Articles

An improved method for the effect estimation of the intermediate event on the outcome based on the susceptible pre-identification

In follow-up studies, the occurrence of the intermediate event may influence the risk of the outcome of interest. Existing methods estimate the effect of the intermediate event by including a time-varying cova...

Authors: Haixia Hu, Ling Wang, Chen Li, Wei Ge and Jielai Xia

Mitigating selection bias in organ allocation models

The lung allocation system in the U.S. prioritizes lung transplant candidates based on estimated pre- and post-transplant survival via the Lung Allocation Scores (LAS). However, these models do not account for...

Authors: Erin M. Schnellinger, Edward Cantu III, Michael O. Harhay, Douglas E. Schaubel, Stephen E. Kimmel and Alisa J. Stephens-Shields

Minimizing bias in massive multi-arm observational studies with BCAUS: balancing covariates automatically using supervision

Observational studies are increasingly being used to provide supplementary evidence in addition to Randomized Control Trials (RCTs) because they provide a scale and diversity of participants and outcomes that ...

Authors: Chinmay Belthangady, Will Stedden and Beau Norgeot

Conducting proportional meta-analysis in different types of systematic reviews: a guide for synthesisers of evidence

Single group data present unique challenges for synthesises of evidence. Proportional meta-analysis is becoming an increasingly common technique employed for the synthesis of single group data. Proportional me...

Authors: Timothy Hugh Barker, Celina Borges Migliavaca, Cinara Stein, Verônica Colpani, Maicon Falavigna, Edoardo Aromataris and Zachary Munn

Patient-centered infertility questionnaire for female clients (PCIQ-F): part I: questionnaire development

Patient-centered care is an essential component of health care quality. To achieve patient-centered care, health care authorities should have a clear definition and an applicable tool to measure the extent of ...

Authors: Hana Hasan Webair, Tengku Alina Tengku Ismail, Shaiful Bahari Ismail, Azza Jameel Khaffaji, Nik Hazlina Nik Hussain, Azidah Abdul Kadir, Rosediani Muhamad, Fatin Aina Abu Bakar, Nur Raihan Ismail and Nagwa Badri

Clinical researchers’ lived experiences with data quality monitoring in clinical trials: a qualitative study

Fundamental to the success of clinical research that involves human participants is the quality of the data that is generated. To ensure data quality, clinical trials must comply with the Good Clinical Practic...

Authors: Lauren Houston, Ping Yu, Allison Martin and Yasmine Probst

A Bayesian latent class mixture model with censoring for correlation analysis in antimicrobial resistance across populations

The emergence of antimicrobial resistance across populations is a global threat to public health. Surveillance programs often monitor human and animal populations to evaluate trends of emergence in these popul...

Authors: Min Zhang, Chong Wang and Annette M. O’Connor

Strategies to maximise study retention and limit attrition bias in a prospective cohort study of men reporting a history of injecting drug use released from prison: the prison and transition health study

There are significant challenges associated with studies of people released from custodial settings, including loss to follow-up in the community. Interpretation of findings with consideration of differences b...

Authors: Ashleigh Cara Stewart, Reece Cossar, Shelley Walker, Anna Lee Wilkinson, Brendan Quinn, Paul Dietze, Rebecca Winter, Amy Kirwan, Michael Curtis, James R. P. Ogloff, Stuart Kinner, Campbell Aitken, Tony Butler, Emma Woods and Mark Stoové

A meta-review demonstrates improved reporting quality of qualitative reviews following the publication of COREQ- and ENTREQ-checklists, regardless of modest uptake

Reviews of qualitative studies allow for deeper understanding of concepts and findings beyond the single qualitative studies. Concerns on study reporting quality led to the publication of the COREQ-guidelines ...

Authors: Y. de Jong, E. M. van der Willik, J. Milders, C. G. N. Voorend, Rachael L. Morton, F. W. Dekker, Y. Meuleman and M. van Diepen

Applying a novel approach to scoping review incorporating artificial intelligence: mapping the natural history of gonorrhoea

Systematic and scoping literature searches are increasingly resource intensive. We present the results of a scoping review which combines the use of a novel artificial-intelligence-(AI)-assisted Medline search...

