Articles

Use of partitioned GMM marginal regression model with time-dependent covariates: analysis of Chinese Longitudinal Healthy Longevity Study

Elderly population’s health is a major concern for most industrial nations. National health surveys provide a measure of the state of elderly health. One such survey is the Chinese Longitudinal Healthy Longevi...

Authors: Elsa Vazquez-Arreola, Dan Xue and Jeffrey R. Wilson

Re-engaging an inactive cohort of young adults: evaluating recruitment for the Kidskin Young Adult Myopia Study

Recent changes in communication technologies, including increased reliance on mobile phones and the internet, may present challenges and/or opportunities to re-engaging inactive study cohorts. We evaluate our ...

Authors: Gareth Lingham, David A. Mackey, Nicola Seed, Lisa Ryan, Elizabeth Milne, Robyn M. Lucas, Maria Franchina, Samantha Sze-Yee Lee and Seyhan Yazar

Optimal, minimax and admissible two-stage design for phase II oncology clinical trials

The article aims to compare the efficiency of minimax, optimal and admissible criteria in Simon’s and Fleming’s two-stage design.

Authors: Fei Qin, Jingwei Wu, Feng Chen, Yongyue Wei, Yang Zhao, Zhiwei Jiang, Jianling Bai and Hao Yu

Fuzzy cognitive mapping and soft models of indigenous knowledge on maternal health in Guerrero, Mexico

Effective health care requires services that are responsive to local needs and contexts. Achieving this in indigenous settings implies communication between traditional and conventional medicine perspectives. ...

Authors: Ivan Sarmiento, Sergio Paredes-Solís, David Loutfi, Anna Dion, Anne Cockcroft and Neil Andersson

Frequently repeated measurements -our experience of collecting data with SMS

As technology is advancing, so are the possibilities for new data collection methods in research, potentially improving data quality and validity of the results. In Sweden, a system using frequent repeated dat...

Authors: I. Axén, I. Jensen, E. Butler Forslund, B. Grahn, V. Jørgensen, C. H. Opava and L. Bodin

A randomized trial of mail and email recruitment strategies for a physician survey on clinical trial accrual

Patient participation in cancer clinical trials is suboptimal. A challenge to capturing physicians’ insights about trials has been low response to surveys. We conducted a study using varying combinations of ma...

Authors: Caitlin C. Murphy, Simon J. Craddock Lee, Ann M. Geiger, John V. Cox, Chul Ahn, Rasmi Nair, David E. Gerber, Ethan A. Halm, Katharine McCallister and Celette Sugg Skinner

What feedback do reviewers give when reviewing qualitative manuscripts? A focused mapping review and synthesis

Peer review is at the heart of the scientific process. With the advent of digitisation, journals started to offer electronic articles or publishing online only. A new philosophy regarding the peer review proce...

Authors: Oliver Rudolf HERBER, Caroline BRADBURY-JONES, Susanna BÖLING, Sarah COMBES, Julian HIRT, Yvonne KOOP, Ragnhild NYHAGEN, Jessica D. VELDHUIZEN and Julie TAYLOR

Methodological tools and sensitivity analysis for assessing quality or risk of bias used in systematic reviews published in the high-impact anesthesiology journals

A crucial element in the systematic review (SR) methodology is the appraisal of included primary studies, using tools for assessment of methodological quality or risk of bias (RoB). SR authors can conduct sens...

Authors: Marija Franka Marušić, Mahir Fidahić, Cristina Mihaela Cepeha, Loredana Gabriela Farcaș, Alexandra Tseke and Livia Puljak

Patient information, communication and competence empowerment in oncology (PIKKO) – evaluation of a supportive care intervention for overall oncological patients. Study protocol of a non-randomized controlled trial

Cancer patients have to undergo a difficult medical therapy and are also confronted with various psychological, social and economic problems. Support is available from many providers, but patients often gain n...

Authors: Nico Schneider, Anna Bäcker, Katja Brenk-Franz, Christian Keinki, Jutta Hübner, Florian Brandt, Geraldine von der Winkel, Lutz Hager, Bernhard Strauss and Uwe Altmann

Developing model biobanking consent language: what matters to prospective participants?

