Background & Aims

Chemotherapy-induced peripheral neuropathy is a debilitating effect of several neurotoxic treatments for cancer (1-3). Patient- (PROM) and Clinician-reported Outcome Measures (ClinROM) are commonly used to assess CIPN. There is no consensus on a gold-standard measurement tool, impacting our ability identify effective preventative and palliative agents in clinical trials and to detect CIPN onset and monitor its progression during treatment in real-world situations. The COsensus-based Standards for the selection of health Measurement Instruments (COSMIN) is systematic methodology assessing the quality of studies reporting on psychometric properties of PROM and ClinROM (4-7). This methodology could help to identify CIPN tools with the best measurement properties, moving us toward identification of a gold standard measure for use in research and in clinical contexts.

Aim: To determine the methodological quality of CIPN PROM and ClinROM.

Methods

Eligibility criteria: Studies reporting psychometric proprieties of CIPN PROM and ClinROM among adults ?18 years were included. No language or publication year restriction, 4 databases searched from inception to 31 December 2021.

COSMIN analysis consisted of 3 steps (4-7): 1)Risk of Bias (RoB) Checklist was used to assess the quality of each study separately by evaluating 10 psychometric properties; 2) RoB scores for each study were evaluated according to established criteria for good measurement properties; 3)Evidence for the methodological quality for each measurement property per PROM and per ClinROM was pooled from data from the first 2 steps and summarized to obtain an overall quality score, rated as sufficient (COSMIN criteria for sufficient quality met), insufficient (criteria not met), inconsistent (criteria inconsistent across studies), indeterminate (not all information provided).

Results

53 PROM, 22 ClinROM, and 1 Mixed PROM-ClinROM were identified from 81 studies. The 4 most common families of PROM included variations of the European Organization for Research and Treatment of Cancer (n=10), the Functional Assessment of Cancer Therapy (n=5), the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (n=4), and the M.D. Anderson Symptom Inventory (n=3). The most common families of ClinROM included variations of the Total Neuropathy Score (n=6) and the National Cancer Institute- Common Terminology Criteria for Adverse Events (n=5). Methodological quality was sufficient for 0/53 PROM and 3/22 ClinROM (14%). These ClinROM included Von Frey filaments measuring Tactile Threshold, Bio-Thesiometer measuring Vibration Threshold, TSA-II measuring Cool and Warm Detection and Cold and Heat Pain Thresholds. Methodological quality was insufficient for 27/53 PROM (51%) and 3/22 ClinROM (14%), and indeterminate for 26/53 PROM (49%), 16/22 ClinROM (72%) and 1/1 Mixed tool (100%).

Conclusions

Most CIPN PROM and ClinROM have insufficient or indeterminate quality, mainly stemming from a lack of information provided in the manuscript, insufficient sample sizes for planned analyses, and the non-involvement of people with lived experience of CIPN and other stakeholders in tool development studies. Future psychometric studies of CIPN PROM and ClinROM need to improve their transparency, include all results of analyses described in the manuscript, and be appropriately powered for planned analyses. Future tool development efforts should include people with lived experience of CIPN and other stakeholders to improve their validity.

References

1. Smith EML. Current methods for the assessment and management of taxane-related neuropathy. Clin J Oncol Nurs. 2013;17:22-34.
2. Flatters SJL, Dougherty PM, Colvin LA. Clinical and preclinical perspectives on Chemotherapy-Induced Peripheral Neuropathy (CIPN): a narrative review. BJA: British Journal of Anaesthesia. 2017;119(4):737-49.
3. Colvin LA. Chemotherapy-induced peripheral neuropathy: where are we now? Pain. 2019;160 Suppl 1(Suppl 1):S1-S10.
4. Mokkink LB, Boers M, van der Vleuten CPM, Bouter LM, Alonso J, Patrick DL, et al. COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error of outcome measurement instruments: a Delphi study. BMC Med Res Methodol. 2020;20(1):293.
5. Mokkink LB, de Vet HCW, Prinsen CAC, Patrick DL, Alonso J, Bouter LM, et al. COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures. 2018;27(5):1171-9.
6. Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol. 2010;63(7):737-45.
7. Prinsen CAC, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HCW, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018;27(5):1147-57.

Presenting Author

Philippe Bérubé-Mercier

Poster Authors

Philippe Bérubé-Mercier

PhD candidate

Université Laval

Lead Author

Marie-Ève Cimon

M.Sc

Oncology Division, Centre de recherche du CHU de Québec – Université Laval, Québec, Quebec, Canada

Lead Author

Kaitlin McGarragle

Oncology Division, Centre de recherche du CHU de Québec – Université Laval, Québec, Quebec, Canada

Lead Author

Maxime Bouchard

Oncology Division, Centre de recherche du CHU de Québec – Université Laval, Québec, Quebec, Canada

Lead Author

Tiffany Li

School of Medical Sciences, Brain and Mind Center,?The University of Sydney,?Sydney,?New South Wales

Lead Author

Susanna B. Park

PhD

School of Medical Sciences, Brain and Mind Center,?The University of Sydney,?Sydney,?New South Wales

Lead Author

Ève Bouhêlier

Centre de recherche du CHU de Québec – Université Laval, Québec, Quebec, Canada

Lead Author

Lye-Ann Robichaud

Department of Psychology,?Université de Montréal,?Montreal,?Quebec, Canada

Lead Author

Diane Tapp

PhD

Faculté des sciences infirmières, Université Laval, Québec, QC, Canada

Lead Author

Jennifer S. Gewandter

PhD

University of Rochester

Lead Author

Lynn Gauthier

Oncology Division, Centre de recherche du CHU de Québec – Université Laval, Québec, Quebec, Canada

Lead Author

Topics

  • Assessment and Diagnosis