Variation In Patient-reported Outcomes Research Articles

Status quo of pain-related patient-reported outcomes and perioperative pain management in 10,415 patients from 10 countries: Analysis of registry data.

Postoperative pain is common at the global level, despite considerable attempts for improvement, reflecting the complexity of offering effective pain relief. In this study, clinicians from Mexico, China, and eight European countries evaluated perioperative pain practices and patient-reported outcomes (PROs) in their hospitals as a basis for carrying out quality improvement (QI) projects in each country. PAIN OUT, an international perioperative pain registry, provided standardized methodology for assessing management and multi-dimensional PROs on the first postoperative day, in patients undergoing orthopaedic, general surgery, obstetric & gynaecology or urological procedures. Between 2017 and 2019, data obtained from 10,415 adult patients in 105 wards, qualified for analysis. At the ward level: 50% (median) of patients reported worst pain intensities ≥7/10 NRS, 25% spent ≥50% of the time in severe pain and 20-34% reported severe ratings for pain-related functional and emotional interference. Demographic variables, country and surgical discipline explained a small proportion of the variation in the PROs, leaving about 88% unexplained. Most treatment processes varied considerably between wards. Ward effects accounted for about 7% and 32% of variation in PROs and treatment processes, respectively. This comprehensive evaluation demonstrates that many patients in this international cohort reported poor pain-related PROs on the first postoperative day. PROs and treatments varied greatly. Most of the variance of the PROs could not be explained. The findings served as a basis for devising and implementing QI programmes in participating hospitals. In preparation for quality improvement projects, we comprehensively evaluated pain-related patient-reported outcomes (PROs) and treatment practices of 10,415 adult patients spanning 10 countries. PROs were generally poor. Demographics, country and surgical discipline explained a small proportion of variation for the PROs, about 88% remained unexplained. Treatment practices varied considerably between wards. Ward effects accounted for about 7% and 32% of variation in PROs and treatment processes, respectively. Future studies will aim to identify treatments which are associated with improved outcomes.

"You can't touch, you can't bond": Exploring COVID-19 pandemic impacts on rheumatoid arthritis patient goals and communication with clinicians.

