Table 5.

Review of psychometric properties of identified questionnaires using modified version of COSMIN checklist

PRO	Study used in	Conceptual model	Reliability	Content validity	Construct validity	Responsiveness to change	Target population of PRO: generic, cancer, disease, or ACT specific
SF-36 Health Survey (SF-36) [50]	Hoogland, Maziarz	Eight multi-item dimensions covering functional status, wellbeing and overall evaluation of health	Internal consistency and test–retest demonstrated	Patient interviews conducted	Yes—scores distributed as expected for sex, age, social class, use of health services and for patients with chronic disease	Not mentioned	Generic
Patient-Reported Outcome Measurement Information System-29 (PROMIS-29) [48]	Hoogland, Mullane, Ruark, Wang	Assesses pain intensity using a single 0–10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain	Internal consistency. More reliable than existing summary scores	No details provided	No details provided	No details provided	Generic
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) [51]	Hoogland, Sidana	PRO-based measurement system to capture symptomatic adverse events by self-report in cancer clinical trials	Test–retest reliability was acceptable for 36/49 pre-specified items	Patient interviews conducted	Overall, 119/124 items met at least one construct validity criterion	Statistically significant correlations were observed between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes for all 27 pre-specified items (median r = 0.43, range 0.10–0.56; all P ≤ .006)	Cancer specific
Inventory of Depression and Anxiety Symptoms (IDAS) [52]	Knight	To create specific symptom scales reflecting distinctive aspects of depression and anxiety	Test–retest reliability figures ranged from 0.72 to 0.83. Good internal consistency	No details provided	Presented data correlating the IDAS with both the HRSD and the IMAS, we have not yet examined it in relation to formal DSM-IV diagnoses of major depression and the anxiety disorders	No details provided	Generic
Brief Pain Inventory (BPI) [53]	Knight	Measures sensory and reactive pain. Rate intensity and how much pain interferes with activities	Good internal consistency (CA 0.78–0.95 across the two scales). Test–retest reliability is mixed	Patient interviews conducted	Factor analysis was consistent across different clinical groups	Ability to detect clinically meaningful change	Generic
Fatigue Severity Index (FSI)	Knight	Questionnaire could not be located
Pittsburgh Sleep Quality Index (PSQI) [54]	Knight	Aims to discriminate between good and poor sleepers and be a useful tool for researchers and clinicians. Assesses sleep duration and latency and frequency and severity of sleep problems	Good test–retest reliability	Developed using experience with patients but interviews not mentioned	Significant differences across groups	Not mentioned	Generic
Simplified QoL questionnaire	Li	None	None	None	None	None	Study specific
European Organisation for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) [55]	Martin, Shah	Generate a core questionnaire incorporating a range of physical, emotional and social health issues relevant to a broad spectrum of cancer patients, irrespective of specific diagnosis. This core instrument could then be supplemented by diagnosis-specific (e.g. lung cancer or breast cancer) and/or treatment-specific questionnaire modules	The recommended 0.7 for good internal consistency between groups was met for 8 of the 9 subscales	Patient interviews	Could discriminate across clinical criteria	Significant changes in the right direction were reported for functional scales	Cancer specific
European Organisation for Research and Treatment of Cancer Multiple Myeloma (EORTC MY20)	Martin, Shah	To assess the disease-specific symptoms of myeloma and their impact on everyday life and treatment-related issues, mainly side effects of chemotherapy. To be used in conjunction with QLQ-C30	Internal consistency was greater than 0.7 CA for all scales	Interviews with patients, oncologists and haematologists	Correlations with QLQ-C30 items. Two subscales (disease symptoms and side effects) and the body image item could discriminate by PS and patients with/without fractures	Pain was only scale to show significant change over time	Disease specific (myeloma)
EuroQoL 5D (EQ-5D-5L) [56]	Martin, Wang, Shah	Generic instrument for describing and valuing health	Korean version reliable in cancer patients	Patient interviews	Scores were reported in expected direction for key characteristics, e.g. age, education, smoking, status	Could detect improvements and deterioration in health (breast cancer)	Generic