Efforts to improve informed consent have led to calls for providing information a reasonable person would want to have, in a way that facilitates understanding of the reasons why one might or might not want to...

Authors: Laura M. Beskow, Catherine M. Hammack-Aviran and Kathleen M. Brelsford

Similar responses to EQ-5D-3L by two elicitation methods: visual analogue scale and time trade-off

Health-related quality of life (HRQoL) is often measured using EQ-5D-3L by the elicitation methods of visual analogue scale (VAS) and time trade-off (TTO). Although many countries have constructed both nationa...

Authors: Xiuying Wang, Lin Zhuo, Yifei Ma, Ting Cai, Aviva Must, Ling Xu and Lang Zhuo

Application of the matched nested case-control design to the secondary analysis of trial data

A nested case-control study is an efficient design that can be embedded within an existing cohort study or randomised trial. It has a number of advantages compared to the conventional case-control design, and ...

Authors: Christopher Partlett, Nigel J. Hall, Alison Leaf, Edmund Juszczak and Louise Linsell

Social media as a recruitment platform for a nationwide online survey of COVID-19 knowledge, beliefs, and practices in the United States: methodology and feasibility analysis

The COVID-19 pandemic has evolved into one of the most impactful health crises in modern history, compelling researchers to explore innovative ways to efficiently collect public health data in a timely manner....

Authors: Shahmir H. Ali, Joshua Foreman, Ariadna Capasso, Abbey M. Jones, Yesim Tozan and Ralph J. DiClemente

Current methods for development of rapid reviews about diagnostic tests: an international survey

Rapid reviews (RRs) have emerged as an efficient alternative to time-consuming systematic reviews—they can help meet the demand for accelerated evidence synthesis to inform decision-making in healthcare. The s...

Authors: Ingrid Arevalo-Rodriguez, Karen R. Steingart, Andrea C. Tricco, Barbara Nussbaumer-Streit, David Kaunelis, Pablo Alonso-Coello, Susan Baxter, Patrick M. Bossuyt, José Ignacio Emparanza and Javier Zamora

Improving assent in health research: a rapid systematic review

Enrolment in a research study requires the participant’s informed consent. In the case of minors, informed consent of the respective legal guardian is obtained in conjunction with informed assent of the undera...

Authors: Dominik Soll, Maria Magdalena Guraiib, Nigel Campbell Rollins and Andreas Alois Reis

Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide

Shifts in data sharing policy have increased researchers’ access to individual participant data (IPD) from clinical studies. Simultaneously the number of IPD meta-analyses (IPDMAs) is increasing. However, rate...

Authors: Matthew Ventresca, Holger J. Schünemann, Fergus Macbeth, Mike Clarke, Lehana Thabane, Gareth Griffiths, Simon Noble, David Garcia, Maura Marcucci, Alfonso Iorio, Qi Zhou, Mark Crowther, Elie A. Akl, Gary H. Lyman, Viktoria Gloy, Marcello DiNisio…

A mixed methods case study investigating how randomised controlled trials (RCTs) are reported, understood and interpreted in practice

While randomised controlled trials (RCTs) provide high-quality evidence to guide practice, much routine care is not based upon available RCTs. This disconnect between evidence and practice is not sufficiently ...

Authors: Ben E. Byrne, Leila Rooshenas, Helen S. Lambert and Jane M. Blazeby

Using alcohol consumption diary data from an internet intervention for outcome and predictive modeling: a validation and machine learning study

Alcohol use disorder (AUD) is highly prevalent and presents a large treatment gap. Self-help internet interventions are an attractive approach to lowering thresholds for seeking help and disseminating evidence...

Authors: Philip Lindner, Magnus Johansson, Mikael Gajecki and Anne H. Berman

Experts’ perceptions on the use of visual analytics for complex mental healthcare planning: an exploratory study

Health experts including planners and policy-makers face complex decisions in diverse and constantly changing healthcare systems. Visual analytics may play a critical role in supporting analysis of complex hea...

