bluuebunny/crossref_metadata_2025_split huggingface dataset:
Integrated Short-term Palliative Rehabilitation to improve quality of life and equitable care access in incurable cancer (INSPIRE): a multinational European research project
Authors: Bayly Joanne , Ahmedzai Hilde Hjelmeland , Blandini Maria Grazia , Bressi Barbara , Caraceni Augusto Tommaso , Carvalho Vasconcelos Joana , Costi Stefania , Fugazzaro Stefania , Guberti Monica , Guldin Mai-Britt , Hauken May , Higginson Irene , Laird Barry J.A. , Ling Julie , Normand Charles , Nottelmann Lise , Oldervoll Line , Payne Cathy , Prevost A. Toby , Stene Guro B. , Vanzulli Elisa , Veber Eduardo , Economos Guillaume , Maddocks Matthew 
Published: June 2023

Background: Disability related to incurable cancer affects over a million Europeans each year and people with cancer rank loss of function among the most common unmet supportive care needs. Objectives: To test the clinical and cost-effectiveness of an integrated short-term palliative rehabilitation intervention, to optimise function and quality of life in people affected by incurable cancer. Design: This is a multinational, parallel group, randomised, controlled, assessor blind, superiority trial. Methods: The INSPIRE consortium brings together leaders in palliative care, oncology and rehabilitation from partner organisations across Europe, with complementary expertise in health service research, trials of complex interventions, mixed-method evaluations, statistics and economics. Partnership with leading European civil society organisations ensures citizen engagement and dissemination at the highest level. We will conduct a multinational randomised controlled trial across five European countries, recruiting participants to assess the effectiveness of palliative rehabilitation for people with incurable cancer on the primary outcome – quality of life – and secondary outcomes including disability, symptom burden and goal attainment. To support trial conduct and enhance analysis of trial data, we will also conduct: comparative analysis of current integration of rehabilitation across oncology and palliative care services; mixed-method evaluations of equity and inclusivity, processes and implementation for the intervention, at patient, health service and health system levels. Finally, we will conduct an evidence synthesis, incorporating INSPIRE findings, and a Delphi consensus to develop an international framework for palliative rehabilitation practice and policy, incorporating indicators, core interventions, outcomes and integration methods. Scientific contribution: If positive, the trial could produce a scalable and equitable intervention to improve function and quality of life in people with incurable cancer and reduce the burden of care for their families. It could also upskill the practitioners involved and motivate future research questions. The intervention could be adapted and integrated into different health systems using existing staff and services, with little or no additional cost.
Model selection for component network meta-analysis in connected and disconnected networks: a simulation study
Authors: Petropoulou Maria , Rücker Gerta , Weibel Stephanie , Kranke Peter , Schwarzer Guido 
Published: June 2023

AbstractBackgroundNetwork meta-analysis (NMA) allows estimating and ranking the effects of several interventions for a clinical condition. Component network meta-analysis (CNMA) is an extension of NMA which considers the individual components of multicomponent interventions. CNMA allows to “reconnect” a disconnected network with common components in subnetworks. An additive CNMA assumes that component effects are additive. This assumption can be relaxed by including interaction terms in the CNMA.MethodsWe evaluate a forward model selection strategy for component network meta-analysis to relax the additivity assumption that can be used in connected or disconnected networks. In addition, we describe a procedure to create disconnected networks in order to evaluate the properties of the model selection in connected and disconnected networks. We apply the methods to simulated data and a Cochrane review on interventions for postoperative nausea and vomiting in adults after general anaesthesia. Model performance is compared using average mean squared errors and coverage probabilities.ResultsCNMA models provide good performance for connected networks and can be an alternative to standard NMA if additivity holds. For disconnected networks, we recommend to use additive CNMA only if strong clinical arguments for additivity exist.ConclusionsCNMA methods are feasible for connected networks but questionable for disconnected networks.
Use of days alive without life support and similar count outcomes in randomised clinical trials – an overview and comparison of methodological choices and analysis methods
Authors: Granholm Anders , Kaas-Hansen Benjamin Skov , Lange Theis , Munch Marie Warrer , Harhay Michael O. , Zampieri Fernando G. , Perner Anders , Møller Morten Hylander , Jensen Aksel Karl Georg 
Published: June 2023

