Precision medicine implementation and research-practice partnerships: implications of measurement scale differential item functioning

Background: Omics-based biomarkers (OBMs) inform precision medicine (PM). As omics-based technologies gradually move into clinical settings, however, a co-occurrence of biomedical research and clinical practice is likely an important variable in the implementation of PM. Currently, little is known about the implications of such research-practice co-occurrence. Methods: This study used data collected from a pilot study designed to inform a full-scale PM implementation study through the validation of the measurement tool. It applied item response theory (IRT) methods to assess the tool’s reliability and measurement invariance across two study subgroups associated with research and practice settings. Results: The study sample consisted of 31 participants. Measurement invariance assessment was through differential item functioning (DIF) analysis with bootstrapping through Monte Carlo simulation. Overall, 13 out of 22 items that formed the PMI scale had DIF at significance level α=0.25. Item response functions (IRFs) revealed how each subgroup members responded to scale items and their attitudes towards factors that influence PM implementation. Conclusions: Attitudinal similarities and differences towards factors influencing PM implementation amongst those in biomedical research as compared with those in practice were established. Results indicated PM implementation knowledge that is unique and common to both groups. The study established the validity and reliability of the new PM implementation measurement tool for the two subgroups.

[1]  van der Ark,et al.  Mokken Scale Analysis in R , 2007 .

[2]  van der Ark,et al.  New Developments in Mokken Scale Analysis in R , 2012 .

[3]  D. Thissen,et al.  Using effect sizes for research reporting: examples using item response theory to analyze differential item functioning. , 2006, Psychological methods.

[4]  P. Shrout,et al.  Mediation in experimental and nonexperimental studies: new procedures and recommendations. , 2002, Psychological methods.

[5]  N. Holtzman,et al.  Will genetics revolutionize medicine? , 2000, The New England journal of medicine.

[6]  Klaas Sijtsma,et al.  On the Use, the Misuse, and the Very Limited Usefulness of Cronbach’s Alpha , 2008, Psychometrika.

[7]  S. Hanash Disease proteomics : Proteomics , 2003 .

[8]  John C. Wooley,et al.  A Primer on Metagenomics , 2010, PLoS Comput. Biol..

[9]  Martha L. Stocking,et al.  Developing a Common Metric in Item Response Theory , 1983 .

[10]  B. Farsides,et al.  Genomics England’s implementation of its public engagement strategy: Blurred boundaries between engagement for the United Kingdom’s 100,000 Genomes project and the need for public support , 2017, Public understanding of science.

[11]  M. Tavakol,et al.  Making sense of Cronbach's alpha , 2011, International journal of medical education.

[12]  Paul K Crane,et al.  lordif: An R Package for Detecting Differential Item Functioning Using Iterative Hybrid Ordinal Logistic Regression/Item Response Theory and Monte Carlo Simulations. , 2011, Journal of statistical software.

[13]  Mark J. Gierl,et al.  Evaluating Type I Error and Power Rates Using an Effect Size Measure With the Logistic Regression Procedure for DIF Detection , 2001 .

[14]  C. Rotimi,et al.  Translational Genomics in Low- and Middle-Income Countries: Opportunities and Challenges , 2015, Public Health Genomics.

[15]  J. Shao,et al.  PSEUDO-R 2 IN LOGISTIC REGRESSION MODEL , 2006 .

[16]  H. Swaminathan,et al.  Detecting Differential Item Functioning Using Logistic Regression Procedures , 1990 .

[17]  C. McHorney,et al.  Assessment of Differential Item Functioning for Demographic Comparisons in the MOS SF-36 Health Survey , 2006, Quality of Life Research.

[18]  S. Hurst,et al.  A call for policy action in sub-Saharan Africa to rethink diagnostics for pregnancy affected by sickle cell disease: differential views of medical doctors, parents and adult patients predict value conflicts in Cameroon. , 2014, Omics : a journal of integrative biology.

[19]  Gerald van Belle,et al.  Differential Item Functioning Analysis With Ordinal Logistic Regression Techniques: DIFdetect and difwithpar , 2006, Medical care.

[20]  Anderson Rb On the comparability of meaningful stimuli in cross-cultural research. , 1967 .

[21]  S. Hey,et al.  Cell and Gene Therapy Trials: Are We Facing an ‘Evidence Crisis’? , 2019, EClinicalMedicine.

[22]  Klaas Sijtsma,et al.  Reliability of test scores in nonparametric item response theory , 1987 .

[23]  M. Ramsay,et al.  Direct-to-consumer genetic testing: to test or not to test, that is the question. , 2013, South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde.

[24]  P. Parfrey,et al.  Community engagement with genetics: public perceptions and expectations about genetics research , 2015, Health expectations : an international journal of public participation in health care and health policy.

[25]  N. Schmitt Uses and abuses of coefficient alpha. , 1996 .

[26]  Wenyu Wang,et al.  Making Sense of the Epigenome Using Data Integration Approaches , 2019, Front. Pharmacol..

[27]  Oliver P. John,et al.  It’s What You Ask and How You Ask It: An Itemmetric Analysis of Personality Questionnaires , 1986 .

[28]  Douglas D. Heckathorn,et al.  Respondent-driven sampling : A new approach to the study of hidden populations , 1997 .

[29]  N. Tiffin Unique considerations for advancing genomic medicine in African populations. , 2014, Personalized medicine.

[30]  S. Teutsch,et al.  Recommendations from the EGAPP Working Group: can tumor gene expression profiling improve outcomes in patients with breast cancer? , 2009, Genetics in Medicine.

[31]  R. Lewontin,et al.  Pitfalls of genetic testing. , 1996, The New England journal of medicine.

[32]  James C. Anderson,et al.  Predicting the performance of measures in a confirmatory factor analysis with a pretest assessment of their substantive validities. , 1991 .

[33]  Douglas D. Heckathorn,et al.  Respondent-driven sampling II: deriving valid population estimates from chain-referral samples of hi , 2002 .

[34]  Using item response theory to investigate the structure of anticipated affect: do self-reports about future affective reactions conform to typical or maximal models? , 2015, Front. Psychol..

[35]  G I Murray,et al.  Proteomics: a new approach to the study of disease , 2000, The Journal of pathology.

[36]  Lawrence D. True,et al.  Guidelines for the Development and Incorporation of Biomarker Studies in Early Clinical Trials of Novel Agents , 2010, Clinical Cancer Research.

[37]  F. Collins,et al.  A new initiative on precision medicine. , 2015, The New England journal of medicine.

[38]  Klaas Sijtsma,et al.  Reliability Estimation for Single Dichotomous Items Based on Mokken's IRT Model , 1995 .

[39]  P. Glasziou,et al.  Teaching evidence based medicine , 2004, BMJ : British Medical Journal.

[40]  G. Nilsson,et al.  Investigating psychometric properties and dimensional structure of an educational environment measure (DREEM) using Mokken scale analysis – a pragmatic approach , 2018, BMC Medical Education.

[41]  B. Zumbo,et al.  Differential Item Functioning Results May Change Depending On How An Item Is Scored: An Illustration With The Center For Epidemiologic Studies Depression Scale , 2003 .

[42]  D. Blacker,et al.  Differential Item Functioning Between Ethnic Groups in the Epidemiological Assessment of Depression , 2008, The Journal of nervous and mental disease.