Authors: Erin I. Walsh, Younjin Chung, Nicolas Cherbuin and Luis Salvador-Carulla

Which interactions matter in economic evaluations? A systematic review and simulation study

We aimed to assess the magnitude of interactions in costs, quality-adjusted life-years (QALYs) and net benefits within a sample of published economic evaluations of factorial randomised controlled trials (RCTs...

Authors: Helen Dakin and Alastair Gray

Generation and evaluation of synthetic patient data

Machine learning (ML) has made a significant impact in medicine and cancer research; however, its impact in these areas has been undeniably slower and more limited than in other application domains. A major re...

Authors: Andre Goncalves, Priyadip Ray, Braden Soper, Jennifer Stevens, Linda Coyle and Ana Paula Sales

Association between antipsychotic drug dose and length of clinical notes: a proxy of disease severity?

Most structured clinical data, such as diagnosis codes, are not sufficient to obtain precise phenotypes and assess disease burden. Text mining of clinical notes could provide a basis for detailed profiles of p...

Authors: Freja Karuna Hemmingsen Sørup, Søren Brunak and Robert Eriksson

Psychometric properties of measures of substance use: a systematic review and meta-analysis of reliability, validity and diagnostic test accuracy

Synthesis of psychometric properties of substance use measures to identify patterns of use and substance use disorders remains limited. To address this gap, we sought to systematically evaluate the psychometri...

Authors: Glenn-Milo Santos, Steffanie A. Strathdee, Nabila El-Bassel, Poonam Patel, Divya Subramanian, Danielle Horyniak, Ryan R. Cook, Charlotte McCullagh, Phillip Marotta, Foram Choksi, Brian Kang, Isabel Allen and Steven Shoptaw

An assessment of the quality of current clinical meta-analyses

The objective of this study was to assess the overall quality of study-level meta-analyses in high-ranking journals using commonly employed guidelines and standards for systematic reviews and meta-analyses.

Authors: Irbaz Hameed, Michelle Demetres, Derrick Y. Tam, Mohamed Rahouma, Faiza M. Khan, Drew N. Wright, Keith Mages, Antonio P. DeRosa, Becky Baltich Nelson, Kevin Pain, Diana Delgado, Leonard N. Girardi, Stephen E. Fremes and Mario Gaudino

Baseline-adjusted proportional odds models for the quantification of treatment effects in trials with ordinal sum score outcomes

Sum scores of ordinal outcomes are common in randomized clinical trials. The approaches routinely employed for assessing treatment effects, such as t-tests or Wilcoxon tests, are not particularly powerful in dete...

Authors: Muriel Buri, Armin Curt, John Steeves and Torsten Hothorn

Evaluation of survival extrapolation in immuno-oncology using multiple pre-planned data cuts: learnings to aid in model selection

Due to limited duration of follow up in clinical trials of cancer treatments, estimates of lifetime survival benefits are typically derived using statistical extrapolation methods. To justify the method used, ...

Authors: Ash Bullement, Anna Willis, Amerah Amin, Michael Schlichting, Anthony James Hatswell and Murtuza Bharmal

Feasibility and evaluation of a large-scale external validation approach for patient-level prediction in an international data network: validation of models predicting stroke in female patients newly diagnosed with atrial fibrillation

To demonstrate how the Observational Healthcare Data Science and Informatics (OHDSI) collaborative network and standardization can be utilized to scale-up external validation of patient-level prediction models...

Authors: Jenna M. Reps, Ross D. Williams, Seng Chan You, Thomas Falconer, Evan Minty, Alison Callahan, Patrick B. Ryan, Rae Woong Park, Hong-Seok Lim and Peter Rijnbeek

Framing the numerical findings of Cochrane plain language summaries: two randomized controlled trials

Cochrane systematic review Plain language Summaries (CSR PLSs should serve as a tool for the evidence translation to non-medical population. However, the evidence of optimal type of numerical presentation in C...

