Psychometric properties and longitudinal measurement invariance of the Treatment-induced Neuropathy Assessment Scale in the Chinese cancer chemotherapy population

doi:10.21203/rs.3.rs-4723813/v1

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Psychometric properties and longitudinal measurement invariance of the Treatment-induced Neuropathy Assessment Scale in the Chinese cancer chemotherapy population

https://doi.org/10.21203/rs.3.rs-4723813/v1

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Background: Background: Treatment-induced peripheral neuropathy is one of the most complex toxicities to diagnose and manage in cancer patients. The Treatment-Induced Neuropathy Assessment Scale (TNAS) is a valid instrument in English for assessing the severity and course of neuropathy across various cancer treatments; it has not been evaluated for psychometric properties in non-Western samples, nor has it been tested for longitudinal measurement invariance.

Aim: To evaluate psychometric properties and longitudinal measurement invariance of the TNAS in Chinese cancer patients.

Design: A longitudinal observational study.

Methods: A total of 316 patients were surveyed at three time points. Confirmatory factor analysis (CFA), convergent validity, longitudinal measurement invariance, criterion validity, and Internal consistency reliability were evaluated.

Results: CFA supported the 2-factor structure of the original TNAS construct at three-time points. The composite reliability (CR) and the average variance extracted (AVE) indicated that the TNAS had good convergent validity. TNAS exhibited strong measurement invariance over time and was reliable across different time points. The correlation of TNAS with the EORTC QLQ-CIPN20 showed good criterion validity. Moreover, the TNAS and sub-scales had high internal consistency at three-time points.

Conclusion: The findings suggest that the TNAS is a reliable and valid instrument with adequate psychometric properties and temporal stability. Our results support the use of TNAS in clinical practice to measure treatment-induced peripheral neuropathy and track changes in neuropathy symptoms.

cancer

longitudinal measurement invariance

psychometric properties

scale

treatment-induced peripheral neuropathy

Treatment-induced peripheral neuropathy (TIPN) is one of the most complex toxicities to diagnose and manage in cancer patients and may limit patients’ ability to receive optimal therapy[1, 2]. Chemotherapy-induced peripheral neuropathy (CIPN) is the most widely recognized form of TIPN, although it can also be caused by other cancer therapies (such as molecular therapies, radiation, and surgery)[3]. TIPN-related symptoms often include pain, tingling, numbness, heightened sensitivity to temperature variations, and impaired fine motor skills[4]. Studies have indicated that these symptoms may impair daily function and reduce quality of life[5, 6]. When severe, TIPN can even necessitate altering the therapy dosage, disrupting clinical treatment plans, and having an impact on treatment outcomes[7]. TIPN is often cumulative and persistent[8], and as surgery, radiation, and targeted therapy are the standard treatments for multiple types of cancer, the number of patients experiencing TIPN is expected to increase. Thus, a systematic evaluation instrument is needed to assess TIPN and understand the increasing burden of residual treatment-related neuropathic effects.

The peripheral neuropathy symptomology is diverse, depending on the treatment method used (such as the type of chemotherapy agents) and the treatment dose[9]. Research on neuropathy symptoms has expanded from an initial focus on pain alone to multidimensional symptoms of sensory, motor, and autonomic changes[10, 11]. Currently, methods for capturing the multifaceted nature of TIPN include objective neurobiological tests, clinician evaluation, and subjective patient reports. The equipment for neurophysiological testing is expensive and complex to operate, requiring professional knowledge and training to operate correctly, which makes it difficult to promote in multicenter pilots[12, 13]. Furthermore, due to subjective differences among evaluators, clinician evaluation has a wide range of score variances, making it difficult to capture changes in clinical symptoms[14]. It’s significant to note that prior studies have demonstrated a moderate correlation between the findings of neurobiological tests and patient reports of their symptoms, as well as a moderate correlation between patient reports and clinician evaluation[15, 16]. Given that the effects of symptoms are experienced subjectively, patient-reported outcomes (PROs) are more appropriate for clinical practice than objective neurobiological tests when monitoring adverse events and symptom perception, and more accurate and reliable in capturing a wide range of TIPN symptoms than clinician evaluation.

