Scoring

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SEXUAL FUNCTION AND SATISFACTION

MEASURE DIFFERENCES

A brief guide to differences between the PROMIS

Sexual Function and Satisfaction instruments:

ADULT

PROMIS Pool v2.0 – Sexual Function and Satisfaction: Anal Discomfort with Sexual Activity

PROMIS Pool v2.0 – Sexual Function and Satisfaction: Bother Regarding Sexual Function (Female)

PROMIS Pool v2.0 – Sexual Function and Satisfaction: Bother Regarding Sexual Function (Male)

PROMIS Pool v2.0 – Sexual Function and Satisfaction: Factors Interfering with Sexual Satisfaction

PROMIS Pool v2.0 – Sexual Function and Satisfaction: Screeners

PROMIS Pool v2.0 – Sexual Function and Satisfaction: Sexual Activities (Female)

PROMIS Pool v2.0 – Sexual Function and Satisfaction: Sexual Activities (Male)

PROMIS Pool v2.0 – Sexual Function and Satisfaction: Therapeutic Aids for Sexual Activity (Female)

PROMIS Pool v2.0 – Sexual Function and Satisfaction: Therapeutic Aids for Sexual Activity (Male)

PROMIS Scale v2.0 – Sexual Function and Satisfaction: Erectile Function

PROMIS Scale v2.0 – Sexual Function and Satisfaction: Interest in Sexual Activity

PROMIS Scale v2.0 – Sexual Function and Satisfaction: Oral Discomfort with Sexual Activity

PROMIS Scale v2.0 – Sexual Function and Satisfaction: Oral Dryness with Sexual Activity

PROMIS Scale v2.0 – Sexual Function and Satisfaction: Orgasm – Ability

PROMIS Scale v2.0 – Sexual Function and Satisfaction: Orgasm – Pleasure

PROMIS Scale v2.0 – Sexual Function and Satisfaction: Satisfaction with Sex Life

PROMIS Scale v2.0 – Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity

PROMIS Scale v2.0 – Sexual Function and Satisfaction: Vaginal Lubrication for Sexual Activity

PROMIS Scale v2.0 – Sexual Function and Satisfaction: Vulvar Discomfort with Sexual Activity - Clitoral

PROMIS Scale v2.0 – Sexual Function and Satisfaction: Vulvar Discomfort with Sexual Activity - Labial

PROMIS Sexual Function and Satisfaction v2.0 Brief Profile (Female)

PROMIS Sexual Function and Satisfaction v2.0 Brief Profile (Male)

PROMIS Sexual Function and Satisfaction v2.0 Full Profile (Female)

PROMIS Sexual Function and Satisfaction v2.0 Full Profile (Male)

PROMIS Bank v1.0 – Sexual Function and Satisfaction: Global Satisfaction with Sex Life*

PROMIS Bank v1.0 – Sexual Function and Satisfaction: Interest in Sexual Activity*

PROMIS Bank v1.0 – Sexual Function and Satisfaction: Lubrication*

PROMIS Bank v1.0 – Sexual Function and Satisfaction: Vaginal Discomfort*

PROMIS Bank v1.0 – Sexual Function and Satisfaction: Erectile Function*

PROMIS Pool v1.0 – Sexual Function and Satisfaction: Orgasm*

PROMIS Pool v1.0 – Sexual Function and Satisfaction: Interfering Factors*

PROMIS Pool v1.0 – Sexual Function and Satisfaction: Therapeutic Aids*

PROMIS Pool v1.0 – Sexual Function and Satisfaction: Sexual Activities*

PROMIS Pool v1.0 – Sexual Function and Satisfaction: Anal Discomfort*

PROMIS Pool v1.0 – Sexual Function and Satisfaction: Screener Items*

PROMIS Sexual Function Profile v1.0 (Female)*

PROMIS Sexual Function Profile v1.0 (Male)*

PROMIS Sexual Function Profile v1.0 (Male and Female)*

*Retired measure

INTRODUCTION

This document describes resources for the multiple versions of PROMIS l Function and Satisfaction instruments.

It is divided into two sections: the first section is for v2.0 instruments and the second section is for v1.0

instruments.

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SECTION 1: SEXUAL FUNCTION AND SATISFACTION (SexFS)

VERSION 2.0

This section provides information on the PROMIS® SexFS v2.0 domains (Table 1) and profile measures (Table 2).

Table 1. PROMIS SexFS v2.0 Domains

# of

items

Calibrated or

Uncalibrated

Scored

Requires Activity

Screener?

Satisfaction with Sex Life

Calibrated

Scored

Yes

Vaginal Lubrication for Sexual Activity

Calibrated

Scored

Yes

Vaginal Discomfort with Sexual Activity

Calibrated

Scored

Yes

Erectile Function

Calibrated

Scored

Yes

Vulvar Discomfort with Sexual Activity – Labial

Calibrated

Scored

Yes

Vulvar Discomfort with Sexual Activity – Clitoral

Calibrated

Scored

Yes

Oral Discomfort with Sexual Activity

Calibrated

Scored

Yes

Oral Dryness with Sexual Activity

Calibrated

Scored

Yes

Orgasm – Pleasure

Calibrated

Scored

Yes

Orgasm – Ability

Uncalibrated

Scored

Yes

Interest in Sexual Activity

Uncalibrated

Scored

Bother Regarding Sexual Function

Uncalibrated

Unscored

Factors Interfering with Sexual Satisfaction

Uncalibrated

Unscored

Therapeutic Aids for Sexual Activity

Uncalibrated

Unscored

Sexual Activities

Uncalibrated

Unscored

Anal Discomfort with Sexual Activity

Uncalibrated

Scored

Yes

Sexual Function Screener Items

Screener

Unscored

Refers to whether the domain consists of IRT-calibrated items or not.

