BACKGROUND: Implementing patient-reported outcome measures (PROMs) to measure and evaluate health outcomes is increasing worldwide. Along with this emerging trend, it is important to identify which guidelines, frameworks, checklists, and recommendations exist, and if and how they have been used in implementing PROMs, especially in clinical quality registries (CQRs).
OBJECTIVE: This review aims to identify existing publications, as well as publications that discuss the application of actual guidelines, frameworks, checklists, and recommendations on PROMs\' implementation for various purposes such as clinical trials, clinical practice, and CQRs. In addition, the identified publications will be used to guide the development of a new guideline for PROMs\' implementation in CQRs, which is the aim of the broader project.
METHODS: A literature search of the databases MEDLINE, Embase, CINAHL, PsycINFO, and Cochrane Central Register of Controlled Trials will be conducted since the inception of the databases, in addition to using Google Scholar and gray literature to identify literature for the scoping review. Predefined inclusion and exclusion criteria will be used for all phases of screening. Existing publications of guidelines, frameworks, checklists, recommendations, and publications discussing the application of those methodologies for implementing PROMs in clinical trials, clinical practice, and CQRs will be included in the final review. Data relating to bibliographic information, aim, the purpose of PROMs use (clinical trial, practice, or registries), name of guideline, framework, checklist and recommendations, the rationale for development, and their purpose and implications will be extracted. Additionally, for publications of actual methodologies, aspects or domains of PROMs\' implementation will be extracted. A narrative synthesis of included publications will be conducted.
RESULTS: The electronic database searches were completed in March 2024. Title and abstract screening, full-text screening, and data extraction will be completed in May 2024. The review is expected to be completed by the end of August 2024.
CONCLUSIONS: The findings of this scoping review will provide evidence on any existing methodologies and tools for PROMs\' implementation in clinical trials, clinical practice, and CQRs. It is anticipated that the publications will help us guide the development of a new guideline for PROMs\' implementation in CQRs.
BACKGROUND: PROSPERO CRD42022366085; https://tinyurl.com/bdesk98x.
UNASSIGNED: DERR1-10.2196/52572.

BACKGROUND: Adrenoleukodystrophy (ALD) is a multifaceted, X-linked, neurodegenerative disorder that comprises several clinical phenotypes. ALD affects patients through a variety of physical, emotional, social, and other disease-specific factors that collectively contribute to disease burden. To facilitate clinical care and research, it is important to identify which symptoms are most common and relevant to individuals with any subtype of ALD.
METHODS: We conducted semi-structured qualitative interviews and an international cross-sectional study to determine the most prevalent and important symptoms of ALD. Our study included adult participants with a diagnosis of ALD who were recruited from national and international patient registries. Responses were categorized by age, sex, disease phenotype, functional status, and other demographic and clinical features.
RESULTS: Seventeen individuals with ALD participated in qualitative interviews, providing 1709 direct quotes regarding their symptomatic burden. One hundred and nine individuals participated in the cross-sectional survey study, which inquired about 182 unique symptoms representing 24 distinct symptomatic themes. The symptomatic themes with the highest prevalence in the overall ALD sample cohort were problems with balance (90.9%), limitations with mobility or walking (87.3%), fatigue (86.4%), and leg weakness (86.4%). The symptomatic themes with the highest impact scores (on a 0-4 scale with 4 being the most severe) were trouble getting around (2.35), leg weakness (2.25), and problems with balance (2.21). A higher prevalence of symptomatic themes was associated with functional disability, employment disruption, and speech impairment.
CONCLUSIONS: There are many patient-relevant symptoms and themes that contribute to disease burden in individuals with ALD. These symptoms, identified by those having ALD, present key targets for further research and therapeutic development.

