Patient-reported outcome measures developed for non\u2013cystic fibrosis bronchiectasis may be applied to cystic fibrosis bronchiectasis

Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): National Research Foundation of Korea grants funded by the Korea government (2021R1C1C100849812). Background The patient-reported outcome such as health-related quality of life (HRQoL) is important in providing patient-centered care to patients with hypertension. Previous studies have shown that comorbidities are negatively associated with HRQoL in patients with hypertension. To effectively improve their HRQoL, it is crucial to comprehend the mechanism of how comorbid diseases affect the HRQoL. Patients with multimorbidity experience an increased burden of treatment associated with simultaneously managing multiple chronic conditions. The treatment burden can contribute to poor HRQoL. Therefore, we hypothesize that treatment burden mediates the association between the number of comorbidities and HRQoL among patients with hypertension. Because most studies on the HRQoL of patients with hypertension have been conducted in older people, levels of treatment burden are different between older and younger patients, this study was conducted in young and middle-aged hypertensive patients with comorbidities. Purpose To examine the mediating effect of treatment burden on the association between the number of comorbidities and HRQoL in young and middle-aged hypertensive patients with comorbidities. Methods Hypertensive patients (age 19-54 years) with additional diseases completed the cross-sectional questionnaire survey. The number of comorbidities was measured based on self-report using the list of 20 or more chronic conditions. The treatment burden was measured with the 13-item Multimorbidity Treatment Burden Questionnaire, and high scores indicate a higher level of treatment burden. HRQoL was measured with the Patient-Reported Outcomes Measurement Information System-29 profile v2.1 (PROMIS-29 v2.1). The scores from the PROMIS-29 v2.1 were used to compute the PROMIS-Preference scores, which is a summary score of the HRQoL. The PROMIS-Preference scores ranged from 0 (bad health) to 1 (ideal health). To examine the mediating role of treatment burden on the relationship between the number of comorbidities and HRQoL, the mediation analysis was performed after adjusting for sex. This analysis was conducted using Mplus 8.8 with 5000 bootstrap samples. Results A total of 186 hypertensive patients with comorbidities (mean age 44.9 years; 72% male) were included in this study. Patients had an average of 2.6 additional chronic conditions along with hypertension. (SD: 1.7). The mean HRQoL score was 0.35 (SD: 0.21). The direct effect of the number of comorbidities on HRQoL was significant, and the indirect effect mediated by treatment burden was also significant (Figure). Conclusion We found that the treatment burden mediated the association between the number of comorbidities and HRQoL in young and middle-aged patients with hypertension and comorbidities. These findings suggest that strategies to lower the treatment burden are important to improve the HRQoL in this population.

The surgical management of locally recurrent rectal cancer (LRRC) has become widely accepted to afford cure and improve quality of life in this subset of patients. Thus far, traditional surgical and oncological markers have been used to highlight the success of surgical intervention. The use of patient-reported outcomes, specifically health-related quality of life (HRQoL), is sparse in these patients. This may be in part due to the lack of well-designed, validated instruments. This study identifies HRQoL issues relevant to patients undergoing surgery for LRRC, with the aim of developing a conceptual framework of HRQoL specific to LRRC to enable measurement of patient-reported outcomes in this cohort of patients. Qualitative focus groups were undertaken at two institutions to identify relevant HRQoL themes. The principles of thematic content analysis were used to analysis data. NViVo10 was used to analyse data. Twenty-one patients participated in six consecutive focus groups. Two patterns of themes emerged related to HRQoL and healthcare service delivery and utilization. Identified themes related to HRQoL included symptoms, sexual function, psychological impact, role and social functioning and future perspective. Under healthcare service and delivery and utilization the subdomain of disease management, treatment expectations and healthcare professionals were identified. This is the first qualitative study undertaken exclusively in patients with LRRC to ascertain relevant HRQoL outcomes. The impact of LRRC on patients is wide-ranging and extends beyond traditional HRQoL outcomes. The study operationalizes the identified outcomes into a conceptual framework, which will provide the basis for the development of a LRRC-specific patient-reported outcome measure.

