with 16 home-based care workers in the district. Participants were recruited through a local non-governmental organisation (NGO) in the region, and via snowball sampling. All interactions were recorded, translated and transcribed and sought to identify the available resources and barriers in using them.ResultsParticipants reported six main sources of reproductive information and contraceptives: public health facilities, NGO mobile clinics, other women, Mganga wa Asili (witchdoctors/traditional doctors) and Duka la Dawa (pharmacy). Women users and healthcare workers identified a range of individual (age, marital status and geography) and health system-wide factors shaping women’s reproductive choices and preventing uptake of contraceptives. The study also revealed structural factors such as gender, ethnicity, indigeneity as key determinants of access and health seeking, placing women from Sukuma and Maasai communities is the most disadvantageous position. Historical social disadvantage, patriarchal social controls and the pressure to preserve sociocultural traditions that women experience in the Maasai and Sukuma tribes underpin their disconnect from mainstream services.ConclusionWomen’s reproductive choices and their uptake of contraceptives are shaped by the interaction of a range of individual, household, institutional and structural factors. An intersectional lens enables examination of the ways in which these factors interact and mutually constitute disadvantage and privilege.
Effects of interorganisational information technology networks on patient safety: a realist synthesis
Authors: Keen Justin , Abdulwahid Maysam Ali , King Natalie , Wright Judy M , Randell Rebecca , Gardner Peter , Waring Justin , Longo Roberta , Nikolova Silviya , Sloan Claire , Greenhalgh Joanne 
Published: October 2020

ObjectiveHealth services in many countries are investing in interorganisational networks, linking patients’ records held in different organisations across a city or region. The aim of the systematic review was to establish how, why and in what circumstances these networks improve patient safety, fail to do so, or increase safety risks, for people living at home.DesignRealist synthesis, drawing on both quantitative and qualitative evidence, and including consultation with stakeholders in nominal groups and semistructured interviews.Eligibility criteriaThe coordination of services for older people living at home, and medicine reconciliation for older patients returning home from hospital.Information sources17 sources including Medline, Embase, CINAHL, Cochrane Library, Web of Science, ACM Digital Library, and Applied Social Sciences Index and Abstracts.OutcomesChanges in patients’ clinical risks.ResultsWe did not find any detailed accounts of the sequences of events that policymakers and others believe will lead from the deployment of interoperable networks to improved patient safety. We were, though, able to identify a substantial number of theory fragments, and these were used to develop programme theories.There is good evidence that there are problems with the coordination of services in general, and the reconciliation of medication lists in particular, and it indicates that most problems are social and organisational in nature. There is also good evidence that doctors and other professionals find interoperable networks difficult to use. There was limited high-quality evidence about safety-related outcomes associated with the deployment of interoperable networks.ConclusionsEmpirical evidence does not currently justify claims about the beneficial effects of interoperable networks on patient safety. There appears to be a mismatch between technology-driven assumptions about the effects of networks and the sociotechnical nature of coordination problems.PROSPERO registration numberCRD42017073004.
Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol
Authors: Hu Tingting , Li Shunrong , Huang Heng , Huang Hui , Tan Luyuan , Chen Yanbo , Deng Heran , Wu Jiannan , Zhu Liling , Zhang Jian , Su Fengxi , Chen Kai 
Published: October 2020

IntroductionThe ideal treatment for idiopathic granulomatous mastitis (IGM) remains unclear. In a prospective, single-centre, pilot study, we reported that ductal lavage treatment for non-lactational mastitis patients had a 1-year clinical complete response (cCR) rate of >90%, without any significant adverse events. Thus, in this multicentre, randomised, open-label, non-inferiority trial, we will aim to compare the effectiveness and safety of ductal lavage vs oral corticosteroids as the first-line treatment for patients with IGM.Methods and analysisThe trial will be conducted at the Breast Tumor Center of Sun Yat-sen Memorial Hospital in China and at least at one participating regional centre. We plan to recruit 140 eligible IGM patients who will be randomised into the ductal lavage group or oral corticosteroid group with a 1:1 ratio. The patients in the oral corticosteroid group will receive Methylprednisolone or prednisone for 6 months. The patients in the ductal lavage group will receive ductal lavage and breast massage, as previously reported. All the participants will be followed up at the clinic for 1 year post randomisation. The primary endpoint of this trial will be the 1-year cCR rate, and the secondary endpoints will include the time to cCR, treatment failure rate, relapse rate and protocol compliance rate. The trial was designed to determine whether ductal lavage is non-inferior to oral corticosteroids (1-year cCR rate assumed to be 90%), with a non-inferiority margin of 15%.Ethics and disseminationThe ethics committee of Sun Yat-sen Memorial Hospital at Sun Yat-sen University approved the study (2018-Lun-Shen-Yan-No. 30). The results of the trial will be communicated to the participating primary care practices, published in international journals and presented at international clinical and scientific conferences.Trial registration numberClinicalTrials.gov Registry (NCT03724903); Pre-results.
Adherence to lipid-lowering guidelines for secondary prevention and potential reduction in CVD events in Swedish primary care: a cross-sectional study
Authors: Ödesjö Helena , Björck Staffan , Franzén Stefan , Hjerpe Per , Manhem Karin , Rosengren Annika , Thorn Jörgen , Adamsson Eryd Samuel 
Published: October 2020

