Author: Ray Baser
Date: 2023-10-16

# Descriptions of Instruments Scored by PROscorer

#### Ray Baser

#### 2023-10-16

# Introduction:

This vignette includes descriptions of the instruments scored by the PROscorer package.

PROBLEM: Patient reported outcome (PRO) measures and other PRO-like instruments are often poorly and inadequately described in formal research protocol documents and in published reports of study results.

CONSEQUENCES: In protocols, this makes it difficult or impossible to evaluate the suitability of the PRO measures as study outcomes, including whether the proposed analysis plans are appropriate. The same consequences apply to published study results. In addition, poor PRO measure descriptions in published studies hinder the ability interpret, replicate, and reproduce study results. Altogether, this impedes the scientific progress of research that relies upon PRO and similar measures.

SOLUTION: Create a repository of high-quality descriptions of specific PRO instruments (i.e., this vignette document), written according to explicit guidelines for describing PRO measures in research protocols and papers.

This document is intended to ease the burden of writing research protocols and manuscripts for studies with quality of life (QOL) or other patient-reported outcome (PRO) measures as endpoints.

The descriptions are written with sufficient detail to be included in formal research protocol documents that utilize the instruments as outcome measures. They are also suitable for the “Measures” subsection of manuscripts reporting the results of such studies (potentially with editing, to meet word limits). They were written with these purposes in mind, and follow the below “Guidelines for Describing PRO Measures” that I developed based on several sources of “best practices” for describing PRO measures (references coming soon) and on my personal experience as a protocol review committee chair at a large cancer center.

# How to Use These Descriptions:

Each instrument description is complete with relevant references. In most cases, the description can be copied and pasted directly into your document with only very minor modifications.

The following modifications are needed:

- Move the references to the References section of the your document, and update in-text citation numbers accordingly.

- If not all of the scored scales of the instrument are of interest to the study objectives, then add a sentence indicating the focal scale scores.

Please cite the PROscorer package and this vignette document (I hope to obtain DOIs soon):

Baser, RE (2023). PROscorer: Scoring Functions for Patient-Reported Outcome (PRO) Measures and Other Psychometric Instruments. R Package Version 0.0.4. https://cran.r-project.org/package=PROscorer

Baser, RE (2023). Descriptions of Instruments Scored by PROscorer. R Package Vignette version 0.0.4. https://cran.r-project.org/package=PROscorer

# Guidelines for Describing Patient Reported Outcome Measures (PROMs):

I developed the following guidelines during my years of service as a chair of the Biostatistics Protocol Review Committee at a large cancer treatment and research institution. If you would like to contribute a scoring function to the PROscorer package, please use these guidelines to write a description of your instrument. I plan to update these guidelines soon into a more user-friendly checklist, but this should get you started.

Information to Include in Descriptions of PRO Measures:

1. The total number of questions/items on the instrument(s), their response format (e.g., 5-point Likert scale, True/False, etc.), and the time period for which respondents are asked to consider each item (e.g., “In past week, how often …”).

2. The names of any subscale scores that the instrument yields, descriptions of the specific constructs that each of these subscales are intended to measure, the number of items included on each subscale, the range of scores that is possible on each subscale, the interpretation of higher scores (e.g., higher scores indicate more/less severe symptom levels), and, if available, reliability coefficients (e.g., internal consistency, test-retest) for each subscale score and, if relevant, for the instrument’s total score.

   1. Many PROM scores have validated cut-points that divide the scores into 2 or more range categories believed to be clinically or diagnostically relevant. If the PROM has such score categories, provide the score cut-points or ranges defining each category as well as the clinical interpretation of each category.

3. A citation and reference to the instrument’s original psychometric validation study, and any relevant subsequent validation studies. At least one reference should indicate how the instrument is scored. Please also mention the PROscorer R package and the relevant PROscorer scoring function, and please cite the PROscorer R package.

4. Estimates of how long it will take study participants to complete the PROM, as well as an estimate of how long it will take them to complete the full battery of PROMs.

# Instrument Descriptions:

## Female Sexual Function Index (FSFI)

The Female Sexual Function Index (FSFI) is a multidimensional self-report measure of female sexual functioning[REF 1]. It asks women to rate its 19 items according to “the past 4 weeks” using a Likert-type response format. Four of the items are scored from 1 to 5, and fifteen are scored from 0 to 5 (with 0 corresponding to response option “Did not attempt intercourse”). It takes approximately 5-10 minutes to complete.

