Exercise is medicine in oncology: Engaging clinicians to help patients move through cancer.

Multiple organizations around the world have issued evidence-based exercise guidance for patients with cancer and cancer survivors. Recently, the American College of Sports Medicine has updated its exercise guidance for cancer prevention as well as for the prevention and treatment of a variety of cancer health-related outcomes (eg, fatigue, anxiety, depression, function, and quality of life). Despite these guidelines, the majority of people living with and beyond cancer are not regularly physically active. Among the reasons for this is a lack of clarity on the part of those who work in oncology clinical settings of their role in assessing, advising, and referring patients to exercise. The authors propose using the American College of Sports Medicine's Exercise Is Medicine initiative to address this practice gap. The simple proposal is for clinicians to assess, advise, and refer patients to either home-based or community-based exercise or for further evaluation and intervention in outpatient rehabilitation. To do this will require care coordination with appropriate professionals as well as change in the behaviors of clinicians, patients, and those who deliver the rehabilitation and exercise programming. Behavior change is one of many challenges to enacting the proposed practice changes. Other implementation challenges include capacity for triage and referral, the need for a program registry, costs and compensation, and workforce development. In conclusion, there is a call to action for key stakeholders to create the infrastructure and cultural adaptations needed so that all people living with and beyond cancer can be as active as is possible for them.

Lymphedema Rates Following Axillary Lymph Node Dissection With and Without Immediate Lymphatic Reconstruction: A Prospective Trial.

BACKGROUND: Immediate lymphatic reconstruction (ILR) has been proposed to decrease lymphedema rates. The primary aim of our study was to determine whether ILR decreased the incidence of lymphedema in patients undergoing axillary lymph node dissection (ALND). METHODS: We conducted a two-site pragmatic study of ALND with or without ILR, employing surgeon-level cohort assignment, based on breast surgeons' preferred standard practice. Lymphedema was assessed by limb volume measurements, patient self-reporting, provider documentation, and International Classification of Diseases, Tenth Revision (ICD-10) codes. RESULTS: Overall, 230 patients with breast cancer were enrolled; on an intention-to-treat basis, 99 underwent ALND and 131 underwent ALND with ILR. Of the 131 patients preoperatively planned for ILR, 115 (87.8%) underwent ILR; 72 (62.6%) were performed by one breast surgical oncologist and 43 (37.4%) by fellowship-trained microvascular plastic surgeons. ILR was associated with an increased risk of lymphedema when defined as ≥10% limb volume change on univariable analysis, but not on multivariable analysis, after propensity score adjustment. We did not find a statistically significant difference in limb volume measurements between the two cohorts when including subclinical lymphedema (≥5% inter-limb volume change), nor did we see a difference in grade between the two cohorts on an intent-to-treat or treatment received basis. For all patients, considering ascertainment strategies of patient self-reporting, provider documentation, and ICD-10 codes, as a single binary outcome measure, there was no significant difference in lymphedema rates between those undergoing ILR or not. CONCLUSION: We found no significant difference in lymphedema rates between patients undergoing ALND with or without ILR.

Cancer-related Fatigue in Lung Cancer: A Research Agenda: An Official American Thoracic Society Research Statement.

Background: Fatigue is the most common symptom among cancer survivors. Cancer-related fatigue (CRF) may occur at any point in the cancer care continuum. Multiple factors contribute to CRF development and severity, including cancer type, treatments, presence of other symptoms, comorbidities, and medication side effects. Clinically, increasing physical activity, enhancing sleep quality, and recognizing sleep disorders are integral to managing CRF. Unfortunately, CRF is infrequently recognized, evaluated, or treated in lung cancer survivors despite more frequent and severe symptoms than in other cancers. Therefore, increased awareness and understanding of CRF are needed to improve health-related quality of life in lung cancer survivors. Objectives: 1) To identify and prioritize knowledge and research gaps and 2) to develop and prioritize research questions to evaluate mechanistic, diagnostic, and therapeutic approaches to CRF among lung cancer survivors. Methods: We convened a multidisciplinary panel to review the available literature on CRF, focusing on the impacts of physical activity, rehabilitation, and sleep disturbances in lung cancer. We used a three-round modified Delphi process to prioritize research questions. Results: This statement identifies knowledge gaps in the 1) detection and diagnostic evaluation of CRF in lung cancer survivors; 2) timing, goals, and implementation of physical activity and rehabilitation; and 3) evaluation and treatment of sleep disturbances and disorders to reduce CRF. Finally, we present the panel's initial 32 research questions and seven final prioritized questions. Conclusions: This statement offers a prioritized research agenda to 1) advance clinical and research efforts and 2) increase awareness of CRF in lung cancer survivors.