Hepatitis C treatment and quality of life – You can’t always get what you want, but you might get what you need

Background and Aims ANCA associated vasculitis (AAV) is associated with increased morbidity. Recent years has seen improvement in clinical outcomes yet little work has been done to better understand the patient's role within this condition. Patient reported outcome measures (PROMs) are increasingly standard in clinical research outcomes, as well as an overall indicator for good quality patient care. With the exception of Robson et al AAV-PRO [1], little research has been done to develop validated disease specific tools for patients living with AAV. We aim to develop a disease specific tool that can be used in clinical practice to aid patients and clinicians in understanding and track changes in health-related quality of life (HRQoL) over time. Method AAV patients from a single centre were invited to take part in focus groups conducted using a semi-structured topic guide. Participants were asked to discuss topics relating to four broad areas; 1) the effects of AAV on everyday life and living, 2) the effects of treatment on everyday life and living, 3) the role of patients in health management and the patient experience 4) a review of existing generic and disease specific PROM tools (SF-36 and AAV-PRO). Audio transcript of each focus group was transcribed verbatim and data was analysed using a combination of inductive and deductive framework analysis [2]. Results Twenty-eight patients with AAV were invited to participate, 19 attended one of three, 2.5 hour focus groups, 2 patients failed to attend, 4 declined and 3 were unavailable. The mean age of participants was 66.6 +9.4 years and there was a near equal male to female split (10:9). The median time from diagnosis as 7.4 years. Three participants had active or newly diagnosed AAV with BVAS scores of >10. Five participants had previously required dialysis with 1 receiving a renal transplant. All participants received glucocorticoid and immunosuppressive therapy (cyclophosphamide and or Rituximab), 15 (78.9%) were still receiving immunotherapy. Full analysis of the qualitative data is being undertaken. Preliminary findings outlined what was most important to participants when considering HRQoL. Areas acknowledged included; self-identity, social roles e.g. fulfilling caring responsibilities, fears of relapse and disease and treatment burden. Fifty-six deductive and inductive codes were identified which have been further categorised. Participants felt existing tools lacked consideration of some key issues. Scoring systems were considered to be negativity worded e.g. mild, moderate, severe, with the term ‘none’ being the only positive option. Participants reported that existing tools overlooked positive factors which impact HRQoL, such as symptom validation, close clinician monitoring and improvement with treatment. Limitations were noted when trying to address transient or inconsistent symptoms and difficulty separating vasculitis from other health conditions when answering questions. Participants expressed a preference for using a PROM as part of their clinical care and felt that completing it prior to clinic would be most helpful and facilitate discussions with healthcare professionals. The use of an electronic-PROM was widely supported and would support clinicians and patients to monitor changes over time. Conclusion The AAV-PRO represents a significant advancement over generic tools such as the SF-36, however, existing PROMs are not without limitations and are primarily used in research practices. Our study revealed that patients desire active participation in HRQoL discussions and further work to incorporate this into the clinic setting is needed. We are continuing to develop a PROM tool that can be used to assess patients HRQoL in relation to their AAV in the outpatient setting. We believe this will allow a deeper understanding of the disease burden and could support a comprehensive, patient-centred approach to decision-making, offering new insights and identifying the need for supportive care. On a broader scale, these insights can be utilized to compare treatments, shed light on inequalities and facilitate enhancements in services.

Importance of responder criteria for reporting health-related quality-of-life data in clinical trials for advanced cancer: recommendations of Common Sense Oncology and the European Organisation for Research and Treatment of Cancer.

