bluuebunny/crossref_metadata_2025_split huggingface dataset:
Unintended pregnancy and associated factors during COVID-19 pandemic in Ethiopia: Community-based cross-sectional study
Authors: Molla Wondwosen , Hailemariam Shewangizaw , Mengistu Nebiyu , Madoro Derebe , Bayisa Yesuneh , Tilahun Ruth , Wudneh Aregahegn , Ayele Getnet Melaku 
Published: August 2022

Introduction: The term ‘unintended pregnancy’ refers to a pregnancy that occurred when no children were desired or occurred earlier than desired. Unintended births account for one out of every three births in Ethiopia, and they are the leading cause of maternal morbidity and mortality. During the coronavirus disease (COVID-19) pandemic, this could be useful. COVID-19 has a significant impact on maternal health care utilization, including family planning services. As a result, this study aimed to assess unintended pregnancy and associated factors in Ethiopia during the COVID-19 pandemic. Method: A community-based cross-sectional study was conducted in Gedeo zone, Ethiopia, from April 1 to May 30, 2021. A simple random sampling technique was utilized to get 383 pregnant women from their respective kebeles. A structured questionnaire was used to collect data during a face-to-face interview. The data were coded, cleaned, and entered into Epidemiological Data Version 3.1 before being exported to the Statistical Package for Social Science Version 23.0 for analysis. A bivariate and multivariable logistic regression model was used to identify statistically significant associations between dependent and independent variables. The odds ratio, with a 95% confidence interval and a P value of 0.05%, was considered statistically significant. Result: A total of 383 pregnant women participated in the study, giving a response rate of 90.8%. During the COVID-19 pandemic, 140 (36.6%) participants stated that their current pregnancy was unintended. Unintended pregnancy was significantly associated with respondents’ age (adjusted odds ratio (AOR) = 5.214 (1.449–18.762)), primary decision maker for family planning services (AOR = 9.510 (5.057–17.887)), and fear of COVID-19 to visit a health care facility (AOR = 7.061 (2.665–18.710)). Conclusion: During the COVID-19 era, more than one-third of women had unintended pregnancies. Unintended pregnancy was significantly associated with respondents’ age, autonomy to use contraceptive methods, and fear of COVID-19, which required them to attend a health care institution.
Stromal vascular fraction therapy for knee osteoarthritis: a systematic review
Authors: Boada-Pladellorens Anna , Avellanet Mercè , Pages-Bolibar Esther , Veiga Anna 
Published: August 2022

Background: Regenerative cell therapies, such as adipose-derived stromal vascular fraction (SVF), have been postulated as potential treatments for knee osteoarthritis (KOA). Objectives: To assess the efficacy and safety of SVF treatment against placebo and other standard therapies for treating KOA in adult patients. Design: A systematic review. Data sources and methods: We searched the following databases: MEDLINE via PubMed, Epistemonikos, PEDro, DynaMed, TripDatabase, Elsevier via Clinicalkey and Cochrane Controlled Trials Register. We included prospective interventional studies where treatment with SVF in adults with KOA was compared against placebo or other standard therapies, and results were objectively measured with at least one widely recognised osteoarthritis scale. Results: Among 266 studies published until May 2021, nine met our inclusion criteria. A total of 239 patients (274 knees) were included in our study. The follow-up ranged from 6 to 24 months. Six studies had a control group (only one being placebo). All studies showed that SVF improved pain and functionality measured, in most cases, with the visual analogue scale and the Western Ontario and McMaster Universities Osteoarthritis Index. In addition, five studies reported an improvement in anatomical structures, as detected in MR images. However, the number of cells contained in SVF varied substantially between different studies, which could induce a comparison bias. Conclusion: Although based on a small number of dissimilar studies, SVF was considered a safe treatment for KOA and could be promising in terms of pain, functionality and anatomical structure improvement. However, SVF products need to be standardised, the number of cells homogenised and the use of concomitant treatments reduced to establish proper comparisons. Registration: PROSPERO registration number: CRD42021284187.
Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes
Authors: Deshpande Sunil , Weinzimer Stuart A. , Gibbons Kathryn , Nally Laura M. , Weyman Kate , Carria Lori , Zgorski Melinda , Laffel Lori M. , Doyle Francis J. , Dassau Eyal 
Published: August 2022

