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This manuscript summarizes available evidence-based best practices in the development, translation, and cultural adaptation of one type of outcome measure for adults with hearing impairment, patient-reported outcome measures (PROMs). It presents the development of the Cochlear Implant Quality of Life (CIQOL) instruments and the ongoing translation and cultural adaptation of the CIQOL-35 Profile from English to French as case studies and discusses useful lessons for selecting, developing, translating, culturally adapting, and using PROMs. Relevant best practice guides are introduced, described and their steps are illustrated with examples. Future trends in hearing-related PROMs, including computerized adaptive testing, patient-reported experience measures (PREMs), economic evaluation and allocation of scarce resources, and PROMs in low-resource settings, are discussed. The manuscript concludes on the lessons that can be learned from implementation science for the successful and sustainable integration of PROMs in clinical practice.

PurposeIn current cancer care, there is a growing debate about the value of using patient-reported outcome measures (PROMs) in daily clinical follow-up. A systematic review of the literature was conducted to assess the evidence of the effectiveness of the routine use of PROMs in daily cancer care in terms of patient outcomes, patient experiences and process indicators and to identify the effect of giving feedback about PROM findings to patients and/or health care professionals (HCPs).MethodsA systematic search was performed. Studies were eligible for inclusion when they (1) used a PROM as an intervention, with or without feedback to patients and/or HCPs, compared with not using a PROM, and (2) used a PROM as an intervention with feedback to patients and/or HCPs, compared with using a PROM without giving feedback to patients and/or HCPs.ResultsAfter screening of 8341 references, 22 original studies met the inclusion criteria. Most studies found a positive effect on survival, symptoms, HRQoL and patient satisfaction. In general, using feedback to patient and/or HCPs about the PROM results led to better symptom control, HRQoL, patient satisfaction and patient-doctor communication. The majority of included studies had insufficient power to detect significant differences in the outcomes assessed.ConclusionThis review shows that predominantly positive findings were found in the use of a PROM in daily cancer care. Additionally, more positive effects were seen when feedback is provided to patient and/or health care professionals, and it is thus highly recommended that this is always done.

Background. Purpose Interstitial lung disease (ILD) is a common manifestation of Systemic Sclerosis (SSc) and a leading cause of death. The assessment of respiratory symptoms, with lung physical examination and pulmonary function tests, represents a useful approach to monitoring pulmonary disease progression. However, there is currently no consensus on the optimal monitoring strategies for these patients. A specific patient-reported outcome measure (PROM), the Living with Idiopathic Pulmonary Fibrosis Questionnaire (L-IPF), has been validated for patients with idiopathic pulmonary fibrosis and has shown correlation with FVC% predicted and DLCO% values [1]. Its adapted version, the Living with Pulmonary Fibrosis Questionnaire (L-PF), is designed for patients with any fibrosing interstitial lung disease and was also used in the INBUILD study [2]. The aim of this study is to evaluate the L-PF in our patients with SSc-ILD.   Materials and Methods. L-PF consists of 44 items, divided into two modules: Symptoms (subdivided into dyspnea, cough, and energy) and Impact. Scores for both modules range from 0 (no symptoms and/or impact) to 100 (maximum symptoms and/or impact). The correlation between L-PF and the Systemic Sclerosis Impact of Disease (ScleroID), a comprehensive PROM developed for SSc, was analysed. Data are presented as medians (interquartile range). SSc subgroups were compared using the Mann–Whitney U test and correlation analysis using the Spearman coefficient (rs).   Results. L-PF was administered to 55 consecutive patients with SSc-ILD. Their demographic and clinical features are detailed in Table 1. A negative correlation was found between DLCO% and all L-PF domains: Cough (rs= -0.454, p=0.001), Total Symptoms (rs= -0.386, p=0.007), Impact (rs= -0.335, p=0.037), Dyspnea (rs= -0.285, p=0.047) and Energy (rs = -0.299, p=0.039). In addition, ScleroID correlated positively with all L-PF domains except Cough: Total Symptoms (rs=0.612, p<0.0001) (Figure 1), Impact (rs=0.634, p<0.0001), Dyspnea (rs=0.667, p<0.0001) and Energy (rs=0.544, p <0.0001). No significant correlations were observed with FVC%, ILD and SSc duration, or age. No significant differences in L-PF domain scores were observed when stratifying the cohort by sex, smoking status, age (< or > 60 years), cutaneous subset, antibody profile, ILD radiological pattern, FVC (< or > 75%), SSc duration, or ILD duration (< or > 10 years).   Conclusions. In this cohort of patients with SSc-ILD, the L-PF questionnaire was correlated with DLCO values, which might reflect ILD effects and lung microvascular damage in SSc. Moreover, the correlation between L-PF and ScleroID, a validated measure of disease burden for SSc patients, suggests that L-PF might capture symptoms and impact of ILD also in them. The Authors thank GILS (Gruppo Italiano Lotta Sclerodermia) for kindly supporting the project