Musculoskeletal CareEarly View SHORT REPORTFree Access “You can't touch, you can't bond”: Exploring COVID-19 pandemic impacts on rheumatoid arthritis patient goals and communication with clinicians Elizabeth Hulen, Corresponding Author Elizabeth Hulen Elizabeth.Hulen@va.gov orcid.org/0000-0002-7681-4719 Center to Improve Veteran Involvement in Care/VA Portland Health Care System, Portland, Oregon, USA Correspondence Elizabeth Hulen, VA Portland Health Care System, 3170 US Veterans Hospital Road, Portland OR, 97239, USA. Email: Elizabeth.Hulen@va.govSearch for more papers by this authorChristopher Larsen, Christopher Larsen Center to Improve Veteran Involvement in Care/VA Portland Health Care System, Portland, Oregon, USASearch for more papers by this authorRachel Matsumoto, Rachel Matsumoto Center to Improve Veteran Involvement in Care/VA Portland Health Care System, Portland, Oregon, USASearch for more papers by this authorPatricia Katz, Patricia Katz University of California, San Francisco, San Francisco, California, USASearch for more papers by this authorJennifer L. Barton, Jennifer L. Barton Center to Improve Veteran Involvement in Care/VA Portland Health Care System, Portland, Oregon, USA Oregon Health and Science University, Portland, Oregon, USASearch for more papers by this author Elizabeth Hulen, Corresponding Author Elizabeth Hulen Elizabeth.Hulen@va.gov orcid.org/0000-0002-7681-4719 Center to Improve Veteran Involvement in Care/VA Portland Health Care System, Portland, Oregon, USA Correspondence Elizabeth Hulen, VA Portland Health Care System, 3170 US Veterans Hospital Road, Portland OR, 97239, USA. Email: Elizabeth.Hulen@va.govSearch for more papers by this authorChristopher Larsen, Christopher Larsen Center to Improve Veteran Involvement in Care/VA Portland Health Care System, Portland, Oregon, USASearch for more papers by this authorRachel Matsumoto, Rachel Matsumoto Center to Improve Veteran Involvement in Care/VA Portland Health Care System, Portland, Oregon, USASearch for more papers by this authorPatricia Katz, Patricia Katz University of California, San Francisco, San Francisco, California, USASearch for more papers by this authorJennifer L. Barton, Jennifer L. Barton Center to Improve Veteran Involvement in Care/VA Portland Health Care System, Portland, Oregon, USA Oregon Health and Science University, Portland, Oregon, USASearch for more papers by this author First published: 08 September 2022 https://doi.org/10.1002/msc.1689AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat 1 INTRODUCTION The rapid shift to telehealth during the COVID-19 pandemic changed how patients and clinicians interact and communicate (Srinivasan et al., 2020). Effective patient-clinician communication is essential to support shared decision making (SDM) around treatment goals. Goal concordance (or agreement) between patients and clinicians is associated with improved outcomes in chronic disease management (Heisler et al., 2003; Lafata et al., 2013) and increased medication adherence among patients with rheumatoid arthritis (RA) (Barton, Markwardt et al., 2021). Despite calls for SDM in the management of RA patients, communication is often suboptimal (Barton, Imoden et al., 2010; Barton, Markwardt et al., 2021) and patient and clinician goals can vary widely (Hulen et al., 2017). A recent study found that one in five patient-clinician dyads is discordant around the RA patient's number one goal for treatment. In the immediate phase of the pandemic, many outpatient visits for RA patients shifted from clinic to phone or video visits (George et al., 2021). Clinic staff and clinicians rapidly reorganised to minimise disruptions in care. While telehealth for RA patients during the pandemic may not be associated with variation in patient-reported outcomes like pain and general health (Gomez et al., 2021), its impacts on communication around goal concordance and SDM remain unexplored. Therefore, in this study, we examined the impacts of the pandemic and care delivery via telehealth on patient goals, patient-clinician goal communication, and management of RA using a mixed methods approach. 2 PATIENTS AND METHODS 2.1 Design This mixed methods study included a one-time survey of RA patients and a focus group with rheumatologists. The study was approved by the VA/OHSU Joint IRB (# e15851). 2.2 Study population Patients with RA who had a telehealth visit between March 1 and 31 July 2020 (university and Veterans Affairs patients) were invited to participate in a one-time survey via mail or phone. Rheumatology clinicians from the same university and Veterans Affairs sites were invited via email to participate in a 60-min focus group facilitated by the lead author. Patient study participants received a gift card for completion of study activities. 2.3 Survey Patient survey questions included demographics, health status, COVID-19 impacts, treatment goals, stress, communication, and optional free-text comments. Additionally, the survey measured resiliency using the Brief Resilience Scale (BRS) (Smith et al., 2008), decisional conflict, and clinician empathy using the Consultation and Relational Empathy (CARE) measure (Mercer et al., 2004). 2.4 Focus group A semi-structured guide was used to direct the clinician focus group. Topics included telehealth and technology, patient treatment goals, and telehealth use. Examples of specific questions included: “What challenges did you face when using telehealth?”; “How often would your goals and your patients' goals align?”; “What was your initial reaction when you learnt that you would likely be using telehealth more often?”; and “Does the use of telehealth appear to affect your patients' communication with you?” 2.5 Analysis Descriptive and bivariate analyses were conducted on survey items and qualitative content analysis was performed on free-text comments. Bivariate analyses were conducted, stratified by stress levels caused by the pandemic (moderate—high stress vs. little—no stress caused by the pandemic). Survey analyses were performed using Microsoft Excel. The transcript from the clinician focus group was analysed by a member of the research team (EH) using a framework matrix, which is a theme-based approach for pragmatic qualitative analysis (Averill, 2002). 3 RESULTS 3.1 RA patient survey Of the 159 eligible patients invited to participate, 59 (37%) completed the survey. Patients were 71% male, 86% white, 85% Veterans, and 22% with limited health literacy. The average age of patients was 69 ± 10.5 years. Most patients (66%) ranked having less pain as their first goal followed by having fewer problems doing daily activities (34%) and avoiding medication side effects (22%) (Table 1). Over half (58%) of patients reported moderate to high stress from COVID-19. Compared with patients who experienced lower stress, those who experienced moderate to high stress reported increased decisional conflict, lower resiliency, and indicated lower levels of perceived clinician empathy. Goals stratified by stress levels showed that those with moderate to high stress more often prioritised sleep, work, and fatigue over those with low stress (Table 2). TABLE 1. Rheumatoid arthritis patient participants' number one ranked goal, stratified by level of pandemic-related stress (low vs. moderate to high) TABLE 2. Measures of emotional support, resiliency, self-efficacy, decisional conflict, empathy, and trust in clinician by stress level from COVID-19 among 59 rheumatoid arthritis (RA) patients Measureaa Scoring: All scales with higher number indicating higher levels of concept being measured. Ranges: Emotional support (0–20), Resilience scale (0–5), CARE (0–50), Trust in Physician (0–100). Total (n = 59) Mean, SD or N (%) Moderate to high stress (n = 34) Low stress (n = 25) p-value Emotional support (0–20) 59 17 (4.37) 16.15 18.16 0.075 Resilience scale (0–5) 57 3.76 (0.90) 3.50 (33) 4.10 (24) 0.012 Self-efficacy, mean SD (0–10) 59 6.44 (2.20) 6.00 7.04 0.095 SUREbb Proportion with a score of 4 out of 4 indicating no decisional conflict. 