Authors: Jane Whelan, Mohammad Ghoniem, Nicolas Médoc, Mike Apicella and Ekkehard Beck

Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT)

Healthcare decisions are ideally based on clinical trial results, published in study registries, as journal articles or summarized in secondary research articles. In this research project, we investigated the ...

Authors: Anette Blümle, Katharina Wollmann, Karin Bischoff, Philipp Kapp, Szimonetta Lohner, Edris Nury, Kai Nitschke, Jasmin Zähringer, Gerta Rücker and Martin Schumacher

Evaluation of statistical methods used in the analysis of interrupted time series studies: a simulation study

Interrupted time series (ITS) studies are frequently used to evaluate the effects of population-level interventions or exposures. However, examination of the performance of statistical methods for this design ...

Authors: Simon L. Turner, Andrew B. Forbes, Amalia Karahalios, Monica Taljaard and Joanne E. McKenzie

Evaluating the impact of covariate lookback times on performance of patient-level prediction models

The goal of our study is to examine the impact of the lookback length when engineering features to use in developing predictive models using observational healthcare data. Using a longer lookback for feature e...

Authors: Jill Hardin and Jenna M. Reps

Predicting postoperative surgical site infection with administrative data: a random forests algorithm

Since primary data collection can be time-consuming and expensive, surgical site infections (SSIs) could ideally be monitored using routinely collected administrative data. We derived and internally validated ...

Authors: Yelena Petrosyan, Kednapa Thavorn, Glenys Smith, Malcolm Maclure, Roanne Preston, Carl van Walravan and Alan J. Forster

Recruitment principles and strategies for supportive care research in pediatric oncology

Variations in clinical practice contribute to negative outcomes for children with cancer. Research in this area is imperative to standardise practice, yet such research is challenging to undertake, and a signi...

Authors: Natalie Bradford, Christine Cashion, Paula Condon, Shelley Rumble and Alison Bowers

Impact of a non-constant baseline hazard on detection of time-dependent treatment effects: a simulation study

Non-proportional hazards are common with time-to-event data but the majority of randomised clinical trials (RCTs) are designed and analysed using approaches which assume the treatment effect follows proportion...

Authors: Kim Jachno, Stephane Heritier and Rory Wolfe

The effect of home visits as an additional recruitment step on the composition of the final sample: a cross-sectional analysis in two study centers of the German National Cohort (NAKO)

Participation in epidemiologic studies has been declining over the last decades. In addition to postal invitations and phone calls, home visits can be conducted to increase participation. The aim of this study...

Authors: Lilian Krist, Ahmed Bedir, Julia Fricke, Alexander Kluttig and Rafael Mikolajczyk

Use of research electronic data capture (REDCap) in a COVID-19 randomized controlled trial: a practical example

Randomized controlled trials (RCT) are considered the ideal design for evaluating the efficacy of interventions. However, conducting a successful RCT has technological and logistical challenges. Defects in ran...

Authors: Sina Kianersi, Maya Luetke, Christina Ludema, Alexander Valenzuela and Molly Rosenberg

Correction to: Applied comparison of large-scale propensity score matching and cardinality matching for causal inference in observational research

Authors: Stephen P. Fortin, Stephen S. Johnston and Martijn J. Schuemie

Two-stage sampling in the estimation of growth parameters and percentile norms: sample weights versus auxiliary variable estimation

The use of auxiliary variables with maximum likelihood parameter estimation for surveys that miss data by design is not a widespread approach, despite its documented improved efficiency over traditional approa...

Authors: George Vamvakas, Courtenay Norbury and Andrew Pickles

Using web conferencing to engage Aboriginal and Torres Strait Islander young people in research: a feasibility study

While web conferencing technologies are being widely used in communication and collaboration, their uptake in conducting research field work has been relatively slow. The benefits that these technologies offer...

Authors: Kate Anderson, Alana Gall, Tamara Butler, Brian Arley, Kirsten Howard, Alan Cass and Gail Garvey

Bayesian Hodges-Lehmann tests for statistical equivalence in the two-sample setting: Power analysis, type I error rates and equivalence boundary selection in biomedical research

Null hypothesis significance testing (NHST) is among the most frequently employed methods in the biomedical sciences. However, the problems of NHST and p-values have been discussed widely and various Bayesian alt...

