One report, multiple aims: orthopedic surgeons vary how they use patient-reported outcomes with patients.

PURPOSE: We conducted semi-structured qualitative interviews with surgeons to assess their goals for incorporating a patient-reported outcome measure (PROM)-based shared decision report into discussions around surgical and non-surgical treatment options for osteoarthritis of the knee and hip. METHODS: Surgeons actively enrolling patients into a study incorporating a standardized PROM-based shared decision report were invited to participate in a semi-structured interview lasting 30 min. Open-ended questions explored how the surgeon used report content, features that were helpful, confusing, or could be improved, and how use of the report fit into the surgeon's workflow. We used a conventional content analysis approach. RESULTS: Of the 16 eligible surgeons, 11 agreed to participate with 9 completing the interview and 2 withdrawing due to work demands. We identified 8 themes related to PROM-based report use: Acceptability, Patient Characteristics, Communication Goals, Useful Content, Not Useful Content, Challenges, Training Needs, and Recommended Improvements. Additional sub-themes emerged for Communication Goals (7) and Challenges (8). All surgeons shared positive feedback about using the report as part of clinical care. Whereas surgeons described the use of the report to achieve different goals, the most common uses related to setting expectations for post-surgical outcomes (89%) and educating patients (100%). CONCLUSION: Surgeons tailor their use of a PROM-based report with individual patients to achieve a range of aims. This study suggests multiple opportunities to further our understanding of the ways PROMs can be used in clinical practice. The way PROM information is visually displayed and multi-component reports are assembled can facilitate diverse aims.

Using bookmarking methods with orthopedic clinicians and patients with fractures produces score interpretation labels for patient-reported outcome measures.

OBJECTIVE: The objective of this study was to determine the patient-reported outcome measure (PROM) score ranges associated with descriptive labels (i.e., within normal limits, mild, moderate, severe) by using bookmarking methods with orthopedic clinicians and patients who have experienced a bone fracture. STUDY DESIGN AND SETTING: We created vignettes comprised of six items and responses from the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Function, Physical Function, and Pain Interference item banks reflecting different levels of severity. Two groups of patients with fractures (n = 11) and two groups of orthopedic clinicians (n = 16) reviewed the vignettes and assigned descriptive labels independently and then discussed as a group until reaching consensus via a videoconference platform. RESULTS: PROMIS Physical Function and Pain Interference thresholds (T = 50, 40, 25/30 and T = 50/55, 60, 65/70, respectively) for patients with bone fractures were consistent with the results from other patient populations. Upper Extremity thresholds were about 10 points (1 SD) more severe (T = 40, 30, 25/20) compared to the other measures. Patient and clinician perspectives were similar. CONCLUSION: Bookmarking methods generated meaningful score thresholds for PROMIS measures. These thresholds between severity categories varied by domain. Threshold values for severity represent important supplemental information to interpret PROMIS scores clinically.

Patients' perspectives on the benefits of feedback on patient-reported outcome measures in a web-based personalized decision report for hip and knee osteoarthritis.

BACKGROUND: Applications of patient-reported outcome measures (PROMs) for individual patient management are expanding with the support of digital tools. Providing PROM-based information to patients can potentially improve care experiences and outcomes through informing and activating patients. This study explored patients' perspectives on the benefits of receiving feedback on PROMs in the context of a web-based personalized decision report to guide care for their hip or knee osteoarthritis. METHODS: This qualitative descriptive interview study was nested in a pragmatic clinical trial of a personalized report, which includes descriptive PROM scores and predicted postoperative PROM scores. Patients completed a semi-structured interview within 6 weeks of an office visit with an orthopaedic surgeon. Only patients who reported receiving the report and reviewing it with the surgeon and/or a health educator were included. Data were iteratively analyzed using a combination of deductive and inductive coding strategies. RESULTS: Twenty-five patients aged 49-82 years (60% female, 72% surgical treatment decision) participated and described three primary benefits of the PROM feedback within the report: 1. Gaining Information About My Health Status, including data teaching new information, confirming what was known, or providing a frame of reference; 2. Fostering Communication Between Patient and Surgeon, encompassing use of the data to set expectations, ask and answer questions, and facilitate shared understanding; and 3. Increasing My Confidence and Trust, relating to the treatment outcomes, treatment decision, and surgeon. CONCLUSIONS: Patients identified actual and hypothetical benefits of receiving feedback on PROM scores in the context of a web-based decision report, including advantages for those who had already made a treatment decision before seeing the surgeon. Findings provide insight into patients' perspectives on how digital PROM data can promote patient-centered care. Results should be considered in the context of the homogeneous sample and complex trial. While participants perceived value in this personalized report, questions remain regarding best practices in patient-facing data presentation and engagement. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03102580. Registered on 5 April 2017.

