bluuebunny/crossref_metadata_2025_split huggingface dataset:
Frailty and postoperative urinary tract infection
Authors: Tuddenham Susan A. , Gearhart Susan L. , Wright III E. James , Handa Victoria L. 
Published: October 2022

Abstract
Background
Among older adults, postoperative urinary tract infection is associated with significant harms including increased risk of hospital readmission and perioperative mortality. While risk of urinary tract infection is known to increase with age, the independent association between frailty and postoperative urinary tract infection is unknown. In this study we used 2014–2018 data from the U.S. National Surgical Quality Improvement Program (NSQIP) to investigate whether frailty is an independent risk factor for postoperative urinary tract infection, controlling for age and other relevant confounders.

Methods
Frailty was assessed using the modified Frailty Index. Postoperative urinary tract infection was defined as any symptomatic urinary tract infection (of the kidneys, ureters, bladder, or urethra) developing within 30 days of the operative procedure. To examine associations between frailty and other specific factors and postoperative urinary tract infection, chi squared tests, students t-tests, and logistic regression modelling were used.

Results
Urinary tract infection was identified after 22,356 of 1,724,042 procedures (1.3%). In a multivariable model controlling for age and other patient and surgical characteristics, the relative odds for urinary tract infection increased significantly with increasing frailty score. For example, compared to a frailty score of 0, the relative odds for urinary tract infection for a frailty score of 3 was 1.50 (95% confidence interval 1.41, 1.60). The relative odds associated with the maximum frailty score (5) was 2.50 (95% confidence interval 1.73, 3.61).

Conclusions
Frailty is associated with postoperative urinary tract infection, independent of age. Further research should focus on the underlying mechanisms and strategies to mitigate this risk among frail adults.
Safety, pharmacokinetics and efficacy of SCT200, an anti-EGFR monoclonal antibody in patients with wild-type KRAS/NRAS/BRAF metastatic colorectal cancer: a phase I dose-escalation and dose-expansion study
Authors: Zhang Wen , Han Xiaohong , Yang Lin , Song Yuanyuan , Xie Liangzhi , Gai Wenlin , Wang Yan , Shi Yuankai 
Published: October 2022

Abstract
Background
An over-expression of the epidermal growth factor receptor (EGFR) has been observed in colorectal cancer and is associated with aggressive disease and poor prognosis. SCT200 is a newly developed recombinant, fully humanized, anti-EGFR monoclonal antibody. This study aimed to evaluate its safety, tolerability, pharmacokinetics (PK), and efficacy in patients with wild-type KRAS/NRAS/BRAF metastatic colorectal cancer (mCRC).

Methods
This phase I study comprising dose-escalation phase and dose-expansion phase. SCT200 was administrated intravenously to groups of three to six patients. An every 3-week dosing cycle (0.5–15.0 mg/kg) and multiple dosing schedule were evaluated. Blood samples were collected at preset intervals for PK assessment, radiological imaging was used for efficacy assessment, and continuous safety monitoring was performed in each group during the study.

Results
From December 16, 2014 to December 31, 2018, fifty-six patients with wild-type KRAS/NRAS/BRAF mCRC receiving ≥ 1 dose of SCT200 were evaluated. Among them, 44.6% (25/56) of the patients failed at least two prior lines of chemotherapy. No dose-limiting toxicities occurred in any group. All of the patients experienced treatment-emergent adverse events (TEAEs). 96.4% (54/56) of patients experienced treatment-related adverse events (TRAEs), and 26.8% (15/56) of patients with Grade ≥ 3 TRAEs. No serious TRAEs were observed. The most common TRAEs were dermotoxicity and hypomagnesemia. PK analysis showed non-linear PK in the range of 0.5 - 8.0 mg/kg of single dose SCT200, the clearance decreased, and the elimination half-life (T1/2) prolonged following dose increase. In the multiple-dose period, the clearance decreased, peak concentration increased, and T1/2 prolonged during prolonged drug administration, and a steady state was reached after five consecutive dose of 6.0 mg/kg quaque week (QW). The objective response rate (ORR) was 30.4% (17/56, 95% confidence interval [CI], 18.8%–44.1%). The ORR in the dose-expansion group (6.0 mg/kg QW) was 48.0% (12/25, 95% CI, 27.8%–68.7%), the median progression-free survival was 5.2 months (95%CI, 3.6–5.5), and the median overall survival was 20.2 months (95%CI, 12.1-not reached).

