Background:Utility analysis is well-established for comparing treatment options but challenging to assess with patients in clinical care. Preference assessment may be more feasible, but it is not yet known whether it correlates with utilities. The aims of this study were to (1) assess women's rankings, ratings, and utilities for tissue-based, implant-based, and no reconstruction after total mastectomy; and (2) explore assessment methods and correlations with clinical and psychosocial factors. Methods:Forty patients considering or undergoing breast reconstruction completed 3 assessments-card ranking, visual analog scale, and standard gamble-and psychosocial questionnaires. Each woman rated 9 health states with case-matched images: 4 excellent, good, fair, and poor outcomes for tissue-based reconstruction; 4 for implant-based reconstruction; and 1 image for no reconstruction. Nonparametric tests compared assessment methods. Descriptive statistics summarized rankings, ratings, and utilities. Multivariable regression models assessed correlations with clinical/psychosocial factors. Results:Median standard gamble utilities by category were 0.97 (excellent), 0.95 (good), 0.94 (fair), and 0.92 (poor) for tissue-based reconstruction; 0.99 (excellent), 0.96 (good), 0.94 (fair), and 0.94 (poor) for implant-based reconstruction; and 0.86 for no reconstruction. The standard gamble required 20-40 minutes, and some patients found it difficult. The visual analog scale required 5 minutes and correlated with the standard gamble. Psychosocial characteristics correlated with the scores; however, a more diverse sample is needed. Conclusions:All assessments showed that women highly value breast reconstruction after mastectomy. For time-limited clinical care, the visual analog scale is brief, understandable, and clearly illustrates preferences to support shared decision-making.

Background:Previous studies have explored the ability of artificial intelligence (AI) tools based on large language models, such as Chat Generative Pre-Trained Transformer (ChatGPT), to answer patient questions about breast reconstruction. In this study, we assessed the quality of questions generated by ChatGPT for breast reconstruction patients to ask their providers. Methods:ChatGPT was prompted to generate appearance-related questions representative of what patients might ask during breast reconstruction consultations. As a benchmark, a comparison group of questions from credible online sources was compiled. Blinded to the source, surgeons assessed the quality of questions in terms of their acceptability, contribution to the informed consent process, and contribution to the shared decision-making process. Surgeons were also asked to report their agreement on whether questions were generated by an AI tool. Results:Experienced reconstructive surgeons rated ChatGPT-generated questions about appearance-related outcomes of breast reconstruction as acceptable (15 of 16), likely to positively contribute to the informed consent process (15 of 16), and likely to positively contribute to the shared decision-making process (16 of 16). These ratings were comparable to those for benchmark questions. Surgeons did not readily recognize questions as being AI-generated. Differences in surgeon assessments were most pronounced regarding the perceived potential for the questions to contribute to the informed consent process. Conclusions:The quality of ChatGPT-generated questions related to appearance concerns is comparable to that of questions sourced from reputable online websites. Patients may benefit from discussion with their providers about best practices for using AI tools in preparation for consultations.

