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Introduction Patient‐reported outcomes (PROs) are direct reports from patients about the status of their health condition without amendment or interpretation by others. Patient‐reported outcome measures (PROMs) are the tools used to measure PROs; they are usually validated questionnaires patients complete by self‐assessing their health status. Whilst the benefits of using PROs and PROMs to guide real‐time patient care are well established, they have not been adopted by many oncology institutions worldwide. This literature review aimed to examine the barriers associated with using PROs and PROMs in routine oncology care. Methods A literature search was conducted across EMBASE, Medline and CINAHL databases. Studies detailing barriers to routine PRO use for real‐time patient care were included; those focusing on PRO collection in the research setting were excluded. Results Of 1165 records captured, 14 studies informed this review. At the patient level, patient time, incapacity and difficulty using electronic devices to complete PROMs were prominent barriers. At the health professional level, major barriers included health professionals’ lack of time and knowledge to meaningfully interpret and integrate PRO data into their clinical practice and the inability for PRO data to be acted upon. Prominent barriers at the service level included difficulties integrating PROs and PROMs into clinical workflows and inadequate information technology (IT) infrastructures for easy PRO collection. Conclusion This review has outlined potential barriers to routine PRO use in the oncology setting. Such barriers should be considered when implementing PROs into routine clinical practice. Patient‐reported outcomes (PROs) are direct reports from patients about the status of their health condition without amendment or interpretation by others. This review article outlines potential barriers to routine PRO use in the oncology setting. Such barriers should be considered when implementing PROs into routine clinical practice.

Patient-reported outcome measures (PROMs) are self-rated scales and indices developed to improve the detection of the patients’ subjective experience. Given that a considerable number of PROMs are available, it is important to evaluate their validity and usefulness in a specific research or clinical setting. Published guidelines, based on psychometric criteria, do not fit in with the complexity of clinical challenges, because of their quest for homogeneity of components and inadequate attention to sensitivity. Psychometric theory has stifled the field and led to the routine use of scales widely accepted yet with a history of poor performance. Clinimetrics, the science of clinical measurements, may provide a more suitable conceptual and methodological framework. The aims of this paper are to outline the major limitations of the psychometric model and to provide criteria for clinimetric patient-reported outcome measures (CLIPROMs). The characteristics related to reliability, sensitivity, validity, and clinical utility of instruments are critically reviewed, with particular reference to the differences between clinimetric and psychometric approaches. Of note is the fact that PROMs, rating scales, and indices developed according to psychometric criteria may display relevant clinimetric properties. The present paper underpins the importance of the clini­metric methodology in choosing the appropriate PROMs. CLIPROM criteria may also guide the development of new indices and the validation of existing PROMs to be employed in clinical settings.

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.

The assessment of patient reported outcomes and health-related quality of life continue to be rapidly evolving areas of research and this new edition reflects the development within the field from an emerging subject to one that is an essential part of the assessment of clinical trials and other clinical studies.

Background Patient‐reported outcome measures (PROMs) measure patients’ perspectives on health outcomes and are increasingly used in health care. To capture the patient's perspective, it is essential that patients are involved in PROM development Objective This article reviews in what ways and to what extent patients are involved in PROM development and whether patient involvement has increased over time. Search strategy Literature was searched in PubMed, EMBASE, MEDLINE and the Cochrane Methodology Register. Inclusion criteria Studies were included if they described a new PROM development. Data extraction Basic information and information regarding patient involvement in development phases was recorded. Main results A total of 189 studies, describing the development of 193 PROMs, were included. Most PROMs were meant for chronic disease patients (n = 59) and measured quality of life (n = 28). In 25.9% of the PROM development studies, no patients were involved. Patients were mostly involved during item development (58.5%), closely followed by testing for comprehensibility (50.8%), while patient involvement in determining which outcome to measure was minimal (10.9%). Some patient involvement took place in the development of most PROMs, but in only 6.7% patients were involved in all aspects of the development. Patient involvement did not increase with time. Conclusions Although patient involvement in PROM development is essential to develop valid patient‐centred PROMs, patients are not always involved. When patients are involved, their level of involvement varies considerably. These variations suggest that further attention to building and/or disseminating consensus on requirements for patient involvement in PROM development is necessary.

