Navigating the future landscape of uterine fibroid research: a comprehensive summary of patient-centered outcome measures and implications

Abstract

Background

Uterine fibroid constitutes a significant burden for affected women and research in this area has increasingly focused on patient-centered outcomes, with patient-reported outcome measures (PROMs) becoming crucial in related studies.

Objectives

We aim to summarize the key aspects and PROMs utilized in previous studies, recommend suitable tools for effective evaluations, and emphasize critical areas for future research.

Method

A literature search was conducted in the Medline, CINAHL, Embase, and Web of Science databases, covering the period from inception through October 2024.

Main results

75 studies met the criteria for inclusion and these studies highlight that PROMs utilized in research associated with uterine fibroids encompass a wide range of evaluations, spanning from quality of life, menstrual details, psychological well-being, pelvic floor conditions, pain intensity, menopause symptoms, to sexual function, body image, and other related assessments. Despite using various PROMs in published studies, current clinical trials on uterine fibroids mainly rely on general questionnaires, employing questionnaires specifically designed for uterine fibroids.

Conclusion

By summarizing the research, we provide an overview of existing PROMs for uterine fibroids, revealing a gap due to the lack of specific PROMs. This review contributes to uterine fibroid research by promoting accurate assessments, leading to better treatment options and enhanced patient quality of life.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12905-025-03926-6.

Introduction

Uterine fibroids, the most common benign gynecologic tumors, affect 20–40% of women of reproductive age and up to 80% of Black women by age 50 years [1, 2]. They cause uncomfortable symptoms such as heavy menstrual bleeding, abdominal discomfort, increased urinary frequency, subfertility, chronic pelvic pain, and iron-deficiency anemia, which can strongly affect women’s health. Two-thirds of women with uterine fibroids report feeling tired or worn out, and over 40% express feeling sad or discouraged some, most, or all of the time [3]. Besides, uterine fibroids have profound daily - life consequences, significantly affecting various aspects of women’s lives. Related symptoms and mental stress can decrease productivity, increase absenteeism, and put a strain on intimate partnerships.

Although fibroids are generally non - life - threatening, they can take a significant toll on a woman’s quality of life. As a result, research in this field has gradually shifted its focus towards patient - centered outcomes [4]. The reason for this shift is that, despite their benign nature and effective manageability [5, 6]uterine fibroids still pose a substantial burden on women’s anxiety [7–9] levels and overall well-being [10]. Consequently, many contemporary clinical studies about treatment and prognosis prioritize outcome indicators like patients’ quality of life [11]. Besides, with the rising popularity of emerging treatment options, it becomes all the more crucial to understand the significance of accurate and responsive Patient - Reported Outcome Measures (PROMs) in evaluating how effective these treatments truly are [12, 13].

Patient-reported outcome (PRO) measures (PROMs), reporting patients’ views of their symptoms, functional status, and health-related quality of life (QoL), can be used to quantify the psychological impacts of diseases such as uterine fibroids, evaluate the outcomes of therapeutic management, and influence healthcare organization and delivery [14]. Despite the benign nature and high treatability of uterine fibroids, high levels of uterine fibroid-related anxiety, bleeding, and other negative impacts constitute a significant burden for affected women, thereby necessitating comprehensive assessment and focus [9, 15–17]. However, the absence of a summary concerning the key aspects and Patient-Reported Outcome Measures (PROMs) employed in uterine fibroid research has obscured vital insights, hindered the identification of valuable points, and impeded the progression of research efforts.

In this review, we aim to summarize the focused aspects and PROMs used in previous studies on uterine fibroids, recommend available PROMs for effective evaluations, highlight crucial directions for future research, and promote advancements in this field.

Methods

Search strategy and article selection

This study is a scoping review aimed at mapping the existing literature on patient-reported outcome measures (PROMs) in patients with uterine fibroids, and a comprehensive literature search was conducted using Medline, CINAHL, Embase, and Web of Science databases from inception to October 2024 (Literature Search Strategy was shown supplement). The search strategy consisted of (1) the construct of interest: patient-reported outcome measures (PROMs); (2) the target population: leiomyoma; and (3) excluded standards. The full search strategy of all databases is included as supplementary material. The results of the searches were consolidated, and duplicate records were eliminated using Endnote X9.