Development of National Research and Clinical Agendas for Patient-Reported Outcomes in IR: Proceedings from a Multidisciplinary Consensus Panel

BackgroundThe clinical relevance of Health-Related Quality of Life (HRQoL) in meningioma patients has been increasingly acknowledged in recent years. Various questionnaires have been used. However, almost none of these questionnaires has been particularly developed for and/or validated in this patient group. Therefore, the aim of this study was to assess the relevance and comprehensiveness of existing HRQoL questionnaires used in meningioma research and to assess the agreement between patients and health care professionals (HCPs) on the most relevant and important HRQoL issues.MethodsA systematic literature search, following the PRISMA statement, was conducted to identify all HRQoL questionnaires used in meningioma research. Semi-structured interviews were organized with patients and HCPs to (1) assess the relevance of all issues covered by the questionnaires (score 0–3: not relevant–highly relevant), (2) assess the ten most important issues, and (3) identify new relevant HRQoL issues.ResultsFourteen different questionnaires were found in the literature, comprising 140 unique issues. Interviews were conducted with 20 patients (median age 57, 71% female) and 10 HCPs (4 neurosurgeons, 2 neurologists, 2 radiotherapists, 1 rehabilitation specialist, 1 neuropsychologist; median experience 13 years). Meningioma patients rated 17–80% of the issues in each of the questionnaires as relevant, HCPs 90–100%. Patients and HCPs agreed on the relevance of only 49 issues (35%, Cohen’s kappa: 0.027). Both patients and HCPs considered lack of energy the most important issue. Patients and HCPs suggested five additional relevant issues not covered by current HRQoL questionnaires.ConclusionsExisting HRQoL questionnaires currently used in meningioma patients do not fully cover all relevant issues to these patients. Agreement between patients and HCPs on the relevance of issues was poor. Both findings support the need to develop and validate a meningioma-specific HRQoL questionnaire.

What's missing in sex chromosome aneuploidies? Representation and inclusion

Patient-Reported Outcome Measures (PROMs) are important tools to assess outcomes relevant to patients, with Health-Related Quality Of Life (HRQOL) as an important construct to be measured. Many different HRQOL PROMs are used in the type 2 diabetes field, however a complete overview of these PROMs is currently lacking. We therefore aimed to systematically describe and classify the content of all PROMs that have specifically been developed or validated to measure (aspects of) HRQOL in people with type 2 diabetes. A literature search was performed in PubMed and EMBASE until 31 December 2021. Studies on the development or validation of a PROM measuring HRQOL, or aspects of HRQOL, in people with type 2 diabetes were included. Title and abstract and full-text screening were conducted by two independent researchers and data extraction was performed independently by one of the researchers. Data were extracted on language in which the PROM was developed, target population, construct(s) being measured, names of (sub)scales and number of items per (sub)scale. In addition, all PROMs and subscales were classified according to specific aspects of HRQOL based on the Wilson & Cleary model (symptom status, functional status, general health perceptions) to aid researchers in PROM selection. In total 220 studies were identified that developed or validated PROMs that measure (aspects of) HRQOL in people with type 2 diabetes. Of the 116 unique HRQOL PROMs, 91 (of the subscales) measured symptom status, 60 measured functional status and 26 measured general health perceptions. In addition, 16 of the PROMs (subscales) measured global quality of life. 61 of the 116 PROMs (subscales) also include characteristics of the individual (e.g. aspects of personality, coping) or environment (e.g. social or financial support) and patient-reported experience measures (PREMs, e.g. measure of a patient's perception of their personal experience of the healthcare they have received, e.g. treatment satisfaction), which are not part of the HRQOL construct. Only 9 of the 116 PROMs measure all aspects of HRQOL based on the Wilson & Cleary model. Finally, 8 of the 116 PROMs stating to measure HRQOL, measured no HRQOL construct. In conclusion, a large number of PROMs are available for people with type 2 diabetes, which intend to measure (aspects of) HRQOL. These PROMs measure a large variety of (sub)constructs, which are not all HRQOL constructs, with a small amount of PROMs not measuring HRQOL at all. There is a need for consensus on which aspects of HRQOL should be measured in people with type 2 diabetes and which PROMs to use in research and daily practice. PROSPERO: CRD42017071012. COMET database: http://www.comet-initiative.org/studies/details/956.