Indicates whether T-scores centered

around U.S. population means are available.

Indicates whether domain is only intended for sexual active adults.

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INTRODUCTORY VIDEO

An introductory video about the PROMIS SexFS v2.0 can be found here:

https://www.youtube.com/watch?v=CQwo_2GIaJA

SEXUAL FUNCTION AND SATISFACTION DOMAINS

The PROMIS SexFS v2.0 measures a range of sexual activities, symptoms, functioning, and evaluation of

experiences over the past 30 days. Also included are general screener items that ask about sexual activity in the

past 30 days and reasons for not having sexual activity. The SexFS v2.0 measures are universal rather than

disease-specific. The SexFS v2.0 includes the following domains:

Screener Items ask about sexual activity in the past 30 days and reasons for not having sexual activity.

Interest in Sexual Activity assesses a conscious awareness of wanting to engage in sexual activity during the

past 30 days. Items are gender-nonspecific. Higher scores indicate greater interest.

Satisfaction with Sex Life assesses how satisfying and pleasurable the person regards his or her sexual life in

the past 30 days with no limitation on how the person defines “sex life.” Items are gender-nonspecific. Higher

scores indicate more satisfying sexual activities.

Orgasm – Ability assesses the ease with which a person has been able to have an orgasm over the past 30 days.

It is measured with a single, gender-nonspecific item for which higher scores indicate a greater ability to have

an orgasm.

Table 2. PROMIS SexFS v2.0

Profiles

Full Profile Items (#)

Brief Profile Items (#)

Sexual activity

in past 30 days

No sexual

activity in past

30 days

Sexual activity

in past 30

days

No sexual

activity in past

30 days

Interest in Sexual Activity

Sexual Activity Screener

Reasons for No Sexual Activity

Erectile Function (men)

Lubrication (women)

Vaginal Discomfort (women)

Labial Discomfort (women)

Clitoral Discomfort (women)

Orgasm Ability

Orgasm Pleasure

Satisfaction with Sex Life

Oral Discomfort

Oral Dryness

Anal Discomfort

Total # of Items (Men)

Total # of Domains/scores (Men)

Total # of Items (Women)

Total # of Domains/scores

(Women)

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Orgasm – Pleasure assesses how pleasurable or satisfying the person's orgasms have felt in the past 30 days.

Items are gender-nonspecific. Higher scores indicate more pleasurable orgasms.

Erectile Function assesses the frequency and quality of achieving and maintaining an erection for sexual activity

over the past 30 days. Higher scores indicate better function.

Vaginal Discomfort with Sexual Activity assesses physical discomfort of the vagina during and immediately

following sexual activity, including sensations of pain, rubbing, burning, pulling, or ripping experienced over the

past 30 days. Higher scores indicate greater discomfort.

Vulvar Discomfort with Sexual Activity – Clitoral assesses the degree of physical discomfort, including pain, of

the clitoris experienced with sexual activity in the past 30 days. Higher scores indicate greater discomfort.

Vulvar Discomfort with Sexual Activity – Labial assesses the degree of physical discomfort, including pain, of

the labia experienced with sexual activity in the past 30 days. Higher scores indicate greater discomfort.

Vaginal Lubrication for Sexual Activity scale assesses the wetness or dryness of the vagina experienced for

sexual activity over the past 30 days. Higher scores indicate greater lubrication. These items are intended to

assess the lubrication of the vagina without the assistance of personal lubricant products. As a result, it is

recommended that respondents be instructed to select item responses in accordance with their natural vaginal

lubrication only and to disregard the additive effects of personal lubricants.

Anal Discomfort with Sexual Activity assesses physical discomfort, irritation, pain, and/or bleeding around the

anus or rectum during or after sexual activity over the past 30 days. Items are gender-nonspecific.

Oral Discomfort with Sexual Activity assesses the degree of physical discomfort in the mouth, including pain

and/or irritation, experienced with sexual activity in the past 30 days. Items are gender-nonspecific. Higher

scores indicate greater discomfort.

Oral Dryness with Sexual Activity assesses the lack of saliva in the mouth experienced with sexual activity in

the past 30 days. Items are gender-nonspecific. Higher scores indicate greater dryness.

Factors Interfering with Sexual Satisfaction is a collection of items, each of which assesses the person’s

perception of the degree to which various factors affected their satisfaction with sex life in the past 30 days.

These factors include symptoms of disease, side effects from treatment, and other experiences that have been

identified by patients. Some items are gender-nonspecific. These items are intended to be stand-alone items

and do not comprise a unidimensional scale.

