PROMIS and legacy measures compared in a supportive care intervention for breast cancer patients and caregivers: Experience from a randomized trial.
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ABSTRACT: Objective
Accurate and efficient measurement of patient-reported outcomes is key in cancer symptom management trials. The newer Patient Reported Outcomes Measurement Information System (PROMIS) and previously developed measures of similar conceptual content (legacy) are available to measure symptoms and functioning. This report compares the performance of two sets of measures, PROMIS and legacy, in a recently completed trial of a supportive care intervention that enrolled breast cancer patients and their friend or family caregivers.Methods
Patient-caregiver dyads (N = 256) were randomized to either reflexology delivered by caregivers or usual care control. Post-intervention, PROMIS and legacy measures of symptoms and functioning were analyzed in relation to trial arm, while adjusting for baseline values. Responsiveness of the two sets of measures was assessed using effect sizes and P-values for the effect of trial arm on patients' and caregivers' symptom and functioning outcomes.Results
Similar conclusions about intervention effects were found using PROMIS and legacy measures for pain, fatigue, sleep, anxiety, physical, and social functioning. Different conclusions were obtained for patient and caregiver depression: legacy measures indicated the efficacy of reflexology, while PROMIS depression measure did not.Conclusion
Evidence of similar responsiveness supports the use of either set of measures for symptoms and functioning in clinical and general populations. Differences between PROMIS and legacy measures of depression need to be considered when choosing instruments for use in trials of supportive care interventions and in clinical practice.
SUBMITTER: Sikorskii A
PROVIDER: S-EPMC8009331 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 was recently developed to assess physical and mental health and provide an estimated EuroQol-5 Dimension (EQ-5D) score. This instrument needs to be validated for specific patient cohorts such as those with rotator cuff pathology.HypothesisThere is moderate to high correlation between the PROMIS Global-10 and legacy patient-reported outcome measures; PROMIS Global-10 will not show ceiling effects; and estimated EQ-5D scores will show good correlation and low variance with actual EQ-5D scores.Study designCohort study (diagnosis); Level of evidence, 2.MethodsA total of 323 patients with rotator cuff disease were prospectively enrolled before treatment. Each patient completed the PROMIS Global-10, EQ-5D, American Shoulder and Elbow Surgeons (ASES) shoulder assessment form, and Single Assessment Numeric Evaluation (SANE), and those with known rotator cuff tears completed the Western Ontario Rotator Cuff Index (WORC). Spearman correlations were calculated. Bland-Altman agreement tests were conducted between estimated EQ-5D scores from the PROMIS and actual EQ-5D scores. Ceiling and floor effects were assessed, defined as ≥15% respondents with highest or lowest possible score.ResultsCorrelation between the PROMIS Global-10 and EQ-5D was excellent (0.70, P < .0001). Correlation of the PROMIS physical scores was excellent-good with the ASES (0.62, P < .0001), good with the WORC (0.47, P < .0001), and good with the SANE (0.41, P < .0005). Correlation between the PROMIS mental scores was poor with the ASES (0.34, P < .0001), the WORC (0.32, P = .0016), and the SANE (0.24, P < .0001). No floor or ceiling effects were found. Agreement analysis showed substantial variance in individual scores, despite the overall similarity in mean scores between the estimated and actual EQ-5D scores, indicating poor agreement. Bland-Altman 95% limits of agreement for estimated EQ-5D scores ranged from 34% below to 31% above actual EQ-5D scores.ConclusionPhysical function scores of the PROMIS Global-10 show high correlation with legacy patient-reported outcome instruments, suggesting that it is a reliable tool for outcome assessment in a population with rotator cuff pathology. The large variability in 95% limit of agreement suggested that the estimated EQ-5D scores from the PROMIS Global-10 cannot replace traditional EQ-5D scores.