Quality of Life for Patients Diagnosed with Diabetic Foot

Characterization of sleep in emerging adults with cystic fibrosis on elexacaftor/tezacaftor/ivacaftor

Patient-reported outcome measures (PROMs) are used widely within the addictions field. Their value could be increased by greater use of qualitative methods incorporating patients' perspectives. Qualitative methods can also add value to the quantitative scores produced by PROMs. Patient-reported outcome measures (PROMs) are self-completion questionnaires that assess a patient's health status or health-related quality of life at a single time-point. They can be used for many purposes, including baseline recording, gauging treatment needs, monitoring patient progress, evaluating clinical outcomes and helping to understand mechanisms of behaviour change. PROMs can be generic [e.g. the Short-Form 36 (SF-36)] or condition-specific [e.g. the Arthritis Impact Measurement Scales (AIMS)] 1. Within the addictions, PROMs have been used widely; for example, to measure cravings [e.g. the Minnesota Cocaine Craving Scale (MCCS)], withdrawal symptoms (e.g. the Mood and Physical Symptoms scale) and dependence [e.g. Severity of Dependence Scale (SDS)]. PROMs are often (but not always) designed using qualitative methods and with the patient perspective in mind. The use of qualitative research in PROM development is recommended by the Cochrane Handbook for Systematic Reviews of Interventions 2. This states that the concepts used in a PROM (e.g. craving, withdrawal, dependence, tolerance, intensity, distress, recovery) should be elicited from the target population and patients should be involved in generating the questions used in a PROM to ensure that all relevant aspects of those concepts are captured (i.e. that the PROM has good content validity) 2. The involvement of patients is also crucial, given that professionals' assessments of their patients' treatment needs and health status often differ from their patients' own assessments, and patients and professionals may disagree about the relative importance of specific health outcomes 3-7. Furthermore, this mismatch may change over time. In designing PROMs, we therefore need early and meaningful engagement with purposively selected groups of patients and/or service users through in-depth interviews, focus groups or other open consultation processes. Without this, the concepts, domains and questions used by researchers and clinicians may not be meaningful or relevant to the people whose condition is being assessed 8. Equally, PROMs may try to measure inappropriate, contradictory or objectionable outcomes or use ambiguous and unclear language that deters completion or generates unreliable results 7. When assessing aspects of addiction, a remotely constructed measure, however scientifically valuable, may inadvertently alienate patients by presuming certain negative behaviours or attributes (such as criminal activity, immorality or lack of control) or using language that is experienced as stigmatizing (such as 'abuse', 'addict', 'sick' or 'deviant') 7. Cognitive interviewing—a qualitative technique that involves asking respondents to think out loud as they complete a structured questionnaire—is a particularly valuable method that can be used in PROM design to pretest and improve questions that may be sensitive, intrusive or too difficult for some individuals to understand 9. It is not that patients' self-reports are more important than assessments made by clinicians; nor are they more accurate than objectively measured outcomes. It is also not the case that PROMs, even those developed with and by patients, provide the definitive approach for assessing an individual's health status or health-related quality of life. Even with extensive qualitative and consultative groundwork, PROMs can still fail to capture important aspects of an individual patient's experiences. Knowing whether or not someone has stopped craving drugs is valuable, but cannot reveal whether or not they are pleased with this change in health status. Scores relating to a particular health outcome, or aspect of a health outcome, may mean very different things to different people at different times. Some smokers may fear weight gain more than lung disease, while some drinkers may be deterred from excessive alcohol consumption more by erectile dysfunction than by gastritis. In order to appreciate fully the numerical scores produced by PROMs, supplementary narratives, descriptions or analysis arising from verbal reports will often be required. Our own ongoing experiences of developing a PROM for addiction recovery find that patients enjoy completing a structured questionnaire that captures important aspects of their lives. Nonetheless, they are seldom content to tick a response box and then move silently and mechanistically on to the next question. Instead, they want to discuss their responses, often reflecting on how they might have answered the question differently in different circumstances. These accompanying PROM narratives provide valuable contextual information that might be used to frame subsequent therapeutic work within clinical practice. Equally, they might be analysed using standard qualitative techniques to complement and expand upon the quantitative PROM scores. Robust PROMs are not therefore simply the product of good mixed-methods research; they can also generate valuable mixed-methods data. Combining closed PROM questions with open qualitative prompts and probes that capture individuals' personal perspectives seems to offer the optimal way of understanding and measuring patient reported outcomes of addiction and its related constructs. J.N. is part-funded by, and J.S. also receives support from, the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King's College London. J.S. is a clinician and has had, and continues to have, clinical responsibilities and has also worked with a range of types of treatment and rehabilitation service providers. He has also worked with pharmaceutical companies to seek to identify new or improved treatments, and also with a range of governmental and non-governmental organizations. A fuller account is given on his personal web-page of the Addictions Department of King's College London at http://www.kcl.ac.uk/ioppn/depts/addictions/people/hod.aspx. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health.

