Patient-Reported Treatment Satisfaction with Oral Rivaroxaban Versus Standard Therapy in the Treatment of Acute Symptomatic Pulmonary Embolism

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1163-1163 ◽  
Author(s):  
Martin Prins ◽  
Luke Bamber ◽  
Stefan Cano ◽  
Maria Wang ◽  
Anthonie WA Lensing ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Health Outcomes ◽  
Repeated Measures ◽  
Treatment Satisfaction ◽  
Repeated Measure ◽  
Patient Treatment ◽  
Patient Acceptance ◽  
Symptomatic Pulmonary Embolism ◽  
Patient Reported ◽  
Over Time

Abstract Abstract 1163 Background: Rivaroxaban treatment for symptomatic venous thromboembolism does not require routine laboratory monitoring, dose adjustments, or bridging with a parenteral anticoagulant and thus has the potential to reduce patient treatment burden compared with standard of care. It is becoming increasingly important to consider the views of patients in treatment decisions to improve adherence and, consequently, health outcomes. We investigated patient-reported outcomes in the EINSTEIN PE study, a large, open-label, randomized trial of patients with acute symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis. This trial compared oral rivaroxaban with dose-adjusted enoxaparin overlapping with, and followed by, vitamin K antagonist (VKA) treatment. Methods: As part of the EINSTEIN PE study, 2397 patients from 7 countries (Canada, France, Germany, Italy, Netherlands, UK, and USA) were requested to complete a newly developed and validated measure of anticoagulation treatment satisfaction – the Anti-Clot Treatment Scale (ACTS) – at scheduled visits during treatment: Day 15, then at Months 1, 2, 3, 6, and 12. The ACTS consists of 2 scales: ACTS Burdens (12 items, scored on a 12–60 scale) and ACTS Benefits (3 items, scored on a 3–15 scale). The ACTS Burdens scale captures the negative aspects of patients' anticoagulation experience (e.g. hassle/inconvenience, worry/frustration, and activity limitations), whereas the ACTS Benefits scale records the positive aspects (e.g. confidence, reassurance, and satisfaction). For each scale, higher total scores indicate better acceptance. In addition, patients completed the Treatment Satisfaction Questionnaire for Medication version II (TSQM II) at Months 1, 3, 6, and 12, primarily as a validation benchmark for the ACTS scale. There are 4 TSQM II subscales (Effectiveness, Side-Effects, Convenience, and Global Satisfaction), all of which are scored on a 0–100 scale. A pre-specified repeated measures analysis, stratified by intended treatment duration, with time (visit) as the repeated measure factor, was used to compare ACTS Burdens and ACTS Benefits scores between treatment groups in the intention-to-treat population; the analysis was repeated for the 4 TSQM II subscales. Results: Patients reported a lower burden and a higher perceived benefit in the rivaroxaban with higher mean ACTS scores across visits (Table). Mean ACTS Burdens scores were 55.4 versus 51.9 for rivaroxaban and enoxaparin/VKA, respectively (p<0.0001), and mean ACTS Benefits scores were 11.9 versus 11.4, respectively (p<0.001), in favorof rivaroxaban. The ACTS Burdens scores had a consistent treatment effect over time, but the difference in ACTS Benefits scores between the groups was not constant over time and showed a greater difference at Month 2 and later time points. The TSQM II scores confirmed the greater patient-reported treatment satisfaction, with higher scores shown in patients treated with rivaroxaban in all 4 subscales; the Convenience subscale had the largest difference. Conclusions: Patients with acute symptomatic pulmonary embolism reported a lower burden, higher perceived benefits, and improved treatment satisfaction with rivaroxaban compared with enoxaparin/VKA. The improved convenience of treatment, as perceived by patients, may contribute to increased patient acceptance of and adherence to anticoagulant treatment, with consequently improved health outcomes. Disclosures: Prins: Bayer Healthcare: Consultancy, Honoraria. Bamber:Bayer Healthcare: Employment. Cano:Bayer Healthcare: Research Funding. Wang:Bayer Healthcare: Employment. Lensing:Bayer Healthcare: Employment.

