bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cost-effectiveness analysis and budget impact of rivaroxaban compared with dalteparin in patients with cancer at risk of recurrent venous thromboembolism
Authors: de Jong Lisa A , van der Velden Annette W G , Hulst Marinus van , Postma Maarten J 
Published: November 2020

ObjectivesIn the ‘Comparison of an Oral Factor Xa Inhibitor With Low Molecular Weight Heparin in Patients With Cancer With Venous Thromboembolism’ (SELECT-D) trial, rivaroxaban showed relatively low venous thromboembolism (VTE) recurrence but higher bleeding compared with dalteparin in patients with cancer. We aim to calculate the cost-effectiveness and budget impact of rivaroxaban compared with dalteparin in patients with cancer at risk of recurrent VTE.SettingWe built a Markov model to calculate the cost-effectiveness from a societal perspective over a 5-year time horizon for the Dutch healthcare setting.ParticipantsA hypothetical cohort of 1000 cancer patients with VTE entered the model with baseline characteristics based on the SELECT-D trial.InterventionSix months of treatment with rivaroxaban (15 mg two times per day for first 3 weeks followed by 20 mg once daily) was compared with 6 months of treatment with dalteparin (200 IU/kg daily during month 1 followed by 150 IU/kg daily).Primary and secondary outcome measuresThe primary outcome of the cost-effectiveness analysis was the incremental cost-effectiveness ratio (ICER). The robustness of the model was evaluated in probabilistic and univariate sensitivity analyses. A budget impact analysis was performed to calculate the total annual financial consequences for a societal perspective in the Netherlands.ResultsIn the base case and all scenarios, rivaroxaban were cost-saving while also slightly improving the patient’s health, resulting in economically dominant ICERs. In the probabilistic sensitivity analysis, 77.8% and 98.7% of the simulations showed rivaroxaban to be cost-saving and more effective for a 5-year and 6-month time horizon, respectively. Rivaroxaban can save up to €11 326 763 (CI €5 164 254 to €17 363 231) in approximately 8000 cancer patients with VTE per year compared with dalteparin based on a 1-year time horizon.ConclusionsTreatment with rivaroxaban is economically dominant over dalteparin in patients with cancer at risk for recurrent VTE in the Netherlands. The use of rivaroxaban instead of dalteparin can save over €10 million per year, primarily driven by the difference in drug costs.
Impact of reimbursement rates on the length of stay in tertiary public hospitals: a retrospective cohort study in Shenzhen, China
Authors: Ning Jie , Liu Lingrui , Cherlin Emily , Peng Yarui , Yue Jingkai , Xiong Haoling , Tao Hongbing 
Published: November 2020

ObjectiveTo examine the association between reimbursement rates and the length of stay (LOS).DesignA retrospective cohort study.SettingThe study was conducted in Shenzhen, China by using health administrative database from 1 January 2015 to 31 December 2017.Participants6583 patients with acute myocardial infarction (AMI), 12 395 patients with pneumonia and 10 485 patients who received percutaneous coronary intervention (PCI) surgery.MeasuresThe reimbursement rate was defined as one minus the ratio of out-of-pocket to the total expenditure, multiplied by 100%. The outcome of interest was the LOS. Multilevel negative binomial regression models were constructed to control for patient-level and hospital-level characteristics, and the marginal effect was reported when non-linear terms were available.ResultsEach additional unit of the reimbursement rate was associated with an average of an additional increase of 0.019 (95% CI, 0.015 to 0.023), 0.011 (95% CI, 0.009 to 0.014) and 0.013 (95% CI, 0.010 to 0.016) in the LOS for inpatients with AMI, pneumonia and PCI surgery, respectively. Adding the interaction term between the reimbursement rate and in-hospital survival, the average marginal effects for the deceased inpatients with AMI and PCI surgery were 0.044 (95% CI, 0.031 to 0.058) and 0.034 (95% CI, 0.017 to 0.051), respectively. However, there was no evidence that higher reimbursement rates prolonged the LOS of the patients who died of pneumonia (95% CI, −0.013 to 0.016).ConclusionsThe findings indicate that the higher the reimbursement rate, the longer the LOS; and implementing dynamic supervision and improving the service capabilities of primary healthcare providers may be an important strategy for reducing moral hazard in low-income and middle-income countries including China.
Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT)
Authors: Clair Carole , Augsburger Aurélie , Birrer Priska , Locatelli Isabella , Schwarz Joelle , Greub Gilbert , Zanchi Anne , Jacot-Sadowski Isabelle , Puder Jardena J 
Published: November 2020

