The effects of cross-gender hormones on the quality of life of transgender individuals: a systematic review protocol

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1 The effects of cross-gender hormones on the quality of life of transgender individuals: a systematic review protocol Stefan Rowniak 1,2 Lindsay Bolt 2 1 School of Nursing and Health Professions, University of San Francisco 2 Institute for Nursing Excellence; UCSF Centre for Evidence Based Patient and Family Care: an Affiliate Center of the Joanna Briggs Institute Review question/objective Corresponding author: Stefan Rowniak srrowniak@usfca.edu What are the effects of cross-gender hormone treatment on the quality of life of transgender persons? Background A burgeoning area of primary care is transgender care. The most important aspect of this care is the provision of the means to transition to the gender that is felt to embody a person s true gender identity. The transgender population consists of a wide variety of individuals with various gender identities. Included in this systematic review will be male-to-female transgender individuals (known as transwomen), female-to-male individuals (or transmen) and people who may be taking cross-gender hormones but prefer not to identify as part of a gender binary. Given the multiple changes in healthcare in the United States, including the elimination of transgender exclusions in health insurance policies and an increasing number of policies accepting reassignment procedures, there will be an growing number of people who will be obtaining coverage for this kind of care. 1,2 Likewise, as the United States opens its health coverage to transgender people, it might lead to a similar trend in other parts of the world. In the United States, transgender care will begin to shift from the specialized clinics that have traditionally provided this care to more generalist primary care providers. 3,4 Transitioning for a transgender person typically begins with counseling to ascertain the need and appropriateness of the desired transition. 5 For those who desire a physical transition, this can be achieved through the use of cross-gender hormones and, for those who choose and are able to afford it, various types of gender reassignment surgery are available. 6 For many transgender individuals, hormones are the only medical aspect of transitioning that is desired. The hormones used for transition are estrogen and various anti-androgen agents for transwomen, and testosterone for transmen. 6 These hormones are provided on an off-label basis. Scarce research in this area has highlighted that the short and medium term medical risks of taking cross-gender hormones are small and are outweighed by the necessity of the hormones to enable the patients to live as their preferred doi: /jbisrir Page 93

2 gender. 7 The literature has primarily examined both transmen and transwomen using hormones as subjects, although one study focused solely on transmen. 8 Quality of life is a broad concept that involves the subjective judgment of individuals regarding both positive and negative aspects of a number of domains relevant to living one s life as fully as possible with regard to optimum mental and physical health. 9 When weighing all of the consequences of prescribing hormonal therapy, quality of life is an essential factor for health providers to consider. It is also an important consideration for the transgender population because of external factors that greatly impact on both physical and mental health. 3,5,8 Transgender individuals are often subjected to verbal and physical attacks, sometimes as extreme as murder, and the process of transition is, for many, one characterized by loss. 3,5,10 This can be the loss of family, friends, employment, housing and health care. 10 As a result of prejudice and stigmatization, transgender people have suffered from numerous health disparities. These include an increased prevalence of psychological conditions when compared to the general population, such as depression, suicidal ideation and substance abuse exacerbated by the lack of social support. 3,10,11 Transwomen have also been reported to have one the highest incidence rates of HIV in US studies. 11 Certainly one of the greatest impacts on the health and wellbeing of the transgender population is the everyday threat of violence. There are also reports of discrimination against transgender patients from health care providers. 10,12,13 As a result of discrimination from the larger society and from healthcare providers, many transgender individuals delay or completely avoid seeking necessary medical care. In some cases, care is actually denied. 10 In the United States, the Affordable Care Act has begun to address some of the disparities in the care received and health outcomes of transgender individuals by making it illegal for insurance companies to deny coverage to anyone because they may be transgender, which is seen as a preexisting condition, a practice that has been common among insurers. 10,14 However, there is currently no guarantee that once covered, a transgender person will receive the cross-gender hormones for transition-related care that they desire and find to be medically necessary due, in part, to a lack of competent providers who are knowledgeable in transgender care. 3,10,15 It is important to understand this background when considering studies examining any aspect of the quality of life transgender people, with or without cross-gender hormones. Several studies have examined the quality of life for transgender individuals either taking or not taking hormones or compared with a non-transgender population. 8,16-18 Some have used validated tools that measure quality of life, such as the Short-Form 36-Question Health Survey (SF-36), which uses eight domains;: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health. Other quality of life scales used in the literature regarding transgender subjects include the World Health Organization Quality of Life-BREF (WHOQOL-BREF), the Satisfaction With Life Scale (SWLS), the Subjective Happiness Scale (SHS), and the Subjective Quality of Life Analysis (SQUALA). Other studies have employed tools that measure specific domains of quality of life, such as self-esteem using the Social Self-Esteem Inventory, mood using the Beck Depression Inventory or the Minnesota Multiphasic Personality Inventory, global functioning using the Global Assessment of Functioning, social anxiety using the Social Anxiety and Depression Scale, and psychological functioning using the Spielberger s Trait Anxiety or the State-Trait Personality Inventory. 17,19,20 Doctors and nurses have been reported as often lacking in basic competence to adequately provide care to transgender individuals. 3,10,15 One of the usual first steps is the ability to provide cross-gender doi: /jbisrir Page 94