Paediatric localized scleroderma (LS) can negatively impact health-related quality of life (HRQoL) by causing skin fibrosis, abnormal limb development, disfigurement, and side-effects from immunosuppressive treatment. Studies to date have rarely included qualitative data gathered directly from paediatric patients with LS. To assess the impact of LS on HRQoL among affected youth and their caregivers using qualitative description. Youth with all subtypes of LS and their caregivers were purposively sampled to participate in age-appropriate focus groups (younger children, early adolescents, adolescents). Each group started with a drawing exercise followed by in-depth discussion of topics including skin symptoms (e.g. itch, pain, tightness), functional impairment, physical appearance, family and peer relationships, and treatment burden. Focus groups were transcribed verbatim and co-coded, with adjudication of differentially applied codes. The study findings were triangulated via comparison with adult reports and published literature. Eleven youth aged 9-16 years and 16 caregivers participated in three focus groups each. Major identified areas of impact included uncomfortable skin symptoms, physical functioning limitations, extracutaneous manifestations, body image, bullying and teasing, unwanted questioning from others, and treatment side-effects and burden. This is the first qualitative study of HRQoL in LS to include all major LS subtypes. We identified domains of HRQoL impacted by LS, some of which replicate earlier findings and some of which were novel. As impact also changed with developmental stage, our findings support the need for ongoing, formal evaluation of HRQoL in children and adolescents with LS. What is already known about this topic? Paediatric localized scleroderma (LS) negatively impacts health-related quality of life (HRQoL) via skin fibrosis, musculoskeletal and other extracutaneous manifestations from the disease process, and side-effects of systemic immunosuppression. The full impact of LS and its treatment on HRQoL is incompletely understood, with only one published qualitative study of youth with LS, which was limited to facial involvement. There are no qualitative studies of HRQoL in other LS subtypes to date. What does this study add? This is the first qualitative evaluation of HRQoL in youth with LS inclusive of all disease subtypes. Our study confirms that LS affects HRQoL across multiple distinct domains, including uncomfortable skin sensations, impacts on body image, bullying and teasing from peers, unwanted intrusive questioning, physical limitations, extracutaneous manifestations and high treatment burden. These results indicate the need for ongoing clinical assessment of paediatric patients in these domains. What are the clinical implications of the work? These results support the need to care for patients with LS holistically by synthesizing cutaneous, musculoskeletal and extracutaneous disease assessments with multidimensional evaluation of psychosocial impact and adverse effects of treatments. The development of an LS-specific HRQoL measure would advance such efforts.