57 49 (86%) 32 (75%) 100% 0.003 CARE: Consultation and Relational Empathy (0–50) 59 43.86 (8.33) 42.06 46.31 0.034 Trust in physician (0–100) 56 87.96 (12.41) 86.45 (31) 89.82 0.296 a Scoring: All scales with higher number indicating higher levels of concept being measured. Ranges: Emotional support (0–20), Resilience scale (0–5), CARE (0–50), Trust in Physician (0–100). b Proportion with a score of 4 out of 4 indicating no decisional conflict. Analysis of free text comments indicated RA patients' additional concerns involving social isolation, stress, and the overall response to the pandemic. The following are selected quotes from patients that illustrate these concerns. I feel as if I’m under some sort of house arrestDefinitely impacting my mental health as well as the lack of socialisationTotal lack of leadership and outright lies regarding COVID-19Complications with shoulders and many flaresWorry over exposure, people don’t wear masks in grocery stores 3.2 Focus group with clinicians Six clinicians from university and Veterans Affairs clinics participated in a one-time, 60-min group. In our analysis of focus group data, we focussed on content that could aid in understanding how a rapid shift to telehealth due to the COVID-19 pandemic impacted goal discussion and goal setting among patients and clinicians in rheumatology care (Table 3 for focus group results). However, except for discussions surrounding medications and vulnerability to COVID-19 infection, explicit conversations about patient goals have not held a central place in the patient-clinician encounter given extensive disruptions to care. Instead, clinicians described focussing on adapting to new types of patient and system-level challenges to provide safe and effective rheumatology care. TABLE 3. Rheumatology clinician focus group results Thematic category Representative quotation Logistical challenges in clinic They're [MAs] spending an inordinate amount of time on being tech support (Clinician 5) It's hard for us to continue to give quality care. One of the conversations we've had [was] MAs maybe not doing meds reconciliation and the physicians doing that. Well, we don't have time either. I think that our healthcare system has not risen to the challenge [and] has not supported us appropriately for the challenge of the extra behind the scenes work that has to go on with these virtual visits (Clinician 3) Insurance and medications We've had funding reduced, we have insurance reimbursement reduced and the workload has gone way up as a result of virtual visits. And I honestly think it's a matter of time where there's a serious medical error If there hasn't been one already (Clinician 1) I worry that our insurers are going to give us trouble because for some of our drugs, they [insurers] want you to document how many tender and swollen joints you have before you start the drug, and then six months later to prove efficacy. If you don't have documentation, how are we going to be able to get approval for the drug? (Clinician 3) Clinician-patient relationship challenges I have a lot of trouble forming a good relationship with patients over virtual phone…it's kind of embarrassing, but I don't really remember them…it's hard to really connect to people you're meeting for the first time over the phone (Clinician 2) I see telehealth as an impediment to personal relations with patients. You can't touch, you can't bond, you can't necessarily get all of the nuances of the body language (Clinician 3) To me, it's just, it's fundamentally a different relationship when you're on the video and the dog starts barking and a child interrupts or whatever…but in clinic I have a professional way to interact and there's sort of a standard. It just doesn't exist on the phone. And it allows you to explore questions…other things that allowed for me to educate them as I go…and that education of a patient is lost (Clinician 5) Clinicians described logistical challenges to a rapid implementation of telehealth. First, the extra work generated by telehealth visits monopolised medical assistant (MA) time, while attempts to shift typical MA tasks to other healthcare personnel were unsuccessful. Clinicians pointed out that many of their patients had difficulty utilising technology to access their telehealth appointments and that the current configuration of clinical practice does not have enough time built in for staff to address this need. Next, clinicians expressed concern over insurance approval for medications requiring disease activity documentation through physical exam and lack of financial reimbursement for extra work performed, with implications for patient safety and efficacy of treatments. Clinicians also described telehealth as an impediment to forming high-quality relationships with patients primarily due to the absence of physical co-location, but also because it altered the formality of the visit, potentially undermining patient education. Lastly, as mentioned earlier, clinicians described having discussions with their patients regarding perceptions that it was unsafe to take certain medications or that having a rheumatic disease made them more vulnerable to COVID-19 infection. While this challenge is not directly related to telehealth implementation, it does represent a new challenge that clinicians must face using telehealth. 4 DISCUSSION RA patients with greater self-reported pandemic-related stress prioritised goals of better function and improved sleep. Previous research has shown that these types of goals may not be shared as top goals by clinicians (Barton, Markwardt et al., 2021), leading to discordance and potentially undermining SDM. Additionally, RA patient participants with higher levels of stress reported increased decisional conflict, decreased resilience, and lower levels of clinician empathy. Clinicians, on the other hand, reported that they experienced difficulties with implementing safe and effective virtual care and that this has left little room to focus on fostering high-quality relationships with patients. Some of these difficulties included adapting to a change in visit formality, increased workload, and ensuring medication safety and insurance reimbursement in the absence of a physical exam. Evaluations of pandemic telehealth implementation in other outpatient settings have documented similar challenges, in particular lack of physical examination, rapid workflow changes, and lack of personal connection in video visits that limit rapport building (George et al., 2021; Gomez et al., 2021; Srinivasan et al., 2020). Our findings indicate that patients who report greater levels of stress have different goals and may be more vulnerable to rapid changes in care delivery. Patients under increased stress reported lower levels of clinician empathy which align with focus group results showing that clinicians lacked the capacity to focus on developing relationships with patients because of pandemic-related constraints. Additionally, clinicians reported that the change in visit formality undermined patient education, creating additional challenges for goal discussion and SDM. These challenges may undermine goal concordance between patients and clinicians leading to adverse outcomes given that effective RA patient-clinician communication is integral to symptom assessment, treatment selection, and medication adherence. Considering increased patient stress levels and impediments to patient-clinician relationship building, health systems must implement telehealth-specific supports to both patients and clinicians to ensure effective communication, goal discussion, and access to high-quality care. AUTHOR CONTRIBUTIONS All authors made substantial contribution to: (1) article concept and design (2) acquisition, analysis, and interpretation of data; and (3) writing and critical revision of content. All authors have approved the final version for publication. ACKNOWLEDGEMENTS The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Department of Veterans Affairs. Dr. Barton's work was supported by the NIH (grant K23-AR-064372). CONFLICT OF INTEREST The authors declare no conflict of interest. ETHICS STATEMENT The study was approved by the VA/OHSU Joint IRB (#e15851). Open Research DATA AVAILABILITY STATEMENT Research data are not shared. REFERENCES Averill, J. B. (2002). Matrix analysis as a complementary analytic strategy in qualitative inquiry. Qualitative Health Research, 12(6), 855– 866. https://doi.org/10.1177/10432302012006011CrossrefPubMedWeb of Science®Google Scholar Barton, J. L., Imboden, J., Graf, J., Glidden, D., Yelin, E. H., & Schillinger, D. (2010). Patient-physician discordance in assessments of global disease severity in rheumatoid arthritis. Arthritis Care & Research, 62(6), 857– 864. https://doi.org/10.1002/acr.20132Wiley Online LibraryPubMedWeb of Science®Google Scholar Barton, J. L., Markwardt, S., Niederhausen, M., Schue, A., Dougherty, J., Katz, P., Saha, S., & Yelin, E. H. (2021). Are we on the same page?: A cross-sectional study of patient-clinician goal concordance in rheumatoid arthritis. Arthritis Care & Research. In press. Wiley Online LibraryGoogle Scholar George, M. D., Venkatachalam, S., Banerjee, S., Baker, J. F., Merkel, P. A., Gavigan, K., Curtis, D., Danila, M. I., Curtis, J. R., & Nowell, W. B. (2021). Concerns, healthcare use, and treatment interruptions in patients with common autoimmune rheumatic diseases during the COVID-19 pandemic. 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The brief resilience scale: Assessing the ability to bounce back. International Journal of Behavioral Medicine, 15(3), 194– 200. https://doi.org/10.1080/10705500802222972CrossrefPubMedWeb of Science®Google Scholar Srinivasan, M., Asch, S., Vilendrer, S., Thomas, S. C., Bajra, R., Barman, L., Edwards, L. M., Filipowicz, H., Giang, L., Jee, O., Mahoney, M., Nelligan, I., Phadke, A. J., Torres, E., & Artandi, M. (2020). Qualitative assessment of rapid system transformation to primary care video visits at an academic medical center. Annals of Internal Medicine, 173(7), 527– 535. https://doi.org/10.7326/m20-1814CrossrefPubMedWeb of Science®Google Scholar Early ViewOnline Version of Record before inclusion in an issue ReferencesRelatedInformation