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Project description:BackgroundThe US Food and Drug Administration issued an Emergency Use Authorization for remdesivir use in patients with severe COVID-19.MethodsWe utilized data from 2 quaternary acute care hospitals. The outcomes of interest were the impact of remdesivir on in-hospital death by day 28 and time to recovery, clinical improvement, and discharge. We utilized Cox proportional hazards models and stratified log-rank tests.ResultsTwo hundred twenty-four patients were included in the study. The median age was 59 years; 67.0% were male; 17/125 patients (13.6%) who received supportive care and 7/99 patients (7.1%) who received remdesivir died. The unadjusted risk for 28-day in-hospital death was lower for patients who received remdesivir compared with patients who received supportive care (hazard ratio [HR], 0.42; 95% CI, 0.16-1.08). Although this trend remained the same after adjusting for age, sex, race, and oxygen requirements on admission (adjusted HR [aHR], 0.49; 95% CI, 0.19-1.28), as well as chronic comorbidities and use of corticosteroids (aHR, 0.44; 95% CI, 0.16-1.23), it did not reach statistical significance. The use of remdesivir was not associated with an increased risk of acute kidney injury (AKI) or liver test abnormalities. Although not statistically significant, the rate ratios for time to recovery, clinical improvement, and discharge were higher in women and black or African American patients.ConclusionsPatients on remdesivir had lower, albeit not significant, all-cause in-hospital mortality, and the use of remdesivir did not increase the risk for AKI. Promising signals from this study need to be confirmed by future placebo-controlled randomized clinical trials.
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Project description:BackgroundPatients diagnosed with high-grade gliomas experience a varying and complex symptom burden, and face a high mortality rate. As a consequence, patients with high-grade gliomas and their caregivers have imminent and changing rehabilitative and supportive care needs.ObjectivesTo give a detailed overview of non-pharmacological rehabilitative and supportive care interventions for patients with high-grade gliomas and/or their caregivers, and provide an appraisal of the methodological quality of these studies.MethodPubMed, Cumulative Index of Nursing and Allied Health Literature and Embase were searched for literature published from 1995 to May 2013. Data from eight studies were reviewed for substantive methods and results. Methodological quality was described and assessed using the scoring system for appraising mixed methods research and concomitantly appraising qualitative, quantitative and mixed methods primary studies in mixed study reviews.ResultsThe search yielded 914 unique publications, of which 9 were classified eligible for this review. There is preliminary evidence that cognitive group therapy improves memory skills in patients with high-grade gliomas, early physical training improves functional outcome and massage therapy reduces stress. Patients and caregivers found that telephone follow-up and a specialist nurse function was an effective and useful way to achieve information and support. Finally, psycho-education increased feelings of mastery among caregivers.ConclusionsAs evidence is beginning to emerge, there is a need for well-designed longitudinal and randomised controlled trials of non-pharmacological interventions in high-grade glioma patients and their caregivers in order to develop clinical guidelines for supportive and rehabilitative approaches in this unique population.
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Project description:Millennial caregivers, born between 1981 and 1996, are an understudied caregiver group. They experience stress-related consequences of caregiving and are unique in their developmental stage and generational norms. The purpose of this study was to understand the context of caregiving and stressors for these caregivers. In total, 42 caregivers were recruited through Research Match and social media platforms. Caregivers completed online surveys with open-ended response questions and 15 caregivers completed semistructured interviews. Data were analyzed deductively and inductively using the Stress Process Model as a framework. Millennial caregivers described uncertainty and disruption as overarching experiences. Stressors related to balancing caregiving, work, and family responsibilities were most prominent. Caregivers reported needing support from friends/family, health care team members, community, and work/governmental policy. Mental health treatment was identified as most helpful for managing stress. Millennial caregivers have distinctive contexts that impact their caregiving needs. Caregiving interventions must take these needs into consideration.
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Project description:The Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) scales are reliable and publicly accessible; however, little is known about how responsive they are to detect change in clinical trials and how their responsiveness compares with legacy measures. The study purpose was to evaluate responsiveness for the PROMIS-PI scales and to compare their responsiveness with legacy pain measures. We used data from 3 clinical trials totaling 759 participants. The clinical trials included patients with chronic low back pain (n = 261), chronic back or osteoarthritis pain (n = 240), and a history of stroke (n = 258). At both baseline and follow-up, participants completed PROMIS-PI scales and legacy pain measures (Brief Pain Inventory Interference scale; Pain, Enjoyment, General Activity scale; 36-Item Short Form Survey (SF-36) Bodily Pain scale; and Roland-Morris Disability Questionnaire). We measured global ratings of pain change, both prospectively and retrospectively, as anchors to identify patients as improved, unchanged, or worsened. Responsiveness was assessed with standardized response means, statistical tests comparing change groups, and area under the curve analysis. The PROMIS-PI scales had largely comparable responsiveness with the Brief Pain Inventory Interference and Pain, Enjoyment, General Activity scales. The 4 PROMIS-PI short forms had comparable responsiveness. For all pain questionnaires, responsiveness varied based on the study population and whether pain improved or worsened. PERSPECTIVE: This article presents 1) how responsive the PROMIS-PI scales were to detect change over time in the context of 3 clinical trials and 2) how their responsiveness compared with legacy pain measures. The findings can help researchers and clinicians choose between different patient-reported pain outcome measures.
