bluuebunny/crossref_metadata_2025_split huggingface dataset:
Association Between Triglyceride-Glucose Index (TyG Index) and Type 2 Diabetes Mellitus: A Systematic Review
Authors: Liberty Iche Andriyani , Putri Naufal Karyna 
Published: April 2023

Background: Insulin Resistance has a major role in the pathogenesis of diabetes mellitus where there is a decrease in sensitivity in peripheral tissues. The emergence of insulin resistance, 1-2 decades precedes before the diagnosis of type 2 diabetes mellitus is established. This theory is supported by the usefulness of insulin resistance as a marker of future diabetes or the prevention of type 2 diabetes by insulin-sensitizing agents. Recently, there is evidence that has been suggested to measure insulin resistance as surrogate marker by calculated the triglyceride and glucose which is so called as “Fasting triglyceride-glucose index” or can be shorten as “TyG index”. This study reported a systematic review of association between TyG index and type 2 diabetes mellitus from various literatures to make a conclusion as a basis for further research.
Methods: A literature search in EBSCOhost, ProQuest, MEDLINE, and NCBI database was performed to retrieve and review studies reporting the association between TyG index and type 2 diabetes.
Results: All studies showed that higher TyG index were associated with higher type 2 diabetes (HR 4.36, 10.38, 9.54 for each).
Conclusion: This systematic review provides further evidence about higher TyG index is related to higher risk of development type 2 diabetes. It represents that TyG index can predicting the risk of incident T2DM.
Sample sizes for non-inferiority studies based on the difference between two proportions: a unified approach for difference, ratio and odds ratio models
Authors: Cesana Bruno Mario , Antonelli Paolo 
Published: April 2023

Background: It is never easy to make sample size calculation for two-arm, non-inferiority studies with a primary proportion outcome not only because the different parameterisations involved in the difference, ratio, and odds ratio models lead to different non-inferiority margins and different sample size results, but also because of the different efficiency of the respective sample size formulae.
Methods: According to a formal statistical approach, we showed how to express the non-inferiority margins of the three models by keeping the probability (success or failure) of the standard treatment fixed (considered as “known” in the planning phase of a trail), and equal under the null and alternative hypotheses as the statistical basis for sample size calculation.
Results: We have obtained the sample size formulae and their respective power formulae for the three considered models both for success and failure probabilities. A sample size table for non-inferiority success studies is reported for illustrative purposes. In addition, we have compared the sample sizes from the three models by means of graphic and theoretical approaches and we have shown their asymptotic relationships. Furthermore, we have obtained the formulae for switching among the three considered models. Finally, we have correct some previously published formulae for sample size calculations.
Conclusion: The clearly separate approach to the probabilities of success and failure of the three considered models shown in this paper makes it possible to switch among them consistently and equivalently and to choose the probability formulation for the most parsimonious model.
The difference of free light chains as a predictor of kidney damage in patients with Multiple Myeloma
Authors: Mancuso Salvatrice , Carlisi Melania , Serra Nicola , Sardo Mariano , Bertuglia Giuseppe , Pappalardo Emanuela , Siragusa Sergio 
Published: April 2023

Background: Multiple myeloma (MM) is a malignant neoplasm characterized by the clonal expansion of plasma cells that can release monoclonal immunoglobulins (monoclonal component) or part of theme. Since 2001, the k and λ serum free light chains (sFLC) evaluation and their ratio (rFLC) have made up the laboratory analysis more sensitive and precise in MM patients. The role of rFLC has been widely studied and discussed and now it is validated in the literature. Instead, the value of free light chains difference (dFLC), especially in MM is less known yet. The aim of this study is to evaluate the relationship between the dFLC and the kidney damage parameters in patients with MM, in comparison with the rFLC value.
Methods: We conducted a retrospective population-based study on 58 MM patients and we individuated two groups obtained considering the measures of dFLC and rFLC in relation to abnormal and normal values of some renal function markers, such us Bence-Jones proteinuria (BJ), albuminuria, proteinuria and serum creatinine. The Mann-Whitney test was used to test the difference between two independent samples.
Results: We observed a significant greater mean score of dFLC in patients with abnormal levels of BJ (2322.91>297.47, p=0.0001), albuminuria (2650.61>671.37, p=0.0016) and proteinuria (2327.19>593.14, p= 0.0025), while there was no significant difference for serum creatinine (1636.18<1870.85, p=0.994). Instead, no differences were observed for the rFLC parameter.
Conclusion: The data obtained allow us to conclude that dFLC can be considered a potential predictor of renal damage in MM patients, even better than rFLC.
Alcohol and the young: how does the press face the problem?
Authors: Concina Diego , Giubertoni Ailia , Spina Paolo , Allara Elias , Faggiano Fabrizio , Avogadro Alcohol Group  
Published: April 2023

