Articles

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

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

RITS: a toolbox for assessing complex interventions via interrupted time series models

Various interacting and interdependent components comprise complex interventions. These components create difficulty in assessing the true impact of interventions designed to improve patient-centered outcomes....

Authors: Maricela Cruz, Marco A. Pinto-Orellana, Daniel L. Gillen and Hernando C. Ombao

Evaluating the relationship between citation set size, team size and screening methods used in systematic reviews: a cross-sectional study

Standard practice for conducting systematic reviews (SRs) is time consuming and involves the study team screening hundreds or thousands of citations. As the volume of medical literature grows, the citation set...

Authors: Katie O’Hearn, Cameron MacDonald, Anne Tsampalieros, Leo Kadota, Ryan Sandarage, Supun Kotteduwa Jayawarden, Michele Datko, John M. Reynolds, Thanh Bui, Shagufta Sultan, Margaret Sampson, Misty Pratt, Nick Barrowman, Nassr Nama, Matthew Page and James Dayre McNally

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

Managing overlap of primary study results across systematic reviews: practical considerations for authors of overviews of reviews

Overviews often identify and synthesise a large number of systematic reviews on the same topic, which is likely to lead to overlap (i.e. duplication) in primary studies across the reviews. Using a primary stud...

Authors: Carole Lunny, Dawid Pieper, Pierre Thabet and Salmaan Kanji

Consequences of ignoring clustering in linear regression

Clustering of observations is a common phenomenon in epidemiological and clinical research. Previous studies have highlighted the importance of using multilevel analysis to account for such clustering, but in ...

Authors: Georgia Ntani, Hazel Inskip, Clive Osmond and David Coggon

Comparing regression modeling strategies for predicting hometime

Hometime, the total number of days a person is living in the community (not in a healthcare institution) in a defined period of time after a hospitalization, is a patient-centred outcome metric increasingly us...

Authors: Jessalyn K. Holodinsky, Amy Y. X. Yu, Moira K. Kapral and Peter C. Austin

Bayesian updating: increasing sample size during the course of a study

A priori sample size calculation requires an a priori estimate of the size of the effect. An incorrect estimate may result in a sample size that is too low to detect effects or that is unnecessarily high. An a...

Authors: Mirjam Moerbeek

Noncollapsibility and its role in quantifying confounding bias in logistic regression

Confounding bias is a common concern in epidemiological research. Its presence is often determined by comparing exposure effects between univariable- and multivariable regression models, using an arbitrary thr...

Authors: Noah A. Schuster, Jos W. R. Twisk, Gerben ter Riet, Martijn W. Heymans and Judith J. M. Rijnhart

Risk prediction in multicentre studies when there is confounding by cluster or informative cluster size

Clustered data arise in research when patients are clustered within larger units. Generalised Estimating Equations (GEE) and Generalised Linear Models (GLMM) can be used to provide marginal and cluster-specifi...

Authors: Menelaos Pavlou, Gareth Ambler and Rumana Z. Omar

Comparison of six statistical methods for interrupted time series studies: empirical evaluation of 190 published series

The Interrupted Time Series (ITS) is a quasi-experimental design commonly used in public health to evaluate the impact of interventions or exposures. Multiple statistical methods are available to analyse data ...

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

Strengthening methods for tracking adaptations and modifications to implementation strategies

Developing effective implementation strategies requires adequate tracking and reporting on their application. Guidelines exist for defining and reporting on implementation strategy characteristics, but not for...

Authors: Amber D. Haley, Byron J. Powell, Callie Walsh-Bailey, Molly Krancari, Inga Gruß, Christopher M. Shea, Arwen Bunce, Miguel Marino, Leah Frerichs, Kristen Hassmiller Lich and Rachel Gold

Multiple imputation to quantify misclassification in observational studies of the cognitively impaired: an application for pain assessment in nursing home residents

Despite experimental evidence suggesting that pain sensitivity is not impaired by cognitive impairment, observational studies in nursing home residents have observed an inverse association between cognitive im...

Authors: Anthony P. Nunes, Danni Zhao, William M. Jesdale and Kate L. Lapane

The INSPIRE Population Survey: development, dissemination and respondent characteristics

Most older adults prefer to continue living at home despite increasing care needs and demand for services. To aid in maintaining independence, integrated care models for community-dwelling older people are pro...

