Patient adherence to patient-reported outcome measure (PROM) completion in clinical care: current understanding and future recommendations.

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly being used as an assessment and monitoring tool in clinical practice. However, patient adherence to PROMs completions are typically not well documented or explained in published studies and reports. Through a collaboration between the International Society for Quality-of-Life Research (ISOQOL) Patient Engagement and QOL in Clinical Practice Special Interest Groups (SIGs) case studies were collated as a platform to explore how adherence can be evaluated and understood. Case studies were drawn from across a range of clinically and methodologically diverse PROMs activities. RESULTS: The case studies identified that the influences on PROMs adherence vary. Key drivers include PROMs administeration methods within a service and wider system, patient capacity to engage and clinician engagement with PROMs information. It was identified that it is important to  evaluate  PROMs integration and adherence from multiple perspectives. CONCLUSION: PROM completion rates are an important indicator of patient adherence. Future research prioritizing an understanding of PROMs completion rates by patients is needed.

Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis: A Randomized Clinical Trial with an Observational Cohort.

OBJECTIVE: To compare secondary patient reported outcomes of perceptions of treatment success and function for patients treated for appendicitis with appendectomy vs. antibiotics at 30 days. SUMMARY BACKGROUND DATA: The Comparison of Outcomes of antibiotic Drugs and Appendectomy trial found antibiotics noninferior to appendectomy based on 30-day health status. To address questions about outcomes among participants with lower socioeconomic status, we explored the relationship of sociodemographic and clinical factors and outcomes. METHODS: We focused on 4 patient reported outcomes at 30 days: high decisional regret, dissatisfaction with treatment, problems performing usual activities, and missing >10 days of work. The randomized (RCT) and observational cohorts were pooled for exploration of baseline factors. The RCT cohort alone was used for comparison of treatments. Logistic regression was used to assess associations. RESULTS: The pooled cohort contained 2062 participants; 1552 from the RCT. Overall, regret and dissatisfaction were low whereas problems with usual activities and prolonged missed work occurred more frequently. In the RCT, those assigned to antibiotics had more regret (Odd ratios (OR) 2.97, 95% Confidence intervals (CI) 2.05-4.31) and dissatisfaction (OR 1.98, 95%CI 1.25-3.12), and reported less missed work (OR 0.39, 95%CI 0.27-0.56). Factors associated with function outcomes included sociodemographic and clinical variables for both treatment arms. Fewer factors were associated with dissatisfaction and regret. CONCLUSIONS: Overall, participants reported high satisfaction, low regret, and were frequently able to resume usual activities and return to work. When comparing treatments for appendicitis, no single measure defines success or failure for all people. The reported data may inform discussions regarding the most appropriate treatment for individuals. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02800785.

A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.

BACKGROUND: Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis. METHODS: We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith. RESULTS: In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50). CONCLUSIONS: For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA ClinicalTrials.gov number, NCT02800785.).

One report, multiple aims: orthopedic surgeons vary how they use patient-reported outcomes with patients.

PURPOSE: We conducted semi-structured qualitative interviews with surgeons to assess their goals for incorporating a patient-reported outcome measure (PROM)-based shared decision report into discussions around surgical and non-surgical treatment options for osteoarthritis of the knee and hip. METHODS: Surgeons actively enrolling patients into a study incorporating a standardized PROM-based shared decision report were invited to participate in a semi-structured interview lasting 30 min. Open-ended questions explored how the surgeon used report content, features that were helpful, confusing, or could be improved, and how use of the report fit into the surgeon's workflow. We used a conventional content analysis approach. RESULTS: Of the 16 eligible surgeons, 11 agreed to participate with 9 completing the interview and 2 withdrawing due to work demands. We identified 8 themes related to PROM-based report use: Acceptability, Patient Characteristics, Communication Goals, Useful Content, Not Useful Content, Challenges, Training Needs, and Recommended Improvements. Additional sub-themes emerged for Communication Goals (7) and Challenges (8). All surgeons shared positive feedback about using the report as part of clinical care. Whereas surgeons described the use of the report to achieve different goals, the most common uses related to setting expectations for post-surgical outcomes (89%) and educating patients (100%). CONCLUSION: Surgeons tailor their use of a PROM-based report with individual patients to achieve a range of aims. This study suggests multiple opportunities to further our understanding of the ways PROMs can be used in clinical practice. The way PROM information is visually displayed and multi-component reports are assembled can facilitate diverse aims.