Comparison of Objective Measures of Trismus and Salivation With Patient-Reported Outcomes Following Treatment for Head and Neck Cancer

Xerostomia and reduced mouth opening are negatively associated with quality of life after radiation therapy (RT) for head and neck cancer. Studies comparing objective measures of function with patient-reported outcomes (PROs) have not revealed a clear association. To determine how much of the variation in PROs is explained by objective measures of salivary gland and oral cavity functions (salivary flow and maximal interincisal opening). This cross-sectional study at a single academic cancer center evaluated 112 patients who underwent RT for head and neck cancer between January 2016 and March 2021. Measurements of pre-RT and post-RT saliva and a complete PROs scale within 6 months of the post-RT measurement were analyzed using pairwise associations. Three independently scored PRO scales from the validated FACE-Q Head and Neck Cancer Module were evaluated: eating and drinking, eating distress, and salivation. Three objective measures were analyzed: maximal interincisal opening, stimulated salivary flow, and unstimulated salivary flow. Univariable linear regression models were performed for each PRO against each objective measure, and coefficients of determination (R2) and 95% CIs were reported. The patient cohort comprised 86 men (77%). Median age was 61 years (IQR, 53-68 years), 89 patients (80%) were White, and 61 patients (54%) were current or former smokers. Unstimulated saliva accounted for only a small portion of variation on the salivation scale (R2 = 14.0%). The remaining associations were even smaller (R2 = 5.0%-10.0%). No upper 95% CI bound included an R2 of 30%, suggesting that objective measurements do not explain a high level of the variation in PROs. In this cross-sectional study, objective measurements of salivary flow and mouth opening explained only a small fraction of variation in PROs. These findings suggest that factors other than objective function, including patient adaptation, are the dominant influence on PROs in this population. Patient-reported outcomes should be integrated into head and neck cancer clinical care and research. Additional research is required to evaluate which clinicopathological factors influence PROs for salivation, eating and drinking, and eating distress.

Variation in Patient-Reported Outcomes in Young and Old Patients Up to 4 to 6 Years After Arthroscopic Partial Meniscectomy

To assess the variation in changes in patient-reported outcomes 4 to 6 years after arthroscopic partial meniscectomy (APM). Prospective cohort study. Orthopedic departments at public hospitals. Patients (n = 447) from the Knee Arthroscopy Cohort Southern Denmark undergoing APM. All patients underwent APM. Change in KOOS4 scores from baseline before surgery to ∼5 years (range 4-6 years) after surgery. KOOS4 is the average aggregated score of 4 of 5 of the Knee injury and Osteoarthritis Outcome Score (KOOS) excluding the activities of daily living subscale (minimal clinical important improvement ∼10 points). A mixed linear model adjusted for sex and body mass index was used to assess change from baseline to ∼5-year follow-up. Change in KOOS4 was divided into 5 categories based on change from baseline to ∼5-year follow-up: <0 points, 0 to 9 points, 10 to 19 points, 20 to 29 points, and ≥30 points. On average, patient-reported outcomes continued to improve from baseline to ∼5-year follow-up (mean KOOS4 change: 26, 95% CI, 24-28). Proportions in the different response groups were <0 points (12%), 0 to 9 points (13%), 10 to 19 points (16%), 20 to 29 points (19%), and ≥30 points (40%), with no difference between younger (≤40 years, n = 75) and older (>40 years, n = 337) patients (P = 0.898). Patient-reported outcomes on average improved up to ∼5 years after APM; however, large variability was observed. The similar variability in younger and older patients questions the assumption that younger patients with traumatic injuries experience larger benefits from APM.

Evaluation of Patient- and Surgeon-Specific Variations in Patient-Reported Urinary Outcomes 3 Months After Radical Prostatectomy From a Statewide Improvement Collaborative