IntroductionFew studies have assessed the efficacy of smoking cessation interventions in individuals with type 2 diabetes, but interventions adapted to the specific needs of this population are warranted. The aim of this study is to assess the efficacy of a smoking cessation intervention in a population of smokers with type 2 diabetes and to measure the metabolic impact of smoking cessation.Methods and analysisThe study is an open-label, randomised control trial. Participants recruited from a sanitary region of Switzerland will be randomly allocated to either the intervention or the control arm. The intervention group will have four individual counselling sessions over 12 weeks. Trained research nurses will conduct the behavioural intervention, using motivational interviews and addressing diabetes and gender specificities. The control group will have one short counselling session at baseline and will be given written information on smoking cessation. Both groups will have a follow-up visit at 26 and 52 weeks. Demographic and medical data will be collected at baseline and follow-up, along with blood and urine samples. The primary study outcome is continuous smoking abstinence validated by expired-air carbon monoxide from week 12 to week 52. Secondary study outcomes are continuous and 7-day point prevalence smoking abstinence at 12 and 26 weeks; change in motivation to quit and cigarette consumption; and change in glycosylated haemoglobin levels, body weight, waist circumference and renal function after smoking cessation. In a subsample of 80 participants, change in stool microbiota from baseline will be measured at 3, 8 and 26 weeks after smoking cessation.Ethics and disseminationEthical approval has been obtained by the competent ethics committee (Commission cantonale d’éthique de la recherche sur l’être humain, CER-VD 2017–00812). The results of the study will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numbersClinicalTrials.gov NCT03426423 and SNCTP000002762; Pre-results.
Course of DISease In patients reported to the Swedish CPAP Oxygen and VEntilator RegistrY (DISCOVERY) with population-based controls
Authors: Palm Andreas , Ågren Krister , Grote Ludger , Ljunggren Mirjam , Midgren Bengt , Sundh Josefin , Theorell-Haglöw J , Ekström Magnus 
Published: November 2020

PurposeChronic hypoxic and hypercapnic respiratory failure and obstructive sleep apnoea (OSA) are chronic diseases associated with decreased quality of life and increased mortality. The rationale behind the set up the retrospective nationwide DISCOVERY cohort was to study several questions including disease course and risk factors for incident disease, impaired quality of life, hospitalisation risk and mortality in patients with chronic respiratory failure with long-term oxygen therapy (LTOT), long-term mechanical ventilation (LTMV) and obstructive sleep apnoea (OSA) on treatment with continuous positive airway pressure (CPAP).Participants and settingsData from the national quality registry for respiratory insufficiency and sleep apnoea (Swedevox) and a population-based control group from Statistics Sweden were merged with governmental registries, the Swedish Cancer Registry, the Swedish Cause of Death Registry, the Swedish Drug registry, the Swedish National Patient Registry and the Swedish Dental Health Registry and with national quality registries for diabetes, rheumatic diseases (Swedish Rheumatology Quality Registry), stroke (RiksStroke), heart failure (RiksSvikt), acute heart infarction care (SwedeHeart) and intensive care (SIR) and with socioeconomic data from Statistics Sweden (SCB).Findings to dateThe cohort comprises 25 804 unique patients with LTOT since 1987 (54.1% females, age 73.3±9.8 years, body mass index (BMI) 26.6±6.5 kg/m2), 8111 with LTMV since 1996 (48.6% women, age 60.6±16.9 years, BMI 32.9±10.8 kg/m2), 65 809 with OSA on CPAP since 2010 (29.5% women, age 57.2±12.5 years, BMI 31.9±6.2 kg/m2) and 145 224 persons in a population-based control group from same time span up to March 2018 (51.7% women, age 49.9±20.4 year, BMI 24.9±4.0 years).Future plansIn patients with chronic respiratory failure and sleep apnoea important questions regarding comorbidity burden, hospitalisation rate, mortality and treatment outcomes are still unexplored to a large extent. The DISCOVERY cohort will provide unique opportunities by its size and comprehensiveness to fill this clinically relevant gap of knowledge.
Does intermittent exposure to high altitude increase the risk of cardiovascular disease in workers? A systematic narrative review
Authors: Aragón-Vela Jerónimo , Bejder Jacob , R Huertas Jesús , Plaza-Diaz Julio , Nordsborg Nikolai B 
Published: November 2020