Risk factors for reduced function in women with a history of breast cancer.

PURPOSE: People with a history of breast cancer are at risk of losing function during and after treatment. Unfortunately, little is known about the individual and additive effects of specific treatment, disease-related, and demographic factors that may contribute to functional decline. This manuscript reports the results of a multi-center study to evaluate the effects of these factors on function. METHODS: In this cross-sectional study, women with a history of breast cancer referred to physical medicine and rehabilitation cancer rehabilitation clinics were administered the PROMIS® Cancer Function Brief 3D Profile to evaluate function in the domains of physical function, fatigue, and social participation. Clinical and demographic information, including treatment history and disease status, was recorded by clinicians. Patients were analyzed in two groups: those with active disease on antineoplastic treatment, and those with no evidence of disease (NED). A multivariable model was constructed to detect associations between clinical and demographic factors. RESULTS: In patients with NED, the presence of chemotherapy-induced peripheral neuropathy (CIPN) was strongly associated with reduced function in all three domains. In those with active disease, having brain metastases was significantly associated with reduced function in all domains and CIPN with reduced physical function. Radiation was associated with improved function in both cohorts. CONCLUSIONS: Among women seeking rehabilitative care, CIPN and the presence of brain metastases were most strongly associated with a decline in function. The effects of radiation on function were unexpected and may be partially explained by the treatment's role in symptom management. Clinicians who treat breast cancer should consider a patient's functional status when providing supportive care.

Implementing cancer symptom management interventions utilizing patient-reported outcomes: a pre-implementation evaluation of barriers and facilitators.

PURPOSE: Symptoms can negatively impact quality of life for patients with a history of cancer. Digital, electronic health record (EHR)-integrated approaches to routine symptom monitoring accompanied by evidence-based interventions for symptom management have been explored as a scalable way to improve symptom management, particularly between clinic visits. However, little research has evaluated barriers and facilitators to implementing these approaches in real-world settings, particularly during the pre-implementation phase. Pre-implementation assessment is critical for informing the selection and sequencing of implementation strategies and intervention adaptation. Thus, this study sought to understand pre-implementation perceptions of a remote cancer symptom monitoring and management intervention that uses electronic patient-reported outcome measures for symptom assessment. METHODS: We interviewed 20 clinical and administrative stakeholders from 4 geographic regions within an academic medical center and its affiliated health system during the months prior to initiation of a stepped-wedge, cluster randomized pragmatic trial. Transcripts were coded using the Consolidated Framework for Implementation Research [CFIR] 2.0. Two study team members reviewed coded transcripts to understand how determinants were relevant in the pre-implementation phase of the trial and prepared analytic memos to identify themes. RESULTS: Findings are summarized in four themes: (1) ability of the intervention to meet patient needs [recipient characteristics], (2) designing with care team needs in mind [innovation design and adaptability], (3) fit of the intervention with existing practice workflows [compatibility], and (4) engaging care teams early [engaging deliverers]. CONCLUSION: Attention to these aspects when planning intervention protocols can promote intervention compatibility with patients, providers, and practices thereby increasing implementation success.

Impact of comorbidities and extent of lymphadenectomy on quality of life in endometrial cancer patients treated with minimally invasive surgery in the era of sentinel lymph nodes.

OBJECTIVE: To identify predictors of quality of life (QoL) among patients who undergo surgical staging with sentinel lymph node (SLN) biopsy or lymphadenectomy for endometrial cancer. METHODS: Patients who underwent minimally invasive surgery for primary endometrial cancer at the Mayo Clinic from October 2013 to June 2016 were mailed a 30-item QoL in Cancer survey (QLQ-C30) and a validated 13-item lower extremity lymphedema screening questionnaire. Patients who answered <50% of the items or had a pre-operative history of lymphedema were excluded. Multivariable linear regression models were fit to evaluate predictors of QoL using inverse-probability of treatment weighting to adjust for differences at the time of the surgery between the lymphadenectomy and SLN groups. RESULTS: The 221 patients included in the analysis were stratified into two groups: patients who underwent (1) bilateral lymphadenectomy as 'backup' after SLN mapping (lymphadenectomy group; n=101) or (2) SLN removal with or without side-specific lymphadenectomy (SLN group; n=120). On multivariable analysis, obesity, lower extremity lymphedema, and kidney disease had significant (p<0.05) and clinically meaningful negative impacts on global QoL. Declines in average adjusted global QoL scores were marked (19.7 points lower) in patients with BMI ≥40 kg/m2 and lower extremity lymphedema compared with non-obese patients without lower extremity lymphedema. In contrast, there was only a 2.9 point difference in the adjusted average global QoL score between the SLN and lymphadenectomy groups. CONCLUSIONS: Lower extremity lymphedema coupled with obesity predicts poorer QoL in patients who undergo surgical staging for endometrial cancer. In this population, reduction of lower extremity lymphedema by performing SLN instead of lymphadenectomy and earlier targeted interventions may improve patients' QoL. Future research focusing on targeted interventions is needed.