Purpose Systematic reviews of patient-reported outcome measures (PROMs) differ from reviews of interventions and diagnostic test accuracy studies and are complex. In fact, conducting a review of one or more PROMs comprises of multiple reviews (i.e., one review for each measurement property of each PROM). In the absence of guidance specifically designed for reviews on measurement properties, our aim was to develop a guideline for conducting systematic reviews of PROMs. Methods Based on literature reviews and expert opinions, and in concordance with existing guidelines, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) steering committee developed a guideline for systematic reviews of PROMs. Results A consecutive ten-step procedure for conducting a systematic review of PROMs is proposed. Steps 1-4 concern preparing and performing the literature search, and selecting relevant studies. Steps 5-8 concern the evaluation of the quality of the eligible studies, the measurement properties, and the interpretability and feasibility aspects. Steps 9 and 10 concern formulating recommendations and reporting the systematic review. Conclusions The COSMIN guideline for systematic reviews of PROMs includes methodology to combine the methodological quality of studies on measurement properties with the quality of the PROM itself (i.e., its measurement properties). This enables reviewers to draw transparent conclusions and making evidence-based recommendations on the quality of PROMs, and supports the evidence-based selection of PROMs for use in research and in clinical practice.

Background Patient‐reported outcome measures (PROMs) are questionnaires that collect health outcomes directly from the people who experience them. This review critically synthesizes information on generic and selected condition‐specific PROMs to describe trends and contemporary issues regarding their development, validation and application. Methods We reviewed academic and grey literature on validated PROMs by searching databases, prominent websites, Google Scholar and Google Search. The identification of condition‐specific PROMs was limited to common conditions and those with a high burden of disease (eg cancers, cardiovascular disorders). Trends and contemporary issues in the development, validation and application of PROMs were critically evaluated. Results The search yielded 315 generic and condition‐specific PROMs. The largest numbers of measures were identified for generic PROMs, musculoskeletal conditions and cancers. The earliest published PROMs were in mental health‐related conditions. The number of PROMs grew substantially between 1980s and 2000s but slowed more recently. The number of publications discussing PROMs continues to increase. Issues identified include the use of computer‐adaptive testing and increasing concerns about the appropriateness of using PROMs developed and validated for specific purposes (eg research) for other reasons (eg clinical decision making). Conclusions The term PROM is a relatively new designation for a range of measures that have existed since at least the 1960s. Although literature on PROMs continues to expand, challenges remain in selecting reliable and valid tools that are fit‐for‐purpose from the many existing instruments. Patient or public contribution Consumers were not directly involved in this review; however, its outcome will be used in programmes that engage and partner with consumers.

(1) Background: The standard surgical approach to amputation has failed to evolve significantly over the past century. Consequently, standard amputations often fall short with regard to improving the quality of life (QoL) for patients. A modified lower extremity amputation technique incorporating agonist–antagonist myoneural interface (AMI) constructs provides patients with a novel alternative to standard amputation and, to-date, has demonstrated overall significant improvements in their physical and mental wellbeing. (2) Methods: Five PROMs surveys, (1) EQ-5D-3L, (2) Lower Extremity Functional Scale (LEFS), (3) PROMIS-57, (4) Short Form-36 (SF-36), and (5) Sickness Impact Profile (SIP), were administered to our research cohort pre-operatively (baseline) and at various timepoints post-operatively. (3) Results: The cohort’s baseline and 12-month post-operative responses were compared to determine score improvement. Significant improvements were demonstrated across all survey domains (p < 0.05). (4) Conclusions: Modified lower extremity amputation with AMI construction has the potential to provide amputees with increased quality of life when compared to the pre-operative state. However, further investigation is necessary to determine whether the patient-reported outcome measures of the AMI amputee cohort are superior to those who receive a standard amputation.

Purpose Service user involvement in instrument development is increasingly recognised as important, but is often not done and seldom reported. This has adverse implications for the content validity of a measure. The aim of this paper is to identify the types of items that service users felt were important to be included or excluded from a new Recovering Quality of Life measure for people with mental health difficulties. Methods Potential items were presented to service users in face-to-face structured individual interviews and focus groups. The items were primarily taken or adapted from current measures and covered themes identified from earlier qualitative work as being important to quality of life. Content and thematic analysis was undertaken to identify the types of items which were either important or unacceptable to service users. Results We identified five key themes of the types of items that service users found acceptable or unacceptable; the items should be relevant and meaningful, unambiguous, easy to answer particularly when distressed, do not cause further upset, and be non-judgemental. Importantly, this was from the perspective of the service user. Conclusions This research has underlined the importance of service users' views on the acceptability and validity of items for use in developing a new measure. Whether or not service users favoured an item was associated with their ability or intention to respond accurately and honestly to the item which will impact on the validity and sensitivity of the measure.

