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International audience; Outcomes reported in randomized controlled trials in peritoneal dialysis (PD) are diverse, are measured inconsistently, and may not be important to patients, families, and clinicians. The Standardized Outcomes in Nephrology-Peritoneal Dialysis (SONG-PD) initiative aims to establish a core outcome set for trials in PD based on the shared priorities of all stakeholders. We convened an international SONG-PD stakeholder consensus workshop in May 2018 in Vancouver, Canada. Nineteen patients/caregivers and 51 health professionals attended. Participants discussed core outcome domains and implementation in trials in PD. Four themes relating to the formation of core outcome domains were identified: life participation as a main goal of PD, impact of fatigue, empowerment for preparation and planning, and separation of contributing factors from core factors. Considerations for implementation were identified: standardizing patient-reported outcomes, requiring a validated and feasible measure, simplicity of binary outcomes, responsiveness to interventions, and using positive terminology. All stakeholders supported inclusion of PD-related infection, cardiovascular disease, mortality, technique survival, and life participation as the core outcome domains for PD.

Social support is a key component of transplantation evaluation in the United States. Social support definitions and evaluation procedures require examination to achieve clear, consistent implementation. We surveyed psychosocial clinicians from the Society for Transplant Social Workers and American Society of Transplant Surgeons about their definitions and evaluation procedures for using social support to determine transplant eligibility. Bivariate statistical analysis was used for quantitative data and content analysis for qualitative data. Among 276 psychosocial clinicians (50.2% response rate), 92% had ruled out patients from transplantation due to inadequate support. Social support definitions varied significantly: 10% of respondents indicated their center lacked a definition. Key domains of social support included informational, emotional, instrumental, motivational, paid support, and the patient’s importance to others. Almost half of clinicians (47%) rarely or never requested second opinions when excluding patients due to social support. Confidence and perceived clarity and consistency in center guidelines were significantly associated with informing patients when support contributed to negative wait-listing decisions ( P = .001). Clinicians who excluded fewer patients because of social support offered significantly more supportive health care ( P = .02). Clearer definitions and more supportive care may reduce the number of patients excluded from transplant candidacy due to inadequate social support.

BACKGROUND We assessed long-term patient-reported dysphagia and xerostomia outcomes following definitive surgical management with transoral robotic surgery (TORS) in patients with oropharyngeal cancer (OPC) via a cross-sectional survey study. METHODS Patients with OPC managed with primary oropharyngeal surgery as definitive treatment at least 1 year ago between 2015 and 2019 were identified. The M. D. Anderson Dysphagia Inventory (MDADI) and Xerostomia Inventory (XI) scores were compared across treatment types (i.e., no adjuvant therapy [TORS-A] vs. adjuvant radiotherapy [TORS+RT] vs. adjuvant chemoradiotherapy [TORS+CT/RT]). RESULTS The sample had 62 patients (10 TORS-A, 30 TORS+RT, 22 TORS+CT/RT). TORS-A had clinically and statistically significantly better MDADI scores than TORS+RT (p = 0.03) and TORS+CT/RT (p = 0.02), but TORS+RT and TORS+CT/RT were not significantly different. TORS-A had clinically and statistically significantly less XI than TORS+RT (p

Background. In the United States, patients wear a one-piece, reusable cloth gown during colonoscopy procedures. Many patients report embarrassment related to bodily exposure during colonoscopy. This may limit participation in colorectal cancer screening programs. Aims. To assess whether the use of a novel, disposable patient garment (Privacy Pants, Jackson, MS), which increases patient coverage, can reduce embarrassment related to bodily exposure and increase colonoscopy acceptance rates. Methods. Patients were offered a novel gown, and they completed questionnaires before and after colonoscopy. Results. A total of 120 patients participated. 54% were female and 82% were Caucasian. The novel gown had high overall satisfaction (8.3) and was associated with a sense of respect during the procedure (9.4). 67% (80) of the patients had a prior colonoscopy, and of these, 76% would request a novel gown over a traditional gown for future procedures. Among all study participants, a high rate of acceptability for repeat colonoscopy if recommended by their doctors was reported (mean of 9.4). Nonwhites were more likely to have a concern for embarrassment addressed by using novel gowns as compared to whites (P value 0.02). Conclusion. All participants, particularly women and nonwhite participants, reported high rates of respect and satisfaction and decrease in embarrassment utilizing the novel gown during colonoscopy. Patients who had prior colonoscopy with a traditional gown preferred the novel garment. A novel procedure gown may enhance colonoscopy acceptance by minimizing embarrassment.

It remains unclear whether use of self-fixating mesh during laparoscopic inguinal hernia repair (LIHR) impacts postoperative quality of life (QoL). We hypothesize patients receiving self-fixating mesh during totally extraperitoneal (TEP) LIHR will report less pain and improved QoL compared to those receiving non-fixating mesh. An IRB-approved, single-blinded randomized controlled trial was conducted. Patients with primary, unilateral inguinal hernias were randomized to receive either non-fixating (control) or self-fixating mesh. Clinical visits were conducted 3 weeks and 1 year after LIHR. A validated Surgical Outcomes Measurement System (SOMS) instrument was used to assess patients’ QoL preoperatively and postoperatively along with Carolinas Comfort Scale (CCS) at 3 weeks and 1 year after surgery. Comparisons between self-fixating and non-fixating mesh groups were made using Chi-square, Wilcoxon rank-sum or independent samples t tests. Two hundred and seventy patients were enrolled (137 non-fixating vs 133 self-fixating). Preoperatively, there was no difference in mean age, BMI, or median hernia duration between groups (57.9 vs 56.6 years, p = 0.550; 26.1 vs 26.8, p = 0.534; 3.0 vs 3.0 months, p = 0.846). Median operative times (34 vs 34 min, p = 0.545) and LOS were similar. More patients in the non-fixating group received tacks (43 vs 19, p = 0.001). Patients receiving non-fixating mesh recorded better mean SOMS scores for the first 3 days following surgery (Day 1: p = 0.005; Day 2: p = 0.002; Day 3: p = 0.024, Table 1) indicating less pain. No differences in pain were seen 3 weeks or 1 year postoperatively. There were zero recurrences found during clinical follow-up in either of the groups. Patients receiving self-fixating mesh report worse postoperative pain in the first 2–3 days than those receiving non-fixating mesh. The groups showed no differences across QoL metrics (SOMS and CCS) at 3 weeks or 1 year postoperatively. Self-fixating mesh does not appear to positively impact QoL after TEP LIHR.

