Articles

A systematic review of studies with a representative sample of refugees and asylum seekers living in the community for participation in mental health research

The aim was to review the literature to identify the most effective methods for creating a representative sample of refugee and asylum seeker groups living in the community to participate in health and mental ...

Authors: Joanne C. Enticott, Frances Shawyer, Shiva Vasi, Kimberly Buck, I-Hao Cheng, Grant Russell, Ritsuko Kakuma, Harry Minas and Graham Meadows

Leveraging the EHR4CR platform to support patient inclusion in academic studies: challenges and lessons learned

The development of Electronic Health Records (EHRs) in hospitals offers the ability to reuse data from patient care activities for clinical research. EHR4CR is a European public-private partnership aiming to d...

Authors: Yannick Girardeau, Justin Doods, Eric Zapletal, Gilles Chatellier, Christel Daniel, Anita Burgun, Martin Dugas and Bastien Rance

Research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions

The most rigorous method for evaluating the effectiveness of diagnostic tests is through randomised trials that compare test-treatment interventions: complex interventions comprising episodes of testing, decis...

Authors: Lavinia Ferrante di Ruffano, Jacqueline Dinnes, Sian Taylor-Phillips, Clare Davenport, Chris Hyde and Jonathan J. Deeks

Test-treatment RCTs are susceptible to bias: a review of the methodological quality of randomized trials that evaluate diagnostic tests

There is a growing recognition for the need to expand our evidence base for the clinical effectiveness of diagnostic tests. Many international bodies are calling for diagnostic randomized controlled trials to ...

Authors: Lavinia Ferrante di Ruffano, Jacqueline Dinnes, Alice J. Sitch, Chris Hyde and Jonathan J. Deeks

Performance of Firth-and logF-type penalized methods in risk prediction for small or sparse binary data

When developing risk models for binary data with small or sparse data sets, the standard maximum likelihood estimation (MLE) based logistic regression faces several problems including biased or infinite estima...

Authors: M. Shafiqur Rahman and Mahbuba Sultana

Erratum to: Exploring functional data analysis and wavelet principal component analysis on ecstasy (MDMA) wastewater data

Authors: Stefania Salvatore, Jørgen G. Bramness and Jo Røislien

A statistical method utilizing information of imported cases to estimate the transmissibility for an influenza pandemic

In a new influenza pandemic, travel data such as arrival times of cases seeded by the originating country can be regarded as a combination of the epidemic size and the mobility networks of infections connectin...

Authors: Ka Chun Chong, Benny Chung Ying Zee and Maggie Haitian Wang

Participant retention practices in longitudinal clinical research studies with high retention rates

There is a need for improving cohort retention in longitudinal studies. Our objective was to identify cohort retention strategies and implementation approaches used in studies with high retention rates.

Authors: Martha Abshire, Victor D. Dinglas, Maan Isabella A. Cajita, Michelle N. Eakin, Dale M. Needham and Cheryl Dennison Himmelfarb

Estimation of treatment preference effects in clinical trials when some participants are indifferent to treatment choice

In the two-stage randomised trial design, a randomly sampled subset of study participants are permitted to choose their own treatment, while the remaining participants are randomised to treatment in the usual ...

Authors: Stephen D. Walter, Robin M. Turner, Petra Macaskill, Kirsten J. McCaffery and Les Irwig

A comparison of analytic approaches for individual patient data meta-analyses with binary outcomes

Individual patient data meta-analyses (IPD-MA) are often performed using a one-stage approach-- a form of generalized linear mixed model (GLMM) for binary outcomes. We compare (i) one-stage to two-stage approa...

Authors: Doneal Thomas, Robert Platt and Andrea Benedetti

On the censored cost-effectiveness analysis using copula information

Information and theory beyond copula concepts are essential to understand the dependence relationship between several marginal covariates distributions. In a therapeutic trial data scheme, most of the time, ce...

Authors: Charles Fontaine, Jean-Pierre Daurès and Paul Landais

Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned

In spite of efforts to employ risk-based strategies to increase monitoring efficiency in the academic setting, empirical evidence on their effectiveness remains sparse. This mixed-methods study aimed to evalua...

Authors: Belinda von Niederhäusern, Annette Orleth, Sabine Schädelin, Nawal Rawi, Martin Velkopolszky, Claudia Becherer, Pascal Benkert, Priya Satalkar, Matthias Briel and Christiane Pauli-Magnus

Self-controlled designs in pharmacoepidemiology involving electronic healthcare databases: a systematic review

Observational studies are widely used in pharmacoepidemiology. Several designs can be used, in particular self-controlled designs (case-crossover and self-controlled case series). These designs offer the advan...