Background: alcohol is an important component of the Mediterranean diet and its moderate use is protective against cardiovascular risk. Binge drinking, i.e. the heavy consumption of alcohol over a short period of time, is the main consumption pattern of young people in Western countries and may lead to severe toxic effects in many organs. Mass media often address the issue by suggesting prevention measures; however, they may also have the unintended effect of encouraging alcohol misuse. This study aims to assess how the Italian press faces excessive alcohol consumption in young people, comparing the messages given by the press with scientific recommendations.
Methods: articles published by the 6 best-selling Italian newspapers and the 4 best-selling Italian magazines were collected from October 15th to November 14th 2009. Medline database, governmental and non-governmental sources were searched for scientific recommendations regarding primary prevention of alcohol misuse. Press articles were described and analysed by filling out a predefined form.
Results: fourteen newspaper articles regarding alcohol were found, 79% belonging to the news section. Six quotations of scientific recommendations were found: two about drink-driving, two about raising public awareness, one about Monitoring and Evaluation, and one about community and workplace action.
Conclusions: scientific recommendations were often inadequately reported by the Italian press. The most covered recommendations, designed driver and public educational intervention, are also the least effective according to international literature. Therefore, a further effort is needed to tackle this issue in a more scientifically sound way.
Finding the Right Distribution for Highly Skewed Zero-inflated Clinical Data
Authors: Gupta Resmi , Marino Bradley S. , Cnota James F. , Ittenbach Richard F. 
Published: April 2023

Discrete, highly skewed distributions with excess numbers of zeros often result in biased estimates and misleading inferences if the zeros are not properly addressed. A clinical example of children with electrophysiologic disorders in which many of the children are treated without surgery is provided. The purpose of the current study was to identify the optimal modeling strategy for highly skewed, zeroinflated data often observed in the clinical setting by: (a) simulating skewed, zero-inflated count data; (b) fitting simulated data with Poisson, Negative Binomial, Zero-Inflated Poisson (ZIP) and Zero-inflated Negative Binomial (ZINB) models; and, (c) applying the aforementioned models to actual, highlyskewed, clinical data of children with an EP disorder. The ZIP model was observed to be the optimal model based on traditional fit statistics as well as estimates of bias, mean-squared error, and coverage.
Bevacizumab for advanced ovarian cancer treatment. A GRADE based approach
Authors: Pappagallo Giovanni L. , Torri Valter 
Published: April 2023

