Preamble

Systematic Review of Patient-Reported Outcome Measures for Cancer Immunotherapy Based on the COSMIN Guidelines

SU Zhenzhen¹, WANG Yixuan², ZHANG Liyan¹*, LIAN Xuemin³, LIU Dan²

¹Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education)/Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing 100142, China
²Peking University School of Nursing, Beijing 100191, China
³Department of Health and Medical Care, Tianjin Medical University General Hospital, Tianjin 300052, China

*Corresponding author: ZHANG Liyan, Chief Superintendent Nurse; E-mail: zl54920@bjmu.edu.cn

[Abstract]

Background: Accurate assessment of immune-related adverse events (irAEs) in cancer patients through patient-reported outcomes facilitates early identification of irAEs and enables timely development and implementation of targeted interventions, which are essential for ensuring continued treatment and favorable prognosis. Currently, commonly used patient-reported outcome measures (PROMs) for cancer immunotherapy are primarily generic scales with poor content validity; nearly 30% of common irAEs cannot be measured, and specific PROMs vary in their items without unified standards. Moreover, the lack of systematic evaluation of measurement properties makes it difficult to select optimal assessment tools.

Objective: To evaluate the psychometric properties of PROMs for cancer immunotherapy and provide evidence-based guidance for healthcare professionals to accurately assess irAEs and quality of life in cancer patients.

Methods: Following the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines, we searched CNKI, Wanfang Data, SinoMed, PubMed, Embase, CINAHL, and ProQuest databases from inception to December 31, 2024. Studies evaluating at least one measurement property of PROMs related to cancer immunotherapy were included. Two researchers independently conducted literature screening and data extraction. Quality assessment was performed using the Chinese version of the COSMIN Risk of Bias checklist and the COSMIN content validity scoring system. The modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to determine recommendation grades.

Results: Nine studies were included, encompassing nine immunotherapy PROMs: Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM), Chinese version of FACT-ICM (C-FACT-ICM), Patient-Reported Outcome for Fighting Financial Toxicity (PROFFIT), PRO-CTCAE Lung Cancer Subscale, MD Anderson Symptom Inventory Module Specific to Immunotherapy for Early-Phase Trials (MDASI-Immunotherapy EPT), Chinese version of MDASI-Immunotherapy EPT, Lung Cancer Immunotherapy PRO-CTCAE Subset, Cancer Immunotherapy Patient Symptom Self-Report Scale, and Self-Report Symptom Inventory of Immune-Related Adverse Events in Patients with Lung Cancer (SRSI-irAEs-LC). None reported cross-cultural validity, measurement error, or responsiveness. For content validity, FACT-ICM and PROFFIT were rated as "adequate," while others were "uncertain." For internal consistency, FACT-ICM was not validated, and PROFFIT was rated as "inadequate." No scale met criteria for high-level evidence of "inadequate" measurement properties, resulting in B-level recommendations for all nine tools.

Conclusion: C-FACT-ICM may be tentatively recommended (Grade B) for measuring patient-reported outcomes across various cancer immunotherapy contexts to enhance clinical applicability. However, overall methodological quality and psychometric properties of cancer immunotherapy PROMs require further validation and improvement.

[Keywords] Cancer; Immunotherapy; Patient-reported outcome; Assessment tools; Systematic review; Psychometrics; COSMIN

1. Materials and Methods

This study followed the 2024 PRISMA-COSMIN guideline for reporting systematic reviews of outcome measurement instruments and was registered in the PROSPERO database (registration number: CRD42023458328).

1.1 Search Strategy

We conducted systematic searches in CNKI, Wanfang Data, SinoMed, PubMed, Embase, CINAHL, and ProQuest from database inception to December 31, 2024. Manual searches of reference lists from included studies were also performed. The search combined MeSH terms and free-text keywords including "immunotherapy," "patient reported outcome measures," "index," and "development" in English, and corresponding Chinese terms. The PubMed search strategy is shown in [TABLE:1].

1.2 Inclusion and Exclusion Criteria

Inclusion criteria: (1) Adult cancer patients receiving ICIs; (2) Studies evaluating at least one measurement property of immunotherapy PROMs; (3) Chinese or English language publications.

Exclusion criteria: (1) Studies using PROMs solely as outcome measures or as validation criteria for other PROMs; (2) Reviews, commentaries, case reports, or conference abstracts; (3) Unavailable full texts or duplicate publications.