Abstract Introduction: As the COVID-19 pandemic began, concerns arose that timely utilization of elective breast cancer care would decrease due to state moratoriums, travel restrictions, or fear, resulting in poorer long-term outcomes. Advances in telemedicine provided a new avenue for care; however, rapid implementation brought concerns about variable uptake and disparities. To support longitudinal clinical and epidemiological studies, this analysis described elective breast cancer care utilization during the first year of the pandemic, including patient, hospital, and geographic barriers and facilitators. Methods: The Multidisciplinary Breast Reconstruction Research Program team reviewed all breast cancer surgeries and procedures at The University of Texas MD Anderson Cancer Center during the pre-pandemic (March 1, 2019 to February 29, 2020) and pandemic (March 1, 2020 to February 28, 2021) periods. The team identified procedures that were deemed elective or preference-sensitive, and summarized the timeline of pandemic milestones and changes, including the implementation of telemedicine appointments. A data analyst summarized the distributions of completed, canceled, rescheduled, and never completed procedures. T tests and analyses of variance tested differences between the pre-pandemic and pandemic year. Generalized linear models assessed patient, hospital, and geographic factors that correlated with successful access to, and completion of, procedures. Two focus groups reviewed data and informed the interpretation of results. Results: During the first pandemic year, 30 breast care procedures were identified that were postponed during March-April, July-August, and December-January. Surprisingly, no decrease in overall utilization of elective care procedures was observed; in fact, 19% more elective breast cancer care surgeries and procedures were scheduled (4752 pre-pandemic vs 4003 pandemic) in 13% more episodes of care (2723 pre-pandemic vs 2415 pandemic). As expected, rescheduling of procedures increased 98% (from 14% pre-pandemic to 27% pandemic); however, the majority of procedures were able to be completed by the end of the year (72% pre-pandemic, 73% pandemic). Telemedicine did not significantly mediate successful completion, as the majority of procedures were prophylactic or reconstructive surgeries. However, extended hours (p = 0.03) and proximity to the hospital facilitated access and successful completion of care (p< 0.01). The most common procedures that were not able to be performed within the first year of the pandemic were autologous breast reconstruction, revision, and mastopexy. Notably, patients reported slightly improved rates of anxiety and depression during the initial pandemic year (11% vs 14%, p = 0.04), possibly due to relative privation or comparison bias. Clinicians and patients/survivors noted several “lessons learned” that may inform access and preference-sensitive care delivery. Conclusions: Despite three periods of state-mandated discontinuation of elective care procedures, the majority of patients were able to access and successfully complete elective breast cancer care during the first year of the COVID-19 pandemic. Future studies and initiatives may use this information to explore innovations in care delivery and short- and long-term effects on health outcomes. Citation Format: Haoqi Wang, Greg Reece, Mary Catherine Bordes, Mia Markey, Aubri Hoffman. Pandemic Shifts: How did elective breast cancer care change? [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-27-02.

Background: Young adults with low sexual health literacy levels may find it difficult to make informed decisions about contraceptive methods. We developed and pilot-tested a web-based decision aid-Healthy Sex Choices-designed to support diverse young adults with their contraceptive decision-making. Objective: This pilot study aimed to evaluate whether the Healthy Sex Choices decision aid is acceptable and feasible to patients and clinicians. Methods: We used the Ottawa Decision Support Framework and the International Patient Decision Aid Standards to develop and pilot the decision tool. We first conducted a needs assessment with our advisory panel (5 clinicians and 2 patients) that informed decision aid development. All panelists participated in semistructured interviews about their experience with contraceptive counseling. Clinicians also completed a focus group session centered around the development of sex education content for the tool. Before commencing the pilot study, 5 participants from ResearchMatch (Vanderbilt University Medical Center) assessed the tool and suggested improvements. Results: Participants were satisfied with the tool, rating the acceptability as "good." Interviewees revealed that the tool made contraceptive decision-making easier and would recommend the tool to a family member or friend. Participants had a nonsignificant change in knowledge scores (53% before vs 45% after; P=.99). Overall, decisional conflict scores significantly decreased (16.1 before vs 2.8 after; P<.001) with the informed subscale (patients feeling more informed) having the greatest decline (23.1 vs 4.7; mean difference 19.0, SD 27.1). Subanalyses of contraceptive knowledge and decisional conflict illustrated that participants of color had lower knowledge scores (48% vs 55%) and higher decisional conflict (20.0 vs 14.5) at baseline than their white counterparts. Conclusions: Participants found Healthy Sex Choices to be acceptable and reported reduced decisional conflict after using the tool. The development and pilot phases of this study provided a foundation for creating reproductive health decision aids that acknowledge and provide guidance for diverse patient populations.

PURPOSE:Fertility preservation is an increasingly important topic in adolescent and young adult cancer survivorship, yet treatments remain under-utilized, possibly due to lack of awareness and understanding. The internet is widely used by adolescents and young adults and has been proposed to fill knowledge gaps and advance high-quality, more equitable care. As a first step, this study analyzed the quality of current fertility preservation resources online and identified opportunities for improvement. METHODS:We conducted a systematic analysis of 500 websites to assess the quality, readability, and desirability of website features, and the inclusion of clinically relevant topics. RESULTS:The majority of the 68 eligible websites were low quality, written at college reading levels, and included few features that younger patients find desirable. Websites mentioned more common fertility preservation treatments than promising experimental treatments, and could be improved with cost information, socioemotional impacts, and other equity-related fertility topics. CONCLUSIONS:Currently, the majority of fertility preservation websites are about, but not for, adolescent and young adult patients. High-quality educational websites are needed that address outcomes that matter to teens and young adults, with a priority on solutions that prioritize equity. IMPLICATIONS FOR CANCER SURVIVORS:Adolescent and young adult survivors have limited access to high-quality fertility preservation websites that are designed for their needs. There is a need for the development of fertility preservation websites that are clinically comprehensive, written at appropriate reading levels, inclusive, and desirable. We include specific recommendations that future researchers can use to develop websites that could better address AYA populations and improve the fertility preservation decision making process.