Authors: Riko Kelter

Modeling of atrophy size trajectories: variable transformation, prediction and age-of-onset estimation

To model the progression of geographic atrophy (GA) in patients with age-related macular degeneration (AMD) by building a suitable statistical regression model for GA size measurements obtained from fundus aut...

Authors: Charlotte Behning, Monika Fleckenstein, Maximilian Pfau, Christine Adrion, Lukas Goerdt, Moritz Lindner, Steffen Schmitz-Valckenberg, Frank G Holz and Matthias Schmid

Creating efficiencies in the extraction of data from randomized trials: a prospective evaluation of a machine learning and text mining tool

Machine learning tools that semi-automate data extraction may create efficiencies in systematic review production. We evaluated a machine learning and text mining tool’s ability to (a) automatically extract da...

Authors: Allison Gates, Michelle Gates, Shannon Sim, Sarah A. Elliott, Jennifer Pillay and Lisa Hartling

A roadmap to using randomization in clinical trials

Randomization is the foundation of any clinical trial involving treatment comparison. It helps mitigate selection bias, promotes similarity of treatment groups with respect to important known and unknown confo...

Authors: Vance W. Berger, Louis Joseph Bour, Kerstine Carter, Jonathan J. Chipman, Colin C. Everett, Nicole Heussen, Catherine Hewitt, Ralf-Dieter Hilgers, Yuqun Abigail Luo, Jone Renteria, Yevgen Ryeznik, Oleksandr Sverdlov and Diane Uschner

Evaluation of a geriatrics primary care model using prospective matching to guide enrollment

Few definitive guidelines exist for rigorous large-scale prospective evaluation of nonrandomized programs and policies that require longitudinal primary data collection. In Veterans Affairs (VA) we identified ...

Authors: Valerie A. Smith, Courtney Harold Van Houtven, Jennifer H. Lindquist and Susan N. Hastings

Symptom clusters among cancer survivors: what can machine learning techniques tell us?

Knowledge regarding symptom clusters may inform targeted interventions. The current study investigated symptom clusters among cancer survivors, using machine learning techniques on a large data set.

Authors: Koen I. Neijenhuijs, Carel F. W. Peeters, Henk van Weert, Pim Cuijpers and Irma Verdonck-de Leeuw

Negative SARS-CoV-2 PCR or rapid antigen test result and the subsequent risk of being infectious: a mathematical simulation study

A considerable proportion of SARS-CoV-2 transmission occurs from asymptomatic and pre-symptomatic cases. Therefore, different polymerase chain reaction (PCR)- or rapid antigen test (RAT)-based approaches are b...

Authors: Ralf Krumkamp, Benno Kreuels, Veronika K. Jaeger, Jürgen May, Rafael Mikolajczyk and André Karch

Quantifying and communicating the burden of COVID-19

An essential aspect of preventing further COVID-19 outbreaks and to learn for future pandemics is the evaluation of different political strategies, which aim at reducing transmission of and mortality due to CO...

Authors: Maja von Cube, Jéan-Francois Timsit, Andreas Kammerlander and Martin Schumacher

Hospital workers mental health during the COVID-19 pandemic: methods of data collection and characteristics of study sample in a university hospital in Milan (Italy)

The COVID-19 pandemic is currently a severe challenge for healthcare workers, with a considerable impact on their mental health. In order to focus preventive and rehabilitation measures it’s fundamental to ide...

Authors: A Fattori, F Cantù, A Comotti, V Tombola, E Colombo, C Nava, L Bordini, L Riboldi, M Bonzini and P Brambilla

Comparison of prevalence and exposure-disease associations using self-report and hospitalization data among enrollees of the world trade center health registry

Although many studies have investigated agreement between survey and hospitalization data for disease prevalence, it is unknown whether exposure-chronic disease associations vary based on data collection metho...

