bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cost-effectiveness and willing-to-pay thresholds for vertebral augmentation of osteoporotic vertebral fractures, what are they based on: a systematic review
Authors: Pron Gaylene , Hwang Matthew , Nasralla Mehran , Smith Roger , Cheung Angela , Murphy Kieran 
Published: July 2023

ObjectiveAlthough there is substantial clinical evidence on the safety and effectiveness of vertebral augmentation for osteoporotic vertebral fractures, cost-effectiveness is less well known. The objective of this study is to provide a systematic review of cost-effectiveness studies and policy-based willingness-to-pay (WTP) thresholds for different vertebral augmentation (VA) procedures, vertebroplasty (VP) and balloon kyphoplasty (BK), for osteoporotic vertebral fractures (OVFs).DesignA systematic review targeting cost-effectiveness studies of VA procedures for OVFs.Data sourcesSix bibliographic databases were searched from inception up to May 2021.Eligibility criteria for study selectionStudies were eligible if meeting all predefined criteria: (1) VP or BK intervention, (2) OVFs and (3) cost-effectiveness study. Articles not written in English, abstracts, editorials, reviews and those reporting only cost data were excluded.Data extraction and synthesisInformation was extracted on study characteristics, cost-effective estimates, summary decisions and payer WTP thresholds. Incremental cost-effective ratio (ICER) was the main outcome measure. Studies were summarised by a structured narrative synthesis organised by comparisons with conservative management (CM). Two independent reviewers assessed the quality (risk of bias) of the systematic review and cost-effectiveness studies by peer-reviewed checklists.ResultsWe identified 520 references through database searching and 501 were excluded as ineligible by titles and abstract. Ten reports were identified as eligible from 19 full-text reviews. ICER for VP versus CM evaluated as cost per quality-adjusted life-year (QALY) ranged from €22 685 (*US$33 395) in Netherlands to £−2240 (*US$−3273), a cost-saving in the UK. ICERs for BK versus CM ranged from £2706 (*US$3954) in UK to kr600 000 (*US$90 910) in Sweden. ICERs were within payer WTP thresholds for a QALY based on historical benchmarks.ConclusionsBoth VP and BK were judged cost-effective alternatives to CM for OVFs in economic studies and were within WTP thresholds in multiple healthcare settings.
What are the treatment remission, response and extent of improvement rates after up to four trials of antidepressant therapies in real-world depressed patients? A reanalysis of the STAR*D study’s patient-level data with fidelity to the original research protocol
Authors: Pigott H Edmund , Kim Thomas , Xu Colin , Kirsch Irving , Amsterdam Jay 
Published: July 2023

ObjectiveReanalyse the patient-level data set of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study with fidelity to the original research protocol and related publications.DesignThe study was open label and semirandomised examining the effectiveness of up to four optimised and increasingly aggressive, antidepressant therapies in depressed adults. Patients who failed to gain adequate relief from their level 1 trial on the SSRI citalopram could receive up to three additional treatment trials in levels 2–4.Setting41 North American psychiatry and primary care treatment centres.Participants4041 adults screened positive for major depressive disorder. In contrast to most clinical trials, STAR*D enrolled patients seeking care (vs recruited) and included patients with a wide range of common comorbid medical and psychiatric conditions to enhance the generalisability of findings to real-world clinical practice.InterventionsSTAR*D evaluated the relative effectiveness of 13 antidepressants therapies in treatment levels 2–4 for depressed patients who failed to gain adequate benefit from their level 1 medication trial.Main outcome measuresAccording to the STAR*D protocol, the primary outcome was remission, defined as a score <8 on the blinded Hamilton Rating Scale for Depression (HRSD). Response was a secondary outcome defined as ≥50% reduction in HRSD scores. STAR*D’s protocol specifically excluded all non-blinded clinic-administered assessments from use as research outcome measures.ResultsSTAR*D investigators did not use the protocol-stipulated HRSD to report cumulative remission and response rates in their summary article and instead used a non-blinded clinic-administered assessment. This inflated their report of outcomes, as did their inclusion of 99 patients who scored as remitted on the HRSD at study outset as well as 125 who scored as remitted when initiating their next-level treatment. These patients should have been excluded from data analysis. In contrast to the STAR*D-reported 67% cumulative remission rate after up to four antidepressant treatment trials, the rate was 35.0% when using the protocol-stipulated HRSD and inclusion in data analysis criteria.ConclusionSTAR*D’s cumulative remission rate was approximately half of that reported.
Associations of three thermogenic adipokines with metabolic syndrome in obese and non-obese populations from the China plateau: the China Multi-Ethnic Cohort
Authors: Zhao Zhimin , Huang Juan , Zhong Dubo , Wang Yanjiao , Che Zhuohang , Xu Yahui , Hong Rudan , Qian Ying , Meng Qiong , Yin Jianzhong 
Published: July 2023