ObjectivesThe protective effect of lipid-lowering treatment for secondary prevention after coronary heart disease (CHD) has been well documented. Current guidelines recommend a target level for low-density lipoprotein cholesterol (LDL-C) of ≤1.8 mmol/L. The aim was to describe lipid-lowering treatment patterns and to provide an estimate of the potential reductions in cardiovascular disease (CVD) events with improved adherence to guidelines.DesignCross-sectional.SettingPrimary care in a large Swedish region.Participants37 120 patients with CHD in a Swedish regional primary care quality register (QregPV), by 31 December 2015.Primary and secondary outcome measuresProportion of patients on statin treatment and proportion of patients achieving LDL-C ≤1.8 mmol/L. Estimated number of CVD events calculated for (1) current treatment, (2) improved treatment and (3) lowered LDL-C, based on applying rate reductions from meta-analyses of randomised trials to the potentially undertreated population. Risk estimation modelling was based on 52 042 patients in the same register on January 2011 followed for 5 years.ResultsOf 37 120 patients, 18% reached LDL-C ≤1.8 mmol/L and 32% were not on statin treatment. Based on individual risks, the estimated number of CVD events in the study group over 5 years was 9209/37 120. If all patients without a statin or with less potent statin treatment were given atorvastatin 80 mg, an estimated reduction of CVD events by 14% (7901 vs 9209) was seen. If all patients achieved LDL-C ≤1.8 mmol/L, the number of events was estimated to be reduced by 18% (7577 vs 9209).ConclusionOne-third of patients with CHD in primary care were not on lipid-lowering treatment. Based on the assumption that included patients would react to statin therapy the same way as the patients in randomised trials, improved adherence to treatment guidelines could lead to a substantial reduction in new CVD events.
Early Parenting Acceptance and Commitment Therapy ‘Early PACT’ for parents of infants with cerebral palsy: a study protocol of a randomised controlled trial
Authors: Whittingham Koa , Sheffield Jeanie , Mak Catherine , Dickinson Corrine , Boyd Roslyn N 
Published: October 2020

IntroductionNew international clinical practice guidelines exist for identifying infants at high risk of cerebral palsy (CP) earlier: between 12 to 24 weeks corrected age, significantly earlier than previous diagnosis windows in Australia at 19 months. The earlier detection of infants at high risk of CP creates an opportunity for earlier intervention. The quality of the parent-infant relationship impacts various child outcomes, and is leveraged in other forms of intervention. This paper presents the protocol of a randomised controlled trial of an online parent support programme, Early Parenting Acceptance and Commitment Therapy (Early PACT) for families of infants identified as at high risk of CP. We predict that participating in the Early PACT programme will be associated with improvements in the parent-infant relationship, in parent mental health and well-being as well as infant behaviour and quality of life.Methods and analysisThis study aims to recruit 60 parents of infants (0 to 2 years old corrected age) diagnosed with CP or identified as at high risk of having CP. Participants will be randomly allocated to one of two groups: Early PACT or waitlist control (1:1). Early PACT is an online parent support programme grounded in Acceptance and Commitment Therapy (ACT). It is delivered as a course on an open source course management system called edX. Early PACT is designed to support parental adjustment and parent-infant relationship around the time of early diagnosis. Assessments will be conducted at baseline, following completion of Early PACT and at 6-month follow-up (retention). The primary outcome will be the quality of parent-child interactions as measured by the Emotional Availability Scale. Standard analysis methods for randomised controlled trial will be used to make comparisons between the two groups (Early PACT and waitlist control). Retention of effects will be examined at 6-month follow-up.Ethics and disseminationThis study is approved through appropriate Australian and New Zealand ethics committees (see in text) with parents providing written informed consent. Findings from this trial will be disseminated through peer-reviewed journal publications and conference presentations.Trial registration detailsThis trial has been prospectively registered on 12 June 2018 to present (ongoing) with the Australian New Zealand Clinical Trials Registry (ACTRN12618000986279); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=3 74 896
Healthcare experiences of patients with chronic heart failure in Germany: a scoping review
Authors: Dieckelmann Mirjam , Petersen Juliana J , Güthlin Corina , Reinhardt Felix , Plath Jasper , Jeitler Klaus , Semlitsch Thomas , Gerlach Ferdinand M , Siebenhofer Andrea 
Published: October 2020