Living donor kidney transplant (LDKT) imparts the best graft and patient survival for most end-stage kidney disease (ESKD) patients. Yet, there remains variation in post-LDKT health-related quality of life (HRQOL). Improved understanding of post-LDKT HRQOL can help identify patients for interventions to maximize the benefit of LDKT. For 477 LDKT recipients transplanted between 11/2007 and 08/2016, we assessed physical, mental, social, and kidney-targeted HRQOL pre-LDKT, as well as 3 and 12 months post-operatively using the SF-36, Kidney Disease Quality of Life—Short Form (KDQOL-SF), and the Functional Assessment of Cancer Therapy—Kidney Symptom Index 19 item version (FKSI-19). We then examined trajectories of each HRQOL domain using latent growth curve models (LGCMs). We also examined associations between decline in HRQOL from 3 months to 12 months post-LDKT and death censored graft failure (DCGF) using Cox regression. Large magnitude effects (d > 0.80) were observed from pre- to post-LDKT change on the SF-36 Vitality scale (d = 0.81) and the KDQOL-SF Burden of Kidney Disease (d = 1.05). Older age and smaller pre- to post-LDKT decreases in serum creatinine were associated with smaller improvements on many HRQOL scales across all domains in LGCMs. Higher DCGF rates were associated with worse physical [e.g., SF-36 PCSoblique hazard ratio (HR) 1.18; 95% CI 1.01–1.38], mental (KDQOL-SF Cognitive Function HR 1.27; 95% CI 1.00–1.62), and kidney-targeted (FKSI-19 HR: 1.18; 95% CI 1.00–1.38) HRQOL domains. Clinical HRQOL monitoring may help identify patients who are most likely to have failing grafts and who would benefit from post-LDKT intervention.

INTRODUCTION: An individual’s understanding of disease risk factors and outcomes is important for the ability to make healthy lifestyle choices and decisions about disease treatment. Peripheral artery disease (PAD) is a condition with increasing global prevalence and high risk of adverse patient outcomes. This study seeks to understand the adequacy of disease understanding in patients with PAD. METHODS: This was an observational study of patients with PAD recruited from vascular surgery outpatient clinic and PAD clinical studies at a single academic medical center over an 8-month period. A 44-item paper survey assessed demographic and socioeconomic information, knowledge of personal medical history, PAD risk factors, consequences of PAD, and health education preferences. Patients with documented presence of PAD were offered the survey. Patients unable to complete the survey or provide informed consent were not considered eligible. Disease “awareness” was defined as correct acknowledgement of the presence or absence of a disease, including PAD, in the personal medical history. “PAD knowledge score” was the percentage of correct responses to questions on general PAD risk factors and consequences. Of 126 eligible patients, 109 participated. Bivariate analysis was used to study factors associated with awareness of PAD diagnosis. Factors associated with the PAD knowledge score were studied using the Pearson correlation coefficient, two-sample T-test, or one-way ANOVA. P value < .05 was considered statistically significant. RESULTS: Mean participant age was 69.4 ± 11.0 years and 39.4% (N=43) were female. Most participants (78.9%; N=86) had critical limb-threatening ischemia. Only 65.4% (N=70) of participants were aware of a diagnosis of PAD, which was less than their awareness of related comorbidities. Factors positively associated with PAD diagnosis awareness were female sex (81.4% vs. 54.7%; P=.004) and history of percutaneous leg revascularization (78.6% vs. 47.9%; p=.001). Among 17 patients who had undergone major leg amputation, 35% (N=6) were unaware of a diagnosis of PAD. PAD knowledge scores correlated positively with an awareness of PAD diagnosis (59.1% vs. 48.7%; P=.02) and negatively with a history of hypertension (53.4% vs. 68.1%; P=.001). Most participants (86.5%; N=90) expressed a desire to be further educated on PAD. The most popular education topics were dietary recommendations, causes, and treatment for PAD. CONCLUSION: Patients with PAD have deficits in their awareness of this diagnosis and general knowledge about PAD. Future research priorities should further define these deficits and their causes in order to inform new strategies that foster information-seeking behavior and effective educational programs for PAD.

Prospective and longitudinal studies have examined liver donors' medical outcomes beyond the first 1 to 2 years postdonation. There is no analogous longitudinal evidence on long-term psychosocial outcomes, including patient-reported clinically significant mental health problems and perceptions of physical well-being. We examined prevalence, descriptive characteristics, and predictors of diagnosable mental health conditions and self-reported physical health problems, including fatigue and pain, in the long-term years after liver donation.Donors from 9 centers who initially completed telephone interviews at 3 to 10 years postdonation (mean, 5.8 years; SD, 1.9) were reinterviewed annually for 2 years using validated measures. Outcomes were examined descriptively. Repeated-measures regression analyses evaluated potential predictors and correlates of outcomes.Of 517 donors initially interviewed (66% of those eligible), 424 (82%) were reassessed at least once. Prevalence rates of major depression and clinically significant pain were similar to general population norms; average fatigue levels were better than norms. All prevalence rates showed little temporal change. Anxiety and alcohol use disorder rates exceeded normative rates at 1 or more assessments. Longer postdonation hospitalization, female sex, higher body mass index, concerns about donation-related health effects, and burdensome donation-related financial costs were associated with increased risk for most outcomes (P's0.05). Men were at higher risk for alcohol use disorder (P0.001).Anxiety and alcohol use disorders were more common than would be expected; they may warrant increased research attention and clinical surveillance. Surveillance for long-term problems in the areas assessed may be optimized by targeting donors at higher risk based on identified predictors and correlates.

When considering an asymptomatic inguinal hernia, surgeons must weigh the risks of watchful waiting against the risk of operative complications. Laparoscopy offers the benefit of reduced postoperative pain, which, for appropriate surgical candidates, may strengthen the case for repair. This study compares general and disease-specific quality of life following totally extraperitoneal (TEP) laparoscopic inguinal hernia repair (LIHR) of asymptomatic and symptomatic hernias. We summarize prospective data from 387 patients who underwent TEP LIHR between 2009 and 2015 by four surgeons at a single institution. Asymptomatic individuals were identified by pain scores of zero at preoperative clinic visits. Validated quality of life (QOL) measurements were administered preoperatively and at 3 weeks, 6 months, and 1-year postop. Comparisons were made using Chi-square test, t test, or Mann–Whitney U test. Changes over time were assessed using longitudinal mixed effects models. A cohort of 79 asymptomatic cases were compared to 308 symptomatic individuals. The asymptomatic cohort had larger median hernia defects (2.5 vs 2 cm, p

In its original publication, an erroneous version of Fig. 2d was included in the manuscript. The corrected figure has now been added.

Psychological assessment in the medical setting presents many opportunities and challenges. On the question of what constitutes empirically supported assessment practice, there are few clear answers and perhaps fewer exemplars. The goal of this article was not to review the current status of empirically supported assessment in medical settings, but rather to highlight some areas of measurement innovation that may move this field toward its promise of a more stable evidence base supporting the use of patient-reported outcome measures for clinical research, patient education, and clinical care. In addition, assessment in the medical setting provides one very unique opportunity that many psychologists are not honed in on: the use of psychological assessment to assess quality health care. This is an emerging reality that poses significant methodological puzzles and opens doors for those committed to psychological assessment.