1.3 Literature Screening and Data Extraction

Two researchers independently performed literature screening and data extraction using a pre-designed form, with cross-checking to ensure accuracy and completeness. Discrepancies were resolved through discussion or by a third researcher when necessary. Extracted data included: first author, publication year, country, sample size; PROMs name, target population, recall period, dimensions/item count, language; and evaluated measurement properties (content validity, structural validity, internal consistency, etc.).

1.4 Evaluation Methods

1.4.1 Evaluation Procedure

Following COSMIN guidelines, two trained researchers independently assessed methodological quality and measurement properties, with cross-checking and third-researcher arbitration for disagreements. First, the Chinese version of the COSMIN Risk of Bias checklist was used to evaluate methodological quality. Next, the Chinese version of the COSMIN content validity scoring system and updated COSMIN criteria for good measurement properties were applied. Finally, evidence was synthesized and recommendation grades were determined using the modified GRADE approach.

1.4.2 Evaluation Tools

(1) Methodological quality assessment: The Chinese COSMIN Risk of Bias checklist evaluates 10 modules: PROMs development, content validity, structural validity, internal consistency, cross-cultural validity, reliability, measurement error, criterion validity, hypothesis testing, and responsiveness. Each module contains 3–35 items rated as "very good (V)," "adequate (A)," "doubtful (D)," "inadequate (I)," or "not applicable." The lowest rating determines the overall quality per module.

(2) Measurement property assessment: The Chinese COSMIN content validity scoring system evaluates relevance, comprehensiveness, and comprehensibility. Updated COSMIN criteria assess structural validity, internal consistency, reliability, measurement error, hypothesis testing, cross-cultural validity, criterion validity, and responsiveness. Properties are rated as "adequate (+)," "inadequate (-)," or "uncertain (?)." Inconsistent findings across studies yield an overall rating of "inconsistent (±)."

(3) Evidence grading: The modified GRADE approach evaluates four factors: risk of bias, inconsistency, imprecision, and indirectness. Recommendation levels are "high," "moderate," "low," and "very low." Starting with an assumed "high" quality for each property, grades are downgraded based on these factors. Final recommendation grades are: Grade A (recommended) for adequate content validity plus at least low-level evidence of adequate internal consistency; Grade B (potential for use) for PROMs not meeting Grade A or C criteria; Grade C (not recommended) for high-level evidence of inadequate measurement properties.

2. Results

2.1 Literature Screening Results

The initial search yielded 2,280 articles: CNKI (n=31), Wanfang (n=0), SinoMed (n=3), PubMed (n=1,512), Embase (n=688), CINAHL (n=2), and ProQuest (n=44). Three additional references were identified through manual searches. After deduplication, 1,569 articles remained. Following screening against inclusion/exclusion criteria, nine studies were ultimately included [FIGURE:1].

2.2 Characteristics of Included Studies and PROMs

Among the nine included studies, seven involved development and psychometric testing of immunotherapy PROMs, while two were cross-cultural adaptation and validation studies. Considering differences in item content between Chinese and English versions, adapted scales were treated as separate tools, yielding nine distinct immunotherapy PROMs: FACT-ICM, C-FACT-ICM, PROFFIT, PRO-CTCAE Lung Cancer Subscale, MDASI-Immunotherapy EPT, Chinese version of MDASI-Immunotherapy EPT, Lung Cancer Immunotherapy PRO-CTCAE Subset, Cancer Immunotherapy Patient Symptom Self-Report Scale, and SRSI-irAEs-LC. Development years ranged from 2020–2024, with item counts ranging from 8–116. Two studies included patients receiving various treatments (chemotherapy, immunotherapy), while seven focused exclusively on immunotherapy patients. Basic characteristics are summarized in [TABLE:2].

2.3 Measurement Properties and Methodological Quality

None of the nine studies reported cross-cultural validity, measurement error, or responsiveness. Other methodological and measurement property evaluations are detailed below.

2.3.1 Validity Assessment

Content validity: Three studies consulted experts and target patients regarding relevance, comprehensiveness, and comprehensibility, with subsequent tool modifications, yielding "very good" methodological quality ratings. Except for PRO-CTCAE-LC (which did not specify a recall period and received an "uncertain" rating), the other two tools were rated as having "adequate" content validity. Two studies had insufficient comprehensiveness assessment: one conducted cognitive interviews with 10 patients but only consulted six oncology experts about linguistic appropriateness, relevance, and comprehensiveness; another used only quantitative surveys with eight experts and 20 patients. Both received "doubtful" methodological quality ratings and "uncertain" content validity ratings. Four studies inadequately described their content validity testing procedures, resulting in "inadequate" methodological quality and "uncertain" content validity ratings.