Authors: Howard E. Alper, Jennifer Brite, James E. Cone and Robert M. Brackbill

Predisposing factors of long-term responsiveness in a cardio-metabolic cohort: Tehran Lipid and Glucose Study

Non-participation in cohort studies, if associated with both the exposure and occurrence of the event, can introduce bias in the estimates of interest. This study aims to identify factors associated with follo...

Authors: Leila Cheraghi, Parisa Amiri, Golnaz Vahedi-Notash, Sara Jalali-Farahani, Davood Khalili and Fereidoun Azizi

Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach

Data monitoring of clinical trials is a tool aimed at reducing the risks of random errors (e.g. clerical errors) and systematic errors, which include misinterpretation, misunderstandings, and fabrication. Trad...

Authors: Markus Harboe Olsen, Mathias Lühr Hansen, Sanam Safi, Janus Christian Jakobsen, Gorm Greisen and Christian Gluud

Use of machine learning techniques to identify HIV predictors for screening in sub-Saharan Africa

HIV prevention measures in sub-Saharan Africa are still short of attaining the UNAIDS 90–90-90 fast track targets set in 2014. Identifying predictors for HIV status may facilitate targeted screening interventi...

Authors: Charles K. Mutai, Patrick E. McSharry, Innocent Ngaruye and Edouard Musabanganji

Machine learning in medicine: a practical introduction to natural language processing

Unstructured text, including medical records, patient feedback, and social media comments, can be a rich source of data for clinical research. Natural language processing (NLP) describes a set of techniques us...

Authors: Conrad J. Harrison and Chris J. Sidey-Gibbons

A new method for testing reproducibility in systematic reviews was developed, but needs more testing

To develop and test an approach to test reproducibility of SRs.

Authors: Dawid Pieper, Simone Heß and Clovis Mariano Faggion Jr.

Correction to: How to specify healthcare process improvements collaboratively using rapid, remote consensus-building: a frame work and a case study of its application

Authors: Jan W. van der Scheer, Matthew Woodward, Akbar Ansari, Tim Draycott, Cathy Winter, Graham Martin, Karolina Kuberska, Natalie Richards, Ruth Kern and Mary Dixon-Woods

A new hybrid record linkage process to make epidemiological databases interoperable: application to the GEMO and GENEPSO studies involving BRCA1 and BRCA2 mutation carriers

Linking independent sources of data describing the same individuals enable innovative epidemiological and health studies but require a robust record linkage approach. We describe a hybrid record linkage proces...

Authors: Yue Jiao, Fabienne Lesueur, Chloé-Agathe Azencott, Maïté Laurent, Noura Mebirouk, Lilian Laborde, Juana Beauvallet, Marie-Gabrielle Dondon, Séverine Eon-Marchais, Anthony Laugé, Catherine Noguès, Nadine Andrieu, Dominique Stoppa-Lyonnet and Sandrine M. Caputo

Overcoming the problems caused by collinearity in mixed-effects logistic model: determining the contribution of various types of violence on depression in pregnant women

Collinearity is a common and problematic phenomenon in studies on public health. It leads to inflation in variance of estimator and reduces test power. This phenomenon can occur in any model. In this study, a ...

Authors: Sanaz Khalili, Javad Faradmal, Hossein Mahjub, Babak Moeini and Khadijeh Ezzati-Rastegar

A multiyear systematic survey of the quality of reporting for randomised trials in dentistry, neurology and geriatrics published in journals of Spain and Latin America

The Iberoamerican Cochrane Network is currently developing an extensive project to identify Spanish-language journals that publish original clinical research in Spain and Latin America. The project is called B...

Authors: Vivienne C. Bachelet, María S. Navarrete, Constanza Barrera-Riquelme, Víctor A. Carrasco, Matías Dallaserra, Rubén A. Díaz, Álvaro A. Ibarra, Francisca J. Lizana, Nicolás Meza-Ducaud, Macarena G. Saavedra, Camila Tapia-Davegno, Alonso F. Vergara and Julio Villanueva

Characteristics and practices of school-based cluster randomised controlled trials for improving health outcomes in pupils in the United Kingdom: a methodological systematic review

Cluster randomised trials (CRTs) are increasingly used to evaluate non-pharmacological interventions for improving child health. Although methodological challenges of CRTs are well documented, the characterist...