Background: A smartphone-based automated insulin delivery (AID) controller device can facilitate use of interoperable components and acceptance in adolescents and children. Methods: Pediatric participants (N = 20, 8F) with type 1 diabetes were enrolled in three sequential age-based cohorts: adolescents (12-<18 years, n = 8, 5F), school-age (8-<12 years, n = 7, 2F), and young children (2-<8 years, n = 5, 1F). Participants used the interoperable artificial pancreas system (iAPS) and zone model predictive control (MPC) on an unlocked smartphone for 48 hours, consumed unrestricted meals of their choice, and engaged in various unannounced exercises. Primary outcomes and stopping criteria were defined using fingerstick blood glucose (BG) data; secondary outcomes compared continuous glucose monitoring (CGM) data with preceding sensor augmented pump (SAP) therapy. Results: During AID, there was no more than one BG <50 mg/dL except in one young child participant; no instance of more than two episodes of BG ≥300 mg/dL lasting longer than 2 hours; and no adverse events. Despite large meals (total of 404.9 grams of carbs) and unannounced exercise (total of 182 minutes), overall CGM percent time in range (TIR) of 70 to 180 mg/dL during AID was statistically similar to SAP (63.5% vs 57.3%, respectively, P = .145). Overnight glucose standard deviation was 43 mg/dL (vs SAP 57.9 mg/dL, P = .009) and coefficient of variation was 25.7% (vs SAP 34.9%, P < .001). The percent time in closed-loop mode and connected to the CGM was 92.7% and 99.6%, respectively. Surveys indicated that participants and parents/guardians were satisfied with the system. Conclusions: The smartphone-based AID was feasible and safe in sequentially younger cohorts of adolescents and children. ClinicalTrials.gov: NCT04255381 ( https://clinicaltrials.gov/ct2/show/NCT04255381 )
eHealth policy in Spain: A comparative study between general population and groups at risk of social exclusion in Spain
Authors: Fernández Da Silva Ángela , Buceta Bran Barral , Mahou-Lago Xosé María 
Published: August 2022

Background In recent years, the healthcare sector has experienced accelerated progress in terms of the inclusion of Information and Communication Technologies (ICTs) in its procedures and formalities. However, public administrations have been unable to adapt to the peculiarities of the most vulnerable groups. This leads to marginalization of at-risk groups within the healthcare system and contributes to the widening of the so-called digital divide. Methods Based on the analysis of the literature, three dimensions have been constructed to identify the level of inclusion of web portals: the perception of quality, the perception of usability, and the importance attributed to their content. In order to obtain data on each of these dimensions, a study was designed based on the user test methodology as a central element (identifying and evaluating 11 vulnerable groups) and, in parallel, a survey of the general population and heuristic tests. Results A high percentage of vulnerable people at risk of social exclusion are not receiving adequate healthcare due to the digitalization of the system and the implementation of scarcely inclusive health web portals, which pose significant barriers in service provision for the 11 selected collectives. Meanwhile, the general population is being introduced to eHealth benefits, although the latter did not have high levels of digitization or a broad portfolio of services. Conclusions The general population has a relatively positive perspective of eHealth services, but only a minority of them make intensive use of them, and they are not widespread in Spain as a whole. Meanwhile, the population at risk of exclusion lacks the skills and resources to make real use of eHealth, needing “digital intermediaries” from the social sphere to achieve results. eHealth policies are not taking into account people with higher levels of marginalization, aggravating their exclusion and the digital divide.
Safety and efficacy of classical complement pathway inhibition with sutimlimab in chronic immune thrombocytopenia
Authors: Broome Catherine M. , Röth Alexander , Kuter David J. , Scully Marie , Smith Roy , Wang Jennifer , Reuter Caroline , Hobbs William , Daak Ahmed 
Published: August 2022