Objective With a growing population of young cancer survivors, there is an increasing need to address the gaps in evidence regarding cancer survivors’ obstetric outcomes, fertility care access, and experiences. As part of a large research program, this study engaged survivors and experts in co-developing and testing the validity, reliability, acceptability, and feasibility of a scale to assess survivor-reported barriers to motherhood after cancer. Methods Scale items were developed based on literature and expert review of 226 reproductive health items, and six experience and focus groups with 26 survivors of breast and gynecological cancers. We then invited 128 survivors to complete the scale twice, 48 hours apart, and assessed the scale’s psychometric properties using exploratory factor analyses including reliability, known-group validity, and convergent validity. Results Item development identified three primary themes: multifaceted barriers for cancer survivors; challenging decisions about whether and how to pursue motherhood; and a timely need for evidence about obstetric outcomes. Retained items were developed into a 24-item prototype scale with four subscales. Prototype testing showed acceptable internal consistency (Cronbach’s alpha=0.71) and test-retest reliability (intraclass correlation coefficient=0.70). Known-group validity was supported; the scale discriminated between groups by age (x=70.0 for patients ≥35 years old vs 54.5 for patients <35 years old, p=0.02) and years since diagnosis (x=71.5 for ≥6 years vs 54.3 for<6 years, p=0.01). The financial subscale was correlated with the Economic StraiN and Resilience in Cancer measure of financial toxicity (ρ=0.39, p<0.001). The scale was acceptable and feasibly delivered online. The final 22-item scale is organized in four subscales: personal, medical, relational, and financial barriers to motherhood. Conclusion The Survivorship Oncofertility Barriers Scale demonstrated validity, reliability, and was acceptable and feasible when delivered online. Implementing the scale can gather the data needed to inform shared decision making and to address disparities in fertility care for survivors.

This Viewpoint discusses strategies to optimize oncofertility care and improve the survivorship experience of women with cancer.

BACKGROUND:Contraceptive care is a key element of reproductive health, yet only 12%-30% of women report being able to access and receive the information they need to make these complex, personal health care decisions. Current guidelines recommend implementing shared decision-making approaches; and tools such as patient decision aid (PtDA) applications have been proposed to improve patients' access to information, contraceptive knowledge, decisional conflict, and engagement in decision-making and contraception use. To inform the design of meaningful, effective, elegant, and feasible PtDA applications, studies are needed of all users' current experiences, needs, and barriers. While multiple studies have explored patients' experiences, needs, and barriers, little is known about clinicians' experiences, perspectives, and barriers to delivering contraceptive counseling.OBJECTIVE:This study focused on assessing clinicians' experiences, including their perspectives of patients' needs and barriers. It also explored clinicians' suggestions for improving contraceptive counseling and the feasibility of a contraceptive PtDA.METHODS:Following the decisional needs assessment approach, we conducted semistructured interviews with clinicians recruited from the Society of Family Planning. The Ottawa Decision Support Framework informed the interview guide and initial codebook, with a specific focus on decision support and decisional needs as key elements that should be assessed from the clinicians' perspective. An inductive content approach was used to analyze data and identify primary themes and suggestions for improvement.RESULTS:Fifteen clinicians (12 medical doctors and 3 nurse practitioners) participated, with an average of 19 years of experience in multiple regions of the United States. Analyses identified 3 primary barriers to the provision of quality contraceptive counseling: gaps in patients' underlying sexual health knowledge, biases that impede decision-making, and time constraints. All clinicians supported the development of contraceptive PtDAs as a feasible solution to these main barriers. Multiple suggestions for improvement were provided, including clinician- and system-level training, tools, and changes that could support successful implementation.CONCLUSIONS:Clinicians and developers interested in improving contraceptive counseling and decision-making may wish to incorporate approaches that assess and address upstream factors, such as sexual health knowledge and existing heuristics and biases. Clinical leaders and administrators may also wish to prioritize solutions that improve equity and accessibility, including PtDAs designed to provide education and support in advance of the time-constrained consultations, and strategic training opportunities that support cultural awareness and shared decision-making skills. Future studies can then explore whether well-designed, user-centered shared decision-making programs lead to successful and sustainable uptake and improve patients' reproductive health contraceptive decision-making.