Responsiveness and interpretation of the PROMIS Cancer Function Brief 3D Profile.

BACKGROUND: Measuring function with valid and responsive tools in patients with cancer is essential for driving clinical decision-making and for the end points of clinical trials. Current patient-reported outcome measurements of function fall short for many reasons. This study evaluates the responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3D Profile, a novel measure of function across multiple domains. METHODS: Two hundred nine participants across five geographically distinct tertiary care centers completed the assessment and pain rating at two outpatient cancer rehabilitation clinic visits. Patients and providers completed a global rating of change measure at the second visit to indicate whether the patient was improving or worsening in function. Multiple response indices and linear models measured whether the measure was responsive to self-reported and clinician-rated changes over time. Correlations between changes in function and changes in anchors (pain rating and performance status) were also calculated. RESULTS: Function as measured by the PROMIS Cancer Function Brief 3D Profile changed appropriately as both patients and clinicians rated change. Small to moderate effect sizes supported the tool's responsiveness. Function was moderately correlated with pain and more strongly correlated with performance status, and changes in function corresponded with changes in anchor variables. No floor/ceiling effect was found. CONCLUSIONS: The PROMIS Cancer Function Brief 3D Profile is sensitive to changes over time in patients with cancer. The measure may be useful in clinical practice and as an end point in clinical trials. LAY SUMMARY: We gave patients a questionnaire by which they told their physicians how well they were functioning, including how fatigued they were. This study tested that questionnaire to see whether the scores would change if patients got better or worse.

Factors Associated With Physical Activity Levels in Patients With Breast Cancer.

Physical activity (PA) is associated with improvement in breast cancer treatment-related symptoms and survival, yet most breast cancer survivors do not meet national PA guidelines. This study aimed to identify characteristics of participants that were associated with an increased likelihood of meeting PA guidelines. Adults with breast cancer seen at Mayo Clinic (Rochester, MN) were surveyed regarding their PA participation, and those who self-reported at least 150 minutes of moderate and/or strenuous aerobic PA weekly on average were considered to be "meeting guidelines". Three thousand participants returned PA data. Younger age, completion of the survey 7-12 years after diagnosis, absence of recurrence, no bilateral mastectomy, absence of metastatic disease, and lower BMI at the time of survey completion were associated with PA participation (P < .05 in univariate and multivariate analyses). Findings were similar when a threshold of 90 minutes was applied. These results may inform the development of targeted PA-facilitating interventions.

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.

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.

Correlation and Crosswalks Between Patient-Reported Functional Outcomes and PROMIS Physical Function Among Medically Ill Patients.

OBJECTIVES: To develop scoring crosswalks between a new multidomain patient-reported outcome measure, the Functional Assessment in Acute Care (FAMCAT), with a Patient-Reported Outcomes Measurement (PROMIS) measure of physical function, and examine correlations with existing legacy instruments. DESIGN: Cross-sectional, single-group design study. SETTING: Large, Midwestern academic teaching hospital. PARTICIPANTS: A sample of patients (N=1885; 53% men; average age, 62±16y) hospitalized on the general medical services between May 2016 and June 2017. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Scores from the FAMCAT administered via computerized adaptive testing were compared with scores on the 8-item PROMIS Physical Function (PROMIS PF) short form. RESULTS: Correlations with the FAMCAT and the PROMIS PF were strong for initial scores (MCAT_Mobilty: r=0.78, P<.0001; MCAT_DailyAct: r=0.81, P<.0001). The Applied Cognition scale did not demonstrate adequate correlations and thus was not a candidate for crosswalk scores. Although the MCAT_Mobility scale could be initially linked, subsequent analysis did not support a valid crosswalk. Linking criteria were applied with the Daily Activity scale to developing a final concordance table. CONCLUSIONS: The FAMCAT Daily Activity scale yielded robust correlations to develop crosswalk scores with the PROMIS PF. The resulting crosswalk conversion metric may be useful to compare outcomes across these constructs for assessing functional abilities among patients on general medical services. The Applied Cognition and Basic Mobility scales did not meet the criteria; therefore, alternate legacy instruments are needed to develop additional crosswalks.