ObjectiveSeveral working groups (eg, miners, flight crews and soldiers) are subjected to chronic intermittent hypoxic exposure. The cardiovascular implications have been studied but not systematically reviewed with focus on possible negative health implications. The aim of the present review was to systematically evaluate the hypothesis that intermittent hypoxic exposure causes cardiovascular stress detrimental to health in workers.DesignSystematic review.Data sourcesElectronic database search of PubMed, Scopus and Web of Science up to April 2020.Eligibility criteriaStudies of workers ≥18 years repeatedly subjected to months to years of irregular intermittent hypoxia, lasting from a few hours (eg, flight crews), one or a few days (eg, soldiers), or several days to weeks (eg, miners working at high altitude), written in English and evaluating the effect of intermittent hypoxia on cardiovascular disease were included. Animal studies, books, book chapters, personal communication and abstracts were excluded. The primary outcome measure was changes in standardised mortality ratio.Data extraction and synthesisTwo independent reviewers extracted data and assessed risk of bias using the Cochrane Collaboration’s tool.Results119 articles were identified initially, 31 of which met the inclusion criteria. Of these, 17 were retrospective cohort mortality studies (irregular short-term intermittent hypoxia), and 14 studies were observational (long-term intermittent hypoxia). The population of irregular short-term intermittent hypoxia users (flight crew) showed a lower mortality by cardiovascular disease. Long-term intermittent hypoxia over several years such as in miners or soldiers may produce increased levels of cardiac disorders (12 studies), though this is probably confounded by factors such as obesity and socioeconomic status.ConclusionThis systematic narrative review found that cardiovascular disease mortality in flight crews is lower than average, whereas miners and soldiers exposed to intermittent hypoxia experience increased risks of cardiovascular diseases. The impact of socioeconomic status and lifestyle appears of importance.PROSPERO registry numberCRD42020171301.
Effects of smart garments on the well-being of athletes: a scoping review protocol
Authors: Al Mahmud Abdullah , Wickramarathne Tharushi Indeewari , Kuys Blair 
Published: November 2020

IntroductionWith the advancements in wearable electronics, electronically integrated smart garments started to transpire in our daily lives. Smart garment technologies are incorporated into sportswear applications to enhance the well-being and performance of athletes. Smart garments applications in the sports sector are increasing, and the variety of smart garment applications available in the literature is overwhelming. Therefore, it is essential to compare the vast array of technologies incorporated in smart garments for athletes to understand the knowledge gaps for future studies. The protocol paper aims to examine the smart garments used in the sports domain to enhance the health and well-being of athletes.Methods and analysisRelevant studies will be retrieved using predefined search terms from Scopus, Web of Science, Science Direct, PubMed and IEEE Xplore. The retrieved articles will be eliminated in two phases: title and abstract screening and full-text screening. The included articles will be primary studies published in the English language within the last 10 years. Subsequently, the included articles will be further studied to extract data using a data extraction form. The extracted data will undergo a thematic analysis. Also, quantitative analysis will be carried out using descriptive statistics.Ethics and disseminationThe results of this review will provide a comprehensive understanding of smart garment concepts used in the sports domain. The findings of this scoping review will be shared through a journal publication and a conference presentation. Ethical approval is not needed for this scoping review.Protocol registration numberDOI 10.17605/OSF.IO/34MF2 (https://osf.io/34mf2)
Understanding public preferences and trade-offs for government responses during a pandemic: a protocol for a discrete choice experiment in the UK
Authors: Genie Mesfin G , Loría-Rebolledo Luis Enrique , Paranjothy Shantini , Powell Daniel , Ryan Mandy , Sakowsky Ruben Andreas , Watson Verity 
Published: November 2020