Understanding variation in patient-reported outcomes following radical prostatectomy may inform efforts to reduce morbidity after this procedure. To describe patient-reported urinary outcomes following radical prostatectomy in the diverse practice settings of a statewide quality improvement program and to explore whether surgeon-specific variations in observed outcomes persist after accounting for patient-level factors. This prospective population-based cohort study included 4582 men in the Michigan Urological Surgery Improvement Collaborative who underwent radical prostatectomy as primary management of localized prostate cancer between April 2014 and July 2018 and who agreed to complete validated questionnaires prior to surgery and at 3, 6, and 12 months after surgery. Data were analyzed from 2019 to June 2019. Radical prostatectomy. Patient- and surgeon-level analyses of patient-reported urinary function 3 months after radical prostatectomy. Outcomes were measured using validated questionnaires with results standardized using previously published methods. Urinary function survey scores are reported on a scale from 0 to 100 with good function established as a score of 74 or higher. For the 4582 men undergoing radical prostatectomy within the Michigan Urological Surgery Improvement Collaborative who agreed to complete surveys, mean (SD) age was 63.3 (7.1) years. Survey response rates varied: 3791 of 4582 (83%) responded at baseline, 3282 of 4137 (79%) at 3 months, 2975 of 3770 (79%) at 6 months, and 2213 of 2882 (77%) at 12 months. Mean (SD) urinary function scores were 88.5 (14.3) at baseline, 53.6 (27.5) at 3 months, 68.0 (25.1) at 6 months, and 73.7 (23.0) at 12 months. Regression analysis demonstrated that older age, lower baseline urinary function score, body mass index (calculated as weight in kilograms divided by height in meters squared) of 30 or higher, clinical stage T2 or higher, and lack of bilateral nerve-sparing surgery were associated with a lower probability of reporting good urinary function 3 months after surgery. When evaluating patients with good baseline function, the rate at which individual surgeons' patients reported good urinary function 3 months after surgery varied broadly (0% to 54.5%; P < .001). Patients receiving surgery from top-performing surgeons were more likely to report good 3-month function. This finding persisted after accounting for patient risk factors. In this study, patient- and surgeon-level urinary outcomes following prostatectomy varied substantially. Documenting surgeon-specific variations after accounting for patient factors may facilitate identification of surgical factors associated with superior outcomes.

Influence of deprivation and rurality on patient-reported outcomes of men living with and beyond prostate cancer diagnosis in the UK: A population-based study

BackgroundIn the UK, inequalities exist in prostate cancer incidence, survival and treatment by area deprivation and rurality. This work aimed to identify variation in patient-reported outcomes of men with prostate cancer by area type. MethodsA population-based survey of men 18–42 months after prostate cancer diagnosis (N = 35608) measured self-assessed health (SAH) using the EQ-5D and five functional domains using the Expanded Prostate Cancer Index Composite (EPIC-26). ResultsMean SAH was higher for men in least deprived areas compared to most deprived (difference 6.3 (95 %CI 5.6–7.2)). SAH scores were lower for men in most urban areas compared to most rural (difference 2.4 (95 %CI 1.8–3.0)). Equivalent estimates in the general population reported a 13 point difference by deprivation and a 4 point difference by rurality. For each EPIC-26 domain, functional outcomes were better for men in the least deprived areas, with clinically meaningful differences observed for urinary incontinence and hormonal function. There were no clinically meaningful differences in EPIC-26 outcomes by rurality with less than a three point difference in scores for each domain between urban and rural areas. ConclusionIn men 18–42 months post diagnosis of prostate cancer in the UK, impacts of area deprivation and rurality on self-assessed health related quality of life were not greater than would be expected in the general population. However, clinically meaningful differences were identified for some prostate functional outcomes (urinary and hormonal function) by deprivation. No impact by rurality of residence was identified.

Psychosocial factors affecting variation in patient-reported outcomes after elbow fractures

The purpose of this study was to identify factors associated with limitations in function measured by patient-reported outcome measures (PROMs)6-9 months after elbow fractures in adultsfrom a range of demographic, injury, psychological, and social variables measured within a week and 2-4 weeks after injury. We enrolled 191 adult patients sustaining an isolated elbow fracture and invited them to complete PROMs at their initial visit to the orthopedic outpatient clinic (within a maximum of 1 week after fracture), between 2 and 4 weeks, and between 6 and 9 months after injury; 183 patients completed the final assessment. Bivariate analysis was performed, followed by multivariable regression analysis accounting for multicollinearity. This was evaluated using partial R2, correlation matrices, and variable inflation factor assessment. There was a correlation between multiple variables within a week of injury and 2-4 weeks after injury with PROMs 6-9 months after injury in bivariate analysis. Kinesiophobia measured within a week of injury and self-efficacy measured at 2-4 weeks were the strongest predictors of limitations 6-9 months after injury in multivariable regression. Regression models accounted for substantial variance in all PROMs at both time points. Developing effective coping strategies to overcome fears related to movement and reinjuryand finding ways of persevering with activity despite pain within a month of injurymay enhance recovery after elbow fractures. Heightened fears around movement and suboptimal coping ability are modifiable using evidence-based behavioral treatments.

Geographical variations in patient-reported outcomes after total hip arthroplasty between 2008 - 2012

BackgroundHealth care on equal terms is a cornerstone of the Swedish health care system. Total hip arthroplasty (THA) is considered a success story in Sweden with low frequency of reoperations and restored health-related quality of life (HRQoL). Administratively, health care in Sweden is locally self-governed by 21 counties. In this longitudinal nation-wide observational study we assessed the possible geographical variations in 1-year follow-up patient-reported outcomes (PROs): EQ-5D index, EQ VAS, Pain VAS and Satisfaction VAS.MethodsStudy population consisted of 36,235 Swedish THA patients, operated during 2008 to 2012 due to hip osteoarthritis. Individual data came from Swedish Hip Arthroplasty Register, Statistics Sweden and National Board of Health and Welfare. We used descriptive statistics together with multivariable regression analysis to analyse the data.ResultsWe observed county level differences in both preoperative and postoperative PROs. The results showed that the differences observed in preoperative PROs could not fully explain the differences observed in postoperative PROs, even after adjustment for patient demographics (age, sex, BMI, Elixhauser comorbidity index, marital status, educational level and disposable income). This indicates that other factors might influence the outcome after THA.ConclusionLikely, structural and process differences such as indication for surgery have an influence on PROs after surgery. Standardization of care at hospital levels may decrease geographical variations in postoperative HRQoL. Remaining differences will then possibly be associated to patient demographics.