Background: Appearance counseling is an important component of the consent process for breast reconstruction. The purpose of appearance counseling is to help the patient form realistic expectations of what she might look like after breast reconstruction. In this article, we introduce a recommender system, "BreastDecisions," for appearance counseling that suggests photographs of previous patients that are tailored to a specific patient to help her form realistic expectations of her own reconstruction. Methods: We present user specifications and algorithm parameters needed to incorporate the recommender system into the appearance counseling workflow. We demonstrate the system for a common counseling scenario using a knowledgebase of previous breast reconstruction patients. The medical appropriateness of the recommended photographs for use in appearance counseling was evaluated by experts using a four-point rating system. Results: The recommender system presents photographs that are medically appropriate for counseling a specific patient, depicts typical outcomes, and adapts to a variety of clinical workflows. For each of 33 patients taken as examples of breast reconstruction patients, we used the system to identify photographs for appearance counseling. The baseline average medical appropriateness of the recommended photographs was between mostly appropriate (some explanation needed) and medically appropriate (minimal explanation needed). We demonstrate filtering and ranking steps to reduce the number of recommended photographs and increase the average medical appropriateness. Conclusions: Our recommender system automatically suggests photographs of previous breast reconstruction patients for use in counseling a patient about appearance outcomes. The system is patient-specific and customizable to a particular surgeon's practice.

A patient’s comprehension and memory of conversations with their providers plays an important role in their healthcare. Adult breast cancer patients whose legal sex was female and who underwent treatment at the Center for Reconstructive Surgery at The University of Texas MD Anderson Cancer Center were asked to indicate which breast reconstruction procedures they discussed with their surgeon. We focused on the three most frequent responses: (a) participants who remembered discussing implant-based, tissue-based, and combination procedures; (b) participants who remembered only an implant-based option being discussed; and (c) participants who remember only a tissue-based option being discussed. We used multinomial logistic regression models to explore the psychosocial factors associated with patients’ recollections of their breast reconstruction options after discussions with their reconstructive surgeons, controlling for medical factors that impact surgical decision-making. Our analyses identified body mass index, body image investment, and body image as statistically significantly associated with the reconstructive options that a participant recalls discussing with their surgeon. Our findings highlight body image investment and body image as important psychological factors that may influence what patients remember from consultations about breast reconstruction options.

Introduction Although decisions about breast reconstruction surgery include patients’ perspectives, little is known about which options patients recall discussing and how their psychosocial factors influence their recall. The purpose of this study was to explore whether psychosocial factors were associated with the breast reconstruction options a patient remembers discussing with their reconstructive surgeon, controlling for medical factors that impact surgical decision-making. Material and methods From 2011 to 2014, we recruited English-speaking adults whose legal sex was female who had an appointment at The University of Texas MD Anderson Cancer Center to discuss breast reconstruction. After the clinical consultation, participants indicated which reconstruction procedures they remembered discussing with their reconstructive surgeon (choose all that apply): (1) implant-based, (2) tissue-based, (3) combination of implant and tissue. Analyses focused on three groups: participants who remembered (a) only an implant-based option being discussed; (b) only a tissue-based option being discussed; and (c) implant-based, tissue-based, and combination options being discussed. We investigated the association between which reconstruction option(s) a participant remembered discussing with her reconstructive surgeon and her body image investment (Appearance Schemas Inventory-Revised (ASI-R)), body image (Body Image Scale (BIS)), and overall psychological distress (Brief Symptom Inventory-18 (BSI-18)), considering participant age and Body Mass Index (BMI). Multiple multinomial logistic regression models were used to investigate the associations of participant factors with the reconstruction options they remembered discussing with their surgeon. Akaike information criterion (AIC) was applied to select the best-fitting multivariable model. Results Out of 306 participants,138 participants remembered discussing only implant-based reconstruction; 118 participants remembered discussing only tissue-based reconstruction; and 50 participants remembered discussing implant-based, tissue-based, and combination options. The majority of participants were Caucasian (74.8%) and non-Hispanic (75.2%). BMI, body image investment, and body image were identified as associated with remembering different reconstruction options being discussed and were included in the multiple multinomial logistic regression model. Greater body image investment (i.e., higher ASI-R composite score) was significantly associated with higher odds of remembering discussing only implant-based reconstruction as compared to remembering discussing only tissue-based reconstruction, adjusted for the other factors in the model (adjusted odds ratio [OR] = 1.70, 95% CI = 1.04-2.79, p-value = 0.035). Greater body image dissatisfaction or concerns (i.e., higher BIS score) was associated with higher odds of remembering discussing only tissue-based reconstruction compared to remembering discussing only implant-based reconstruction, adjusted for the other factors in the model (adjusted OR = 1.04, 95% CI = 1.00-1.08, p-value = 0.045). Conclusion Our findings indicate that even when adjusted for BMI, patients with higher body image investment may be more likely to remember discussions about implant-based reconstruction, and patients with greater body image dissatisfaction may be more likely to remember discussions about tissue-based reconstruction. Tailored counseling approaches may be recommended to ensure all patients equally attend to and consider all medically-relevant options when discussing breast reconstruction surgery. Citation Format: Haoqi Wang, Jun Liu, Mary Catherine Bordes, Deepti Chopra, Gregory P Reece, Mia K Markey, Aubri S Hoffman. When discussing breast reconstruction, do psychosocial characteristics influence which surgical options patients remember? [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-09-04.