Considerations to Support Use of Patient-Reported Outcomes Measurement Information System Pediatric Measures in Ambulatory Clinics.

OBJECTIVE: To identify challenges to the use of Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric measures in the ambulatory pediatric setting and possible solutions to these challenges. STUDY DESIGN: Eighteen semistructured telephone interviews of health system leaders, measurement implementers, and ambulatory pediatric clinicians were conducted. Five coders used applied thematic analysis to iteratively identify and refine themes in interview data. RESULTS: Most interviewees had roles in leadership or the implementation of patient-centered outcomes; 39% were clinicians. Some had experience using PROMIS clinically (44%) and 6% were considering this use. Analyses yielded 6 themes: (1) selection of PROMIS measures, (2) method of administration, (3) use of PROMIS Parent Proxy measures, (4) privacy and confidentiality of PROMIS responses, (5) interpretation of PROMIS scores, and (6) using PROMIS scores clinically. Within the themes, interviewees illuminated specific unique considerations for using PROMIS with children, including care transitions and privacy. CONCLUSIONS: Real-world challenges continue to hamper PROMIS use. Ongoing efforts to disseminate information about the integration of PROMIS measures in clinical care is critical to impacting the health of children.

PROMIS® Adult Health Profiles: Efficient Short-Form Measures of Seven Health Domains.

BACKGROUND: There is a need for valid self-report measures of core health-related quality of life (HRQoL) domains. OBJECTIVE: To derive brief, reliable and valid health profile measures from the Patient Reported Outcomes Measurement Information System® (PROMIS®) item banks. METHODS: Literature review, investigator consensus process, item response theory (IRT) analysis, and expert review of scaling results from multiple PROMIS data sets. We developed 3 profile measures ranging in length from 29 to 57 questions. These profiles assess important HRQoL domains with highly informative subsets of items from respective item banks and yield reliable information across mild-to-severe levels of HRQoL experiences. Each instrument assesses the domains of pain interference, fatigue, depression, anxiety, sleep disturbance, physical function, and social function using 4-, 6-, and 8-item short forms for each domain, and an average pain intensity domain score, using a 0-10 numeric rating scale. RESULTS: With few exceptions, all domain short forms within the profile measures were highly reliable across at least 3 standard deviation (30 T-score) units and were strongly correlated with the full bank scores. Construct validity with ratings of general health and quality of life was demonstrated. Information to inform statistical power for clinical and general population samples is also provided. CONCLUSIONS: Although these profile measures have been used widely, with summary scoring routines published, description of their development, reliability, and initial validity has not been published until this article. Further evaluation of these measures and clinical applications are encouraged.

Establishing clinically-relevant terms and severity thresholds for Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures of physical function, cognitive function, and sleep disturbance in people with cancer using standard setting.

PURPOSE: Patient-Reported Outcomes Measurement Information System® (PROMIS®) physical function, cognitive function, and sleep disturbance measures are increasingly used in cancer care. However, there is limited guidance for interpreting the clinical meaning of scores. This study aimed to apply bookmarking, a standard setting methodology, to identify PROMIS score thresholds in the context of cancer care. METHODS: Using item parameters, we constructed vignettes of five items covering the range of possible scores. Focus groups were held with cancer care providers and people with cancer. Terminology for categorizing levels of severity was explored. Participants rank ordered vignettes by severity and then placed bookmarks between vignettes representing different levels of severity. Group discussion was held until consensus on bookmark placement was reached. RESULTS: Clinicians selected "within normal limits," "mild," "moderate," and "severe" to describe levels of severity. Both patients and clinicians were able to apply these labels, but there was not unanimous support for any set of descriptors. Clinicians and patients agreed on all severity thresholds for sleep disturbance. For cognitive and physical function, clinicians and patients agreed on the threshold between "within normal limits" and "mild." However, patients required greater dysfunction than clinicians before applying "moderate" and "severe" labels. CONCLUSIONS: Bookmarking can be applied to develop provisional score interpretation for PROMIS measures. Patients and clinicians were frequently consistent in their bookmark placement. When there was variance, patients required more dysfunction before assigning more severity. Additional research with other cancer samples is needed to evaluate the replicability and generalizability of our findings.

