A View of the Development of Patient-Reported Outcomes Measures, Their Clinical Integration, Electronification, and Potential Impact on Rehabilitation Service Delivery.

Recognition of the importance of a patient's perception of their status and experience has become central to medical care and its evaluation. This recognition has led to a growing reliance on the use of patient-reported outcome measures (PROMs). Nevertheless, although awareness of PROMs and acceptance of their utility has increased markedly, few of us have a good insight into their development; their utility relative to clinician-rated and performance measures such as the FIM and 6-minute walk test or how their "electronification" and incorporation into electronic health records (EHRs) may improve the individualization, value, and quality of medical care. In all, the goal of this commentary is to provide some insight into historical factors and technology developments that we believe have shaped modern clinical PROMs as they relate to medicine in general and to rehabilitation in particular. In addition, we speculate that while the growth of PROM use may have been triggered by an increased emphasis on the centrality of the patient in their care, future uptake will be shaped by their embedding in EHRs and used to improve clinical decision support though their integration with other sources of clinical and sociodemographic data.

Adaptive Measurement of Change: A Novel Method to Reduce Respondent Burden and Detect Significant Individual-Level Change in Patient-Reported Outcome Measures.

OBJECTIVE: To describe the adaptive measurement of change (AMC) as a means to identify psychometrically significant change in reported function of hospitalized patients and to reduce respondent burden on follow-up assessments. DESIGN: The AMC method uses multivariate computerized adaptive testing (CAT) and psychometric hypothesis tests based in item response theory to more efficiently measure intra-individual change using the responses of a single patient over 2 or more testing occasions. Illustrations of the utility of AMC in clinical care and estimates of AMC-based item reduction are provided using the Functional Assessment in Acute Care Multidimensional Computerized Adaptive Test (FAMCAT), a newly developed functional multidimensional CAT-based measurement of basic mobility, daily activities, and applied cognition. SETTING: Two quaternary hospitals in the Upper Midwest. PARTICIPANTS: Four hundred ninety-five hospitalized patients who completed the FAMCAT on 2 to 4 occasions during their hospital stay. INTERVENTION: N/A. RESULTS: Of the 495 patients who completed more than 1 FAMCAT, 72% completed 2 sessions, 13% completed 3, and 15% completed 4, with 22.1%, 23.4%, and 23.0%, respectively, exhibiting significant multivariate change. Use of the AMC in conjunction with the FAMCAT reduced respondent burden from that of the FAMCAT alone for follow-up assessments. On average, when used without the AMC, 22.7 items (range, 20.4-24.4) were administered during FAMCAT sessions. Post hoc analyses determined that when the AMC was used with the FAMCAT a mean±standard deviation reduction in FAMCAT number of items of 13.6 (11.1), 13.1 (9.8), and 18.1 (10.8) would occur during the second, third, and fourth sessions, respectively, which corresponded to a reduction in test duration of 3.0 (2.4), 3.0 (2.8), and 4.7 (2.6) minutes. Analysis showed that the AMC requires no assumptions about the nature of change and provides data that are potentially actionable for patient care. Various patterns of significant univariate and multivariate change are illustrated. CONCLUSIONS: The AMC method is an effective and parsimonious approach to identifying significant change in patients' measured CAT scores. The AMC approach reduced FAMCAT sessions by an average of 12.6 items (55%) and 2.9 minutes (53%) among patients with psychometrically significant score changes.

Association of Function, Symptoms, and Social Support Reported in Standardized Outpatient Clinic Questionnaires With Subsequent Hospital Discharge Disposition and 30-Day Readmissions.