Authors: Ivan Buljan, Ružica Tokalić, Marija Roguljić, Irena Zakarija-Grković, Davorka Vrdoljak, Petra Milić, Livia Puljak and Ana Marušić

Adjusting for comorbidity in incidence-based DALY calculations: an individual-based modeling approach

The co-occurrence of two or more medical conditions in the same individual is not uncommon. If disability-adjusted life year (DALY) calculations are carried out for each condition separately, multimorbidity ma...

Authors: Scott A. McDonald, Juanita A. Haagsma, Alessandro Cassini and Brecht Devleesschauwer

Application of principal component analysis and logistic regression model in lupus nephritis patients with clinical hypothyroidism

Previous studies indicate that the prevalence of hypothyroidism is much higher in patients with lupus nephritis (LN) than in the general population, and is associated with LN’s activity. Principal component an...

Authors: Ting Huang, Jiarong Li and Weiru Zhang

Accurate confidence intervals for risk difference in meta-analysis with rare events

Meta-analysis provides a useful statistical tool to effectively estimate treatment effect from multiple studies. When the outcome is binary and it is rare (e.g., safety data in clinical trials), the traditiona...

Authors: Tao Jiang, Baixin Cao and Guogen Shan

Implications of sex offender classification on reporting demographic characteristics, health, and criminal careers: results from an Australian jurisdiction

Cross-sectional and retrospective offence data are often used to classify sex offenders in epidemiological and survey research, but little empirical evidence exists regarding the practical implications of this...

Authors: Mathew Gullotta, David Greenberg, Armita Adily, Jesse Cale and Tony G. Butler

How are systematic reviews of prevalence conducted? A methodological study

There is a notable lack of methodological and reporting guidance for systematic reviews of prevalence data. This information void has the potential to result in reviews that are inconsistent and inadequate to ...

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

Ordinal logistic regression model describing factors associated with extent of nodal involvement in oral cancer patients and its prospective validation

Oral cancer is the most common cancer among Indian men, and has strong tendency of metastatic spread to neck lymph node which strongly influences prognosis especially 5 year survival-rate and also guides the r...

Authors: Vishwajeet Singh, Sada Nand Dwivedi and S. V. S. Deo

Bayesian joint modelling of longitudinal and time to event data: a methodological review

In clinical research, there is an increasing interest in joint modelling of longitudinal and time-to-event data, since it reduces bias in parameter estimation and increases the efficiency of statistical infere...

Authors: Maha Alsefri, Maria Sudell, Marta García-Fiñana and Ruwanthi Kolamunnage-Dona

Study design factors influencing patients’ willingness to participate in clinical research: a randomised vignette-based study

High patient participation in clinical research reduces selection bias and ensures the generalizability of study findings. We explored study-related factors that may influence patients’ willingness to particip...

Authors: Angèle Gayet-Ageron, Sandrine Rudaz and Thomas Perneger

Engaging with Indigenous Australian communities for a human papilloma virus and oropharyngeal cancer project; use of the CONSIDER statement

The prevalence of oral HPV infection and HPV-related oropharyngeal squamous cell carcinoma (OPSCC) among Indigenous Australians is unknown. This paper outlines the engagement, consultation and recruitment stra...

Authors: Joanne Hedges, Gail Garvey, Zell Dodd, Warren Miller, Terry Dunbar, Cathy Leane, Amanda Mitchell, Isaac Hill and Lisa Jamieson

schema: an open-source, distributed mobile platform for deploying mHealth research tools and interventions

Mobile applications for health, also known as ‘mHealth apps’, have experienced increasing popularity over the past ten years. However, most publicly available mHealth apps are not clinically validated, and man...

Authors: Adrian B. R. Shatte and Samantha J. Teague

What was visualized? A method for describing content of performance summary displays in feedback interventions

Visual displays such as charts and tables may significantly moderate the effects of audit and feedback interventions, but the systematic study of these intervention components will likely remain limited withou...

Authors: Dahee Lee, Veena Panicker, Colin Gross, Jessica Zhang and Zach Landis-Lewis

Validity and reliability of State-Trait Anxiety Inventory in Danish women aged 45 years and older with abnormal cervical screening results

State Trait Anxiety Inventory (STAI) scale was developed in the 1980’s and has been widely used both in clinical settings and in research. However the Danish version of STAI has not been validated. The aim of ...