IntroductionSocial distancing and lockdown measures are among the main government responses to the COVID-19 pandemic. These measures aim to limit the COVID-19 infection rate and reduce the mortality rate of COVID-19. Given we are likely to see local lockdowns until a treatment or vaccine for COVID-19 is available, and their effectiveness depends on public acceptability, it is important to understand public preference for government responses.Methods and analysisUsing a discrete choice experiment (DCE), this study will investigate the public’s preferences for pandemic responses in the UK. Attributes (and levels) are based on: (1) lockdown measures described in policy documents; (2) literature on preferences for lockdown measures and (3) a social media analysis. Attributes include: lockdown type; lockdown length; postponement of usual non-urgent medical care; number of excess deaths; number of infections; impact on household spending and job losses. We will prepilot the DCE using virtual think aloud interviews with respondents recruited via Facebook. We will collect preference data using an online survey of 4000 individuals from across the four UK countries (1000 per country). We will estimate the relative importance of the attributes, and the trade-offs individuals are willing to make between attributes. We will test if respondents’ preferences differ based on moral attitudes (using the Moral Foundation Questionnaire), socioeconomic circumstances (age, education, economic insecurity, health status), country of residence and experience of COVID-19.Ethics and disseminationThe University of Aberdeen’s College Ethics Research Board (CERB) has approved the study (reference: CERB/2020/6/1974). We will seek CERB approval for major changes from the developmental and pilot work. Peer-reviewed papers will be submitted, and results will be presented at public health and health economic conferences nationally and internationally. A lay summary will be published on the Health Economics Research Unit blog.
Feasibility and acceptability of implementing early infant diagnosis of HIV in Papua New Guinea at the point of care: a qualitative exploration of health worker and key informant perspectives
Authors: Mohamed Yasmin , Kupul Martha , Gare Janet , Badman Steven G , Silim Selina , Vallely Andrew J , Luchters Stanley , Kelly-Hanku Angela 
Published: November 2020

IntroductionEarly infant diagnosis (EID) of HIV and timely initiation of antiretroviral therapy can significantly reduce morbidity and mortality among HIV-positive infants. Access to EID is limited in many low-income and middle-income settings, particularly those in which standard care involves dried blood spots (DBS) sent to centralised laboratories, such as in Papua New Guinea (PNG). We conducted a qualitative exploration of the feasibility and acceptability of implementing a point-of-care (POC) EID test (Xpert HIV-1 Qualitative assay) among health workers and key stakeholders working within the prevention of mother-to-child transmission of HIV (PMTCT) programme in PNG.MethodsThis qualitative substudy was conducted as part of a pragmatic trial to investigate the effectiveness of the Xpert HIV-1 Qualitative test for EID in PNG and Myanmar. Semistructured interviews were undertaken with 5 health workers and 13 key informants to explore current services, experiences of EID testing, perspectives on the Xpert test and the feasibility of integrating and scaling up POC EID in PNG. Coding was undertaken using inductive and deductive approaches, drawing on existing acceptability and feasibility frameworks.ResultsHealth workers and key informants (N=18) felt EID at POC was feasible to implement and beneficial to HIV-exposed infants and their families, staff and the PMTCT programme more broadly. All study participants highlighted starting HIV-positive infants on treatment immediately as the main advantage of POC EID compared with standard care DBS testing. Health workers identified insufficient resources to follow up infants and caregivers and space constraints in hospitals as barriers to implementation. Participants emphasised the importance of adequate human resources, ongoing training and support, appropriate coordination and a sustainable supply of consumables to ensure effective scale-up of the test throughout PNG.ConclusionsImplementation of POC EID in a low HIV prevalence setting such as PNG is likely to be both feasible and beneficial with careful planning and adequate resources.Trial registration number12616000734460.
BEAM study (Breathing, Education, Awareness, Movement): a randomised controlled feasibility trial of tai chi exercise in patients with COPD
Authors: Yeh Gloria Y. , Litrownik Daniel , Wayne Peter M. , Beach Douglas , Klings Elizabeth S. , Reyes Nieva Harry , Pinheiro Adlin , Davis Roger B. , Moy Marilyn L. 
Published: November 2020