EuroQoL 5D EQ-5D-3L [57]	Laetsch	A standardised non-disease-specific instrument for describing and valuing HRQOL			Responses conform to what would be expected for key characteristics		Generic
EuroQoL 5D Youth (EQ-5D-Y) [58]	Laetsch	A standardised non-disease-specific instrument suitable for children and adolescents	Test–retest results were good for most domains. Ceiling effects for mobility and self-care	Interviews with healthy and chronically ill young people	High correlations with existing questionnaires. Able to distinguish between those with chronic pain and those without	Largest treatment effect observed in chronically ill children. Poorer responses in children with minimal pr no health concerns	Generic
Patient-Reported Outcome Measurement Information System Global Health (PROMIS Global Health) [59]	Mullane, Ruark	Global health refers to a person’s general evaluations of health rather than any of its specific components. The global health items include global ratings of the five primary PROMIS domains (physical function, fatigue, pain, emotional distress and social health) and general health perceptions that cut across domains			Correlations with comparable items from PROMIS		Generic
Additional questions	Mullane, Ruark	None	None	None	None	None	Study specific
MD Anderson Symptom Inventory (MDASI) [60]	Wang	Brief measure of the impact and severity of symptom items	The values of a for the two sets of symptom items and the interference scales, respectively, were 0.85, 0.82 and 0.91 for the validation sample and 0.87, 0.87 and 0.94 for the cross-validation sample, which shows a high level of reliability for these sets of items	Clinician assessment but patients not mentioned	Able to differentiate between PS	Not mentioned	Cancer specific
Single-item HRQOL	Wang	None	None	None	None	None	Study specific
CAR T-cell therapy-specific symptoms	Wang	None	None	None	None	None	Study specific
The Pediatric Quality-of-Life Inventory (PedsQL) [61]	Laetsch	Integrates generic core scales and disease-specific modules into one measurement system. Designed to measure core health domains covered in WHO	Most self-report scales and proxy-report scales approached or exceeded the minimum reliability standard of 0.70	No details provided	The PedsQL performed as hypothesized utilising the known-groups method. The PedsQL differentiated HRQOL between healthy children and those with acute or chronic health conditions and was correlated with measures of morbidity and illness burden. The MTMM analyses tested convergent and discriminant validity across methods. The heterotrait-monomethod analyses are consistent with the conceptualization of the PedsQL as measuring an integrated multidimensional construct	No details provided	Generic (paediatric)
Functional Assessment Cancer Therapy-General (FACT-G) [62]	Sidana	Generic scale which can be combined with disease-specific modules. Quality of life treated as a subjective multidimensional concept	Good internal consistency demonstrated for the subscales	Patient interviews used to generate items	Convergent and divergent validity were demonstrated when compared with other measures. Able to differentiate between stage of disease	Could detect change over time in performance status	Cancer specific
Quality of Life in Neurological Disorders (Neuro-QoL v2) [63]	Sidana	Neuro-QoL is a new, standardized approach to measuring HRQL across common neurologic conditions		Patient-focus groups		Conditional minimal detectable change scores have been estimated for Neuro-QoL short forms. Thresholds for severity of four Neuro-QoL measures (fatigue, upper extremity function, lower extremity function-mobility, sleep disturbance) have been estimated using a modified bookmarking methodology based on the perspective of individuals with multiple sclerosis and clinicians	Disease specific (neurological)
Functional Assessment of Cancer Therapy (FACT-Lym) [64]	Maziarz	Lymphoma-specific questionnaire designed to compliment FACT-G	Internal consistency coefficients for the 15-item LymS (0.79, 0.85 and 0.84 T1–T3) and test–retest stability (0.84) indicated good reliability	Interviews with clinicians and patients	Did not differentiate between patient groups defined by NHL grade. Patients currently on treatment had lower FACT-Lym scores. Moderate correlations with POMS, SF-36 and PCS	Able to differentiate between three patient groups overtime (worse unchanged better)	Disease specific (lymphoma)