Promoting measurement-based care and quality measure development: The APA mental and behavioral health registry initiative.

Measurement-based care has important implications across multiple avenues in mental and behavioral health care, including clinical care, quality improvement, and accountability. Using measurement-based care to demonstrate that quality care is being provided within the context of cost-efficient care could strengthen the position of mental and behavioral health providers as critical members of the health care system. Yet when measurement-based care is used to assess performance of providers, and then that performance influences reimbursement, it must be done with great care and deliberation so as not to result in unintended consequences such as punishing providers. Given psychology's expertise in measurement, the American Psychological Association (APA) and its members are uniquely suited to be leaders in promoting measurement-based care to assess quality and value. In this policy analysis paper, we examine the importance of measurement-based behavioral and mental health care across a variety of public service populations. We describe the increased federal regulatory focus on promoting quality and cost efficient care, the importance of defining and measuring quality care, and introduce an important resource being developed by APA to promote provider engagement in measurement-based care and effective participation in payment reform efforts in health care. We conclude with specific recommendations for how the field can move forward with using measurement-based care to assess accountability. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

A Mixed-Methods Approach to Understanding Variation in Social Support Requirements and Implications for Access to Transplantation in the United States.

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.

Excluding patients from transplant due to social support: Results from a national survey of transplant providers.

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.

How important is social support in determining patients' suitability for transplantation? Results from a National Survey of Transplant Clinicians.

BACKGROUND: National 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. METHODS: The 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). RESULTS: Five 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 (p<0.05). For providers concerned with avoiding organ waste, social support was the most influential factor, while it was the least influential for clinicians concerned with fairness (p<0.05). CONCLUSIONS: Social 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.

Assessment in health psychology: Introduction to the special issue.

For the past 27 years, Psychological Assessment has been committed to publishing empirical research relevant to clinical assessment of basic and applied cognition, personality, interpersonal behavior, psychopathology, forensics, and biological psychology. There is growing interest in the use of patient-centered outcomes in medical/surgical care and for measuring health care performance. Patient-centered outcome measures complement traditional clinical outcomes of morbidity and mortality, capturing the patient's perspective regarding their health and its treatment. In this issue, we highlight 11 articles that address different aspects of such work. The articles in this special issue represent both the depth and breadth of the opportunities that exist for psychological assessment in the health setting. While there are countless patient-centered measures currently in use to measure health and health outcomes, the evidence base for their use can be quite variable (Butt, 2016). The hope is that future issues of Psychological Assessment will highlight more work in this area.

Improvement in patient-reported physical and mental health after parathyroidectomy for primary hyperparathyroidism.

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 < .05). 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.

Optimizing informed consent in living liver donors: Evaluation of a comprehension assessment tool.

Adult-to-adult living liver donation is associated with considerable risks with no direct medical benefit to liver donors (LDs). Ensuring that potential LDs comprehend the risks of donation is essential to medically and ethically justify the procedure. We developed and prospectively evaluated the initial psychometrics of an "Evaluation of Donor Informed Consent Tool" (EDICT) designed to assess LDs' comprehension about the living donation process. EDICT includes 49 true/false/unsure items related to LD informed consent. Consecutive LDs undergoing evaluation at 1 academic medical center from October 2012 to September 2014 were eligible for participation in pretest/posttest interviews. Medical records were reviewed for postdonation complications. Twenty-seven LDs participated (96% participation rate). EDICT demonstrated good internal consistency reliability at pretest, 2 days before donating (Cronbach's α = 0.78), and posttest, 1 week after donating (α = 0.70). EDICT scores significantly increased over time (P = 0.01) and demonstrated good test-retest reliability (r = 0.68; P < 0.001). EDICT was associated with race/ethnicity (P = 0.02) and relationship to the recipient (P = 0.01; pretest), and income (P = 0.01) and insurance (P = 0.01; posttest), but not with decisional conflict, preoperative preparedness, satisfaction, or decisional regret (pretest and posttest). Donor complications did not impact postdonation EDICT scores. In conclusion, EDICT has promising measurement properties and may be useful in the evaluation of informed consent for potential LDs.

