Abstract

PurposeTo investigate the role of symptom clusters in the analysis and utilisation of patient reported outcome measures (PROMs) for data modelling and clinical practice. To compare symptom clusters with scales, and to explore their value in PROMs interpretation and symptom management.MethodsA dataset called RT01 (ISCRTN47772397) of 843 prostate cancer patients was used. PROMs were reported with the University of California, Los Angeles Prostate Cancer Index (UCLA-PCI). Symptom clusters were explored with hierarchical cluster analysis (HCA) and average linkage method (correlation > 0.6). The reliability of the Urinary Function Scale was evaluated with Cronbach’s Alpha. The strength of the relationship between the items was investigated with Spearman’s correlation. Predictive accuracy of the clusters was compared to the scales by receiver operating characteristic (ROC) analysis. Presence of urinary symptoms at 3 years measured with the late effects on normal tissue: subjective, objective, management tool (LENT/SOM) was an endpoint.ResultsTwo symptom clusters were identified (urinary cluster and sexual cluster). The grouping of symptom clusters was different than UCLA-PCI Scales. Two items of the urinary function scales (“number of pads” and “urinary leak interfering with sex”) were excluded from the urinary cluster. The correlation with the other items in the scale ranged from 0.20 to 0.21 and 0.31 to 0.39, respectively. Cronbach’s Alpha showed low correlation of those items with the Urinary Function Scale (0.14–0.36 and 0.33–0.44, respectively). All urinary function scale items were subject to a ceiling effect. Clusters had better predictive accuracy, AUC = 0.70 –0.65, while scales AUC = 0.67–0.61.ConclusionThis study adds to the knowledge on how cluster analysis can be applied for the interpretation and utilisation of PROMs. We conclude that multiple-item scales should be evaluated and that symptom clusters provide a study-specific approach for modelling and interpretation of PROMs.

Highlights

  • Patient reported outcome measures (PROMs) are health questionnaires that are completed directly by patients to measure patients’ health status or health-related quality of life (HRQOL)

  • We used MRC RT01 (ISCRTN47772397), a dataset consisting of 843 prostate cancer patients in a randomised controlled trial coordinated for the UK Medical Research Council (MRC) [30, 31]

  • Baseline characteristics of the MRC RT01 study participants are presented in Table 1 and are reported in more detail elsewhere [30]

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Summary

Introduction

Patient reported outcome measures (PROMs) are health questionnaires that are completed directly by patients to measure patients’ health status or health-related quality of life (HRQOL). With significant improvements in rates of long-term survival [2], longitudinal PROMs in prostate cancer play a important role as they offer the ability to assess and address health concerns or HRQOL issues of individual patients [3,4,5]. Other important clinical applications of PROMs include aiding treatment choices as well as identifying high-risk cancer patients, to achieve the best possible long-term health-related outcomes [6, 7]. These are all key challenges of modern oncology and PROMs play a strategic role in this as they enable tailored treatments and outcomes according to priorities, risks or concerns of individual patients [8, 9]. PROMs data are complex, with large number of variables (HRQOL, symptoms, function, bother, performance or heath concerns) measured on different scales (with different levels, ratios or frequencies) and with confounders that can be attributed to cancer treatment or individual patient characteristics

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