Dataset Information

The chemotherapy-induced peripheral neuropathy outcome measures standardization study: from consensus to the first validity and reliability findings.

ABSTRACT:

Background

Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating and dose-limiting complication of cancer treatment. Thus far, the impact of CIPN has not been studied in a systematic clinimetric manner. The objective of the study was to select outcome measures for CIPN evaluation and to establish their validity and reproducibility in a cross-sectional multicenter study.

Patients and methods

After literature review and a consensus meeting among experts, face/content validity were obtained for the following selected scales: the National Cancer Institute-Common Toxicity Criteria (NCI-CTC), the Total Neuropathy Score clinical version (TNSc), the modified Inflammatory Neuropathy Cause and Treatment (INCAT) group sensory sumscore (mISS), the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, and CIPN20 quality-of-life measures. A total of 281 patients with stable CIPN were examined. Validity (correlation) and reliability studies were carried out.

Results

Good inter-/intra-observer scores were obtained for the TNSc, mISS, and NCI-CTC sensory/motor subscales. Test-retest values were also good for the EORTC QLQ-C30 and CIPN20. Acceptable validity scores were obtained through the correlation among the measures.

Conclusion

Good validity and reliability scores were demonstrated for the set of selected impairment and quality-of-life outcome measures in CIPN. Future studies are planned to investigate the responsiveness aspects of these measures.

SUBMITTER: Cavaletti G

PROVIDER: S-EPMC3551481 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The chemotherapy-induced peripheral neuropathy outcome measures standardization study: from consensus to the first validity and reliability findings.

Cavaletti G G Cornblath D R DR Merkies I S J ISJ Postma T J TJ Rossi E E Frigeni B B Alberti P P Bruna J J Velasco R R Argyriou A A AA Kalofonos H P HP Psimaras D D Ricard D D Pace A A Galiè E E Briani C C Dalla Torre C C Faber C G CG Lalisang R I RI Boogerd W W Brandsma D D Koeppen S S Hense J J Storey D D Kerrigan S S Schenone A A Fabbri S S Valsecchi M G MG Mazzeo A A Pace A A Pessino A A Schenone A A Toscano A A Argyriou A A AA Brouwer B B Frigeni B B Piras B B Briani C C Dalla Torre C C Dominguez Gonzalez C C Faber C G CG Tomasello C C Binda D D Brandsma D D Cortinovis D D Psimaras D D Ricard D D Storey D D Cornblath D R DR Galiè E E Lindeck Pozza E E Rossi E E Vanhoutte E K EK Lanzani F F Pastorelli F F Altavilla G G Cavaletti G G Granata G G Kalofonos H P HP Ghignotti I I Merkies I S J ISJ Bruna J J Hense J J Heimans J J JJ Mattavelli L L Padua L L Reni L L Bakkers M M Boogerd M M Campagnolo M M Cazzaniga M M Eurelings M M Leandri M M Lucchetta M M Penas Prado M M Russo M M Valsecchi M G MG Piatti M L ML Alberti P P Bidoli P P Grant R R Plasmati R R Velasco R R Lalisang R I RI Meijer R J RJ Fabbri S S Dorsey S G SG Galimberti S S Kerrigan S S Koeppen S S Postma T J TJ Boogerd W W Grisold W W

Annals of oncology : official journal of the European Society for Medical Oncology 20120821 2

<h4>Background</h4>Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating and dose-limiting complication of cancer treatment. Thus far, the impact of CIPN has not been studied in a systematic clinimetric manner. The objective of the study was to select outcome measures for CIPN evaluation and to establish their validity and reproducibility in a cross-sectional multicenter study.<h4>Patients and methods</h4>After literature review and a consensus meeting among experts, face/content v ...[more]