Therapeutic Aids for Sexual Activity is a collection of items, each of which assesses the use in the past 30 days

of hormones, personal lubrications, medications, or devices intended to allow for or improve sexual function.

Some items are gender-nonspecific. These items are intended to be stand-alone items and do not comprise a

unidimensional scale.

Sexual Activities is a collection of items, each of which assesses the frequency of engaging in specific

affectionate or sexual behaviors either alone or with a partner in the past 30 days. Some items are gender-

nonspecific. These items are intended to be “stand-alone” items and do not comprise a unidimensional scale.

Bother Regarding Sexual Function is a collection of items, each of which assesses the degree of bother people

report for each specific aspect of sexual functioning in the past 30 days. Some items are gender-nonspecific.

These items are intended to be “stand-alone” items and do not comprise a unidimensional scale.

INTRODUCTION TO ASSESSMENT OPTIONS

All items in the PROMIS SexFS were not intended to be administered together, as some domains might not be

relevant for particular situations and reliable scores can be generated without having to administer all of the

items in a domain. Researchers should select the sexual function and satisfaction domains and items that are

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relevant to their specific sample. There are multiple assessment options: the full profile, brief profile, and

customized short forms of any individual domain (that is, a selection of items from the desired domain). When

administering any of these options, instruct participants to answer all of the items (i.e., questions or statements)

presented. Tables 1 and 2 show how many items are in each individual domain and profile. Any of these options

can be administered on paper or by computer.

Whether one uses a customized short form or profile, for those domains marked “calibrated,” the score metric

is derived from Item Response Theory (IRT), a family of statistical models that link individual questions to a

presumed underlying trait or concept within the overall domain of sexual function, represented by items in the

item banks. When choosing among the options available, it is useful to consider the precision gained with longer

instruments versus the psychological, physical, and cognitive burden placed on respondents as a result of the

number of questions asked.

INSTRUMENT DIFFERENCES

Tables 1 and 2 provide a helpful overview of the different instruments and assessment options. To summarize

the tables, of the PROMIS SexFS instruments, 9 are calibrated scales. This means that if one or more items from

within that instrument are administered, a respondent’s score will be calculated using item response theory

statistics. Three of the instruments are scored but not calibrated. The items within those instruments are

combined to create a score, but this score is not based on item response theory statistics. Five of the

instruments do not have calibrated items and are not scored, that is, items within those instruments are not

combined in any way to create a score. Each item in these instruments measures a very specific construct

corresponding only to that item (e.g., how much radiation burns have affected one’s satisfaction with their sex

life). For any given item in these uncalibrated instruments, the researcher can use the raw item responses

directly for analyses.

Profiles

Profiles are of collections of short forms and items that assess a person with respect to multiple aspects of

sexual function and satisfaction. The SexFS currently includes Brief Profiles and Full Profiles (see below). Items

were selected for inclusion based on rankings using psychometric and pragmatic criteria: (1) maximum interval

information (where applicable, i.e., IRT information curves reflected the greatest degree of precision for the

greatest range of the latent variable of interest), (2) consistent item formatting, and (3) content coverage.

Brief Profiles (Male, Female)

The Brief Profiles—one for males, one for females—efficiently assess interest in sexual activity followed by a

screener item about sexual activity. For those who have not been sexually active in the past 30 days, a fourth

and final question asks about reasons for not having sexual activity. For those who have been sexually active in

the past 30 days, men are asked about erectile function, while women are asked about vaginal lubrication,

vaginal discomfort, and vulvar discomfort; men and women are asked about orgasm and satisfaction with sex

life. These are the domains that are most likely relevant for the majority of healthy people and those suffering

from chronic diseases.

Full Profiles (Male, Female)

The Full Profiles—one for males, one for females—includes all of the domains measured in the Brief Profiles, but

also adds oral dryness, oral discomfort, and anal discomfort. For the domains that overlap between the Brief and

Full Profiles, the Full Profiles use equal or greater number of items to assess each domain.

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Customized Short Forms

Within any of the 9 calibrated scales, users can select one or more items to create a customized short form for

measuring that domain. Selection of the items could be based on suitability of the item for the particular

population of interest. Note that the items that generally perform the best from the 9 calibrated scales are

found on the Brief Profiles and Full Profiles (see above).

In selecting among assessment options, the differences are domain coverage and instrument length. If you are

working with a sample in which you want the most precise measure, use a longer short form. If you have little

room for additional measures but really wanted to capture something as a secondary outcome, use a shorter

instrument (e.g., brief profile or just 1 or 2 domains of interest).

PREVIEW OF SAMPLE ITEM

Below is an excerpt from the paper version of the Brief Profile (Female). This is the paper version format used

for all profile instruments. It is important to note that automatic scoring is not available for paper

administration.

VERSION DIFFERENCES

Some PROMIS domains have multiple versions of instruments (i.e., v1.0, v1.1, v2.0). Generally, it is

recommended that you use the most recent version available which can be identified as the instrument with

the highest version number.