Authors: Flaka Siqeca, Katrina Obas, Olivia Yip, Samuel Stenz, Penelope Vounatsou, Matthias Briel, Matthias Schwenkglenks, Carlos Quinto, Eva Blozik, Andreas Zeller, Leah L. Zullig, Sabina De Geest and Mieke Deschodt

How to analyze work productivity loss due to health problems in randomized controlled trials? A simulation study

An increasing number of randomized controlled trials (RCTs) have measured the impact of interventions on work productivity loss. Productivity loss outcome is inflated at zero and max loss values. Our study was...

Authors: Wei Zhang and Huiying Sun

Psychometric properties of instruments to measure parenting practices and children’s movement behaviors in low-income families from Brazil

Childhood obesity has increased remarkably in low and middle-income (LMIC) countries. Movement behaviors (physical activity, screen time, and sleep) are crucial in the development of overweight and obesity in ...

Authors: Widjane Sheila Ferreira Goncalves, Rebecca Byrne, Pedro Israel Cabral de Lira, Marcelo Tavares Viana and Stewart G. Trost

The minimal perceived change: a formal model of the responder definition according to the patient’s meaning of change for patient-reported outcome data analysis and interpretation

Patient-Reported Outcomes (PROs) are standardized questionnaires used to measure subjective outcomes such as quality of life in healthcare. They are considered paramount to assess the results of therapeutic in...

Authors: Antoine Vanier, Véronique Sébille, Myriam Blanchin and Jean-Benoit Hardouin

Development and validation of a risk index to predict kidney graft survival: the kidney transplant risk index

Kidney graft failure risk prediction models assist evidence-based medical decision-making in clinical practice. Our objective was to develop and validate statistical and machine learning predictive models to p...

Authors: Sameera Senanayake, Sanjeewa Kularatna, Helen Healy, Nicholas Graves, Keshwar Baboolal, Matthew P. Sypek and Adrian Barnett

Estimating age-specific COVID-19 fatality risk and time to death by comparing population diagnosis and death patterns: Australian data

Mortality is a key component of the natural history of COVID-19 infection. Surveillance data on COVID-19 deaths and case diagnoses are widely available in the public domain, but they are not used to model time...

Authors: Ian C. Marschner

A scoping review of Q-methodology in healthcare research

Q-methodology is an approach to studying complex issues of human ‘subjectivity’. Although this approach was developed in the early twentieth century, the value of Q-methodology in healthcare was not recognised...

Authors: Kate Churruca, Kristiana Ludlow, Wendy Wu, Kate Gibbons, Hoa Mi Nguyen, Louise A. Ellis and Jeffrey Braithwaite

Modelling hospital outcome: problems with endogeneity

Mortality modelling in the critical care paradigm traditionally uses logistic regression, despite the availability of estimators commonly used in alternate disciplines. Little attention has been paid to covari...

Authors: John L. Moran, John D. Santamaria and Graeme J. Duke

Most published meta-regression analyses based on aggregate data suffer from methodological pitfalls: a meta-epidemiological study

Due to clinical and methodological diversity, clinical studies included in meta-analyses often differ in ways that lead to differences in treatment effects across studies. Meta-regression analysis is generally...

Authors: Michael Geissbühler, Cesar A. Hincapié, Soheila Aghlmandi, Marcel Zwahlen, Peter Jüni and Bruno R. da Costa

Systematic review and meta analysis of differential attrition between active and control arms in randomized controlled trials of lifestyle interventions in chronic disease

Attrition is a major obstacle for lifestyle interventions sustained for the medium-to-long term and can have significant consequences on the internal validity of a trial. When the degree of attrition differs b...

Authors: Bevens W, Shoushtari A, Jelinek P, Jelinek GA and Weiland TJ

Development of a clinical tool for rating the body function categories of the ICF generic-30/rehabilitation set in Japanese rehabilitation practice and examination of its interrater reliability

The International Classification of Functioning, Disability, and Health (ICF) Generic-30 (Rehabilitation) Set is a tool used to assess the functioning of a clinical population in rehabilitation. The ICF Generi...

Authors: Yuki Senju, Masahiko Mukaino, Birgit Prodinger, Melissa Selb, Yuki Okouchi, Kouji Mizutani, Megumi Suzuki, Shin Yamada, Shin-Ichi Izumi, Shigeru Sonoda, Yohei Otaka, Eiichi Saitoh and Gerold Stucki

Delays in reporting and publishing trial results during pandemics: cross sectional analysis of 2009 H1N1, 2014 Ebola, and 2016 Zika clinical trials

Pandemic events often trigger a surge of clinical trial activity aimed at rapidly evaluating therapeutic or preventative interventions. Ensuring rapid public access to the complete and unbiased trial record is...