Tyrosine kinase inhibitors (TKIs) allow many patients with chronic myeloid leukemia (CML) to live normal life spans but have the potential to impact patients' health-related quality of life (HRQOL). Patient-reported outcome (PRO) measures can provide valuable information to inform treatment decision-making. Here, we review pivotal studies that used PRO measures to evaluate HRQOL of patients with CML in the first-line and treatment-free remission (TFR), and identify areas for future research. PRO measures commonly studied in patients with CML include the SF-36, FACT-Leu, EORTC QLQ-CML24, and MDASI CML. Cohort or cross-sectional studies provide the most data on PRO measures in patients with CML, with less information available from randomized controlled trials (RCTs). Patients with CML taking TKIs have worse HRQOL compared to matched controls, with a few studies seeing a larger effect in younger patients (< 60years old). No single TKI consistently has better HRQOL compared to other agents. Fatigue is a predominant symptom associated with impaired HRQOL across many studies. Studies evaluating TFR show stable or improved HRQOL after TKI discontinuation. There are areas of HRQOL detrimental to patients with other types of cancer (e.g., cognition, sexuality) that warrant further evaluation in patients with CML. Understanding the HRQOL of patients with CML is increasingly important as patients live near-normal life expectancies. PRO measures have the potential to inform treatment decisions in this patient population. Future research opportunities include using PRO measures in RCTs and expanding the HRQOL topics studied in patients with CML.