BackgroundLittle is known about how well postoperative pain is managed in living liver donors, despite pain severity being the strongest predictor of persistent pain with long-lasting disability.MethodsWe conducted a prospective multicenter study of 172 living liver donors. Self-reported outcomes fo

There are an estimated 14,000 randomized trials published in chronic kidney disease. The most frequently reported outcomes are biochemical endpoints, rather than clinical and patient-reported outcomes including cardiovascular disease, mortality, and quality of life. While many trials have focused on optimizing kidney health, the heterogeneity and uncertain relevance of outcomes reported across trials may limit their policy and practice impact. The international Standardized Outcomes in Nephrology (SONG) Initiative was formed to identify core outcomes that are critically important to patients and health professionals, to be reported consistently across trials. We convened a SONG Implementation Workshop to discuss the implementation of core outcomes. Eighty-two patients/caregivers and health professionals participated in plenary and breakout discussions. In this report, we summarize the findings of the workshop in two main themes: socializing the concept of core outcomes, and demonstrating feasibility and usability. We outline implementation strategies and pathways to be established through partnership with stakeholders, which may bolster acceptance and reporting of core outcomes in trials, and encourage their use by end-users such as guideline producers and policymakers to help improve patient-important outcomes. ispartof: pages:1053-1068 ispartof: Kidney Int vol:94 issue:6 pages:1053-1068 ispartof: location:United States status: published

For many patients with end-stage kidney disease, transplantation improves survival and quality of life compared with dialysis. However, complications and side effects in kidney transplant recipients can limit their ability to participate in activities of daily living including work, study, and recreational activities. The aim of this study was to identify the characteristics, content, and psychometric properties of the outcome measures used to assess life participation in kidney transplant recipients. We searched MEDLINE, Embase, PsycINFO, and CINAHL from inception to July 2018 for all studies that reported life participation in kidney transplant recipients. Two authors identified instruments measuring life participation and reviewed for characteristics. In total, 230 studies were included: 19 (8%) randomized trials, 17 (7%) nonrandomized trials, and 194 (85%) observational studies. Across these studies, we identified 29 different measures that were used to assess life participation. Twelve (41%) measures specifically assessed aspects of life participation (eg, disability assessment, daily activities of living), while 17 (59%) assessed other constructs (eg, quality of life) that included questions on life participation. Validation data to support the use of these measures in kidney transplant recipients were available for only 7 measures. A wide range of measures have been used to assess life participation in kidney transplant recipients, but validation data supporting the use of these measures in this population are sparse. A content relevant and validated measure to improve the consistency and accuracy of measuring life participation in research may inform strategies for transplant recipients to be better able to engage in their life activities. ispartof: AMERICAN JOURNAL OF TRANSPLANTATION vol:19 issue:8 pages:2306-2317 ispartof: location:United States status: published

Objective Integrating patient-reported outcomes (PROs) into electronic health records (EHRs) can improve patient-provider communication and delivery of care. However, new system implementation in health-care institutions is often accompanied by a change in clinical workflow and organizational culture. This study examines how well an EHR-integrated PRO system fits clinical workflows and individual needs of different provider groups within 2 clinics. Materials and Methods Northwestern Medicine developed and implemented an EHR-integrated PRO system within the orthopedics and oncology departments. We conducted interviews with 11 providers who had interacted with the system. Through thematic analysis, we synthesized themes regarding provider perspectives on clinical workflow, individual needs, and system features. Results Our findings show that EHR-integrated PROs facilitate targeted conversation with patients and automated triage for psychosocial care. However, physicians, psychosocial providers, and medical assistants faced different challenges in their use of the PRO system. Barriers mainly stemmed from a lack of actionable data, workflow disruption, technical issues, and a lack of incentives. Discussion This study sheds light on the ecosystem around EHR-integrated PRO systems (such as user needs and organizational factors). We present recommendations to address challenges facing PRO implementation, such as optimizing data collection and auto-referral processes, improving data visualizations, designing effective educational materials, and prioritizing the primary user group. Conclusion PRO integration into routine care can be beneficial but also require effective technology design and workflow configuration to reach full potential use. This study provides insights into how patient-generated health data can be better integrated into clinical practice and care delivery processes.

The psychosocial evaluation is well-recognized as an important component of the multifaceted assessment process to determine candidacy for heart transplantation, lung transplantation, and long-term mechanical circulatory support (MCS). However, there is no consensus-based set of recommendations for either the full range of psychosocial domains to be assessed during the evaluation, or the set of processes and procedures to be used to conduct the evaluation, report its findings, and monitor patients' receipt of and response to interventions for any problems identified. This document provides recommendations on both evaluation content and process. It represents a collaborative effort of the International Society for Heart and Lung Transplantation (ISHLT) and the Academy of Psychosomatic Medicine, American Society of Transplantation, International Consortium of Circulatory Assist Clinicians, and Society for Transplant Social Workers. The Nursing, Health Science and Allied Health Council of the ISHLT organized a Writing Committee composed of international experts representing the ISHLT and the collaborating societies. This Committee synthesized expert opinion and conducted a comprehensive literature review to support the psychosocial evaluation content and process recommendations that were developed. The recommendations are intended to dovetail with current ISHLT guidelines and consensus statements for the selection of candidates for cardiothoracic transplantation and MCS implantation. Moreover, the recommendations are designed to promote consistency across programs in the performance of the psychosocial evaluation by proposing a core set of content domains and processes that can be expanded as needed to meet programs' unique needs and goals. ispartof: JOURNAL OF HEART AND LUNG TRANSPLANTATION vol:37 issue:7 pages:803-823 ispartof: location:United States status: published

Social support is used to determine transplant eligibility despite lack of an evidence base and vague regulatory guidance. It is unknown how many patients are disqualified from transplantation due to inadequate support, and whether providers feel confident using these subjective criteria to determine eligibility. Transplant providers (n = 551) from 202 centers estimated that, on average, 9.6% (standard deviation = 9.4) of patients evaluated in the prior year were excluded due to inadequate support. This varied significantly by United Network for Organ Sharing region (7.6%-12.2%), and by center (21.7% among top quartile). Significantly more providers used social support in listing decisions than believed it ought to be used (86.3% vs 67.6%). Nearly 25% believed that using social support in listing determinations was unfair or were unsure; 67.3% felt it disproportionately impacted patients of low socioeconomic status. Overall, 42.4% were only somewhat or not at all confident using social support to determine transplant suitability. Compared to surgical/medical transplant providers, psychosocial providers had 2.13 greater odds of supporting the criteria (P = .03). Furthermore, 69.2% supported revised guidelines for use of social support in listing decisions. Social support criteria should be reconsidered in light of the limited evidence, potential for disparities, practice variation, low provider confidence, and desire for revised guidelines.

BACKGROUND Patients who receive adjuvant chemotherapy have reported cognitive impairments that may last for years after the completion of treatment. Working memory-related and long-term memory-related changes in this population are not well understood. The objective of this study was to demonstrate that cancer-related cognitive impairments are associated with the under recruitment of brain regions involved in working and recognition memory compared with controls. METHODS Oncology patients (n = 15) who were receiving adjuvant chemotherapy and had evidence of cognitive impairment according to neuropsychological testing and self-report and a group of age-matched, education group-matched, cognitively normal control participants (n = 14) underwent functional magnetic resonance imaging. During functional magnetic resonance imaging, participants performed a nonverbal n-back working memory task and a visual recognition task. RESULTS On the working memory task, when 1-back and 2-back data were averaged and contrasted with 0-back data, significantly reduced activation was observed in the right dorsolateral prefrontal cortex for oncology patients versus controls. On the recognition task, oncology patients displayed decreased activity of the left-middle hippocampus compared with controls. Neuroimaging results were not associated with patient-reported cognition. CONCLUSIONS Decreased recruitment of brain regions associated with the encoding of working memory and recognition memory was observed in the oncology patients compared with the control group. These results suggest that there is a reduction in neural functioning postchemotherapy and corroborate patient-reported cognitive difficulties after cancer treatment, although a direct association was not observed. Cancer 2016;122:258–268. © 2015 American Cancer Society.

