bluuebunny/crossref_metadata_2025_split huggingface dataset:
Frequency and clinical features of radiographic head injury caused by inpatient falls: a single-centre retrospective cohort study
Authors: Tokioka Fumiaki , Okamoto Hiroshi , Shiotsu Akiko , Hashimoto Toru 
Published: April 2023

ObjectivesThe lack of clear criteria makes it difficult for clinicians to determine which patients should be imaged after an inpatient fall. This study identified the clinical characteristics of patients who required a head CT scan following an inpatient fall.DesignThis was a retrospective cohort study conducted from January 2016 to December 2018. We obtained the data from our safety surveillance database, which record all cases of inpatient falls in our hospital.SettingSingle-centre, tertiary, secondary care hospital.ParticipantsWe included all consecutive patients who claimed to have fallen and bruised their heads as well as patients who were confirmed to have a bruise on the head but were unavailable to be interviewed about the fall.Primary and secondary outcome measuresThe primary outcome was radiographic head injury revealed on head CT after a fall.ResultsOverall, 834 adult patients (662 confirmed and 172 suspected cases) were included. The median age was 76 years, and 62% were men. Patients with radiographic head injury were more likely to have a lower platelet count, consciousness disturbance and new vomiting episodes compared with those without radiographic head injury (all p<0.05). The use of anticoagulants or antiplatelets was not different between patients with and without radiographic head injury. Among the 15 (1.8%) patients with a radiographic head injury, 13 with intracranial haemorrhage had at least one of the following characteristics: received anticoagulant or antiplatelet agents, platelet count of <2.0×109/L, consciousness disturbance or new vomiting episodes. There were no deaths among patients with radiographic head injuries.ConclusionsThe incidence of radiographic head injury due to falls in adult inpatients with suspected or confirmed head injuries was 1.8%. Only patients with risk factors had radiographic head injuries, which might help reduce the number of unnecessary CT scans in inpatient falls.Trial registration numberStudy protocol (Kurashiki Central Hospital, Medical ethical committee. IRB no. 3750).
Safe shortening of antibiotic treatment duration for complicatedStaphylococcus aureusbacteraemia (SAFE trial): protocol for a randomised, controlled, open-label, non-inferiority trial comparing 4 and 6 weeks of antibiotic treatment
Authors: Buis DTP , van Werkhoven CH , van Agtmael MA , Bax HI , Berrevoets M , de Boer MGJ , Bonten MJM , Bosmans JE , Branger J , Douiyeb S , Gelinck LBS , Jong E , Lammers AJJ , Van der Meer JTM , Oosterheert JJ , Sieswerda E , Soetekouw R , Stalenhoef JE , Van der Vaart TW , Bij de Vaate EA , Verkaik NJ , Van Vonderen MGA , De Vries PJ , Prins JM , Sigaloff KCE 
Published: April 2023

IntroductionA major knowledge gap in the treatment of complicatedStaphylococcus aureusbacteraemia (SAB) is the optimal duration of antibiotic therapy. Safe shortening of antibiotic therapy has the potential to reduce adverse drug events, length of hospital stay and costs. The objective of the SAFE trial is to evaluate whether 4 weeks of antibiotic therapy is non-inferior to 6 weeks in patients with complicated SAB.Methods and analysisThe SAFE-trial is a multicentre, non-inferiority, open-label, parallel group, randomised controlled trial evaluating 4 versus 6 weeks of antibiotic therapy for complicated SAB. The study is performed in 15 university hospitals and general hospitals in the Netherlands. Eligible patients are adults with methicillin-susceptible SAB with evidence of deep-seated or metastatic infection and/or predictors of complicated SAB. Only patients with a satisfactory clinical response to initial antibiotic treatment are included. Patients with infected prosthetic material or an undrained abscess of 5 cm or more at day 14 of adequate antibiotic treatment are excluded. Primary outcome is success of therapy after 180 days, a combined endpoint of survival without evidence of microbiologically confirmed disease relapse. Assuming a primary endpoint occurrence of 90% in the 6 weeks group, a non-inferiority margin of 7.5% is used. Enrolment of 396 patients in total is required to demonstrate non-inferiority of shorter antibiotic therapy with a power of 80%. Currently, 152 patients are enrolled in the study.Ethics and disseminationThis is the first randomised controlled trial evaluating duration of antibiotic therapy for complicated SAB. Non-inferiority of 4 weeks of treatment would allow shortening of treatment duration in selected patients with complicated SAB. This study is approved by the Medical Ethics Committee VUmc (Amsterdam, the Netherlands) and registered under NL8347 (the Netherlands Trial Register). Results of the study will be published in a peer-reviewed journal.Trial registration numberNL8347 (the Netherlands Trial Register).
Efficacy of carbapenems versus alternative antimicrobials for treating complicated urinary tract infections caused by antimicrobial-resistant Gram-negative bacteria: protocol for a systematic review and meta-analysis
Authors: Maeda Masayuki , Hasegawa Takeshi , Noma Hisashi , Ota Erika 
Published: April 2023