Authors: Nathalie Gault, Johann Castañeda-Sanabria, Yann De Rycke, Sylvie Guillo, Stéphanie Foulon and Florence Tubach

Utilising identifier error variation in linkage of large administrative data sources

Linkage of administrative data sources often relies on probabilistic methods using a set of common identifiers (e.g. sex, date of birth, postcode). Variation in data quality on an individual or organisational ...

Authors: Katie Harron, Gareth Hagger-Johnson, Ruth Gilbert and Harvey Goldstein

Testing a systematic approach to identify and prioritise barriers to successful implementation of a complex healthcare intervention

Multiple barriers may inhibit the adoption of clinical interventions and impede successful implementation. Use of standardised methods to prioritise barriers to target when selecting implementation interventio...

Authors: Louise E. Craig, Leonid Churilov, Liudmyla Olenko, Dominique A. Cadilhac, Rohan Grimley, Simeon Dale, Cintia Martinez-Garduno, Elizabeth McInnes, Julie Considine, Jeremy M. Grimshaw and Sandy Middleton

Efficient confidence limits for adaptive one-arm two-stage clinical trials with binary endpoints

Recently, several adaptive one-arm two-stage designs have been developed by fully using the information from previous stages to reduce the expected sample size in clinical trials with binary endpoints as prima...

Authors: Guogen Shan, Hua Zhang and Tao Jiang

What impact do assumptions about missing data have on conclusions? A practical sensitivity analysis for a cancer survival registry

Within epidemiological and clinical research, missing data are a common issue and often over looked in publications. When the issue of missing observations is addressed it is usually assumed that the missing d...

Authors: M. Smuk, J. R. Carpenter and T. P. Morris

Impact of communities, health, and emotional-related factors on smoking use: comparison of joint modeling of mean and dispersion and Bayes’ hierarchical models on add health survey

The analysis of correlated binary data is commonly addressed through the use of conditional models with random effects included in the systematic component as opposed to generalized estimating equations (GEE) ...

Authors: Jie Pu, Di Fang and Jeffrey R. Wilson

Motivations for (non)participation in population-based health studies among the elderly – comparison of participants and nonparticipants of a prospective study on influenza vaccination

Participation in epidemiological studies has strongly declined in recent years. We examined the reasons for (non)participation in population-based health studies among participants and nonparticipants of a pro...

Authors: Manas K. Akmatov, Leonhard Jentsch, Peggy Riese, Marcus May, Malik W. Ahmed, Damaris Werner, Anja Rösel, Jana Prokein, Inga Bernemann, Norman Klopp, Blair Prochnow, Thomas Illig, Christoph Schindler, Carlos A. Guzman and Frank Pessler

Erratum to: A threshold method for immunological correlates of protection

Authors: Xuan Chen, Fabrice Bailleux, Kamal Desai, Li Qin and Andrew J. Dunning

Evaluation of biases present in the cohort multiple randomised controlled trial design: a simulation study

The cohort multiple randomised controlled trial (cmRCT) design provides an opportunity to incorporate the benefits of randomisation within clinical practice; thus reducing costs, integrating electronic healthc...

Authors: Jane Candlish, Alexander Pate, Matthew Sperrin and Tjeerd van Staa

Assessing and adjusting for non-response in the Millennium Cohort Family Study

In conducting population-based surveys, it is important to thoroughly examine and adjust for potential non-response bias to improve the representativeness of the sample prior to conducting analyses of the data...

Authors: Nida H. Corry, Christianna S. Williams, Mike Battaglia, Hope Seib McMaster and Valerie A. Stander

Psychometric analysis of the brief symptom inventory 18 (BSI-18) in a representative German sample

The BSI-18 contains the three six-item scales somatization, depression, and anxiety as well as the Global Severity Index (GSI), including all 18 items. The BSI-18 is the latest and shortest of the multidimensi...

Authors: Gabriele Helga Franke, Susanne Jaeger, Heide Glaesmer, Claus Barkmann, Katja Petrowski and Elmar Braehler

Estimating the size of the homeless adolescent population across seven cities in Cambodia

The Government of Cambodia has committed to supporting family care for vulnerable children, including homeless populations. Collecting baseline data on the numbers and characteristics of homeless adolescents w...

Authors: Lindsay Stark, Beth L. Rubenstein, Kimchoeun Pak, Rosemary Taing, Gary Yu, Sok Kosal and Leslie Roberts

Measuring health-related quality of life in cervical cancer patients: a systematic review of the most used questionnaires and their validity

Data on health-related quality of life (HRQoL) is paramount for shared and evidence based decision-making. Since an overview of cervical cancer HRQoL tools and their validity appears to be lacking, we performe...

Authors: Casper Tax, Marlie E. Steenbergen, Petra L. M. Zusterzeel, Ruud L. M. Bekkers and Maroeska M. Rovers

Ridle for sparse regression with mandatory covariates with application to the genetic assessment of histologic grades of breast cancer

Many questions in statistical genomics can be formulated in terms of variable selection of candidate biological factors for modeling a trait or quantity of interest. Often, in these applications, additional co...

Authors: Jing Zhai, Chiu-Hsieh Hsu and Z. John Daye

Multiple triangulation and collaborative research using qualitative methods to explore decision making in pre-hospital emergency care

Paramedics make important and increasingly complex decisions at scene about patient care. Patient safety implications of influences on decision making in the pre-hospital setting were previously under-research...

Authors: Maxine Johnson, Rachel O’Hara, Enid Hirst, Andrew Weyman, Janette Turner, Suzanne Mason, Tom Quinn, Jane Shewan and A. Niroshan Siriwardena

Estimating cardiovascular disease incidence from prevalence: a spreadsheet based model

Disease incidence and prevalence are both core indicators of population health. Incidence is generally not as readily accessible as prevalence. Cohort studies and electronic health record systems are two major...

Authors: Xue Feng Hu, Kue Young and Hing Man Chan

Comparison of methods for estimating the attributable risk in the context of survival analysis

The attributable risk (AR) measures the proportion of disease cases that can be attributed to an exposure in the population. Several definitions and estimation methods have been proposed for survival data.

Authors: Malamine Gassama, Jacques Bénichou, Laureen Dartois and Anne C. M. Thiébaut

Erratum to: Sample size calculations for cluster randomised controlled trials with a fixed number of clusters

Authors: Karla Hemming, Alan J Girling, Alice J Sitch, Jennifer Marsh and Richard J Lilford

Estimating a population cumulative incidence under calendar time trends

The risk of a disease or psychiatric disorder is frequently measured by the age-specific cumulative incidence. Cumulative incidence estimates are often derived in cohort studies with individuals recruited over...

Authors: Stefan N. Hansen, Morten Overgaard, Per K. Andersen and Erik T. Parner

A double SIMEX approach for bivariate random-effects meta-analysis of diagnostic accuracy studies

Bivariate random-effects models represent a widely accepted and recommended approach for meta-analysis of test accuracy studies. Standard likelihood methods routinely used for inference are prone to several dr...

Authors: Annamaria Guolo

Development of a Microsoft Excel tool for one-parameter Rasch model of continuous items: an application to a safety attitude survey

Many continuous item responses (CIRs) are encountered in healthcare settings, but no one uses item response theory’s (IRT) probabilistic modeling to present graphical presentations for interpreting CIR results...

Authors: Tsair-Wei Chien, Yang Shao and Shu-Chun Kuo

Centralising and optimising decentralised stroke care systems: a simulation study on short-term costs and effects

Centralisation of thrombolysis may offer substantial benefits. The aim of this study was to assess short term costs and effects of centralisation of thrombolysis and optimised care in a decentralised system.

Authors: Maarten M. H. Lahr, Durk-Jouke van der Zee, Gert-Jan Luijckx, Patrick C. A. J. Vroomen and Erik Buskens

Outcome-sensitive multiple imputation: a simulation study

Multiple imputation is frequently used to deal with missing data in healthcare research. Although it is known that the outcome should be included in the imputation model when imputing missing covariate values,...

Authors: Evangelos Kontopantelis, Ian R. White, Matthew Sperrin and Iain Buchan

G-computation of average treatment effects on the treated and the untreated

Average treatment effects on the treated (ATT) and the untreated (ATU) are useful when there is interest in: the evaluation of the effects of treatments or interventions on those who received them, the presenc...

Authors: Aolin Wang, Roch A. Nianogo and Onyebuchi A. Arah

Clinical prediction in defined populations: a simulation study investigating when and how to aggregate existing models

Clinical prediction models (CPMs) are increasingly deployed to support healthcare decisions but they are derived inconsistently, in part due to limited data. An emerging alternative is to aggregate existing CP...

Authors: Glen P. Martin, Mamas A. Mamas, Niels Peek, Iain Buchan and Matthew Sperrin

Can longitudinal generalized estimating equation models distinguish network influence and homophily? An agent-based modeling approach to measurement characteristics

Connected individuals (or nodes) in a network are more likely to be similar than two randomly selected nodes due to homophily and/or network influence. Distinguishing between these two influences is an importa...

Authors: Kori Sauser Zachrison, Theodore J. Iwashyna, Achamyeleh Gebremariam, Meghan Hutchins and Joyce M Lee

Multiple and mixed methods in formative evaluation: Is more better? Reflections from a South African study

Formative programme evaluations assess intervention implementation processes, and are seen widely as a way of unlocking the ‘black box’ of any programme in order to explore and understand why a programme funct...

Authors: Willem Odendaal, Salla Atkins and Simon Lewin

A comparative study: classification vs. user-based collaborative filtering for clinical prediction

Recommender systems have shown tremendous value for the prediction of personalized item recommendations for individuals in a variety of settings (e.g., marketing, e-commerce, etc.). User-based collaborative fi...

Authors: Fang Hao and Rachael Hageman Blair

Inter-rater reliability of the QuIS as an assessment of the quality of staff-inpatient interactions

Recent studies of the quality of in-hospital care have used the Quality of Interaction Schedule (QuIS) to rate interactions observed between staff and inpatients in a variety of ward conditions. The QuIS was d...

Authors: Ines Mesa-Eguiagaray, Dankmar Böhning, Chris McLean, Peter Griffiths, Jackie Bridges and Ruth M Pickering

Sexual Health questions included in the Health Behaviour in School-aged Children (HBSC) Study: an international methodological pilot investigation

This paper describes the methodological developments of the sexual health items included in the Health Behaviour in School-aged Children (HBSC) study since their mandatory inclusion in the study in 2002. The c...

Authors: Honor Young, András Költő, Marta Reis, Elizabeth M. Saewyc, Nathalie Moreau, Lorraine Burke, Alina Cosma, Béat Windlin, Saoirse Nic Gabhainn and Emmanuelle Godeau

Joint models for longitudinal and time-to-event data: a review of reporting quality with a view to meta-analysis

Joint models for longitudinal and time-to-event data are commonly used to simultaneously analyse correlated data in single study cases. Synthesis of evidence from multiple studies using meta-analysis is a natu...

Authors: Maria Sudell, Ruwanthi Kolamunnage-Dona and Catrin Tudur-Smith

Erratum to: Assessment of predictive performance in incomplete data by combining internal validation and multiple imputation

Authors: Simone Wahl, Anne-Laure Boulesteix, Astrid Zierer, Barbara Thorand and Mark A. van de Wiel

ImpRess: an Implementation Readiness checklist developed using a systematic review of randomised controlled trials assessing cognitive stimulation for dementia

Research reporting results of clinical trials, psychosocial or technological interventions frequently omit critical details needed to inform implementation in practice. The aim of this article is to develop an...

Authors: Amy Streater, Aimee Spector, Elisa Aguirre, Jacki Stansfeld and Martin Orrell

Drug*placebo interaction effect may bias clinical trials interpretation: hybrid balanced placebo and randomized placebo-controlled design

Conventional randomized placebo-controlled study design assumes the absence of drug*placebo interaction. We hypothesized the presence of such an interaction and that conventionally estimated drug effect might ...

Authors: Muhammad M. Hammami, Safa Hammami, Reem Al-Swayeh, Eman Al-Gaai, Faduma Abdi Farah and Sophia J. S. De Padua

Recommendations for the analysis of individually randomised controlled trials with clustering in one arm – a case of continuous outcomes

In an individually randomised controlled trial where the treatment is delivered by a health professional it seems likely that the effectiveness of the treatment, independent of any treatment effect, could depe...

Authors: Laura Flight, Annabel Allison, Munyaradzi Dimairo, Ellen Lee, Laura Mandefield and Stephen J. Walters

Erratum to: Statistical methodology for age-adjustment of the GH-2000 score detecting growth hormone misuse

Authors: Dankmar Böhning, Walailuck Böhning, Nishan Guha, David A. Cowan, Peter H. Sönksen and Richard I. G. Holt

No rationale for 1 variable per 10 events criterion for binary logistic regression analysis

Ten events per variable (EPV) is a widely advocated minimal criterion for sample size considerations in logistic regression analysis. Of three previous simulation studies that examined this minimal EPV criteri...

Authors: Maarten van Smeden, Joris A. H. de Groot, Karel G. M. Moons, Gary S. Collins, Douglas G. Altman, Marinus J. C. Eijkemans and Johannes B. Reitsma

Conducting a large, multi-site survey about patients’ views on broad consent: challenges and solutions

As biobanks play an increasing role in the genomic research that will lead to precision medicine, input from diverse and large populations of patients in a variety of health care settings will be important in ...

Authors: Maureen E. Smith, Saskia C. Sanderson, Kyle B. Brothers, Melanie F. Myers, Jennifer McCormick, Sharon Aufox, Martha J. Shrubsole, Nanibaá A. Garrison, Nathaniel D. Mercaldo, Jonathan S. Schildcrout, Ellen Wright Clayton, Armand H. Matheny Antommaria, Melissa Basford, Murray Brilliant, John J. Connolly, Stephanie M. Fullerton…