AbstractBackgroundDays alive without life support (DAWOLS) and similar outcomes that seek to summarise mortality and non-mortality experiences are increasingly used in critical care research. The use of these outcomes is challenged by different definitions and non-normal outcome distributions that complicate statistical analysis decisions.MethodsWe scrutinized the central methodological considerations when using DAWOLS and similar outcomes and provide a description and overview of the pros and cons of various statistical methods for analysis supplemented with a comparison of these methods using data from the COVID STEROID 2 randomised clinical trial. We focused on readily available regression models of increasing complexity (linear, hurdle-negative binomial, zero–one-inflated beta, and cumulative logistic regression models) that allow comparison of multiple treatment arms, adjustment for covariates and interaction terms to assess treatment effect heterogeneity.ResultsIn general, the simpler models adequately estimated group means despite not fitting the data well enough to mimic the input data. The more complex models better fitted and thus better replicated the input data, although this came with increased complexity and uncertainty of estimates. While the more complex models can model separate components of the outcome distributions (i.e., the probability of having zero DAWOLS), this complexity means that the specification of interpretable priors in a Bayesian setting is difficult.Finally, we present multiple examples of how these outcomes may be visualised to aid assessment and interpretation.ConclusionsThis summary of central methodological considerations when using, defining, and analysing DAWOLS and similar outcomes may help researchers choose the definition and analysis method that best fits their planned studies.Trial registrationCOVID STEROID 2 trial, ClinicalTrials.gov: NCT04509973, ctri.nic.in: CTRI/2020/10/028731.
Determinants of medication adherence in hemodialysis patients: a cross-sectional study based on capability-opportunity-motivation and behavior model
Authors: Mirzaei-Alavijeh Mehdi , Hamzeh Behrooz , Omrani Hamidreza , Esmailli Sharareh , Khakzad Saeid , Jalilian Farzad 
Published: June 2023

Abstract
Background
Medication adherence is a key component of successful dialysis in end-stage renal disease (ESRD). The aim of this study was to use the Capability-Opportunity-Motivation and Behavior (COM-B) model in order to identify the most important determinants of medication adherence among ESRD patients.

Methods
This research was a cross-sectional design that was conducted in two steps in 2021. In the first step, COM-B components of patients undergoing hemodialysis (HD) therapy were extracted through literature review. The second step was a cross-sectional study among 260 ESRD patients referred to the dialysis unit from Kermanshah, in the west of Iran. Data was collected using a written questionnaire by interviews. The data was analyzed in SPSS version 16 software.

Results
The mean age of respondents was 50.52 years [95% CI: 48.71, 52.33], ranged from 20 to 75 years. The mean score of medication adherence was 11.95 [95% CI: 11.64, 12.26], ranged from 4 to 20. Medication adherence is higher among patients with higher education (P = 0.009) and those who were employed (P < 0.001) and was significantly related to income (r = 0.176), while it was inversely and significantly related to the medication duration (r=-0.250). Motivation (Beta: 0.373), self-efficacy (Beta: 0.244), and knowledge (Beta: 0.116) are stronger determinants of medication adherence.

Conclusion
COM-B model can be proposed as an integrated framework in predicting medication adherence among ESRD patients. Our findings provide theory-based recommendations that can help future clinical and research decision-making for the development, implementation, and evaluation of treatment adherence interventions in Iranian ESRD patients. The use of COM-B model can provide a comprehensive explanation about medication adherence in ESRD patients. Future research should be focus on increasing motivation, self-efficacy and knowledge of Iranian ESRD patients in order to increasing medication adherence.
A multi-centre randomized controlled trial investigating Consolidation Chemotherapy with and without oxaliplatin in distal rectal cancer and Watch & Wait
Authors: Habr-Gama Angelita , São Julião Guilherme Pagin , Ortega Cinthia D. , Vailati Bruna Borba , Araujo Sergio , Jorge Thiago , Sabbaga Jorge , Rossi Gustavo L. , D’Alpino Renata , Kater Fabio Roberto , Aguilar Patricia Bailão , Mattacheo Adrian , Perez Rodrigo Oliva ,   Latin American Rectal Cancer Consortium (LARCC)
Published: June 2023