ObjectivesTo review systematically the past 10 years of research activity into the healthcare experiences (HCX) of patients with chronic heart failure (CHF) in Germany, in order to identify research foci and gaps and make recommendations for future research.DesignIn this scoping review, six databases and grey literature sources were systematically searched for articles reporting HCX of patients with CHF in Germany that were published between 2008 and 2018. Extracted results were summarised using quantitative and qualitative descriptive analysis.ResultsOf the 18 studies (100%) that met the inclusion criteria, most were observational studies (60%) that evaluated findings quantitatively (60%). HCX were often concerned with patient information, global satisfaction as well as relationships and communication between patients and providers and generally covered ambulatory care, hospital care and rehabilitation services. Overall, the considerable heterogeneity of the included studies’ outcomes only permitted relatively trivial levels of synthesis.ConclusionIn Germany, research on HCX of patients with CHF is characterised by missing, inadequate and insufficient information. Future research would benefit from qualitative analyses, evidence syntheses, longitudinal analyses that investigate HCX throughout the disease trajectory, and better reporting of sociodemographic data. Furthermore, research should include studies that are based on digital data, reports of experiences gained in under-investigated yet patient-relevant healthcare settings and include more female subjects.
Trends in national pharmaceutical expenditure on diabetes in Ireland 2011–2015: a repeated cross-sectional study
Authors: O Neill Kate N , Bennett Kathleen E , Mc Hugh Sheena M , Fitzgerald Anthony P , Kearney Patricia M 
Published: October 2020

ObjectivesTo explore trends in pharmaceutical expenditure on diabetes between 2011 and 2015, describing trends in expenditure on blood glucose-lowering medications and estimating the effect of cost-containment measures implemented during this time.DesignRepeated cross-sectional study of national pharmacy claims data in Ireland.ParticipantsPatients’ dispensed items used in the treatment or management of diabetes.Primary and secondary outcomesTotal expenditure associated with diabetes was calculated by extracting data on all diabetes-related items dispensed to eligible patients. Costs were categorised into two groups. Diabetes-specific items include items used directly in diabetes treatment (WHO-Anatomical Therapeutic Chemical (ATC): A10, V07, V04) and diabetes-related include all other condition-related items (WHO-ATC: B01, C, H04, N03, N06). The impacts of two specific cost-containment measures, co-payments and reference pricing, were assessed using segmented linear regression analyses of interrupted time-series.ResultsTotal expenditure varied over the study period, peaking at €216 994 441 in 2012. Expenditure on diabetes-specific items increased steadily by 18% reaching €153 621 477 in 2015, with blood glucose-lowering medications accounting for 73% of this increase. During the same period, expenditure on diabetes-related items decreased by 32% to €50 835 856. The introduction of reference pricing for atorvastatin in November 2013 resulted in immediate costs savings of €2.4 million per yearly quarter (level-change p<0.001).ConclusionsThe increasing expenditure on blood glucose-lowering medications negates the effect of recent cost-containment measures, presenting a significant challenge for the provision of diabetes care. Innovative policies are required to ensure high-quality diabetes care can be provided at an equitable, affordable and sustainable rate.
Comparing patients’ and other stakeholders’ preferences for outcomes of integrated care for multimorbidity: a discrete choice experiment in eight European countries
Authors: Rutten-van Mölken Maureen , Karimi Milad , Leijten Fenna , Hoedemakers Maaike , Looman Willemijn , Islam Kamrul , Askildsen Jan E , Kraus Markus , Ercevic Darija , Struckmann Verena , Gyorgy Pitter János , Cano Isaac , Stokes Jonathan , Jonker Marcel 
Published: October 2020

ObjectivesTo measure relative preferences for outcomes of integrated care of patients with multimorbidity from eight European countries and compare them to the preferences of other stakeholders within these countries.DesignA discrete choice experiment (DCE) was conducted in each country, asking respondents to choose between two integrated care programmes for persons with multimorbidity.SettingPreference data collected in Austria (AT), Croatia (HR), Germany (DE), Hungary (HU), the Netherlands (NL), Norway (NO), Spain (ES), and UK.ParticipantsPatients with multimorbidity, partners and other informal caregivers, professionals, payers and policymakers.Main outcome measuresPreferences of participants regarding outcomes of integrated care described as health/well-being, experience with care and cost outcomes, that is, physical functioning, psychological well-being, social relationships and participation, enjoyment of life, resilience, person-centredness, continuity of care and total costs. Each outcome had three levels of performance.Results5122 respondents completed the DCE. In all countries, patients with multimorbidity, as well as most other stakeholder groups, assigned the (second) highest preference to enjoyment of life. The patients top-three most frequently included physical functioning, psychological well-being and continuity of care. Continuity of care also entered the top-three of professionals, payers and policymakers in four countries (AT, DE, HR and HU). Of the five stakeholder groups, preferences of professionals differed most often from preferences of patients. Professionals assigned lower weights to physical functioning in AT, DE, ES, NL and NO and higher weights to person-centredness in AT, DE, ES and HU. Payers and policymakers assigned higher weights than patients to costs, but these weights were relatively low.ConclusionThe well-being outcome enjoyment of life is the most important outcome of integrated care in multimorbidity. This calls for a greater involvement of social and mental care providers. The difference in opinion between patients and professionals calls for shared decision-making, whereby efforts to improve well-being and person-centredness should not divert attention from improving physical functioning.