Concordance between 8-1-1 HealthLink BC Emergency iDoctor-in-assistance (HEiDi) virtual physician advice and subsequent health service utilization for callers to a nurse-managed provincial health information telephone service.

BACKGROUND: British Columbia 8-1-1 callers who are advised by a nurse to seek urgent medical care can be referred to virtual physicians (VPs) for supplemental assessment and advice. Prior research indicates callers' subsequent health service use may diverge from VP advice. We sought to 1) estimate concordance between VP advice and subsequent health service use, and 2) identify factors associated with concordance to understand potential drivers of discordant cases. METHODS: We linked relevant provincial administrative databases to obtain inpatient, outpatient, and emergency service use by callers. We developed operational definitions of concordance collaboratively with researcher, patient, VP, and management perspectives. We used Kaplan-Meier curves to describe health service use post-VP consultation and Cox regression to estimate the association of caller factors (rurality, demography, attachment to primary care) and call factors (reason, triage level, time of day) with concordance as hazard ratios. RESULTS: We analyzed 17,188 calls from November 16, 2020 to April 30, 2021. Callers advised to attend an emergency department (ED) immediately were the most concordant (73%) while concordance was lowest for those advised to seek Family Physician (FP) care either immediately (41%) or within 7 days (47%). Callers unattached to FPs were less likely to schedule an FP visit (hazard ratio = 0.76 [95%CI: 0.68-0.85]). Rural callers were less likely to attend an ED within 48 h when advised to go immediately (0.53 [95%CI:0.46-0.61]) compared to urban callers. Rural callers advised to see an FP, either immediately (1.28 [95%CI:1.01-1.62]) or within 7 days (1.23 [95%CI: 1.11-1.37]), were more likely to do so than urban callers. INTERPRETATION: Concordance between VP advice and subsequent caller health service use varies substantially by category of advice and caller rurality. Concordance with advice to "Go to ED" is high overall but to access primary care is below 50%, suggesting potential issues with timely access to FP care. Future research from a patient/caller centered perspective may reveal additional barriers and facilitators to concordance.

Patient and public involvement in the design and conduct of a large, pragmatic observational trial to investigate recurrent, high-risk non-muscle-invasive bladder cancer.

BACKGROUND: Patient-centered approaches to research design are particularly important for diseases with complex treatment decision-making, such as recurrent, high-grade non-muscle-invasive bladder cancer (NMIBC). The objective of this article is to describe patient and public involvement (PPI) in designing a large, pragmatic observational trial and to articulate barriers, challenges, and lessons learned for future design. METHODS: Through multistakeholder involvement, a large, pragmatic observational trial was designed to investigate the outcomes of high-risk, recurrent NMIBC, and it was titled Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO). CISTO's design used the Guidance for Reporting Involvement of Patients and the Public 2 reporting checklist for PPI and built on prior engagement infrastructure in partnership with the Bladder Cancer Advocacy Network. RESULTS: CISTO's PPI began with research prioritization to identify the highest priority questions facing patients with NMIBC. A pragmatic observational study design was selected and refined through stakeholder input. PPI included patients and caregivers organized into an advocate advisory board and clinicians, researchers, payers, and industry representatives organized into an external advisory board. An engagement plan was created to define the stages of PPI and the level and nature of the involvement of each group. PPI was measured quantitatively and qualitatively through evaluation surveys and iterative feedback from board members, with changes made for continuous improvement. CONCLUSIONS: Through intentional PPI, CISTO aims to produce pragmatic and generalizable results that will allow patients to make informed decisions for recurrent, high-risk NMIBC based on their personal experiences. LAY SUMMARY: Involving patients and other stakeholders in research ensures that it reflects the outcomes that matter most to them. This is especially important when research focuses on conditions in which patients face difficult decisions about treatment options. This article describes the key role that stakeholders played in shaping the Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO) study. It compares treatments for recurrent noninvasive bladder cancer and describes how stakeholders were engaged to design and develop the study and the practices that supported their involvement.

Establishing Clinically Significant Patient-reported Outcomes for Diverticular Disease.

