official website and that any information you provide is encrypted The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Department of Veteran Affairs. Some experts recommend an AUC0.70 as a threshold for responsiveness when using a criterion standard anchor but also acknowledge that criterion standards often do not exist for patient-reported outcomes (PROs) [29, 45]. KK, JK and POM designed the study, TMD, MBJ and EEK collected data, KK, TES, JK and POM nalyzed the data, KK and CXC drafted the manuscript. It should be noted that scores on these self-report scales represent depressive symptom severity rather than a depressive disorder diagnosis; the latter requires a clinical assessment. However, as already discussed, criterion standard anchors for patient-reported outcomes are lacking. J Orthop Res. In contrast, the SSM trial (sample 3) revealed larger SRMs for worsening with the PHQ-9 and PHQ-2. The PHQ-2 comprises the first two items of the PHQ-9 that capture depressed mood and anhedonia. Navas-Otero A, Calvache-Mateo A, Martn-Nez J, Calles-Plata I, Ortiz-Rubio A, Valenza MC, Lpez LL. Cronbachs alphas for baseline PROMIS raw scores in the three trials ranged from 0.89 to 0.95. In general, the measures were better able to detect depression improvement than worsening. Change in mood is rated on a 7-point scale with the following response options: 3 (much worse), 2 (moderately worse), 1 (a little worse), 0 (no change),+1 (a little better),+2 (moderately better), or+3 (much better). SRM values of 0.2, 0.5, and 0.8 represent thresholds for small, moderate and large changes, respectively [3, 21]. In contrast, the SSM trial (sample 3) revealed larger SRMs for worsening with the PHQ-9 and PHQ-2. The Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines consider SRMs and other effect size metrics an imperfect approach to assessing responsiveness [29] and also discuss the limitations of transition anchors such as global rating of change. Responses from the five items are summed and then transformed to a 0100 scale where a lower number represents more severe symptoms. 2017;123:32735. PDF Patient-Reported Outcome Measures (PROMs) Descriptions Deyo RA, Centor RM. We used both prospective and retrospective global ratings of change for mood as the anchors (i.e., criteria) to identify patients who had changed since baseline. The PROMIS Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. https://doi.org/10.1186/s12955-021-01674-3, DOI: https://doi.org/10.1186/s12955-021-01674-3. Yost KJ, Eton DT, Garcia SF, Cella D. Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients. For this reason, fixed-length scales have been offered as a viable option by PROMIS developers [4]. The proportion of patients reporting any improvement by retrospective GRC was 57%, 40%, and 57% in CAMEO, SPACE, and SSM, respectively. The study was approved by the Indiana University, Indianapolis Veteran Affairs (VA), and Minneapolis VA institutional review boards. See this image and copyright information in PMC. In contrast, scales did not distinguish worse from unchanged except in one instance (the PHQ-9 in the SPACE trial). Revicki D, Hays RD, Cella D, Sloan J. J Clin Epidemiol. It is scored 0 to 6 and has been validated as an ultra-brief screening tool [12] with some evidence of responsiveness [13, 14]. As shown in Table 2, all measures successfully detected differences among depression improved, unchanged, and worsened groups when classified by the prospective global rating of change for mood. The four PROMIS depression scales ranging from 4 to 8 items had similar responsiveness, a finding previously reported for PROMIS pain scales [20]. 2). For each scale, respondents are asked how often in the past 7days they have experienced specific depression symptoms, using a 5-point ordinal rating scale of Never, Rarely, Sometimes, Often, and Always. Raw score totals are converted to an item response theory-based T-scores. SRM values of 0.2, 0.5, and 0.8 represent thresholds for small, moderate and large changes, respectively [3, 21]. Depression Assessment Instruments - American Psychological Association Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, et al. Husted JA, Cook RJ, Farewell VT, Gladman DD. Kroenke K, Baye F, Lourens SG. PMC Deyo RA, Katrina R, Buckley DI, Michaels L, Kobus A, Eckstrom E, Forro V, Morris C. Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in older adults with chronic musculoskeletal pain. Medicinal cannabis for Australian patients with chronic refractory pain including arthritis. Specifically, patients were categorized into three groups based on global ratings of mood change: better, same, and worse. To find out more visit our privacy policy. Additional support was provided by the National Institute of Nursing Research under award number 5T32 NR007066, the Indiana UniversityPurdue University Indianapolis Enhanced Mentoring Program with Opportunities for Ways to Excel in Research (EMPOWER) Grant, KL2TR001106 and UL1TR001108 grants funded by the National Center for Advancing Translational Sciences Clinical and Translational Sciences Award, and Department of Veterans