Background The majority of patients with primary hyperparathyroidism (PHPT) are diagnosed without the classic signs of renal or osseous complications. Vague and subjective symptoms have been attributed to PHPT but have been difficult to measure during the medical encounter. The Patient-Reported Outcomes Measurement Information System (PROMIS) of the National Institutes of Health contains validated measures of physical and mental health that can be administered by the use of computer-adaptive testing (CAT). The objective of this study was to evaluate the feasibility of PROMIS assessment in the clinical setting to measure changes in patient-reported health before and after parathyroidectomy. We hypothesized that patients undergoing parathyroidectomy for PHPT would report greater improvement in mental and physical health compared with control patients. Methods Adult PHPT patients scheduled for parathyroidectomy and control patients requiring diagnostic thyroid operation were enrolled prospectively during a 6-month period. Patients were administered clinically relevant PROMIS health domains via CAT at a preoperative visit and 3 weeks after operation. A change in score of 5 or greater for each PROMIS instrument was defined as clinically important. Statistical significance of pre/post-surgery changes in scores was determined using paired t tests. Results A total of 35 patients with PHPT and 9 control patients completed the study. The mean number of PROMIS items answered during an assessment was 67 (range 51–121, SD 15.4). Median completion time was 8.2 minutes (range 3.4–38.4, SD 4.7). Clinically important improvement after parathyroidectomy in the PHPT group was greater than in the control group in 5 PROMIS domains. The score improvement experienced by PHPT patients was 8.8 in Fatigue, 6.7 in Sleep-Related Impairment, 5.0 in Anxiety, 7.0 in Applied Cognition, and 6.2 in Depression (all P Conclusion PROMIS is an efficient clinical assessment platform for measuring patient-reported outcomes in PHPT via CAT. Several domains of physical and mental health in patients with PHPT show statistically and clinically important improvement after parathyroidectomy.

Background. Hepatopulmonary syndrome (HPS) is a complication of advanced liver disease. The impact of HPS on survival is not clearly understood. Material and methods. A prospective study was carried out at Department of Medicine, King Edward Medical University Lahore from June 2011 to May 2012. Patients with cirrhosis of liver were evaluated for presence of HPS with arterial blood gas analysis and saline bubble echocardiography. All patients were followed for 6 months for complications and mortality. Cox regression analysis was done to evaluate role of HPS on patient survival. Results. 110 patients were included in the study. Twenty-nine patients (26%) had HPS. MELD score was significantly higher (p < 0.01) in patients with HPS (18.93 ± 3.51) as compared to that in patients without HPS (13.52 ± 3.3). Twenty two (75.9%) patients of Child class C, 5 (17.2%) patients of Child class B and 2 (6.9%) patients of Child class A had HPS (P 0.03). The clinical variables associated with presence of HPS were spider nevi, digital clubbing, dyspnea, and platypnea. HPS significantly increased mortality during six month follow up period (HR: 2.47, 95% CI: 1.105.55). Child-Pugh and MELD scores were also associated with increased mortality. HPS was no longer associated with mortality when adjustment was done for age, gender, Child-Pugh, and MELD scores (HR: 0.44, 95% CI: 0.14-1.41). Both the Child-Pugh and MELD scores remained significantly associated with mortality in the multivariate survival analysis. Conclusions. HPS indicates advanced liver disease. HPS does not affect mortality when adjusted for severity of cirrhosis.

A 60-year-old African-American male presented to the emergency department with abdominal pain and distention associated with decreased appetite and weight loss for several weeks. A computed tomography (CT) scan of the abdomen and pelvis showed an 8 cm mesenteric mass with surrounding stranding and poorly defined borders. The patient underwent exploratory laparotomy and complete resection of the mass since the frozen section could not give a definite diagnosis. Histopathology showed fibro-adipose tissue with lymphoid hyperplasia, vague nodular collections of foamy histiocytes with giant cell reaction, marked chronic inflammation, fat necrosis, and prominent sclerosis/fibrosis. Methenamine silver and acid-fast stains were negative for fungal and mycobacterial organisms respectively. Examination of tissue with immunohistostains showed increased immunoglobulin G4 (IgG4)-positive plasma cells. Other features observed were scattered areas of phlebitis, pockets of tissue eosinophilia, and focal storiform fibrosis leading to the diagnosis of IgG4-related sclerosing mesenteritis. The patient did not require steroids after the surgical resection and was disease free at six-month follow up.

Little is known about living liver donors' perceptions of their physical well-being following the procedure. We collected data on donor fatigue, pain, and other relevant physical outcomes as part of the prospective, multicenter Adult-to-Adult Living Donor Liver Transplantation Cohort Study consortium. A total of 271 (91%) of 297 eligible donors were interviewed at least once before donation and 3, 6, 12, and 24 months after donation using validated measures when available. Repeated measures regression models were used to identify potential predictors of worse physical outcomes. We found that donors reported more fatigue immediately after surgery that improved by 2 years after donation, but not to predonation levels. A similar pattern was seen across a number of other physical outcomes. Abdominal or back pain and interference from their pain were rated relatively low on average at all study points. However, 21% of donors did report clinically significant pain at some point during postdonation study follow-up. Across multiple outcomes, female donors, donors whose recipients died, donors with longer hospital stays after surgery, and those whose families discouraged donation were at risk for worse physical well-being outcomes. In conclusion, although not readily modifiable, we have identified risk factors that may help identify donors at risk for worse physical outcomes for targeted intervention. Liver Transplantation 00 000-000 2018 AASLD.

International audience; Fatigue is one of the most highly prioritized outcomes for patients and clinicians, but remains infrequently and inconsistently reported across trials in hemodialysis. We convened an international Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) consensus workshop with stakeholders to discuss the development and implementation of a core outcome measure for fatigue. 15 patients/caregivers and 42 health professionals (clinicians, researchers, policy makers, and industry representatives) from 9 countries participated in breakout discussions. Transcripts were analyzed thematically. 4 themes for a core outcome measure emerged. Drawing attention to a distinct and all-encompassing symptom was explicitly recognizing fatigue as a multifaceted symptom unique to hemodialysis. Emphasizing the pervasive impact of fatigue on life participation justified the focus on how fatigue severely impaired the patient's ability to do usual activities. Ensuring relevance and accuracy in measuring fatigue would facilitate shared decision making about treatment. Minimizing burden of administration meant avoiding the cognitive burden, additional time, and resources required to use the measure. A core outcome measure that is simple, is short, and includes a focus on the severity of the impact of fatigue on life participation may facilitate consistent and meaningful measurement of fatigue in all trials to inform decision making and care of patients receiving hemodialysis.

Background & Aims There are few long-term studies of the health-related quality of life (HRQOL) in living liver donors. This study aimed to characterize donor HRQOL in the Adult to Adult Living Donor Liver Transplantation Study (A2ALL) up to 11years post-donation. Methods Between 2004 and 2013, HRQOL was assessed at evaluation, at 3months, and yearly post-donation in prevalent liver donors using the short-form survey (SF-36), which provides a physical (PCS) and a mental component summary (MCS). Results Of the 458 donors enrolled in A2ALL, 374 (82%) had SF-36 data. Mean age at evaluation was 38 (range 18–63), 47% were male, 93% white, and 43% had a bachelor's degree or higher. MCS and PCS means were above the US population at all time points. However, at every time point there were some donors who reported poor scores (>1/2 standard deviation below the age and sex adjusted mean) (PCS: 5.3–26.8%, MCS: 10.0–25.0%). Predictors of poor PCS and MCS scores included recipient's death within the two years prior to the survey and education less than a bachelor's degree; poor PCS scores were also predicted by time since donation, Hispanic ethnicity, and at the 3-month post-donation time point. Conclusions In summary, most living donors maintain above average HRQOL up to 11years prospectively, supporting the notion that living donation does not negatively affect HRQOL. However, targeted support for donors at risk for poor HRQOL may improve overall HRQOL outcomes for living liver donors.