BACKGROUND: Diverticular disease can undermine health-related quality of life. The diverticulitis quality of life (DV-QOL) instrument was designed and validated to measure patient-reported burden of diverticular disease. However, values reflecting meaningful improvement (i.e., minimal clinically important difference [MCID]) and the patient acceptable symptom state (PASS) have yet to be established. We sought to establish the MCID and PASS of the DV-QOL and describe the characteristics of those with DV-QOL above the PASS threshold. MATERIALS AND METHODS: We performed a prospective cohort study of adults with diverticular disease from seven centers in Washington and California (2016-2018). Patients were surveyed at baseline, then quarterly up to 30 mo. To determine the MCID and PASS for DV-QOL, we applied various previously established distribution- and anchor-based approaches and compared the resulting values. RESULTS: The study included 177 patients (mean age 57 y, 43% women). A PASS threshold of 3.2/10 distinguished between those with and without health-related quality of life-impacting diverticulitis with acceptable accuracy (area under the curve 0.76). A change of 2.2 points in the DV-QOL was the most appropriate MCID: above the distribution-based MCIDs and corresponding to patient perception of importance of change (AUC 0.70). Patients with DV-QOL ≥ PASS were more often men, younger, had Medicaid, had more serious episodes of diverticulitis, and had an occupational degree or high-school education or less. CONCLUSIONS: Our study is the first to define MCID and PASS for DV-QOL. These thresholds are critical for measuring the impact of diverticular disease and the evaluation of treatment effectiveness.

Translating clinical and patient-reported data to tailored shared decision reports with predictive analytics for knee and hip arthritis.

INTRODUCTION: New informatics tools can transform evidence-based information to individualized predictive reports to serve shared decisions in clinic. We developed a web-based system to collect patient-reported outcomes (PROs) and medical risk factors and to compare responses to national registry data. The system generates predicted outcomes for individual patients and a report for use in clinic to support decisions. We present the report development, presentation, and early experience implementing this PRO-based, shared decision report for knee and hip arthritis patients seeking orthopedic evaluation. METHODS: Iterative patient and clinician interviews defined report content and visual display. The web-system supports: (a) collection of PROs and risk data at home or in office, (b) automated statistical processing of responses compared to national data, (c) individualized estimates of likely pain relief and functional gain if surgery is elected, and (d) graphical reports to support shared decisions. The system was implemented at 12 sites with 26 surgeons in an ongoing cluster randomized trial. RESULTS: Clinicians and patients recommended that pain and function as well as clinical risk factors (e.g., BMI, smoking) be presented to frame the discussion. Color and graphics support patient understanding. To date, 7891 patients completed the assessment before the visit and 56% consented to study participation. Reports were generated for 98% of patients and 68% of patients recalled reviewing the report with their surgeon. CONCLUSIONS: Informatics solutions can generate timely, tailored office reports including PROs and predictive analytics. Patients successfully complete the pre-visit PRO assessments and clinicians and patients value the report to support shared surgical decisions.

Sustaining improvements in relational coordination following team training and practice change: A longitudinal analysis.

BACKGROUND: Poor communication is a leading cause of errors in health care. Structured interprofessional bedside rounds are a promising model to improve communication. PURPOSE: The aim of the study was to test if an intervention to improve communication and coordination in an inpatient heart failure care unit would result in lasting change. METHODOLOGY/APPROACH: The relational coordination (RC) survey was administered to seven workgroups (i.e., nurses, physicians) at baseline (2015) and three subsequent years following the intervention (team training, leadership development workshops, and structured interprofessional bedside round implementation). Descriptive analysis and mixed-effects models were used to assess the impact of the intervention on improving RC. RESULTS: During the study period (2015-2018), 344 participants completed the survey for an overall response rate of 53.5% (n = 643). Postintervention, the RC index significantly increased from 3.79 to 4.08 (p < .001) and remained significantly higher over 2 years, with an RC index of 4.12 and 4.04, respectively (p < .001). The range of RC scores between and within workgroups narrowed over time, with nonrotating workgroups showing the most improvements. CONCLUSION: Findings indicate that positive changes as a result of the intervention have been sustained, despite high rates of turnover among all workgroups. Notably, positive change in RC was found to be more pronounced for nonrotating workgroups compared to team members who rotate within the hospital (i.e., pharmacists who rotate to other units every month). PRACTICE IMPLICATIONS: This intervention holds promise for teams seeking best practice models of "high-reliability" care organization and delivery. Sustained changes from this intervention represent an important area of future practice-based research.

A scoping review of new implementations of interprofessional bedside rounding models to improve teamwork, care, and outcomes in hospitals.