Assessment of stress and self-efficacy for the NIH Toolbox for Neurological and Behavioral Function.

BACKGROUND AND OBJECTIVES: The NIH Toolbox for Neurological and Behavioral Function assessment battery contains measures in the domains of cognitive function, motor function, sensory function, and emotional health. It was designed for use in epidemiological and clinical trials health-related research. DESIGN: This paper describes the first phase of instrument development for the stress and self-efficacy subdomain of emotional health. Based on an extensive literature review and expert consultation, 127 measures were initially considered for inclusion in this subdomain, including measures of stress, self-efficacy, emotion regulation, and coping. RESULTS: Several measures, including emotion regulation and measures of coping strategies, did not meet criteria that were a priori established for inclusion. Psychometric properties of the remaining candidate measures were evaluated using data from five independent samples (combined N = 3175). Confirmatory and exploratory factor analyses indicated the Perceived Stress Scale and the General Self-Efficacy Scale each assessed single dimensions. CONCLUSIONS: Based on their psychometric performance, these two instruments were selected for inclusion and subsequent national norming for the NIH Toolbox.

National survey of adult transplant hepatologists on the pediatric-to-adult care transition after liver transplantation.

Adult transplant hepatologists face challenges in providing care to young adults who received liver transplants during childhood. Because prior studies have focused mainly on pediatric providers, understanding these issues from the perspective of the adult hepatologist may provide novel insights and identify key barriers to care in this population. We conducted a national survey of adult transplant hepatologists to assess factors that may affect the transition of recipients from pediatric care to adult care. More than half of transplant hepatologists from all United Network for Organ Sharing regions (236/408 or 57.8%) completed the survey, and they reported that only 46.1% of patients arrived at their first adult clinic with both adequate knowledge of their condition and a parent/guardian. Moreover, 32.4% reported having no transition strategy, and only 15.5% reported having a formal transition program. The respondents reported that the greatest barriers to optimal care were patients' poor adherence and their limited knowledge and management of their condition. Those who reported participating in a formal transition program were less likely to report an inability of patients to discuss the impact of their condition on their overall daily life, fitness, and sexuality as a barrier to transition (odds ratio = 0.40, 95% confidence interval = 0.16-1.00). Our survey suggests that a formalized transition process is uncommon in adult transplant hepatology clinics and that improving patient knowledge, understanding specific components of effective transition programs, and incorporating input from adult providers in designing such programs may improve this process.

A Pilot Assessment of Ethnic Differences in Cosmetic Outcomes following Breast Conservation Therapy.

BACKGROUND: One of the primary benefits of breast conserving therapy (BCT) is the potential ability to preserve the aesthetic appearance of the breast. However, current literature and clinical experience suggest that the aesthetic benefits of BCT may not be equally shared among ethnic groups. This is a pilot study that uses novel techniques to evaluate the cosmetic outcomes of African American and white women following BCT. METHODS: A total of 21 participants (10 African American and 11 white) completed the study. Cosmetic outcomes following BCT were evaluated by a multidisciplinary team using both quantitative and qualitative measures, including 3-dimensional photographic analysis and a pilot questionnaire. Preliminary measures were taken to evaluate the validity of the questionnaire. RESULTS: There were no statistically significant differences in objective measures of breast symmetry between African American patients and white patients (P > 0.05 in all cases). However, all raters reported the African American patients to have worse breast symmetry and appearance when compared with white patients. Interrater reliability was found to be fair with regard to the nipple complex questions [intraclass correlation (ICC), 0.56], good with regard to the breast mound questions (ICC, 0.66), and poor with regard to the scar appearance questions (ICC = 0.32). CONCLUSIONS: Although generalizing the results of this study is limited by the small sample size, it seems that there is a difference in the perception of cosmetic outcomes between white and African American patients. The novel techniques of cosmetic evaluation used in this study show promise toward identifying variables that can affect cosmetic outcome following BCT.