Aims and methodTo assess adolescents' perceptions of their psychiatric illness and the role of various demographic factors in a Pakistani setting. Adolescents with various psychiatric diagnoses were interviewed using a structured questionnaire including the Illness Perceptions Questionnaire–Revised (IPQ-R).ResultsFifty-two adolescents with various psychiatric illnesses were interviewed; their mean age was 12.7 years and the majority (67%) were female. Males had significantly higher scores on timeline and emotional representation (PClinical implicationsDespite the importance of early intervention in psychiatric problems, engaging youth in the treatment process in Pakistan remains difficult. Better understanding of how adolescents perceive their psychiatric difficulties may play a significant role in developing culturally sensitive interventions and better utilisation of services.

BackgroundNational guidelines require programmes use subjective assessments of social support when determining transplant suitability, despite limited evidence linking it to outcomes. We examined how transplant providers weigh the importance of social support for kidney transplantation compared with other factors, and variation by clinical role and personal beliefs.MethodsThe National survey of the American Society of Transplant Surgeons and the Society of Transplant Social Work in 2016. Using a discrete choice approach, respondents compared two hypothetical patient profiles and selected one for transplantation. Conditional logistic regression estimated the relative importance of each factor; results were stratified by clinical role (psychosocial vs medical/surgical providers) and beliefs (outcomes vs equity).ResultsFive hundred and eighy-four transplant providers completed the survey. Social support was the second most influential factor among transplant providers. Providers were most likely to choose a candidate who had social support (OR=1.68, 95% CI 1.50 to 1.86), always adhered to a medical regimen (OR=1.64, 95% CI 1.46 to 1.88), and had a 15 years life expectancy with transplant (OR=1.61, 95% CI 1.42 to 1.85). Psychosocial providers were more influenced by adherence and quality of life compared with medical/surgical providers, who were more influenced by candidates' life expectancy with transplant (pConclusionsSocial support is highly influential in listing decisions and may exacerbate transplant disparities. Providers’ beliefs and reliance on social support in determining suitability vary considerably, raising concerns about transparency and justice.

Background The Functional Assessment of Cancer Therapy-Prostate (FACT-P) and the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Prostate Symptom Index-17 (NFPSI-17) are 2 commonly used measures for patient-reported outcomes in prostate cancer trials. Their use may be enhanced by a better understanding of how change scores on the measures should be interpreted. Methods Using data from the phase 3 Alpharadin in Symptomatic Prostate Cancer Patients trial, this study estimated important change scores on the FACT-P and the NFPSI-17 via a combination of distribution- and anchor-based methods. These data were also used to establish evidence for the validity of the NFPSI-17. Results The available data suggested the following important difference ranges: 2 to 4 points for the Prostate Cancer Subscale, 5.5 to 8.5 points for the Trial Outcome Index, 1 to 1.5 points for the 3-item Pain Scale, 1 to 2 points for the 4-item Pain Scale, 4 to 6 points for the NFPSI-17, 2 to 3.5 points for NFPSI-Disease-Related Symptoms-Physical, 0.5 points for NFPSI-Disease-Related Symptoms-Emotional, 1 to 1.5 points for NFPSI-Treatment Side Effects, and 0.5 to 1 point for NFPSI-Function/Well-Being. The internal consistency reliability of the NFPSI-17 and most of its subscales was good to excellent (>.70). Significant support was also found for the known groups validity of the NFPSI-17 (and most of its subscales) on the basis of the Eastern Cooperative Oncology Group performance status, the total alkaline phosphatase, the presence of a skeletal-related event during treatment, and the prostate-specific antigen response before the end of treatment. Conclusions The secondary analysis supports the continued use of the FACT-P, the NFPSI-17, and its related subscales in future research on the quality of life of patients with symptomatic castration-resistant prostate cancer with bone metastases.

Dermatomyositis (DM), a myopathy associated with inflammation and muscle weakness, has historically been difficult to diagnose. Recently, nuclear matrix protein (NXP-2) antibodies have been described as a myositis-specific antibody that may aid in the diagnostic evaluation. We present the case of a 21-year-old, previously healthy, African American male with DM. He presented to our outpatient clinic with periorbital swelling and a rash, for which he was started on prednisone by an ophthalmologist. Towards the end of the prednisone taper, he began to experience muscle weakness, a worsening rash, and dysphagia to solids with a resultant loss of 60 pounds within a month. He was transferred to a tertiary care hospital where he was further evaluated and ultimately diagnosed with dermatomyositis, supported by skin and muscle biopsies, and was found to be positive for NXP-2. He was given intravenous immunoglobulin (IVIG) and high-dose steroids with improvement.

Background Upper limb transplantation is a life-enhancing rather than life-saving procedure. Little research has investigated how individuals with upper limb amputations perceive the benefits and risks of this complex procedure. To address this knowledge gap, the authors conducted qualitative research with individuals with upper limb amputations to understand their perspectives. Methods Twenty-two individuals with upper limb amputations (age range, 24 to 73 years) participated in a focus group (n=5) or semistructured interview (n=17) about the benefits and risks of upper limb transplantation. Data were analyzed by means of constant comparative methods and a two-phase analysis process. Results Participants identified enhanced functional performance and improved appearance as the greatest potential benefits. Over half of participants indicated that function was a more important consideration than appearance. Enhanced function performance was a relative concept strongly influenced by individual expectations, which varied widely. Increased sensation, psychological well-being, and social acceptability were also described as potential benefits. Identified risks included health risks and the demands of transplantation and recovery, decreased functional performance, and uncertainty over outcomes from upper limb transplantation as an experimental procedure. Participants also expressed concerns regarding the psychological impact of negative outcomes and adverse events. Conclusions Participants had a large variation in their perceived importance of the many risks and benefits of upper limb transplantation. These findings elucidate how potential upper limb transplantation candidates evaluate the benefits and risks of the procedure. The findings can also inform important issues to address and outcomes to assess in the pretransplant and posttransplant settings.

Context Symptom cluster research expands cancer investigations beyond a focus on individual symptoms in isolation. Objectives We conducted a prospective longitudinal study of sleep, fatigue, depression, anxiety, and perceived cognitive impairment in patients with breast cancer undergoing chemotherapy. Methods Patient-reported outcome measures were administered prior to chemotherapy, at Cycle 4 Day 1, and six months after initiating chemotherapy. Participants were divided into four groups and assigned a symptom cluster index (SCI) score based on the number/severity of symptoms reported at enrollment. Results Participants ( N = 80) were mostly women (97.5%) with Stage II (69.0%) breast cancer, 29–71 years of age. Scores on all measures were moderately-highly correlated across all time points. There were time effects for all symptoms, except sleep quality (nonsignificant trend), with most symptoms worsening during chemotherapy, although anxiety improved. There were no significant group × time interactions; all four SCI groups showed a similar trajectory of symptoms over time. Worse performance status and quality of life were associated with higher SCI score over time. Conclusion With the exception of anxiety, the coherence of the symptom cluster was supported by similar patterns of severity and change over time in these symptoms (trend for sleep quality). Participants with higher SCI scores prior to chemotherapy continued to experience greater symptom burden during and after chemotherapy. Early assessment and intervention addressing this symptom cluster (vs. individual symptoms) may have a greater impact on patient performance status and quality of life for patients with higher SCIs.