IntroductionComplicated urinary tract infections (cUTIs) are associated with poor prognosis. The widespread infection of multidrug-resistant Gram-negative uropathogens such as extended-spectrum beta-lactamase-producing bacteria has limited the efficacy of antibiotics used for treating cUTI. Considering the existence of antimicrobial-resistant (AMR) uropathogens, carbapenem is the last-resort antibiotic for cUTI. Given that carbapenem overuse has facilitated the spread of carbapenem-resistant Gram-negative bacteria, carbapenem dependence should be urgently reduced. However, improvement on the clinical outcomes of alternative antibiotics against cUTI caused by AMR uropathogens has not yet been systematically evaluated. Thus, this systematic review and meta-analysis aims to explore and compare the clinical outcomes of cUTI caused by AMR uropathogens between carbapenem and non-carbapenem antibiotics.Methods and analysisThe study inclusion criteria will be considered based on the PICO model consisting the following elements: population—adult patients with cUTIs caused by Gram-negative uropathogens; intervention—non-carbapenem class of antimicrobial agents with in vitro activities against Gram-negative uropathogens; comparison—treatment of carbapenem class antibiotics; outcome—a clinical and microbiological cure. Relevant articles published until December 2022 will be systematically searched in February 2023, using electronic databases such as PubMed, the Cochrane Library, EMBASE and ClinicalTrials.gov. Two independent reviewers will screen the select literature and then assess the full-text article to meet the inclusion criteria. The risk of bias will be assessed using the Cochrane risk-of-bias assessment tool. The treatment effects of antibiotics will be estimated as a risk ratio with a 95% CI, using the random-effects model.Ethics and disseminationThis protocol and systematic review will not include direct patient data; thus, informed consent will be waived. The results of this study will be published in an international peer-reviewed journal for wider information dissemination.PROSPERO registration numberCRD42022356064.
Understanding the experience in the healthcare system of non-migrant and migrant frequent users of the emergency department in French-speaking Switzerland: a comparative qualitative study
Authors: Cariello Carmen , Grazioli Véronique S , Nikles Justin , Schmutz Elodie , Hugli Olivier , Bodenmann Patrick 
Published: April 2023

BackgroundPrevious research revealed the vulnerability of frequent users of emergency department (FUED) because of concomitant medical, psychological and social issues. Case management (CM) provides FUED with effective medical and social support, however, the heterogeneity of this population has highlighted the need to explore the specific needs of FUED subpopulations. In response, this study aimed to explore qualitatively the lived experience of migrant and non-migrant FUED in the healthcare system to identify unmet needs.MethodsAdult migrant and non-migrant FUED (≥ 5 visits in the ED in the past 12 months) were recruited in a Swiss university hospital to collect qualitative data on their experience within the Swiss health system. Participants were selected based on predefined quotas for gender and age. Researchers conducted one-on-one semistructured interviews until reaching data saturation. Inductive conventional content analysis was used to analyse qualitative data.ResultsIn total, 23 semistructured interviews were conducted (11 migrant FUED and 12 non-migrant FUED). Four main themes emerged from the qualitative analysis: (1) self-evaluation of the Swiss healthcare system; (2) orientation within the healthcare system; (3) relationship with caregivers and (4) perception of own health. While both groups were overall satisfied with the healthcare system and care provided, migrant FUED reported language and financial barriers to access it. Both groups expressed overall satisfaction over their relationship with healthcare professionals, although migrant FUED reported a feeling of illegitimacy to consult the ED based on social status, whereas non-migrant FUED felt more often the need to justify their use of the ED. Finally, migrant FUED perceived their own health to be affected by their status.ConclusionThis study highlighted difficulties specific to subpopulations of FUED. For migrant FUED, these included access to care and impact of migrant status on own health. Adapting CM to the specific needs of migrant FUED could help reduce their vulnerability.
Global prevalence of hospital admissions for low back pain: a systematic review with meta-analysis
Authors: Melman Alla , Lord Harrison J , Coombs Danielle , Zadro Joshua , Maher Christopher G , Machado Gustavo C 
Published: April 2023