Background: in advanced ovarian cancer, over the last 10 years no studies have demonstrated more appropriate therapeutic options compared to the current standard Carboplatin-Paclitaxel (Cb-P) regimen. Two phase III randomized studies (GOG-218 36 and ICON-7 37) have recently demonstrated the efficacy of bevacizumab (recombinant monoclonal antibody that binds with a high affinity to VEGF-A) in adjunct to Cb-P, with 12-15 months maintenance treatment.
Methods: the quality of evidence provided was assessed by the use of the GRADE method. Each outcome (deemed to be essential for the purpose of evaluation of the intervention) was assessed to express the degree of confidence in the entity of the beneficial and/or harmful effects of the intervention. Thus, limitations in the quality of conducting the studies (risk of bias), direct applicability/relevance of results to the target population, and precision of results were taken into account.
Results: the GOG-218 and the ICON7 study (high-risk subgroup) demonstrated with MODERATE confidence an improvement in critical outcomes PFS and OS, with an absolute reduction of 96 (GOG-218) – 103 (ICON-7) episodes of progression, and 40 (GOG-218) – 135 (ICON-7) deaths per 1 000 patients. A marked increase in risk of hypertension of Grade ≥3 was observed, with an absolute increase of 59 episodes per 1 000 patients in the ICON-7 study, and 157 episodes in the GOG-218 study, respectively, the majority of which were controlled by means of appropriate treatment. The increased risk of other adverse events considered was negligible.
Conclusions: the positive effects produced should be viewed as taking prevalence over the negative effects (FAVOURABLE benefit/harm ratio).
Digit preference in Nigerian censuses data of 1991 and 2006
Authors: Dahiru Tukur , Dikko Hussaini G. 
Published: April 2023

Background: censuses in developing countries are prone to errors of age misreporting due to ignorance, low literacy levels and other social, economic and cultural factors. Ages are commonly rounded with great affinity for 0 or 5. This tendency to digit preference and/or avoidance results in age heaping or concentration of ages at certain digits. This study examined the extent of digit preference in the Nigerian census data of 1991 and 2006.
Methods: this study utilized age data from the 1991 and 2006 Nigerian censuses reported in single years. The Whipple and Myers indices were used to determine the extent of digit preference.
Results: both the 1991 and 2006 census data showed the expected pattern of errors, with Whipple and Myers indices being beyond acceptable levels. The Whipple index for 1991 and 2006 was 293 and 251 respectively, while the Myers index was 62.3 and 67.1 respectively. There was a strong preference for terminal digits 0 and 5, followed by 8 whereas terminal digits 1 and 9 were strongly avoided.
Conclusions: the quality of age data in Nigerian census data is poor as a result of misreporting and no significant improvement or difference was observed between 1991 and 2006 censuses.
Two-stage re-estimation adaptive design: a simulation study
Authors: Galli Francesca , Mariani Luigi 
Published: April 2023

Background: adaptive clinical trial design has been proposed as a promising new approach to improve the drug discovery process. Among the many options available, adaptive sample size re-estimation is of great interest mainly because of its ability to avoid a large ‘up-front’ commitment of resources. In this simulation study, we investigate the statistical properties of two-stage sample size re-estimation designs in terms of type I error control, study power and sample size, in comparison with the fixed-sample study.
Methods: we simulated a balanced two-arm trial aimed at comparing two means of normally distributed data, using the inverse normal method to combine the results of each stage, and considering scenarios jointly defined by the following factors: the sample size re-estimation method, the information fraction, the type of group sequential boundaries and the use of futility stopping. Calculations were performed using the statistical software SAS™ (version 9.2).
Results: under the null hypothesis, any type of adaptive design considered maintained the prefixed type I error rate, but futility stopping was required to avoid the unwanted increase in sample size. When deviating from the null hypothesis, the gain in power usually achieved with the adaptive design and its performance in terms of sample size were influenced by the specific design options considered.
Conclusions: we show that adaptive designs incorporating futility stopping, a sufficiently high information fraction (50-70%) and the conditional power method for sample size re-estimation have good statistical properties, which include a gain in power when trial results are less favourable than anticipated.
New indicators of illegal drug use to compare drug user populations for policy evaluation
Authors: Fabi Francesco , Mammone Alessia , Rossi Carla 
Published: April 2023