PROs are increasingly recognized as valuable for collecting peripheral neuropathy symptom information. Existing patient-reported outcome measures (PROMs) can capture several aspects of neuropathy, such as the European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20)[17], the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity subscale (FACT/GOG-Ntx)[18], and the National Cancer Institute Patient-Reported Outcome Common Terminology Criteria for Adverse Events-Numbness & tingling (PRO-CTCAE)[19]. Although a variety of PROMs have been developed to assess neuropathy, as symptoms develop progressively during neurotoxic chemotherapy administration[8], it is critical that existing PROMs follow a rigorous scientific approach during development to identify key symptoms, discriminate between agents associated with the development of neuropathy, and detect neurological dysfunction and change in its severity over time[20, 21].

According to the guidance for industry announced by the US Food and Drug Administration (FDA)[22]: “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims”, the development of PROM needs to address issues related to the conceptual framework, item development, endpoint models, psychometric properties. The guidance explicitly states that PROMs’ content validity (items and dimensions) should be supported by evidence from qualitative studies. However, the content domains of the most widely used neuropathy measures, the CIPN20 and the FACT-GOG/Ntx, were not developed and validated through qualitative patient interviews. Additionally, most existing PROMs for neuropathy, including the CIPN20 and the FACT-GOG/Ntx, are based on the quality of life (QOL) paradigm. In general, symptoms are the most direct indicators of physiological changes caused by disease and treatment that are perceived and reported by patients. Although QOL is an important indicator in assessing the side effects of cancer treatment, symptom burden is more proximal to the physiological changes that cause side effects (such as peripheral neuropathy), so it is a more sensitive measure in research and practice[23].

Based on the requirements of the FDA guidance and considering the limitations of existing measures, Mendoza et al. from the University of Texas MD Anderson Cancer Center developed the Treatment-Induced Neuropathy Assessment Scale (TNAS), a PROM of TIPN symptom burden, to address issues related to the adequacy of currently available measures[24]. Symptom items for the initial versions of TNAS (v1.0 and v2.0) were generated by consultation with clinical expert panels and literature reviews, as well as reports of the initial set of items by patients with multiple types of cancer[25]. Preliminary psychometric evaluation indicated that TNAS showed good responsiveness, validity, and reliability and that specific sensory and motor deficits were generally more bothersome to patients than pain. Given that the development and validation of PROMs should be an iterative process, these measures may need to be revised as new relevant information is generated[26]. To ensure that the TNAS strictly complies with FDA guidance on establishing the content validity of PROMs used in labeling claims, Mendoza et al. further conducted one-on-one qualitative interviews and cognitive debriefing with patients receiving treatments known to induce TIPN to appropriately refine the tool to form the final version of the TNAS (TNAS v3.0)[27]. Then, it was validated in psychometric evaluation in patients with colorectal cancer, multiple myeloma, or gynecologic cancer receiving oxaliplatin, bortezomib, or taxane-platinum anticancer therapies. TNASv3.0 includes nine items, two dimensions (sensory and interference), and has shown good psychometric properties. Multiple studies have confirmed that TNASv3.0 is an informative, practical PROM that imposes little burden on patients and can be used in clinical trials at multiple sites[27].

Currently, the MD Anderson Cancer Center has translated the English version of TNAS into Chinese and Hebrew, but psychometric verification has only been performed on the English version of TNAS. Although several studies have shown that TNAS is a reliable and valid instrument, an important direction for future research should focus on cultural validation and include samples from non-western countries to test the psychometric properties of TNAS. Thus, one of the purposes of this study is to test the reliability and validity of TNAS in China. Furthermore, this study also evaluated a characteristic of the TNAS that has not been tested in the Western literature: in addition to testing the factor structure proposed by the original TNAS, we also analyzed whether this factor structure is invariant over time, that is, longitudinal measurement invariance[28]. Longitudinal measurement invariance is of equal importance to reliability and validity because if the factor structure of an instrument changes over time, inferences based on the results of follow-up studies may be inaccurate[29]. Therefore, given the rigorous scientific development and iteration process of TNAS and its keen ability to capture TIPN symptoms and severity, this study aimed to measure the reliability, validity, and temporal stability of TNAS in Chinese cancer patients receiving chemotherapy, which will help increase the evidence of good psychological properties and stability of TNAS in non-western countries and also help promote its application in Chinese clinical settings. Before the start of this study, our research team contacted MD Anderson Cancer Center to obtain the Chinese version of TNAS and the authorization to conduct psychological properties and longitudinal measurement invariance testing in China.

2.1 Design

A quantitative survey with a longitudinal design was used to determine the psychometric properties and longitudinal measurement invariance of TNAS. This design required the distribution of questionnaires to patients at three-time points within 3 months after the start of chemotherapy (1 month, 2 months, and 3 months after the start of chemotherapy).

