Clinical Outcome Assessments and LGBTQIA+ Patients
A transgender man takes part in a Patient Reported Outcome (PRO) assessment for a new drug. The first
two items he reads on the questionnaire are:
- What was your sex at birth, male or female?
- Do you menstruate?
Why might these questions be a problem? Well, some trans men menstruate, while others do not, and trans men are unlikely to identify as female. The juxtaposition of these two closed questions may make that trans man feel as though he is being forced to self-identify as a woman.
In the context of this assessment, we assume that it is important for us to know a patient’s birth sex, perhaps because of chromosomal-specific effects. We can, however, obtain this information without phrasing the question in a way that might alienate some respondents.
With this in mind, take another look at the questions. Does the way they are phrased and ordered take account of what we know about gender in 2024? Do they risk making the patient feel unseen and invalidated? Is this wording likely to encourage him to engage fully with the rest of the questionnaire?
This is not just an issue for psychometricians. All too often, healthcare literature reflects hetero or cisgender norms, sidelining other identities, and undermining trust and care quality. It’s a problem across the sector. One of the solutions is LGBTQIA+ sensitivity reading.
What it’s Not: Sensitivity Reading v Sensitivity Analysis
If you work in this field, you’ll be familiar with sensitivity analysis. This is an important concept in assessing the robustness of findings or conclusions, and for the sake of clarity, we would ideally not use the word ‘sensitivity’ in this context. However ‘sensitivity reading’ is a concept widely used across academia and publishing, and sufficiently well known that we feel changing it would lead to confusion.
Scoping the Problem
When you start looking at COAs from an LGBTQIA+ perspective, you begin to notice just how many problematic questions are out there. For example:
- Are you male or female?
- Are you married?
- Do you use contraception?
- How many sexual partners have you had in the last year?
- Are you comfortable with your body?
If you remember that the LGBTQIA+ community includes trans, non-binary, intersex, queer, gay, asexual, lesbian and gender-diverse individuals, it starts to become apparent why these questions might lead to problems. We will come back to them.
Why does any of this matter? There are several reasons:
- Respondents who feel recognised and respected are more likely to properly engage with a PRO survey, leading to more honest and complete answers, and more accurate data. This is especially important for understanding how drugs work in minority groups, such as trans people, who are often on HRT and may have a different profile of efficacy to the overall sample.
- The ethos behind COA research is to better understand the patient experience, and the context of this work is improving the lives of individuals. Alienating or excluding certain minorities from your survey by the way you word the items is a failure to live up to those principles.
- Organizations that properly address LGBTQIA+ inclusivity in their COAs can ensure that they satisfy anti-discrimination laws, and establish themselves as leaders in healthcare inclusivity.
What is LGBTQIA+ Sensitivity Reading?
LGBTQIA+ sensitivity reading involves a close analysis and improvement of the language used in COAs to ensure inclusivity and respect. There are essentially two stages to the process:
- Review for bias: Deconstruct the question to root out hidden assumptions in the language.
- Inclusive redesign: LGBTQIA+ sensitivity reading experts with lived experience rephrase the
question to ensure cultural competence and relevance.
How it Works
Let’s take a closer look at the five examples mentioned above. Why are these problematic and how can they be improved to be inclusive of LGBTQIA+ identities?
1. Are you male or female?
This question asserts a binary understanding of gender, one that excludes nonbinary, genderqueer, and other gender-diverse individuals.
Suggested revision:
What is your gender? (e.g., male, female, nonbinary, genderqueer, prefer to self-describe: ______, or prefer not to say).
Rationale: This phrasing acknowledges that there are diverse gender identities, and gives individual respondents the chance to not disclose or to self identify.
2. Are you married?
This question assumes marriage as the primary or sole framework for relationships and may exclude people in other committed relationships (e.g., partnerships, polyamorous relationships) or those who don’t ascribe to traditional marital structures.
Suggested revision:
What is your current relationship status? (e.g, single, married, partnered, in a relationship, or prefer not to say).
Rationale: This version provides space for varied relationship structures and respects individual preferences around sharing this information.
3. Do you use contraception?
This question assumes a heteronormative context where contraception is linked solely to preventing pregnancy. It may not apply or be relevant to people in same-sex relationships, people who are asexual, or those who use contraception for other reasons (e.g., managing hormonal conditions).
Suggested revision:
Do you use any methods or medications related to reproductive or sexual health? (e.g., contraception, hormone therapy, or other methods).
Rationale: This broader phrasing reflects diverse uses of contraception and includes LGBTQIA+ individuals who may use hormonal or reproductive health medications for reasons unrelated to pregnancy.
4. How many sexual partners have you had in the last year?
This question could come across as invasive, and its framing may stigmatize people based on assumptions about “acceptable” numbers. Additionally, it doesn’t account for people who may not have traditional “sexual partners” or for those who engage in other types of intimate relationships.
Suggested revision:
How many partners have you engaged in sexual or intimate activity with in the last year? (optional response)”.
Rationale: Using “intimate activity” ensures inclusivity of various sexual orientations, relationship styles, and definitions of intimacy, while offering the option not to respond.
5. Are you comfortable with your body?
This question could unintentionally conflate body image issues with gender dysphoria, which may alienate transgender or nonbinary individuals. It also lacks nuance for anyone with complex feelings about their body.
Suggested revision:
How do you feel about your body? (e.g., comfortable, somewhat comfortable, uncomfortable, or prefer to describe: ______)”.
Rationale: This framing is less binary, allows for a range of experiences, and gives space for transgender and nonbinary people to elaborate on body-related feelings without presumption.
Why DIY is Not the Way to Go
Okay, you get it. It’s important to make COA questionnaires inclusive. Can’t you just incorporate that into your existing process without going to the trouble of arranging LGBTQIA+ sensitivity reading?
The risk of a DIY approach is that non-experts may make tokenistic revisions, or overlook biases of which they are simply unaware, leading to an ineffective item, and a less satisfactory outcome.
Those with lived experience of LGBTQIA+ issues will be more attuned to the nuanced biases that can exist in our language, and combining this experience with precise linguistic skills is the most effective way to ensure that your COA is fully inclusive.
Invest in Sensitivity Reading Services
Inclusive medical literature is a cornerstone of equitable healthcare. By asking thoughtful, inclusive questions in our COAs, we can respect diversity and improve outcomes for patients and providers alike. Our LGBTQIA+ sensitivity reading service draws on expertise and lived experience to help you to design questionnaires that respect and serve everyone.