Introduction Patient-reported outcome measures (PROMs), including patient-reported outcomes (PROs), are one of two primary sources of data about patients on dialysis (1); the other is biologically based patient data. The Food and Drug Administration definition of a PRO is “any report coming from patients about a health condition and its treatment, without interpretation of the patient’s response by a clinician or anyone else” (2). We argue that this definition fits PROMs more generally and that PROs are a subset of that. Like other fields of medicine, in dialysis, PROMs are used as quality assessment and performance measures. Incorporating PROMs into clinical practice across medicine improves outcomes, such as patients’ survival (3). In a meta-analysis, 65% of studies provided evidence that PROMs improved processes of care (e.g., patient education and diagnoses), 47% of studies provided evidence that PROMs improved the outcomes of care (e.g., functional status), and 42% of studies provided evidence that PROMs improved satisfaction with care (4). Because the Centers for Medicare and Medicaid Services (CMS) pays for the cost of dialysis for the vast majority of patients with ESRD, they have a significant stake in understanding the quality of that care and its outcomes. The CMS is particularly interested in patient experience with care and health-related quality of life (HRQOL) and has codified recommendations or requirements that these PROMs be collected on all patients on dialysis. This paper outlines the major methodologic recommendations around use of PROMs in dialysis that we generated in a white paper commissioned by the Kidney Care Quality Alliance (KCQA). These recommendations were generated through a systematic review of the PROM literature and include (1) continue the use of the Kidney Disease Quality of Life 36-item version (KDQOL-36) for dialysis centers’ internal quality improvement activities and the In-Center Hemodialysis Consumer Assessment of Health Care Providers and Systems (ICH-CAHPS) measures for public dialysis center performance monitoring but promote efforts to modify these instruments by incorporating Patient Reported Outcomes Measurement Information System (PROMIS) general health items (KDQOL-36) and reducing the length of the ICH-CAHPS, (2) adopt a PROM of whether patients on dialysis have been informed about their option for transplant and all dialysis options, (3) evaluate equivalence between electronic and paper versions of PROMs before widespread use of electronic administration, (4) explore reimbursement of costs of PROM administration and training, and (5) continue development of provider trainings in PROM administration and interpretation (Table 1). These recommendations were made to the KCQA on the basis of our review and research into methodologic challenges around the use of PROMs in dialysis. Table 1. - Recommendations for use of patient-reported outcome measures in dialysis centers Category Recommendations Selection of PROMs Continue the use of the KDQOL-36 for dialysis centers’ internal quality improvement activities and the ICH-CAHPS for public dialysis center performance monitoring but promote efforts to modify these instruments by incorporating PROMIS general health items (KDQOL-36) and reducing the length of the ICH-CAHPS Adopt a PROM of whether patients have been informed about their option for transplant and all dialysis options Mode of administration Evaluate equivalence between electronic and paper versions of PROMs before widespread use of electronic administration Support for PROM use Explore reimbursement of costs and support for training for PROM administration from the CMS, the ESRD Networks, or professional societies Continue development of provider trainings in PROM administration and interpretation PROM, patient-reported OUTCOME measure; KDQOL-36, Kidney Disease Quality of Life 36-item version; ICH-CAHPS, In-Center Hemodialysis Consumer Assessment of Health Care Providers and Systems; PROMIS, Patient Reported Outcomes Measurement Information System; CMS, Centers for Medicare and Medicaid Services. Recommendation 1 Two of the most commonly used PROM instruments in dialysis facilities are the KDQOL-36 (5) and the ICH-CAHPS (6). The KDQOL-36 is the measure of choice for the CMS’s requirement of annual HRQOL assessment among all patients on dialysis. The ICH-CAHPS is mandated to be assessed twice annually by all patients on dialysis and is included as a clinical measure in the payment year 2019 Quality Improvement Program (QIP). Both of these instruments were developed with extensive patient and expert input, helping ensure that they represent the views and experiences of patients on dialysis and providers (5,6). In addition, support for the reliability (e.g., internal consistency reliability ≥0.80) and validity of the KDQOL-36 has been evidenced (7). Support for the reliability and validity of the ICH-CAHPS has also been presented (6). Finally, both of these measures have been administered to thousands of patients on dialysis, making possible clinically meaningful comparisons of individual patients with national and state norms and key clinical subgroups. As noted above, the ICH-CAHPS is administered as part of the CMS’s QIP. The KDQOL-36 is often administered to help meet the CMS’s requirement for annual quality of life assessment by vendors, like the Medical Education Institute, which administer the KDQOL-36 to thousands of patients on dialysis yearly. Considering these advantages, we recommend the continued use of the KDQOL-36 instrument with patients on dialysis for the purposes of dialysis centers’ internal quality improvement and the continued use of the ICH-CAHPS for the CMS’s dialysis center performance monitoring. There are opportunities to improve both of these measures. The KDQOL-36 incorporates the Medical Outcomes Study 12 Item Short Form Health Survey (SF-12) as its generic HRQOL core. However, the National Institutes of Health PROMIS measures are the state of the science in generic HRQOL measurement (8) and suitable as a replacement for the SF-12. In head to head comparisons, the PROMIS measures have shown better reliability than legacy measures, like the SF-12. The ICH-CAHPS composites could be made more parsimonious by using an approach similar to that used for the Consumer Assessment of Health Care Providers and Systems clinician and group survey, resulting in shorter surveys (9). Recommendation 2 In addition to HRQOL and patient experience, there are many other PROMs that provide relevant information about patients on dialysis. The decision making of patients with ESRD about their treatment is