ObjectivesTo determine the proportion of low back pain presentations that are admitted to hospital from the emergency department (ED), the proportion of hospital admissions due to a primary diagnosis of low back pain and the mean hospital length of stay (LOS), globally.MethodsWe searched MEDLINE, CINAHL, EMBASE, Web of Science, PsycINFO and LILACS from inception to July 2022. Secondary data were retrieved from publicly available government agency publications and international databases. Studies investigating admitted patients aged >18 years with a primary diagnosis of musculoskeletal low back pain and/or lumbosacral radicular pain were included.ResultsThere was high heterogeneity in admission rates for low back pain from the ED, with a median of 9.6% (IQR 3.3–25.2; 9 countries). The median percentage of all hospital admissions that were due to low back pain was 0.9% (IQR 0.6–1.5; 30 countries). The median hospital LOS across 39 countries was 6.2 days for ‘dorsalgia’ (IQR 4.4–8.6) and 5.4 days for ‘intervertebral disc disorders’ (IQR 4.1–8.4). Low back pain admissions per 100 000 population had a median of 159.1 (IQR 82.6–313.8). The overall quality of the evidence was moderate.ConclusionThis is the first systematic review with meta-analysis summarising the global prevalence of hospital admissions and hospital LOS for low back pain. There was relatively sparse data from rural and regional regions and low-income countries, as well as high heterogeneity in the results.
Medical use and combination drug therapy among US adult users of central nervous system stimulants: a cross-sectional analysis
Authors: Moore Thomas J , Wirtz Phillip W , Curran Jill N , Alexander G Caleb 
Published: April 2023

ObjectiveExamine patterns of adult medical use of amphetamine and methylphenidate stimulant drugs, classified in the USA as Schedule II controlled substances with a high potential for psychological or physical dependence.DesignCross-sectional study.Setting and participantsPrescription drug claims for US adults, age 19–64 years, included in a commercial insurance claims database with 9.1 million continuously enrolled adults from 1 October 2019, through 31 December 2020. Stimulant use was defined as adults filling one or more stimulant prescriptions during calendar 2020.Outcome measuresThe primary outcome was an outpatient prescription claim, service date and days’ supply for central nervous system (CNS)-active drugs. Combination-2 was defined as 60 days or more of combination treatment with a Schedule II stimulant and one or more additional CNS-active drugs. Combination-3 therapy was defined as the addition of 2 or more additional CNS-active drugs. Using service date and days’ supply, we examined the number of stimulant and other CNS-active drugs for each of the 366 days of 2020.ResultsAmong 9 141 877 continuously enrolled adults, the study identified 276 223 individuals (3.0%) using Schedule II stimulants during 2020. They filled a median of 8 (IQR, 4–11) prescriptions for these stimulant drugs that provided 227 (IQR, 110–322) treatment days of exposure. Among this group, 125 781 (45.5%) combined use of one or more additional CNS active drugs for a median of 213 (IQR, 126–301) treatment days. Also, 66 996 (24.3%) stimulant users used two or more additional CNS-active drugs for a median of 182 (IQR, 108–276) days. Among stimulants users, 131 485 (47.6%) were exposed to an antidepressant, 85 166 (30.8%) filled prescriptions for anxiety/sedative/hypnotic medications and 54 035 (19.6%) received opioid prescriptions.ConclusionA large proportion of adults using Schedule II stimulants are simultaneously exposed to one or more other CNS-active drugs, many with tolerance, withdrawal effects or potential for non-medical use. There are no approved indications and limited clinical trial testing of these multi-drug combinations, and discontinuation may be challenging.
Exploring the views of low-acuity emergency department consulters on an educational intervention and general practitioner appointment service: a qualitative study in Berlin, Germany
Authors: Kümpel Lisa , Oslislo Sarah , Resendiz Cantu Rebecca , Möckel Martin , Heintze Christoph , Holzinger Felix 
Published: April 2023