Abstract
Chronic/refractory immune thrombocytopenia (ITP) is a rare and pathophysiologically heterogeneous disorder with variable responsiveness to available treatments. Sutimlimab, a first-in-class humanized monoclonal anti-C1s IgG4 antibody, selectively inhibits the classical pathway. This phase 1 study (NCT03275454) assessed the safety, efficacy, pharmacokinetics, and pharmacodynamics of biweekly sutimlimab in patients with chronic/refractory ITP with an inadequate response to ≥2 therapies (platelet count ≤ 30 × 109/L). Twelve patients (median age 42 years) received sutimlimab for a median of 20.5 weeks followed by a median 2-week washout period (part A). In part B, 7 of the 12 eligible patients received sutimlimab retreatment for a median of 113 weeks. In part A, the mean (standard deviation) platelet count increased from 25 × 109/L (17) to 54 × 109/L (60) 24 hours after starting sutimlimab, maintaining ≥50 × 109/L throughout part A. Five patients (42%) achieved durable platelet count responses (≥50 × 109/L in ≥50% of follow-up visits) and 4 achieved complete response (platelet count ≥100 × 109/L). The mean platelet count returned to baseline during washout and increased upon retreatment in part B. The mean platelet count improvements accompanied the rapid inhibition of the classical pathway. There were 74 treatment-emergent adverse events in part A (n = 10) and 70 in part B (n = 6). Five serious adverse events were observed; 1 event (migraine) was assessed by the investigator as related to sutimlimab. These results demonstrated that in some patients with ITP, autoantibodies activate the classical complement pathway, accelerating platelet destruction or impairing platelet production and contributing to treatment failure. Thus, C1s inhibition may be a safe and beneficial therapeutic approach for patients with chronic/refractory ITP.
Targeted therapy with the mutant IDH2 inhibitor enasidenib for high-risk IDH2-mutant myelodysplastic syndrome
Authors: DiNardo Courtney D. , Venugopal Sangeetha , Lachowiez Curtis , Takahashi Koichi , Loghavi Sanam , Montalban-Bravo Guillermo , Wang Xuemei , Carraway Hetty , Sekeres Mikkael , Sukkur Ameenah , Hammond Danielle , Chien Kelly , Maiti Abhishek , Masarova Lucia , Sasaki Koji , Alvarado Yesid , Kadia Tapan , Short Nicholas J. , Daver Naval , Borthakur Gautam , Ravandi Farhad , Kantarjian Hagop M. , Patel Bhumika , Dezern Amy , Roboz Gail , Garcia-Manero Guillermo 
Published: August 2022

Abstract
The isocitrate dehydrogenase enzyme 2 (IDH2) gene is mutated in ∼5% of patients with myelodysplastic syndrome (MDS). Enasidenib is an oral, selective, mutant IDH2 inhibitor approved for IDH2-mutated (mIDH2) relapsed/refractory acute myeloid leukemia. We designed a 2-arm multicenter study to evaluate safety and efficacy of (A) the combination of enasidenib with azacitidine for newly diagnosed mIDH2 MDS, and (B) enasidenib monotherapy for mIDH2 MDS after prior hypomethylating agent (HMA) therapy. Fifty patients with mIDH2 MDS enrolled: 27 in arm A and 23 in arm B. Median age of patients was 73 years. The most common adverse events were neutropenia (40%), nausea (36%), constipation (32%), and fatigue (26%). Hyperbilirubinemia from off-target UGT1A1 inhibition occurred in 14% of patients (8%; grades 3 and 4), and IDH-inhibitor–associated differentiation syndrome (IDH-DS) in 8 patients (16%). In the combination arm, the overall response rate (ORR: complete remission [CR] + marrow CR [mCR] + partial remission) was 74%, including 70% composite CR (CRc: CR + mCR). Median time to best response was 1 month (range, 1-4), and a median of 4 cycles was received (1-32). The median overall survival (OS) was 26 months (range, 14 to not reached). In the enasidenib monotherapy cohort after HMA failure, ORR and CRc were both 35% (n = 8), with 22% CR (n = 5). Median time to first response was 27 days, and time to best response was 4.6 months (2.7-7.6 months). A median of 7 cycles was received (range, 1-29), and the median OS was 20 months (range, 11 to not reached). Enasidenib is an effective treatment option for mIDH2 MDS, both in combination with azacitidine for treatment-naïve high-risk MDS, and as a single agent after prior HMA therapy. This trial is registered at www.clinicaltrials.gov as #NCT03383575.
Blood titanium levels in patients with large and sliding titanium implants
Authors: Tognini Martina , Hothi Harry , Tucker Stewart , Broomfield Edel , Shafafy Masood , Gikas Panos , Di Laura Anna , Henckel Johann , Hart Alister 
Published: August 2022