Building on v1.0 of the PROMIS Sexual Function and Satisfaction measure (SexFS), a comprehensive

development process was undertaken to create an expanded and improved PROMIS SexFS v2.0. This tool

assesses multiple components of sexual functioning, and the validation process included a strong focus on

inclusiveness with regard to literacy level, race, age, sexual orientation, and health conditions. Note that while

v1.0 was developed exclusively in cancer patients, v2.0 retains the content validity for cancer patients and

expands on it, making v2.0 a better measure for cancer populations than v1.0. Scores from v1.0 measures

should not be compared to scores from v2.0 measures. Those who have administered items from the SexFS v1.0

and wish to use v2.0 scoring should contact the developers for more information.

Several features of SexFS v2.0 are consistent with v1.0. The measurement system is modular and customizable

in that users need only measure those sexual function domains of relevance to their particular study or sample.

One important change from v1.0 to 2.0 is that scores are now expressed using a meaningful metric, with scores

centered around norms for the population of sexually active US adults. Norms are provided herein for age and

sex to aid in the interpretation of SexFS scores. Also, differential item functioning (DIF) was examined by gender,

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sexual activity, and age to assess the appropriateness of items across different groups of people. Finally, the v2.0

domains demonstrated good convergent and known groups validity and reliability. The final set of items is

applicable for both men and women, those sexually active with a partner and without, and those who identify as

heterosexual or straight, lesbian, gay, or bisexual.

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SECTION 2: THE PROMIS SEXUAL FUNCTION AND SATISFACTION

MEASURES V1.0

INTRODUCTION

Through the PROMIS Cancer Supplement, instruments assessing multiple components of sexual functioning

were developed. Together, these instruments are known as the PROMIS Sexual Function and satisfaction

measures v1.0 (PROMIS SexFS). Some instruments are gender specific. Most items are not specific to cancer, but

had only been validated in cancer populations at the time of their publication. The PROMIS SexFS uses a 30-day

recall period. Where possible, items use response options common to other PROMIS instruments. Some PROMIS

SexFS instruments include items from other sexual function instruments, such as the Female Sexual Function

Index and the UCLA Prostate Cancer Index. Table 3 includes a list of the available PROMIS SexFS v1.0 domains.

V1.0 DOMAIN DEFINITIONS

Global Satisfaction with Sex Life is the person’s overall evaluation of his or her sex life. No limitation is placed

on what the person includes in his or her definition of “sex life.” Higher scores indicate more satisfaction with

sex life. Lower scores indicate less satisfaction with sex life.

Interest in Sexual Activity refers to a conscious awareness of wanting to engage in sexual activity. Items are

gender-neutral. Higher scores indicate more interest. Lower scores indicate less interest.

Lubrication refers to the wetness or dryness of the vagina during sexual activity. Higher scores indicate more

lubrication. Lower scores indicate less lubrication. These items are intended to assess the lubrication of the

vagina without the assistance of personal lubricant products. As a result, it is recommended that respondents be

instructed to select item responses in accordance with their natural vaginal lubrication only and to disregard the

additive effects of personal lubricants.

Table 3: PROMIS Sexual Function and Satisfaction v1.0 Instruments

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Vaginal Discomfort refers to the degree of physical discomfort of the vagina during and immediately following

sexual activity. Higher scores indicate more discomfort as reflected by pain and/or uncomfortable tightness.

Lower scores indicate less discomfort as indicated by no pain, bleeding, and/or uncomfortable tightness.

Erectile Function refers to the ability to achieve and maintain an erection for sexual activity. Higher scores

indicate better function. Lower scores indicate poorer function.

Orgasm assesses the degree to which the person has experienced a satisfying climax. It includes a gender-

neutral item for which higher scores indicate a greater ability to have satisfying orgasms, and lower scores

indicate less ability. It also includes male-specific items that ask about timing of ejaculation and pain or burning

during or after ejaculation. These can be administered and scored as single items.

Interfering Factors is a collection of items each of which assesses the person’s perception of the degree to which

various factors affect satisfaction with sex life. These factors include symptoms of disease and side effects from

treatment and other issues that have been identified by patients. These items are intended to be “stand alone”

items and do not comprise a unidimensional scale. Some items are gender-specific.

Therapeutic Aids is a collection of items each of which assesses the use of hormones, personal lubrications,

medications, or devices intended to allow for or improve sexual function. These items are intended to be “stand

alone” items and do not comprise a unidimensional scale.

Sexual Activities is a collection of items each of which assesses the frequency of engaging in specific intimate or

sexual behaviors either alone or with a partner. These items are intended to be “stand alone” items and do not

comprise a unidimensional scale. Some items are gender-specific.

Anal Discomfort is an evaluation of anal irritation, pain, or bleeding during or after anal sex. Items are only

asked of people who indicate in the activities subdomain they have had anal sex in the past 30 days. There have

not been enough data collected to do psychometric evaluation of these items.

Sexual Function Screener Items ask about sex (gender), whether people are in a relationship that could involve

sexual activity, and whether they have had any type of sexual activity with a partner in the past 30 days.

INTRODUCTION TO ASSESSMENT OPTIONS

PROMIS has 11 sexual function and satisfaction v1.0 instruments (see Table 3). All items in the PROMIS SexFS

were not intended to be administered together, as some domains might not be relevant for particular situations

and reliable scores can be generated without having to administer all of the items in a domain. Researchers

should select the sexual function and satisfaction domains and items that are relevant to their specific sample.