ObjectivesLow-acuity patients presenting to emergency departments (EDs) frequently have unmet ambulatory care needs. This qualitative study explores the patients’ views of an intervention aimed at education about care options and promoting primary care (PC) attachment.DesignQualitative telephone interviews were conducted with a subsample of participants of an interventional pilot study, based on a semi-structured interview guide. The data were analysed through qualitative content analysis.SettingThe study was carried out in three EDs in the city centre of Berlin, Germany.ParticipantsThirty-two low-acuity ED consulters with no connection to a general practitioner (GP) who had participated in the pilot study were interviewed; (f/m: 15/17; mean age: 32.9 years).InterventionIn the pilot intervention, ED patients with low-acuity complaints were provided with an information leaflet on appropriate ED usage and alternative care paths and they were offered an optional GP appointment scheduling service. Qualitative interviews explored the views of a subsample of the participants on the intervention.ResultsInterviewees perceived both parts of the intervention as valuable. Receiving a leaflet about appropriate ED use and alternatives to the ED was viewed as helpful, with participants expressing the desire for additional online information and a wider distribution of the content. The GP appointment service was positively assessed by the participants who had made use of this offer and seen as potentially helpful in establishing a long-term connection to GP care. The majority of patients declining a scheduled GP appointment expected no personal need for further medical care in the near future or preferred to choose a GP independently.ConclusionsLow-acuity ED patients seem receptive to information on alternative acute care options and prevailingly appreciate measures to encourage and facilitate attachment to a GP. Promoting PC integration could contribute to a change in future usage behaviour.Trial registration numberDRKS00023480.
Reducing the carbon footprint of research: experience from the NightLife study
Authors: Quann Niamh , Burns Steph , Hull Katherine L , Cluley Victoria , Richardson Carla , MacConaill Kateryna , Conefrey Carmel , Rooshenas Leila , Eborall Helen , Burton James O 
Published: April 2023

BackgroundAs set out in the Climate Change Act (2008), the UK National Health Service (NHS) has made a commitment to halve greenhouse gas emissions by 2025 and reach net zero by 2050. Research forms a core part of NHS activity and reducing the carbon footprint of clinical trials is a core element of the National Institute for Health and Care Research Carbon Reduction Strategy (2019).Key argumentsHowever, support from funding organisations on how to achieve these targets is lacking. This brief communication article reports the reduction in the carbon footprint of the NightLife study, an ongoing multicentre randomised controlled trial assessing the impact of in-centre nocturnal haemodialysis on quality of life.ConclusionBy using remote conferencing software and innovative data collection methods, we demonstrated a total saving of 136 tonnes of carbon dioxide equivalent over three workstreams during the first 18 months of the study, following grant activation on 1 January 2020. In addition to the environmental impact, there were additional benefits seen to cost as well as increased participant diversity and inclusion. This work highlights ways in which trials could be made less carbon intensive, more environmentally sustainable and better value for money.
Social inequalities in aggravating factors of somatic symptom persistence (SOMA.SOC): study protocol for a mixed-method observational study focusing on irritable bowel syndrome and fatigue
Authors: von dem Knesebeck Olaf , Barbek Rieke , Makowski Anna Christin 
Published: April 2023