Article eligibility criteria

We considered studies for inclusion if they met the following criteria: (1) assessed patient-reported outcome in uterine fibroid patients, (2) utilized a Patient-Reported Outcome (PRO) instrument, and (3) were full-text original articles published in English in a peer-reviewed journal. Exclusion criteria were applied to studies that: (1) employed only a portion or an unvalidated short form of a Patient-Reported Outcome Measure (PROM), (2) were published in languages other than English, and (3) were published as abstracts, letters, theses, or editorials.

Selection of studies

Two independent researchers conducted the initial screening of potentially eligible studies by reviewing titles and abstracts from the retrieved studies. Full texts were then scrutinized for abstracts that aligned with the inclusion criteria. In cases of disagreement, conflicts were resolved through discussion.

Results

A total of 381 records were retrieved from four databases (Fig. 1). After removing 34 duplicate records, 265 unrelated records, and seven non-standard questionnaires, 75 records met the eligibility criteria and were included for comprehensive analysis (Supplementary Table 1).

Fig. 1.

Flow of the literature search

Patient-reported Outcome Measures (PROMs) utilized in research associated with uterine fibroids encompass a wide range of evaluations, spanning from quality of life, menstrual details, psychological well-being, pelvic floor conditions, pain intensity, menopause symptoms, to sexual function, body image, and other related assessments (Fig. 2). Although various Patient-Reported Outcome Measures appear in published studies, contemporary clinical trials on uterine fibroids primarily employ general questionnaires designed for multiple conditions. Besides, a limited number of studies and clinical trials utilize questionnaires (4 PROMS: UFS-QoL, UF-DBD, PASM-UF, FSD) specifically designed for uterine fibroids (Table 1), and only 16 studies were about validation of PROMs (Supplementary Table 2).

Fig. 2.

Patient-Reported Outcomes (PROMs) framework for uterine fibroids

Table 1.