Structural validity: Five studies evaluated structural validity. Three used confirmatory factor analysis (CFA) with adequate sample sizes, receiving "very good" methodological quality ratings. Two reported RMSEA <0.06, yielding "adequate" structural validity ratings. Two studies used exploratory factor analysis (EFA) without reporting fit indices, receiving "adequate" methodological quality and "uncertain" structural validity ratings.

Criterion validity: One study reported criterion validity with correlation coefficients >0.7 using established assessment tools, receiving an "inadequate" methodological quality rating but "adequate" criterion validity rating.

2.3.2 Reliability Assessment

Internal consistency: Six studies evaluated internal consistency, calculating Cronbach's α for each unidimensional scale or subscale, resulting in "very good" methodological quality ratings. All six demonstrated Cronbach's α ≥0.7, indicating "adequate" internal consistency. Three studies did not conduct internal consistency validation.

Test-retest reliability: Three studies reported test-retest reliability. Two calculated intraclass correlation coefficients (ICC) ≥0.7 but used 3-week intervals, exceeding COSMIN's 2-week requirement, resulting in "inadequate" methodological quality but "adequate" test-retest reliability ratings. One study calculated Pearson correlation coefficients with a 1-week interval without evidence of absence of systematic change, yielding "inadequate" methodological quality and "uncertain" test-retest reliability ratings.

2.3.3 Hypothesis Testing

Three studies evaluated construct validity through convergent and discriminant validity testing in similar populations, with >75% of results supporting hypotheses, receiving "very good" methodological quality and "adequate" hypothesis testing ratings.

2.4 Evidence Quality and Recommendations

Risk of bias: Four studies received "inadequate" ratings for content validity methodology, downgrading evidence quality by two levels; two received "doubtful" ratings, downgrading by one level. Five studies received "very good" or "adequate" ratings for structural validity, with no downgrading. One study's criterion validity was downgraded two levels due to "inadequate" methodology. Six studies maintained internal consistency evidence quality without downgrading. Three studies had test-retest reliability evidence downgraded two levels due to "inadequate" methodology. Three studies maintained hypothesis testing evidence quality without downgrading.

Imprecision: Three studies addressed only content validity; remaining studies had sample sizes >100, with no downgrading. Indirectness: Two studies included patients receiving treatments beyond immunotherapy, resulting in one-level downgrading; others were not downgraded. No inconsistency was reported across studies.

Final ratings: Content validity was "adequate" for FACT-ICM and PROFFIT, "uncertain" for others. Internal consistency was "adequate" for six tools, not validated for FACT-ICM, and "inadequate" for PROFFIT. No tool met criteria for high-level evidence of inadequate properties, resulting in no Grade C recommendations. All nine tools received Grade B recommendations [TABLE:4].

3. Discussion

3.1 Methodological Quality of Immunotherapy PROMs Requires Improvement

Content validity assessment was incomplete, with qualitative methods needing refinement. Content validity is the most crucial measurement property. According to COSMIN guidelines, it requires evaluation of relevance, comprehensiveness, and comprehensibility from both patient and expert perspectives. However, several scales inadequately addressed content validity during development, relying primarily on expert consultation while neglecting patient perspectives, and failing to clearly report recall periods and instructions, compromising overall quality. This finding aligns with similar evaluations of palliative care quality assessment tools and cancer fatigue assessment instruments.

Additionally, two studies used only quantitative surveys without qualitative research, possibly due to time and resource constraints or emphasis on quantitative data collection. Qualitative interviews provide indispensable depth for understanding patient experiences and needs. For example, one study conducted three rounds of cognitive interviews with adult cancer patients during PROM development, effectively eliminating gaps and achieving professional, comprehensible semantic transformations. Future development of immunotherapy PROMs should include cognitive interviews with ≥7 patients by ≥2 experienced researchers to ensure items align with target population understanding. Reporting should strictly follow COSMIN guidelines and qualitative research reporting standards to enhance comprehensiveness and standardization.

Criterion validity was often confused with hypothesis testing. Criterion validity assesses how well PROMs reflect a "gold standard," while hypothesis testing examines correlations with other measures or differences between subgroups. Researchers frequently failed to distinguish these methods in reporting. For instance, one study reported criterion validity when it actually conducted hypothesis testing, contrary to COSMIN requirements. Future studies should carefully review COSMIN guidelines to ensure appropriate design and reporting, clearly describing methods and results, specifying comparator instruments, and avoiding confusion. For abbreviated scales, source scales can serve as "gold standards" for criterion validity assessment.