BACKGROUND: Several systematic reviews (SRs) assessing the use of telemedicine for musculoskeletal conditions have been published in recent years. However, the landscape of evidence on multiple clinical outcomes remains unclear.
OBJECTIVE: We aimed to summarize the available evidence from SRs on telemedicine for musculoskeletal disorders.
METHODS: We conducted an umbrella review of SRs with and without meta-analysis by searching PubMed and EMBASE up to July 25, 2022, for SRs of randomized controlled trials assessing telemedicine. We collected any kind of patient-reported outcome measures (PROMs), patient-reported experience measures (PREMs), and objective measures, including direct and indirect costs. We assessed the methodological quality with the AMSTAR 2 tool (A Measurement Tool to Assess systematic Reviews 2). Findings were reported qualitatively.
RESULTS: Overall, 35 SRs published between 2015 and 2022 were included. Most reviews (n=24, 69%) were rated as critically low quality by AMSTAR 2. The majority of reviews assessed \"telerehabilitation\" (n=29) in patients with osteoarthritis (n=13) using PROMs (n=142 outcomes mapped with n=60 meta-analyses). A substantive body of evidence from meta-analyses found telemedicine to be beneficial or equal in terms of PROMs compared to conventional care (n=57 meta-analyses). Meta-analyses showed no differences between groups in PREMs (n=4), while objectives measures (ie, \"physical function\") were mainly in favor of telemedicine or showed no difference (9/13). All SRs showed notably lower costs for telemedicine compared to in-person visits.
CONCLUSIONS: Telemedicine can provide more accessible health care with noninferior results for various clinical outcomes in comparison with conventional care. The assessment of telemedicine is largely represented by PROMs, with some gaps for PREMs, objective measures, and costs.
BACKGROUND: PROSPERO CRD42022347366; https://osf.io/pxedm/.

OBJECTIVE: People with low socioeconomic status are disproportionately affected by kidney failure, and their adverse outcomes may stem from unmet health-related social needs. This study explored hemodialysis patient perspectives on health-related social needs and recommendations for intervention.
METHODS: Qualitative study using semistructured interviews.
METHODS: Thirty-two people with low socioeconomic status receiving hemodialysis at 3 hemodialysis facilities in Austin, Texas.
METHODS: Interviews were analyzed for themes and subthemes using the constant comparative method.
RESULTS: Seven themes and 21 subthemes (in parentheses) were identified: (1) kidney failure was unexpected (never thought it would happen to me; do not understand dialysis); (2) providers fail patients (doctors did not act; doctors do not care); (3) dialysis is detrimental (life is not the same; dialysis is all you do; dialysis causes emotional distress; dialysis makes you feel sick); (4) powerlessness (dependent on others; cannot do anything about my situation); (5) financial resource strain (dialysis makes you poor and keeps you poor; disability checks are not enough; food programs exist but are inconsistent; eat whatever food is available; not enough affordable housing; unstable housing affects health and well-being); (6) motivation to keep going (faith, support system, will to live); and (7) interventions should promote self-efficacy (navigation of community resources, support groups).
CONCLUSIONS: Limited quantitative data such as on dialysis vintage, and limited geographic representation.
CONCLUSIONS: Dialysis exacerbates financial resource strain, and health-related social needs exacerbate dialysis-related stress. The participants made recommendations to address social needs with an emphasis on increasing support and community resources for this population.
UNASSIGNED: People receiving dialysis often experience health-related social needs, such as food and housing needs, but little is known about how these impact patients\' health and well-being or how to best address them. We interviewed people receiving dialysis about how health-related social needs affect them and what they think dialysis facilities can do to help them address those needs. The participants reported that they often lose their independence after starting dialysis and health-related social needs are common, exacerbate their stress and emotional distress, and reduce their sense of well-being. Dialysis facilities may be able to enhance the experience of these patients by facilitating connections with local resources and providing opportunities for patients to support one another.

OBJECTIVE: To produce a culturally adapted translation of the Rapid Assessment of Physical Activity (RAPA) questionnaire for German speaking Austrians and to conduct a linguistic validation of the new language version.
METHODS: The original English RAPA questionnaire was translated into German for Austria and underwent an independent forward and back translation, followed by cognitive debriefing interviews with older adults aged 55 to 78 years with and without health conditions (n = 13), for linguistic validation.
RESULTS: Several distinct choices were made in the translation of the RAPA questionnaire to German, including the use of colloquial terms for \'physical activity\' and \'intensity\'; and the decision to keep to the original examples and images of different physical activities for illustrating the intensity levels (light, moderate, vigorous) of physical activity. In cognitive debriefing, interviewees commented that some example activities for the respective intensity levels could - depending on the individual - also represent a higher or lower intensity level; and that the wording of RAPA items 4 and 5, which describe the category \'under-active regular\' aerobic activity, was difficult to understand. Both issues were addressed and resolved through minor iterative modifications made during the cognitive debriefing process.
CONCLUSIONS: A new version of the RAPA questionnaire in German for Austria has been produced by forward and back translation and linguistic validation. The questionnaire may now undergo psychometric evaluation.