Authors: Christopher W. Jones, Amanda C. Adams, Elizabeth Murphy, Rachel P. King, Benjamin Saracco, Karen R. Stesis, Susan Cavanaugh, Brian W. Roberts and Timothy F. Platts-Mills

Social media attention and citations of published outputs from re-use of clinical trial data: a matched comparison with articles published in the same journals

Data-sharing policies in randomized clinical trials (RCTs) should have an evaluation component. The main objective of this case–control study was to assess the impact of published re-uses of RCT data in terms ...

Authors: N. Anthony, C. Pellen, C. Ohmann, D. Moher and F. Naudet

Strategies for assessing the impact of loss to follow-up on estimates of neurodevelopmental impairment in a very preterm cohort at 2 years of age

Loss to follow-up is a major challenge for very preterm (VPT) cohorts; attrition is associated with social disadvantage and parents with impaired children may participate less in research. We investigated the ...

Authors: Aurélie Piedvache, Stef van Buuren, Henrique Barros, Ana Isabel Ribeiro, Elizabeth Draper and Jennifer Zeitlin

Open science saves lives: lessons from the COVID-19 pandemic

In the last decade Open Science principles have been successfully advocated for and are being slowly adopted in different research communities. In response to the COVID-19 pandemic many publishers and research...

Authors: Lonni Besançon, Nathan Peiffer-Smadja, Corentin Segalas, Haiting Jiang, Paola Masuzzo, Cooper Smout, Eric Billy, Maxime Deforet and Clémence Leyrat

Discovering the underlying typology of emergency departments

We hypothesized that monitoring the volume of activity and overall performance indicators is not sufficient to understand the underlying differences between emergency departments. We aimed to understand the un...

Authors: Marine Demarquet, Laurie Fraticelli, Julie Freyssenge, Clément Claustre, Mikaël Martinez, Jonathan Duchenne, Carlos El Khoury, Abdesslam Redjaline and Karim Tazarourte

Validity of using mobile phone surveys to evaluate community health worker program in Mali

The monitoring and evaluation of public health programs based on traditional face-to-face interviews in hard-to-reach and unstable regions present many challenges. Mobile phone-based methods are considered to ...

Authors: Xiaomeng Chen, Diwakar Mohan, Abdoulaye Maïga, Emily Frost, Djeneba Coulibaly, Luay Basil, Birahim Yaguemar Gueye, Mariam Traore Guindo, Assa Sidibé Keita, Haoua Dembelé Keita and Melissa A. Marx

Incorporating single-arm studies in meta-analysis of randomised controlled trials: a simulation study

Use of real world data (RWD) from non-randomised studies (e.g. single-arm studies) is increasingly being explored to overcome issues associated with data from randomised controlled trials (RCTs). We aimed to c...

Authors: Janharpreet Singh, Keith R. Abrams and Sylwia Bujkiewicz

A method for assessing robustness of the results of a star-shaped network meta-analysis under the unidentifiable consistency assumption

In a star-shaped network, pairwise comparisons link treatments with a reference treatment (often placebo or standard care), but not with each other. Thus, comparisons between non-reference treatments rely on i...

Authors: Jeong-Hwa Yoon, Sofia Dias and Seokyung Hahn

An ego-centred approach for the evaluation of spatial effects on health in urban areas based on parametric semi-variogram models: concept and validation

Neighbourhood is a complex structure but of high relevance for health. Its operationalisation remains however a challenge.The aim of this work is to present a new application of the use of semi-variograms as a...

Authors: Odile Sauzet, Janne H. Breiding, Kim A. Zolitschka, Jürgen Breckenkamp and Oliver Razum

IPDfromKM: reconstruct individual patient data from published Kaplan-Meier survival curves

When applying secondary analysis on published survival data, it is critical to obtain each patient’s raw data, because the individual patient data (IPD) approach has been considered as the gold standard of dat...

Authors: Na Liu, Yanhong Zhou and J. Jack Lee

Randomized test-treatment studies with an outlook on adaptive designs

Diagnostic accuracy studies aim to examine the diagnostic accuracy of a new experimental test, but do not address the actual merit of the resulting diagnostic information to a patient in clinical practice. In ...

Authors: Amra Hot, Patrick M. Bossuyt, Oke Gerke, Simone Wahl, Werner Vach and Antonia Zapf