PurposeSystematic reviews of patient-reported outcome measures (PROMs) are important tools to select the most suitable PROM for a study or clinical application. Conducting these reviews is challenging, and the quality of these reviews needs to be improved. We updated the COSMIN guideline for systematic reviews of PROMs, including the COSMIN Risk of Bias checklist, and the COSMIN criteria for good measurement properties.MethodsAdaptations to the methodology were based on our experience with applying the COSMIN guideline, through discussions among the authors, and results from two related Delphi studies.ResultsThe updated guideline places more emphasis on key aspects that are often missing or sub optimally conducted in published systematic reviews of PROMs, such as formulating a well-defined research question and developing a comprehensive search strategy, assessing risk of bias, applying criteria for good measurement properties, summarizing results, and grading the quality of the evidence. We also stress the importance of evaluating the measurement properties of each subscale of a PROM separately and evaluating content validity of all included PROMs.ConclusionThe quality of systematic reviews of PROMs can be improved by using this updated version of the COSMIN guideline for systematic reviews of PROMs. Improved quality will lead to better PROM selection and increased standardization of PROM use.Plain English summaryPatient-reported outcome measures (PROMs) are questionnaires that measure aspects of health from the patient perspective. To measure a specific health aspect, often dozens of PROMs are available. To choose the best PROM, a systematic review of PROMs can be conducted, in which all information on the quality and feasibility of each available PROM is collected, rated, and compared. Based on such a review a choice for the most suitable PROM for a certain study or clinical application can be made. However, conducting a systematic review of PROMs is very challenging, because nine quality aspects of PROMs need to be taken into account.In this article, we present an updated step-by-step guideline for conducting systematic reviews of PROMs. Each of these steps is described in detail in an accompanying manual. This updated guideline helps researchers to conduct systematic reviews of PROMs in a systematic and transparent way. It also helps readers of systematic reviews to understand how the review was conducted and to check the conclusions about which PROMs are recommended based on their quality.

Tools have been developed to facilitate communication and support information exchange between people diagnosed with cancer and their physicians. Patient‐reported outcome measures, question prompt lists, patient‐held records, tape recordings of consultations, decision aids, and survivorship care plans have all been promoted as potential tools, and there is extensive literature exploring their impact on patient outcomes. Eleven systematic reviews of studies evaluating tools to facilitate patient‐physician communication were reviewed and summarized in this overview of systematic reviews. Across the systematic reviews, 87 publications reported on 84 primary studies involving 15,381 participants. Routine use of patient‐reported outcome measures and feedback of results to clinicians can improve pain management, physician‐patient communication, and symptom detection and control; increase utilization of supportive care; and increase patient involvement in care. Question prompt lists can increase the number of questions asked by patients without increasing consultation length and may encourage them to reflect and plan questions before the consultation. There is limited benefit in audio recording consultations or using patient‐held records during consultations. Physicians should be supported by adequately resourced health services to respond effectively to the range of clinical and broader patient needs identified through the routine use of tools to facilitate communication.

Purpose Patient-reported outcome and experience measures (PROMs/PREMs) are well established in research for many health conditions, but barriers persist for implementing them in routine care. Implementation science (IS) offers a potential way forward, but its application has been limited for PROMs/PREMs. Methods We compare similarities and differences for widely used IS frameworks and their applicability for implementing PROMs/PREMs through case studies. Three case studies implemented PROMs: (1) pain clinics in Canada; (2) oncology clinics in Australia; and (3) pediatric/adult clinics for chronic conditions in the Netherlands. The fourth case study is planning PREMs implementation in Canadian primary care clinics. We compare case studies on barriers, enablers, implementation strategies, and evaluation. Results Case studies used IS frameworks to systematize barriers, to develop implementation strategies for clinics, and to evaluate implementation effectiveness. Across case studies, consistent PROM/PREM implementation barriers were technology, uncertainty about how or why to use PROMs/PREMs, and competing demands from established clinical workflows. Enabling factors in clinics were context specific. Implementation support strategies changed during pre-implementation, implementation, and post-implementation stages. Evaluation approaches were inconsistent across case studies, and thus, we present example evaluation metrics specific to PROMs/PREMs. Conclusion Multilevel IS frameworks are necessary for PROM/PREM implementation given the complexity. In cross-study comparisons, barriers to PROM/PREM implementation were consistent across patient populations and care settings, but enablers were context specific, suggesting the need for tailored implementation strategies based on clinic resources. Theoretically guided studies are needed to clarify how, why, and in what circumstances IS principles lead to successful PROM/PREM integration and sustainability.