Perceptions of the risks and benefits of upper limb transplantation among individuals with upper limb amputations.

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.

Assessing psychological well-being: self-report instruments for the NIH Toolbox.

OBJECTIVE: Psychological well-being (PWB) has a significant relationship with physical and mental health. As a part of the NIH Toolbox for the Assessment of Neurological and Behavioral Function, we developed self-report item banks and short forms to assess PWB. STUDY DESIGN AND SETTING: Expert feedback and literature review informed the selection of PWB concepts and the development of item pools for positive affect, life satisfaction, and meaning and purpose. Items were tested with a community-dwelling US Internet panel sample of adults aged 18 and above (N = 552). Classical and item response theory (IRT) approaches were used to evaluate unidimensionality, fit of items to the overall measure, and calibrations of those items, including differential item function (DIF). RESULTS: IRT-calibrated item banks were produced for positive affect (34 items), life satisfaction (16 items), and meaning and purpose (18 items). Their psychometric properties were supported based on the results of factor analysis, fit statistics, and DIF evaluation. All banks measured the concepts precisely (reliability ≥0.90) for more than 98% of participants. CONCLUSION: These adult scales and item banks for PWB provide the flexibility, efficiency, and precision necessary to promote future epidemiological, observational, and intervention research on the relationship of PWB with physical and mental health.

Important and relevant symptoms including pain concerns in hepatocellular carcinoma (HCC): a patient interview study.

PURPOSE: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

Emotion assessment using the NIH Toolbox.

One of the goals of the NIH Toolbox for Assessment of Neurological and Behavioral Function was to identify or develop brief measures of emotion for use in prospective epidemiologic and clinical research. Emotional health has significant links to physical health and exerts a powerful effect on perceptions of life quality. Based on an extensive literature review and expert input, the Emotion team identified 4 central subdomains: Negative Affect, Psychological Well-Being, Stress and Self-Efficacy, and Social Relationships. A subsequent psychometric review identified several existing self-report and proxy measures of these subdomains with measurement characteristics that met the NIH Toolbox criteria. In cases where adequate measures did not exist, robust item banks were developed to assess concepts of interest. A population-weighted sample was recruited by an online survey panel to provide initial item calibration and measure validation data. Participants aged 8 to 85 years completed self-report measures whereas parents/guardians responded for children aged 3 to 12 years. Data were analyzed using a combination of classic test theory and item response theory methods, yielding efficient measures of emotional health concepts. An overview of the development of the NIH Toolbox Emotion battery is presented along with preliminary results. Norming activities led to further refinement of the battery, thus enhancing the robustness of emotional health measurement for researchers using the NIH Toolbox.

Measurement of fatigue in cancer, stroke, and HIV using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale.

OBJECTIVE: Given the importance of fatigue in cancer, stroke and HIV, we sought to assess the measurement properties of a single, well-described fatigue scale in these populations. We hypothesized that the psychometric properties of the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale would be favorable and that the scale could serve as a useful indicator of fatigue in these populations. METHODS: Patients were eligible for the study if they were outpatients, aged 18 or older, with a diagnosis of cancer (n=297), stroke (n=51), or HIV/AIDS (n=51). All participants were able to understand and speak English. Patients answered study-related questions, including the FACIT-F using a touch-screen laptop, assisted by the research assistant as necessary. Clinical information was abstracted from patients' medical records. RESULTS: Item-level statistics on the FACIT-F were similar across the groups and internal consistency reliability was uniformly high (α>0.91). Correlations with performance status ratings were statistically significant across the groups (range r=-0.28 to -0.80). Fatigue scores were moderately to highly correlated with general quality of life (range r=0.66-0.80) in patients with cancer, stroke, and HIV. Divergent validity was supported in low correlations with variables not expected to correlate with fatigue. CONCLUSIONS: Originally developed to assess cancer-related fatigue, the FACIT-F has utility as a measure of fatigue in other populations, such as stroke and HIV. Ongoing research will soon allow for comparison of FACIT-F scores to those obtained using the fatigue measures from the Patient-Reported Outcomes Measurement Information System (PROMIS®; www.nihpromis.org) initiative.