UNASSIGNED: To identify the latent classes of resilience in patients with esophageal cancer after esophagectomy and develop a deeper understanding of the association between these classes and patient-reported symptoms.
UNASSIGNED: China accounts for more than half of the global burden of esophageal cancer, and patients with esophageal cancer experience numerous symptoms that affect their quality of life and prognosis. Given that resilience is a key element that alleviates the progression of symptoms, it may represent a potential means of to enhancing cancer patients\' physical and psychological well-being.
UNASSIGNED: The study was implemented in the thoracic surgery departments of three tertiary hospitals in eastern China. The participants were patients who were still hospitalized after esophagectomy. Data were gathered by self-report questionnaires, and a latent class analysis was utilized to identify different categories of resilience among the patients.
UNASSIGNED: A total of 226 patients were recruited. The three classes of resilience identified included high strength and striving (53.5%), medium resilience but weak self-recovery (35.9%), and minimal tenacity and external support (10.6%). Patients with low income (OR = 12.540, p = 0.004) were more likely to be in the minimal tenacity and external support class. Patients without comorbidities (OR = 2.413, p = 0.013) and aged 66-70 years (OR = 4.272, p < 0.001) were more likely to be in the high strength and striving class. The patient-reported symptoms and symptom-related interference of patients after esophagectomy varied considerably among the three categories of resilience.
UNASSIGNED: Accurate interventions should be devised and executed according to the features of each type of resilience in patients after esophagectomy to maximize intervention efficacy. These findings highlight the important role of precision nursing.