Summary of characteristics of proms utilized in uterine fibroid research

	PROMs	Introduction	Specific for uterine fibroid
Quality of life
	The Uterine Fibroid Symptom and Quality of Life	Generic measure of health-related quality of life	Yes
	The Short Form Survey	Physical functioning, social/role functioning, mental and general health, perceptions, bodily pain, and vitality	No
	The Short Form Survey	Generic measure of health-related quality of life	No
	The EuroQoL Five Dimensions Questionnaire	Generic measure of health-related quality of life	No
	The Health Utilities Index Mark 3	Health and related quality of life: vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain	No
	The World Health Organization quality of life	Overall quality of life and general health: physical health, psychological, social relationships and environment	No
Menstruation evaluation
	The Pictorial Blood Loss Assessment Chart	Semi-quantitative evaluation of menstrual blood loss: the number of tampons used and the degree to which they are stained with blood	No
	The Aberdeen Bleeding Score	Evaluate menstrual symptoms and quality of life	No
	The Menstrual Bleeding Questionnaire	Menstrual and Gynecological symptoms	No
	The Mansfield-Voda-Jorgensen Menstrual Bleeding Scale	Quantified bleeding	No
	The Menstrual Pictogram Superabsorbent Polymer-containing Version 3	Quantified bleeding	No
	The Uterine Fibroid Daily Bleeding Diary	Rate the severity of vaginal bleeding in the past 24 hours’ from “No vaginal bleeding,” to “Very severe”	Yes
	The Menstrual Impact Questionnaire	Measure the effect of HMB on a woman’s self-assessment of menstrual blood loss (MBL), limitations in social/leisure activities, physical activities, and ability to work	No
Mental condition evaluation
	The Perioperative Anxiety Symptoms for Uterine Fibroids	Measure the perioperative anxiety symptoms of uterine fibroids: pain, lack of appetite, fatigue (tiredness), disturbed sleep, and anxiety	Yes
	The Self-Rating Anxiety Scale	General anxiety disorder	No
	The Hospital Anxiety and Depression Scale	Measure to detect depression and anxiety	No
	The Hamilton Rating Scale for Anxiety	Measure anxiety severity: psychological and somatic symptoms associated with anxiety	No
	The State-Trait Anxiety Inventory	General anxiety disorder	No
	The Symptom Checklist 90	Distinguish patients with/without psychosomatic diseases: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, photic anxiety, paranoid ideation, psychoticism, others	No
	The Patient Health Questionnaire	Screening, diagnosing, monitoring and measuring the severity of depression	No
	The Depression Self-Rating Scale	Measure the affective, psychological, and somatic aspects of depression,	No
Pelvic floor related- symptoms
	The Urogenital distress inventory	Assesses the presence and experienced bother of pelvic floor symptoms associated with lower urinary tract dysfunction: irritative, stress, and obstructive/discomfort symptoms	No
	The Incontinence Impact Questionnaire	Measure disease-specific quality of life in women with stress urinary incontinence	No
	The Defecation distress inventory	Assesses the presence and experienced bother of defecatory symptoms: constipation, painful defecation, fecal incontinence, and flatus incontinence	No
Pain evaluation
	The McGill Pain Questionnaire Short-Form	Provide quantitative measures of clinical pain that would capture its sensory, affective and other qualitative components, and allow statistical analysis of data collected during clinical research and practice	No
	The Visual Analogue Scale	Measure pain intensity from 0 “no symptoms” to 10 “very severe symptoms	No
Fibroid Symptom evaluation
	The Fibroid Symptom Diary	Assessed fibroid-related bleeding severity, menstrual cramping, and fatigue.	Yes
Sexual function evaluation
	The Sexual Activity Questionnaire	Focused on the relational, emotional, and behavioral aspects of sexual activity	No
	The Sexual Outcomes in Women Questionnaire	Assess the impact of pelvic problems on sexual desire, frequency, satisfaction, orgasm, and discomfort	No
	The Female Sexual Function Index	Measure female sexual function	No
	The Questionnaire for Screening Sexual Dysfunctions	Detect sexual dysfunctions	No
Body Image evaluation
	The Body Image Scale	Measure body image concerns	No
Menopause evaluation
	The Menopause Rating Scale	Measure the severity of aging-symptoms; somato-vegetative symptoms: sweating/hot flushes, heart discomfort, sleep problems, joint and muscle problems, categorized; psychological symptoms: depressive mood, irritability, anxiety, and physical/mental exhaustion, categorized; urogenital symptoms: sexual problems, bladder problems, and vaginal dryness, categorized.	No
	The Kupperman Index	Measure the severity of aging-symptoms: urinary infection, sexual complaints, sweating/hot flushes, palpitation, vertigo, headache, paresthesia, formication, arthralgia, myalgia, fatigue, nervousness, melancholia	No
Other
	The Patient Theory Questionnaire	Evaluate patients’ beliefs about the causes of myomas	No
	The Comprehensive Score for Financial Toxicity	Assess objective and subjective financial distress experienced by patients of their treatment.	No
	The Decision Conflict Scale	Measures personal perceptions of: option - choosing uncertainty; modifiable uncertainty - contributing factors; effective decision - making	No
	The Everyday discrimination scale	Assess the health effects of perceived discrimination	No

Quality of life assessment has emerged as essential for patients with uterine fibroids, particularly in evaluating and comparing levels before and after treatment. The Uterine Fibroid Symptom and Quality of Life questionnaire specifically evaluates fibroid-related quality of life and represents the most widely used self-administered instrument for assessing fibroid-related symptoms and health-related QoL [18, 19]. However, the remaining six questionnaires constitute general assessment tools not specific to this condition.