OBJECTIVE: To determine whether patient-reported information, routinely collected in an outpatient setting, is associated with readmission within 30 days of discharge and/or the need for post-acute care after a subsequent hospital admission. DESIGN: Retrospective cohort study. Six domains of patient-reported information collected in the outpatient setting (psychological distress, respiratory symptoms, musculoskeletal pain, family support, mobility, and activities of daily living [ADLs]) were linked to electronic health record hospitalization data. Mixed effects logistic regression models with random intercepts were used to identify the association between the 6 domains and outcomes. SETTING: Outpatient clinics and hospitals in a Midwestern health system. PARTICIPANTS: 7671 patients who were hospitalized 11,445 times between May 2004 and May 2014 (N=7671). INTERVENTION: None. MAIN OUTCOME MEASURES: 30-day hospital readmission and discharge home vs facility. RESULTS: Domains were significantly associated with 30-day readmission and placement in a facility. Specifically, mobility (odds ratio [OR]=1.30; 95% confidence interval [CI], 1.16, 1.46), ADLs (OR=1.27; 95% CI, 1.13, 1.42), respiratory symptoms (OR=1.26; 95% CI, 1.12, 1.41), and psychological distress (OR=1.20; 95% CI, 1.07, 1.35) had the strongest associations with 30-day readmission. The ADL (OR=2.52; 95% CI, 2.26, 2.81), mobility (OR=2.35; 95% CI, 2.10, 2.63), family support (OR=2.28; 95% CI, 1.98, 2.62), and psychological distress (OR=1.38; 95% CI, 1.25, 1.52) domains had the strongest associations with discharge to an institution. CONCLUSIONS: Patient-reported function, symptoms, and social support routinely collected in outpatient clinics are associated with future 30-day readmission and discharge to an institutional setting. Whether these data can be leveraged to guide interventions to address patient needs and improve outcomes requires further research.

Does the Mode of PROM Administration Affect the Responses of Hospitalized Patients?

OBJECTIVE: To determine whether a multidimensional computerized adaptive test, the Functional Assessment in Acute Care Multidimensional Computerized Adaptive Test (FAMCAT), could be administered to hospitalized patients via a tablet computer rather than being orally administered by an interviewer. DESIGN: A randomized comparison of the responses of hospitalized patients to interviewer vs tablet delivery of the FAMCAT and its assessment of applied cognition, daily activity, and basic mobility. SETTING: Two quaternary teaching hospitals in the Upper Midwest. PARTICIPANTS: A total of 300 patients (127 men, 165 women), average age 61.2 (range, 18-97) hospitalized on medical services or rehospitalized on surgical services were randomly assigned to either a tablet (150) or an interview (150) group. INTERVENTION: Electronic tablet vs interview. MAIN OUTCOME MEASURES: Item response theory point estimates of the FAMCAT latent scales, their psychometric standard errors, number of items administered per domain, the determinant (an indicator of overall precision of the latent trait vector), as well as the time that patients required to complete their FAMCAT sessions. RESULTS: Of the 300 patients, 292 completed their assessments. The assessments of 4 individuals in each group was interrupted by clinical care and were not included in the analyses. A significant (P=.009) mode effect (ie, interview vs tablet) was identified when all outcome variables were considered simultaneously. However, the only outcome that was affected by the administration mode was test duration: tablet administration reduced the roughly 6-minute test time required by both approaches by only 20 seconds, which, though statistically significant, was clinically insignificant. CONCLUSIONS: The results of a FAMCAT assessment, at least for this cohort of hospitalized patients, are independent of administration via tablet computer or interview.

Levels of secretory leukocyte protease inhibitor expression in acute wounds.

OBJECTIVE: Even with our best practices, we are frequently unable to prevent slow and stalled wound healing-particularly in people with impaired circulation and conditions such as diabetes. As a result, greater insight into the nature of wound healing and alternative treatment approaches is needed. An avenue that may be of particular promise is increasing understanding of the role of secretory leukocyte protease inhibitor (SLPI) as there is evidence that it enhances wound healing, its expression increases in response to inflammation and infection, and it exhibits anti-protease, anti-inflammatory, antiviral antibacterial and antifungal activities. METHOD: The response of SLPI levels to wounding and skin injury was assessed by taking punch skin biopsies from healthy volunteers and assessing the levels of SLPI at the site of injury at the time of wounding (baseline) as well as one, two, three, four, seven, nine and 12 weeks later. RESULTS: A total of 35 volunteers took part in the study. Significant elevations were found: levels of SLPI were greatly increased, 12 times that at baseline, and remained elevated at three weeks despite re-epithelialisation having occurred. CONCLUSION: These findings not only suggest that levels of SLPI rise rapidly following wounding, but that these elevations are sustained, and continue to increase even when re-epithelialisation has occurred. These results suggest that the role and potential benefits of this protease inhibitor deserve further exploration.