Poor communication within healthcare teams occurs commonly, contributing to inefficiency, medical errors, conflict, and other adverse outcomes. Interprofessional bedside rounds (IBR) are a promising model that brings two or more health professions together with patients and families as part of a consistent, team-based routine to share information and collaboratively arrive at a daily plan of care. The purpose of this systematic scoping review was to investigate the breadth and quality of IBR literature to identify and describe gaps and opportunities for future research. We followed an adapted Arksey and O'Malley Framework and PRISMA scoping review guidelines. PubMed, CINAHL, PsycINFO, and Embase were systematically searched for key IBR words and concepts through June 2020. Seventy-nine articles met inclusion criteria and underwent data abstraction. Study quality was assessed using the Mixed Methods Assessment Tool. Publications in this field have increased since 2014, and the majority of studies reported positive impacts of IBR implementation across an array of team, patient, and care quality/delivery outcomes. Despite the preponderance of positive findings, great heterogeneity, and a reliance on quantitative non-randomized study designs remain in the extant research. A growing number of interventions to improve safety, quality, and care experiences in hospital settings focus on redesigning daily inpatient rounds. Limited information on IBR characteristics and implementation strategies coupled with widespread variation in terminology, study quality, and design create challenges in assessing the effectiveness of models of rounds and optimal implementation strategies. This scoping review highlights the need for additional studies of rounding models, implementation strategies, and outcomes that facilitate comparative research.

Capturing the patient voice: implementing patient-reported outcomes across the health system.

PURPOSE: Supporting the capture and use of patient-reported outcomes (PROs) at the point-of-care enriches information about important clinical and quality of life outcomes. Yet the ability to scale PROs across healthcare systems has been limited by knowledge gaps around how to manage the diversity of PRO uses and leverage health information technology. In this study, we report learnings and practice insights from UW Medicine's practice transformation efforts to incorporate patient voice into multiple areas of care. METHODS: Using a participatory, action research approach, we engaged with UW Medicine clinical and administrative stakeholders experienced with PRO implementation to inventory PRO implementations across the health system, characterize common clinical uses for PROs, and develop recommendations for system-wide governance and implementation of PROs. RESULTS: We identified a wide breadth of PRO implementations (n = 14) in practice and found that nearly half (47%) of employed PRO measures captured shared clinical domains (e.g., depression). We developed three vignettes (use cases) that illustrate how users interact with PROs, characterize common ways PRO implementations support clinical care across the health system (1) Preventive care, (2) Chronic/Specialty care, and (3) Surgical/Interventional care), and elucidate opportunities to enhance efficient PRO implementations through system-level standards and governance. CONCLUSIONS: Practice transformation efforts increasingly require integration of the patient voice into clinical care, often through the use of PROs. Learnings from our work highlight the importance of proactively considering how PROs will be used across the layers of healthcare organizations to optimize the design and governance of PROs.

Purposeful interprofessional team intervention improves relational coordination among advanced heart failure care teams.

Effective delivery of healthcare is highly interdependent within and between interprofessional (IP) care teams and the patients they serve. This is particularly true for complex health conditions such as advanced heart failure (AHF). Our Academic Practice Partnership received funding to carry out IP workforce development with inpatient AHF care teams. Our objectives were to (a) identify challenges in team functioning that affected communication and relationships among the AHF care teams, (b) collaboratively identify a focal work process in need of improvement, and (c) test whether facilitated the implementation of team training and work process changes would lead to improvements in team communication, relationships, and process outcomes. The health-care team identified implementation of structured IP bedside rounds (SIBR) as the preferred approach to improving collaborative care. Utilizing a cross-sectional pre/post design, changes in team communication and relationships before and after a team intervention that included TeamSTEPPS training and SIBR implementation, were assessed using a validated Relational Coordination (RC) survey. The study population included AHF care team members (n ~ 100) representing seven workgroups (e.g., nurses, pharmacists) from two inpatient cardiology units at a 450-bed academic medical center in the Pacific Northwest during 2015-2016. Improvements in RC scores were demonstrated across all seven RC dimensions from baseline (Year 1) to follow-up (Year 2). Percent change on each of the seven dimensions ranged from 3.57% to 9.85%. Changes were statistically significant for improvements between baseline and follow-up on all but one of the seven RC dimensions (shared knowledge). The IP team intervention was associated with improvements in RC from baseline to follow-up. Additional research is needed to assess patient perspectives and outcomes of the IP team intervention. Findings of this study are consistent with the growing body of RC and SIBR research and provide a useful model of an IP team-based intervention in clinical practice.

Educating Emergency Department Staff on the Identification and Treatment of Human Trafficking Victims.