Conclusions
SCT200 showed favorable safety, PK profile, and preliminary efficacy for patients with wild-type KRAS/NRAS/BRAF mCRC.

Trial registration
This study was registered with ClinicalTrials.gov (NCT02211443).
Design decisions and data completeness for experience sampling methods used in psychosis: systematic review
Authors: Deakin Emilia , Ng Fiona , Young Emma , Thorpe Naomi , Newby Christopher , Coupland Carol , Craven Michael , Slade Mike 
Published: October 2022

Abstract
Background
The experience sampling method (ESM) is an intensive longitudinal research method.
Participants complete questionnaires at multiple times about their current or very recent state. The design of ESM studies is complex. People with psychosis have been shown to be less adherent to ESM study protocols than the general population. It is not known how to design studies that increase adherence to study protocols. A lack of typology makes it is hard for researchers to decide how to collect data in a way that allows for methodological rigour, quality of reporting, and the ability to synthesise findings. The aims of this systematic review were to characterise the design choices made in ESM studies monitoring the daily lives of people with psychosis, and to synthesise evidence relating the data completeness to different design choices.

Methods
A systematic review was conducted of published literature on studies using ESM with people with psychosis. Studies were included if they used digital technology for data collection and reported the completeness of the data set. The constant comparative method was used to identify design decisions, using inductive identification of design decisions with simultaneous comparison of design decisions observed. Weighted regression was used to identify design decisions that predicted data completeness. The review was pre-registered (PROSPERO CRD42019125545).

Results
Thirty-eight studies were included. A typology of design choices used in ESM studies was developed, which comprised three superordinate categories of design choice: Study context, ESM approach and ESM implementation. Design decisions that predict data completeness include type of ESM protocol used, length of time participants are enrolled in the study, and if there is contact with the research team during data collection.

Conclusions
This review identified a range of design decisions used in studies using ESM in the context of psychosis. Design decisions that influence data completeness were identified. Findings will help the design and reporting of future ESM studies. Results are presented with the focus on psychosis, but the findings can be applied across different mental health populations.
Similarities in cardiometabolic risk factors among random male-female pairs: a large observational study in Japan
Authors: Nakaya Naoki , Nakaya Kumi , Tsuchiya Naho , Sone Toshimasa , Kogure Mana , Hatanaka Rieko , kanno Ikumi , Metoki Hirohito , Obara Taku , Ishikuro Mami , Hozawa Atsushi , Kuriyama Shinichi 
Published: October 2022

Abstract
Background:
Previous observational studies have shown similarities in cardiometabolic risk factors between spouses. It is still possible that this result reflects the age similarity of spouses rather than environmental factors of spouses (e.g. cohabitation effect). To clarify the importance of mate cardiometabolic risk factors for similarity of environmental factors, it is necessary to examine whether they are observed in random male-female pairs while maintaining the age of the spousal pairs. This study aimed to determine whether the similarities found between spousal pairs for cardiometabolic risks were also observed between random male-female pairs.

Methods:
This cross-sectional study included 5,391 spouse pairs from Japan; data were obtained from a large biobank study. For pairings, women of the same age were randomly shuffled to create new male-female pairs of the same age as that of the original spouse pairs. Similarities in cardiometabolic risk factors between the random male-female pairs were analysed using Pearson’s correlation or age-adjusted logistic regression analyses.

Results:
The mean ages of the men and women were 63.2 and 60.4 years, respectively. Almost all cardiometabolic risk factors similarities were not noted in cardiometabolic risk factors, including the continuous risk factors (anthropometric traits, blood pressure, glycated haemoglobin level, and lipid traits); lifestyle habits (smoking, drinking, and physical activity); or diseases (hypertension, type 2 diabetes mellitus, and metabolic syndrome) between the random male-female pairs. The age-adjusted correlation coefficients ranged from − 0.007 for body mass index to 0.071 for total cholesterol. The age-adjusted odds ratio (95% confidence interval) for current drinkers was 0.94 (0.81 − 1.09); hypertension, 1.07 (0.93 − 1.23); and type 2 diabetes mellitus, 1.08 (0.77 − 1.50).