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Project description:PurposeTo analyze time to completion of preoperative legacy patient-reported outcomes (PROs) and more recent computer adaptive Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires in patients with symptomatic femoroacetabular impingement syndrome undergoing primary hip arthroscopy.MethodsA retrospective analysis was conducted on patients undergoing hip arthroscopy by a single fellowship-trained hip arthroscopist. Inclusion criteria were patients undergoing primary arthroscopic hip surgery and completion of at least 1 legacy PRO or PROMIS questionnaire at the preoperative time point. Exclusion criteria were history of contralateral or ipsilateral hip surgery, non-English-speaking patients, patients who completed PROs by phone or by paper form, and patients who did not complete preoperative PROs. Legacy PROs included modified Harris Hip Score (mHHS), Hip Outcome Score (HOS), International Hip Outcome Tool (iHOT-12), and Hip Pain Visual Analog Scale (VAS-Pain). PROMIS PROs included Physical Function (PROMIS-PF), Pain Interference (PROMIS-PI), and Depression (PROMIS-D). Only preoperative PROs were included in the analysis. Completion time was calculated using the questionnaire start and stop time reported by the survey collecting software. The median and interquartile range of each PRO were reported for analysis of central tendency and statistical dispersion, respectively.ResultsA total of 1,901 patients and 269 patients were included in the legacy and PROMIS groups, respectively. The median time required for completion of each PRO in (minutes: seconds) format was as follows: mHHS (1:29), HOS (3:58), iHOT (2:11), VAS-Pain (0:32), PROMIS-PF (0:46), PROMIS-PI (0:37), and PROMIS-D (0:43). The interquartile range of the middle 50% of respondents was as follows; mHHS (0:58), HOS (2:46), iHOT (1:22), VAS-Pain (0:28), PROMIS-PI (0:19), PROMIS-D (0:29), and PROMIS-PF (0:20).ConclusionsThis study supports that preoperative PROMIS forms require less time to complete than preoperative legacy PROs and are not significantly influenced by age, race, or workers compensation status.Level of evidenceLevel IV, case series.
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Project description:Little is known about the decision-making processes around seeking more supportive care for dementia. Persons with dementia are often left out of decision-making regarding seeking more supportive care as their dementia progresses. This paper provides a description of findings from the Decision-making in Alzheimer's Research project (DMAR) investigating the process of decision-making about transitions to more supportive care. We conducted 61 qualitative interviews with two stakeholder groups: 24 persons with dementia, and 37 informal caregivers to explore supportive care decisions and associated decision-making factors from the perspectives of persons with dementia and their caregivers. We identified four main decisions that persons with dementia and their informal caregivers played a role in: (1) sharing household responsibilities; (2) limiting routine daily activities; (3) bringing in formal support; and (4) moving to a care facility. Based on our findings we developed a schematized roadmap of decision-making that we used to guide the discussion of our findings. Four crosscutting themes emerged from our analysis: unknowns and uncertainties, maintaining life as you know it, there's no place like home and resource constraints. These results will be incorporated into the development of instruments whose goal is to identify preferences of persons with dementia and their caregivers, in order to include persons with dementia in care decisions even as their dementia progresses.