More than 25% of patients with uterine fibroids experience prolonged or heavy menstrual bleeding [20]potentially leading to iron deficiency anemia [21]. Therefore, this prevalence necessitates consideration of bleeding in uterine fibroid research, with seven menstruation-related questionnaires currently in use. These instruments include the Pictorial Blood Loss Assessment Chart (PBAC) [22]Aberdeen Bleeding Score, Menstrual Bleeding Questionnaire (MBQ), Mansfield-Voda-Jorgensen Menstrual Bleeding Scale (MVJ), the menstrual pictogram superabsorbent polymer-containing version 3 (MP SAP-c v3), and the Uterine Fibroid Daily Bleeding Diary (UF-DBD), which are utilized to evaluate menstrual blood loss [23, 24]. Additionally, the Menstrual Impact Questionnaire specifically assesses heavy menstrual bleeding’s impact on quality of life [25].

Research has demonstrated uterine fibroids’ significant impact on patients’ mental health, with improved mental state serving as a treatment effectiveness indicator [26]. Actually, anxiety regarding heavy bleeding and pelvic pain constitutes the primary stressor for patients with uterine fibroids [7]resulting in elevated rates of self-harm within this population [8]. 80% of American patients with uterine fibroids opt for surgery due to anxiety and malignancy concerns [27]. Disease-related anxiety represents the most prevalent emotional burden among these patients, primarily associated with fibroid size and number, treatment requirements, and potential side-effects [9]. Related to significant patient-reported health disabilities (including bodily pain, mental health, social functioning, and sex life satisfaction), uterine fibroids appear to be a vital psychosocial stressor; disability scores after fibroid diagnosis can exceed those in diabetes mellitus, heart disease, and breast cancer [28]. The following Patient-Reported Outcome Measures (PROMs) were utilized to assess anxiety or depression in patients with uterine fibroids: the Perioperative Anxiety Symptoms related to Uterine Fibroids (PASM-UF), the Self-Rating Anxiety Scale (SAS), the Hospital Anxiety and Depression Scale (HADS), the Hamilton Anxiety Scale (HAMA), the State-Trait Anxiety Inventory (STAI), the Patient Health Questionnaire-9 (PHQ-9), Zung’s Anxiety Self-Rating Scale, and Depression Self-Rating Scale [29, 30]. Among these, PASM-UF was specifically developed to evaluate anxiety symptoms related to uterine fibroids, encompassing pain, loss of appetite, fatigue, disturbed sleep, and anxiety [31].

Currently, there is a focus on fibroid surgery and its potential to improve bladder symptoms and defecatory function [32]. In this field, three commonly used tools are the Urogenital Distress Inventory (UDI), the Incontinence Impact Questionnaire, and the Defecation Distress Inventory (DDI) [33]. Additionally, the McGill Pain Questionnaire (MPQ) and the Visual Analogue Scale (VAS) were utilized for evaluating fibroid-related pain [34]. Meanwhile, the Fibroid Symptom Diary (FSD) served as a tool to assess fibroid-related pain, bleeding severity, menstrual cramping, and fatigue [35].

It is well-established that benign gynecological diseases adversely impact sexual function [36]. Although some patients hesitate to receive surgery like hysterectomy due to concerns about potential negative effects on their sexual well-being [37]research has shown that uterine artery embolization (UAE) can enhance the sexual and psychological well-being of women with symptomatic uterine fibroids [38]. Therefore, in order to elucidate the relationship between sexual function, disease, and treatment, and to optimize management and improve the sexual function of patients with uterine fibroid, it is crucial to consider the sexual function of patients. This This assessment involves various patient-reported outcome measures, including the Sexual Activity Questionnaire (SAQ), the Sexual Outcomes in Women Questionnaire (SHOW-Q), the Female Sexual Function Index, and the Questionnaire for Screening Sexual Dysfunctions (QSD) [38, 39]. Furthermore, when addressing symptoms associated with menopause in patients with fibroids, the Menopause Rating Scale (MRS) and the Kupperman Index have been employed [40, 41].

