Assessing chemotherapy-induced peripheral neuropathy with patient reported outcome measures: a systematic review of measurement properties and considerations for future use

Li, Tiffany; Park, Susanna B.; Battaglini, Eva; King, Madeleine; Kiernan, Matthew C.; Goldstein, David; Rutherford, Claudia

doi:10.1007/s11136-022-03154-7

Cited by 24 publications

(21 citation statements)

References 75 publications

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“…The most commonly used PROMs (patient-reported outcome measures) to identify CIPN are the QLQ-CIPN20 and the FACT/GOG-Ntx questionnaire [ 14 , 15 ]. Among other things, they ask about the symptoms of the last 7 days, while, in our case, in addition to the current complaints, the onset of symptoms (and their presentation) was asked separately.…”

Section: Discussionmentioning

confidence: 99%

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Chemotherapy-induced polyneuropathy in cancer care—the patient perspective

Prager

Passig

Micke

et al. 2023

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Purpose Chemotherapy-related polyneuropathy (CIPN) is a very common, often dose-limiting side effect that affects the patients’ quality of life. Treatment usually consists of a combination of medicinal, medical, and individualized treatment approaches, although the effectiveness of these therapies is insufficient for many patients. The aim of this article is to review and evaluate the impact of CIPN on patients’ daily lives and possible effective treatment approaches. Methods A standardized questionnaire was developed based on ten anonymous telephone interviews with CIPN patients. The content of the questionnaire was divided into 5 categories: demographics, clinical presentation, everyday symptoms, treatment of CIPN symptoms, and medical care. Mostly closed questions were used but multiple choice and individual additions by free text answers were possible. Results CIPN limits patients’ quality of life over a long period of time. In addition to diurnal and situational fluctuations, the emotional burden negatively affects patients’ daily lives in many ways. From the patients’ point of view, the individually implemented therapy measures were most effective in treating their complaints. But even the combination of different therapy methods insufficiently alleviates the symptoms of the patients. Conclusion It is important and necessary to comprehensively inform patients about CIPN as a possible side effect, to point out prevention strategies, and to critically examine and evaluate different therapy approaches. In this way, misunderstandings of the doctor-patient relationship can be avoided. In addition, patient satisfaction and quality of life can be increased in the long term.

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Section: Discussionmentioning

confidence: 99%

“…In contrast to the two already established PROMs, our questionnaire asked about the localization of the complaints not only in the hands and feet, but in the entire body. We also asked in more detail about the respective impact on the daily lives of those affected [ 14 ].…”

Section: Discussionmentioning

confidence: 99%

Chemotherapy-induced polyneuropathy in cancer care—the patient perspective

Prager

Passig

Micke

et al. 2023

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“…Furthermore, MIDs were estimated separately for the sensory and motor subscales of the QLQ-CIPN20. 16 However, due to a lack of demonstrated structural validity for these QLQ-CIPN20 subscales, 9 it has been recommended that the PROM be used in its entirety, rather than individual subscales. 40…”

Section: Comparison With Previous Mids Studiesmentioning

confidence: 99%

“…5 Previously demonstrated discordance between patient-and clinicianreported CIPN 6 suggests that PROMs may depict a broader spectrum of CIPN severity than clinician-based assessments, 7 enabling better understanding of symptom manifestation and effects on function. 8 A number of PROMs have been developed to assess CIPN 9 ; the 2 most commonly used and extensively validated are the EORTC Quality of Life -Chemotherapy-Induced Peripheral Neuropathy questionnaire (QLQ-CIPN20) 10 and the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group -Neurotoxicity questionnaire (FACT/GOG-NTX). 11 Previous studies have demonstrated that both PROMs are responsive in identifying change in CIPN symptoms over time.…”

Section: Introductionmentioning

confidence: 99%

Patient-Reported Outcome Measures in Chemotherapy-Induced Peripheral Neurotoxicity: Defining Minimal and Clinically Important Changes