Authors: L. W. Gustafson, P. Gabel, A. Hammer, H. H. Lauridsen, L. K. Petersen, B. Andersen, P. Bor and M. B. Larsen

Analysis of Bayesian posterior significance and effect size indices for the two-sample t-test to support reproducible medical research

The replication crisis hit the medical sciences about a decade ago, but today still most of the flaws inherent in null hypothesis significance testing (NHST) have not been solved. While the drawbacks of p-values ...

Authors: Riko Kelter

Psychometric properties of a short version of the Job Anxiety Scale

Occupational stress and specifically job anxiety are crucial factors in determining health outcomes, job satisfaction as well as performance. In order to assess this phenomenon, the Job Anxiety Scale is one of...

Authors: Bjarne Schmalbach, Andreas Kalkbrenner, Markus Bassler, Andreas Hinz and Katja Petrowski

Assessing repeatability and reproducibility of Anterior Active Rhinomanometry (AAR) in children

Repeatability and reproducibility are essential for clinicians for several purposes. Although discouraged, use of the Coefficient of Variation (CV) for assessing repeatability and reproducibility, rather than ...

Authors: Giovanna Cilluffo, Anna Maria Zicari, Giuliana Ferrante, Velia Malizia, Salvatore Fasola, Marzia Duse, Giovanna De Castro, Valentina De Vittori, Laura Schiavi, Giulia Brindisi, Paolo Petrelli and Stefania La Grutta

Data sources and methods used to determine pretest probabilities in a cohort of Cochrane diagnostic test accuracy reviews

A pretest probability must be selected to calculate data to help clinicians, guideline boards and policy makers interpret diagnostic accuracy parameters. When multiple analyses for the same target condition ar...

Authors: Michiel S. Oerbekke, Kevin Jenniskens, Rob J. P. M. Scholten and Lotty Hooft

Modelling seizure rates rather than time to an event within clinical trials of antiepileptic drugs

Predictive models within epilepsy are frequently developed via Cox’s proportional hazards models. These models estimate risk of a specified event such as 12-month remission. They are relatively simple to produ...

Authors: Laura J. Bonnett, Jane L. Hutton and Anthony G. Marson

Clustering of continuous and binary outcomes at the general practice level in individually randomised studies in primary care - a review of 10 years of primary care trials

In randomised controlled trials, the assumption of independence of individual observations is fundamental to the design, analysis and interpretation of studies. However, in individually randomised trials in pr...

Authors: Beth Stuart, Taeko Becque, Michael Moore and Paul Little

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

In the original publication of this article [1], the number “− 0.49” in the below sentence in the Results section should be changed to “-3.23”, and this typo does not affect the wider conclusions.

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

Methodological challenges of analysing COVID-19 data during the pandemic

Authors: Martin Wolkewitz and Livia Puljak

Assessing the quality of health research from an Indigenous perspective: the Aboriginal and Torres Strait Islander quality appraisal tool

The lack of attention to Indigenous epistemologies and, more broadly, Indigenous values in primary research, is mirrored in the standardised critical appraisal tools used to guide evidence-based practice and s...

Authors: Stephen Harfield, Odette Pearson, Kim Morey, Elaine Kite, Karla Canuto, Karen Glover, Judith Streak Gomersall, Drew Carter, Carol Davy, Edoardo Aromataris and Annette Braunack-Mayer

Telephone versus web panel National Survey for monitoring adoption of preventive behaviors to climate change in populations: a case study of Lyme disease in Québec, Canada

To monitor the adoption of climate change adaptive behaviors in the population, public health authorities have to conduct national surveys, which can help them target vulnerable subpopulations. To ensure relia...

Authors: Grâce Ngambo Domche, Pierre Valois, Magalie Canuel, Denis Talbot, Maxime Tessier, Cécile Aenishaenslin, Catherine Bouchard and Sandie Briand