Assessing whether ad hoc clinician-generated patient questionnaires provide psychometrically valid information.

BACKGROUND: The provision of psychometrically valid patient reported outcomes (PROs) improves patient outcomes and reflects their quality of life. Consequently, ad hoc clinician-generated questionnaires of the past are being replaced by more rigorous instruments. This change, while beneficial, risks the loss/orphaning of decades-long information on difficult to capture/chronically ill populations. The goal of this study was to assess to the quality of data retrieved from these legacy questionnaires. METHODS: Participants included 8563 patients who generated a total of 12,626 hospital admissions over the 2004-2014 study period. Items used to screen for issues related to function, mood, symptoms, and social support among patients with chronic disease were identified in our medical center's patient information questionnaire. Cluster and exploratory factor analyses (EFA) followed by multidimensional item response theory (MIRT) analyses were used to select items that defined factors. Scores were derived with summation and MIRT approaches; inter-factor relationships and relationships of factor scores to assigned diagnostic codes were assessed. Rasch analyses assessed the constructs' measurement properties. RESULTS: Literature review and clinician interviews yielded four hypothesized constructs: psychological distress/wellbeing, symptom burden, social support, and physical function. Rasch analyses showed that, while all had good measurement properties, only one, function, separated individuals well. In exploratory factor analyses (EFA), 11 factors representing depression, respiratory symptoms, musculoskeletal pain, family support, mobility, activities of daily living, alcohol consumption, weight loss, fatigue, neurological disorders, and fear at home were identified. Based on the agreement between EFA and cluster analyses as well as Cronbach's alpha, six domains were retained for analyses. Correlations were strong between activities of daily living and mobility (.84), and moderate between pain and mobility (.37) and psychological distress (.59) Known-group validity was supported from the relationships between factor scores and the relevant diagnostic code assignments (.12 to .20). CONCLUSIONS AND DISCUSSION: Items from ad hoc clinician-generated patient information questionnaires can be aggregated into valid factors that assess supportive care domains among chronically ill patients. However, the binary response options offered by many screening items limit their information content and consequently, as highlighted by Rasch analyses, their ability to meaningfully discriminate trait levels in these populations.

How Receptive Are Patients With Late Stage Cancer to Rehabilitation Services and What Are the Sources of Their Resistance?

OBJECTIVE: To describe the proportion and characteristics of patients with late stage cancer that are and are not receptive to receiving rehabilitation services, and the rationale for their level of interest. DESIGN: Prospective mixed-methods study. SETTING: Comprehensive cancer center in a quaternary medical center. PARTICIPANTS: Adults with stage IIIC or IV non-small cell or extensive stage small cell lung cancer (N=311). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Telephone-acquired responses to the administration of (1) the Activity Measure for Post Acute Care Computer Adaptive Test (AM-PAC-CAT); (2) numerical rating scales for pain, dyspnea, fatigue, general emotional distress, and distress associated with functional limitations; (3) a query regarding receptivity to receipt of rehabilitation services, and (4) a query about rationale for nonreceptivity. RESULTS: Overall, 99 (31.8%) of the study's 311 participants expressed interest in receiving rehabilitation services: 38 at the time of enrollment and an additional 61 during at least 1 subsequent contact. Participants expressing interest were more likely to have a child as primary caregiver (18.18% vs 9.91%, P=.04) and a musculoskeletal comorbidity (42.4% vs 31.6%, P=.05). Function-related distress was highly associated with receptivity, as were lower AM-PAC-CAT scores. Reasons provided for lack of interest in receiving services included a perception of their limited benefit, being too busy, and prioritization below more pressing tasks/concerns. CONCLUSIONS: One-third of patients with late stage lung cancer are likely to be interested in receiving rehabilitation services despite high levels of disability and related distress. These findings suggest that patient misperception of the role of rehabilitation services may be a barrier to improved function and quality of life. Efforts to educate patients on the benefits of rehabilitation and to more formally integrate rehabilitation as part of comprehensive care may curb these missed opportunities.