The challenge of measuring intra-individual change in fatigue during cancer treatment.

PURPOSE: To evaluate how well three different patient-reported outcomes (PROs) measure individual change. METHODS: Two hundred and fourteen patients (from two sites) initiating first or new chemotherapy for any stage of breast or gastrointestinal cancer participated. The 13-item FACIT Fatigue scale, a 7-item PROMIS® Fatigue Short Form (PROMIS 7a), and the PROMIS® Fatigue computer adaptive test (CAT) were administered monthly online for 6 months. Reliability of measured change was defined, under a population mixed effects model, as the ratio of estimated systematic variance in rate of change to the estimated total variance of measured individual differences in rate of change. Precision of individual measured change, the standard error of measurement of change, was given by the square root of the rate-of-change sampling variance. Linear and quadratic models were examined up to 3 and up to 6 months. RESULTS: A linear model for measured change showed the following by 6 and 3 months, respectively: PROMIS CAT (0.363 and 0.342); PROMIS SF (0.408 and 0.533); FACIT (0.459 and 0.473). Quadratic models offered no noteworthy improvement over linear models. Both reliability and precision results demonstrate the need to improve the measurement of intra-individual change. CONCLUSIONS: These results illustrate the challenge of reliably measuring individual change in fatigue with a level of confidence required for intervention. Optimizing clinically useful measurement of intra-individual differences over time continues to pose a challenge for PROs.

Myotonic dystrophy health index: Correlations with clinical tests and patient function.

INTRODUCTION: The Myotonic Dystrophy Health Index (MDHI) is a disease-specific patient-reported outcome measure. Here, we examine the associations between the MDHI and other measures of disease burden in a cohort of individuals with myotonic dystrophy type-1 (DM1). METHODS: We conducted a cross-sectional study of 70 patients with DM1. We examined the associations between MDHI total and subscale scores and scores from other clinical tests. Participants completed assessments of strength, myotonia, motor and respiratory function, ambulation, and body composition. Participants also provided blood samples, underwent physician evaluations, and completed other patient-reported outcome measures. RESULTS: MDHI total and subscale scores were strongly associated with muscle strength, myotonia, motor function, and other clinical measures. CONCLUSIONS: Patient-reported health status, as measured by the MDHI, is associated with alternative measures of clinical health. These results support the use of the MDHI as a valid tool to measure disease burden in DM1 patients.

Bringing PROMIS to practice: brief and precise symptom screening in ambulatory cancer care.

BACKGROUND: Supportive oncology practice can be enhanced by the integration of a brief and validated electronic patient-reported outcome assessment into the electronic health record (EHR) and clinical workflow. METHODS: Six hundred thirty-six women receiving gynecologic oncology outpatient care received instructions to complete clinical assessments through Epic MyChart, an EHR patient communication portal. Patient Reported Outcomes Measurement Information System (PROMIS) computer adaptive tests (CATs) were administered to assess fatigue, pain interference, physical function, depression, and anxiety. Checklists identified psychosocial concerns, informational and nutritional needs, and risk factors for inadequate nutrition. Assessment results, including PROMIS T scores with documented severity thresholds, were immediately populated in the EHR. Clinicians were notified of clinically elevated symptoms through EHR messages. EHR integration was designed to provide automated triage to social work providers for psychosocial concerns, to health educators for information, and to dietitians for nutrition-related concerns. RESULTS: Four thousand forty-two MyChart messages sent, and 3203 (79%) were reviewed by patients. The assessment was started by 1493 patients (37%), and once they started, 93% (1386 patients) completed the assessment. According to first assessments only, 49.8% of the patients who reviewed the MyChart message completed the assessment. Mean PROMIS CAT T scores indicated a lower level of physical function and elevated anxiety in comparison with the general population. Fatigue, pain, and depression scores were comparable to those of the general population. Impaired physical functioning was the most common basis for clinical alerts and occurred in 4% of the patients. CONCLUSIONS: PROMIS CATs were used to measure common cancer symptoms in routine oncology outpatient care. Immediate EHR integration facilitated the use of symptom reporting as the basis for referral to psychosocial and supportive care.