UNASSIGNED: The Patient Evaluation Measure (PEM) is a region-specific patient reported outcome measure (PROM) for hand and wrist disorders, first introduced in English for patients with hand surgery in 1995. The purpose of the study was to assess the psychometric properties of the translated and cross-culturally adapted Slovenian version of PEM (PEM-Slo).
UNASSIGNED: The study was designed as a single-centre observational prospective study conducted from July 2020 to March 2021. The psychometric evaluation was performed on fifty-one patients with miscellaneous hand and wrist disorders. Reliability was tested for internal consistency and test-retest reliability. Convergent and divergent validity, responsiveness, floor and ceiling effect, and interpretability with the determination of minimal detectable change (MDC) and minimal clinically important difference (MCID) were assessed.
UNASSIGNED: The PEM-Slo has excellent internal consistency (Cronbach\'s α 0.932) and good to excellent test-retest reliability (intraclass correlation coefficient=0.874). Convergent validity was proved with high to moderate correlations of PEM-Slo with DASH, grip strength and self-care, usual activities, and pain EQ-5D-5L subscales, whereas no correlation of PEM-Slo with EQ-5D-5L mobility and anxiety/depression subscale confirmed divergent validity. The PEM-Slo responsiveness was high (standardised response mean=1.42, effect size=1.25). MDC was 18.01 and MCID was 17.31. No floor or ceiling effect was found.
UNASSIGNED: The PEM-Slo is a reliable, valid and responsive PROM for Slovenian-speaking patients with hand and wrist disorders.
UNASSIGNED: Vprašalnik Bolnikova ocena stanja (angl. Patient Evaluation Measure – PEM) je samoocenjevalni regijsko specifičen vprašalnik za bolnike z okvaro zapestja in roke, ki vsebuje 18 postavk, razdeljenih v 3 dele. Prvič je bil uporabljen v angleškem jeziku v Veliki Britaniji leta 1995 pri bolnikih po operativnem posegu na roki, kasneje se je njegova uporaba razširila na bolnike z različnimi okvarami roke. Namen raziskave je bil oceniti psihometrične lastnosti predhodno prevedene in medkulturno prilagojene slovenske različice vprašalnika (PEM-Slo).
UNASSIGNED: Raziskava je potekala v času od julija 2020 do marca 2021 in je bila zasnovana kot prospektivna observacijska študija. Prevod vprašalnika PEM je bil izdelan po veljavnih priporočilih za dvosmerno prevajanje. Razumevanje prevoda je bilo preizkušeno na 12 preiskovancih. V psihometrično analizo vprašalnika PEM je bilo vključenih 51 preiskovancev z različnimi okvarami zapestja in roke. Ob prvem ocenjevanju (T1) so preiskovanci izpolnili vprašalnike PEM, DASH in EQ-5D-5L, izmerjena je bila mišična moč stiska roke. Ob drugem ocenjevanju po 2 do 4 dneh (T2) so ponovno izpolnili vprašalnik PEM. Zadnja ocena (T3) je bila enaka oceni ob T1. Zanesljivost vprašalnika PEM je bila ocenjena z notranjo skladnostjo in zanesljivostjo ponovljene meritve. Ocenili smo tudi standardno napako merjenja in najmanjšo zaznavno spremembo, konstruktno veljavnost s konvergentno in divergentno veljavnostjo glede na povezanost podobnih in različnih konstruktov vseh treh vprašalnikov ter povezanost ocene PEM z mišično močjo stiska roke. Ocenjen je bil tudi učinek tal in stropa vprašalnika PEM in njegova najmanjša klinično pomembna sprememba.
UNASSIGNED: Povprečna starost 51 preiskovancev (26 moških) je bila 53 let. Slovenski prevod so preiskovanci sprejeli kot dobro razumljivega. PEM-Slo ima odlično notranjo skladnost (Cronbachova α 0,932) in dobro do odlično zanesljivost ponovljene meritve (znotrajrazredni količnik povezanosti s 95-% območjem zaupanja (ICC) je znašal 0,874). Povezanost med dosežki PEM-Slo, DASH ter med nekaterimi postavkami vprašalnika EQ-5D-5L (skrb zase, vsakdanje aktivnosti, bolečina/neugodje) ter z močjo stiska roke je bila zmerne do močne stopnje, kar kaže na konvergentno veljavnost PEM-Slo. Ni pa bilo statistično značilne povezanosti med dosežkom PEM-Slo in postavkama pokretnost, tesnoba/potrtost EQ-5D-5L, kar potrjuje divergentno veljavnost. Tudi odzivnost vprašalnika PEM-Slo je bila visoka. Najmanjša zaznavna sprememba PEM-Slo je znašala 18,01, najmanjša klinično pomembna sprememba pa 17,31. Učinka tal in stropa nismo ugotovili.
UNASSIGNED: Slovenska različica vprašalnika PEM-Slo je zanesljiva, veljavna in odzivna samoocenjevalna lestvica za slovensko populacijo bolnikov z okvarami zapestja in roke in je prosto dostopna za uporabo v klinične in raziskovalne namene.

Post-COVID-19 condition (PCC), colloquially known as long COVID, is a multisystem condition characterized by persistent symptoms beyond 4 weeks after the SARS-CoV-2 infection. More than 60 million people with PCC worldwide need prompt assessment, diagnosis, and monitoring, with many requiring specialist help from a multidisciplinary team of health care professionals (HCPs). Consequently, a scalable digital system is required for both people with PCC and HCPs to capture the breadth of symptoms and their impact on health, using patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs).
We aim to develop and implement a novel PCC digital PROM (DPROM) platform for (1) securely collecting PROM and PREM data from people with PCC, (2) enabling users to monitor symptoms longitudinally and assess response to treatment, (3) generating reports for the electronic health records (EHRs), (4) providing summary reports on PCC services based on national requirements, and (5) facilitating the sharing of relevant data with authorized research teams to accelerate our understanding of this new condition and evaluate new strategies to manage PCC.
We (1) undertook requirement analysis with people with PCC, HCPs, and researchers to identify the needs of the DPROM platform and determine its required functionalities; (2) designed and developed a clinically useful web portal for staff and a mobile app for patients, with a web-based alternative app to improve patient and staff choice, limit the risk of digital exclusion, and account for variability across services; (3) determined the PROMs and PREMs that PCC services would prefer to use on the platform; and (4) designed the summary report function that can be generated for each user for the EHR and for reporting to national health authorities.
A DPROM platform to record PCC symptom profile, condition severity, functional disability, and quality of life, based on the C19-YRS (Yorkshire Rehabilitation Scale) and other PROMs and PREMs, was developed. Individual-level medical information and details on the COVID-19 illness can be captured systematically. The platform generates easy-to-understand scores, radar plots and line graphs for people with PCC to self-monitor their condition and for HCPs to assess the natural course of the condition and the response to interventions. Clinics can configure a suite of PROMs and PREMs based on their local and national service and commissioning requirements and support research studies which require large-scale data collection on PROMs. The DPROM platform enables automatic aggregate data analysis for services to undertake service evaluation and cost-effectiveness analysis. The DPROM platform generated summary report can be uploaded to the EHRs of people with PCC.
A multifunctional DPROM platform to assess, grade, and monitor PCC has been developed. Future research will analyze the system\'s usability in specialist PCC clinical services and other long-term conditions.