Regional Variations in Quality of Survival Among Men with Prostate Cancer Across the United Kingdom

BackgroundProstate cancer incidence, treatment, and survival rates vary throughout the UK, but little is known about regional differences in quality of survival. ObjectiveTo investigate variations in patient-reported outcomes between UK countries and English Cancer Alliances. Design, setting, and participantsA cross-sectional postal survey of prostate cancer survivors diagnosed 18–42mo previously. Outcome measurements and statistical analysisUrinary, bowel, and sexual problems and vitality were patient reported using the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. General health was also self-assessed. Regional variations were identified using multivariable log-linear regression. Results and limitationsA total of 35823 men responded, 60.8% of those invited. Self-assessed health was significantly lower than the UK average in Wales and Scotland. Respondents reported more urinary incontinence in Scotland, more urinary irritation/obstruction in Scotland and Northern Ireland (NI), poorer bowel function in Scotland and NI, worse sexual function in Scotland, and reduced vitality/hormonal function in Scotland, Wales, and NI. Self-assessed health was poorer than the English average in South Yorkshire and North-East and Cumbria, with more urinary incontinence in North-East and Cumbria and Peninsula, greater sexual problems in West Midlands, and poorer vitality in North-East and Cumbria and West Midlands. Limitations include difficulty identifying clinically significant differences and limited information on pretreatment conditions. ConclusionsDespite adjustment for treatment, and clinical and sociodemographic factors, quality of survival among prostate cancer survivors varied by area of residence. Adoption of best practice from areas performing well could support enhanced survival quality in poorer performing areas, particularly with regard to bowel problems and vitality, where clinically relevant differences were reported. Patient summaryWe conducted a UK-wide survey of patient's quality of life after treatment for prostate cancer. Outcomes were found to vary depending upon where patients live. Different service providers need to ensure that all prostate cancer patients receive the same follow-up care.

Wide Variability in Patient-Reported Outcomes Measures After Fusion for Lumbar Spinal Stenosis: A Systematic Review.

Study Design:Systematic review.Objectives:The purpose of this study is to review outcomes reporting methodology in studies evaluating fusion for lumbar spinal stenosis.Methods:A systematic review of PubMed and Embase databases was conducted from January 2007 to June 2017 for English language studies with minimum of 2 years postoperative follow-up reporting outcomes after fusion for lumbar spinal stenosis. Two reviewers assessed each study; those meeting inclusion criteria were examined for pertinent data. Outcome measures were categorized into relevant domains: pain/symptomatology, function/disability, and surgical satisfaction. Return to work reporting was also recorded.Results:Of 123 studies meeting inclusion criteria, 76% included posterior-only fusion, 32% included posterior/transforaminal interbody fusion, and 5% included anterior/lateral interbody fusion (non-mutually exclusive). There was significant variation in patient-reported outcomes (PROs) used—studies reported 31 unique PROs assessing at least one domain: 22 evaluating pain, 23 evaluating function, and 3 evaluating surgical satisfaction. Most commonly utilized PROs were the Oswestry Disability Index (73% of studies), Visual Analog Scale (55%), and 36-Item Short Form Survey (32%). The remaining 28 measures were used in 14% of studies or fewer. PROs specific to symptoms of lumbar spinal stenosis, such as the Zurich Claudication Questionnaire, were only used rarely (7/123 studies). Only 14% of studies reported on time to return to work.Conclusions:The literature surrounding fusion in the setting of lumbar stenosis is characterized by substantial variability in outcomes reporting. Very few studies utilized measures specific to lumbar spinal stenosis. Efforts to standardize outcomes reporting would facilitate comparisons of surgical interventions.

Patient-reported outcomes of adults with congenital heart disease from eight European countries: scrutinising the association with healthcare system performance.

Inter-country variation in patient-reported outcomes of adults with congenital heart disease has been observed. Country-specific characteristics may play a role. A previous study found an association between healthcare system performance and patient-reported outcomes. However, it remains unknown which specific components of the countries' healthcare system performance are of importance for patient-reported outcomes. The aim of this study was to investigate the relationship between components of healthcare system performance and patient-reported outcomes in a large sample of adults with congenital heart disease. A total of 1591 adults with congenital heart disease (median age 34 years; 51% men; 32% simple, 48% moderate and 20% complex defects) from eight European countries were included in this cross-sectional study. The following patient-reported outcomes were measured: perceived physical and mental health, psychological distress, health behaviours and quality of life. The Euro Health Consumer Index 2015 and the Euro Heart Index 2016 were used as measures of healthcare system performance. General linear mixed models were conducted, adjusting for patient-specific variables and unmeasured country differences. Health risk behaviours were associated with the Euro Health Consumer Index subdomains about patient rights and information, health outcomes and financing and access to pharmaceuticals. Perceived physical health was associated with the Euro Health Consumer Index subdomain about prevention of chronic diseases. Subscales of the Euro Heart Index were not associated with patient-reported outcomes. Several features of healthcare system performance are associated with perceived physical health and health risk behaviour in adults with congenital heart disease. Before recommendations for policy-makers and clinicians can be conducted, future research ought to investigate the impact of the healthcare system performance on outcomes further.

Self-reported quality of life and hope in phase-I trial participants: An observational prospective cohort study.

For advanced cancer patients deliberating early clinical trial participation, adequate information about expected effect on quality of life (HRQoL) and hope, may support decision making. The aim was to assess the potential relation of HRQoL to eligibility for phase-I trial participation, and to observe the variations in patient-reported outcomes. Patients completed questionnaires at preconsent (n=124), baseline (n=96), and after first evaluation of a phase-I trial (n=76). The Mann-Whitney U test was used to test differences between eligible and ineligible patients. Univariate logistic regression was performed for eligibility. Factorial repeated-measures ANOVA compared the outcomes of patients continuing vs. stopping participation after first evaluation over time. Eligibility is associated with significant better global health OR=0.946, 95% CI [0.918, 0.975], p=0.001, physical functioning OR=0.959, 95% CI [0.933, 0.985], p=0.002, role functioning OR=0.974, 95% CI [0.957, 0.991] and better appetite OR=1.114 95% CI [1.035, 1.192]. HRQoL outcomes like global health, social functioning and appetite decline in all patients and differ between patients continuing or having to end participation. Over time, hope and tenacity decline in all patients and coping strategies alter in patients stopping participation. Trial participation influences patient-reported outcomes. Global health may predict for eligibility and trial continuation. Informing patients could affect patients' decision making.