Timmins

Trinh

et al. 2023

Journal of the National Comprehensive Cancer Network

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Background: Chemotherapy-induced peripheral neurotoxicity (CIPN) is a common complication of cancer treatment that produces functional disability. Increasingly, patient-reported outcome measures (PROMs) are used to assess CIPN, providing a broader symptom perspective than clinician-graded scales. Understanding when a reported change in CIPN symptoms meets the threshold for clinical significance is challenging. This study aimed to provide interpretation guidelines for validated CIPN PROMs, and thereby enable estimation of thresholds to identify clinically relevant symptoms. Methods: Patients commencing neurotoxic cancer treatments were assessed at 3 timepoints: baseline, midtreatment, and end-of-treatment. Trajectory of CIPN development was assessed by means of CIPN PROMs, EORTC Quality of Life – Chemotherapy-Induced Peripheral Neuropathy questionnaire (QLQ-CIPN20), and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity questionnaire (FACT/GOG-NTX). Thresholds were estimated for CIPN PROMs using the NCI CTCAE sensory neuropathy scale as the clinical anchor by midtreatment and end-of-treatment. Patients were assigned to a clinical change group according to CIPN development: either no development; grade 1 neuropathy (minimally important difference [MID]); or grade 2 neuropathy (clinically important difference). Distribution-based estimates (SD, 0.5) were also evaluated as supportive evidence. Results: In total, 406 patients were recruited to the study, of whom 62% (n=199/320) developed CIPN by midtreatment and 80% (n=274/343) by end-of-treatment. Anchor-based MID estimates by midtreatment were 5.06 (95% CI, 4.26–5.86) for the QLQ-CIPN20 and 3.54 (95% CI, 2.87–4.20) for the FACT/GOG-NTX. End-of-treatment MIDs were estimated to be 7.32 (95% CI, 6.23–8.40) for the QLQ-CIPN20 and 4.84 (95% CI, 3.98–5.70) for the FACT/GOG-NTX. Distribution-based MID estimations yielded lower values than anchor-based methods, at 3.73 for the QLQ-CIPN20 and 2.64 for the FACT/GOG-NTX at midtreatment and 5.52 for the QLQ-CIPN20 and 3.64 for the FACT/GOG-NTX at end-of-treatment. Conclusions: Findings from the present series aid meaningful interpretation for commonly used validated CIPN PROMs and provide thresholds that serve as guidance on how to interpret score changes, which will be useful for design and evaluation of clinical trials and clinical practice.

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“…While there remains no gold-standard clinical outcome measures for CIPN [ 9 ], there are a range of validated methods examining large fibre dysfunction in CIPN, including neurophysiological assessments, clinical examination [ 10 ] and patient-reported outcome measures [ 11 ]. However, there is a lack of validated tools to measure small nerve fibre damage or autonomic neuropathy in CIPN [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

Association of electrochemical skin conductance with neuropathy in chemotherapy-treated patients

Mahfouz

Park

et al. 2022

Clin Auton Res

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Purpose Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse event of cancer treatment that can affect sensory, motor, or autonomic nerves. Assessment of autonomic neuropathy is challenging, with limited available tools. Accordingly, it is not routinely assessed in chemotherapy-treated patients. In this study, we aimed to examine whether electrochemical skin conductance (ESC) via Sudoscan, a potential measure of autonomic function, associates with subjective and objective measures of CIPN severity and autonomic neuropathy. Methods A cross-sectional assessment of patients who completed neurotoxic chemotherapy 3–24 months prior was undertaken using CIPN patient-reported outcomes (EORTC-QLQ-CIPN20), clinically graded scale (NCI-CTCAE), neurological examination score (TNSc), autonomic outcome measure (SAS), and Sudoscan. Differences in CIPN severity between participants with or without ESC dysfunction were investigated. Linear regression analyses were used to identify whether ESC values could predict CIPN severity. Results A total of 130 participants were assessed, with 93 participants classified with CIPN according to the clinically graded scale (NCI-CTCAE/grade ≥ 1), while 49% demonstrated hands or feet ESC dysfunction (n = 46). Participants with ESC dysfunction did not significantly differ from those with no dysfunction on multiple CIPN severity measures (clinical-grade, patient-report, neurological examination), and no differences on the autonomic outcome measure (SAS) (all p > 0.0063). Linear regression analyses showed that CIPN could not be predicted by ESC values. Conclusions The inability of ESC values via Sudoscan to predict clinically-graded and patient-reported CIPN or autonomic dysfunction questions its clinical utility for chemotherapy-treated patients. The understanding of autonomic neuropathy with chemotherapy treatment remains limited and must be addressed to improve quality of life in cancer survivors.

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Assessing chemotherapy-induced peripheral neuropathy with patient reported outcome measures: a systematic review of measurement properties and considerations for future use

Cited by 24 publications

References 75 publications

Chemotherapy-induced polyneuropathy in cancer care—the patient perspective

Chemotherapy-induced polyneuropathy in cancer care—the patient perspective

Patient-Reported Outcome Measures in Chemotherapy-Induced Peripheral Neurotoxicity: Defining Minimal and Clinically Important Changes

Association of electrochemical skin conductance with neuropathy in chemotherapy-treated patients

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