2.2 Setting and Participants

Patients were recruited from the outpatient and inpatient oncology departments of two tertiary hospitals in Tianjin and Jiangxi, China, from February 2024 to July 2024. The inclusion criteria for patients were as follows: 1) diagnosed with cancer and received bortezomib, oxaliplatin, or taxane-platinum-based chemotherapy for the first time; 2) aged above 18; 3) were able to complete the questionnaire independently; and 4) were willing to participate. The exclusion criteria were cognitive or psychiatric impairments and suffering from severe heart, liver, kidney, and other serious complications.

2.3 Procedures

The research team consists of an associate professor as the leader, two master students, and two registered nurses as research assistants, all of whom have been systematically trained. Recruitment was conducted by research members who approached the potential participants when they entered the hospitals. Research members presented the content and purpose of the research to potential participants, assessed them to determine whether they met the inclusion and exclusion criteria, and assured them that participation was voluntary. After obtaining written consent, the researcher distributed the questionnaires to the participants. Once they completed the questionnaire, the researcher immediately checked their questionnaire to ensure the integrity of the data. If there were missing values, the questionnaires were returned to the participants so that they could fill in the missing items. The questionnaires were administered to patients from baseline T1 (1 month after the start of the first chemotherapy), T2 (2 months after the start of the first chemotherapy), and T3 (3 months after the start of the first chemotherapy).

2.4 Measures

Demographics and Clinical Information

Demographic and clinical information was obtained from the participants using a questionnaire designed by the researcher that yielded information about age, gender, diagnosis, cancer stage, and type of chemotherapy.

The Treatment-Induced Neuropathy Assessment Scale (TNAS)

The TNAS is a 9-item, 2-factor patient-reported outcome measure to assess the severity and course of neuropathy across various cancer treatments[24]. The TNAS instruments are scored on a 0 to 10 scale, with 0 = the symptom is not present and 10 = the symptom is as bad as you can imagine. Hence, an overall arithmetic average of all the items can be calculated, with higher scores indicating more severe neuropathy. Two subscale scores can also be calculated to assess symptoms related to the sensory and interference dimensions. The sensory subscale score is the mean of six sensory items: numbness, tingling, pain, heat or burning, cold sensation, and disturbed sleep. The interference subscale score is the mean of three items: difficulty walking, difficulty balancing, and difficulty using the hands[27]. In the original version of the study, the TNAS showed good psychometric properties, and the subsequent studies also reported the strong internal consistency of the TNAS (Cronbach alpha = .86 for the total score with individual subscales ranging from .82–.85).

European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20)

The EORTC QLQ-CIPN20 is a 20-item measure consisting of sensory, motor, and autonomic domains. All items are rated on a 4-point Likert scale (1 = “not at all” to 4 = “very much”)[17]. The total score and three subscale scores were calculated and linearly transformed into a 0–100 scale according to the scoring manual, with higher scores indicating more severe CIPN symptoms. The Chinese version of the EORTC QLQ-CIPN20 showed good internal consistency (Cronbach alpha = .90 for the total score with individual subscales ranging from .70–.87)[30].

2.5 Ethical Considerations

This study complied with the Declaration of Helsinki and has obtained the approval of the Ethics Committees of Nanjing Medical University (Ethics No. 2024 − 697). All participants signed the informed consent form and were informed that they had the right to withdraw at any time without prejudice.

2.6 Statistical Analyses

The data analysis was performed using IBM SPSS Statistics Version 26.0 and Analysis of Moment Structure (AMOS) Version 23.0. First, descriptive statistics (frequency, percentages, means, and standard deviations) were used to describe the demographic characteristics of participants.

The Confirmatory Factor Analysis (CFA) was used as a critical step in refining the instrument and identifying the factorial structure of TNAS. Four fit indices were employed to examine the adequacy of model fit: a chi-square to degrees of freedom ratio (χ2/df < 3), the comparative fit index (CFI ≥ 0.90), the Tucker-Lewis index (TLI ≥ 0.90), and the root mean square error of approximation (RMSEA ≤ 0.05) [31]. In CFA, the convergent validity of the TNAS was verified through the factor loading of each item (≥ 0.50), the composite reliability (CR) value (≥ 0.70), and the average variance extracted (AVE) of the 14 factors (≥ 0.50) [32].