one domain where the use of PROMs in dialysis centers should be expanded. Patients with ESRD have multiple types of dialysis from which they may choose. In addition to dialysis, they may choose to pursue a living or deceased donor kidney transplant. All of these treatment options vary in the length and quality of additional life-years that they offer to patients (10). The importance of providing information about transplants to patients is evidenced by the fact that it increases the likelihood that they will pursue and receive transplants (11). For this reason, the CMS’s 2008 Conditions for Coverage for dialysis facilities require that information about the option for kidney transplant be provided to each patient on dialysis. However, patients on dialysis report having received information about transplant less than their providers report giving transplant information, indicating that provider reports may not be as accurate for this purpose (12). Additionally, there is evidence that alternative dialysis options may improve patients’ survival and HRQOL (10). It has been argued recently that, when patients on dialysis are not given access to information about the risks and benefits of all their treatment options, they cannot make informed consent for their dialysis treatment (13). We contend that patient reports of receiving information about their treatment options may be better indicators of whether informed decision making and consent around treatment choices actually occur among patients on dialysis compared with provider reports. Therefore, we recommend that the CMS adopt a PROM of whether patients on dialysis have been informed about their option for transplant and all of their dialysis options. Recommendation 3 A major methodologic challenge faced by dialysis facilities is implementing the best mode of survey administration. The International Society of Quality of Life Research reviewed the resources needed and tradeoffs associated with different modes of administration of PROMs (14), including self-, interviewer-, and computer-administered surveys given in the clinic, by mail, over the telephone, and electronically via the web. All of these options involve a balance of advantages, disadvantages, and resource inputs, each of which is detailed in our full manuscript (J.D. Peipert, R.D. Hays, unpublished manuscript). However, one mode of administration with expanding potential, electronically based PROM surveys, deserves special attention. Electronic administration, either on a computer or portable technologies like tablets, may offer attractive efficiencies over the other modes. One particularly attractive benefit of web-based surveys is the ability to input data into a database directly, avoiding potential problems with data entry. Many PROM instruments were originally developed to be administered in a paper/pencil format. Although these instruments likely do not need to be redeveloped for electronic administration, additional testing for equivalence should be conducted to determine if smaller modifications are required (e.g., updates to instructions and formatting or minor wording changes). Therefore, we recommend that new studies evaluate equivalence between electronic and paper versions of PROMs before widespread use of electronic administration. Additionally, inquiries into the challenges of this mode of administration for older adults, the frail, and those without high levels of technology literacy should be made before large-scale rollout. Recommendation 4 Another major challenge facing dialysis facilities around administering PROMs regards their financial and human resource costs. Administering PROMs requires significant staff time and expertise as well as material costs. Many dialysis staff, who are primarily responsible for administering PROMs to patients, already have a high workload. Along with data entry, interpretation of PROMs’ results and incorporation of these results into clinical intervention are expensive and difficult to accomplish without significant discretionary spending and resource investment (1). Therefore, we recommend that efforts be undertaken to explore reimbursement of costs and support for training for PROM administration from the CMS, the ESRD Networks, or professional societies. Recommendation 5 Related to recommendation 4, an important practical challenge faced in administering standardized PROM instruments in dialysis clinics regards the expertise required to properly administer them. The dialysis providers and staff administering PROMs in face to face or telephonic interviews require a special skill set, including the abilities to gather accurate responses, help patients with their questions and concerns without biasing their responses, execute complex skip patterns, and detect when patients may be giving untruthful responses. PROMs implemented through self-administered surveys (e.g., mailed to the patients) also require expertise, including the ability to execute standardized data entry protocols. These skills are not likely part of the training of many dialysis providers and staff, and therefore, additional training is often required. We recommend the continued development of provider trainings in PROM administration and interpretation to help dialysis providers build these skills. These trainings should target dialysis organizations to help their dialysis providers (e.g., nephrologists) and staff members (e.g., nurses and social workers) sharpen their ability to administer PROMs in clinic. In conclusion, dialysis payers, administrators, providers, and staff deserve recognition for their considerable efforts and successes in incorporating PROMs into routine care. However, there are still many challenges facing dialysis facilities around administering PROMs to their patients. We have identified multiple practical specific recommendations to assist in facing these challenges. These recommendations are intended to help dialysis care decision makers, clinicians, and applied researchers continue to improve the excellent track record of PROM use. Disclosures The authors were compensated by the Kidney Care Quality Alliance (KCQA) to prepare a white paper on methodologic issues around using patient-reported measures in dialysis. The recommendations presented in this manuscript represent the results of the authors’ research but do not necessarily represent the views of the KCQA. R.D.H. was among the team of investigators who originally developed Kidney Disease Quality of Life 36-item version and the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems. Neither investigator benefits financially from the use of these measures.