Nested Cohort Study to Identify Characteristics That Predict Near-Term Disablement From Lung Cancer Brain Metastases.

OBJECTIVE: To test whether the presence of patient- and imaging-level characteristics (1) are associated with clinically meaningful changes in mobility among patients with late-stage cancer with metastatic brain involvement, and (2) can predict their risk of near-term functional decline. DESIGN: Prospective nested cohort study. SETTING: Quaternary academic medical center. PARTICIPANTS: The study population consisted of a nested cohort of the patients with imaging-confirmed brain metastases (n=66) among a larger cohort of patients with late-stage lung cancer (N=311). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Functional evaluations with the Activity Measure for Post-Acute Care Computer Adaptive Test (AM-PAC-CAT) and symptom intensity ratings were collected at monthly intervals for up to 2 years. RESULTS: In exploratory univariate models, whole brain radiation therapy (WBRT) and imaging findings of cerebellar or brainstem involvement were associated with large AM-PAC-CAT score declines reflecting worsening mobility (-4.55, SE 1.12; -2.87, SE, 1.0; and -3.14, SE 1.47, respectively). Also in univariate models, participants with new neurologic signs or symptoms at imaging (-2.48; SE .99), new brain metastases (-2.14, SE .99), or new and expanding metastases (-2.64, SE 1.14) declined significantly. Multivariate exploratory mixed logistic models, including WBRT, cerebellar/brainstem location, presence of new and expanding metastases, and worst pain intensity, had excellent predictive capabilities for AM-PAC-CAT score declines of 7.5 and 10 points (C statistics ≥0.8). CONCLUSIONS: Among patients with lung cancer and brain metastases, cerebellar/brainstem location, new and expanding metastases, and treatment with WBRT may predict severe, near-term mobility losses and indicate a need to consider rehabilitation services.

Scrambler Therapy for the management of chronic pain.

PURPOSE: Chronic pain is a widespread and debilitating condition, encountered by physicians in a variety of practice settings. Although many pharmacologic and behavioral strategies exist for the management of this condition, treatment is often unsatisfactory. Scrambler Therapy is a novel, non-invasive pain modifying technique that utilizes trans-cutaneous electrical stimulation of pain fibers with the intent of re-organizing maladaptive signaling pathways. This review was conducted to further evaluate what is known regarding the mechanisms and mechanics of Scrambler Therapy and to investigate the preliminary data pertaining to the efficacy of this treatment modality. METHODS: The PubMed/Medline, SCOPUS, EMBASE, and Google Scholar databases were searched for all articles published on Scrambler Therapy prior to November 2015. All case studies and clinical trials were evaluated and reported in a descriptive manner. RESULTS: To date, 20 reports, of varying scientific quality, have been published regarding this device; all but one small study, published only as an abstract, provided results that appear positive. CONCLUSION: The positive findings from preliminary studies with Scrambler Therapy support that this device provides benefit for patients with refractory pain syndromes. Larger, randomized studies are required to further evaluate the efficacy of this approach.

Imaging and Clinical Characteristics Predict Near-Term Disablement From Bone Metastases: Implications for Rehabilitation.

OBJECTIVE: To distinguish which patients with bone metastases are at risk for near-term disablement in order to assist clinicians in assessing the appropriateness of referrals for rehabilitation services. DESIGN: Prospective cohort study. SETTING: National Cancer Institute-designated comprehensive cancer center imbedded in a tertiary medical center. PARTICIPANTS: Data were collected from members (n=78) of a patient cohort (N=311) with stage IIIB or IV non-small-cell lung cancer or extensive-stage small-cell lung cancer who developed new or progressive imaging-confirmed bone metastases during the 2-year course of the study. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Functional capabilities were assessed at 3- to 4-week intervals over the study's 2-year duration with the Activity Measure for Post-Acute Care Computer Adaptive Testing. RESULTS: Seventy-eight participants developed new or progressive bone metastases during the study. Most were men, and 83% had non-small-cell lung cancer. Metastases were most frequently located in the ribs (n=62), pelvis (n=49), or the thoracic (n=60) and lumbar spine (n=44). While neither the number of bone metastases nor their specific location was associated with near-term changes in patient mobility, their association with pain or a focal neurologic deficit was strongly associated with large declines in mobility. Similarly, patients whose imaging studies revealed new metastases and the expansion of established metastases were more likely to lose mobility. CONCLUSIONS: The total burden, specific locations, and overall distribution of bone metastases did not predict disablement. Patients with lung cancer-associated bone metastases are at markedly increased risk for declining mobility when their metastases are expanding in size and increasing in number, or are associated with pain or with new neurologic deficits.