Racial Variation in Patient-Reported Outcomes Following Treatment for Localized Prostate Cancer: Results from the CEASAR Study

BackgroundRelatively little is known about the relationship between race/ethnicity and patient-reported outcomes after contemporary treatments for localized prostate cancer. ObjectiveTo test the hypothesis that treatment-related changes in urinary, bowel, sexual, and hormonal function vary by race/ethnicity. Design, setting, and participantsThe Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based, observational study that enrolled 3708 men diagnosed with localized prostate cancer in 2011–2012. Outcome measurements and statistical analysisPatient-reported disease-specific function was measured using the 26-item Expanded Prostate Index Composite (EPIC) at baseline and 6 and 12 mo after enrollment. Mean treatment differences in function were compared by race using risk-adjusted generalized estimating equations. Results and limitationsWhile all race/ethnic groups reported considerable declines in scores for urinary incontinence after radical prostatectomy (RP) when compared to active surveillance, African-American men reported a greater difference than white men did (adjusted difference-in-differences 8.4 points, 95% confidence interval 2.0–14.8; p=0.01). No difference in bother scores was noted and the overall proportion of explained variation attributable to race/ethnicity was relatively small in comparison to primary treatment and baseline function. No clinically significant racial variation was noted for the sexual, bowel, irritative voiding, or hormone domains. Limitations include the lack of well-established thresholds for clinical significance using the EPIC instrument. ConclusionWhile these data demonstrate that incontinence at 1 yr after RP may be worse for African-American compared to white men, the difference appears to be modest overall. Treatment selection and baseline function explain a much greater proportion of the variation in function after treatment. Patient summaryWe observed that the effect of treatment for prostate cancer on patient-reported function did not vary dramatically by race/ethnicity. Compared to white men, African-American men experienced a somewhat more pronounced decline in urinary continence after radical prostatectomy, but the corresponding changes in bother scores were not significantly different between the two groups.

Are Patient-reported Outcomes Correlated With Clinical Outcomes After Surgery?: A Population-based Study.

To evaluate the extent to which patient-reported outcomes (PROs) (eg, health-related quality of life) are distinct from clinical outcomes following bariatric surgery. Hospital quality measurement often focuses on traditional clinical outcomes (eg, complications). However, PROs may provide a unique perspective regarding performance, particularly for common, low-risk procedures. We used data from 11,420 patients who underwent bariatric surgery (2008-2012) from the Michigan Bariatric Surgery Collaborative (39 hospitals). We included both short-term (30-day complication rates) and long-term (1-year weight loss and comorbidity resolution) outcomes. For PROs, we used health-related quality of life assessed by the Health and Activities Limitations Index (HALex) and Bariatric Quality of Life (BQL) index preoperatively and at 1 year. We used multivariable linear regression to determine the association between these PROs and both short and long-term clinical outcomes, adjusting for patient factors and the type of surgical procedure. After adjustment for risk factors and surgical procedure, hospital rankings based on PROs (either the average change in HALex or BQL scores) were not correlated with hospital rankings based on complications. In contrast, both PRO measures were correlated with weight loss. Specifically, the average change in HALex score (R = 0.24, P < 0.002) and average change in BQL score (R = 0.44, P < 0.001) were correlated with hospital average percent excess. One PRO measure-BQL score-was correlated with a decline in the need for medications due to associated comorbidities (R = 0.16, P < 0.01). After accounting for short and long-term clinical outcomes, between 15% and 44% of the variation in PROs remained unexplained at the hospital level. Patient-reported outcomes are not correlated with early perioperative events, but are correlated with measures of clinical effectiveness after bariatric surgery. A comprehensive approach to surgical quality should incorporate both clinical events and self-reported measures of health status throughout the short and long-term recovery period.

Variation in Patient-reported Outcomes Across Hospitals Following Surgery.

Although there is growing interest in applying patient-reported outcomes (PROs) toward surgical quality, the extent to which PROs vary across hospitals following surgical procedures is unknown. We examined variation in PROs, specifically health-related quality of life (HRQOL), across hospitals performing bariatric surgery. A retrospective cohort study. The Michigan Bariatric Surgery Collaborative is a statewide consortium of 39 hospitals performing laparoscopic gastric bypass, gastric banding, or sleeve gastrectomy (n=11,420 patients between 2008 and 2012). We examined generic and disease-specific HRQOL measured by the Health and Activities Limitations Index (HALex) and Bariatric Quality of Life index (BQL) preoperatively and at 1 year. We measured the variation in postoperative HRQOL across hospitals, and the effect of risk and reliability adjustment on hospital ranking. In this cohort, HRQOL varied by 56% (HALex) and 37% (BQL) across hospitals. Patient factors accounted for 58% (HALex) to 71% (BQL) of the variation in HRQOL across hospitals. After risk and reliability adjustment, HRQOL varied by 18% (by HALex) and 14.5% (by BQL) across hospitals, and the proportion of patients who experienced a large improvement in HRQOL by HALex ranged from 33% to 69% and 67% to 92% by BQL. After adjusting for patient factors and reliability, these differences diminished to 55%-64% (HALex) and 79%-84% (BQL). Patient factors explain a large proportion of hospital-level variation in PROs following bariatric surgery, underscoring the importance of risk adjustment. However, some variation in PROs across hospitals remains unexplained, suggesting PROs may represent a viable indicator of hospital performance.