There are multiple assessment options: the brief profile and customized short forms of any individual domain

(that is, a selection of items from the desired domain). When administering any of these options, instruct

participants to answer all of the items (i.e., questions or statements) presented. Table 3 shows how many items

are in each individual domain. Either option can be administered on paper or by computer.

Whether one uses a customized short form or profile, for those domains marked “calibrated,” the score metric

is derived from Item Response Theory (IRT), a family of statistical models that link individual questions to a

presumed underlying trait or concept within the overall domain of sexual function, represented by items in the

item banks. When choosing among the options available, it is useful to consider the precision gained with longer

9/28/2021 PROMIS – Sexual Function and Satisfaction v1.0 Page 10

instruments versus the psychological, physical, and cognitive burden placed on respondents as a result of the

number of questions asked.

INSTRUMENT DIFFERENCES

Five of the SexFS v1.0 instruments are calibrated item banks (e.g. PROMIS Bank v1.0 - Global Satisfaction w Sex

Life). This means that if one or more items from within that instrument are administered, a respondent’s score

will be calculated using item response theory statistics. If these instruments are administered outside of

electronic scoring you may rely on raw score/scale score look-up tables to determine scores (see PROMIS Sexual

Function and Satisfaction Scoring Manual).

Six of the instruments do not have calibrated items (e.g. PROMIS Pool v1.0 - Sexual Activities). This means that

items within those instruments are not combined in any way to create a score. Each item in these instruments

measures a very specific construct corresponding only to that item (e.g., how much radiation burns have

affected one’s satisfaction with their sex life). For any given item in these uncalibrated instruments, the

researcher can use the raw item responses directly for analyses.

PROMIS Sexual Function and Satisfaction Brief Profile v1.0

The PROMIS Sexual Function and Satisfaction Measures Brief Profile (PSxFBP) provides scores on 7 different

subdomains of sexual function: Interest in Sexual Activity, Vaginal Discomfort (women only), Lubrication

(women only), Erectile Function (men only), Orgasm, and Global Satisfaction with Sex Life (see below for

subdomain definitions). The PSxFBP is intended for broad use, although almost all of the development work was

with cancer populations. The PSxFBP is available for men and women and consists of the best items selected

from each subdomain for general purposes. Each question asks respondents to report on their experiences over

the past 30 days.

Customized Short Forms

All items in the PROMIS SexFS were not intended to be administered together. Researchers should select the

sexual function and satisfaction items that are relevant to their specific sample. Some examples are provided.

Example 1: A study proposes to compare three treatment approaches for early stage cervical cancer:

surgery alone, surgery and radiation, and radiation alone. In addition to disease control, cancer treatment

comorbidities are being compared, including sexual function outcomes. The researchers want to measure

key domains of function, including overall sexual satisfaction, interest, vaginal irritation or pain, orgasm, and

lubrication. They are also interested in which side effects from treatments affect participants’ sex lives, as

each of the treatment modalities carries different potential changes in sexual function; surgery usually

results in a foreshortened vaginal canal and radiation may cause vaginal mucosal thinning, vaginal

adhesions, decreased lubrication and vaginal stenosis. The 10-item PSxFBP for women can be used to assess

sexual function broadly and distinguish between sexual side effects associated with treatment modality, and

can be used to help patients make informed treatment decisions. Additional items on surgical scars, pain,

and fatigue from the Interfering Factors instrument can help the researchers determine which side effects

affect satisfaction with sex life for their participants. Finally, the researchers include the items for women

that assess use of Therapeutic Aids to determine whether using personal lubricants or hormones modifies

sexual satisfaction or function.

Example 2: A study designed to promote compliance with SSRI antidepressants proposes to assess whether

sexual function contributes to non-compliance. Patients prescribed fluoxetine are longitudinally followed

with monthly assessments of sexual function and frequency of sexual activities in order to determine the

relationship between sexual dysfunction and non-compliance. The researchers have room for about 20

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items on sexual function, so they choose to use the PSxFBP for men (8-items) and women (10-items) to

gauge function plus the 12 items from the Sexual Activities subdomain. Thus, for all participants in the

study, sexual activities, interest in sexual activity, orgasm, and global satisfaction with sex life are assessed.

For women, lubrication and vaginal discomfort are also assessed, and for men, erectile function is also

assessed.

Example 3: A study of soy-derived estrogen is tested to determine if it improves sexual function among

menopausal women self-identified as having hyposexual desire. The researchers choose to administer all

items from the Interest in Sexual Activity instrument, since sexual desire is their main outcome of interest.

They also administer the PSxFBP for women to assess satisfaction with sex life, lubrication, vaginal

discomfort, and orgasm.

A Note on Response Options for Sexual Activities

Most sexual activity items are available using two different sets of responses. Items identified with an “a” in

their Item ID use the response options 1=Have not done in the past 30 days, 2=Once, 3=Two to three times,

4=Four to five times, 5=Six or more times. Items identified with a “b” in their Item ID use the response options

1=Have not done in the past 30 days, 2=Once a week or less, 3=Once every few days, 4=Once a day, 5=More

than once a day. As you can see, the “a” response options reflect less activity. This set of response options is

likely most appropriate for individuals for whom you expect reduced sexual activity (e.g., cancer patients

receiving chemotherapy). The “b” response options reflect higher levels of sexual activity. This set of response

options would be most appropriate for individuals you expect to have higher levels of sexual activity (e.g.,

healthy individuals). Investigators should carefully consider their purpose in recording sexual activities and select

response options that are most appropriate. It is possible that the “a” and “b” options available here are not the

best for a particular research setting. Investigators might also consider whether a daily sexual activity log could

be used in place of these items, which require a 30-day recall period.