Introduction:This work reviews the current state of patient-reported outcomes research in periocular cosmetic plastic surgery.Materials and Methods:A systematic review of the English-language medical literature from January 1946 through March 2013 was conducted for patient-reported outcomes measures used in periocular cosmetic plastic surgery patient populations. These measures were assessed for adherence to minimum standards recommended by the International Society for Quality of Life Research.Results:Thirteen outcome measures were identified. Upper-lid blepharoplasty was the only procedure for which an instrument, the Blepharoplasty Outcomes Evaluation, had been formally developed in the target patient group (periocular cosmetic surgery), and that met or exceeded minimum standards of reporting. Nine formally developed instruments were identified in the following applications: general facial cosmetic surgery (instruments that may be applied to periocular surgery, which are not restricted to any single fa...

We examined the health-related quality of life (HRQOL) and pain experiences of patients with hepatocellular carcinoma (HCC) and assessed content validity of existing patient-reported pain items for patients with HCC.Semi-structured interviews to elicit symptoms, side effects and concerns were conducted with ten patients with HCC. Symptom and side effect importance was ranked on a 0 to 10 scale. Patients completed pain items from the Functional Assessment of Cancer Therapy--Hepatocellular (FACT-Hep) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire--Hepatocellular-18 (EORTC QLQ-HCC18).Mean age was 58 years (range 33-77). Spontaneously reported symptoms included fatigue (n = 5), diarrhea (n = 5), skin toxicities (n = 5), and loss of appetite (n = 4). Upon questioning, nine of ten patients reported experiencing pain over the course of their treatment. Over half of the importance rankings given for pain were 8 or higher on a 0 to 10 scale. Abdomen (n = 7) and lower back (n = 3) were the most common sites of pain. Pain onset varied from 6 months pre-diagnosis to over 2 years post-diagnosis. All patients indicated that FACT-Hep and EORTC items adequately assessed their pain.Results support the content validity of FACT-Hep pain items for patients with HCC. The finding that patients typically did not spontaneously report pain but often ranked it as very important for their HRQOL upon questioning suggests a need for systematic, routine pain and other symptom assessment and management as an integral component of patient care in advanced HCC.

Our objective was to compare hospital charges and both perioperative and mid-term quality of life between single- (SILC) and multi-incision (MILC) laparoscopic cholecystectomy in a randomized controlled trial.Patients with acute or chronic biliary disease were invited to participate. Pain scores, quality of life, and perioperative outcomes were measured. Patients were followed for 1 year postoperatively in the clinic with examination to document hernia formation.One hundred subjects were randomized to SILC (n = 49) or MILC (n = 51). Demographics were similar for both groups except more women underwent SILC (86% vs 67%, P = .026). Operative time was greater for SILC (63.5 ± 21.0 vs 43.8 ± 24.2 minute, P.0001). Five SILC patients required added ports. One substantial complication occurred in SILC. Pain, the use of analgesics, and duration of hospital stay were equal between groups; however, charges were greater in the SILC group ($17,602 ± $6,089 vs $13,342 ± $8,197, P.0001). Both groups reported similar quality of life and cosmesis. At an average follow-up of SILC (16.4 ± 12.1 months) and MILC (16.2 ± 10.5 months), no novel umbilical hernias were identified.SILC results in longer operative time and greater hospital charges with similar pain and quality of life scores compared with a standard laparoscopic approach.

Background The aim of the present study was to examine the association of diabetes mellitus (DM) with the prevalence and severity of hepatic encephalopathy (HE) in patients with decompensated cirrhosis (DC) and determine the impact of age and gender on this relationship. Methods West Haven criteria was used to prospectively evaluate 352 consecutive patients with DC for the presence of HE. Detailed clinicobiochemical profiling of patients was performed. Categorical data and ordered categorical variables were evaluated using the Chi-squared test for independence and trend, respectively. Continuous normal and non-parametric data were evaluated using the t-test and Mann–Whitney U-test, respectively. Results At the time of admission, HE was present in 50.3% of patients. In all, 118 patients had DM (33.5%). Patients with DM had a significantly higher prevalence (58.5% vs 42.6%; P = 0.03) and severity of HE (Ptrend = 0.01) than patients without DM. However, there were no significant differences between the two groups in terms of Child-Pugh class, MELD scores, the presence of ascites and esophageal varices. Patients with DM had higher platelet counts than those without DM (Ptrend = 0.003). In age and gender subgroup analyses, older patients and men with DM had significantly greater evidence of HE (P = 0.02 and 0.03, respectively). Multivariate analysis showed that DM (P = 0.03) and older age (P = 0.006) were independently related to HE, whereas the association of gender was non-significant. Conclusion Both DM and older age are independently associated with HE in patients with cirrhosis. 摘要 背景 本研究的目的是在失代偿性肝硬化患者中调查糖尿病与肝性脑病患病率以及严重性之间的关系，并且调查了年龄与性别对这种关系的影响。 方法 对连续的352名失代偿性肝硬化患者使用西黑文标准（West Haven criteria）前瞻性地评估了肝性脑病的发病情况。对患者进行了详细的临床生化分析。使用卡方检验分别评估了分类数据以及有序分类变量的独立性与趋势。使用T检验与Mann–Whitney U检验分别评估了连续性的正常数据以及非参数数据。 结果 在入院时，有50.3%的患者出现了肝性脑病。总共有118名患者有糖尿病（33.5%）。糖尿病患者的肝性脑病的患病率（58.5% vs 2.6%；P = 0.03）以及严重程度（Ptrend = 0.01）都比非糖尿病患者显著增高。然而，两组之间的Child-Pugh分级、MELD评分、腹水与食管静脉曲张的出现都没有显著性的差异。与那些非糖尿病患者相比较，糖尿病患者的血小板计数更高（Ptrend = 0.003）。在年龄与性别的亚组分析中，老年患者以及男性糖尿病患者出现肝性脑病的证据更显著（分别P = 0.02与0.03）。多元分析结果显示，糖尿病（P = 0.03）以及老龄（P = 0.006）均与HE呈独立相关，然而与性别的关系却没有显著性的意义。 结论 糖尿病和老龄均与肝硬化性肝性脑病独立相关。

Health researchers and policy-makers increasingly urge both patient and clinician engagement in shared decision making (SDM) to promote patient-centered care. Although SDM has been examined in numerous clinical settings, it has received little attention in solid organ transplantation. This paper describes the application of SDM to the kidney transplantation context. Several distinctive features of kidney transplantation present challenges to SDM including fragmented patient–provider relationships, the time-sensitive and unpredictable nature of deceased organ offers, decision-making processes by transplant providers serving as both organ guardians (given the organ scarcity) versus advocates for specific patients seeking transplantation, variable clinical practices and policies among transplant centers, and patients’ potentially compromised cognitive status and literacy levels. We describe potential barriers to and opportunities for SDM, and posit that SDM is feasible, warranting encouragement in kidney transplantation. We propose strategies to promote and overcome obstacles to SDM in kidney transplantation. We contend that engagement in SDM can be facilitated by re-organization of clinical care, communication and education of providers and patients.