The role of technical advances in the adoption and integration of patient-reported outcomes in clinical care.

BACKGROUND: Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (eg, touchscreen tablets, Internet accessibility, and electronic health records), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. OBJECTIVES: To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. METHODS: Five practical case studies across diverse health care settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, previsit screening, effective evaluation, and electronic health record integration. CONCLUSIONS: These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems.

Linking Physical and Mental Health Summary Scores from the Veterans RAND 12-Item Health Survey (VR-12) to the PROMIS(®) Global Health Scale.

BACKGROUND: Global health measures represent an attractive option for researchers and clinicians seeking a brief snapshot of a patient's overall perspective on his or her health. Because scores on different global health measures are not comparable, comparative effectiveness research (CER) is challenging. OBJECTIVE: To establish a common reporting metric so that the physical and mental health scores on the Veterans RAND 12-Item Health Survey (VR-12 (©) ) can be converted into scores on the corresponding Patient Reported Outcomes Measurement Information System (PROMIS(®)) Global Health scores. DESIGN: Following a single-sample linking design, participants from an Internet panel completed items from the PROMIS Global Health and VR-12 Health Survey. A common metric was created using analyses based on item response theory (IRT), producing score cross-walk tables for the mental and physical health components of each measure. The linking relationships were evaluated by calculating the standard deviation of differences between the observed and linked PROMIS scores and estimating confidence intervals by sample size. PARTICIPANTS: Participants (N = 2025) were 49 % male and 73 % white; mean age was 46 years. MAIN MEASURES: Mental and physical health subscales of the PROMIS Global Health and the VR-12. The mean VR-12 physical component and mental component scores were 45.2 and 46.6, respectively; the mean PROMIS physical and mental health scores were 48.3 and 48.5, respectively. KEY RESULTS: We found evidence that the combined set of VR-12 and PROMIS items were relatively unidimensional and that we could proceed with linking. Linking worked better between the physical health than mental health scores using VR-12 item responses (vs. linking based on algorithmic scores). For each of the cross-walks, users can minimize the impact of linking error with modest increases in sample sizes. CONCLUSIONS: VR-12 scores can be expressed on the PROMIS Global Health metric to facilitate the evaluation of treatment, including CER. Extending these results to other common measures of global health is encouraged.

Myotonic Dystrophy Health Index: initial evaluation of a disease-specific outcome measure.

INTRODUCTION: In preparation for clinical trials we examine the validity, reliability, and patient understanding of the Myotonic Dystrophy Health Index (MDHI). METHODS: Initially we partnered with 278 myotonic dystrophy type-1 (DM1) patients and identified the most relevant questions for the MDHI. Next, we used factor analysis, patient interviews, and test-retest reliability assessments to refine and evaluate the instrument. Lastly, we determined the capability of the MDHI to differentiate between known groups of DM1 participants. RESULTS: Questions in the final MDHI represent 17 areas of DM1 health. The internal consistency was acceptable in all subscales. The MDHI had a high test-retest reliability (ICC = 0.95) and differentiated between DM1 patient groups with different disease severities. CONCLUSIONS: Initial evaluation of the MDHI provides evidence that it is valid and reliable as an outcome measure for assessing patient-reported health. These results suggest that important aspects of DM1 health may be measured effectively using the MDHI.

Selecting patient-reported outcome measures: "what" and "for whom".

Patient-reported outcomes (PROMs) are becoming more widely implemented across health care for important reasons. However, with thousands of PROMs available and the science of psychometrics becoming more widely applied in health measurement, choosing the right ones to implement can be puzzling. This article provides a framework of the different types of PROMs by organizing them into 4 categories based upon "what" is being measured and "from whom" the questions are asked: (1) condition-specific and domain-specific, (2) condition-specific and global, (3) universal and global, and (4) universal and domain-specific. We delve deeper into each category with clinical examples. This framework can empower health care leaders and policymakers to make more informed decisions when selecting the best PROMs to implement, ensuring PROMs deliver on their potential to promote high quality, patient-centered care.