In additional to the FSFI Total score, the FSFI produces 6 subscale scores corresponding to distinct sexual function domains: Desire (2 items), Arousal (4 items), Lubrication (4 items), Orgasm (3 items), Satisfaction (3 items), and Pain (3 items). The FSFI scoring algorithm sums the items on each subscale and then scales the sums so that each subscale has a maximum possible score of 6. The subscales have a minimum possible score of 0 except for Desire and Satisfaction, which have minimum possible scores of 1.2 and 0.8, respectively. This is because those two subscales contain the four items scored 1 to 5 (instead of 0 to 5). The FSFI total score is the sum of the 6 subscale scores and ranges from 2 to 36. Higher scores indicate better functioning for all scores. Accurate scoring for the FSFI is available in the PROscorer R package using the `fsfi()` function[REF 2].

The initial FSFI validation study[REF 1] reported excellent internal consistency reliability for the FSFI total score (Cronbach’s α = 0.97) and subscales (Cronbach’s α range = 0.89 to 0.96). A FSFI total score of 26.55 or less has been validated as a diagnostic cut off score suggestive of female sexual dysfunction[REF 3]. The FSFI has also been validated for assessing sexual function among sexually active female cancer survivors[REF 4].

#### REFERENCES:

1. Rosen, R, Brown, C, Heiman, J, Leiblum, S, Meston, C, Shabsigh, R, … D’Agostino, R. (2000). The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. Journal of Sex & Marital Therapy, 26(2), 191–208.

2. Baser, RE (2023). PROscorer: Scoring Functions for Patient-Reported Outcome (PRO) Measures and Other Psychometric Instruments. R Package Version 0.0.4.

3. Wiegel, M, Meston, C, & Rosen, R. (2005). The Female Sexual Function Index (FSFI): Cross-Validation and Development of Clinical Cutoff Scores. Journal of Sex & Marital Therapy, 31(1), 1–20.

4. Baser, RE, Li, Y, & Carter, J. (2012). Psychometric validation of the female sexual function index (FSFI) in cancer survivors. Cancer, 118(18), 4606–4618.

## Cognitive Causation (CC) and Negative Affect in Risk (NAR)

The Cognitive Causation (CC) and Negative Affect in Risk (NAR) scales are two new measures of intuitive, gut-level aspects of cancer risk perception[REF 1]. The CC scale measures the extent to which respondents believe that thoughts about cancer risk can encourage the development of the disease, and that minimizing such thoughts can actually reduce cancer risk. It originally contained 10 items[REF 1], but it is recommended to score only 7 items[REF 2]. The NAR scale contains 6 items and measures negative anticipatory affect, or negative emotions (e.g., fear) generated during cancer risk information processing. Both the CC and NAR items have 4, Likert-type response options that are assigned numeric scores: Strongly Disagree = 0, Disagree = 1, Agree = 2, and Strongly Agree = 3. Each instrument takes approximately 2-5 minutes to complete.

The preferred scoring method is to first calculate the mean of the item scores, and then transform that mean to range from 0 to 100. Higher scores indicate greater levels of the constructs being measured[REF 2]. A score should only be assigned to respondents who validly completed at least half of items on a given scale. The CC and NAR scales can be accurately scored using the `narcc()` function in the PROscorer R package [REF 3].

Both scales have had consistently high reliability across diverse samples, with Cronbach’s alpha coefficients all 0.89 or higher[REF 1]. The items have also demonstrated measurement invariance across highly diverse samples[REF 2].

#### REFERENCES:

1. Hay, JL, Baser, R, Weinstein, ND, Li, Y, Primavera, L, & Kemeny, MM. (2014). Examining intuitive risk perceptions for cancer in diverse populations. Health, Risk & Society, 16(3), 227–242.

2. Baser, RE, Li, Y, Brennessel, D, Kemeny, MM, & Hay, JL. (2017). Measurement Invariance of Intuitive Cancer Risk Perceptions Across Diverse Populations: The Cognitive Causation and Negative Affect in Risk Scales. Journal of Health Psychology.

3. Baser, RE (2023). PROscorer: Scoring Functions for Patient-Reported Outcome (PRO) Measures and Other Psychometric Instruments. R Package Version 0.0.4.

