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Purpose: The purpose of this study was to perform a comprehensive systematic review of the literature on voicerelated patient-reported outcome (PRO) measures in adults and to evaluate each instrument for the presence of important measurement properties. Method: MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument databases were searched using relevant vocabulary terms and key terms related to PRO measures and voice. Inclusion and exclusion criteria were developed in consultation with an expert panel. Three independent investigators assessed study methodology using criteria developed a priori. Measurement properties were examined and entered into evidence tables. Results: A total of 3,744 studies assessing voice-related constructs were identified. This list was narrowed to 32 PRO measures on the basis of predetermined inclusion and exclusion criteria. Questionnaire measurement properties varied widely. Important thematic deficiencies were apparent: (a) lack of patient involvement in the item development process, (b) lack of robust construct validity, and (c) lack of clear interpretability and scaling. Conclusions: PRO measures are a principal means of evaluating treatment effectiveness in voice-related conditions. Despite their prominence, available PRO measures have disparate methodological rigor. Care must be taken to understand the psychometric and measurement properties and the applicability of PRO measures before advocating for their use in clinical or research applications. [ABSTRACT FROM AUTHOR]

Background The effect of awarding MELD exception points for hepatocellular carcinoma ( HCC) on patient-reported outcomes ( PROs) is unknown. We evaluated the physical and mental health-related quality of life ( HRQOL) and symptoms of anxiety and depression in liver transplant recipients with HCC compared to patients without HCC. Methods The single-center sample measured PROs before and after transplant, which included 1521 multisurvey measurement points among 502 adults (67% male, 28% HCC, follow-up time: <1-131 months). Data were analyzed using multivariable mixed-effects models. Results Longitudinal PRO values did not differ between persons who received HCC exception points and those who did not have HCC. Patients with HCC who did not receive exception points had reduced physical HRQOL ( P=.016), a late decline in mental HRQOL, and delayed reduction in anxiety (time-by-outcome interaction P<.050) compared to patients with HCC who received exception points. Conclusion Transplant recipients who received HCC exception points had PROs that were comparable to those of patients without HCC, and reported better physical HRQOL and reduced symptoms of anxiety compared to patients with HCC who did not receive exception points. These analyses demonstrate the impact of HCC exception points on PROs, and may help inform policy regarding HCC exception point allocation. [ABSTRACT FROM AUTHOR]

Background: The purpose of this study was to advance a checklist of evaluative criteria designed to assess patient-reported outcome (PRO) measures' developmental measurement properties and applicability, which can be used by systematic reviewers, researchers, and clinicians with a varied range of expertise in psychometric measure development methodology. Methods: A directed literature search was performed to identify original studies, textbooks, consensus guidelines, and published reports that propose criteria for assessing the quality of PRO measures. Recommendations from these sources were iteratively distilled into a checklist of key attributes. Preliminary items underwent evaluation through 24 cognitive interviews with clinicians and quantitative researchers. Six measurement theory methodological novices independently applied the final checklist to assess six PRO measures encompassing a variety of methods, applications, and clinical constructs. Agreement between novice and expert scores was assessed. Results: The distillation process yielded an 18-item checklist with six domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (5) scoring and interpretation, and (6) respondent burden and presentation. With minimal instruction, good agreement in checklist item ratings was achieved between quantitative researchers with expertise in measurement theory and less experienced clinicians (mean kappa 0.70; range 0.66-0.87). Conclusions: We present a simplified checklist that can help guide systematic reviewers, researchers, and clinicians with varied measurement theory expertise to evaluate the strengths and weakness of candidate PRO measures' developmental properties and the appropriateness for specific applications. Abbreviations: PRO, Patient-reported outcome; FDA, Food and Drug Administration; HRQOL, Health-related quality of life; COSMIN, COnsensus-based Standards for the selection of health Measurement INstruments; MID, Minimally important difference; MPH, Masters of Public Health; PhD, Doctor of Philosophy; DrPH, Doctor of Public Health [ABSTRACT FROM AUTHOR]

Abstract: Purpose: The aim of this study was to identify race and socioeconomic factors associated with worse outcomes among Tennessee children who sustain firearm injuries. Methods: We queried our institutional pediatric trauma registry and the Davidson County Regional Medical Examiner database for children ages 15 years and younger who sustained firearm injuries between July 1998 and July 2010. Descriptive statistics and logistic regression modeling were used to analyze demographic data, circumstance of injury (unintentional or intentional), odds of death, and characteristics of zip codes (total population, race distribution, and median income) where injuries occurred. Results: One hundred eighty-eight children (median age, 13.2 years; range, 1.1-15.8 years) sustained a firearm injury and were either admitted to our institution or were referred directly to the medical examiner. More whites (n = 109, or 58%) sustained a firearm injury than blacks (n = 79, or 42%), but blacks were overrepresented 2.5-fold more compared with the general Tennessee population. Fifty-four children (29%) died, of whom 35 (65%) were black and 19 (35%) were white (P < .001). Ninety-three children sustained unintentional firearm injuries, and 84 were intentional (n = 67, assault; n = 17, suicide). When data were stratified by intent, 67% of blacks and 12% of whites were assaulted (P < .001). After controlling for age and intent, black children were 4 times more likely to die of firearm injuries than whites (P = .008; 95% confidence interval, 1.4-11.3). Conclusion: In a sample of firearm-injured Tennessee children, blacks were notably overrepresented and far more likely to die than whites. Using zip code data will help to establish firearm injury prevention programs specific to disparate populations and to reduce both violent and accidental childhood firearm injuries. [Copyright &y& Elsevier]