Abstract
Background
Titanium, which is known to be a highly biologically inert element, is one of the most commonly used metals in orthopaedic implants. While cobalt and chromium blood metal ion testing is routinely used in the clinical monitoring of patients with metal-on-metal hip implants, much less is known about the levels of titanium in patients with other implant types. The aim of this study was to better understand the normal ranges of blood titanium levels in patients implanted with large and sliding titanium constructs by comparison with reference levels from conventional titanium hips.

Methods
This study examined data collected from 136 patients. Over a period of 24 months, whole blood samples were collected from 41 patients implanted with large titanium implants: long (range 15 to 30 cm) spine rods with a sliding mechanism (“spine rods”, n = 18), long bone tumour implants (“tumour implants”, n = 13) and 3D-printed customised massive acetabular defect implants (“massive acetabular implants”, n = 10). This data was compared with standard, uncemented primary titanium hip implants (“standard hips”, 15 cm long) (n = 95). Clinical, imaging and blood titanium levels data were collected for all patients and compared statistically between the different groups.

Results
The median (range) of blood titanium levels of the standard hip, spine rods, femoral tumour implants and massive acetabular implants were 1.2 ppb (0.6–4.9), 9.7 ppb (4.0–25.4), 2.6 ppb (0.4–104.4) and 5.7 ppb (1.6–31.5) respectively. Spine rods and massive acetabular implants had significantly greater blood titanium levels compared to the standard hips group (p < 0.001).

Conclusion
This study showed that titanium orthopaedic implants that are large and/or have a sliding mechanism have higher blood titanium levels compared to well-functioning, conventionally sized titanium hips. Reassuringly, the increased levels did not appear to induce adverse metal reactions. This study provides useful baseline data for future studies aimed at assessing blood titanium levels as a biomarker for implant function.
The concept of vulnerability in aged care: a systematic review of argument-based ethics literature
Authors: Sanchini Virginia , Sala Roberta , Gastmans Chris 
Published: August 2022

AbstractBackgroundVulnerability is a key concept in traditional and contemporary bioethics. In the philosophical literature, vulnerability is understood not only to be an ontological condition of humanity, but also to be a consequence of contingent factors. Within bioethics debates, vulnerable populations are defined in relation to compromised capacity to consent, increased susceptibility to harm, and/or exploitation. Although vulnerability has historically been associated with older adults, to date, no comprehensive or systematic work exists on the meaning of their vulnerability. To fill this gap, we analysed the literature on aged care for the meaning, foundations, and uses of vulnerability as an ethical concept.MethodsUsing PRISMA guidelines, we conducted a systematic review of argument-based ethics literature in four major databases: PubMed, Embase®, Web of Science™, and Philosopher’s Index. These covered biomedical, philosophy, bioethical, and anthropological literature. Titles, abstracts, and full texts of identified papers were screened for relevance. The snowball technique and citation tracking were used to identify relevant publications. Data analysis and synthesis followed the preparatory steps of the coding process detailed in the QUAGOL methodology.ResultsThirty-eight publications met our criteria and were included. Publication dates ranged from 1984 to 2020, with 17 publications appearing between 2015 and 2020. Publications originated from all five major continents, as indicated by the affiliation of the first author. Our analyses revealed that the concept of vulnerability could be distinguished in terms of basic human and situational vulnerability. Six dimensions of older adults’ vulnerability were identified: physical; psychological; relational/interpersonal; moral; sociocultural, political, and economic; and existential/spiritual. This analysis suggested three ways to relate to older adults’ vulnerability: understanding older adults’ vulnerability, taking care of vulnerable older adults, and intervening through socio-political-economic measures.ConclusionsThe way in which vulnerability was conceptualised in the included publications overlaps with distinctions used within contemporary bioethics literature. Dimensions of aged care vulnerability map onto defining features of humans, giving weight to the claim that vulnerability represents an inherent characteristic of humans. Vulnerability is mostly a value-laden concept, endowed with positive and negative connotations. Most publications focused on and promoted aged care, strengthening the idea that care is a defining practice of being human.
Management of human resources for health: implications for health systems efficiency in Kenya
Authors: Nyawira Lizah , Tsofa Benjamin , Musiega Anita , Munywoki Joshua , Njuguna Rebecca G. , Hanson Kara , Mulwa Andrew , Molyneux Sassy , Maina Isabel , Normand Charles , Jemutai Julie , Barasa Edwine 
Published: August 2022