PROCEDURES AND DATA IN SUPPORT OF VALIDITY AND RELIABILITY FOR SEXFS

V1.0

Face Validity. Face validity is established when subject matter experts agree that the scale appears to measure

its intended focus. Face validity for the PROMIS SexFS scales was established with a review by expert panels

within and external to the PROMIS SexFS committee; all experts concurred that the items within the scales

appeared to measure sex function.

Content Validity. Content validity refers to how well the scale assesses all aspects of the construct being

measured. Establishing the content validity of PROMIS instruments began with patient input to assure that the

subdomains and their items corresponded to reported patient experiences, and with a review by expert panels

to assure that the selected theoretical constructs corresponded to the scientific literature. Using a consensus-

driven approach, the PROMIS SexFS committee conducted a literature search for articles published from 1991

through 2007, yielding 257 articles that reported the administration of a psychometrically evaluated sexual

function measure to individuals diagnosed with cancer. With few exceptions, the 31 identified measures had not

been widely tested in cancer populations (Jeffery et al., 2009). We collated available items from the measures

and created preliminary domain definitions. Each item was then subjected to detailed review to eliminate

repetition within bins (“winnowing”) and to develop uniform recall periods and response categories. After

qualitative expert item review, 47 extant items were selected for further testing. Concurrently, we conducted 16

focus groups with 109 cancer patients (Flynn et al., 2010). These groups explored the impact of cancer and its

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treatments on sexual experience to determine whether domain definitions and the identified items reflected

patients’ personal experiences. Separate focus groups were held for patients in active treatment for breast,

prostate, lung, colorectal, gynecological, and other (mixed) cancers and for survivors after treatment for breast,

prostate, gynecological, and other cancer types. We developed a matrix of themes and groups, which was

double-coded (inter-rater reliability was over 90%). As a check on the data we received from the patient focus

groups, we conducted 2 clinician focus groups to assess the clinical relevance of the proposed conceptual model

and obtain clinicians’ views of how cancer and its treatment affected patients’ sexual health. New items were

created to address conceptual gaps identified by the focus group participants. With updated items in hand, we

conducted cognitive interviews with patients (n=39) (Fortune-Greeley et al., 2009). Each item was seen by at

least 5 patients, at least 1 of whom was not white and at least 2 of whom had less than a 9

grade reading level.

87 items were passed through to the next phase. We convened 7 experts on sexual function and cancer to

review this work to date.

The item-testing phase consisted of large-scale data collection (n=819; 388 males, 430 females, 1 person did not

specify sex) and administration of the items in national and local samples through the NexCura Internet Panel,

the Duke University tumor registry, and the Duke oncology clinics. (Appendix A shows patient characteristics,

including the distribution of cancer types.) We also added targeted recruitment of additional lesbian, gay, and

bisexual cancer patients and survivors through online communities. Psychometric analysis of the items followed

established PROMIS methodology (Reeve et al., 2007) and resulted in 11 instruments: 5 calibrated and 6

uncalibrated. A summary of fit statistics are shown in Table 4.

Construct Validity. Construct validity refers to how well scores on the measure are related to other variables

that, for theoretical reasons, ought to be related to the measure in question. Construct validity of the PROMIS

SexFS has been assessed in two ways.

First, we used data from the 819 patients with cancer (see above) to examine the correlations between

subdomains of the PROMIS SexFS and other measures of similar constructs. These are displayed in Table 5. In

general, these correlations provide strong evidence for the construct validity of the PROMIS SexFS.

Table 4: Fit Indices for Confirmatory Factor Analysis of Calibrated Domains (v1.0).

9/28/2021 PROMIS – Sexual Function and Satisfaction v1.0 Page 13

Second, we examined whether scores on selected subdomains of the PROMIS SexFS could discriminate between

groups that should, in theory, differ in terms of their sexual experiences. During item testing, participants were

also asked whether they had ever asked an oncology professional about sexual problems. We hypothesized that

asking for help with sexual problems may indicate a clinically meaningful decrement in function. As Table 6

shows, those who had asked for help had significantly greater interest in sexual activity and increased vaginal

discomfort and lower levels of erectile function, lubrication, orgasm, and overall satisfaction. Furthermore, the

differences were as high as three-quarters of a standard deviation. These effect sizes were greater than or equal

to the effects for the corresponding subscales of the FSFI and IIEF. In three cases, the PROMIS SexFS and PSxFBP

detected statistically significant (p<.05) differences between those who did and did not ask, whereas the FSFI or

IIEF did not.

Reliability. Two types of reliability data are available at this time for the PROMIS SexFS. First, estimates of

internal consistency (Cronbach’s alpha) were computed for all calibrated banks. They are displayed in Table 7.