Test-retest reliability reporting was unclear, requiring methodological optimization. Test-retest reliability is fundamental for measuring consistency. COSMIN guidelines require testing under identical conditions with ICC or Kappa calculations. However, some studies either failed to report test-retest reliability or used inappropriate designs. Three studies violated the 2-week interval requirement: two used 3-week intervals (potentially compromising stability), and one used a 1-week interval (risking memory effects). Similar issues have been identified in evaluations of resilience scales and hepatocellular carcinoma PROMs. Future research should optimize test-retest design with appropriate intervals and consistent conditions to ensure stable, reliable instruments.

3.2 Incomplete Reporting of Psychometric Properties Requires Further Validation

Two cross-cultural adaptation studies lacked evaluation of cross-cultural validity, potentially affecting reliability across cultural contexts. Future adaptation studies should assess differential item functioning to ensure applicability and scientific rigor.

Furthermore, none of the nine studies reported measurement error or responsiveness. Measurement error includes systematic and random errors beyond true score changes. COSMIN recommends calculating standard error of measurement, limits of agreement, or minimal detectable change for quantitative data, and percentage agreement for categorical data. Responsiveness reflects sensitivity to change over time. As immunotherapy PROM development is still evolving, future studies should incorporate these properties to enhance scientific validity.

Three studies reported only content validity, omitting structural validity and internal consistency. Structural validity is crucial for evaluating construct alignment and is inseparable from internal consistency assessment. Both properties determine overall tool quality. Development should simultaneously address these through exploratory and confirmatory factor analysis. One study used both approaches, retaining highly sensitive and representative items, providing a model for future immunotherapy PROM development. Comprehensive evaluation of all relevant properties ensures rigorous item selection.

3.3 C-FACT-ICM May Be Tentatively Recommended but Requires Further Validation

The nine tools assessed immunotherapy PRO from multiple dimensions. The Lung Cancer Immunotherapy PRO-CTCAE Subset had the most items but suffered from redundancy, cumbersome administration, and limited validation (only content validity with "inadequate" methodological quality). PRO-CTCAE-LC had the fewest items and simple operation but included all cancer patients, potentially limiting applicability to immunotherapy populations.

Based on psychometric and methodological evaluation, all tools received Grade B recommendations. While FACT-ICM and PROFFIT had "adequate" content validity, FACT-ICM lacked internal consistency validation, and PROFFIT had "inadequate" internal consistency, requiring further reliability testing. Other scales had "uncertain" content validity, indicating need for improvement.

For structural validity, only C-FACT-ICM and SRSI-irAEs-LC were "adequate." C-FACT-ICM received the most comprehensive psychometric evaluation with moderate-to-high-quality evidence supporting content validity, structural validity, and internal consistency. Developed by Meng et al. in 2023 through translation and validation of the original FACT-ICM from Princess Margaret Cancer Centre, Toronto, it comprises FACT-G and ICM subscales covering physical, emotional, social/family, functional well-being, and immunotherapy-specific domains (42 items, Likert 5-point scoring, 0–4 range). Higher scores indicate better quality of life, effectively assessing multidimensional experiences. However, it has not been clinically implemented and lacks cross-cultural validity, measurement error, and responsiveness data. Therefore, C-FACT-ICM may be tentatively recommended (Grade B) for assessing physical, psychological, and social functioning in immunotherapy patients, but requires further validation of missing properties and clinical usability.

Limitations: (1) Only Chinese and English literature was included; (2) Studies not using COSMIN-specified measurement properties were excluded; (3) Newly developed scales without reported properties were excluded, potentially introducing bias. Future research should include more psychometric evaluations, employ diverse assessment tools, and follow up with developers of scales lacking property reports to enhance comprehensiveness.

In conclusion, C-FACT-ICM may be tentatively recommended (Grade B) for measuring patient-reported outcomes across cancer immunotherapy settings to improve clinical applicability. Overall, methodological quality and psychometric properties of cancer immunotherapy PROMs require further validation and refinement. Future studies should adhere to COSMIN guidelines in design and validation to generate high-quality evidence for clinical practice.

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Received: April 10, 2025; Revised: July 10, 2025
Edited by: LI Weixia