Authors: Kitty Parker, Michael Nunns, ZhiMin Xiao, Tamsin Ford and Obioha C. Ukoumunne

High performance implementation of the hierarchical likelihood for generalized linear mixed models: an application to estimate the potassium reference range in massive electronic health records datasets

Converting electronic health record (EHR) entries to useful clinical inferences requires one to address the poor scalability of existing implementations of Generalized Linear Mixed Models (GLMM) for repeated m...

Authors: Cristian G. Bologa, Vernon Shane Pankratz, Mark L. Unruh, Maria Eleni Roumelioti, Vallabh Shah, Saeed Kamran Shaffi, Soraya Arzhan, John Cook and Christos Argyropoulos

Statistical analysis of two arm randomized pre-post designs with one post-treatment measurement

Randomized pre-post designs, with outcomes measured at baseline and after treatment, have been commonly used to compare the clinical effectiveness of two competing treatments. There are vast, but often conflic...

Authors: Fei Wan

Assessing the risk of performance and detection bias in Cochrane reviews as a joint domain is less accurate compared to two separate domains

Initially, the Cochrane risk of bias (RoB) tool had a domain for “blinding of participants, personnel and outcome assessors”. In the 2011 tool, the assessment of blinding was split into two domains: blinding o...

Authors: Ognjen Barcot, Matija Boric, Svjetlana Dosenovic and Livia Puljak

Multivariate meta-analysis of critical care meta-analyses: a meta-epidemiological study

Meta-analyses typically consider multiple outcomes and report univariate effect sizes considered as independent. Multivariate meta-analysis (MVMA) incorporates outcome correlation and synthesises direct eviden...

Authors: John L. Moran

Need of care in interpreting Google Trends-based COVID-19 infodemiological study results: potential risk of false-positivity

Google Trends (GT) is being used as an epidemiological tool to study coronavirus disease (COVID-19) by identifying keywords in search trends that are predictive for the COVID-19 epidemiological burden. However...

Authors: Kenichiro Sato, Tatsuo Mano, Atsushi Iwata and Tatsushi Toda

Absolute mortality risk assessment of COVID-19 patients: the Khorshid COVID Cohort (KCC) study

Already at hospital admission, clinicians require simple tools to identify hospitalized COVID-19 patients at high risk of mortality. Such tools can significantly improve resource allocation and patient managem...

Authors: Hamid Reza Marateb, Maja von Cube, Ramin Sami, Shaghayegh Haghjooy Javanmard, Marjan Mansourian, Babak Amra, Forogh Soltaninejad, Mojgan Mortazavi, Peyman Adibi, Nilufar Khademi, Nastaran Sadat Hosseini, Arash Toghyani, Razieh Hassannejad, Miquel Angel Mañanas, Harald Binder and Martin Wolkewitz

Survey design and analysis considerations when utilizing misclassified sampling strata

A large multi-center survey was conducted to understand patients’ perspectives on biobank study participation with particular focus on racial and ethnic minorities. In order to enrich the study sample with rac...

Authors: Aya A. Mitani, Nathaniel D. Mercaldo, Sebastien Haneuse and Jonathan S. Schildcrout

A new likelihood model for analyses of pharmacoepidemiologic case–control studies which avoids decision rules for determining latent exposure status

Case–control studies based on pharmaco-epidemiological databases typically use decision rules to determine exposure status from information on dates of prescription redemptions, although this induces misclassi...

Authors: Henrik Støvring, Anton Pottegård and Jesper Hallas

Translation, transcultural adaptation and validation to Brazilian Portuguese of tools for adverse drug reaction assessment in children

Children are more vulnerable to adverse drug reactions (ADRs) due to complex changes in the body during the growth process and lack specific pharmacoepidemiologic studies. Causality and Avoidability assessment...

Authors: Elisangela da Costa Lima, Thais de Barros Fernandes, Adair Freitas, Juliana Freire de Lima Sias, Marcelo Gerardin Poirot Land, Mariana Tschoepke Aires, Louise Bracken and Matthew Peak