Challenges in Measuring Applied Cognition: Measurement Properties and Equivalence of the Functional Assessment in Acute Care Multidimensional Computerized Adaptive Test (FAMCAT) Applied Cognition Item Bank.

OBJECTIVE: To present challenges in assessment of applied cognition and the results of differential item functioning (DIF) analyses used to inform the development of a computerized adaptive test (CAT). DESIGN: Measurement evaluation cohort study. DIF analyses of 107 items were conducted across educational, age, and sex groups. DIF hypotheses informed the evaluation of the results. SETTING: Hospital-based rehabilitation from a single hospital system. PARTICIPANTS: A total of 2216 hospitalized patients (N=2216). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Applied cognition item pool from multiple sources. RESULTS: Many items were hypothesized to show DIF, particularly for age. Information was moderately high in the lower (cognitive disability) tail of the distribution, but some items were not informative. Reliability estimates were high (>0.89) across all studied groups, regardless of estimation method. There were 35 items with DIF of high magnitude and 19 with accompanying supportive hypotheses. CONCLUSIONS: A key clinical tool in inpatient rehabilitation medicine is assessment of applied functional cognitive ability to inform patient-centered rehabilitation strategies to improve function. This was the first study to evaluate measurement equivalence of the applied cognition item pool across large samples of hospitalized patients. Although about one-third of the item pool evidenced DIF or low discrimination, results supported placement of most items into the bank and its use across groups differing in education, age, and sex. Six items were classified with salient DIF, defined as consistent DIF of high magnitude and or impact, with confirmatory directional DIF hypotheses, generated by content experts. These were recommended for adjustment or removal from the bank; 4 were deleted from the bank and 2 had lowered CAT exposure (administration frequency) rates. Many items hypothesized to show DIF contained content measuring constructs other than applied cognition such as physical frailty, perceptual difficulties, or skills reflective of greater educational attainment. Challenges in measurement of this construct are discussed.

Can Proxy Ratings Supplement Patient Report to Assess Functional Domains Among Hospitalized Patients?

OBJECTIVE: To (1) characterize the agreement between patient and proxy responses on a multidimensional computerized adaptive testing measure of function, and to (2) determine whether patient, proxy, or multidimensional computerized adaptive testing score characteristics identify when a proxy report can be used as a substitute for patient report in clinical decision making. DESIGN: A psychometric study of the Functional Assessment in Acute Care Multidimensional Computerized Adaptive Testing (FAMCAT) and its 3 scales (Applied Cognition, Daily Activity, and Basic Mobility). SETTING: An upper midwestern quaternary academic medical center PARTICIPANTS: A total of 300 pairs of patients (average age 60.9 years; range, 19-89) hospitalized on general medical services or readmitted to surgical services for postoperative complications and their proxies (average age 60.5 years; range, 20-88). INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: There were 3 outcomes: (1) agreement between patient and proxy scores on the FAMCAT domains, as well as age and sex, analyzed with univariate and multivariate analysis of variance (MANOVA); (2) associations of patient-proxy relationship and FAMCAT score characteristics with patient-proxy score agreement; and (3) presence of psychometrically significant intra-dyad differences in FAMCAT scores. RESULTS: The results of the MANOVA and follow-up ANOVAs indicated that there were no statistically significant differences in FAMCAT scale scores between patient and proxy estimates for either the Daily Activity or Basic Mobility scales. There were significant differences for the Applied Cognition scale (P<.005) between mean patient and proxy scores, with proxies rating patients as functioning at a higher level (mean=0.42) than patients did themselves (mean=0.00). However, psychometrically significant intra-dyadic Applied Cognition score differences occurred in only 14% of dyads, compared with 25% in the other 2 scales. Sex and age were associated with patient-proxy agreement, but the patterns were not sufficiently consistent to permit generalizations regarding the likely validity of a proxy's scores. CONCLUSIONS: Patient and proxy FAMCAT Daily Activity and Basic Mobility scores did not differ significantly, and proxy reporting offers a creditable surrogate for patient report on these domains. Low rates of psychometrically significant intra-dyadic score differences suggest that proxy report may serve as a low-resolution screen for functional deficits in all FAMCAT domains. Approximately half the proxies provided multi-domain profile ratings on the 3 scales that did not differ significantly from these of the associated patients, but more research is needed to identify situations in which proxy profiles could be used in place of those provided by patients.