3 hormones for transition. Essential to the development of competence is an evidence base that informs clinicians about the impact of hormone therapy on transgender patients in transition and their quality of life. A preliminary review of the literature using the PubMed, PsycINFO and CINAHL databases established that there is no systematic review that is published or currently underway addressing the topic of the proposed systematic review, that is, the effects of cross-gender hormone treatment on quality of life. This systematic review will therefore make a novel contribution to the existing body of systematic reviews relating to treatment for transgender persons, and offer useful guidance for practitioners delivering care to this population. Keywords Cross-gender hormones; cross-sex hormones; quality of life; transgender; transsexual Inclusion criteria Types of participants This review will consider studies whose intervention group(s) include transgender women, (male-tofemale transgender individuals) and transmen (female-to-male transgender individuals), as well as people who do not identify with the gender binary on cross-gender hormones. There will be no age limitations on the study participants. Types of intervention(s) and comparators The review will include studies that evaluate cross-gender hormone treatment (or administration). Any study examining the effects of cross gender hormones will be considered, regardless of the length of time of the hormone treatment, variety of cross-gender hormones used, and level of the dosage. The control group(s) will include individuals who identity as transgender who do not use hormones. Types of outcomes The outcome is quality of life (all domains including but not limited to social distress, anxiety and depression) measured using any psychometric tool. These tools include specific quality of life tools such as the SF-36, WHOQOL-BREF, SWLS, SHS and SQUALA. Other tools that investigate depression, anxiety, mood and self-esteem that are equivalent to the various domains of quality of life will also be considered. These tools include the Social Self-Esteem Inventory, the Beck Depression Inventory, the Minnesota Multiphasic Personality Inventory, the Global Assessment of Functioning, the Social Anxiety and Depression Scale, the Spielberger s Trait Anxiety and the State-Trait Personality Inventory. Types of studies This review will consider both experimental and epidemiological study designs including randomized controlled trials, non-randomized controlled trials, quasi-experimental, before and after studies, prospective and retrospective cohort studies, case control studies and analytical cross sectional studies for inclusion. This review will also consider descriptive epidemiological study designs, including case series, individual case reports and descriptive cross sectional studies for inclusion. doi: /jbisrir Page 95

4 Search strategy A three-step search strategy will be utilized to identify studies published in the commercial and grey literature. An initial limited search of PubMed and CINAHL will be undertaken followed by an analysis of the text words contained in the title and abstract, and of the index terms used to describe the articles. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. Only studies published in English will be considered for inclusion. There will be no date limits applied to the literature reviewed. The databases to be searched for commercial literature are: PubMed PsycINFO CINAHL. The search for unpublished studies will include: Google Scholar (advanced), MEDNAR and ProQuest Dissertations and Theses. Initial keywords to be used are: transgender, transsexual, cross-gender hormones, quality of life. Assessment of methodological quality Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using the relevant instrument from the standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) suite of critical appraisal instruments (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer. Data extraction Data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Data synthesis Quantitative data will, where possible be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square and also explored using subgroup analyses based on the different study designs included in this review. If the studies are too heterogeneous to permit meta-analysis, findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate. Conflicts of interest The authors have no conflict of interest to declare. doi: /jbisrir Page 96