Affairs Rehabilitation Research and Development Career Development Award (IK2RX000879). For between-group responsiveness, we compared the amount of change between global rating of change groups. In a longitudinal study of 903 patients with 5 diverse diseases (4 medical conditions and major depressive disorder), two thirds of patients completed PROMIS by CAT and one-third with an 8-item short form [9]. PubMed Because the SRM estimates for the four PROMIS scales were similar, we reported averages of SRMs across the four PROMIS depression short forms in Fig. The mean SRM using the retrospective anchor for the PROMIS average, PHQ-9, and PHQ-2 scores across the CAMEO, SPACE and SSM trials was 0.39, 0.55, and 0.38 for the improved group; 0.19, 0.18, and 0.18 for the unchanged group; and 0.27, 0.28, and 0.20 for the worse group. Other p values were derived from pairwise comparisons of change scores between better vs. same, same vs. worse, and better vs. worse, and were adjusted for multiple comparisons using the TukeyKramer procedure. The purpose of this study was to assess and compare the responsiveness of the PROMIS and Patient Health Questionnaire (PHQ) depression scales in three separate samples. Eval Health Prof. 2017;40:10620. In contrast, the PHQ-9 and PROMIS 8-item short-form had similar responsiveness in identifying depression recovery in a longitudinal study of 701 patients with neurological or psychiatric disorders [8]. Area under the curve (AUC) is the probability of correctly discriminating between patients who have improved and those who have not. 2020;266:1008. Because the assessment and monitoring of depression relies principally on patient-reported symptoms, reliable and valid scales are essential for both research and clinical practice. Data from each of the three trials were analyzed separately rather than pooled, because the three trials involved different clinical populations, study interventions, and follow-up timeframes. PROMIS fatigue item bank had clinical validity across diverse chronic conditions. Across the PROMIS depression, PHQ-9 and PHQ-2 scales, the SRM point estimates were generally similar (Figs. The PROMIS depression and legacy scales had generally comparable responsiveness. J Pain. Askew RL, Cook KF, Revicki DA, Cella D, Amtmann D. Evidence from diverse clinical populations supported clinical validity of PROMIS pain interference and pain behavior. The PROMIS fixed-length scales for a specific domain share some items in common, which may explain in part their comparable responsiveness. Specifically, patients were categorized into three groups based on global ratings of mood change: better, same, and worse. Google Scholar. 1, within-group effect size estimates (i.e., SRMs) were plotted for the PROMIS depression and legacy measures across the three trials. Kroenke K, Baye F, Lourens SG. (, Evidence suggests that PROMIS Global-10 is not appropriate for all populations. Johns SA, Kroenke K, Krebs EE, Theobald DE, Wu J, Tu W. Longitudinal comparison of three depression measures in adult cancer patients. 1). Privacy The PHQ-2 comprises the first two items of the PHQ-9 that capture depressed mood and anhedonia. Norman GR, Stratford P, Regehr G. Methodological problems in the retrospective computation of responsiveness to change: the lesson of Cronbach. Notably, two of the trials only showed fair agreement beyond chance of these two anchors in classifying individuals as better, same or worse, and one trial showed poor to no agreement beyond chance. Responsiveness of PROMIS and Patient Health Questionnaire (PHQ J Clin Epidemiol. HHS Vulnerability Disclosure, Help Bethesda, MD 20894, Web Policies Any improvementa little better; moderate improvementmoderately better, 6month follow-up for CAMEO; 3months for SPACE and SSM. When using the retrospective global rating of change anchor (Table (Table3),3), the ability of measures to detect differences among the three groups was not quite as strong. The prospective global rating of change is the difference between an individuals cross-sectional global rating of mood at two time points (baseline minus follow-up) [17]. 2016;54:41421. Our study has several limitations. Assessing the responsiveness of functional scales to clinical change: an analogy to diagnostic test performance. The Patient Health Questionnaire (PHQ) is a self-report measure designed to screen depressive symptoms. DeLong ER, DeLong DM, Clarke-Pearson DL. Validation of the Fear and Avoidance of Memory Loss scale in community-based older adults. PubMed Central An official website of the United States government. Some researchers suggest an absolute SRM value0.3 indicates responsiveness [22]. The authors declare that they have no conflict of interest. Comparative validity and responsiveness of PHQ-ADS and other composite anxiety-depression measures. Responsiveness is also critical in clinical practice where the purpose is to detect clinically meaningful change over time in order to monitor and, if necessary, adjust treatment. The fact that both measures are public domain and available in numerous translations are additional advantages. Qual