Table 5: Correlations between PROMIS Sexual Function and Satisfaction v1.0 Domains and Corresponding Measures.

9/28/2021 PROMIS – Sexual Function and Satisfaction v1.0 Page 14

All indicate excellent internal consistency. Second, test-retest reliability was examined in a sample of 202

participants (101 male, 101 female), about half of whom had some chronic disease. Participants completed the

PROMIS SexFS twice with one month between test administrations. Intraclass correlation coefficients between

the two administrations are shown in Table 7, ranging from .71 - .87.

Table 6: Effect Sizes Discriminating Askers From Non-Askers

(N=806); v1.0).

9/28/2021 PROMIS – Sexual Function and Satisfaction v1.0 Page 15

The following experts generously provided helpful input to the PROMIS sexual function and satisfaction domain

working group:

Sexual Function and

Satisfaction Domain Group

(including NIH)

Duke Clinical Research

Institute CCGE staff

Duke University School

of Nursing

Erick Janssen, PhD, MA

Ray Rosen, PhD

Stacy Tessler Lindau, MD,

MAPP

Jeanne Carter, PhD

Michael Perelman, PhD

Leslie R. Schover, PhD

John P. Mulhall, MD

David M. Latini, PhD

Barbara L. Andersen, PhD

Sara I. McClelland, PhD

Amy Abernethy, MD

Joan Broderick, PhD

Deborah Bruner, PhD, RN

Jill Cyranowski, PhD

Susan Czajkowski, PhD

Elizabeth Hahn, MA

Diana Jeffery, PhD

Francis Keefe, PhD

Jin-Shei Lai, PhD

Richard Luecht, PhD

Susan Magasi, PhD

Laura Porter, PhD

Jennifer Reese, Phd

Bryce Reeve, PhD

Rebecca Shelby, PhD

Ashley Wilder, Phd, MPH

Carrie Dombeck, MA

Maria Fawzy

Alice Fortune-Greeley

Angel Moore, MSPH

Damon Seils

Janice Tzeng

Lucy Andrzejewski

Teresa Baker

Henry Beresford

Monie Clayton

Teresa Ebel

Linda Folsom

Mindy Kash

Patrick Lane

Diane Langley

Justin Levens

Denise Snyder, MS, RD,

CSO, LDN

Valeda Stull

Megan Williams, MSW,

MSPH

For more information about PROMIS, accessing the PROMIS Sexual Function instruments or administering them,

Table 7: Reliability of Calibrated v1.0 Domains.

9/28/2021 PROMIS – Sexual Function and Satisfaction v1.0 Page 16

FREQUENTLY ASKED QUESTIONS (FAQs)

Q: I am interested in learning more. Where can I do that?

Review the HealthMeasures website at www.healthmeasures.net

Q: Is the SexFS appropriate for LGBT populations?

Self-identified lesbian, gay, and bisexual individuals were engaged in the development process in focus groups,

cognitive interviews, and item testing, and item wording is generally appropriate regardless of sexual

orientation. However, transgender participants were not a particular focus for the v1.0 or v2.0 measure

validation efforts; additional work will be needed to demonstrate validity for transgender participants.

Q: I’m worried that patients might be too embarrassed or offended to answer some of these questions. What

has been the experience of PROMIS with this measure?

In testing v1.0 of this measure in a large population of patients with cancer, there were no more missing data on

the sexual function measure than other measures on different topics that were being tested simultaneously

(e.g., sleep quality, cognitive function, and illness impact). Since then, v2.0 was tested in additional populations

and settings and missing data have not been a significant problem. Skipped items can be minimized by informing

study participants at the outset that your study will be asking about different domains of health that are

important to understand, including (for example) physical function, sleep, sexual function, and fatigue.

Q: Are these instruments available in other languages?

Yes! Look at the HealthMeasures website (

http://www.healthmeasures.net/explore-measurement-

systems/promis/intro-to-promis/available-translations) or current information on PROMIS translations.

Q: Can I make my own short form?

Yes, custom short forms can be made by selecting any items from an item bank. This can be scored using the

Scoring Service (https://www.assessmentcenter.net/ac_scoringservice

REFERENCES

DeWalt, D., Rothrock, N., Yount, S., Stone, A. A., & on behalf of the PROMIS cooperative group. (2007).

Evaluation of item candidates: the PROMIS qualitative item review. Medical Care, 45(5), S12-21.

Fortune-Greeley, A. K., Flynn, K. E., Jeffery, D. D., Williams, M. S., Keefe, F. J., Reeve, B. B., Willis, G. B., &

Weinfurt, K. P. (2009). Using cognitive interviews to evaluate items for measuring sexual functioning across

cancer populations: improvements and remaining challenges. Quality of Life Research, 18(8), 1085-93.

Jeffery, D. D., Tzeng, J. P., Keefe, F.J., Porter, L. S., Hahn, E. A., Flynn, K. E., Reeve, B. B., & Weinfurt, K. P. (2009).

Initial report of the cancer Patient-Reported Outcomes Measurement Information System (PROMIS) sexual

function committee: Review of sexual function measures and domains used in oncology. Cancer, 115(6), 1142-

53.

Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, DeVeillis

R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R. (2010). The

Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of

adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 63(11), 1179-84.