Seamless Integration of Computer-Adaptive Patient Reported Outcomes into an Electronic Health Record.

BACKGROUND: Patient-reported outcome (PRO) measures have become an essential component of quality measurement, quality improvement, and capturing the voice of the patient in clinical care. In 2004, the National Institutes of Health endorsed the importance of PROs by initiating the Patient-Reported Outcomes Measurement Information System (PROMIS), which leverages computer-adaptive tests (CATs) to reduce patient burden while maintaining measurement precision. Historically, PROMIS CATs have been used in a large number of research studies outside the electronic health record (EHR), but growing demand for clinical use of PROs requires creative information technology solutions for integration into the EHR. OBJECTIVES: This paper describes the introduction of PROMIS CATs into the Epic Systems EHR at a large academic medical center using a tight integration; we describe the process of creating a secure, automatic connection between the application programming interface (API) which scores and selects CAT items and Epic. METHODS: The overarching strategy was to make CATs appear indistinguishable from conventional measures to clinical users, patients, and the EHR software itself. We implemented CATs in Epic without compromising patient data security by creating custom middleware software within the organization's existing middleware framework. This software communicated between the Assessment Center API for item selection and scoring and Epic for item presentation and results. The middleware software seamlessly administered CATs alongside fixed-length, conventional PROs while maintaining the display characteristics and functions of other Epic measures, including automatic display of PROMIS scores in the patient's chart. Pilot implementation revealed differing workflows for clinicians using the software. RESULTS: The middleware software was adopted in 27 clinics across the hospital system. In the first 2 years of hospital-wide implementation, 793 providers collected 70,446 PROs from patients using this system. CONCLUSION: This project demonstrated the importance of regular communication across interdisciplinary teams in the design and development of clinical software. It also demonstrated that implementation relies on buy-in from clinical partners as they integrate new tools into their existing clinical workflow.

Development and initial validation of the NCCN/FACT symptom index for advanced kidney cancer.

OBJECTIVES: There is a need for a brief symptom index for advanced kidney cancer that includes perspectives of both patients and clinicians and is consistent with the Food and Drug Administration's guidance for patient-reported outcome measures. This study developed and examined the preliminary reliability and validity of the new National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19. METHODS: Fifty patients with advanced kidney cancer provided open-ended and survey responses ranking their most important symptoms. Responses were reconciled with published clinician reports of the most important symptoms. Ten experienced oncologists rated symptoms as disease- or treatment-related. Patients completed quality-of-life and performance status measures. RESULTS: A 19-item index was produced from symptoms that were rated as most important by patients or clinicians. It includes three subscales: disease-related symptoms (DRS), treatment side effects (TSE), and general function and well-being (FWB). Internal consistency was good for the full instrument (α = 0.83), the DRS subscale (α = 0.76), and the FWB subscale (α = 0.78) but lower for the TSE subscale (α = 0.59). Convergent validity was demonstrated through correlations with the FACT-General. Patients with differing performance status were distinguished by the total score (F2,47 = 17.37; P < .0001), the DRS subscale (F2,47 = 14.22; P < .0001), and the FWB subscale (F2,47 = 13.40; P < .0001) but not the TSE subscale (F2,47 =1.48; P = 0.2380). CONCLUSIONS: The National Comprehensive Cancer Network/FACT-Kidney Symptom Index 19 combines symptoms deemed most important by patients and clinicians. Preliminary evidence suggests that the total score and DRS and FWB subscales are reliable and valid as summary indexes. The TSE subscale may be least relevant given the advent of newer therapies.

Upper-extremity and mobility subdomains from the Patient-Reported Outcomes Measurement Information System (PROMIS) adult physical functioning item bank.