## EORTC QLQ-BLM30

The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BLM30 Muscle-Invasive Bladder Cancer Module is a 30-item questionnaire designed to assess health-related quality of life (HRQoL) in patients with muscle-invasive bladder cancer.[REF 1] The questionnaire asks patients to indicate the extent to which they have experienced each of the problems “during the past week” on a 4-point Likert-type response scale from “Not at all” to “Very much”.

The 30 items of the QLQ-BLM30 yield 7 scale scores. Of the 7 scores, 6 are Symptom Scales and 1 is a Functional Scale. Five of the Symptom Scales are based on multiple items: Urinary Symptoms (7 items), Urostomy Problems (6 items), Future Perspective (3 items), Abdominal Bloating and Flatulence (2 items), and Body Image (3 items). One Symptom Scale is based on a single item (Catheter Use Problems). The single Functional Scale, Sexual Functioning, is based on either 2, 4, 6, or 7 items, depending on whether the respondent is male or female and whether he or she is sexually active. Psychometric validation results for the QLQ-BLM30 are lacking.[REF 1]

The scoring procedure for the QLQ-BLM30 (available at https://qol.eortc.org/questionnaires/) transforms all of the scale and single-item scores to range from 0 to 100. High scores for the functional scale represent high/healthy levels of functioning, but high scores for the symptom scales/items represent high levels of symptomatology/problems. Accurate scoring for the EORTC QLQ-BLM30 is available in the PROscorer R package using the `qlq_blm30()` function[REF 2]. Note that the QLQ-BLM30 instructs respondents to answer subsets of questions conditional on whether they have a urostomy or not, whether they used a catheter during the past week, whether they are a man or a woman, and whether they have been sexually active during the past 4 weeks. Therefore, not all of the scale scores are applicable to all patients.

#### REFERENCES:

1. Rammant E, Fox L, Beyer K, et al. The current use of the EORTC QLQ-NMIBC24 and QLQ-BLM30 questionnaires for the assessment of health-related quality of life in bladder cancer patients: a systematic review. Qual Life Res. Published online January 17, 2023.

2. Baser, RE (2023). PROscorer: Scoring Functions for Patient-Reported Outcome (PRO) Measures and Other Psychometric Instruments. R Package Version 0.0.4.

## EORTC QLQ-C30 (version 3.0)

The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Quality of Life Questionnaire (version 3.0) is a 30-item questionnaire designed to assess the quality of life of cancer patients[REF 1]. The 30 items of the QLQ-C30 yield both multi-item scale scores and single-item scores, for a total of 16 distinct scores. These include one Global Health Status/QoL scale (2 items), five functional scales (Physical Functioning, 5 items; Role Functioning, 2 items; Emotional Functioning, 4 items; Cognitive Functioning, 2 items; and Social Functioning, 2 items), three symptom scales (Fatigue, 3 items; Nausea and Vomiting, 2 items; and Pain, 2 items), six single item symptom scores (Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, and Financial Difficulties; all from single items), and the more recently validated overall summary score (calculated from the other scores, excluding Global Health Status/QoL and Financial Difficulties)[REF 2]. The questionnaire asks patients to indicate the extent to which they have experienced each of the problems “during the past week” on a 4-point Likert-type scale from “Not at all” to “Very much”. The 2 exceptions are the 2 items of the Global Health Status/QoL scale, which patients are asked to rate on a 7-point scale from “Very poor” to “Excellent”.

The scoring procedure for the QLQ-C30[REF 3] transforms all of the scale and single-item scores to range from 0 to 100. High scores for the Global Health Status/QoL scale represents high QoL, high scores for the functional scales represent high/healthy levels of functioning, but high scores for the symptom scales/items represent high levels of symptomatology/problems. The newer overall summary score also ranges from 0 to 100, with higher scores indicating better functioning and lower levels of symptoms. Accurate scoring for the EORTC QLQ-C30 (version 3.0), including the newer overall summary score, is available in the PROscorer R package using the `qlq_c30()` function[REF 4]. The QLQ-C30 has been extensively validated and is widely used in clinical trials. The multi-item scales generally have good internal consistency reliability coefficients[REF 1].

#### REFERENCES:

1. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JCJM, Kaasa S, Klee MC, Osoba D, Razavi D, Rofe PB, Schraub S, Sneeuw KCA, Sullivan M, Takeda F (1993). The European Organisation for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, ; 85: 365-376.