ObjectivesHigh altitude exposure decreases the incidence of obesity and metabolic syndrome, but increases the expression of the thermogenic adipokines (leptin, fat cell fatty acid-binding protein (A-FABP) and visfatin). This study investigated the correlation of these adipokines with obesity and metabolic syndrome (MetS) in populations residing in a plateau-specific environment.DesignCase–control study.SettingWe cross-sectionally analysed data from the China Multi-Ethnic Cohort.ParticipantsA total of 475 obese (OB, body mass index (BMI)≥28.0 kg/m2) plateau Han people and 475 age, sex and region-matched non-obese (NO, 18.5≤BMI<24.0 kg/m2) subjects were recruited. MetS was defined according to the National Cholesterol Education Program Adult Treatment Panel III guidelines.Primary and secondary outcome measuresData with normal distributions were expressed as the mean (Stanard Deviation, SD), and data with skewed distributions were expressed as the median (Interquartile Range, IQR). The participants were grouped and the rank-sum test, χ2test or t-tests was used for comparing groups. Spearman correlation coefficients were estimated to assess the relationships among leptin, A-FABP, visfatin and the components of MetS in each group.ResultsA-FABP was an independent predictor of OB (OR, 1.207; 95% CI, 1.170 to 1.245; p<0.05), ABSI (OR, 1.035; 95%CI, 1.019 to 1.052; p<0.05) and MetS (OR, 1.035; 95% CI, 1.013 to 1.057; p<0.05). Leptin was an independent predictor of MetS in the NO group. Visfatin was an independent predictor of increased ABSI, but not for OB or MetS.ConclusionAn abnormally elevated plasma A-FABP level, but not leptin or visfatin is a potential risk factor for MetS in high-altitude populations.
Preoperative versus postoperative survival in patients with univentricular heart: a nationwide, retrospective study of patients born in 1990–2015
Authors: Erikssen Gunnar , Liestøl Knut , Aboulhosn Jamil , Wik Gunnar , Holmstrøm Henrik , Døhlen Gaute , Gjesdal Ola , Birkeland Sigurd , Hoel Tom Nilsen , Saatvedt Kjell Johan , Seem Egil , Thaulow Erik , Estensen Mette E , Lindberg Harald Lauritz 
Published: July 2023

ObjectivesFew data exist on mortality among patients with univentricular heart (UVH) before surgery. Our aim was to explore the results of intention to perform surgery by estimating preoperative vs postoperative survival in different UVH subgroups.DesignRetrospective.SettingTertiary centre for congenital cardiology and congenital heart surgery.ParticipantsAll 595 Norwegian children with UVH born alive from 1990 to 2015, followed until 31 December 2020.ResultsOne quarter (151/595; 25.4%) were not operated. Among these, only two survived, and 125/149 (83.9%) died within 1 month. Reasons for not operating were that surgery was not feasible in 31.1%, preoperative complications in 25.2%, general health issues in 23.2% and parental decision in 20.5%. In total, 327/595 (55.0%) died; 283/327 (86.5%) already died during the first 2 years of life. Preoperative survival varied widely among the UVH subgroups, ranging from 40/65 (61.5%) among patients with unbalanced atrioventricular septal defect to 39/42 (92.9%) among patients with double inlet left ventricle. Postoperative survival followed a similar pattern. Postoperative survival among patients with hypoplastic left heart syndrome (HLHS) improved significantly (5-year survival, 42.5% vs 75.3% among patients born in 1990–2002 vs 2003–2015; p<0.0001), but not among non-HLHS patients (65.7% vs 72.6%; p=0.22)—among whom several subgroups had a poor prognosis similar to HLHS. A total of 291/595 patients (48.9%) had Fontan surgeryConclusionsSurgery was refrained in one quarter of the patients, among whom almost all died shortly after birth. Long-term prognosis was largely determined during the first 2 years. There was a strong concordance between preoperative and postoperative survival. HLHS survival was improved, but non-HLHS survival did not change significantly. This study demonstrates the complications and outcomes encountering newborns with UVH at all major stages of preoperative and operative treatment.
Does adherence to antiretroviral therapy differ by place of residence in Nigeria? A systematic review and meta-analysis protocol
Authors: Badru Oluwaseun Abdulganiyu , Bain Luchuo Engelbert , Adeagbo Oluwafemi Atanda 
Published: July 2023