Conclusion:
In this study, few similarities in cardiometabolic risk factors were noted among the random male-female pairs. As spouse pairs may share environmental factors, intervention strategies targeting lifestyle habits and preventing lifestyle-related diseases may be effective.
Food insecurity and eating habits of Lebanese children aged 5–11 years during the COVID-19 pandemic and the socioeconomic crisis: a national study
Authors: Gedeon Reine , Hallit Souheil , Wakim Lara Hanna 
Published: October 2022

Abstract
Background
Food insecurity is the lack of access to nutritious healthy food due to economic and financial insufficiencies. Food insecurity is expected to be higher during these difficult times in Lebanon, which is facing many financial, political, economic and health debates. The present study aims to find the prevalence of food insecurity among Lebanese children during the COVID-19 pandemic and its correlates.

Methods
This cross-sectional study enrolled 4001 participants from all Lebanese governorates (March–April 2022). The Ministry of Education and Higher Education randomly disseminated the link to parents of children aged between 5 and 11 years from public and private schools.

Results
The results showed that 1505 (37.6%) and 1497 (37.4%) had moderate and severe food insecurity. A significantly higher percentage of families with severe food insecurity was reported by fathers compared to mothers. In addition, participants who reported a bad overall health status of their children had a severe food insecurity. Moreover, those with a severe food insecurity had their children’s daily snacking habit between meals decreased, with a decreased quantity of meals, intake of vegetables/fruits, the intake of balanced diet, junk food, sugar-sweetened beverages, consumption of sweets/candies/chocolate, consumption of unhealthy food, intake of immunity-boosting food, intake of nutrition supplements, participation in the house chores, number of sleeping hours and sleep quality, as well as stress/anxiety decreased. Finally, a higher mean financial burden was seen in families with severe food insecurity compared to the other groups.

Conclusion
The current study found a high prevalence of moderate to severe food insecurity among Lebanese children during the COVID-19 pandemic. Food insecurity should be seriously discussed in Lebanon due to its rapid development in the middle of all the crises facing the country in order to avoid short and long term consequences on human’s health.
Examining the influence of correlates on different quantile survival times: infant mortality in Bangladesh
Authors: Jamee Ahsan Rahman , Sen Kanchan Kumar , Bari Wasimul 
Published: October 2022

Abstract
Background
Several studies have identified factors influencing infant mortality, but, to the best of knowledge, no studies assessed the factors considering unequal effects on different survival times of infant mortality in Bangladesh. In this study, it was examined how a set of covariates behaves on different quantile survival times related with the infant mortality.

Methods
Data obtained from Bangladesh multiple indicator cluster survey (BMICS), 2019 have been used for purpose of the study. A total of 9,183 reproductive women were included in the study who gave their most recent live births within two years preceding the survey. Kaplan–Meier product limit approach has been applied to find the survival probabilities for the infant mortality, and the log-rank test has also been used to observe the unadjusted association between infant mortality and selected covariates. To examine the unequal effects of the covariates on different quantile survival time of infant mortality, the Laplace survival regression model has been fitted. The results obtained from this model have also been compared with the results obtained from the classical accelerated failure time (AFT) and Cox proportional hazard (Cox PH) models.

Results
The infant mortality in Bangladesh is still high which is around 28 per 1000 live births. In all the selected survival regression models, the directions of regression coefficients were similar, but the heterogenous effects of covariates on survival time were observed in quantile survival model. Several correlates such as maternal age, education, gender of index child, previous birth interval, skilled antenatal care provider, immediate breastfeeding etc. were identified as potential factors having higher impact on initial survival times.