Health-related quality of life (HRQOL) provides a measure of patients’ perception of their symptoms, overall health or disability, and treatment. As such, HRQOL is an important patient-centered outcome and transplant-oriented clinical research endpoint. HRQOL alone, or in tandem with other objective clinical outcome measures, is useful in monitoring clinical practice, informing treatment decisions, and guiding the allocation of healthcare resources. It comprises three domains: physical, mental, and psychosocial wellbeing; and can be measured by generalized or targeted instruments depending on the degree of specificity desired by the clinician or researcher. Patients with end stage renal disease requiring dialysis report diminished quality of life compared to the general population, which in turn is associated with an increased risk of hospitalization and death, particularly in those with a high comorbidity burden. Renal transplantation confers a global quality of life benefit. Physical symptoms like pain, poor sleep quality, and fatigue are perceived to be improved after transplantation by renal transplant recipients with a functioning allograft. Depression and anxiety also improve after transplantation as does social participation and integration. However, on average, HRQOL following renal transplant remains lower than in the general population, partly due to transplant related complications like infection and malignancy and the adverse effects of immunosuppression. Other factors that negatively impact HRQOL after transplant include older recipient age, deceased donor transplantation, female gender, lack of social support, and comorbid conditions such as diabetes and depression. Improved HRQOL after kidney transplantation, especially in the physical domain, has been associated with better patient and allograft survival. Hence it is imperative for transplant clinicians to familiarize themselves with the concepts, measurement, and interpretation of HRQOL as they strive to provide comprehensive care to kidney transplant patients.

Although single-center and cross-sectional studies have suggested a modest impact of liver donation on donor psychological well-being, few studies have assessed these outcomes prospectively among a large cohort. We conducted one of the largest, prospective, multicenter studies of psychological outcomes in living liver donors within the Adult-to-Adult Living Donor Liver Transplantation Cohort Study2 (A2ALL-2) consortium. In total, 271 (91%) of 297 eligible donors were interviewed at least once before donation and at 3, 6, 12, and 24 mo after donation using validated measures. We found that living liver donors reported low rates of major depressive (0-3%), alcohol abuse (2-5%), and anxiety syndromes (2-3%) at any given assessment in their first 2 years after donation. Between 4.7% and 9.6% of donors reported impaired mental well-being at various time points. We identified significant predictors for donors' perceptions of being better people and experiencing psychological growth following donation, including age, sex, relationship to recipient, ambivalence and motivation regarding donation, and feeling that donation would make life more worthwhile. Our results highlight the need for close psychosocial monitoring for those donors whose recipients died (n=27); some of those donors experienced guilt and concerns about responsibility. Careful screening and targeted, data-driven follow-up hold promise for optimizing psychological outcomes following this procedure for potentially vulnerable donors.

Due to the enduring organ shortage, living donor liver transplantation has been a valuable treatment strategy for advanced liver disease patients for over 20 years. A variety of reviews have summarized the extensive data now available on medical and psychosocial risks to living donors in the aftermath of donation. However, evidence on donor medical and psychosocial outcomes beyond the first year postdonation has not been synthesized in any previous review. The evidence base on such "long-term" outcomes has been growing in recent years. A review of this evidence would therefore be timely and could serve as an important resource to assist transplant centers in their efforts to fully educate prospective donors and gain informed consent, as well as develop appropriate postdonation clinical care and surveillance plans. We reviewed recent literature on long-term donor outcomes, considering (a) medical outcomes, including mortality risk, rates of complications, abnormalities detected in laboratory testing, and the progress of liver regeneration; and (b) donor-reported psychosocial outcomes reflecting physical, emotional, and interpersonal/socioeconomic well-being, as well as overall health-related quality of life. We summarize limitations and gaps in available evidence, and we provide recommendations for future research and clinical care activities focused on long-term outcomes in liver donors.

Studies of liver donors' psychosocial outcomes focus on the short term and rely largely on quality-of-life measures not specific to donation. We sought to examine long-term donation effects on 3 psychosocial domains: perceived physical, emotional, and socioeconomic outcomes.Individuals donating 3 to 10 years previously at 9 centers were eligible for telephone surveys. Survey responses were examined descriptively. Cluster analysis was used to identify distinct donor groups based on response profiles across psychosocial domains. Potential predictors of response profiles were evaluated with regression analysis.Five hundred seventeen donors (66%) participated (M = 5.8 years postdonation, SD = 1.9). Fifteen percent to 48% of donors endorsed current donation-related physical health problems and concerns, and 7%-60% reported socioeconomic concerns (eg, insurance difficulties, financial expenditures). However, on average, donors experienced high psychological growth, and 90% felt positively about donation. Cluster analysis revealed 5 donor groups. One group showed high psychological benefit, with little endorsement of physical or socioeconomic concerns (15% of donors). Four groups showed less favorable profiles, with varying combinations of difficulties. The largest such group showed high endorsement of physical concerns and financial expenditures, and only modest psychological benefit (31% of donors). Men and nonHispanic whites were most likely to have unfavorable response profiles (Ps0.01). Compared with donors aged 19 to 30 years, older donors were less likely to have unfavorable profiles; these differences were significant for donors in the40 to 50 year age group (Ps0.008).Even many years postdonation, donors report adverse physical and socioeconomic effects, but positive emotional effects as well. Identification of response profiles and predictors may improve targeting of postdonation surveillance and care.

Because results from single-center (mostly kidney) donor studies demonstrate interpersonal relationship and financial strains for some donors, we conducted a liver donor study involving nine centers within the Adult-to-Adult Living Donor Liver Transplantation Cohort Study 2 (A2ALL-2) consortium. Among other initiatives, A2ALL-2 examined the nature of these outcomes following donation. Using validated measures, donors were prospectively surveyed before donation and at 3, 6, 12, and 24 mo after donation. Repeated-measures regression models were used to examine social relationship and financial outcomes over time and to identify relevant predictors. Of 297 eligible donors, 271 (91%) consented and were interviewed at least once. Relationship changes were positive overall across postdonation time points, with nearly one-third reporting improved donor family and spousal or partner relationships and >50% reporting improved recipient relationships. The majority of donors, however, reported cumulative out-of-pocket medical and nonmedical expenses, which were judged burdensome by 44% of donors. Lower income predicted burdensome donation costs. Those who anticipated financial concerns and who held nonprofessional positions before donation were more likely to experience adverse financial outcomes. These data support the need for initiatives to reduce financial burden.