Purpose Elucidate facilitators, barriers, and key lessons learned regarding the implementation of system-wide clinical patient-reported outcome measure (PROM) programs among United States (US) healthcare leaders. Methods We conducted semi-structured interviews with 35 US healthcare leaders, including chief-level executives, data directors, PROM directors, and department chairs involved in PROM implementation across seven diverse healthcare systems from February to June 2020. Transcripts were coded, evaluated for qualitative themes, and categorized according to the consolidated framework for implementation research (CFIR). Results According to US hospital leaders with experience in existing clinical PROM programs, there are facilitators and barriers to implementation success in each CFIR domain. Allowing clinicians to select PROM measures and ensuring a user-friendly data platform (intervention); adapting data collection to patient home environments (outer setting); informing clinicians of the multi-faceted use of PROM data for research, clinical care, and business (inner setting); implementing PROM education earlier into clinician training (characteristics of individuals); and establishing specialty-agnostic PROM implementation teams (process) were among key facilitators to implementation success. Conclusion Leaders of geographically and clinically diverse PROM programs in the US identify common themes that facilitate successful implementation. Drivers of success depend on factors within and outside the clinical environment. These findings may serve to guide both establishing new PROM programs and refining existing PROM programs.

Prevalence of total hip arthroplasty (THA) has trended upwards over past decades and is projected to increase further. Optimizing outcomes after surgery is essential to avoid surgical revision and maximize outcomes. Low back pain is reported as a problem post THA. Patient-reported outcome measures (PROMs) are commonly used to evaluate THA outcomes but have limitations (e.g., ceiling effects). It is therefore important to assess a comprehensive range of outcomes. Physical outcome measures of spinopelvic alignment and physical functioning demonstrate potential value, but no evidence synthesis has investigated their association with PROMs. The objectives of this systematic review are to evaluate the association between spinopelvic alignment and physical outcome measures of physical functioning with PROMs and characteristics of low back pain after THA. This protocol is aligned with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Cross-sectional and longitudinal cohort studies evaluating the association between the physical outcome measures and PROMs (any outcome measures reported) following THA by any approach/implant will be included except surface replacement and revision THA. Studies investigating THA for developmental pathology and inflammatory conditions will be excluded. A systematic search in MEDLINE (Ovid), Embase (Ovid), Scopus, Web of Science, CINAHL, and the grey literature will be carried out from inception to July 31, 2023. Two independent reviewers will evaluate eligibility of retrieved articles, extract data and assess risk of bias (NIH quality assessment tool) of included studies. A third reviewer will mediate disagreements. Random-effects meta-analyses will be conducted if studies are sufficiently homogeneous in design, population, physical measures and PROMs; reporting odds ratios and 95% confidence intervals. Where meta-analyses are not possible, a narrative synthesis will be conducted. Confidence in cumulative evidence will be assessed using a modified GRADE (Grading of Recommendations Assessment, Development, and Evaluation).

The routine measurement of patient-reported outcomes in cancer clinical care using electronic patient-reported outcome measures (ePROMs) is gaining momentum worldwide. However, a deep understanding of the mechanisms underpinning ePROM interventions that could inform their optimal design to improve health outcomes is needed. This study aims to identify the implicit mechanisms that underpin the effectiveness of ePROM interventions and develop program theories about how and when ePROM interventions improve health outcomes. A realist synthesis of the literature about ePROM interventions in cancer clinical care was performed. A conceptual framework of ePROM interventions was constructed to define the scope of the review and frame the initial program theories. Literature searches of Ovid MEDLINE, Ovid Embase, Scopus, and CINAHL, supplemented by citation tracking, were performed to identify relevant literature to develop, refine, and test program theories. Quality appraisal of relevant studies was performed using the Mixed Methods Appraisal Tool. Overall, 61 studies were included in the realist synthesis: 15 (25%) mixed methods studies, 9 (15%) qualitative studies, 13 (21%) descriptive studies, 21 (34%) randomized controlled trials, and 3 (5%) quasi-experimental studies. In total, 3 initial program theories were developed regarding the salient components of ePROM interventions-remote self-reporting, real-time feedback to clinicians, and clinician-patient telecommunication. The refined theories posit that remote self-reporting enables patients to recognize and report symptoms accurately and empowers them to communicate these to clinicians, real-time feedback prompts clinicians to manage symptoms proactively, and clinician-patient telephone interactions and e-interactions between clinic encounters improve symptom management by reshaping how clinicians and patients communicate. However, the intervention may not achieve the intended benefit if ePROMs become a reminder to patients of their illness and are not meaningful to them and when real-time feedback to clinicians lacks relevance and increases the workload. The key to improving health outcomes through ePROM interventions is enabling better symptom reporting and communication through remote symptom self-reporting, promoting proactive management of symptoms through real-time clinician feedback, and facilitating clinician-patient interactions. Patient engagement with self-reporting and clinician engagement in responding to feedback are vital and may reinforce each other in improving outcomes. Effective ePROM interventions might fundamentally alter how clinicians and patients interact between clinic encounters.