INTRODUCTION: Hospitalization is one of the few circumstances in which the lives of trafficking victims intersect with the general population. Based on survivor testimonies, the majority of human trafficking victims may receive medical treatment in a hospital's emergency department while in captivity. With evidenced-based training, ED personnel have a better opportunity to screen persons who are being trafficked and intervene on their behalf. METHODS: This project examined the efficacy of an innovative, evidence-based online training module (HTEmergency.com) created by the project team. Participants completed a pre-survey to determine learning needs and a post-survey to determine the effectiveness of the online education. The learning module contained a PowerPoint presentation, identification and treatment guidelines, and 2 realistic case studies. RESULTS: Data were collected among ED personnel in 2 suburban hospitals located near a northeast metropolitan city. Seventy-five employees participated in the survey and education. Staff completing the education included nurses, physicians, nurse practitioners/physician assistants, registration, and ED technicians. Results indicated that 89% of participants had not received previous human trafficking training. Less than half of the participants stated that they had a comprehensive understanding of human trafficking before the intervention, with an increase to 93% after education. The training module significantly increased confidence in identification (from an average confidence level of 4/10 to 7/10) and treatment (from an average confidence level of 4/10 to 8/10) of human trafficking victims within the emergency department; 96% found the educational module to be useful in their work setting. DISCUSSION: Participants reported that they are more confident in identifying a possible trafficking victim and are more likely to screen patients for human trafficking after participation in the online training module. The proposed general guideline for care provided ED personnel with a useful tool in perpetuity. The results of this project, coupled with the growth of worldwide human trafficking, highlights the need for focused human trafficking education within the hospital setting.

Prioritizing research topics: a comparison of crowdsourcing and patient registry.

PURPOSE: A cornerstone of patient-centered outcome research is direct patient involvement throughout the research process. Identifying and prioritizing research topics is a critical but often overlooked point for involvement, as it guides what research questions are asked. We assess the feasibility of involving individuals with low back pain in identifying and prioritizing research topics using two approaches: an existing patient registry and an online crowdsourcing platform. We compare and contrast the diversity of participants recruited, their responses, and resources involved. METHODS: Eligible participants completed a survey ranking their five highest priority topics from an existing list and supplying additional topics not previously identified. We analyzed their responses using descriptive statistics and content analysis. RESULTS: The patient registry yielded older (mean age 72.4), mostly White (70%), and well-educated (95% high school diploma or higher) participants; crowdsourcing yielded younger (mean age 36.6 years), mostly White (82%), and well-educated (98% high school diploma or higher) participants. The two approaches resulted in similar research priorities by frequency. Both provided open-ended responses that were useful, in that they illuminate additional and nuanced research topics. Overall, both approaches suggest a preference towards topics related to diagnosis and treatment over other topics. CONCLUSION: Using a patient registry and crowdsourcing are both feasible recruitment approaches for engagement. Researchers should consider their approach, community, and resources when choosing their recruitment approach, as each approach has its own strengths and weaknesses. These approaches are likely most appropriate to supplement or to complement in-person and ongoing engagement strategies.

Surgeon attitudes and practice patterns in managing small bowel obstruction: a qualitative analysis.

BACKGROUND: Historical training instructs surgeons to, "never let the sun set on a small bowel obstruction (SBO)" due to concern for bowel ischemia. However, the routine use of computed tomography scans for ruling out ischemia provides the opportunity for trial of nonoperative management, allowing time for resolution of adhesive SBO. In light of advances in practice, little is known about how surgeons manage these patients, in particular, whether there is consistency in the stated duration for safe nonoperative management. METHODS: Using a case vignette (a patient with computed tomography scan diagnosed complete SBO without bowel ischemia), we interviewed a purposive sample of general surgeons practicing in Washington State to understand stated approaches to clinical management. Interview questions addressed typical practice, preferred timing of surgery, and approach. We conducted a content analysis to understand current practice and attitudes. RESULTS: We interviewed 15 surgeons practicing across Washington State. Surgical practice patterns for patients with SBO varied widely. The period of time that surgeons were willing to manage patients nonoperatively ranged from 1-7 d. Interviews revealed insight into surgical decision-making, the importance of patient preferences, variation in practice, and evidence gaps. All surgeons acknowledged a lack of evidence to support appropriate management of patients with SBO. CONCLUSIONS: Interviews with practicing surgeons highlight a changing paradigm away from routine early surgery for patients with adhesive SBO. However, there is lack of consensus in the appropriate duration of nonoperative management and practices vary considerably. These revealed attitudes inform the feasibility and design of future randomized studies of patients with adhesive SBO.