Conclusion
Infant mortality was significantly influenced by the factors more in the beginning of the infant's life period than at later stages, suggesting that receiving proper care at an early age will raise the likelihood of survival. Policy-making interventions are required to reduce the infant deaths, and the study findings may assist policy makers to revise the programs so that the sustainable development goal 3.2 can be achieved in Bangladesh.
Associations between metabolic factors and radiographic knee osteoarthritis in early disease - a cross-sectional study of individuals with knee pain
Authors: Andersson Maria , Haglund E , Aili K , Bremander A , Bergman S 
Published: October 2022

Abstract
Objective
Metabolic factors have been shown to be associated to severe radiographic knee osteoarthritis (RKOA). However, more knowledge is needed in early clinical knee osteoarthritis (KOA). The aim was to study associations between metabolic factors and radiographic knee osteoarthritis (OA) in individuals with knee pain. A second aim was to study associations between metabolic factors and RKOA in those with normal BMI and in those overweight/obese, respectively.

Method
This cross-sectional study included 282 individuals with knee pain (without cruciate ligament injury) and aged 30–67 years, and 70% women. Waist circumference, body mass index (BMI), proportion of fat and visceral fat area (VFA) were assessed. RKOA was defined as Ahlbäck grade 1 in at least one knee. Fasting blood samples were taken and triglycerides, cholesterol (total, low density lipoprotein (LDL) and high density lipoprotein (HDL)), C-reactive protein (CRP), glucose, HbA1C were analysed. Metabolic syndrome was defined in accordance with the International Diabetes Federation (IDF). Associations were analysed by logistic regression.

Results
Individuals with RKOA were older, had higher BMI, higher VFA, larger waist circumference and had increased total cholesterol, triglycerides and LDL-cholesterol, but not fasting glucose. There was no difference between the group with RKOA vs. non-radiographic group regarding the presence of metabolic syndrome. In a subgroup analysis of individuals with normal BMI (n = 126), those with RKOA had higher VFA, more central obesity, higher levels of CRP and total cholesterol, compared with individuals without RKOA. In individuals with obesity, age was the only outcome associated to RKOA.

Conclusion
There were clear associations between metabolic factors and RKOA in individuals with knee pain, also in those with normal BMI. In individuals with obesity age was the only variable associated to RKOA.

Trial registration:
clinicalTrials.gov Identifier: NCT04928170.
Introduction of a modified Degan classification to specify treatment algorithms in fractures of the anterior process of the calcaneus
Authors: Cibura Charlotte , Lülsdorff Raimund , Ramczykowski Tim , Schildhauer Thomas Armin , Kruppa Christiane 
Published: October 2022

Abstract
Background
Fractures of the anterior process of the calcaneus are often missed, and their treatments and results receive little attention in the current literature. The aim of this study was to specify treatment algorithms through a modification of the Degan classification.

Methods
Between 2009 and 2019, patients with APC fractures were retrospectively analyzed. The Degan classification was used and modified. Type III fractures were further divided into subgroups A (not displaced) and B (displaced). The type of treatment and complications were recorded. Return to work and posttraumatic osteoarthritis were determined as primary and secondary outcome parameters, respectively.

Results
Forty-one patients with 43 fractures were included. Follow-up averaged 35,5 months (range 1,5–152 months). Fractures were eight type I, six type II, 15 type IIIA and 14 type IIIB. The fracture was initially recognized in 29 (70,7%) patients, and missed in 12 (29,3%) patients, respectively. Overall, the delayed diagnosed fractures had a significantly higher complication rate (p < 0,000) than the initially diagnosed fractures and received surgical treatment significantly (p < 0,009) more often.
After surgical treatment of 13 type IIIB, one nonunion occurred. Six missed type IIIA fractures were treated surgically after delayed diagnosis because of persistent symptoms. Two type I fractures required arthrodesis of the Chopart joint. Four patients did not return to work during the follow-up (3 missed type IIIA fractures, 1 type II fracture).