9/28/2021 PROMIS – Sexual Function and Satisfaction v1.0 Page 17

Flynn, K. E., Jeffery, D. D., Keefe, F. J., Porter, L. S., Shelby, R. A., Fawzy, M. R., Gosselin, T. K., Reeve, B. B., &

Weinfurt, K. P. (2011). Sexual functioning along the cancer continuum: focus group results from the Patient-

Reported Outcomes Measurement Information System (PROMIS). Psycho-Oncology, 20(4), 378-86.

Flynn K.E., Reese J.B., Jeffery D.D., Abernethy A.P., Lin L., Shelby R.A., Porter L.S., Dombeck C.B., Weinfurt K.P. (in

press). Patient experiences with communication about sex during and after treatment for cancer. Psycho-

Oncology.

Flynn K.E., Jeffery D.D., Reeve B.B., Lin L., Wilder Smith A., Abernethy A.P., Reese J.B., Weinfurt K.P. “Progress on

the PROMIS® Sexual Function Measure.” Poster presented at the International Society for Quality of Life

Research Annual Conference; October 29, 2010; London, England.

Weinfurt, K. "Improving the Measurement of Sexual Outcomes in Cancer: The NIH PROMIS Approach.” Center

for Outcomes and Policy Research, Dana-Farber Cancer Institute, Boston, Massachusetts, May 17, 2011

Flynn K.E., Weinfurt K.P. “Development and Validation of the PROMIS Sexual Function

Measure.” Presentation at the Duke Translational Medicine Institute Annual Research Career Day; May 20, 2011;

Durham, NC, USA.

Flynn K.E. “Assessing Sexual Health in Cancer Survivors.” Presentation at the Cancer Survivorship and Sexual

Health Symposium sponsored by the International Society for Sexual Medicine and the Sexual Medicine Society

of North America; Washington, DC, USA; June 18, 2011.

Weinfurt K.P., Lin L., Broderick J.E., Dombeck C.B., Fawzy, M.R., Snyder D.C., Williams M.S., Flynn K.E. “Validity of

1-month Recall for Components of Sexual Function.” To be presented as a poster at the International Society for

Quality of Life Research Annual Conference; October 28, 2011; Denver, Colorado, USA.

Flynn K.E., Lin L., Dombeck C., Fawzy M., Abernethy A.P., Bruner D.W., Reese J.B., Reeve B.B., Smith A.W.,

Weinfurt K.P. “Validating the PROMIS

Sexual Function Brief Profile Measures.” To be presented at the

International Society for Quality of Life Research Annual Conference; October 29, 2011; Denver, Colorado, USA.

Weinfurt K.P., Lin L., Broderick J.E., Dombeck C.B., Fawzy, M.R., Snyder D.C., Williams M.S., Flynn K.E. “Mood and

Gender Effects on the Accuracy of 30-day Recall of Sexual Function.” To be presented at the International

Society for Quality of Life Research Annual Conference; October 29, 2011; Denver, Colorado, USA.

9/28/2021 PROMIS – Sexual Function and Satisfaction v1.0 Page 18

Appendix A. Characteristics of Validation Sample

Characteristic

Total

(N = 819)

Age, mean ± SD, y

58.5 ± 11.8

Age group, No. (%)

≤ 40 years

59 (7)

41 to 50 years

127 (16)

51 to 64 years

377 (46)

65 to 79 years

232 (28)

≥ 80 years

21 (3)

Race, No. (%)

Black or African American

80 (10)

American Indian/Alaska Native

10 (1)

Asian

12 (1)

Native Hawaiian/Other Pacific Islander

10 (1)

White

705 (87)

Multiple races or other

2 (< 1)

Hispanic or Latino ethnicity, No. (%)

21 (3)

Educational attainment, No. (%)

Less than high school

21 (3)

High school graduate/GED

100 (12)

Some college

255(31)

College degree

229 (28)

Advanced degree (MA, PhD, MD)

211 (26)

Treatment status in past month, No. (%)

None (ie, posttreatment follow-up)

526 (64)

Undergoing treatment

290 (36)

Radiation therapy

29 (10)

Hormonal therapy (eg, tamoxifen, anastrozole,

leuprolide)

140 (48)

Chemotherapy (injection or oral)

116 (40)

Immunotherapy (eg, interferon)

9 (3)

Other

36 (12)

Recurrence of cancer, No. (%)

151 (18)

Cancer spread to lymph nodes, No. (%)

202 (25)

Cancer spread to another area, No. (%)

134 (16)

Primary cancer diagnosis, No. (%)

Bone/muscle cancer

14 (2)

Brain cancer

4 (< 1)

Breast cancer

252 (35)

Colorectal

98(13)

Esophageal or stomach cancer

17 (2)

Gynecologic cancer

29 (4)

Head/neck cancer

9 (< 1)

Hodgkin lymphoma

23 (3)

Leukemia

20 (3)

Liver cancer

3 (< 1)

Lung cancer

56 (8)

Melanoma

4 (< 1)

Multiple Myeloma

2 (< 1)

Non-Hodgkin lymphoma

12 (2)

Pancreatic cancer

5 (< 1)

Prostate cancer

146 (20)

Urologic cancer

23 (3)