Longitudinal prospective assessment of sleep quality: before, during, and after adjuvant chemotherapy for breast cancer.

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

General population norms for the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI).

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.

Assessment of self-reported negative affect in the NIH Toolbox.

We report on the selection of self-report measures for inclusion in the NIH Toolbox that are suitable for assessing the full range of negative affect including sadness, fear, and anger. The Toolbox is intended to serve as a "core battery" of assessment tools for cognition, sensation, motor function, and emotional health that will help to overcome the lack of consistency in measures used across epidemiological, observational, and intervention studies. A secondary goal of the NIH Toolbox is the identification of measures that are flexible, efficient, and precise, an agenda best fulfilled by the use of item banks calibrated with models from item response theory (IRT) and suitable for adaptive testing. Results from a sample of 1763 respondents supported use of the adult and pediatric item banks for emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) as a starting point for capturing the full range of negative affect in healthy individuals. Content coverage for the adult Toolbox was also enhanced by the development of a scale for somatic arousal using items from the Mood and Anxiety Symptom Questionnaire (MASQ) and scales for hostility and physical aggression using items from the Buss-Perry Aggression Questionnaire (BPAQ).

Single-incision surgery has higher cost with equivalent pain and quality-of-life scores compared with multiple-incision laparoscopic cholecystectomy: a prospective randomized blinded comparison.

BACKGROUND: 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. STUDY DESIGN: 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. RESULTS: 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; p < 0.0001). 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; p < 0.0001); medical/surgical supplies (MI $3,312 ± $6,526 vs SI $5,102 ± $1,529; p < 0.0001); and anesthesia costs (MI $579 ± $7,616 vs SI $820 ± $23,957; p < 0.0001). 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. CONCLUSIONS: We show SI surgery to have higher costs than MI surgery with equivalent quality-of-life scores, pain analogue scores, and pain-medication use.

Development and validation of a symptom index for advanced hepatobiliary and pancreatic cancers: the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy (NCCN-FACT) Hepatobiliary-Pancreatic Symptom Index (NFHSI).

BACKGROUND: The 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire assesses health-related quality of life in patients with liver, bile duct, and pancreatic cancers. Although the FACT-Hep was initially derived from patient input, this study's researchers sought to verify adequate coverage of items by soliciting open-ended input from patients with advanced disease. METHODS: As part of a larger study in collaboration with the National Comprehensive Cancer Network (NCCN), 50 people (60% male, 80% caucasian, average age 60.4 years) with stage 3 or 4 hepatobiliary or pancreatic cancer were recruited. Participants generated and ranked up to 10 important symptoms and concerns that physicians should monitor when assessing the value of chemotherapy. Patients were also able to provide open-ended, qualitative information that was evaluated systematically. Ten expert physicians also provided input on priority symptoms. RESULTS: The resulting 18-item NCCN-FACT Hepatobiliary-Pancreatic Symptom Index (NFHSI-18) demonstrated high internal consistency (α = .89) and moderate to strong correlations with measures of physical well-being (ρ = .76), emotional well-being (ρ = 0.52), and functional well-being (ρ = 0.57). Scores on the NFHSI-18 were also highly correlated with the original hepatobiliary scale of the FACT-Hep (ρ = .82; all P < .001). Compared with patients with better performance status, patients with poor performance status had worse NFHSI-18 symptom scores, F(3,47) = 9.74; P = .0003. CONCLUSIONS: The NFHSI-18 assesses symptoms of importance to patients with hepatobiliary and pancreatic cancers and demonstrates promising measurement properties. The scale is a good candidate for brief symptom assessment in clinical trials.