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.

Ability of the Functional Assessment in Acute Care Multidimensional Computerized Adaptive Test (FAMCAT) to Predict Discharge to Institutional Postacute Care.

OBJECTIVE: To characterize the ability of the patient-reported Functional Assessment in Acute Care Multidimensional Computerized Adaptive Test (FAMCAT) domains to predict discharge disposition when administered during acute care stays. DESIGN: Cohort study. Logistic regression models were estimated to identify the ability of FAMCAT domains to predict discharge to an institution for postacute care (PAC). SETTING: Academic medical center. PARTICIPANTS: Patients admitted to general medicine services from June 2016 to June 2019 (n = 4240). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE(S): Discharge to an institution. RESULTS: In this sample, 10.5% of patients were discharged to an institution for rehabilitation versus home. FAMCAT domain scores were highly predictive of discharge to institutional PAC. Daily Activity and Basic Mobility domains had excellent discriminative ability for discharge to an institution (c-statistic, 0.83 and 0.87, respectively). In best fit models accounting for additional characteristics, discrimination was outstanding for Daily Activity (c-statistic, 0.91; 95% confidence interval, 0.89-0.94) and Basic Mobility (c-statistic 0.92; 95% confidence interval, 0.89-0.94). CONCLUSIONS: The FAMCAT Daily Activity and Basic Mobility domains demonstrated excellent discrimination for identifying patients who discharged to an institutional setting for rehabilitation and outstanding discrimination when adjusted for salient patient factors associated with discharge disposition. Estimates obtained in this investigation are comparable to the best discrimination achieved with clinician-rated measures to identify patients who would require institutional PAC.

Identifying Clinically Relevant Functional Strata to Direct Mobility Preservation Among Patients Hospitalized With Medical Conditions.

OBJECTIVE: To develop a system to guide interpretation of scores generated from the newly developed item response theory (IRT)-based Functional Assessment in Acute Care Multidimensional Computerized Adaptive Test (FAMCAT), which assesses 3 important domains of function: Mobility, Daily Activities, and Applied Cognition. DESIGN: Cross-sectional data was used to inform a modified Delphi approach to establish FAMCAT cutpoints delineating various functional ability levels. SETTING: Large midwestern academic teaching hospital. PARTICIPANTS: Patients hospitalized to an inpatient medical service (N=2049). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: FAMCAT Basic Mobility, Daily Activity, and Applied Cognition scores. RESULTS: IRT-based score estimation data was successfully integrated with expert clinical feedback using a modified Delphi process to arrive at consensus yielding 4 functional level strata (ranging from bed-based mobility to independent mobility) for both the FAMCAT Mobility and Daily Activity scales; 1 cutpoint was supported to delineate 2 functional strata for Applied Cognition. CONCLUSIONS: Meaningful cutpoints were established for each FAMCAT domain using a data-informed, modified Delphi process for achieving consensus. The resulting FAMCAT interpretation guide may be used to develop an ability-matched mobility preservation program and identify patients who may require a higher level of supervision based on the resulting FAMCAT scores.

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.

Examination of the Measurement Equivalence of the Functional Assessment in Acute Care MCAT (FAMCAT) Mobility Item Bank Using Differential Item Functioning Analyses.