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Project description:BackgroundSymptoms account for more than 400 million clinic visits annually in the USA. The SPADE symptoms (sleep, pain, anxiety, depression, and low energy/fatigue) are particularly prevalent and undertreated.ObjectiveTo assess the effectiveness of providing PROMIS (Patient-Reported Outcome Measure Information System) symptom scores to clinicians on symptom outcomes.DesignRandomized clinical trial conducted from March 2015 through May 2016 in general internal medicine and family practice clinics in an academic healthcare system.ParticipantsPrimary care patients who screened positive for at least one SPADE symptom.InterventionsAfter completing the PROMIS symptom measures electronically immediately prior to their visit, the 300 study participants were randomized to a feedback group in which their clinician received a visual display of symptom scores or a control group in which scores were not provided to clinicians.Main measuresThe primary outcome was the 3-month change in composite SPADE score. Secondary outcomes were individual symptom scores, symptom documentation in the clinic note, symptom-specific clinician actions, and patient satisfaction.Key resultsMost patients (84%) had multiple clinically significant (T-score ≥ 55) SPADE symptoms. Both groups demonstrated moderate symptom improvement with a non-significant trend favoring the feedback compared to control group (between-group difference in composite T-score improvement, 1.1; P = 0.17). Symptoms present at baseline resolved at 3-month follow-up only one third of the time, and patients frequently still desired treatment. Except for pain, clinically significant symptoms were documented less than half the time. Neither symptom documentation, symptom-specific clinician actions, nor patient satisfaction differed between treatment arms. Predictors of greater symptom improvement included female sex, black race, fewer medical conditions, and receiving care in a family medicine clinic.ConclusionsSimple feedback of symptom scores to primary care clinicians in the absence of additional systems support or incentives is not superior to usual care in improving symptom outcomes.Trial registrationclinicaltrials.gov identifier: NCT02383862.
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Project description:BackgroundSubstantial investment has gone into research on the efficacy and effectiveness of pharmaceutical and nonpharmacologic interventions for chronic pain. However, synthesizing this extensive literature is challenging because of differences in the outcome measures used in studies of similar or competing interventions. The absence of a common metric makes it difficult to replicate findings, pool data from multiple studies, resolve conflicting conclusions, or reach consensus when interpreting findings.MethodsThis study has a seven-member Advisory Council of chronic pain experts. Preliminary analyses will be performed on data from several large existing datasets; intermediate analyses will be performed using primary data collected from Amazon's Mechanical Turk (MTurk); and cross-validation will use primary data collected from a nationally-representative, probability-based panel. Target sample size for both primary datasets is 1500. The three study aims are as follows: Aim 1 will develop and evaluate links between the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS®-29) and legacy measures used for chronic pain such as the Roland-Morris Disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI). We will assess the best method of score linking and create crosswalk tables. Aim 2 will evaluate and refine the Impact Stratification Score (ISS) based on 9 PROMIS-29 items and proposed by the NIH Research Task Force on chronic low back pain. We will evaluate the ISS in terms of other indicators of condition severity and patient prognosis and outcomes and identify cut-points to stratify chronic pain patients into subgroups. Aim 3 will evaluate the strengths and limitations of MTurk as a data collection platform for estimating chronic pain by comparing its data to other data sources.DiscussionThe accomplishment of Aims 1 and 2 will allow direct comparison of results across past and future studies of chronic pain. These comparisons will help us to understand different results from seemingly similar studies, and to determine the relative effectiveness of all pharmaceutical and nonpharmacologic interventions for chronic pain across different trials. Aim 3 findings will provide valuable information to researchers about the pros and cons of using the MTurk platform for research-based data collection.Trial registrationClinicalTrials.gov: NCT04426812 ; June 10, 2020.
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Project description:BACKGROUND:Multimorbidity challenges the health-care system and requires innovative approaches. In 2015, a 4-month patient-centred interdisciplinary pragmatic intervention was implemented in primary care with the aim of supporting self-management for patients with multimorbidity. OBJECTIVE:To explore the perceptions and experiences of health-care professionals, patients and their caregivers with a 4-month patient-centred interdisciplinary pragmatic intervention in primary care. DESIGN:A descriptive, qualitative study using semi-structured interviews was conducted. SETTING AND PARTICIPANTS:A purposive sample of 30 participants was recruited from seven family medicine groups including patients, caregivers and health-care professionals (HCPs). Interviews were analysed using Thorne's interpretive description approach. RESULTS:Findings were grouped into the benefits and challenges of participating in the intervention. The programme allowed patients to adopt realistic and adapted objectives; to customize interventions to the patient's reality; and to help patients gain confidence, improve their knowledge, skills and motivation to manage their condition. Interprofessional collaboration eased the exchange of information via team meetings and electronic medical records. Challenges were related to collaboration, communication, coordination of work and integration of newly relocated HCPs mainly due to part-time assignments and staff turnover. HCPs part-time schedules limited their availability and hindered patients' follow-up. DISCUSSION AND CONCLUSION:This intervention was useful and rewarding from the HCPs, patients and caregivers' perspective. However, to ensure the success of this complex interdisciplinary intervention, implementers and managers should anticipate organizational barriers such as availability and time management of relocated HCPs.
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