PMID: 22910842

Similar Datasets

Project description:ImportanceChemotherapy-induced peripheral neuropathy (CIPN) is a substantial adverse effect of anticancer treatments. As such, the assessment of CIPN remains critically important in both research and clinic settings.ObjectiveTo compare the validity of various patient-reported outcome measures (PROMs) with neurophysiological and sensory functional measures as the optimal method of CIPN assessment.Design, setting, and participantsThis cohort study evaluated participants treated with neurotoxic chemotherapy across 2 cohorts using a dual-study design. Participants commencing treatment were assessed prospectively at beginning of neurotoxic treatment, midtreatment, and at the end of treatment. Participants who completed treatment up to 5 years prior were assessed cross-sectionally and completed a single assessment time point. Participants were recruited from oncology centers in Australia from August 2015 to November 2022. Data analysis occurred from February to November 2023.ExposuresNeurotoxic cancer treatment including taxanes, platinums, vinca-alkaloids, proteasome inhibitors, and thalidomide.Main outcomes and measuresCIPN was assessed via PROMs (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-CIPN20], Functional Assessment of Cancer Therapy/Gynecological Cancer Group Neurotoxicity Questionnaire (FACT/GOG-Ntx), and the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events [PRO-CTCAE]), neurological and neurophysiological assessment (Total Neuropathy Score and sural and tibial compound nerve amplitudes), and sensory measures (Grating orientation, Von Frey monofilament, and 2-point discrimination tasks). Core measurement properties of CIPN outcome measures were evaluated. Convergent and known-groups validity was assessed cross-sectionally following treatment completion, and responsiveness was evaluated prospectively during treatment. Neurological, neurophysiological, and sensory outcome measure scores were compared between those who reported high and low levels of CIPN symptoms using linear regressions.ResultsA total of 1033 participants (median [IQR] age, 61 [50-59] years; 676 female [65.4%]) were recruited to this study, incorporating 1623 assessments. PROMs demonstrated best ability to accurately assess CIPN (convergent validity), especially the PRO-CTCAE composite score (r = 0.85; P < .001) and EORTC-CIPN20 (r = 0.79; P < .001). PROMS also demonstrated the best ability to discriminate between CIPN severity (known-groups validity) and to detect changes at onset of CIPN development (responsiveness), especially for EORTC-CIPN20 (d = 0.67; 95% CI, 0.52-0.83), FACT/GOG-Ntx (d = 0.65; 95% CI, 0.49-0.81) and the PRO-CTCAE (d = 0.83; 95% CI, 0.64-1.02). Other measures did not achieve threshold for convergent validity (α < 0.7). Neurophysiological and sensory measures did not demonstrate acceptable responsiveness. In regression models, neurological, neurophysiological, and sensory outcome measures were significantly impaired in participants who reported high levels of CIPN symptoms compared with those who reported low levels of CIPN symptoms.Conclusions and relevanceIn this cohort study of 1033 cancer patients, PROMs were the only measures to satisfy all 3 core measurement property criteria (convergent validity, known-groups validity, and responsiveness). These findings suggest that adoption of PROMs in clinical practice can equip clinicians with valuable information in assessing CIPN morbidity.

Project description:BackgroundValid and reliable outcome measure enable measurement of health care service impact. There are limited valid and reliable outcome measures for use in podiatry practice to measure the impact of treatment. This research aimed to test the face validity of the AusTOMs for Physiotherapy (AusTOMs-PT), it's adaptability to podiatry clinical practice and the reliability of its use with podiatrists.MethodsStage 1 used a nominal group technique with podiatrists who worked in public and/or private settings. All podiatrists underwent self-directed training in the AusTOMs framework and measures prior to interviews or focus group discussion. Discussion was centred about transferability of the core scales of the AusTOMs-PT and an adjunct measure, AusTOMs for Occupational Therapy (AusTOMs-OT) to podiatry practice. Stage 2 used 10 case studies representative of people who had foot or ankle concerns. Podiatrists were recruited and trained in the use of the relevant AusTOMs-PT scales. Podiatrists individually scored the cases at two timepoints (1 month apart) using the six scales from the AusTOMs-PT deemed by stage 1 as relevant to podiatry. Intra and inter-rater reliability of scales were determined using intraclass correlation coefficients (ICCs).ResultsThirteen podiatrists participated in individual or focus group interviews in Stage 1. Consensus was gained on six of the nine core scales adopted from the AusTOMs-PT. These were 1. Balance and Postural Control, 3. Musculoskeletal Movement Related Functions, 4. Neurological Movement Related Functions, 5. Pain, 7. Sensory Functions, 8. Skin Functions. Each core scale rated the functional domains of Impairment, Activity Limitation, Participation Restriction and Wellbeing/Distress relating to that presentation of goals of the person in the case study. There were 22 podiatrists complete training and scored two rounds of case studies using the six scales in Stage 2. There were 91%(n = 20) participants with an intra-rater ICC > 0.5 (moderate or greater). Each domain had an inter-rater reliability of > 0.9 (excellent) during the first round.ConclusionsThe AusTOMs-PT for use in podiatry may be implemented to record change in impairment, function, participation and wellbeing of people receiving podiatry treatment. Podiatry specific training and mentoring, together with repeated use could be expected to improve intra-reliability.

Dataset Information

The chemotherapy-induced peripheral neuropathy outcome measures standardization study: from consensus to the first validity and reliability findings.

Background

Patients and methods

Results

Conclusion

Publications

The chemotherapy-induced peripheral neuropathy outcome measures standardization study: from consensus to the first validity and reliability findings.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets