Enhancing the Evaluation of Physical Function Following Orthopaedic Trauma Care: Comparison of PROMIS Computerized Adaptive Testing and Short Musculoskeletal Function Assessment.

OBJECTIVES: To compare measurement properties of Patient-Reported Outcomes Measurement Information System (PROMIS) (physical function [PF] and pain interference [PI]) computerized adaptive testing to traditional Short Musculoskeletal Function Assessment (SMFA) (dysfunction index [DI] and bother index [BI]). To explore factors associated with PROMIS scores. DESIGN: Cross-sectional study. SETTING: Level I Trauma Center. PATIENT SELECTION CRITERIA: Isolated upper/lower extremity fracture patients were recruited from the orthopaedic trauma outpatient clinic (October 1, 2021 to January 1, 2023). OUTCOME MEASURES: Correlations (Pearson), reliability (standard error [SE] [T score]), efficiency (amount of information per item [1 - SE2/Nitems]), and floor/ceiling effects were assessed. An r > 0.7 represented high correlation, and SE ≤ 2.2 represented sufficient reliability. Factors associated with worse PROMIS scores were also identified. RESULTS: In total, 202 patients completed PROMs at median 98 days follow-up. Correlations between PROMIS-PF and SMFA-DI, and PROMIS-PI and SMFA-BI were -0.84 and 0.65. Reliability was very high for both instruments (mean SE 2.0 [PROMIS-PF], SE 2.1 [PROMIS-PI], and SE 1.2 [SMFA-DI], SE 1.8 [SMFA-BI]). Relative efficiency for PROMIS-PF versus SMFA-DI, and PROMIS-PI versus SMFA-BI was 7.8 (SD 2.5) and 4.1 (SD 1.7), respectively. Neither PROMIS nor SMFA exhibited floor/ceiling effects. In the multivariable regression analyses, elevated levels of depression, among other factors, showed an (independent) association with worse PROMIS-PF and PROMIS-PI scores. CONCLUSIONS: PROMIS-PF and PROMIS-PI CATs showed a (high and moderate) correlation with SMFA and hence measure a comparable construct of physical function and discomfort. As computerized adaptive tests are much more efficient to administer, they present a compelling alternative to SMFA for evaluating impact of fracture treatment. The relation between symptoms of depression and PROMIS scores emphasizes the importance of psychosocial aspects of health in orthopaedic trauma patients. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Linking the RCADS-25 to the PROMIS® pediatric item banks Anxiety and Depressive Symptoms in a general Dutch population sample.

PURPOSE: This study aims to link scores of the Revised Child Anxiety and Depression Scale short version (RCADS-25) to the metric of the PROMIS pediatric item banks Anxiety and Depressive Symptoms in a general Dutch population sample. METHODS: The RCADS-25 and PROMIS pediatric item banks Anxiety and Depressive Symptoms were administered online to 2,893 Dutch children and adolescents aged 8-18. Assumptions for linking methods were checked. Linking was achieved by using three item response theory (IRT) and two equipercentile methods. For each method, the observed PROMIS metric scores were compared to the ones predicted from the RCADS-25 subscale scores using correlations, mean and SD of differences, and RMSD. RESULTS: The assumptions for IRT-based and equipercentile linking were met. The IRT-based method using separate calibration with Stocking-Lord constants was considered the optimal choice for linking both RCADS-25 subscales to the PROMIS metric. Based on this Stocking-Lord approach, we created item parameters for RCADS-25 items and two crosswalk tables. CONCLUSION: The RCADS-25 item parameters and crosswalk tables presented in this study are sufficiently valid. Researchers can use these products to translate the RCADS-25 anxiety and depression subscales scores to the PROMIS metric in order to ensure comparability with the previous research.

One-Stop Surgery: An Innovation to Limit Hospital Visits in Children.

INTRODUCTION: One-stop surgery (OSS) allows for same-day outpatient clinic visit, preoperative assessment, and surgical repair. This study aims to determine the efficiency, (cost-)effectiveness, and family satisfaction of one-stop inguinal hernia surgery compared with usual care. MATERIAL AND METHODS: Children (≥ 3 months) with inguinal hernia and American Society of Anesthesiologists (ASA) grades I-II, scheduled for OSS (intervention) or regular treatment (control) between March 1, 2017, and December 1, 2018, were eligible for inclusion. Exclusion criteria consisted of age less than 3 months and ASA grades III-IV. The primary outcome measure was treatment efficiency (i.e., total number of hospital visits and waiting time [days] between referral and surgery). Secondary outcome measures were the effectiveness in terms of complication and recurrence rate, and parent-reported satisfaction and cost-effectiveness using the Dutch Pediatric Quality of Life Healthcare Satisfaction and Institute for Medical Technology Assessment Productivity Cost Questionnaire. RESULTS: Ninety-one (intervention: 54; control: 37) patients (56% boys) were included. Median (interquartile range) number of hospital visits was lower in the intervention group (1 vs 3; p < 0.001). All but one of the OSS patients (98%) were discharged home on the day of surgery. Postoperative complication (1.9% vs 2.7%; p = 0.787) and recurrence rates (0% vs 2.7%; p = 0.407) did not differ between the intervention and control patients. "General satisfaction," "satisfaction with communication," and "inclusion of family" were higher after OSS, while satisfaction about "information," "technical skills," and "emotional needs" were similar. Median (range) follow-up was 28 (15-36) months. CONCLUSIONS: Pediatric one-stop inguinal hernia repair seems to be an effective treatment strategy that limits the number of hospital visits and provides enhanced family satisfaction without compromising the quality of care.

Generic PROMIS item banks in adults with hemophilia for patient-reported outcome assessment: Feasibility, measurement properties, and relevance.

BACKGROUND: Legacy hemophilia-specific questionnaires are considered too long, show floor-/ceiling effects, and/or include irrelevant questions. Patient Reported Outcomes Measurement Information System (PROMIS) item banks, including Computer Adaptive Tests (CATs) and short forms, were designed for more efficient outcome assessment. OBJECTIVES: Evaluate the feasibility, measurement properties, and relevance of seven PROMIS CATs and two short forms in patients with hemophilia. PATIENTS/METHODS: In this cross-sectional study, Dutch adults with hemophilia completed nine PROMIS item banks electronically. Feasibility was assessed by number of items and floor/ceiling effects. Reliability was determined as the proportion of reliable scores (standard error ≤3.2). Construct validity was assessed by comparison with legacy instruments and expected differences between subgroups. Relevance of item banks was determined by proportions of limited scores. RESULTS: Overall, 142 of 373 invited patients (mean age, 47 [range, 18-79], 49% severe hemophilia, 46% receiving prophylaxis) responded. Per CAT item bank, mean number of items answered varied from 5 (range, 3-12) to 9 (range, 5-12), with floor effects in pain interference (26% lowest scores) and depression (18% lowest scores). Construct validity and reliability were good for physical function, pain interference, satisfaction with social roles and activities, and fatigue. The CAT physical function showed the most limited scores (38%). The self-efficacy short forms showed ceiling effects (22%-28%) and no relation with the legacy instruments. CONCLUSIONS: The PROMIS CATs physical function, pain interference, satisfaction with social roles and activities, and fatigue are feasible, reliable, and valid alternatives to legacy instruments for patients with hemophilia, with few items and low floor-/ceiling effects.

A retrospective assessment of the KLIK PROM portal implementation using the Consolidated Framework for Implementation Research (CFIR).

PURPOSE: The KLIK Patient-Reported Outcome Measure (PROM) portal is an evidence-based intervention implemented in clinical practice in > 25 Dutch hospitals for patients (children and adults) who regularly visit the outpatient clinic. Implementation science frameworks can be used to understand why implementation succeeded or failed, to structure barriers and enablers, and to develop implementation strategies to overcome barriers. This paper aimed to (A) retrospectively describe determinants of successful KLIK PROM implementation using the Consolidated Framework for Implementation Research (CFIR), and (B) identify current barriers and match implementation strategies. METHODS: (A) The KLIK implementation process was described retrospectively based on literature and experience, using the 39 CFIR constructs organized in five general domains: intervention characteristics, outer setting, inner setting, characteristics of individuals, and implementation process. (B) The CFIR-Expert Recommendations for Implementing Change (ERIC) Implementation Strategy Matching tool identified current barriers in the KLIK implementation and matched implementation strategies that addressed the identified barriers. RESULTS: (A) The most prominent determinants of successful KLIK PROM implementation lie in the following CFIR domains: intervention characteristics (e.g., easy to use), characteristics of individuals (e.g., motivation), and process of implementation (e.g., support). (B) 13 CFIR constructs were identified as current barriers for implementing the KLIK PROM portal. The highest overall advised ERIC strategy for the specific KLIK barriers was to identify and prepare champions. CONCLUSION: Using an implementation science framework, e.g., CFIR, is recommended for groups starting to use PROMs in clinical care as it offers a structured approach and provides insight into possible enablers and barriers.

Matching Psychosocial Support Needs of Parents of a Child with a Chronic Illness to a Feasible Intervention.

OBJECTIVES: Parents of children with a chronic illness (CI) are at risk for psychosocial problems. The aim of this study was to refine an existing face-to-face intervention into an online psychosocial group intervention for parents by (1) exploring which themes are important, (2) determine what type of intervention parents would like and (3) assess parents' practical preferences. METHODS: Parents of children with a CI (0-18 years) were invited to complete an online questionnaire. To acquire more in-depth information, focus groups and telephone interviews were conducted. Descriptive statistics were used. RESULTS: 272 parents (mean age = 43.1 years, 85% female) participated. Three focus groups (15 parents) and seven telephone interviews were conducted. Most important themes were: the CI of the child, family functioning, taking care of yourself, relationships with others and practical support. Parents preferred a group with parents of children in the same age category. At first, parents preferred face-to-face contact. After an explanation and demonstration of an online intervention, parents became more positive about online support, mostly because they could participate from home. CONCLUSIONS FOR PRACTICE: Parents have a need for psychosocial support focusing on different themes. Professionals should explain and demonstrate an online intervention to parents. Based on these results, Op Koers Online for parents was developed. An RCT to assess feasibility and effectiveness of the intervention is currently running.

Healthcare Professionals' Preferences and Perceived Barriers for Routine Assessment of Patient-Reported Outcomes in Pediatric Oncology Practice: Moving Toward International Processes of Change.

BACKGROUND: Using patient-reported outcomes (PROs) in clinical practice has been shown to enhance detection of health-related quality of life problems and satisfaction with care in children with cancer. This study seeks to identify which PRO information healthcare professionals (HCPs) find useful and what the perceived barriers for routinely assessing PROs are. PROCEDURE: A total of 352 pediatric HCPs (43% male) from 52 countries completed a semistructured online 28-item questionnaire. Descriptive statistics (percentages) were used to identify highly important PRO information and perceived barriers. HCPs' perceived barriers were compared according to gender, years of work experience, and country using a Fishers exact test. RESULTS: The five highest ranked PRO topics relevant in routine assessment by HCPs were as follows: pain (98%), feeling sad or depressed (96%), overall physical symptoms (95%), problems with therapy adherence (94%), and overall emotional issues (93%). Five lowest ranked topics were as follows: difficulties praying (50%), other spiritual concerns (55, 56, and 60%), and feeling bored (60%). Barriers for assessing PROs included: time (58%), insufficient staff (49%), logistics (32%), and financial resources (26%). Providers from developing countries more often reported barriers concerning insufficient staff, logistics, and financial resources. CONCLUSIONS: HCPs strongly value the use of physical and psychosocial PROs within pediatric oncology practice, but mainly perceive organizational barriers for routine assessment. To successfully integrate PROs, efforts should be made to address HCP-perceived barriers, such that patient-reported problems can be detected and timely referrals made.

Dutch-Flemish translation of nine pediatric item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS)®.

PURPOSE: The Patient-Reported Outcomes Measurement Information System (PROMIS(®)) is a new, state-of-the-art assessment system for measuring patient-reported health and well-being of adults and children. It has the potential to be more valid, reliable, and responsive than existing PROMs. The items banks are designed to be self-reported and completed by children aged 8-18 years. The PROMIS items can be administered in short forms or through computerized adaptive testing. This paper describes the translation and cultural adaption of nine PROMIS item banks (151 items) for children in Dutch-Flemish. METHODS: The translation was performed by FACITtrans using standardized PROMIS methodology and approved by the PROMIS Statistical Center. The translation included four forward translations, two back-translations, three independent reviews (at least two Dutch, one Flemish), and pretesting in 24 children from the Netherlands and Flanders. RESULTS: For some items, it was necessary to have separate translations for Dutch and Flemish: physical function-mobility (three items), anger (one item), pain interference (two items), and asthma impact (one item). Challenges faced in the translation process included scarcity or overabundance of possible translations, unclear item descriptions, constructs broader/smaller in the target language, difficulties in rank ordering items, differences in unit of measurement, irrelevant items, or differences in performance of activities. By addressing these challenges, acceptable translations were obtained for all items. CONCLUSION: The Dutch-Flemish PROMIS items are linguistically equivalent to the original USA version. Short forms are now available for use, and entire item banks are ready for cross-cultural validation in the Netherlands and Flanders.

Training clinicians in how to use patient-reported outcome measures in routine clinical practice.

INTRODUCTION: Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor symptoms, evaluate treatment outcomes and support shared decision-making. A key issue limiting successful implementation is clinicians' lack of knowledge on how to effectively utilize PROs data in their clinical encounters. METHODS: Using a change management theoretical framework, this paper describes the development and implementation of three programs for training clinicians to effectively use PRO data in routine practice. The training programs are in three diverse clinical areas (adult oncology, lung transplant and paediatrics), in three countries with different healthcare systems, thus providing a rare opportunity to pull out common approaches whilst recognizing specific settings. For each program, we describe the clinical and organizational setting, the program planning and development, the content of the training session with supporting material, subsequent monitoring of PROs use and evidence of adoption. The common successful components and practical steps are identified, leading to discussion and future recommendations. RESULTS: The results of the three training programs are described as the implementation. In the oncology program, PRO data have been developed and are currently evaluated; in the lung transplant program, PRO data are used in daily practice and the integration with electronic patient records is under development; and in the paediatric program, PRO data are fully implemented with around 7,600 consultations since the start of the implementation. CONCLUSION: Adult learning programs teaching clinicians how to use and act on PROs in clinical practice are a key steps in supporting patient engagement and participation in shared decision-making. Researchers and clinicians from different clinical areas should collaborate to share ideas, develop guidelines and promote good practice in patient-centred care.

Innovations in e-health.

The theme of ISOQOL's 19th Annual Conference in Budapest, Hungary, was The Journey of Quality of Life Research: A Path Towards Personalized Medicine. Innovations in e-health was one of four plenary panels. E-health is changing the landscape of clinical practice and health care, but the best way to leverage the many promised benefits of emerging e-health technologies is still not clear. The Innovations in e-health panel presented emerging changes in technologies and applications that will facilitate clinical decision making, improve quality and efficiency of care, engage individuals in clinical decision making, and empower them to adopt healthy behaviors. The purpose of this paper was to present emerging trends in e-health and considerations for successful adoption of new technologies, and an overview of each of the presentations in the e-health plenary. The presentations included a personal perspective on the use of technology for self-monitoring in Parkinson's disease, an overview of online social networks and emerging technologies, and the collection of patient-reported outcomes through web-based systems in clinical practice. The common thread across all the talks was the application of e-health tools to empower individuals with chronic disease to be actively engaged in the management of their health. Considerations regarding data ownership and privacy, universal access to e-health, interactivity between different types of e-health technologies, and tailoring applications to individual needs were explored.

Monitoring health-related quality of life in paediatric practice: development of an innovative web-based application.

BACKGROUND: Health Related Quality of Life (HRQOL) questionnaires are increasingly used in clinical practice. These Patient Reported Outcomes (PROs) are provided to the paediatrician to facilitate communication with patients during a consultation. The aim of the current article is to describe the development and introduction of a new web-based application for the use of PROs in daily paediatric clinical practice. METHODS: Currently, the use of PROs in daily clinical practice is very time consuming and often has logistical problems. The use of a web-based programme can overcome these problems and contributes to an improved use of PROs in clinical practice. We therefore developed an easily accessible website (KLIK) for outpatient treatment and a training programme for paediatricians to maximize the effectiveness and the practical use of PROs (KLIK PROfile). RESULTS: The KLIK study was launched in August 2008 to evaluate the use of the KLIK PROfile in daily clinical practice. The KLIK study evaluates whether feedback from HRQOL data could influence patient satisfaction with the consultation, the advice given, the type of referrals and topics discussed. In this multicentre study, a control group (without the use of the KLIK PROfile) is compared to an intervention group (with the use of the KLIK PROfile). A sequential cohort design is chosen to avoid contamination between the study groups. CONCLUSIONS: Based on the positive experiences with the use of the KLIK PROfile acquired during the study we conclude that the KLIK PROfile may contribute to systematically monitor and discuss HRQOL issues during consultations. The next steps will be a comprehensive evaluation of the KLIK study data and the implementation of the KLIK PROfile in daily clinical practice in different patient groups.

Development and implementation of a patient reported outcome intervention (QLIC-ON PROfile) in clinical paediatric oncology practice.

OBJECTIVE: The use of patient reported outcomes (PRO) in routine clinical practice is becoming increasingly common, but there is limited knowledge about the development and implementation of PRO. The objective of the current paper is to provide a thorough description of the development and implementation of a PRO on health related quality of life (HRQOL)--the QLIC-ON PROfile--in clinical paediatric oncology practice. METHODS: The development of the QLIC-ON PROfile is explained by elucidating important choices: the HRQOL instrument, the professional that uses the QLIC-ON PROfile, the optimal form of HRQOL feedback and whether or not a clinically important difference is reported. The description of the implementation of the QLIC-ON PROfile focuses on the education and commitment of the professional that uses the QLIC-ON PROfile. Study design and outcome measures are also elaborated on. RESULTS: Important considerations regarding the development and implementation of PRO interventions are reported. These considerations have also resulted in educational material. CONCLUSION: Our study adds to current knowledge of PRO research. This paper can be used as a practical guide for researchers and other professionals, who are interested in setting up PRO interventions in any clinical setting.