Longitudinal measurement invariance was used to determine the configural (similar factor structure), metric (similar factor loadings), and scalar invariance (similar intercepts) of the TNAS over time. Invariance was established by comparing these models based on the following criteria: changes in RMSEA (Δ < 0.015), CFI (Δ < 0.01), and TLI (Δ < 0.01) [33, 34].

A criterion validity analysis was also conducted by determining the value of the Pearson correlation coefficient between the TNAS and the EORTC QLQ-CIPN20.

The reliability of the TNAS was determined based on internal consistency. To evaluate the internal consistency of the TNAS, Cronbach’s alpha was measured. Internal consistency was considered adequate when α ≥ 0.70 [35].

Sample Characteristics

Of the 400 potential participants that were approached, 26 did not meet the inclusion criteria, 13 declined to participate for various reasons, and 361 were eligible for the study and consented to participate. The average age of the patients was 54.34 years (SD = 8.25, range = 33–77). They were predominantly female (64.0%) and diagnosed with breast cancer (40.4%). Characteristics of the participants are presented in Table 1.

CFA

The factorial validity of the TNAS at each time point was explored by estimating the proposed two-factor model. Observed items were used as indicators for the latent factor. No items were removed. The CFA model with two latent subscales demonstrated an adequate fit across multiple fit indices. The results showed that the model fitted the data well at Time 1 [(χ2 /df = 2.137, p < .001), TLI = 0.983, CFI = 0.982, RMSEA = 0.032], Time 2 [(χ2 /df = 1.637, p < .001), TLI = 0.987, CFI = 0.989, RMSEA = 0.017], and Time 3 [(χ2 /df = 2.245, p < .001), TLI = 0.973, CFI = 0.974, RMSEA = 0.027], respectively.

The convergent validity of TNAS was examined by CFA as well as AVE and CR at three time points. The results showed that at T1, the factor loadings of all items ranged from 0.765 to 0.879, the AVE values of the 2 factors were 0.610 and 0.746, and the CR values were 0.901 and 0.890. At T2, the factor loadings of all items ranged from 0.750 to 0.855, the AVE values of the 2 factors were 0.623 and 0.728, and the CR values were 0.911 and 0.889. At T3, the factor loadings of all items ranged from 0.732 to 0.843, the AVE values of the 2 factors were 0.595 and 0.697, and the CR values were 0.897 and 0.872. As described earlier, all criteria displayed good acceptability at the three-time points, indicating that the TNAS has satisfactory convergent validity (Table 2).

Table 1. Demographic and Clinical Characteristics of the Samples (N=312).

Variable	N	%
Age (mean ± SD)	54.34±8.251
Gender
Male	130	36
Female	231	64
Diagnosis
Head and neck cancer	23	6.4
Multiple myeloma	37	10.2
Colorectal cancer	93	25.8
Breast cancer	146	40.4
Ovarian cancer	22	6.1
Lung cancer	40	11.1
Cancer stage
I	81	22.4
II	134	37.1
III	124	34.3
IV	22	6.1
Type of chemotherapy
Bortezomib	37	10.2
Oxaliplatin	101	28.0
Taxane–Platinum	175	48.5
Oxaliplatin+ Taxane–Platinum	48	13.3

Table 2. Factor structures by confirmatory factor analysis (N=312).

Items	Factor	T1			T2			T3
		SE	CR	*AVE*	SE	CR	*AVE*	SE	CR	*AVE*
1	Sensory	0.779	0.901	0.610	0.827	0.911	0.623	0.732	0.897	0.595
2		0.781			0.762			0.777
3		0.797			0.827			0.794
4		0.792			0.750			0.788
5		0.765			0.790			0.754
6		0.780			0.780			0.777
7	Interference	0.862	0.890	0.746	0.852	0.889	0.728	0.842	0.872	0.697
8		0.850			0.853			0.832
9		0.879			0.855			0.830

Note. Item 1: Numbness in arms, legs, hands, or feet;

Item 2: Tingling in arms, legs, hands, or feet;

Item 3: Pain in arms, legs, hands, or feet;

Item 4: Hot or burning sensations in arms, legs, hands, or feet;

Item 5: Feelings of coldness in hands, fingers, feet, or toes;

Item 6: Disturbed sleep due to neuropathy;

Item 7: Difficulty using hands or fingers;

Item 8: Trouble walking;

Item 9: Trouble with balance or falling;

SE= Standardized Estimate; CR= Composite Reliability; AVE= Average Variance Extracted.