Abstract
Background
Neoadjuvant chemoradiation(nCRT) has been considered the preferred initial treatment strategy for distal rectal cancer. Advantages of this approach include improved local control after radical surgery but also the opportunity for organ preserving strategies (Watch and Wait-WW). Consolidation chemotherapy(cCT) regimens using fluoropyrimidine-based with or without oxalipatin following nCRT have demonstrated to increase complete response and organ preservation rates among these patients. However, the benefit of adding oxaliplatin to cCT compared to fluoropirimidine alone regimens in terms of primary tumor response remains unclear. Since oxalipatin-treatment may be associated with considerable toxicity, it becomes imperative to understand the benefit of its incorporation into standard cCT regimens in terms of primary tumor response. The aim of the present trial is to compare the outcomes of 2 different cCT regimens following nCRT (fluoropyrimidine-alone versus fluoropyrimidine + oxaliplatin) for patients with distal rectal cancer.

Methods
In this multi-centre study, patients with magnetic resonance-defined distal rectal tumors will be randomized on a 1:1 ratio to receive long-course chemoradiation (54 Gy) followed by cCT with fluoropyrimidine alone versus fluoropyrimidine + oxaliplatin. Magnetic resonance(MR) will be analyzed centrally prior to patient inclusion and randomization. mrT2-3N0-1 tumor located no more than 1 cm above the anorectal ring determined by sagittal views on MR will be eligible for the study. Tumor response will be assessed after 12 weeks from radiotherapy(RT) completion. Patients with clinical complete response (clinical, endoscopic and radiological) may be enrolled in an organ-preservation program(WW). The primary endpoint of this trial is decision to organ-preservation surveillance (WW) at 18 weeks from RT completion. Secondary endpoints are 3-year surgery-free survival, TME-free survival, distant metastases-free survival, local regrowth-free survival and colostomy-free survival.

Discussion
Long-course nCRT with cCT is associated with improved complete response rates and may be a very attractive alternative to increase the chances for organ-preservation strategies. Fluoropyrimidine-based cCT with or without oxaliplatin has never been investigated in the setting of a randomized trial to compare clinical response rates and the possibility of organ-preservation. The outcomes of this study may significantly impact clinical practice of patients with distal rectal cancer interested in organ-preservation.

Trial registration
www.clinicaltrials.gov NCT05000697; registered on August 11th, 2021.
Risk of retinal vein occlusion in colorectal cancer patients receiving anti-vascular endothelial growth factors – a population-based cohort study
Authors: Lee Wan-Ju Annabelle , Chung Wei-Pang , Shao Shih-Chieh , Lai Edward Chia-Cheng , Chen Yi-Chen , Ho Chung-Han 
Published: June 2023

Abstract
Background
Anti−vascular endothelial growth factors (VEGFs) treatment has been associated with an increased risk of thromboembolic events. Therefore, the use of anti−VEGFs for patients with colorectal cancers (CRC) has raised concerns about the potential risk of retinal vein occlusion (RVO), an ocular disease caused by embolism or venous stasis. This study aims to evaluate the risk of RVO in patients with CRC treated with anti−VEGFs.

Method
We conducted a retrospective cohort study using the Taiwan Cancer Registry and National Health Insurance Database. The study cohort comprised patients newly diagnosed with CRC between 2011 and 2017, who received anti-VEGF treatment. For each patient in the study cohort, a control group comprising four patients newly diagnosed with CRC, but not receiving anti-VEGF treatment, was randomly selected. A washout period of 12 months was implemented to identify new cases. The index date was defined as the date of the first prescription of anti-VEGF drugs. The study outcome was the incidence of RVO, as identified by ICD-9-CM (362.35 and 362.36) or ICD-10-CM codes (H3481 and H3483). Patients were followed from their index date until the occurrence of RVO, death or the end of the study period. Covariates, including patients' age at index date, sex, calendar year of CRC diagnosis, stage of CRC and comorbidities related to RVO, were included. Multivariable Cox proportional hazards regression models were used to calculate hazard ratios (HRs) with adjustments for all covariates to compare the risk of RVO between the anti-VEGF and control groups.

Results
We recruited 6285 patients in the anti-VEGF group and 37,250 patients in the control group, with mean ages of 59.49 ± 12.11 and 63.88 ± 13.17 years, respectively. The incidence rates were 1.06 per 1000 person-years for the anti-VEGF group, and 0.63 per 1000 person-years for the controls. There was no statistically significant difference in RVO risk between the anti-VEGF and control groups (HR: 2.21, 95% CI: 0.87–5.61).

Conclusion
Our results indicated no association between use of anti-VEGF and occurrence of RVO among CRC patients, although the crude incidence rate of RVO was higher in patients receiving anti-VEGF, compared to control patients. Future study with larger sample size is required to confirm our findings.
Microstructural and microperimetric comparison of internal limiting membrane peeling and insertion in large idiopathic macular hole
Authors: Liu Lingzi , Wang Zengyi , Yu Yanping , Yang Xiaohan , Qi Biying , Zhang Ke , Liu Wu 
Published: June 2023

Abstract
Background
The internal limiting membrane (ILM) insertion technique was widely used to treat large macular hole (MH) for the high closure rate. However, the prognosis of closed MH after ILM insertion compared to ILM peeling remains controversial. This study aimed to compare foveal microstructure and microperimeter in large idiopathic MH surgically closed by ILM peeling and ILM insertion.

Methods
This retrospective, non-randomized, comparative study included patients with idiopathic MH (minimum diameter ≥ 650 μm) who underwent primary pars plana vitrectomy (PPV) with ILM peeling or ILM insertion. The initial closure rate was recorded. Patients with initially closed MHs were divided into two groups according to the surgery methods. The best-corrected visual acuity (BCVA), optical coherence tomography (OCT) and microperimeter-3 (MP-3) outcomes of two groups were compared at baseline, 1 and 4 months postoperatively.

Results
For idiopathic MH (minimum diameter ≥ 650 μm), ILM insertion had a significantly higher initial closure rate than ILM peeling (71.19% vs. 97.62%, P = 0.001). Among 39 patients with initially closed MHs who were on regular follow-up, twenty-one were assigned to the ILM peeling group and 18 to the ILM insertion group. Postoperative BCVA improved significantly in both groups. The final BCVA (logMAR) (0.40 vs. 0.88, P < 0.001), macular hole sensitivity (19.66 dB vs. 14.14 dB, P < 0.001), peripheral sensitivity of macular hole (24.63 dB vs. 21.95 dB, P = 0.005), and fixation stability (FS) within 2 degrees (82.42% vs. 70.57%, P = 0.031) were significantly better and external limiting membrane (ELM) defect (330.14 μm vs. 788.28 μm, P < 0.001) and ellipsoid zone (EZ) defect (746.95 μm vs. 1105.11 μm, P = 0.010) were significantly smaller in the ILM peeling group than in the ILM insertion group.

Conclusion
For initially closed MHs (minimum diameter ≥ 650 μm), both ILM peeling and ILM insertion significantly improved the microstructure and microperimeter in the fovea. However, ILM insertion was less efficient at microstructural and functional recovery after surgery.
Relationship between fatigue and quality of life and related factors in family caregivers of patients on hemodialysis
Authors: Akbari Roghayeh , Farsi Zahra , Sajadi Seyedeh Azam 
Published: June 2023

Abstract
Background
The incessant and stressful nature of providing care to patients with chronic diseases can cause fatigue in caregivers. Caregivers’ fatigue and reduced quality of life can reduce the patient’s quality of care. Since it is important to pay attention to the mental health of family caregivers, this study investigated the relationship between fatigue and quality of life and their related factors in family caregivers of patients on hemodialysis.

Methods
This cross-sectional descriptive-analytical study was performed in 2020–2021. One hundred seventy family caregivers were recruited by convenience sampling from two hemodialysis referral centers in the east of Mazandaran province, Iran. The data collection tools were the Family Caregiver Quality of Life questionnaire and Krupp’s fatigue severity scale.

Results
The majority (88%) of caregivers had moderate to severe fatigue. Caregivers’ fatigue was a major factor influencing their quality of life. There was a significant fatigue difference between some categories of kinship and the caregiver’s income level (P < 0.05). Caregivers with lower income and education levels, those who were the patient’s spouse, and those who could not leave the patient alone had significantly worse quality of life than other caregivers (P < 0.05). Also, caregivers living with the patient in the same house had a worse quality of life than those living separately (P = 0.05).

Conclusion
Considering the high prevalence of fatigue among family caregivers of patients on hemodialysis and its adverse effect on their quality of life, it is recommended to perform routine screenings and implement fatigue alleviation interventions for these caregivers.
Exploring spatial patterns, and identifying factors associated with insufficient cash or food received from a productive safety net program among eligible households in Ethiopia: a spatial and multilevel analysis as an input for international food aid programmers
Authors: Demsash Addisalem Workie , Emanu Milkias Dugassa , Walle Agmasie Damtew 
Published: June 2023

Abstract
Background
In low-income countries, households’ food insecurity and the undernutrition of children are the main health problems. Ethiopia is vulnerable to food insecurity and undernutrition among children because its agricultural production system is traditional. Hence, the productive safety net program (PSNP) is implemented as a social protection system to combat food insecurity and enhance agricultural productivity by providing cash or food assistance to eligible households. So, this study aimed to explore spatial patterns of households’ insufficient cash or food receiving from PSNP, and identify its associated factors in Ethiopia.

Methods
The 2019 Ethiopian Mini Demographic and Health Survey dataset was used. A total of 8595 households were included in this study. Data management and descriptive analysis were done using STATA version 15 software and Microsoft Office Excel. ArcMap version 10.7 software was used for spatial exploration and visualization. SaTScan version 9.5 software was used for spatial scan statistics reports. In the multilevel mixed effect logistic regression analysis, explanatory variables with a p-value of less than 0.05 were considered significant factors.

Results
Overall, 13.5% (95% CI: 12.81–14.27%) of the households’ level beneficiaries received cash or food from PSNP. The spatial distribution of households’ benficiaries received cash or food from PSNP was not random, and good access to cash or food from PSNP was detected in Addis Ababa, SNNPR, Amhara, and Oromia regions. Households’ heads aged 25–34 (AOR:1.43, 95% CI: 1.02, 2.00), 35–44 (AOR: 2.41, 95% CI: 1.72, 3.37), and > 34 (AOR: 2.54, 95% CI: 1.83, 3.51) years, being female (AOR: 1.51, 95% CI: 1.27,1.79), poor households (AOR: 1.91, 95% CI:1.52, 2.39), Amhara (AOR:.14, 95% CI: .06, .39) and Oromia (AOR:.36, 95% CI:.12, 0.91) regions, being rural residents (AOR:2.18, 95% CI: 1.21,3.94), and enrollment in CBHS (AOR: 3.34, 95% CI:2.69,4.16) are statistically significant factors.

Conclusions
Households have limited access to cash or food from the PSNP. Households in Addis Ababa, SNNPR, Amhara, and Oromia regions are more likely to receive benefits from PSNP. Encouraging poor and rural households to receive benefits from the PSNP and raise awareness among beneficiaries to use the benefits they received for productivity purposes. Stakeholders would ensure the eligibility criteria and pay close attention to the hotspot areas.