Quantification of Myofascial Taut Bands.

OBJECTIVE: To assess the correlation of clinician-identified myofascial taut bands with their presence and characteristics on magnetic resonance elastography (MRE) imaging. DESIGN: Cross-sectional study. SETTING: A magnetic resonance imaging (MRI) research laboratory. PARTICIPANTS: A convenience sample of adults (N=65; 45 women, 20 men) identified by skilled musculoskeletal physicians as having upper trapezius myofascial pain-associated taut bands. INTERVENTIONS: Subjects had their taut bands outlined and were positioned within a 1.5T MRI machine. Shear waves were induced with a pneumatic transducer located over the belly of the involved muscle. Wave propagation was visualized with MRE images across a vibration cycle. Imaging data were assessed independently by 2 skilled MRE interpreters. MAIN OUTCOME MEASURES: The primary outcome measure was the determination of the intra- and interrater reliabilities of MRE taut band identification and their correlation with clinician identification of band presence. Secondary outcomes consisted of the elucidation of the physical characteristics of taut bands and their surrounding muscle tissue. RESULTS: MRE intra- and interrater reliability was excellent, with kappa coefficients and 95% confidence intervals (CIs) of .86 (.68-1.00) and .93 (.79-1.00), respectively. Stiffness in MRE-identified taut bands was elevated at a mean ± SD of 11.5±2.4 kPa and fell to 5.8±0.9 kPa in surrounding muscle tissue (P<.001); muscular tone in trapezius muscles without a taut band was relatively uniform at 6.6±2.1 kPa. Agreement between the physicians and the MRE raters, however, was relatively poor (63.1%; 95% CI, 50.2%-74.7%). CONCLUSIONS: Our findings suggest that while clinicians may overestimate, and current MRE techniques may underestimate, the presence of taut bands, these bands do exist, can be assessed quantitatively, and do represent localized areas of increased muscle stiffness.

Brief overview and assessment of the role and benefits of cognitive rehabilitation.

Cognition is one of our most important attributes. Arresting its decline, whether in association with normal aging or a diagnosis of mild cognitive impairment, acquired brain injury, or dementia, concerns everyone, regardless of whether their role is that of spouse, child, or clinician. This article provides a brief, and by necessity, somewhat superficial appraisal of the status of our knowledge of the benefits of cognitive rehabilitation in these conditions and the authors' assessment of its strengths and weaknesses. In summary, there is support for the belief that participation in exercise as well as socially and cognitively stimulating activities (whether or not rehabilitative in nature) is beneficial for all but perhaps those with the most severe dementia. Focused efforts at cognitive training/rehabilitation also appear potentially helpful but are best established for those with acquired brain injury. There are, however, caveats to this assessment. For example, cognitive retraining is resource and time intensive while, even for those most likely to benefit, its impact on their daily activities and quality of life remains unclear. In addition, responses to training may vary from person to person and are likely to be influenced by factors such as an individual's acceptance of the need for assistance. Future research may benefit from continued efforts to treat the patient holistically, fit the treatment to those most likely to benefit, and encouraging the translation of training effects to functioning in the real world.

Effects of patient-controlled abdominal compression on standing systolic blood pressure in adults with orthostatic hypotension.