OBJECTIVE: To create upper-extremity and mobility subdomain scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning adult item bank. DESIGN: Expert reviews were used to identify upper-extremity and mobility items from the PROMIS item bank. Psychometric analyses were conducted to assess empirical support for scoring upper-extremity and mobility subdomains. SETTING: Data were collected from the U.S. general population and multiple disease groups via self-administered surveys. PARTICIPANTS: The sample (N=21,773) included 21,133 English-speaking adults who participated in the PROMIS wave 1 data collection and 640 Spanish-speaking Latino adults recruited separately. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We used English- and Spanish-language data and existing PROMIS item parameters for the physical functioning item bank to estimate upper-extremity and mobility scores. In addition, we fit graded response models to calibrate the upper-extremity items and mobility items separately, compare separate to combined calibrations, and produce subdomain scores. RESULTS: After eliminating items because of local dependency, 16 items remained to assess upper extremity and 17 items to assess mobility. The estimated correlation between upper extremity and mobility was .59 using existing PROMIS physical functioning item parameters (r=.60 using parameters calibrated separately for upper-extremity and mobility items). CONCLUSIONS: Upper-extremity and mobility subdomains shared about 35% of the variance in common, and produced comparable scores whether calibrated separately or together. The identification of the subset of items tapping these 2 aspects of physical functioning and scored using the existing PROMIS parameters provides the option of scoring these subdomains in addition to the overall physical functioning score.

Evaluating a web-based personalized decision report for total knee or hip replacement: Lessons learned from patients.

RATIONALE: Patient-reported outcomes (PROs) are increasingly used in the context of clinical care, but evaluation of patients' perspectives of PRO-based applications in routine care remains limited. AIMS AND OBJECTIVES: This paper investigates patients' acceptability of a personalized web-based decision report for total knee or hip replacement and identifies opportunities to refine the report. METHOD: This qualitative evaluation was embedded in a pragmatic cluster randomized trial of the report. We interviewed 25 patients with knee and hip osteoarthritis about their experiences using the personalized decision report in the context of a surgical consultation. The web-based report contained current descriptive PRO scores of pain, function and general physical health; tailored predicted postoperative PRO scores (i.e., personalized likely outcomes based on actual knee or hip replacement outcomes of similar patients in a national registry); and information about alternative nonoperative treatments. Two trained researchers analysed the interview data qualitatively using a combination of inductive and deductive coding. RESULTS: We identified three major categories for evaluation: content of report, presentation of data in report and engagement with report. Patients generally liked the report overall but specifically valued different pages of the report based on where they were in the surgical decision-making process. Patients identified areas of confusion in data presentation related to graph orientation, terminology and interpretation of T-scores. Patients also highlighted support needs to meaningfully engage with the information in the report. CONCLUSION: Our findings highlight areas of opportunity to further refine this personalized web-based decision report and similar patient-facing PRO applications for routine clinical care. Specific examples include additional tailoring of reports via filterable web-based dashboards and scalable educational supports to facilitate more independent patient understanding and use.

Monitoring Adverse Effects of Radiation Therapy in Patients With Head and Neck Cancer: The FACT-HN-RAD Patient-Reported Outcome Measure.