Longitudinal Measurement Invariance and Mean Comparisons

After confirming the factorial structure over time, the next step was to evaluate the temporal equivalence of TNAS through longitudinal measurement invariance. The results summarized in Table 3 showed that configural, metric, and scalar invariance were established. No significant differences in terms of CFI (Δ < 0.01), TLI (Δ < 0.01), and RMSEA (Δ < 0.015) between the configural, metric, and scalar invariance models were found. Thus, the TNAS showed itself to be a consistent measure over time, and mean comparisons can be made. Mean comparisons, with TNAS at Time 1 set as the reference point, showed that TNAS increased at T2 and T3 (P < .001). Figure 1 shows the results of the metric and scalar invariance models of the longitudinal measurement invariance

Table 3

Longitudinal Invariance of the TNAS.
Model	\(\:{}^{2}\)	\(\:\varvec{d}\varvec{f}\)	CFI	TLI	RMSEA	ΔCFI	ΔTLI	ΔRMSEA
1.Configural invariance	317.049	309	0.980	0.982	0.013
2.Metric invariance	341.099	327	0.991	0.991	0.014	0.011	0.010	0.001
3.Scalar invariance	1230.522	345	0.995	0.993	0.019	0.004	0.002	0.005
Note. χ² = Chi-square; \(\:df\)= degrees of freedom; TLI = Tucker-Lewis Index; CFI = comparative fit index; RMSEA = root mean square error of approximation.

Criterion Validity

The criterion validity was assessed with Pearson correlations between the TNAS and the EORTC QLQ-CIPN20. Given that the dimensionality of the EORTC QLQ-CIPN20 has been questioned in several recent studies [15, 36]and there is a lack of evidence for longitudinal measurement invariance of the EORTC QLQ-CIPN20, we only measured the correlation between TNAS and EORTC QLQ-CIPN20 at T1. The result showed that TNAS had a significant positive correlation with EORTC QLQ-CIPN20 (r = 0.502, p < .001), indicating adequate criterion-related validity of the TNAS.

Internal Consistency

To determine internal consistency, Cronbach’s alpha values were calculated individually for the subscales of the TNAS at three time points. The Cronbach’s alpha values of TNAS at the three time points were 0.880, 0.873, and 0.886, respectively, indicating that TNAS has good internal consistency. (See Table 4 for the Cronbach’s alpha values of the two subscales).

Table 4

Mean (SD) and Cronbach’s alpha of TNAS and its subscales at three-time points.
TNAS and Subscales	Mean	SD	Cronbach’s \(\:\varvec{\alpha\:}\)
TNAS_T1	8.816	2.292	0.880
TNAS_T2	9.866	2.483	0.873
TNAS_T3	10.571	2.603	0.886
Sensory_T1	4.173	1.205	0.903
Sensory_T2	5.020	1.391	0.908
Sensory_T3	5.148	1.419	0.897
Interference_T1	4.642	1.547	0.898
Interference_T2	4.845	1.605	0.889
Interference_T3	5.422	1.637	0.872

This study tested the psychometric properties and longitudinal measurement invariance of a Chinese version of the TNAS, a measure for assessing the severity and course of neuropathy across various cancer treatments. This is the first study to evaluate the psychometric properties of TNAS outside of Western countries, as well as the first attempt to establish the longitudinal invariance of TNAS. Our study found that TNAS has adequate reliability and validity, as well as temporal stability, in a Chinese population of cancer chemotherapy patients.

The CFA showed that the Chinese version of TNAS contained 2 factors (sensory and interference), which was consistent with the English version of TNAS [24]. On the factorial level, the results showed that all items loaded significantly and sufficiently on their respective factors at three-time points. All standardized factor loadings loaded significantly on their respective factors and the factor loading of each item ≥ 0.50. Further, the AVE values of the 2 factors ≥ 0.50, and the CR values of the 2 factors ≥ 0.70, implying that all items belong to their respective factors and the TNAS had a good convergent validity. The sensory subscale contains six items related to sensory symptoms: numbness, tingling, pain, heat or burning, cold sensation, and disturbed sleep. In previous quantitative and qualitative studies, the most common and prominent symptoms described by patients regarding their feelings of TIPN were numbness and pain [37, 38]. The interference subscale contains three items related to symptoms that interfere with daily activities: difficulty walking, difficulty balancing, and difficulty using the hands. The items included in this factor were consistent with findings by other researchers, for example, Bennett et al. [39]and Tofthagen et al.[40] found that patients had problems walking on uneven terrain. Patients reported to Bakitas et al.[10] that TIPN caused them to have difficulty driving. Compared with other existing tools, EORTC QLQ-CIPN20 contains three factors: sensory, motor, and autonomic[17], while FACT/GOG-Ntx contains four factors: sensory, motor, hearing, and dysfunction[18]. During the development of the TNAS, according to the results of qualitative interviews with patients, the autonomic side effects were not prominent, and no items to measure these side effects were included in the TNAS[25]. The three-factor structure of EORTC QLQ-CIPN20 and the four-factor structure of FACT/GOG-Ntx have not been supported in previous studies[15, 30, 36]. In contrast, the two-factor structure of TNAS was confirmed at the three-time points in our study, which indicated the good construct validity of TNAS.