UNASSIGNED: Individuals with lung cancer (LC) face a variety of symptoms that significantly impact their lives. We use extensive patient input to determine the relative importance and prevalence of these symptoms and identify which demographic features are associated with a higher level of disease burden.
UNASSIGNED: We performed semi-structured qualitative interviews with participants with LC to identify potentially important symptoms. We then conducted a cross-sectional study, in which participants rated the relative importance of 162 individual symptoms covering 14 symptomatic themes. Participant responses were analyzed by age, sex, disability status, disease duration, LC stage, type of treatment received, and smoking history, among other categories.
UNASSIGNED: Our cross-sectional study had 139 participants with LC. The most prevalent symptomatic themes reported by this population were fatigue (85.5%), impaired sleep and daytime sleepiness (73.5%), and emotional issues (73.0%). The symptomatic themes that had the greatest average impact (on a scale of 0 to 4, with 4 being the most impactful) were social role dissatisfaction (1.67), inability to do activities (1.64), and fatigue (1.60). Disability status had the strongest association with symptomatic theme prevalence. LC stage (stage IV), receipt of therapy, and smoking experience were also associated with higher frequency of symptomatic themes.
UNASSIGNED: Individuals with LC face diverse and disease-specific symptoms that affect their daily lives. Patient insight on the prevalence and relative importance of these symptoms is invaluable to advance meaningful therapeutic interventions.

BACKGROUND: Psoriasis is a common autoimmune dermatologic condition which has a pronounced negative impact on patient quality of life and disease burden. Currently, there are a number of treatments available for psoriasis, with differences in efficacy, mechanism of action, mode of administration, adverse effects, and tolerability. However, a reliable, validated patient-reported instrument to address patient expectations and of psoriasis treatment has not been developed. This project was undertaken with the aim of developing a fit-for-purpose self-reported instrument to inform patient expectations and preferences of psoriasis treatments.
METHODS: Two studies, both utilizing qualitative and quantitative methods, were conducted in patients within the entire spectrum of psoriasis severity. In Study 1, a group concept mapping (GCM) exercise was conducted with dermatologists and moderate-to-severe psoriasis patients to identify concepts important in the treatment of psoriasis. In Study 2, a preliminary Treatment Acceptability Questionnaire (TAQ) was developed using GCM-derived concepts from Studies 1 and 2, followed by cognitive debriefing (CD) telephone interviews of the preliminary TAQ. In Study 2, another GCM exercise was conducted with mild and newly diagnosed psoriasis patients. Psychometric analyses were performed on the TAQ to evaluate validity and reliability.
RESULTS: The Study 1 GCM exercise generated 43 concepts from moderate-to-severe psoriasis patients (n = 20) and dermatologists (n = 10). In Study 2, 37 GCM concepts were generated from mild and newly diagnosed psoriasis patients (n = 20). From the 2 GCM exercises, 28 concepts were selected to form the preliminary TAQ; CD interviews indicated strong understanding and relevance of TAQ items among patients with disease ranging from mild to severe. The final TAQ consisted of 20 items; psychometric analysis demonstrated strong validity and reliability of the TAQ.
CONCLUSIONS: The TAQ is a novel psychometrically validated patient-reported instrument to inform healthcare providers of patients\' expectations of and preferences for treatment of their psoriasis and can help in shared decision making between patients and physicians.