Background: New trends in drug consumption show a trend towards higher poly-use. Epidemiological indicators presently used are mostly based on the prevalence of users of the “main” substances and the ranking of harm caused by drug use is based on a single substance analysis.
Methods: In this paper new indicators are proposed; the approach consider the segmentation of the population with respect to the frequency of use in the last 30 days and the harm score of the various substances used by a poly-user. Scoring is based on single substance score table reported in recent papers and principal component analysis is applied to reduce dimensionality. Any user ischaracterized by the two new scores: frequency of use score and poly-use score.
Results: The method is applied to the drug user populations interviewed in Communities and Low Threshold Services within the Problem Drug Use 2012 survey in four different European countries. The comparison of the poly-use score cumulative distributions gives insight about behavioural trends of drug use and also evaluate the efficacy of the intervention services. Furthermore, the application of this method to School Population Survey 2011 data allows a definition of the expected behaviour of the poly-drug score for the General Population Survey to be representative.
Conclusions: In general, the method is simply and intuitive, and could be applied to surveys containing questions about drug use. A possible limitations could be that the median is chosen for calculating the frequency of use score in questionnaires containing the frequency of drug use in classes.
Ernst L. Wynder: A Pioneer of No Tobacco World
Authors: Bucci Roberto , Colamesta Vittoria , La Torre Giuseppe 
Published: April 2023

Ernst L Wynder was a great epidemiologist who devoted his career to investigate harmful effects of tobacco smoke, in particular his studies represent a landmark in the history of epidemiological research on lung cancer.
The commitment of Ernst Wynder was not limited to the risk factors related to tobacco. In fact, he studied also the role of nutritional factors in the incidence of tumors.
His talent, enthusiasm and tireless energy have allowed him to obtain a complete victory despite the difficulties and the initial loneliness.
Decision support in Down’s syndrome screening using multi-criteria decision analysis: a pilot study
Authors: Erenbourg Anna , Stephenson Judith , Pandya Pranav , Jones Patricia , Dowie Jack 
Published: April 2023

Background: the aim of the study was to develop and pilot use of a decision support system (DSS) to help women choose the option that best respects their personal values among the different screening/diagnostic tests for Down’s syndrome.
Methods: value-bearing considerations were elicited through qualitative interviews. Ten women post-birth and ten health professionals working in the Obstetric Department at UC LH were interviewed. Performance data for the various possible screening strategies on these attributes were entered into a Multi-criteria Decision Analytic model using the Annalisa implementation. Participants piloted the DSS, entering necessary weights for the attributes and observing the resulting scores. Main outcome measures were DSS clarity, usefulness and feasibility in a clinical setting.
Results: most participants found the DSS valuable because it stimulated women to seek information about testing and helped them focus on the main issues affecting their decisions. Annalisa proved a user-friendly DSS that helps women understand the issues around Down’s screening and diagnosis. There was unanimity that its use should be complementary to health professionals’ consultation. Most favoured offering it before consultation so that women could be better informed about options before attending the antenatal booking.
Conclusions: the overall positive comments confirm that a user-friendly decision analysis-based support system can be a valuable instrument at supporting health decisions in this area. Further research is needed to assess whether the intention to make an informed choice is always best addressed by a decision support system, or these remain useful tools only to women more inclined to seek information anyhow.
Treatment of elevated cholesterol in a representative cross-sectional sample of 4 892 Germans: is there a social gradient?
Authors: Laaser Ulrich , Breckenkamp Juergen , Sauzet Odile , Bjegovic-Mikanovic Vesna 
Published: April 2023

Background: effective control of cardiovascular risk factors remains low in most countries and also in Germany. We investigate whether socio-economic status has an impact on the level of medical treatment and control (normalized values) of total cholesterol.
Methods: data on blood lipids from 4 892 participants in the last German Health Survey of 1998 are analysed, adjusting for key determinants in logistic regression analyses. Socio-economic status is not determined by educational achievement alone but also including occupation and household income.
Results: the actual prevalence of total cholesterol of ≥240 mg/dl was 53.4%. Only 3.6% of prevalent cases are under effective treatment. Less favourable values of total cholesterol and HDL are displayed by males and in lower social groups, while the middle groups are in an intermediate position. Chances to be treated for hypercholesterolemia are significantly less favourable for females (odds ratio (OR) estimate: 0.70) and better for the age bands ≥50 (OR 2.37) and ≥60 (OR 3.57), if a general practitioner is visited (OR 1.77), and if living in Eastern Germany (OR 1.89). However, chances are not significantly different according to social status.
Conclusions: statistically significant social group differences cannot be detected at the present low level of effective treatment. This may be different if higher levels of control are achieved.
Quality appraisal of documents producing recommendations for breast, colorectal and cervical cancer screening
Authors: Giorgi Rossi Paolo , Ferroni Eliana , Barca Alessandra , Pantano Pamela , Camilloni Laura , Cogo Carla , Ferri Marica 
Published: April 2023