OBJECTIVE: To assess the effects of patient-controlled abdominal compression on postural changes in systolic blood pressure (SBP) associated with orthostatic hypotension (OH). Secondary variables included subject assessments of their preferences and the ease-of-use. DESIGN: Randomized crossover trial. SETTING: Clinical research laboratory. PARTICIPANTS: Adults with neurogenic OH (N=13). INTERVENTIONS: Four maneuvers were performed: moving from supine to standing without abdominal compression; moving from supine to standing with either a conventional or an adjustable abdominal binder in place; application of subject-determined maximal tolerable abdominal compression while standing; and while still erect, subsequent reduction of abdominal compression to a level the subject believed would be tolerable for a prolonged period. MAIN OUTCOME MEASURES: The primary outcome variable included postural changes in SBP. Secondary outcome variables included subject assessments of their preferences and ease of use. RESULTS: Baseline median SBP in the supine position was not affected by mild (10mmHg) abdominal compression prior to rising (without abdominal compression: 146mmHg; interquartile range, 124-164mmHg; with the conventional binder: 145mmHg; interquartile range, 129-167mmHg; with the adjustable binder: 153mmHg, interquartile range, 129-160mmHg; P=.85). Standing without a binder was associated with an -57mmHg (interquartile range, -40 to -76mmHg) SBP decrease. Levels of compression of 10mmHg applied prior to rising with the conventional and adjustable binders blunted these drops to -50mmHg (interquartile range, -33 to -70mmHg; P=.03) and -46mmHg (interquartile range, -34 to -75mmHg; P=.01), respectively. Increasing compression to subject-selected maximal tolerance while standing did not provide additional benefit and was associated with drops of -53mmHg (interquartile range, -26 to -71mmHg; P=.64) and -59mmHg (interquartile range, -49 to -76mmHg; P=.52) for the conventional and adjustable binders, respectively. Subsequent reduction of compression to more tolerable levels tended to worsen OH with both the conventional (-61mmHg; interquartile range, -33 to -80mmHg; P=.64) and adjustable (-67mmHg; interquartile range, -61 to -84mmHg; P=.79) binders. Subjects reported no differences in preferences between the binders in terms of preference or ease of use. CONCLUSIONS: These results suggest that mild (10mmHg) abdominal compression prior to rising can ameliorate OH, but further compression once standing does not result in additional benefit.

Postacute care: reasons for its growth and a proposal for its control through the early detection, treatment, and prevention of hospital-acquired disability.

Postacute care costs have doubled over the past decade and now account for 17% of Medicare fee-for-service spending. Costs are forecast to continue to rise, paradoxically in large part in response to federal policies and efforts to control health care costs. This commentary introduces a potential solution to this situation and is divided into 4 parts. The first provides a brief review of the policies fostering this growth. The second assesses how the responses of health care providers, while inherently rational, are destructive to the system. The third identifies hospital-acquired disability as a modifiable driver in this scenario, and the fourth discusses how an improvement in detection and a redistribution of hospital-based rehabilitation services may be able to reverse this unsustainable growth.

Honorary authorship.

This issue of Archives of Physical Medicine and Rehabilitation includes an article by Rajasekaran et al that addresses the persistent, difficult, and unsettled issue of unwarranted authorship as it applies to physical medicine and rehabilitation. The findings that it exists and that its frequency is similar to the 25% to 50% rates reported in other medical specialties are discouraging but, unfortunately, not surprising. They do, however, warrant discussion. This commentary attempts to do so and begins with a review of Rajasekaran's findings. It then proceeds to compare them with other work in the literature and concludes with a discussion of (1) why unwarranted authorship matters; (2) if it matters, why does it matter; and (3) what we as authors, editors, and the publishing world can do about it. Our goal is to give us all an improved understanding of the situation as well a little more backbone when dealing with the pressures associated with both overt and covert suggestions for the inclusion of authors that we may believe are unwarranted.

Appropriateness of the treatment of fatigued patients with stage IV cancer.