IntroductionSome studies indicate that persistent somatic symptoms (PSS) are more prevalent among individuals with a low socioeconomic status (SES) and a migration background. However, factors explaining social inequalities in PSS are largely unknown. It is expected that aggravating factors of PSS like illness perception, illness beliefs (health literacy, stigma), illness behaviour and health anxiety may play an important role for this explanation. The SOMA.SOC study will examine social inequalities (according to SES and migration) in factors contributing to symptom persistence in irritable bowel syndrome (IBS) and fatigue.Methods and analysisThe project will collect both quantitative and qualitative data. Quantitative data will be gathered via a representative telephone survey in Germany (N=2400). A vignette design will be used depicting patients varying in sex, condition (IBS/fatigue), occupational status (low/high) and migration (yes/no). In the survey, we will assess public knowledge and beliefs (eg, health literacy), attitudes (stigma) and personal experiences with the condition (eg, somatic symptom burden). Complementary, longitudinal qualitative interviews will be conducted with patients (n=32 at three time points, resulting in N=96 interviews) who will also vary according to sex, condition, occupational status and migration. Patients will be recruited from primary care practices in Hamburg. The interviews will cover origin and development of the condition, coping and help-seeking as well as social interactions and perception of the disease by others (eg, perceived stigma). SOMA.SOC is part of the interdisciplinary SOMACROSS (Persistent SOMAtic Symptoms ACROSS Diseases) research unit.Ethics and disseminationThe study protocol was approved by the Ethics Committee of the Hamburg Medical Association on 25 January 2021 (reference number: 2020–10194- BO-ff). Informed consent will be obtained from all participants. The main findings will be submitted for publication in peer-reviewed journals within 12 months of study completion.
Multidrug chemotherapy, whole-brain radiation and cytarabine therapy for primary central nervous system lymphoma in elderly patients with dose modification based on geriatric assessment: study protocol for a phase II, multicentre, non-randomised study
Authors: Yamasaki Fumiyuki , Fudaba Hirotaka , Asano Kenichiro , Sasayama Takashi , Natsumeda Manabu , Shimabukuro Taichi , Taguchi Kotaro , Koizumi Shinichiro , Nakayama Noriyuki , Fujii Kentaro , Nishibuchi Ikuno , Sugiyama Kazuhiko , Yoshida Kenji , Yonezawa Ushio , Yasutomo Momii , Kawasaki Yukari , Kakuta Kiyohide , Katayama Kosuke , Tanaka Kazuhiro , Nagashima Hiroaki , Tsukamoto Yoshihiro , Ideguchi Makoto , Nishizaki Takafumi , Kurozumi Kazuhiko , Hosoya Tomohiro , Akita Tomoyuki , Kambe Atsushi 
Published: April 2023

IntroductionMultidrug chemoimmunotherapy with rituximab, high-dose methotrexate, procarbazine and vincristine (R-MPV) is a standard therapy for younger patients with primary central nervous system lymphoma (PCNSL); however, prospective data regarding its use in elderly patients are lacking. This multi-institutional, non-randomised, phase II trial will assess the efficacy and safety of R-MPV and high-dose cytarabine (HD-AraC) for geriatric patients with newly diagnosed PCNSL.Methods and analysisForty-five elderly patients will be included. If R-MPV does not achieve complete response, the patients will undergo reduced-dose, whole-brain radiotherapy comprising 23.4 Gy/13 fractions, followed by local boost radiotherapy comprising 21.6 Gy/12 fractions. After achieving complete response using R-MPV with or without radiotherapy, the patients will undergo two courses of HD-AraC. All patients will undergo baseline geriatric 8 (G8) assessment before HD-AraC and after three, five and seven R-MPV courses. Patients with screening scores of ≥14 points that decrease to <14 points during subsequent treatment, or those with screening scores <14 points that decrease from the baseline during subsequent treatment are considered unfit for R-MPV/HD-AraC. The primary endpoint is overall survival, and the secondary endpoints are progression-free survival, treatment failure-free survival and frequency of adverse events. The results will guide a later phase III trial and provide information about the utility of a geriatric assessment for defining chemotherapy ineligibility.Ethics and disseminationThis study complies with the latest Declaration of Helsinki. Written informed consent will be obtained. All participants can quit the study without penalty or impact on treatment. The protocol for the study, statistical analysis plan and informed consent form have been approved by the Certified Review Board at Hiroshima University (CRB6180006) (approval number: CRB2018-0011). The study is ongoing within nine tertiary and two secondary hospitals in Japan. The findings of this trial will be disseminated through national and international presentations and peer-reviewed publications.Trial registrationjRCTs061180093.