2. Giesinger JM, Kieffer JM, Fayers PM, Groenvold M, Petersen MA, Scott NW, Sprangers MAG, Velikova G, Aaronson NK (2016). Replication and validation of higher order models demonstrated that a summary score for the EORTC QLQ-C30 is robust. Journal of Clinical Epidemiology 69:79–88.

3. Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition). Published by: European Organisation for Research and Treatment of Cancer, Brussels 2001.

4. Baser, RE (2023). PROscorer: Scoring Functions for Patient-Reported Outcome (PRO) Measures and Other Psychometric Instruments. R Package Version 0.0.4.

## EORTC QLQ-CR38

The European Organization for Research and Treatment of Cancer (EORTC) QLQ-CR38 Colorectal Cancer Module is a 38-item questionnaire designed to assess health-related quality of life (HRQoL) in patients with colorectal cancer.[REF 1] The questionnaire asks patients to indicate the extent to which they have experienced each of the problems “during the past week” on a 4-point Likert-type response scale from “Not at all” to “Very much”.

The 38 items of the QLQ-CR38 yield 12 scale scores. Of the 12 scores, 8 are Symptom Scales and 4 are Functional Scales. Seven of the Symptom Scales are based on multiple items: Micturition Problems (3 items), Gastrointestinal Tract Symptoms (5 items), Chemotherapy Side-Effects (3 items), Problems with Defecation (Only for Pts WITHOUT a stoma) (7 items), Stoma-Related Problems (Only for Pts w/stoma) (7 items), Male Sexual Problems (2 items), and Female Sexual Problems (2 items). There is 1 single-item symptom scale (Weight Loss). Two of the Functional Scales are based on multiple items: Body Image (3 items), and Sexual Functioning (2 items). The other 2 Functional Scales are based on single items (Sexual Enjoyment and Future Perspective).

Note that the QLQ-CR38 instructs respondents to answer subsets of questions conditional on whether they have a have a stoma or not, whether they are a man or a woman, and whether they have been sexually active during the past 4 weeks. Therefore, not all of the scale scores are applicable to all patients.

The scoring procedure for the QLQ-CR38 transforms all of the scale and single-item scores to range from 0 to 100. High scores for the functional scale represent high/healthy levels of functioning, but high scores for the symptom scales/items represent high levels of symptomatology/problems. Accurate scoring for the EORTC QLQ-CR38 is available in the PROscorer R package using the `qlq_cr38()` function[REF 2]. The scoring instructions for the QLQ-CR38 are no longer available on the EORTC website, and the QLQ-CR38 seems to have been superseded by the QLQ-CR29[REF 3], which was designed in response to concerns that the QLQ-CR38 was outdated and no longer adequately assessed the side effects and possible functional advantages of current treatment regiments for colorectal cancer.

#### REFERENCES:

1. Sprangers MAG, te Velde A, Aaronson NK. The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38). European Journal of Cancer. 1999;35(2):238-247.

2. Baser, RE (2023). PROscorer: Scoring Functions for Patient-Reported Outcome (PRO) Measures and Other Psychometric Instruments. R Package Version 0.0.4.

3. Gujral S, Conroy T, Fleissner C, et al. Assessing quality of life in patients with colorectal cancer: An update of the EORTC quality of life questionnaire. European Journal of Cancer. 2007;43(10):1564-1573.

## EORTC QLQ-CX24

The European Organization for Research and Treatment of Cancer (EORTC) QLQ-CX24 Cervical Cancer Module is a 24-item questionnaire designed to assess health-related quality of life (HRQoL) in patients with cervical cancer.[REF 1]
The questionnaire asks patients to indicate the extent to which they have experienced each of the problems “during the past week” on a 4-point Likert-type response scale from “Not at all” to “Very much”.