Preliminary validation of the Claudication Symptom Instrument (CSI).

This article describes the development of the Claudication Symptom Instrument (CSI) and its measurement properties for evaluating the symptom experience of patients diagnosed with intermittent claudication (IC). We conducted semi-structured qualitative interviews with IC patients for item development and cognitive interviews in which patient comprehension of items was tested. We evaluated measurement properties using data collected and analyzed in the context of an observational comparative effectiveness study of IC treatments. Items measuring five symptom important to patients were developed and cognitively tested: Pain, Numbness, Heaviness, Cramping, and Tingling. Item means (higher means worse) ranged from 1.1 (Tingling) to 2.3 (Pain) (range: 0 'none' to 4 'extreme'). Rasch analysis yielded support for an overall score (χ2=26.5, df=20, p=0.15). The total CSI score differed by clinician-rated severity of mild versus moderate ( p<0.05), but not moderate versus severe. Re-administration of the CSI 5-10 days after baseline yielded an intra-class correlation coefficient of 0.86. Changes in CSI total score and VASCUQOL total score between baseline and 6 months post-treatment were correlated at -0.52 ( p<0.05). The CSI preliminarily meets accepted measurement standards for content validity, internal consistency and test-retest reliability, construct validity, and sensitivity for detecting change. Because of its high test-retest reliability, it may also be useful in clinical care with individual patients. It takes approximately 3 minutes to complete.

Early assessment of the 10-step patient engagement framework for patient-centred outcomes research studies: the first three steps.

Background: A key principle of patient-centred outcomes research (PCOR) is the engagement of patients and other stakeholders in the research process, but the evidence is still emerging on the impact patient engagement has on the research process. A 10-step framework has been developed to provide methodological guidance for patient engagement throughout the research process. However, the utility of the framework for patient engagement has not been tested in actual research studies. Objective: To describe researcher's overall experiences with engaging patients at the beginning of their PCOR research process. Methods: Twelve in-depth interviews were conducted face-to-face and by telephone with PCOR researchers between November 2014 and January 2015 at an Academic Health Center in the eastern USA. All data were audiotaped and transcribed, and NVivo 10 software was used for data analysis. Results: Four major themes emerged (i) the importance of patient engagement and how it provides 'a perspective you can't get unless you talk to the patient'; (ii) the impact of patient engagement; (iii) challenges and barriers of engagement; and (iv) the realities of patient engagement. Conclusions: Researchers' views illustrate the need to re-evaluate patient engagement in PCOR based on current realities. Given the many challenges to engagement that researchers encounter, it may be more productive to redefine the process of patient engagement so that the issues researchers now face are taken into account in future funding announcements, engagement rubrics and methodology frameworks developed.

Prioritizing Patient-Reported Outcomes in Breast Cancer Surgery Quality Improvement.

Breast-cancer-specific tools that measure health-related quality of life (HRQOL) were developed for use in research or clinical practice, and little is known about these tools' performance ability for quality improvement. Furthermore, existing tools may not fully reflect all issues that contribute to quality care as seen by patients. Work is needed to identify and validate patient-reported outcome measures for use in quality improvement in breast cancer surgical care. We conducted an exploratory qualitative study in order to better understand what HRQOL domains and processes of care define high quality surgical care for women undergoing mastectomy for breast cancer from both the patient and clinician perspective. We conducted focus groups and one-on-one interviews with 15 women and administered a prioritization questionnaire to participants. We also conducted a prioritization questionnaire among surgical oncologists, general surgeons, and reconstructive surgeons who are members of the Washington State Medical Association. Both the patient and surgeon prioritization questionnaire asked participants to prioritize HRQOL and treatment satisfaction-related aspects of their breast cancer surgical care at key time points before and after mastectomy. A Stakeholder Advisory Panel was convened to review focus group, interview, and prioritization questionnaire results and make recommendations as to patient-reported outcome domains to focus on and existing instruments to use for quality improvement. Patients and clinicians largely agreed on important HRQOL domains, including emotional well-being, education, communication, and process of care. The Stakeholder Advisory Panel, composed of 12 clinicians and five patients, reviewed study findings and existing patient-reported outcomes measurement tools. The panel recommended that the BREAST-Q, a flexible tool with independently validated modules designed for research and clinical care, is an ideal tool to begin developing novel quality improvement benchmarks focused on patient-reported outcomes.