Importance: Patients undergoing radiation therapy (RT) for head and neck squamous cell carcinoma (HNSCC) experience a range of debilitating adverse effects (AEs). Patient-reported outcome (PRO) measures to quantify these AEs are a necessary and important component of health care; however, currently available PRO options often measure only disease-related symptoms or AEs of non-RT treatments. Objective: To develop a brief PRO measure of the most common AEs associated with RT for HNSCC. Design, Setting, and Participants: This was a qualitative study that followed the US Food and Drug Administration guidelines to develop a brief measure of patient-reported RT-related AEs (the Functional Assessment of Cancer Therapy-Head and Neck Radiotherapy [FACT-HN-RAD] measure). The study included (1) a literature review of clinical trials; (2) secondary analysis of retrospective concept elicitation interviews (CEIs); (3) electronic surveys of practicing radiation oncologists; (4) mapping of existing items to inform the development of the draft version of the measure; and (5) validation of content and face validity via patient cognitive interviews. Analysis was performed of CEI data and interviews with practicing radiation oncologists. Data analysis was conducted from July 1, 2022, to April 21, 2023. Exposures: Surveys and qualitative interviews. Main Outcomes and Measures: The most common patient-reported RT-related AEs among patients with HNSCC. Results: Of 19 CEI participants, 14 (mean [range] age, 67 [49-86] years; 12 [86%] men and 2 [14%] women) described RT-related AEs and were included in the secondary analysis. Eleven (79%) patients reported difficulty swallowing; 8 (57%), oral pain; 7 (50%), dry mouth; 7 (50%), weight loss; 6 (43%), skin burning; 5 (36%), loss of taste; 5 (36%), voice changes (36%); and 5 (36%), fatigue. Nine radiation oncologists (mean [range] time in practice, 8 [1-42] years; 5 [56%] men and 4 [44%] women) reported the most common AEs: 9 (100%) reported dysgeusia; 7 (78%), xerostomia; 7 (78%), mucositis or oral pain; 8 (89%), dysphagia or odynophagia; 6 (67%), dermatitis; and 3 (33%), fatigue. Together these data informed the development of an 8-item AE-focused measure of pain, dysphagia, xerostomia, dysgeusia, voice changes, dermatitis, fatigue, and weight loss. Cognitive interviews with 10 patients (mean [range] age, 61 [29-84] years; 8 [80%] men and 2 [20%] women) demonstrated strong face validity; all (100%) reported that the measure reflected their experience with RT and stated that the length of the questionnaire was "just right." Conclusions and Relevance: The 8-item FACT-HN-RAD measure captures the most common patient- and physician-reported AEs related to RT for HNSCC. This measure offers a means to serially monitor patient-reported treatment-related AEs and recovery over time in both clinical and research settings. Future work will evaluate the psychometric validity of the measure.

The need for a measurement-based care professional practice guideline.

Professional practice guidelines (PPGs) are intended to promote a high level of professional practice and serve as an educational resource, providing pragmatic guidance in a clinical area for psychologists. Measurement-based care (MBC) is an evidence-based psychological practice with accumulating empirical support and alignment with patient-centered care. In connection with the American Psychological Association's Advisory Committee for Measurement-based Care and the Mental and Behavioral Health Registry, this article outlines various lines of support for the development and implementation of an MBC PPG. In addition to research evidence, we address the demonstrated need of this guideline across three domains: public benefit, professional guidance, and legal and regulatory issues. Consistent with the aspirational spirit of a PPG, this article proposes a draft PPG statement and highlights how an MBC PPG would improve service delivery, facilitate implementation of an evidence-based practice associated with symptom reduction, improved retention, and greater patient satisfaction, as well as create a framework that will better align changes in reimbursement models with patients' and providers' treatment goals. We also identify key future directions and critical gaps in MBC science and implementation that require attention. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Translation and cultural adaptation of drug use stigma and HIV stigma measures among people who use drugs in Tanzania.

INTRODUCTION: People who use drugs (PWUD) experience stigma from multiple sources due to their drug use. HIV seroprevalence for PWUD in Tanzania is estimated to range from 18 to 25%. So, many PWUD will also experience HIV stigma. Both HIV and drug use stigma have negative health and social outcomes, it is therefore important to measure their magnitude and impact. However, no contextually and linguistically adapted measures are available to assess either HIV or drug use stigma among PWUD in Tanzania. In response, we translated and culturally adapted HIV and drug use stigma measures among Tanzanian PWUD and described that process in this study. METHODS: This was a cross-sectional study. We translated and adapted existing validated stigma measures by following a modified version of Wild's ten steps for translation and adaptation. We also added new items on stigmatizing actions that were not included in the original measures. Following translation and back translation, we conducted 40 cognitive debriefs among 19 PWUD living with and 21 PWUD not living with HIV in Dar es Salaam to assess comprehension of the original and new items. For challenging items, we made adaptations and repeated cognitive debriefs among ten new PWUD participants where half of them were living with HIV. RESULTS: Most of the original items (42/54, 78%), response options and all items with new 12 stigmatizing actions were understood by participants. Challenges included response options for a few items; translation to Swahili; and differences in participants' interpretation of Swahili words. We made changes to these items and the final versions were understood by PWUD participants. CONCLUSION: Drug use and HIV stigma measures can successfully be translated and culturally adapted among Tanzanian PWUD living with and without HIV. We are currently conducting research to determine the stigma measures' psychometric properties and we will report the results separately.