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.

Background:Since rheumatoid arthritis (RA) is more prevalent among women than men, previous studies have explored the association between various female hormonal factors and the development or progression of RA. Cumulative lifetime estrogen exposure (CLEE) is defined as the summation of endogenous and exogenous exposure of estrogen, and its association with several chronic diseases and quality of life has been suggested. However, none has evaluated how CLEE affects longitudinal changes in the validated disease activity indices or patient-reported outcomes (PROs) of RA over time.Objectives:We aimed to investigate the differences in clinical characteristics between RA patients with lower and higher CLEE using validated disease activity indices and PROs of RA, and to determine the impact of CLEE on the disease course of RA over time using a large nationwide observational RA cohort in Korea.Methods:We included 2878 postmenopausal women with RA from the Korean Observational Study Network for Arthritis. Patients were examined at baseline and for five consecutive years using the Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Disease Activity Score 28 (DAS28), Health Assessment Questionnaire-Disability Index (HAQ-DI), and other PROs. CLEE was calculated by combining reproductive span (age in years at menopause minus age at menarche) and duration of any postmenopausal hormone replacement therapy uses. RA patients were then classified into lower and higher CLEE groups based on the median of 34 years of estrogen exposure. Generalised estimating equation (GEE) analyses were performed to evaluate the impact of CLEE on longitudinal changes in RA activity and PROs.Results:RA patients with lower CLEE (N=1602) were younger (60.1±8.9 vs. 60.8±7.0 years, p=0.024) but had longer disease duration (8.9±7.9 vs. 8.3±7.6 years, p= 0.034) than those with higher CLEE (N=1179). The lower CLEE group had significantly higher disease activity assessed by SDAI (14.6±10.6 vs. 13.2±9.3, p<0.001), CDAI (13.8±10.2 vs. 12.4±9.1, p<0.001), and DAS28 (4.0±1.4 vs. 3.9±1.3, p=0.004) and more radiographic erosion (20.0% vs. 16.9%, p=0.044) than the higher CLEE group at baseline. Furthermore, the lower CLEE group demonstrated worse PROs for global assessment, pain, fatigue, sleep disturbance, functional disability, and health-related quality of life (all p<0.01) than the higher CLEE group at baseline. The GEE model showed that the lower CLEE group was significantly associated with an increase in SDAI (β=0.518, p=0.007) over time after adjusting for age, BMI, disease duration, biologics use, and SDAI at baseline. The lower CLEE group was also significantly associated with an increase in HAQ-DI scores (β=0.050, p<0.001) and a decrease in EQ-5D-utility values (β=-0.024, p<0.001) during the 5-year follow-up period. Among RA patients with active disease at baseline (SDAI>11), the lower CLEE group was significantly associated with not achieving Boolean remission after adjustment for confounders during the follow-up period [HR 0.597 (95% CI 0.421-0.848), p=0.004] (Table 1).Conclusion:RA patients with lower CLEE have higher disease activity, more erosive disease, and worse PROs than those with higher CLEE. Moreover, lower CLEE adversely affects longitudinal changes in disease activity and PROs over time and is also associated with a lower likelihood of achieving clinical remission in RA.REFERENCES: NIL. Acknowledgements:NIL.Disclosure of Interests:None declared.