IntroductionRetention in care is still a significant challenge in the HIV treatment cascade and varies extensively across regions, leading to poor adherence to antiretroviral therapy (ART). Several factors across different socioecological levels, such as health and community-level factors, inhibit ART adherence among people living with HIV (PLWH) in Nigeria. This review seeks to ask whether adherence to ART differs by place of residence in Nigeria.Method and analysisThis systematic review and meta-analysis will follow the updated Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search PubMed, SCOPUS, CINAHL, Web of Science, MEDLINE (Ovid) and Google Scholar from onset to 30 April 2023. We will include only quantitative observational studies or mixed-method studies that measured the association between place of residence (urban and rural) and adherence to ART among PLWH aged ≥15 years. Title and abstract screening, full-text screening, data extraction and quality assessment will be done by two reviewers independently. A third reviewer will resolve disagreements. We will extract the author’s name and year of publication, study aim(s), participant’s characteristics, sample size, sampling method, region and state, adherence definition and adherence level in urban and rural areas. Data will be analysed with Review Manager V.5.4. The Q statistical test will be used to assess between-study heterogeneity, while Higgins and Thompson’s I2will be used to quantify the heterogeneity level. Several subgroups and sensitivity analyses will be conducted.Ethics and disseminationEthical approval is not warranted for this study since primary published data will be utilised. The findings of this review will be published in a high-impact peer-reviewed journal and presented at a conference.PROSPERO registration numberCRD42022371965.
Quantifying the available capacity and resource needs for provision of CAR-T therapies in the National Health Service in Spain: a survey-based study
Authors: Solano Carlos , Castro-Rebollo Pedro , Pérez-Martínez Antonio , López-Corral Lucia , Barba-Suñol Pere , Kwon Mi , Ortiz Valentín , Sanz-Caballer Jaime , Caballero Ana Carolina , Martínez Joaquín , Cedillo Ángel , Sureda Anna 
Published: July 2023

ObjectivesTo estimate the readiness of Spanish National Health Service (NHS) hospitals to provide chimeric antigen receptor T cell (CAR-T), and to identify and quantify the different resources needed to provide CAR-T considering three scenarios defined by 10, 25 and 50 patients per centre per year.DesignTargeted literature review and quantitative study using a questionnaire and telephone interviews. An algorithm was created to determine hospitals’ readiness based on their capacity and capability. All the requirements for quantification were assessed and validated by the steering committee, formed by members of the Spanish Group of Haematopoietic Transplantation and Cell Therapy. A weighting system (from 0 to 1) was established for capability quantification. For resources quantification, a scoring system was established, with 0 points representing the minimum and 3 points the maximum of additional resources that a hospital indicated necessary.Setting40 Spanish hospital centres that perform allogeneic haematopoietic stem cell transplantation were invited to complete the questionnaire for capacity quantification, 28 of which provided valid responses. Nine hospitals participated in the interviews for resource quantification, eight of which had previously been designated by the Ministry of Health (MoH) to provide CAR-T.Outcome measureCurrent capacity of NHS Spanish sites to administer CAR-T under different theoretical scenarios with varying numbers of procedures, and the potential healthcare resources that would be needed to realise the theoretical capacity requirements.ResultsFour hospitals were optimally ready, 17 were somewhat ready and 7 were not ready. The actual extrapolated capacity of the currently designated MoH CAR-T sites would allow treatment of approximately 250 patients per year. Regarding healthcare resource needs, the numbers of haematologists, nurses and beds were the most important limiting factors, and those requiring further growth as patient numbers increased.ConclusionsIncreasing the number of CAR-T-qualified centres and/or increasing resources in the current designated sites are two potential strategies that should be considered to treat CAR-T-eligible patients in Spain.
Discharge prescription patterns for antiplatelet and statin therapy following carotid endarterectomy: an analysis of the vascular quality initiative
Authors: Eppler Michael , Singh Nikhil , Ding Li , Magee Gregory , Garg Parveen 
Published: July 2023