Body image refers to an individual’s cognitive or affective evaluation of their body or appearance, which may manifest as either positive or negative perceptions [42]. In recent decades, research on body image has expanded significantly. Studies have shown that undergoing treatment for fibroids can affect one’s perception of body image post-procedure [43]. Consequently, researchers frequently employ the Body Image Scale and the Physical Component Summary (PCS) to generate evidence and guidelines for systematic fibroid management [32, 43].

A limited number of studies focus on financial status, decision conflict, and patients’ beliefs regarding the causes of myomas. These research efforts employ patient-reported outcome measures (PROMs) such as the Comprehensive Score for Financial Toxicity, the Decision Conflict Scale, the Patient Theory Questionnaire, and the Zenz Everyday Discrimination Scale (EDS) [44].

Last but not least, among the four Patient-Reported Outcome Measures (PROMs) designed for uterine fibroids (Table 2), three focused primarily on anxiety (PASM-UF), bleeding (UF-DBD), or symptoms (FSD) respectively. Consequently, to comprehensively assess different aspects of uterine fibroids, multiple questionnaires need to be administered, creating a potentially time-intensive and demanding process. Only one PROM assessed both symptoms and quality of life (UFS-QoL). Therefore, future development of PROMs for uterine fibroids should emphasize comprehensive assessment to enhance clinical utility and research applications.

Table 2.

Summary of proms specific for uterine fibroid

PROM	Construct(s)	Target population	Mode of administration	Administration time	Recall period	Items (No.)	Scorning rule
The Uterine Fibroid Symptom and Quality of Life (UFS-QoL)	Symptom severity scale (8-item) and HRQL questions (29-item; 6 subscales: concern, activities, energy/mood, control, self-consciousness, and sexual function)	Patients with uterine fibroids	Self-administered, interview-based	10–15 min	Past 3 months	37	5 points scale (1–5)
The Perioperative Anxiety Symptoms for Uterine Fibroids (PASM-UF)	Measure the perioperative anxiety symptoms of uterine fibroids: pain, lack of appetite, fatigue (tiredness), disturbed sleep, and anxiety	Patients with uterine fibroids	Self-administered, interview-based	2–3 min	Now	5	10 points scale (0–10)
The Uterine Fibroid Daily Bleeding Diary (UF-DBD)	Quantified fibroid-related bleeding: Rate the severity of any vaginal bleeding in the past 24 hours’ with “No vaginal bleeding,” “Spotting,” “Mild,” “Moderate,” “Severe,” or “Very severe”.	Patients with uterine fibroids	Self-administered, interview-based	1–2 min	past 24 h	1	0–10 (0 =“No vaginal bleeding”, 1 = “Spotting”, 4 = “Mild”, 6 = “Moderate”, 8 = “Severe”, 10 = “Very Severe”)
The Fibroid Symptom Diary (FSD)	Assessed fibroid-related bleeding severity, menstrual cramping, and fatigue (11 items): 5 items for Menstrual bleeding or spotting; 1 item for cramping (distinct from other pain); 1 item for fatigue; 1 item for and bloating; 3 items for other fibroid-related pain.	Patients with uterine fibroids	Self-administered, interview-based	1–2 min	past 24 h	11	Depends

Discussion

This review synthesizes the current landscape of Patient-Reported Outcome Measures (PROMs) utilized in uterine fibroid research. Our analysis reveals that while the multifaceted impact of fibroids on patient well-being is increasingly recognized—spanning quality of life (QoL), menstrual burden, mental health, pelvic floor dysfunction, pain, menopausal symptoms, sexual function, and body image [45]—the methodological approaches to capturing this complexity remain heterogeneous and often inadequate [3, 46, 47].