Variations in outcome and costs among NHS providers for common surgical procedures: econometric analyses of routinely collected data

BackgroundIt is important that NHS resources are used to their full extent, but efforts to reduce costs may have an adverse effect on patient outcomes. Our research is designed to provide a better understanding of the inter-relationship between costs and health outcomes among NHS providers (hospitals) for common surgical procedures.ObjectivesIn England, patient-reported outcomes measures (PROMs) are collected from patients undergoing one of four elective procedures: unilateral hip replacement, unilateral knee replacement, groin hernia repair and varicose vein surgery. We identify variation in patient-reported outcomes (PROs) across hospitals, assess the relationship between the cost and outcomes among NHS hospitals for these procedures, and determine the extent to which variations in outcomes and costs are due to differences in hospital performance.Data sourcesWe link Hospital Episode Statistics (HES) data with reference cost data and PROM data for patients having the four treatments between April 2009 and March 2010.MethodsThe first part of the empirical analysis focuses on variation in different dimensions of self-reported health status. We argue that each of the EuroQol-5D questionnaire (EQ-5D; European Quality of Life-5 Dimensions) dimensions should be assessed separately. Our graphical summary of the differential impact that hospitals have on PROs indicates the probability of reporting a given health outcome and shows how these probabilities vary across EQ–5D dimensions and hospitals. The second part of the empirical analysis focuses on the performance of hospitals and the inter-relationship between PROs and resource use.ResultsWe find that poorer post-treatment health status is associated with lower initial health status, higher weighted Charlson score, more diagnoses and lower socioeconomic status. We find significantly unexplained variation among hospitals in outcomes for patients undergoing hip replacement, knee replacement or varicose vein surgery, but not for hernia patients. For all four treatments we find significant unexplained variation in resource use among hospitals, whether measured by cost of treatment or length of stay. This suggests that hospitals can improve their utilisation of resources.LimitationsOur analyses are based on the HES. If data are missing from the medical record, or extracted and coded inaccurately, HES will contain errors. Hospitals should minimise these errors. Our study suffers from a large number of missing data, mainly because some hospitals were better than others at administering the baseline survey.ConclusionsThere is no general evidence that hospitals with lower resource use have worse health outcomes. There is a significant positive correlation for varicose veins, but this is sensitive to the choice of resource use and PRO measures. For hip and knee replacement the correlation is either insignificant or negative (depending on the resource use and PRO measures), implying that promoting health outcomes and controlling costs are not contradictory objectives. Indeed, we are able to identify hospitals with better than expected outcomes where resource use is below average. Future research should address how to handle missing data, evaluate hospital performance within the broader health economy, communicate PROMs to prospective patients, evaluate the impact of PROMs on patient choice and provider behaviour and evaluate PROMs for people with chronic conditions.FundingThe National Institute for Health Research Health Service and Delivery Research programme.

Hospital Variation in Patient-Reported Outcomes at the Level of EQ-5D Dimensions

The English Department of Health has introduced routine collection of patient-reported outcome data for selected surgical procedures to facilitate patient choice and increase hospital accountability. However, using aggregate health outcome scores, such as EQ-5D utilities, for performance assessment purposes causes information loss and raises statistical and normative concerns. . For hip replacement surgery, we explore a) the change in patient-reported outcomes between baseline and follow-up on 5 health dimensions (EQ-5D), b) the extent to which treatment impact varies across hospitals, and c) the extent to which hospital performance on EQ-5D dimensions is correlated with performance on the EQ-5D utility index. . We combine information on pre- and postoperative EQ-5D outcomes with routine inpatient data for the financial year 2009-2010. The sample consists of 21,000 patients in 153 hospitals. We employ hierarchical ordered probit risk-adjustment models that recognize the multilevel nature of the data and the response distributions. The treatment impact is modeled as a random coefficient that varies at the hospital level. We obtain hospital-specific empirical Bayes (EB) estimates of this coefficient. We estimate separate models for each EQ-5D dimension and the EQ-5D utility index and analyze correlations of EB estimates across these. . Hospital treatment is associated with improvements in all EQ-5D dimensions. Variability in treatment impact is most pronounced on the mobility and usual activities dimensions. Conversely, only pain/discomfort and anxiety/depression correlate well with performance measures based on utilities. This leads to different assessments of hospital performance across metrics. . Our results indicate which hospitals are better than others in improving health across particular EQ-5D dimensions. We demonstrate the importance of evaluating dimensions of the EQ-5D separately for the purposes of hospital performance assessment.

Surgeon-Level Variation in Patients’ Appraisals of Their Breast Cancer Treatment Experiences

While variation in breast cancer quality indicators has been studied, to date there have been no studies examining the degree of surgeon-level variation in patient-reported outcomes. The purpose of this study is to examine surgeon-level variation in patient appraisals of their breast cancer care experiences. Survey responses and clinical data from breast cancer patients reported to Detroit and Los Angeles Surveillance, Epidemiology and End Results registries from 6/2005 to 2/2007 were merged with attending surgeon surveys (1,780 patients, 291 surgeons). Primary outcomes were patient reports of access to care, care coordination, and decision satisfaction. Random-effects models examined variation due to individual surgeons for these three outcomes. Mean values on each patient-reported outcome scale were high. The amount of variation attributable to individual surgeons in the unconditional models was low to modest: 5.4% for access to care, 3.3% for care coordination, and 7.5% for decision satisfaction. Few factors were independently associated with patient reports of better access to or coordination of care, but less-acculturated Latina patients had lower decision satisfaction. Patients reported generally positive experiences with their breast cancer treatment, though we found disparities in decision satisfaction. Individual surgeons did not substantively explain the variation in any of the patient-reported outcomes.