The 24 items of the QLQ-CX24 yield both multi-item scale scores and single-item scores, for a total of 9 distinct scores. Of the 9 scores, 7 are Symptom Scales and 2 are Functional Scales. Three of the Symptom Scales are based on multiple items: Symptom Experience (11 items), Body Image (3 items), and Sexual/Vaginal Functioning (4 items). The other 4 Symptom Scales (Lymphoedema, Peripheral Neuropathy, Menopausal Symptoms, and Sexual Worry) and both Functional Scales (Sexual Activity, Sexual Enjoyment) are all based on single items. In the original psychometric validation study of the QLQ-CX24, internal consistency reliability coefficients for the multi-item scales were 0.72 for Symptom Experience, 0.86 for Body Image, and 0.87 for Sexual/Vaginal Functioning.[REF 1]

The scoring procedure for the QLQ-CX24 (available at https://qol.eortc.org/questionnaires/) transforms all of the scale and single-item scores to range from 0 to 100. High scores for the functional scales represent high/healthy levels of functioning, but high scores for the symptom scales/items represent high levels of symptomatology/problems. Accurate scoring for the EORTC QLQ-CX24 is available in the PROscorer R package using the `qlq_cx24()` function[REF 2]. Note that the QLQ-CX24 instructs respondents to answer the last 5 questions on the instrument only if they have been sexually active during the past 4 weeks. These 5 items include all 4 items on the Sexual/Vaginal Functioning symptom scale and the 1 item on the Sexual Enjoyment functional scale. These scale scores will be missing for respondents who were not sexually active during the 4 weeks before completing the questionnaire.

#### REFERENCES:

1. Greimel ER, Kuljanic Vlasic K, Waldenstrom AC, et al. The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire cervical cancer module. Cancer. 2006;107(8):1812-1822.

2. Baser, RE (2023). PROscorer: Scoring Functions for Patient-Reported Outcome (PRO) Measures and Other Psychometric Instruments. R Package Version 0.0.4.

## EORTC QLQ-PAN26

The European Organization for Research and Treatment of Cancer (EORTC) QLQ-PAN26 Pancreatic Cancer Module is a 26-item questionnaire designed to assess health-related quality of life (HRQoL) in patients with pancreatic cancer. [REF 1] The questionnaire asks patients to indicate the extent to which they have experienced each of the problems “during the past week” on a 4-point Likert-type response scale from “Not at all” to “Very much”. The 26 items of the QLQ-PAN26 yield both multi-item scale scores and single-item scores, for a total of 17 distinct scores. These include two multi-item functional scales (Satisfaction with Health Care, 2 items; Sexuality, 2 items), five multi-item symptom scales (Pancreatic Pain, 4 items; Digestive Symptoms, 2 items; Hepatic Symptoms, 2 items; Altered Bowel Habit, 2 items; Body Image, 2 items;), and 10 single item symptom scales (Bloating, Taste, Indigestion, Flatulence, Weight Loss, Weakness in Arms and Legs, Dry Mouth, Troubled with Side-Effects, Future Worries, and Planning of Activities).[REF 1]. In a large psychometric validation study of the QLQ-PAN26, internal consistency reliability coefficients for the multi-item scales were generally above 0.70 at the pre-surgical baseline assessment as well as at 14- and 60-day post-surgical assessments, with the exception of the Hepatic Symptoms scale which had poor post-surgery reliability.[REF 2]

The scoring procedure for the QLQ-PAN26 (available at https://qol.eortc.org/questionnaires/) transforms all of the scale and single-item scores to range from 0 to 100. High scores for the functional scales represent high/healthy levels of functioning, but high scores for the symptom scales/items represent high levels of symptomatology/problems. Accurate scoring for the EORTC QLQ-PAN26 is available in the PROscorer R package using the `qlq_pan26()` function[REF 3].

NOTE: At the time this scoring function was written (April 2022), the QLQ-PAN26 had completed Phase 3 testing; however, the official scoring instructions from the EORTC warned that this scaling structure is still preliminary and may change in the future (see https://qol.eortc.org/questionnaires/).

#### REFERENCES:

1. Fitzsimmons D, Johnson CD, George S, et al. Development of a disease specific quality of life (QoL) questionnaire module to supplement the EORTC core cancer QoL questionnaire, the QLQ-PAN26 in patients with pancreatic cancer. Eur. J. Cancer 35: 939-941, 1999.

2. Eaton A, Karanicolas PJ, MChir CDJ, Bottomley A, Allen PJ, Gonen M. Psychometric Validation of the EORTC QLQ-PAN26 Pancreatic Cancer Module for Assessing Health Related Quality of Life after Pancreatic Resection. Journal of the Pancreas. Published online January 1, 2017. Accessed May 10, 2023. https://www.scinapse.io/papers/2592882746

3. Baser, RE (2023). PROscorer: Scoring Functions for Patient-Reported Outcome (PRO) Measures and Other Psychometric Instruments. R Package Version 0.0.4.