BackgroundDespite therapeutic advances, the management of chronic obstructive pulmonary disease (COPD) remains complex. There is growing interest in multidimensional, mind-body exercises to improve both physical and psychosocial aspects of COPD burden. Few US data are available in this population on tai chi (TC) a mind-body exercise incorporating physical activity, breathing and mindful awareness. We explored feasibility and preliminary efficacy of TC in COPD in an US academic medical setting.MethodsPatients with COPD Global Obstructive Lung Disease (GOLD) stages 2–4 were randomised to a 12-week TC programme or education control. At 12 weeks, those in TC were randomised again to continue in maintenance classes or not to further explore optimal duration. All groups were followed to 24 weeks. Feasibility/safety parameters were analysed descriptively. Preliminary between-group differences were estimated in symptoms (dyspnoea, fatigue), health-related quality-of-life (Chronic Respiratory Questionnaire CRQ), cognitive-emotional measures (mood, COPD self-efficacy) and functional status (6 min walk test, lower body strength, flexibility, physical activity).ResultsNinety-two subjects were randomised (N=61 TC, N=31 education). Mean age was 68±8 years, 66% male, mean forced expiratory volume in 1 s % predicted 57±13, 28% were GOLD stage 3–4. Overall retention was 85%. Nineteen adverse events occurred, most being study-unrelated COPD exacerbations. From baseline to 12 weeks, there were between-group improvements favouring TC, in CRQ-total (Cohen’s d effect size (ES)=0.46; adj mean diff (AMD)=0.31), CRQ-emotion (ES=0.54; AMD=0.49), Centre for Epidemiologic Studies Depression (ES=−0.37; AMD=2.39) and Patient-Reported Outcome Measurement Information System (PROMIS)-fatigue (ES=−0.34; AMD=−0.17). From baseline to 24 weeks, there was an improvement favouring TC in CRQ-dyspnoea (ES=0.41; AMD=0.46). Among TC participants, there was a positive effect of maintenance classes on self-efficacy (ES=−0.69; AMD=−0.40), 6 min walk (ES=0.56; AMD=49.26 feet), PROMIS-fatigue (ES=−0.41; AMD=−0.28) and chair stand (0.43; AMD=0.56).ConclusionTC in patients with COPD is feasible and safe. Preliminary analyses support a potential modest role in improving quality-of-life, cognitive-emotional health and function that should be further studied.Trial registration numberNCT01551953.IRB referenceBIDMC 2010P-000412; VA 2540.
Direct access lifestyle training improves liver biochemistry and causes weight loss but uptake is suboptimal in patients with non-alcoholic fatty liver disease
Authors: Patanwala Imran , Molnar Lili Emese , Akerboom Katherine , Lane Katie Elizabeth 
Published: November 2020

ObjectiveTo evaluate the uptake and effectiveness of an existing open access lifestyle intervention forged in collaboration between a third sector organisation, funded by local government and a secondary care non-alcoholic fatty liver disease (NAFLD) service in the North West of England.MethodA service outcome evaluation using precomparison design and postcomparison design was conducted to analyse changes between baseline clinical health records and 12-week follow-up for patients with NAFLD who completed the lifestyle intervention. Lifestyle factors, weight loss, changes in alanine aminotransferase (ALT) enzymes and lipid profiles were compared between patients who completed the programme vs 1:1 matched patients who did not.ResultsOnly 16 of 167 patients with NAFLD offered the intervention completed the programme. Intervention patients achieved significant weight loss (−2.3% p≤0.05) over 12 weeks, where the non-intervention group had non-significant weight gain (+0.95%). ALT improved by 20.6 IU/L in the interventional group and 15.75 IU/L in the non-intervention group; however, this was not statistically different.ConclusionThis study presents first of its kind evaluation of a service collaboration in the UK. Only 1 in 10 patients offered the opportunity completed the programme, a limitation that could affect future strategies. Patient and public involvement research is needed to identify barriers to participation, address adherence issues and identify support mechanisms for lifestyle interventions in patients with NAFLD.