Objective--To present an overview of methods for incorporating the measurement of health-related quality of life and patient satisfaction into a comprehensive outcomes assessment program in the organ transplantation setting. An introduction to basic psychometric concepts as they relate to survey instrument selection is presented, and the complementary nature of health status instruments and preference-based utility measures is discussed. The role of these concepts and measures in a transplant outcomes assessment and research program and the psychometric evidence for selected instruments are described. Data Sources--Descriptions of specific survey instruments were abstracted from published reports or manuals. Data describing the Vanderbilt Transplant Center Patient Satisfaction Inventory were derived from a single institution transplant outcomes research database. Study Selection and Data Extraction--Previously reported research was selected from the literature to provide brief examples of basic concepts, which are not intended to be a comprehensive review of these topics. Illustrative data from the Vanderbilt program were extracted from a longitudinal database. Data Synthesis-Data and published reports were synthesized for descriptive and illustrative purposes. Conclusions--This review describes various types of health-related quality of life and patient satisfaction outcomes assessment tools and measurement methods; introduces considerations relevant to survey instrument selection and development; and outlines the evolution of and psychometric support for a transplant center-wide outcomes assessment and research program. [ABSTRACT FROM AUTHOR]

: Background:Health-related quality of life and functional performance are important outcome measures following heart transplantation. This study investigates the impact of pre-transplant functional performance and post-transplant rejection episodes, obesity and osteopenia on post-transplant health-related quality of life and functional performance.: Methods:Functional performance and health-related quality of life were measured in 70 adult heart transplant recipients. A composite health-related quality of life outcome measure was computed via principal component analysis. Iterative, multiple regression–based path analysis was used to develop an integrated model of variables that affect post-transplant functional performance and health-related quality of life.: Results:Functional performance, as measured by the Karnofsky scale, improved markedly during the first 6 months post-transplant and was then sustained for up to 3 years. Rejection Grade ≥2 was negatively associated with health-related quality of life, measured by Short Form-36 and reversed Psychosocial Adjustment to Illness Scale scores. Patients with osteopenia had lower Short Form-36 physical scores and obese patients had lower functional performance. Path analysis demonstrated a negative direct effect of obesity (β = − 0.28, p < 0.05) on post-transplant functional performance. Post-transplant functional performance had a positive direct effect on the health-related quality of life composite score (β = 0.48, p < 0.001), and prior rejection episodes grade ≥2 had a negative direct effect on this measure (β = −0.29, p < 0.05).: Conclusions:Either directly or through effects mediated by functional performance, moderate-to-severe rejection, obesity and osteopenia negatively impact health-related quality of life. These findings indicate that efforts should be made to devise immunosuppressive regimens that reduce the incidence of acute rejection, weight gain and osteopenia after heart transplantation. J Heart Lung Transplant 2003; 22:000–000. [Copyright &y& Elsevier]

Abstract: Background: Live donor kidney transplantation is the treatment of choice for end-stage renal disease. Open donor nephrectomy (ODN) was the standard until the introduction of the laparoscopic donor nephrectomy (LDN) in 1995. Hand-assisted laparoscopic donor nephrectomy (HALDN) was added shortly thereafter. The laparoscopic techniques are associated with increased operating room times and equipment costs; however, these techniques speed patient return to normal activity. The aim of this study is to evaluate the cost of these techniques. Materials and Methods: A decision analysis model was developed to simulate outcomes for donors undergoing ODN, LDN, and HALDN. Outcomes were simulated from both the institutional perspective (IP) and the societal perspective (SP). Baseline values and ranges were determined from a systematic review of the literature. Sensitivity analyses were conducted to test model strength. Results: From the IP, ODN is the least costly strategy with a cost of $11,000, while the cost is $15,200 for HALDN and $15,800 for LDN. From the SP, HALDN is the least costly strategy costing $27,800, while the cost for LDN is $29,000 and for ODN is $41,000. In sensitivity analysis, ODN only became the dominant strategy if the days till return to work exceeded 58 in the HALDN strategy. LDN and HALDN were nearly equivalent as the rate of open conversion of LDN approached zero. Conclusions: HALDN is the least costly donor nephrectomy strategy, especially from the SP. The primary determinants of cost in this model are conversion to open and days till return to work. [Copyright &y& Elsevier]