ObjectivesDespite guidelines endorsing statin and single antiplatelet therapy (SAPT) therapy post-carotid endarterectomy (CEA), these medications may be either under or inappropriately prescribed. We determined rates of new statin prescriptions as well as change in antiplatelet therapy (APT) regimen at discharge. We identified characteristics associated with these occurrences.DesignWe performed a retrospective Vascular Quality Initiative registry analysis of more than 125 000 patients who underwent CEA from 2013 to 2021.SettingThe Vascular Quality Initiative is a multicentre registry database including academic and community-based hospitals throughout the USA.ParticipantsPatients age≥18 years undergoing CEA with available statin and APT data (preprocedure and postprocedure) were included.Primary and secondary outcome measuresWe determined overall rates of statin and APT prescription at discharge. Multivariate logistic regression was used to determine clinical and demographic characteristics that were mostly associated with new statin prescription or changes in APT regimen at discharge.ResultsStudy participants were predominantly male (61%) and White (90%), with a mean age of 70.6±9.1. 13.1% of participants were not on statin therapy pre-CEA, and 48% of these individuals were newly prescribed one. Statin rates steadily increased throughout the study period: 36.2% in 2013 to 62% in 2021. A higher likelihood of new statin prescription was associated with non-race, diabetes, coronary heart disease, stroke, TIA and a non-elective indication. Older age, female gender, chronic obstructive pulmonary disease and prior carotid revascularisation were associated with a lower likelihood of new statin prescription. Nearly all participants were discharged on APT (63% SAPT and 37% dual antiplatelet therapy, DAPT). Among these individuals, 16% were discharged on a regimen that was different from the one on admission (11 947 (10.7%) of patients were upgraded to DAPT and 5813 (5.2%) were downgraded to SAPT).ConclusionsAlthough statin use has substantially improved following CEA, more than half of individuals not on a statin preprocedure remained this way at discharge. In addition, DAPT at discharge was frequent, a quarter of whom were on SAPT preprocedure. Further efforts are needed to improve rates of new statin prescriptions, ensure appropriate APT intensity at discharge and determine how different discharge APT regimens impact outcomes.
Understanding the chronic pain journey and coping strategies that patients use to manage their chronic pain: a qualitative, patient-led, Canadian study
Authors: Bruce Marcia , Lopatina Elena , Hodge Jamie , Moffat Karen , Khan Sophia , Pyle Pamela , Kashuba Sherri , Wasylak Tracy , Santana Maria-Jose 
Published: July 2023

ObjectiveTo gain an insight into coping strategies that people living with chronic pain use to self-manage their pain.DesignThis qualitative Patient-oriented Research study used the Patient and Community Engagement Research approach. It was conducted by people with chronic pain lived experience, ensuring that patient perspective and needs were considered and addressed throughout the research cycle. Purposeful sampling was used for recruiting individuals living with chronic pain. A focus group and one-on-one semi-structured interviews were conducted via videoconference. The data were analysed iteratively using inductive thematic analysis and narrative story analysis.SettingCalgary, Alberta, Canada.ParticipantsEleven adult participants, between the ages of 18 and 65, who self-identified as living with chronic pain for greater than 2 years.ResultsThree main themes emerged from the data: (1) the elements of chronic pain, (2) the chronic pain journey to acceptance and (3) daily coping strategies for chronic pain. Participants thought it was important to discuss these three themes because the daily coping strategies that they employed at any given time (theme 3) depended on the factors discussed in themes 1 and 2. Overlaying all of this is also a grieving process that people living with chronic pain may have to go through more than once. Participants also identified recommendations for healthcare professionals to support people living with chronic pain.ConclusionsDealing with chronic pain affects all aspects of a person’s life and involves a grieving process. When treating patients with chronic pain, it is important for healthcare professionals to understand the journey that people living with chronic pain go through, not just coping strategies. Diagnosis is critical for a patient’s acceptance and in helping them find their new normal where they can employ daily coping strategies to manage their pain.
Addition of daptomycin for the treatment of pneumococcal meningitis: protocol for the AddaMAP study
Authors: Chavanet Pascal , Fournel Isabelle , Bourredjem Abderrahmane , Piroth Lionel , Blot Mathieu , Sixt Thibault , Binquet Christine 
Published: July 2023