Life Res. Our study has several limitations. A higher T-score represents greater depression severity. Date:May 16, 2019 The 8a and 8b scales share 7 items in common and 1 unique item each. Hung M, Saltzman CL, Greene T, Voss MW, Bounsanga J, Gu Y, Anderson MB, Peters CL, Gililland J, Pelt CE. We measured global ratings of depression change, both prospectively and retrospectively, as anchors to classify patients as improved, unchanged, or worsened. Angst F: The new COSMIN guidelines confront traditional concepts of responsiveness. Data were analyzed from three randomized controlled trials (RCTs) conducted between 2012 and 2017. Pennings JS, Khan I, Davidson CA, Freitag R, Bydon M, Asher AL, Devin CJ, Archer KR. Alzheimers Dement (Amst). Turner D, Schunemann HJ, Griffith LE, Beaton DE, Griffiths AM, Critch JN, Guyatt GH. The .gov means its official. The SRM is the ratio of the mean change to the standardized deviation (SD) of change, and is calculated using the formula (mean baseline scoremean follow-up score)/(SD of change score). What is the Impact of Social Deprivation on Physical and Mental Health in Orthopaedic Patients? Children with JIA may experience difficulty with health related quality of life (HRQOL). In an observational study of 234 patients undergoing inpatient treatment in four psychosomatic rehabilitation centers, the pre-post treatment effect size was similar for the PROMIS depression item bank scale (using all 28 items) and the Center for Epidemiological Studies Depression scale (CES-D) (1.16 vs. 1.09) [7]. For all these reasons, the similarity of AUCs when using a global change anchors is more salient than their absolute value [48]. 42 The PROMIS-Preference (PROPr) . Psychiatry.org - Online Assessment Measures Askew RL, Cook KF, Revicki DA, Cella D, Amtmann D. Evidence from diverse clinical populations supported clinical validity of PROMIS pain interference and pain behavior. The purpose of this study was to assess and compare the responsiveness of the PROMIS and Patient Health Questionnaire (PHQ) depression scales in three separate samples. For example, retrospective anchor analyses in the CAMEO trial (sample 1) found larger absolute SRMs for improvement with the PHQ-9 compared to PROMIS but larger SRMs for worsening with the PROMIS. 2010;10:22. The mean SRM using the retrospective anchor for the PROMIS average, PHQ-9, and PHQ-2 scores across the CAMEO, SPACE and SSM trials was 0.39, 0.55, and 0.38 for the improved group; 0.19, 0.18, and 0.18 for the unchanged group; and 0.27, 0.28, and 0.20 for the worse group. Effect of Perioperative Palliative Care on Health-Related Quality of It should be noted that scores on these self-report scales represent depressive symptom severity rather than a depressive disorder diagnosis; the latter requires a clinical assessment. Characteristics of Frailty in Perimenopausal Women with Long COVID-19. Alternatively, it may be that one anchor is superior to another or that both anchors have limitations, but this would require additional research comparing both anchors to a third independent anchor. A prospective global measure, the Punum Ladder, provides more valid assessments of quality of life than a retrospective transition measure. PROMIS pediatric measures validated in a longitudinal study design in pediatric oncology. Unlike these previous studies that used either an observational design, a single sample, or PROMIS administration by CAT or the entire item bank, we used data from three RCTs and evaluated four PROMIS short forms of varying lengths. Although this anchor lead to more AUC estimates0.70, the sample size of those with moderate change by this anchor was small yielding wide confidence intervals. In a second observational study of 194 patients with depression treated for 12weeks, the PROMIS CAT was similar to the PHQ-9 and CES-D in terms of treatment effect size: 0.84, 0.98, and 1.06, respectively [5]. In most cases, the confidence interval for one measure includedthe point estimates of the other measures (Tables 1 and 2), which indirectly suggests statistically comparable within-group responsiveness across these three measures. This greater sensitivity of symptom scales for detecting improvement has been previously reported for depression [5, 16, 24], pain [20, 22, 25,26,27,28] and anxiety [24]. Clin Orthop Relat Res. Schmitt J, Di Fabio RP. Jensen RE, Moinpour CM, Potosky AL, Lobo T, Hahn EA, Hays RD, Cella D, Smith AW, Wu XC, Keegan TH, et al. In general, measures performed better in detecting depression improvement than depression worsening. Norman GR, Wyrwich KW, Patrick DL. PubMed Sample 3 (SSM trial) consisted of 258 stroke survivors participating in an RCT evaluating the efficacy of a stroke-self-management program. In a longitudinal study of 903 patients with 5 diverse diseases (4 medical conditions and major depressive disorder), two thirds of patients completed PROMIS by CAT and one-third with an 8-item short form [9]. Provided by the Springer Nature SharedIt content-sharing initiative. Disclaimer. 