Laparoscopic inguinal hernia repair has been shown to offer patients the benefit of less postoperative pain as compared to traditional open techniques. However, the risk of experiencing significant postoperative pain may affect patient’s decision making. We aimed to elucidate potential patterns of pain and the predictors of such, up to 2 years postoperatively, using both generic and specific quality of life tools. Patients undergoing laparoscopic totally extra-peritoneal inguinal hernia repair were identified from a prospectively maintained database. Short form-36, Surgical Outcomes Measurement System (SOMS) and Carolinas Comfort Scale (CCS) surveys were administered pre- and postoperatively at 3 weeks, 6 months, 1 and 2 years. Patients with concomitant procedures were excluded. Significant pain was considered mild but bothersome or worse on either specific tool (SOMS scores ≥3/4, CCS scores ≥2). Predictors of significant pain were determined by logistic regression. From 2009 to 2015, 482 patients enrolled in our database underwent elective TEP repair of 626 hernias and completed an assessment tool. Mean age was 57 (±15) years, with 93 % male. Reported pain on all three tools improved significantly from baseline over time (p

Since the development of single-incision surgery, several retrospective studies have demonstrated its feasibility; however, randomized prospective trials are still lacking. We report a prospective randomized single-blinded trial with a cost analysis of single-incision (SI) to multi-incision (MI) laparoscopic cholecystectomy.After obtaining IRB approval, patients with chronic cholecystitis, acute cholecystitis, or biliary dyskinesia were offered participation in this multihospital, multisurgeon trial. Consenting patients were computer randomized into either a transumbilical SI or standard MI group; patient data were then entered into a prospective database.We report 79 patients that were prospectively enrolled and analyzed. Total hospital charges were found to be significantly different between SI and MI groups (MI $15,717 ± $14,231 vs SI $17,817 ± $5,358; p0.0001). Broken down further, the following subcharges were found to also be significant: operating room charges (MI $4,445 ± $1,078 vs SI $5,358 ± 893; p0.0001); medical/surgical supplies (MI $3,312 ± $6,526 vs SI $5,102 ± $1,529; p0.0001); and anesthesia costs (MI $579 ± $7,616 vs SI $820 ± $23,957; p0.0001). A validated survey (ie, Surgical Outcomes Measurement System) was used to evaluate various patient quality-of-life parameters at set visits after surgery; scores were statistically equivalent for fatigue, physical function, and satisfaction with results. No difference was found between visual analogue scale scores or inpatient and outpatient pain-medication use.We show SI surgery to have higher costs than MI surgery with equivalent quality-of-life scores, pain analogue scores, and pain-medication use.

Cross-sectional data suggest that many individuals with breast cancer experience significant sleep disturbance across the continuum of care. Understanding the longitudinal trajectory of sleep disturbance may help identify factors associated with its onset, severity, or influence on health-related quality of life (HRQL). Study objectives were to observe sleep quality in breast cancer patients prior to, during, and after completion of adjuvant chemotherapy, evaluate its relationship with HRQL and explore correlates over time.Participants were administered patient-reported outcome measures including the Pittsburgh Sleep Quality Index (PSQI) and the Functional Assessment of Cancer Therapy--General (FACT-G), which assesses HRQL. Data were collected prospectively 3-14 days prior to beginning chemotherapy, cycle 4 day 1 of chemotherapy, and 6 months following initiation of chemotherapy.Participants (n = 80) were primarily women (97.5 %) with stage II (69.0 %) breast cancer. Total FACT-G scores were negatively correlated with global PSQI scores at each time point (rho = -0.46, -0.41, -0.45; all p 0.001). Poor sleep quality (PSQI ≥ 5) was prevalent at all time points (48.5-65.8 %); however, there were no significant changes within participants over time. Correlates with sleep quality varied across time points. Participants with poor sleep quality reported worse overall HRQL, fatigue, depression, and vasomotor/endocrine symptoms.These findings suggest that early identification of sleep disturbance and ongoing assessment and treatment of contributing factors over the course of care may minimize symptom burden associated with chemotherapy and prevent chronic insomnia in survivorship.

BACKGROUND: Metastatic renal cell cancer is associated with poor long-term survival and has no cure. Traditional clinical endpoints are best supplemented by patient-reported outcomes designed to assess symptoms and function. Normative data was obtained on the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy–Kidney Symptom Index (NFKSI) to aid in score interpretation and planning of future trials. METHODS: General population data were obtained from 2000 respondents, who completed the 19-item NFKSI-19, as well the SF-36 (Short Form 36-item instrument) and the PROMIS-29 (29-item Patient Reported Outcomes Measurement Information System), both general health status measures. Basic demographic and self-reported comorbidity data were also collected. RESULTS: The sample was 50% female, 85.7% caucasian, with an equal distribution across age bands from 18 years to 75 years and older. Most respondents (62.8%) had more than a high school education and reported an Eastern Cooperative Oncology Group performance status of normal activity without symptoms (63.4%). Score distributions on the NFKSI-19, its subscales, and individual items are summarized. CONCLUSIONS: The NFKSI-19 and its subscales now have scores for the general US population, allowing comparability to generic questionnaires such as the SF-36 and PROMIS-29. These data can be used to guide treatment expectations and plan future comparative effectiveness research using the scales. Cancer 2013. © 2012 American Cancer Society.

We conducted a cross-sectional study of patients who underwent pediatric liver transplant (LT) between 1988 and 1992 to evaluate long-term health status. Survivors completed socio-demographic, medical and Health-Related Quality of Life (HRQOL) surveys by mail including the SF-36v2, PedsQL™4.0 Generic Core Scale, PedsQL™ Cognitive Functioning Scale and PedsQL™3.0 Transplant Module. SF-36 scores were converted to SF6D-based utilities and risk factors for lower outcomes were assessed. Eighty-five of 171 patients had survived. Fifty-six were contacted with a response rate of 66%. Median age at LT was 0.86 years (IQR 0.58-3.0) and 64.3% had biliary atresia. Mean age at survey was 23.0 ± 4.4 years: 62% attended college, 68% lived with parents and 80% of those over 23 were employed. Patient health utilities were lower than norms (0.75 ± 0.12 vs. 0.82 ± 0.18, p < 0.01) and correlated with unemployment (p < 0.042), hospitalizations (p < 0.005) and lower education level (p < 0.016). Lower PedsQL™3.0 Transplant Module and PedsQL™ 4.0 Generic Core Scale scores correlated with unemployment (p = 0.006, p = 0.009) and hospitalizations (p = 0.006, p = 0.02). Pediatric transplant recipients who survive to adulthood have lower physical HRQOL, measurable transplant-related disability and lower health utility. Transplantation is life saving; however, physical and psychological sequelae continue to affect health status up to two decades later.

Living donor liver transplantation (LDLT) decreases the shortage of liver grafts for patients in need of a liver transplant, but it involves 2 patients: a recipient and a living donor. Despite the magnitude of the procedure for LDLT donors, only a few studies have investigated the effect of LDLT on the quality of life (QOL) of donors. We performed a systematic search of the MEDLINE database to identify peer-reviewed articles assessing QOL in adults after LDLT donation. Nineteen studies describing 768 unique donors met our inclusion criteria for this review. The median number of donors enrolled in each study was 30 (range = 10-143), and the median follow-up period was 10.4 months (range = 3-51.3 months). Before donation, donor QOL was significantly better than that in control adult populations across all measured QOL domains. Within the first 3 months after donation, the physical domains of QOL were significantly worse than the predonation levels, but they returned to baseline levels within 6 months for the majority of patients (80%-93%). Mental domains of QOL remained unchanged throughout the donation process. Common donor concerns after LDLT included bloating, loss of muscle tone, poor body image, and fatigue. In conclusion, according to our review of the existing literature, most LDLT donors return to their baseline QOL within 6 months. However, there is a lack of long-term data on donor QOL after LDLT, and few standardized assessments include measures of common patient concerns. Additional studies are necessary to develop a comprehensive risk profile for LDLT that includes a rigorous assessment of donor QOL.