OBJECTIVE: To assess differential item functioning (DIF) in an item pool measuring the mobility of hospitalized patients across educational, age, and sex groups. DESIGN: Measurement evaluation cohort study. Content experts generated DIF hypotheses to guide the interpretation. The graded response item response theory (IRT) model was used. Primary DIF tests were Wald statistics; sensitivity analyses were conducted using the IRT ordinal logistic regression procedure. Magnitude and impact were evaluated by examining group differences in expected item and scale score functions. SETTING: Hospital-based rehabilitation. PARTICIPANTS: Hospitalized patients (N=2216). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A total of 111 self-reported mobility items. RESULTS: Two linking items among those used to set the metric across forms evidenced DIF for sex and age: "difficulty climbing stairs step-over-step without a handrail (alternating feet)" and "difficulty climbing 3-5 steps without a handrail." Conditional on the mobility state, the items were more difficult for women and older people (aged ≥65y). An additional 18 items were identified with DIF. Items with both high DIF magnitude and hypotheses related to age were difficulty "crossing road at a 4-lane traffic light with curbs," "jumping/landing on one leg," "strenuous activities," and "descending 3-5 steps with no handrail." Although DIF of higher magnitude was observed for several items, the scale-level effect was relatively small and the exposure rate for the most problematic items was low (0.35, 0.27, and 0.20). CONCLUSIONS: This was the first study to evaluate measurement equivalence of the hospital-based rehabilitation mobility item bank. Although 20 items evidenced high magnitude DIF, 5 of which were related to stairs, the scale-level effect was minimal; however, it is recommended that such items be avoided in the development of short-form measures. No items with salient DIF were removed from calibrations, supporting the use of the item bank across groups differing in education, age, and sex. The bank may thus be useful to assist clinical assessment and decision-making regarding risk for specific mobility restrictions at discharge as well as identifying mobility-related functions targeted for postdischarge interventions. Additionally, with the goal of avoiding long and burdensome assessments for patients and clinical staff, these results could be informative for those using the item bank to construct short forms.

Multidimensional Computerized Adaptive Testing: A Potential Path Toward the Efficient and Precise Assessment of Applied Cognition, Daily Activity, and Mobility for Hospitalized Patients.

OBJECTIVE: To develop and evaluate an efficient and precise variable-length functional assessment of applied cognition, daily activity, and mobility to inform mobility preservation and rehabilitation service delivery among hospitalized patients. DESIGN: A multidimensional item bank tapping into these dimensions was developed, with all items calibrated using a multidimensional graded response model. The items were adaptively selected from the item banks to maximize the test information, and the test ended when a joint stopping rule was satisfied. A simulation study was conducted based on the completed instrument, the Functional Assessment in Acute Care Multidimensional Computerized Adaptive Test (FAMCAT), to compare its measurement precision and efficiency capabilities relative to conventional unidimensional computerized adaptive testing. Precision was measured by the bias and root mean squared error between the estimated and true (ie, simulated) θ estimates, whereas efficiency was measured by average test length. Data were collected by an interviewer reading questions from a tablet computer and entering patients' responses. SETTING: A large Midwestern hospital. PARTICIPANTS: A total of 4143 patients hospitalized with medical diagnosis and/or surgical complications, with 2060 in the calibration sample and 2083 in the validation cohort. INTERVENTION: Not applicable. RESULTS: Among the 2083 patients in the validation sample, FAMCAT administration required an average of 6 (SD=3.11) minutes. Ninety-six percent had their tests terminated by the standard error rule after responding to an average of 22.05 (SD=7.98) items, whereas 15 were terminated by the change in θ rule, with an average test length of 45.27 (SD=11.49). The remaining 76 responded until reaching the maximum test length of 60 items. CONCLUSIONS: The FAMCAT has the potential to satisfy the need for structured, frequent, and precise assessment of functional domains among hospitalized patients with medical diagnosis and/or surgical complications. The results are promising and may be informative for others who wish to develop similar instruments when concurrent assessment of correlated domains is required.

Psychometric Characteristics and Validity of the PROMIS Cancer Function Brief 3D Profile.

OBJECTIVE: To develop an item response theory (IRT)-calibrated, patient-reported outcome measure (the PROMIS Cancer Function Brief 3D Profile) of physical function, including associations with fatigue and social participation, in cancer rehabilitation patients. DESIGN: Large-scale field testing, graded response model IRT analyses, and multivariate regression analysis. SETTING: Six cancer rehabilitation clinics associated with cancer centers across the United States. PARTICIPANTS: Adults (N=616) treated in outpatient cancer rehabilitation medicine clinics. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: The PROMIS(r) Cancer Function 3D Profile (including existing items from PROMIS(r) item banks). RESULTS: A total of 616 patients completed 21 items in the initial item pool. Nine items were removed because of comparatively lower information that they provide according to the IRT item calibrations, low item-total correlations, or bimodal distributions. The remaining items generated a 12-item short form. Regression analyses determined that the items were responsive to and representative of the patient population across trait ranges and multiple domains and subdomains of function. CONCLUSIONS: This psychometric investigation supports the use of the PROMIS Cancer Function Brief 3D Profile for evaluating function in outpatient cancer rehabilitation patients.