2010;32:34559. Evaluating instrument responsiveness in joint function: The HOOS JR, the KOOS JR, and the PROMIS PF CAT. Only a few studies have examined PROMIS depression scale responsiveness. Recent initiatives to incorporate depression and other patient-reported outcome measures into routine practice as well as embedding them in the electronic health record will further enhance symptom detection and management.[49]. The retrospective global rating of change has been widely used to assess responsiveness of patient-reported outcome measures [3, 16]. Samples 1 and 2 were enrolled from Veterans Administration (VA) primary care clinics, and Sample 3 comprised both Veteran and non-Veteran patients. International Journal of Mental Health, 7(3-4), 24-42. . Patient Health Questionnaire 9 items assessing depression symptoms in the past 2 weeks . Because measures seem better in detecting improvement than worsening, calculating the change in score together with a single question about global change may be desirable to optimize recognition of deterioration in symptom-based conditions like depression and pain. Follow-up assessments were conducted 6months after baseline for Sample 1 and 3months after baseline for Samples 2 and 3. A higher T-score represents greater depression severity. Methodologically, our study is relatively unique in using both retrospective and prospective global change anchors allowing assessment of responsiveness with two different global anchors. 2018;27:114757. First, we used omnibus ANOVA tests to compare mean change scores across global rating of change groups (i.e., improved, unchanged, and worsened). Fletcher KE, French CT, Irwin RS, Corapi KM, Norman GR. This work was supported by a National Institute of Arthritis and Musculoskeletal Disorders R01 award to (R01 AR064081) and Department of Veterans Affairs Health Services Research and Development Merit Review awards (IIR 10-128 and IIR 11-125), and VA HSRD QUERI Service Directed Project SDP-10-379). This site needs JavaScript to work properly. Methods for assessing responsiveness: a critical review and recommendations. Cella D, Lai JS, Jensen SE, Christodoulou C, Junghaenel DU, Reeve BB, Stone AA. Lowe B, Kroenke K, Grafe K. Detecting and monitoring depression with a two-item questionnaire (PHQ-2). As shown in Table Table2,2, all measures successfully detected differences among depression improved, unchanged, and worsened groups when classified by the prospective global rating of change for mood. Third, one legacy measure (SF-36 Mental Health) was used only in one trial (CAMEO). Moreover, the four PROMIS depression scales of varying lengths were similarly responsive. Evidence Synthesis No. Two well-validated and widely-used depression measuresthe PHQ-9 and PROMIS scaleshave generally comparable responsiveness. Results: COSMIN guideline for systematic reviews of patient-reported outcome measures. For all three samples, participants were mostly male, non-Hispanic, white, married, and had some college education (Table (Table1).1). Deyo RA, Centor RM. Cella D, Lai JS, Jensen SE, Christodoulou C, Junghaenel DU, Reeve BB, Stone AA. 2007;16:81522. J Clin Epidemiol. Our findings provide initial evidence of responsiveness which should be further tested in other patient samples using additional responsiveness metrics. Author's response. Katz P, Pedro S, Alemao E, Yazdany J, Dall'Era M, Trupin L, Rush S, Michaud K. Estimates of responsiveness, minimally important differences, and patient acceptable symptom state in five patient-reported outcomes measurement information system short forms in systemic lupus erythematosus. For this reason, fixed-length scales have been offered as a viable option by PROMIS developers [4]. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. Kroenke, K., Stump, T.E., Chen, C.X. Our findings provide initial evidence of responsiveness which should be further tested in other patient samples using additional responsiveness metrics. Correlations of the PROMIS-29 v2.0 physical and mental health summary scores with chronic conditions and other health-related quality of life measures were consistent with a priori hypotheses. We used both prospective and retrospective global ratings of change for mood as the anchors (i.e., criteria) to identify patients who had changed since baseline. Unable to load your collection due to an error, Unable to load your delegates due to an error. 1). The Patient Reported Outcomes Measurement Information System (PROMIS) a patient related outcome (PRO) measure, covers HRQOL domains that include physical function, mental health, and social interactions. PubMed Google Scholar. The mean SRM for the PROMIS average, PHQ-9, and PHQ-2 scores across the CAMEO, SPACE and SSM trials was 0.58, 0.63, and 0.53 for the improved group; 0.13, 0.27, and 0.16 for the unchanged group; and 0.29, 0.18, and 0.15 for the worse group. Using PROMIS-29 to predict Neck Disability Index (NDI) scores using a national sample of cervical spine surgery patients. 2019 Aug;477(8):1825-1835. doi: 10.1097/CORR.0000000000000698. Yost KJ, Eton DT, Garcia SF, Cella D. Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients.
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