Abstract
Background
Human resources for health consume a substantial share of healthcare resources and determine the efficiency and overall performance of health systems. Under Kenya’s devolved governance, human resources for health are managed by county governments. The aim of this study was to examine how the management of human resources for health influences the efficiency of county health systems in Kenya.

Methods
We conducted a case study using a mixed methods approach in two purposively selected counties in Kenya. We collected data through in-depth interviews (n = 46) with national and county level HRH stakeholders, and document and secondary data reviews. We analyzed qualitative data using a thematic approach, and quantitative data using descriptive analysis.

Results
Human resources for health in the selected counties was inadequately financed and there were an insufficient number of health workers, which compromised the input mix of the health system. The scarcity of medical specialists led to inappropriate task shifting where nonspecialized staff took on the roles of specialists with potential undesired impacts on quality of care and health outcomes. The maldistribution of staff in favor of higher-level facilities led to unnecessary referrals to higher level (referral) hospitals and compromised quality of primary healthcare. Delayed salaries, non-harmonized contractual terms and incentives reduced the motivation of health workers. All of these effects are likely to have negative effects on health system efficiency.

Conclusions
Human resources for health management in counties in Kenya could be reformed with likely positive implications for county health system efficiency by increasing the level of funding, resolving funding flow challenges to address the delay of salaries, addressing skill mix challenges, prioritizing the allocation of health workers to lower-level facilities, harmonizing the contractual terms and incentives of health workers, and strengthening monitoring and supervision.
SINFONIA study protocol: a phase II/III randomised controlled trial examining benefits of guided online group singing in people with chronic obstructive pulmonary disease and interstitial lung disease and their carers
Authors: Smallwood Natasha , Pascoe Amy , Vogrin Sara , Philip Jennifer 
Published: August 2022

Abstract
Background
Chronic obstructive pulmonary disease (COPD) and interstital lung disease (ILD) are incurable conditions characterised by airflow limitation, persisting respiratory symptoms, and progressive respiratory failure. People living with COPD or ILD often suffer from chronic and severe breathlessness, with limited treatment options and low engagement rates with current therapies. Group singing represents a potential community-based therapy to improve quality of life for patients with COPD or ILD and breathlessness.

Methods
This protocol papers describes SINFONIA, a parallel, double-arm, randomised, blinded-analysis, mixed-methods phase II/III trial of guided, online group singing that will be conducted over 24 months. Adults with confirmed COPD or ILD, on stable treatment for at least four weeks at time of recruitment, with a modified Medical Research Council (mMRC) dyspnoea score of two or greater, who are capable and willing to give consent, and not currently participating in pulmonary rehabilitation will be eligible to participate. Carers may optionally enrol in the trial. Data will be collected on quality of life, anxiety and depression, breathlessness, mastery of breathing, exercise tolerance, loneliness, healthcare utilisation, and carer quality of life (optional). Participants will be randomised 1:1 to intervention or control arms with intervention arm attending one 90 min, guided, online, group singing session per week for 12 weeks and control arm continuing routine care. Phase II of the trial aims to determine the feasibility and acceptability of guided, online group singing and will collect preliminary data on effectiveness. Phase III aims to determine whether guided, online group singing has an effect on quality of life with the primary outcome being a between arm difference in quality of life (36-item Short Form Survey) measured at 12 weeks.

Discussion
SINFONIA is the first study is the first of its kind in Australia and to our knowledge, the first to deliver the singing intervention program entirely online. Determining the feasibility, acceptability, and effectiveness of guided, online group singing is an important step towards improving low-cost, low-risk, community-based therapeutic options for patients living with COPD or ILD and breathlessness.
Trial registration: Phase II—ACTRN12621001274864, registered 20th September 2021; Phase III—ACTRN12621001280897, registered 22nd September 2021.