Conclusion
Missed APC type IIIA fractures are at risk to develop complications, which is why computed tomography diagnostics should be performed if there is any clinical suspicion.
Digitally-supported patient-centered asynchronous outpatient follow-up in rheumatoid arthritis - an explorative qualitative study
Authors: Stenzel Ramona , Hadaschik Katharina , May Susann , Grahammer Manuel , Labinsky Hannah , Welcker Martin , Hornig Johannes , Bendzuck Gerlinde , Elling-Audersch Corinna , Erstling Ulrike , Korbanka Patricia Steffens , Vuillerme Nicolas , Heinze Martin , Krönke Gerhard , Schett Georg , Pecher Ann-Christin , Krusche Martin , Mucke Johanna , Knitza Johannes , Muehlensiepen Felix 
Published: October 2022

Abstract
Objective
A steadily increasing demand and decreasing number of rheumatologists push current rheumatology care to its limits. Long travel times and poor accessibility of rheumatologists present particular challenges for patients. Need-adapted, digitally supported, patient-centered and flexible models of care could contribute to maintaining high-quality patient care. This qualitative study was embedded in a randomized controlled trial (TELERA) investigating a new model of care consisting of the use of a medical app for ePRO (electronic patient-reported outcomes), a self-administered CRP (C-reactive protein) test, and joint self-examination in rheumatoid arthritis (RA) patients. The qualitative study aimed to explore experiences of RA patients and rheumatology staff regarding (1) current care and (2) the new care model.

Methods
The study included qualitative interviews with RA patients (n = 15), a focus group with patient representatives (n = 1), rheumatology nurses (n = 2), ambulatory rheumatologists (n = 2) and hospital-based rheumatologists (n = 3). Data was analyzed by qualitative content analysis.

Results
Participants described current follow-up care as burdensome. Patients in remission have to travel long distances. Despite pre-scheduled visits physicians lack questionnaire results and laboratory results to make informed shared decisions during face-to-face visits. Patients reported that using all study components (medical app for ePRO, self-performed CRP test and joint self-examination) was easy and helped them to better assess their disease condition. Parts of the validated questionnaire used in the trial (routine assessment of patient index data 3; RAPID3) seemed outdated or not clear enough for many patients. Patients wanted to be automatically contacted in case of abnormalities or at least have an app feature to request a call-back or chat. Financial and psychological barriers were identified among rheumatologists preventing them to stop automatically scheduling new appointments for patients in remission. Rheumatology nurses pointed to the potential lack of personal contact, which may limit the holistic care of RA-patients.

Conclusion
The new care model enables more patient autonomy, allowing patients more control and flexibility at the same time. All components were well accepted and easy to carry out for patients. To ensure success, the model needs to be more responsive and allow seamless integration of education material.

Trial registration
The study was prospectively registered on 2021/04/09 at the German Registry for Clinical Trials (DRKS00024928).
Heterogeneity in pragmatic randomised trials: sources and management
Authors: Giraudeau Bruno , Caille Agnès , Eldridge Sandra M. , Weijer Charles , Zwarenstein Merrick , Taljaard Monica 
Published: October 2022

Abstract
Background
Pragmatic trials aim to generate evidence to directly inform patient, caregiver and health-system manager policies and decisions. Heterogeneity in patient characteristics contributes to heterogeneity in their response to the intervention. However, there are many other sources of heterogeneity in outcomes. Based on the expertise and judgements of the authors, we identify different sources of clinical and methodological heterogeneity, which translate into heterogeneity in patient responses—some we consider as desirable and some as undesirable. For each of them, we discuss and, using real-world trial examples, illustrate how heterogeneity should be managed over the whole course of the trial.

Main text
Heterogeneity in centres and patients should be welcomed rather than limited. Interventions can be flexible or tailored and control interventions are expected to reflect usual care, avoiding use of a placebo. Co-interventions should be allowed; adherence should not be enforced. All these elements introduce heterogeneity in interventions (experimental or control), which has to be welcomed because it mimics reality. Outcomes should be objective and possibly routinely collected; standardised assessment, blinding and adjudication should be avoided as much as possible because this is not how assessment would be done outside a trial setting. The statistical analysis strategy must be guided by the objective to inform decision-making, thus favouring the intention-to-treat principle. Pragmatic trials should consider including process analyses to inform an understanding of the trial results. Needed data to conduct these analyses should be collected unobtrusively. Finally, ethical principles must be respected, even though this may seem to conflict with goals of pragmatism; consent procedures could be incorporated in the flow of care.