5 References 1. Radix A, Silva M. Beyond the guidelines: challenges, controversies, and unanswered questions. Pediatr Ann. 2014;43(6):e Stroumsa D. The state of transgender health care: policy, law, and medical frameworks. Am J Public Health. 2014;104(3):e Institute of Medicine. The health of lesbian, gay, bisexual, and transgender people: Building a foundation for better understanding. Washington, DC: Institute of Medicine; Gardner IH, Safer JD. Progress on the road to better medical care for transgender patients. Curr Opin Endocrinol Diabetes Obes. 2013;20(6): Bockting WO, Knudson G, Goldberg J, M. Counseling and mental health care for transgender adults and loved ones. International Journal of Transgenderism. 2006;9(3/4): Gorton RN, Buth J, Spade D. Medical Therapy and Health Maintenance for Transgender Men: A Guide for Health Care Providers [Internet]. [Cited on March 15, 2015]. Available from: 7. Gooren LJ, Giltay EJ, Bunck MC. Long-term treatment of transsexuals with cross-sex hormones: extensive personal experience. J Clin Endocrinol Metab. 2008;93(1): Newfield E, Hart S, Dibble S, Kohler L. Female-to-male transgender quality of life. Qual Life Res. 2006;15(9): Centers for Disease Control and Prevention. Quality of life n.d. [Internet]. [11/1/14]. Available from: Grant J, M., Mottet L, A., Tanis J, D., Harrison J, Herman J, L., Keisling M. Injustice at Every Turn: A Report of the National Transgender Discrimination Survey. Washington, DC: National Center for Transgender Equality and National Gay and Lesbian Task Force; Herbst JH, Jacobs ED, Finlayson TJ, McKleroy VS, Neumann MS, Crepaz N. Estimating HIV prevalence and risk behaviors of transgender persons in the United States: a systematic review. AIDS Behav. 2008;12(1): Lambda Legal. When Health Care Isn't Caring: Lambda Legal's Survey of Discrimination Against LGBT People and People With HIV. New York, NY: Lambda Legal, National Women's Law Center. Health Care Refusals Harm Patients: The Threat to LGBT People and Individuals Living With HIV/AIDS. Washington, DC: National Women's Law Center, Family Equality Council. The Affordable Care Act and Families with Parents Who Are LGBT: Everything You Need To Know 2015 [5/25/15]. [Internet]. [Cited on May 25, 2015]. Available from: Khalili J, Leung LB, Diamant AL. Finding the perfect doctor: identifying lesbian, gay, bisexual, and transgender-competent physicians. Am J Public Health. 2015;105(6): doi: /jbisrir Page 97

6 16. Gorin-Lazard A, Baumstarck K, Boyer L, Maquigneau A, Gebleux S, Penochet JC, et al. Is hormonal therapy associated with better quality of life in transsexuals? A cross-sectional study. J Sex Med. 2012;9(2): Gorin-Lazard A, Baumstarck K, Boyer L, Maquigneau A, Penochet JC, Pringuey D, et al. Hormonal therapy is associated with better self-esteem, mood, and quality of life in transsexuals. J Nerv Ment Dis. 2013;201(11): Gomez-Gil E, Zubiaurre-Elorza L, de Antonio IE, Guillamon A, Salamero M. Determinants of quality of life in Spanish transsexuals attending a gender unit before genital sex reassignment surgery. Qual Life Res. 2014;23(2): Gomez-Gil E, Zubiaurre-Elorza L, Esteva I, Guillamon A, Godas T, Cruz Almaraz M, et al. Hormone-treated transsexuals report less social distress, anxiety and depression. Psychoneuroendocrinology. 2012;37(5): Keo-Meier CL, Herman LI, Reisner SL, Pardo ST, Sharp C, Babcock JC. Testosterone Treatment and MMPI-2 Improvement in Transgender Men: A Prospective Controlled Study. J Consult Clin Psychol Insert page break doi: /jbisrir Page 98

7 Appendix I: Appraisal instruments MAStARI appraisal instrument test doi: /jbisrir Page 99

8 test message doi: /jbisrir Page 100

9 Insert doi: /jbisrir Page 101

10 Appendix II: Data extraction instruments MAStARI data extraction instrument doi: /jbisrir Page 102

11 Insert page break doi: /jbisrir Page 103