Background: Many women with breast cancer search the internet for photographs of their potential reconstruction outcomes, but little is known about the quality, variety, and relevance of images patients are viewing. Methods: Breast reconstruction outcome photographs identified by a Google Images search were assessed based on the American Society of Plastic Surgeons/Plastic Surgery Foundation photographic guidelines. Information such as source metadata, breast reconstruction procedure information, and subject demographics was collected from the photographs. Additional analyses were conducted to assess whether nipple reconstruction or tattooing occurred and was disclosed, whether a symmetry procedure was performed and disclosed, and whether donor site scarring is visible in abdominal flap photographs. Results: We acquired and analyzed 114 photograph sets. Although a variety of images were readily available, the majority of photograph sets did not follow photographic guidelines or provide sufficient information. Most photograph sets (60%) indicated symmetry procedures when a symmetry procedure was evident, but only 40% of photograph sets disclosed a nipple procedure when a nipple procedure was evident. Only 40% of abdominal flap photographs showed donor site scarring. Subject demographics were largely missing: 50% of photograph sets included subject age, 3% included race or ethnicity, and 12% included weight or BMI. Conclusions: Although breast reconstruction outcome photographs shown by “Dr. Google” represent a variety of reconstruction types, they typically lack information that a patient needs to assess self-applicability. Patients may benefit from discussion with their healthcare team about the strengths and limitations of breast reconstruction outcome photographs available on the internet.

Patients’ preferences regarding changing or maintaining their breast size after mastectomy and reconstruction are important but understudied determinants of post-surgical satisfaction and quality of life. The goal of this study was to identify factors associated with preferences for changing or maintaining breast size for women undergoing breast reconstruction at The University of Texas MD Anderson Cancer Center in the United States from 2011 to 2014. The average age of participants was 45.7 ± 9.1 years. At baseline, mean average breast volumes were 755.7 ± 328.4 mL for all women (n = 48), 492.3 mL ± 209.3 for 13 women who preferred to be “bigger than now,” 799.2 mL ± 320.9 for 25 women who preferred to remain “about the same,” and 989.3 mL ± 253.1 for 10 women who preferred “smaller than now.” Among the 23 women who preferred to change their breast size, 19 desired to shift toward the mean. Women with the smallest and largest 20% of baseline breast size were more likely to desire a change toward the mean (p = 0.006). Multinomial logistic regression models found average breast volume and satisfaction with breast size to be the most important factors associated with preferences for changing or maintaining breast size for women undergoing breast reconstruction. This study provides preliminary evidence for a “Goldilocks principle” in women’s preferences for breast size change in the context of breast reconstruction, and identifies hypotheses for future studies of the associations among preference for change in breast size, preference achievement, and post-reconstruction body image.