BACKGROUND: Fatigue among patients with cancer is prevalent, disabling, and treatable. While fatigue management guidelines have been in place for a decade, their use remains unclear. METHODS: We surveyed 160 patients with stage IV lung (40), breast (40), colon (40), and prostate (40) cancer who reported moderate to severe fatigue (i.e., >5 of 10 on an 11-point numerical rating scale). Participants were queried about receipt of treatments in fatigue management domains emphasized in the National Comprehensive Cancer Network guidelines: general management strategies, activity enhancement, psychosocial strategies, and pharmaceuticals. RESULTS: The cohort was half male, had a mean age of 67, and reported an average fatigue rating of 6.4. Participants reported treatment or receipt of specific guidance in the fatigue management domains as follows: general management strategies 16.8 %, activity enhancement 11.9 %, psychosocial strategies 9.9 %, and pharmaceuticals 37.3 %. Fatigue >7 of 10 increased the likelihood of instruction in activity enhancement but no other domain. CONCLUSION: The low rates of guideline-congruent treatment reported here are concerning, particularly as better validated behavioral treatments were the least prescribed.

Cost considerations regarding the prospective surveillance model for breast cancer survivors.

For this article, the authors examined the cost implications of the prospective surveillance model (PSM) for breast cancer (BC) survivors, a comprehensive framework designed to preemptively reduce the incidence and virulence of common impairments. The model clearly has the potential of providing significant benefits. However, its accompanying costs and resource requirements remain unclear and may be substantial. Thus, it is critical to examine which BC survivors may benefit from the PSM, how much they will benefit, and the costs of this benefit before its implementation. Because the PSM is not rigidly prescriptive, its examination must allow for different scenarios with emphasis on 4 critical determinants of cost--whether all or only high-risk BC survivors participate, assessment frequencies and locations, the credentials of the assessors, and requirements for supportive equipment. Another issue is the distribution of its cost: hypothetical implementation strategies vary widely in their distribution of fiscal burden across key stakeholders--survivors, providers, and payers--whose financial responsibilities will be an important factor in whether and how rapidly they adopt the PSM. Accurate valuation of the PSM will require capture of direct and indirect cost savings and benefits. Currently, a lack of data regarding these parameters, as well as outcomes that can be reliably attributed to the PSM, impedes cost-effectiveness analyses. Because the PSM may enhance many health state characteristics, assessments that integrate overall composite measures with evaluations of common, discrete impairments may be required to comprehensively assess its benefits.

Improving the Delivery of Function-Directed Care During Acute Hospitalizations: Methods to Develop and Validate the Functional Assessment in Acute Care Multidimensional Computerized Adaptive Test (FAMCAT).

OBJECTIVE: To (1) develop a patient-reported, multidomain functional assessment tool focused on medically ill patients in acute care settings; (2) characterize the measure's psychometric performance; and (3) establish clinically actionable score strata that link to easily implemented mobility preservation plans. DESIGN: This article describes the approach that our team pursued to develop and characterize this tool, the Functional Assessment in Acute Care Multidimensional Computer Adaptive Test (FAMCAT). Development involved a multistep process that included (1) expanding and refining existing item banks to optimize their salience for hospitalized patients; (2) administering candidate items to a calibration cohort; (3) estimating multidimensional item response theory models; (4) calibrating the item banks; (5) evaluating potential multidimensional computerized adaptive testing (MCAT) enhancements; (6) parameterizing the MCAT; (7) administering it to patients in a validation cohort; and (8) estimating its predictive and psychometric characteristics. SETTING: A large (2000-bed) Midwestern Medical Center. PARTICIPANTS: The overall sample included 4495 adults (2341 in a calibration cohort, 2154 in a validation cohort) who were admitted either to medical services with at least 1 chronic condition or to surgical/medical services if they required readmission after a hospitalization for surgery (N=4495). INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Not applicable. RESULTS: The FAMCAT is an instrument designed to permit the efficient, precise, low-burden, multidomain functional assessment of hospitalized patients. We tried to optimize the FAMCAT's efficiency and precision, as well as its ability to perform multiple assessments during a hospital stay, by applying cutting edge methods such as the adaptive measure of change (AMC), differential item functioning computerized adaptive testing, and integration of collateral test-taking information, particularly item response times. Evaluation of these candidate methods suggested that all may enhance MCAT performance, but none were integrated into initial MCAT parameterization. CONCLUSIONS: The FAMCAT has the potential to address a longstanding need for structured, frequent, and accurate functional assessment among patients hospitalized with medical diagnoses and complications of surgery.