Predicting the Reasons of Customer Complaints: A First Step Toward Anticipating Quality Issues of In Vitro Diagnostics Assays with Machine Learning

Background Vendors in the health care industry produce diagnostic systems that, through a secured connection, allow them to monitor performance almost in real time. However, challenges exist in analyzing and interpreting large volumes of noisy quality control (QC) data. As a result, some QC shifts may not be detected early enough by the vendor, but lead a customer to complain. Objective The aim of this study was to hypothesize that a more proactive response could be designed by utilizing the collected QC data more efficiently. Our aim is therefore to help prevent customer complaints by predicting them based on the QC data collected by in vitro diagnostic systems. Methods QC data from five select in vitro diagnostic assays were combined with the corresponding database of customer complaints over a period of 90 days. A subset of these data over the last 45 days was also analyzed to assess how the length of the training period affects predictions. We defined a set of features used to train two classifiers, one based on decision trees and the other based on adaptive boosting, and assessed model performance by cross-validation. Results The cross-validations showed classification error rates close to zero for some assays with adaptive boosting when predicting the potential cause of customer complaints. Performance was improved by shortening the training period when the volume of complaints increased. Denoising filters that reduced the number of categories to predict further improved performance, as their application simplified the prediction problem. Conclusions This novel approach to predicting customer complaints based on QC data may allow the diagnostic industry, the expected end user of our approach, to proactively identify potential product quality issues and fix these before receiving customer complaints. This represents a new step in the direction of using big data toward product quality improvement.

[1]  Trevor Hastie,et al.  An Introduction to Statistical Learning , 2013, Springer Texts in Statistics.

[2]  T. Fiers,et al.  Long-term stability of laboratory tests and practical implications for quality management , 2013, Clinical chemistry and laboratory medicine.

[3]  Li Li,et al.  Deep Patient: An Unsupervised Representation to Predict the Future of Patients from the Electronic Health Records , 2016, Scientific Reports.

[4]  Michael I. Jordan,et al.  Machine learning: Trends, perspectives, and prospects , 2015, Science.

[5]  Alexander Katayev,et al.  Changing the paradigm of laboratory quality control through implementation of real-time test results monitoring: For patients by patients. , 2015, Clinical Biochemistry.

[6]  S. Brunak,et al.  Mining electronic health records: towards better research applications and clinical care , 2012, Nature Reviews Genetics.

[7]  Alex Gillespie,et al.  Patient complaints in healthcare systems: a systematic review and coding taxonomy , 2014, BMJ quality & safety.

[8]  Zhen Li,et al.  A comparison of machine learning algorithms for chemical toxicity classification using a simulated multi-scale data model , 2008, BMC Bioinformatics.

[9]  Matías Gámez,et al.  adabag: An R Package for Classification with Boosting and Bagging , 2013 .

[10]  Clinical correlation between a point-of-care testing system and laboratory automation for lipid profile. , 2015, Clinica chimica acta; international journal of clinical chemistry.

[11]  Kenneth Goossens,et al.  Monitoring laboratory data across manufacturers and laboratories--A prerequisite to make "Big Data" work. , 2015, Clinica chimica acta; international journal of clinical chemistry.

[12]  R. Leone,et al.  Influence of Regulatory Measures on the Rate of Spontaneous Adverse Drug Reaction Reporting in Italy , 2008, Drug safety.

[13]  Tony Badrick,et al.  Assessment of machine-learning techniques on large pathology data sets to address assay redundancy in routine liver function test profiles , 2015, Diagnosis.

[14]  Sebastian Thrun,et al.  Dermatologist-level classification of skin cancer with deep neural networks , 2017, Nature.

[15]  Viju Raghupathi,et al.  An Overview of Health Analytics , 2013 .

[16]  J. Mayer,et al.  Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database. , 2009, The Journal of thoracic and cardiovascular surgery.

[17]  S. Vasikaran Anatomy and history of an external quality assessment program for interpretative comments in clinical biochemistry. , 2015, Clinical biochemistry.

[18]  Pascal Vincent,et al.  Representation Learning: A Review and New Perspectives , 2012, IEEE Transactions on Pattern Analysis and Machine Intelligence.

[19]  T. Guilford,et al.  Breeding phenology and winter activity predict subsequent breeding success in a trans-global migratory seabird , 2015, Biology Letters.

[20]  Per Hyltoft Petersen,et al.  Median of patient results as a tool for assessment of analytical stability. , 2015, Clinica chimica acta; international journal of clinical chemistry.

[21]  Diego J. Pedregal,et al.  Time series methods applied to failure prediction and detection , 2010, Reliab. Eng. Syst. Saf..

[22]  Enrico Zio,et al.  Failure and reliability prediction by support vector machines regression of time series data , 2011, Reliab. Eng. Syst. Saf..

[23]  Blaz Zupan,et al.  Predictive data mining in clinical medicine: Current issues and guidelines , 2008, Int. J. Medical Informatics.

[24]  Peter J. Pronovost,et al.  Underreporting of Patient Safety Incidents Reduces Health Care's Ability to Quantify and Accurately Measure Harm Reduction , 2010, Journal of patient safety.

[25]  I. Pavlov,et al.  Patient result median monitoring for clinical laboratory quality control. , 2011, Clinica chimica acta; international journal of clinical chemistry.

[26]  Ronald Alsop 世界鳥瞰 海外特約 THE WALL STREET JOURNAL 米企業好感度1位はJ&J、最下位ブリヂストン , 2001 .

[27]  M. Dramé,et al.  Notoriety bias in a database of spontaneous reports: the example of osteonecrosis of the jaw under bisphosphonate therapy in the French national pharmacovigilance database , 2014, Pharmacoepidemiology and drug safety.

[28]  P. Mastroianni,et al.  [Causes for the underreporting of adverse drug events by health professionals: a systematic review]. , 2014, Revista da Escola de Enfermagem da U S P.

[29]  Yoav Freund,et al.  Experiments with a New Boosting Algorithm , 1996, ICML.

[30]  Peter K. Ghavami,et al.  An Investigation of Applications of Artificial Neural Networks in Medical Prognostics , 2012 .