BACKGROUND:When designing and developing patient decision aids, guidelines recommend involving patients and stakeholders. There are myriad ways to do this. We aimed to describe how such involvement occurs by synthesizing reports of patient decision aid design and development within a user-centered design framework and to provide context by synthesizing reports of user-centered design applied to other personal health tools.METHODS:We included articles describing at least one development step of 1) a patient decision aid, 2) user- or human-centered design of another personal health tool, or 3) evaluation of these. We organized data within a user-centered design framework comprising 3 elements in iterative cycles: understanding users, developing/refining prototype, and observing users.RESULTS:We included 607 articles describing 325 patient decision aid projects and 65 other personal health tool projects. Fifty percent of patient decision aid projects reported involving users in at least 1 step for understanding users, 35% in at least 1 step for developing/refining the prototype, and 84% in at least 1 step for observing users' interaction with the prototype. In comparison, other personal health tool projects reported 91%, 49%, and 92%, respectively. A total of 74% of patient decision aid projects and 92% of other personal health tool projects reported iterative processes, both with a median of 3 iterative cycles. Preliminary evaluations such as usability or feasibility testing were reported in 66% of patient decision aid projects and 89% of other personal health tool projects.CONCLUSIONS:By synthesizing design and development practices, we offer evidence-based portraits of user involvement. Those wishing to further align patient decision aid design and development with user-centered design methods could involve users earlier, design and develop iteratively, and report processes in greater detail.

BACKGROUND:Decades of effectiveness research has established the benefits of using patient decision aids (PtDAs), yet broad clinical implementation has not yet occurred. Evidence to date is mainly derived from highly controlled settings; if clinicians and health care organizations are expected to embed PtDAs as a means to support person-centered care, we need to better understand what this might look like outside of a research setting.AIM:This review was conducted in response to the IPDAS Collaboration's evidence update process, which informs their published standards for PtDA quality and effectiveness. The aim was to develop context-specific program theories that explain why and how PtDAs are successfully implemented in routine healthcare settings.METHODS:Rapid realist review methodology was used to identify articles that could contribute to theory development. We engaged key experts and stakeholders to identify key sources; this was supplemented by electronic database (Medline and CINAHL), gray literature, and forward/backward search strategies. Initial theories were refined to develop realist context-mechanism-outcome configurations, and these were mapped to the Consolidated Framework for Implementation Research.RESULTS:We developed 8 refined theories, using data from 23 implementation studies (29 articles), to describe the mechanisms by which PtDAs become successfully implemented into routine clinical settings. Recommended implementation strategies derived from the program theory include 1) co-production of PtDA content and processes (or local adaptation), 2) training the entire team, 3) preparing and prompting patients to engage, 4) senior-level buy-in, and 5) measuring to improve.CONCLUSIONS:We recommend key strategies that organizations and individuals intending to embed PtDAs routinely can use as a practical guide. Further work is needed to understand the importance of context in the success of different implementation studies.

The analysis of single nucleotide polymorphisms (SNPs) together with conventional short tandem repeat (STR) and mitochondrial DNA (mtDNA) typing provide a forensic genetic approach for the identification of pathological and autoptical specimens in cases where the average length of DNA fragments is shorter than 150 bp in highly degraded samples. We applied a forensic genetic approach to digesta accidentally left after a training autopsy. PCR products were not amplified from samples containing the STR loci or common sequences used for mtDNA typing. The application of SNPs and deletion polymorphisms provides an alternative approach for DNA typing analysis.

BACKGROUND:Researchers developing personal health tools employ a range of approaches to involve prospective users in design and development.OBJECTIVE:The aim of this paper was to develop a validated measure of the human- or user-centeredness of design and development processes for personal health tools.METHODS:We conducted a psychometric analysis of data from a previous systematic review of the design and development processes of 348 personal health tools. Using a conceptual framework of user-centered design, our team of patients, caregivers, health professionals, tool developers, and researchers analyzed how specific practices in tool design and development might be combined and used as a measure. We prioritized variables according to their importance within the conceptual framework and validated the resultant measure using principal component analysis with Varimax rotation, classical item analysis, and confirmatory factor analysis.RESULTS:We retained 11 items in a 3-factor structure explaining 68% of the variance in the data. The Cronbach alpha was .72. Confirmatory factor analysis supported our hypothesis of a latent construct of user-centeredness. Items were whether or not: (1) patient, family, caregiver, or surrogate users were involved in the steps that help tool developers understand users or (2) develop a prototype, (3) asked their opinions, (4) observed using the tool or (5) involved in steps intended to evaluate the tool, (6) the process had 3 or more iterative cycles, (7) changes between cycles were explicitly reported, (8) health professionals were asked their opinion and (9) consulted before the first prototype was developed or (10) between initial and final prototypes, and (11) a panel of other experts was involved.CONCLUSIONS:The User-Centered Design 11-item measure (UCD-11) may be used to quantitatively document the user/human-centeredness of design and development processes of patient-centered tools. By building an evidence base about such processes, we can help ensure that tools are adapted to people who will use them, rather than requiring people to adapt to tools.