When considering the temporal stability or the factorial equivalence of the TNAS over time, the results provided support for configural, metric, and scalar invariance. This implied that the two-factor structure (sensory and interference) of TNAS is measured equally and consistently across time. The TNAS thus showed similar factor structures, factor loadings, and intercepts at three-time points. The current results support the instrument’s temporal stability, which implied that latent mean differences indicate actual temporal changes in the factors over time and not changes in the meaning of constructs. Therefore, even as a brief TIPN symptom measurement tool, the TNAS can be used for mean comparisons in longitudinal studies.

Results also indicated high criterion validity of the TNAS with another established measure of neuropathy, the EORTC QLQ-CIPN20. Our results showed that TNAS was moderately correlated with EORTC-CIPN20, indicating that there was some overlap between TNAS and EORTC-CIPN20, which was consistent with the previous study [27]. EORTC-CIPN20 includes sensory, motor, and autonomic domains, while TNAS didn’t include any items for autonomic side effects based on the qualitative interview result.Given that the TNAS is brief and less burdensome (only 2 minutes to complete), it can be considered a convenient and rapid measure of neuropathy in clinical practice. Finally, the level of internal consistency for all constructs at three-time points suggested that the TNAS was a reliable measure of TIPN. This is in line with other findings [24, 27] that showed high levels of internal consistency for the Chinese version of the TNAS.

While this study provided valuable insights into the psychometric properties and longitudinal measurement invariance of the TNAS, several limitations must be considered. First, the sample is limited to the urban areas of Tianjin and Jiangxi, China. The results may therefore not be generalizable. Second, due to the lack of evidence on the temporal stability of the EORTC QLQ-CIPN20, we only observed the correlation between the TNAS and the EORTC QLQ-CIPN20 at the one-time point. In the future, instruments with temporal stability should be selected to longitudinally investigate the criterion validity of the TNAS. Third, the neuropathic symptoms collected in this study were patients’ perceptions of the symptoms within 24 hours, which may be subject to memory bias. Future research should adopt ecological momentary assessments to timely capture patients’ current symptoms. Finally, it is suggested that more diverse population groups be considered for future validation studies. The TNAS would benefit from a large-scale cross-cultural validation study to determine whether the same neuropathic symptom perceptions are measured across ethnic groups.

In conclusion, our results support the TNAS as a valid and reliable measure for TIPN within the current context. Additionally, this is the first attempt to test the longitudinal measurement invariance of the TNAS empirically. Accurate measurement and tracking of TIPN are valuable for designing interventions to prevent or reduce exacerbations caused by TIPN. These promising findings contribute to future research and clinical practice on TIPN.

Acknowledgments:

The authors would like to express gratitude to all participants and also acknowledge the contributions made by the volunteers during this study.

Funding statement:

There are no conflicts of interest on the part of any named author and no funding in our study.

Ethical statement:

This study has obtained the approval of the Ethics Committees of Nanjing Medical University (Ethics No. 2024-697).

Consent to participate

All participants in this study agreed to participate and provided written informed consent.

Consent for publication

All authors of this manuscript agreed to publish.

CONFLICT OF INTEREST

There are no conflicts of interest on the part of any named author.

AUTHOR CONTRIBUTIONS

Y.J. and Y.L. were involved in the study’s conception and design. Y.J., Y.L., L.X., and H.M were involved in data collection and analysis. Y.J. and C.T. drafted the manuscript.

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No competing interests reported.

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Psychometric properties and longitudinal measurement invariance of the Treatment-induced Neuropathy Assessment Scale in the Chinese cancer chemotherapy population

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Abstract

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1. INTRODUCTION

2. METHODS

2.1 Design

2.2 Setting and Participants

2.3 Procedures

2.4 Measures

2.5 Ethical Considerations

2.6 Statistical Analyses

3. RESULT

4. DISCUSSION

5. CONCLUSION

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References

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