Background: Breast, cervical, and colorectal cancer screening are evidence-based interventions recommended by most governmental agencies and scientific societies. The aim of this review is to assess the quality of guidelines on screening and to describe differences according to the context in which they were produced.
Methods: A literature search of the main databases, websites on health care, and guidelines, as well as the websites of several scientific societies was carried out in order to identify the most recent guidelines (since 2000) on cervical, breast, and colorectal cancer screening. Only documents written in Italian or English were included. Two investigators independently assessed quality by using the AGREE (Appraisal of Guidelines, Research and Evaluation in Europe) instrument.
Results: Thirty-three, 32, and 18 relevant documents for cervical, breast, and colorectal cancer, respectively, were identified. Only some documents (19, 12 and 13 for cervical, breast, and colorectal cancer, respectively) could be evaluated with AGREE. Items included in the domain “scope and purpose” obtained the highest scores, followed by “clarity of presentation” domain, while “applicability”, “patient involvement,” and “conflict of interest disclosure” domains obtained the lowest scores. The quality did not improve in more recent documents. Documents produced by governmental agencies, on average, had higher scores than documents by scientific societies, particularly for “stakeholder involvement” and “applicability”.
Conclusions: Documents from different countries and health systems differ in terms of the main recommendations given and in the quality of the documents. Those produced by governmental agencies have a more multidisciplinary authorship and pay more attention to applicability than do those produced by scientific societies.
Analyzing socioeconomic related health inequality in mothers and children using the concentration index
Authors: Amirian Hossein , Poorolajal Jalal , Roshanaei Ghodratollah , Esmailnasab Nader , Moradi Ghobad 
Published: April 2023

Background: The effect of socioeconomic inequity on major public health indices such as maternal and child mortality rates in low- and middle-income countries are less understood and needs to be evaluated through the concentration index.
Method: This cross-sectional study was conducted in 2012 in Hamadan City, the west of Iran, and 1400 households were enrolled through a stratified cluster random sampling method. The effect of inequity on health outcomes was investigated via a three-stage procedure including: (a) definition of health outcomes; (b) measuring socioeconomic status using an asset index; and (c) measuring inequality of health outcome using concentration index (CI).
Results: There was inequality for all outcomes of interest. The CI was negative for low birth weight, underweight, stunting, wasting, minor injuries, moderate injuries, consanguineous marriage, child with disability, short birth spacing, and adolescent pregnancy indicating the disproportionate concentration of the health outcomes among the poor. On the other hand, CI was positive for preterm birth, Nonexclusive breastfeeding, severe injuries, incomplete health care, cesarean section, and advanced maternal age indicating opposite conclusion.
Conclusion: According to our results, there is a health inequality between the poor and the rich subgroups which may increase the risk of mothers and infant mortality and morbidity rates among the poor while the majority of the conditions related to the health outcomes are preventable.
Challenges in dental statistics: survey methodology topics
Authors: Pizzo Giuseppe , Milani Silvano , Spada Elena , Ottolenghi Livia 
Published: April 2023

This paper gathers some contributions concerning survey methodology in dental research, as discussed during the first Workshop of the SISMEC STATDENT working group on statistical methods and applications in dentistry, held in Ancona on the 28th September 2011.
The first contribution deals with the European Global Oral Health Indicators Development (EGOHID) Project which proposed a comprehensive and standardized system of epidemiological tools (questionnaires and clinical forms) for national data collection on oral health in Europe. The second contribution regards the design and conduct of trials to evaluate the clinical efficacy and safety of toothbrushes and mouthrinses. Finally, a flexible and effective tool used to trace dental age reference charts tailored to Italian children is presented.