Moreover, the significance of quality of life assessment in uterine fibroids research has been established, highlighting the need for more evidence to support the selection of the most fitting Patient-Reported Outcome Measures (PROMs). The UFS-QoL, disease-specific and extensively validated [48–51]offers a valuable tool for comprehensively evaluating fibroid-related symptoms and their impact on QoL. However, the frequent reliance on generic PROMs in research and clinical trials poses a significant limitation. These instruments fail to capture the distinct symptomatology and lived experiences unique to uterine fibroid patients, potentially obscuring critical treatment effects or patient burdens [52–54].

Heavy menstrual bleeding, a hallmark symptom, highlight the challenge of quantifying subjective experiences. Tools like the Pictorial Blood Assessment Chart (PBAC) and Aberdeen Bleeding Score provide structured approaches for assessing blood loss, facilitating treatment evaluation. Nevertheless, their practical limitations and variable correlation with objective measures [55, 56]leading to an unmet need for more precise, patient-friendly, and clinically meaningful assessment methodologies in this domain.

Beyond physical symptoms, the psychological health of uterine fibroids—including heightened anxiety, depression, and distress—demand greater attention [57, 58]. These factors are intrinsically linked to treatment adherence, decision-making, and long-term recovery. Integrating validated psychological assessments into both research protocols and clinical practice is therefore not merely supplementary but essential for a holistic understanding of patient needs and for tailoring effective, personalized management strategies. Future research must prioritize investigating the underlying mechanisms linking fibroids to mental health burden and rigorously evaluating targeted psychosocial interventions.

As research into the quality of life of patients with uterine fibroids progresses, sexual function and body image have increasingly emerged as pivotal areas of interest. These dimensions are vital to patients’ overall well-being [59, 60]. Consequently, it is essential to conduct more studies that focus on the impact of treatment on patients’ sexual function and body image, in order to refine and enhance treatment plans [61].

A critical observation from our synthesis is the persistent disconnect between the recognized multidimensionality of the fibroid experience and the tools used to measure it. Clinical trials predominantly utilize generic PROMs, with only a minority employing the disease-specific UFS-QoL. Moreover, even existing fibroid-specific tools often capture a limited spectrum of impact, necessitating burdensome combinations of multiple questionnaires to achieve a comprehensive assessment [62]. This fragmented approach creates significant respondent burden and analytical complexity, hindering both research efficiency and clinical utility.

Consequently, there is a compelling and urgent need to advance PROM development and application in this field. Rather than seeking a single “best” instrument, our aim is to guide researchers and clinicians towards a more sophisticated approach: selecting or developing PROMs based on a clear conceptual framework of fibroid impact that aligns with the specific research question or clinical context. This requires prioritizing instruments with proven validity, reliability, responsiveness, and relevance to the specific dimensions under investigation. Optimizing assessment could involve refining existing tools, developing modular instruments, or creating novel, comprehensive fibroid-specific PROMs capable of capturing the full breadth of patient experiences efficiently [63].

Conclusion

By summarizing previous research, we provide valuable references associated with assessment and PROMs for future studies on uterine fibroids. Furthermore, we highlight the existing gap due to the current lack of uterine fibroids-specific PROMs. Additionally, recommending effective Patient-Reported Outcome Measures (PROMs) tools will assist researchers in more accurately assessing treatment efficacy and improvements in patients’ quality of life. These efforts will contribute to advancements in the field of uterine fibroids, offering patients better treatment options and enhanced quality of life.

Electronic supplementary material

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Author contributions

Shuhao Yang: Design, data collection, analysis, and drafting the manuscript. Qing Yan, Fei Liu, Wei Yan: Data collection. Suzhen Yuan, Minli Zhang, Zhangying Wu: Analysis. Ya Li: Study conception, review of study design and review of draft manuscript. Tao Xiang: review of draft manuscript; Wenwen Wang: Study conception, review of study design and review of draft manuscript.dy design and review of draft manuscript.

Funding

This work was supported by the National Key Research and Development Program of China (2022YFC2704100); Knowledge Innovation Program of Wuhan -Basic Research (2023020201010041); National Natural Science Foundation of China (NSFC) Regional Project (81760266).

Data availability

Data is provided within supplementary information.

Declarations

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.