BackgroundThe leading cause of acute bacterial meningitis in adults isStreptococcus pneumoniae. This infection is associated with high rates of mortality and morbidity related, among other factors, to the excessive host response to the pneumococcal lysis. Experimental in vitro and in vivo data show that the combination of corticosteroids/third-generation cephalosporins and the non-lytic antibiotic, daptomycin, has synergistic effects with (1) a rapid cerebrospinal fluid sterilisation, (2) less brain damages and (3) less loss of cognitive performances. Despite these encouraging results, daptomycin has never been evaluated in adult patients with pneumococcal meningitis.Methods and analysisThe AddaMAP trial is a phase II, open-label, Simon’s two-stage, multicentre trial that has been designed to assess the efficacy and safety of adding daptomycin (10 mg/kg/d for 8 days) to the recommended treatment (corticosteroids+third generation cephalosporin) in adults with confirmed pneumococcal meningitis. The main endpoint is the disability-free survival (defined as modified Rankin Scale mRS≤2) at day 30. Secondary outcomes are overall mortality, disability at D30 and D90 (mRS, Glasgow Coma Scale and Glasgow Outcome Scales, mini-mental score), hearing loss (Hearing Handicap Inventory Test at D30 and D90, routine audiometric test and Hearing-it test at D30), and quality of life (12-item Short Form Survey and WHO QOL BREF). Seventy-two analysable patients are required.Ethics and disseminationThe study protocol was approved by the Institutional Review Board of the IDF 1 of the ethics committee on 16 January 2018, and authorisation was obtained from the Agence Nationale de Securité des Médicaments et des Produits de Santé on 22 September 2017. The results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03480191.
Efficacy of smartphone-based virtual reality relaxation in providing comfort to patients with cancer undergoing chemotherapy in oncology outpatient setting in Indonesia: protocol for a randomised controlled trial
Authors: Gautama Made Satya Nugraha , Haryani Haryani , Huang Tsai-Wei 
Published: July 2023

IntroductionPatients with cancer undergoing chemotherapy experience various physical and psychological problems and discomfort. Virtual reality (VR) can be used in technology-based non-pharmacological therapy that can serve as a potential distractor in the symptom management of patients with cancer undergoing chemotherapy. We propose a smartphone-based virtual reality relaxation (S-VR) technique as a complementary modality to provide comfort to patients with cancer, and we will evaluate its effect on patients with cancer undergoing chemotherapy.Methods and analysisWe will recruit 80 patients from the One Day Chemotherapy ‘Tulip’ Center of Dr. Sardjito General Hospital, Yogyakarta, Indonesia. This will be a two-arm parallel randomised controlled trial, with a 1:1 allocation and the primary outcome assessor blinded. This study will be divided into two groups: (1) an intervention group, with participants receiving 360° panoramic video content and music relaxation intervention through a VR device (head-mounted display) placed on their head during chemotherapy for ±10 min plus standard care and (2) a control group, with participants receiving guided imagery relaxation therapy in the form of a leaflet plus standard care. We will measure the outcomes after one chemotherapy cycle for each participant. The primary outcome is the effectiveness of the S-VR in improving the comfort of patients. The secondary outcome is the effect of the S-VR on the patients’ symptom management self-efficacy, pain, anxiety, blood pressure (systolic blood pressure and diastolic blood pressure) and pulse rate.Ethics and disseminationThis study was approved by the Medical and Health Research Ethics Committee of the Faculty of Medicine, Public Health and Nursing of Universitas Gadjah Mada—Dr. Sardjito General Hospital, Yogyakarta, Institutional Review Board (approval number: KE/FK/0301/EC/2023). Written informed consent will be obtained from all participants who enrol in the study. Dissemination will be conducted through peer-reviewed publications and conference presentations.Trial registration numberNCT05756465.