Safety profile of ripretinib, including impact of alopecia, and Palmar-Plantar Erythrodysesthesia Syndrome (PPES) on patient-reported outcomes (PROs), in ≥ fourth-line advanced gastrointestinal stromal tumors (GIST): Analyses from INVICTUS.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 11539-11539
Author(s):  
Suzanne George ◽  
Michael C. Heinrich ◽  
John Raymond Zalcberg ◽  
Sebastian Bauer ◽  
Hans Gelderblom ◽  
...  
Keyword(s):  
Safety Profile ◽  
Repeated Measures ◽  
Fixed Effects ◽  
Statistical Significance ◽  
P Value ◽  
Tolerability Profile ◽  
Patient Reported ◽  
The Impact ◽  
Advanced Gist ◽  
Over Time

11539 Background: Ripretinib is a novel switch-control TKI that broadly inhibits KIT and PDGFRA kinase signaling. In INVICTUS (NCT03353753), a randomized, double-blind, placebo (PBO)-controlled trial of ripretinib in ≥4th-line advanced GIST, ripretinib reduced the risk of disease progression or death by 85% vs PBO with a favorable overall safety profile. Common ( > 20%) adverse events (AEs) included, but were not limited to, alopecia and PPES. Exploratory analyses evaluated the impact of alopecia and PPES on quality of life (QoL). Methods: Patients (pts) with advanced GIST previously treated with at least imatinib, sunitinib, and regorafenib were randomized (2:1) to ripretinib 150 mg QD or PBO. AEs were graded using CTCAE v4 and PROs collected using EQ-5D-5L (EQ5D) and EORTC QLQ-C30 (C30). Repeated measures (RM) models assessed the impact of alopecia and PPES on 5 PROs (EQ5D visual analogue scale; and C30 physical functioning, role functioning, and the overall health and overall QoL questions) within the ripretinib arm. Fixed effects were sex, alopecia/PPES, and ECOG scores at baseline. Results: 128/129 randomized pts received treatment (85 ripretinib 150 mg QD; 43 PBO). Alopecia, regardless of causality, occurred in 44 (51.8%) on ripretinib (34 [40.0%] grade 1; 10 [11.8%] grade 2) and 2 (4.7%) on PBO (both grade 1). PPES occurred in 18 (21.2%) on ripretinib (11 [12.9%] grade 1; 7 [8.2%] grade 2); none on PBO. The median times in days to first occurrence and worst severity grade with ripretinib were 57.0 and 62.5 for alopecia; 56.5 and 57.0 for PPES. The RM models showed a slight trend towards improvement in PRO score over time for pts with alopecia; the only association reaching a P-value of < 0.05 was between alopecia and increased overall QoL. None of the associations between PPES and PRO scores reach P < 0.05. All PRO p-values are nominal, and no statistical significance is being claimed. Conclusions: Ripretinib had a favorable overall safety and tolerability profile. When stratified by alopecia and PPES, patient-reported assessments of function, overall health, and overall QoL were maintained over time. For both alopecia and PPES, onset and maximum severity occurred almost simultaneously, indicating that these events generally did not progressively worsen. These results suggest that alopecia and PPES are manageable and do not have a negative effect on function, overall health, and QoL. Clinical trial information: NCT03353753 .

Food Insecurity and Mental Health Trajectories During the COVID-19 Pandemic: Longitudinal Evidence

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 408-409
Author(s):  
Dexia Kong ◽  
Peiyi Lu ◽  
Elissa Kozlov ◽  
Mack Shelley
Keyword(s):  
Mental Health ◽  
Depressive Symptoms ◽  
Longitudinal Data ◽  
Health Outcomes ◽  
Food Insecurity ◽  
Repeated Measures ◽  
Mental Health Outcomes ◽  
Mixed Effect ◽  
Health Trajectories ◽  
Over Time

Abstract The extent to which food insecurity impacts changes in mental health outcomes over time in the context of Covid-19 remains unknown. Using longitudinal data from a nationally representative survey, the objectives of the present study were to: (1) assess the prevalence of food insecurity among U.S. adults amid the Covid-19 pandemic; and (2) investigate the relationships between food insecurity statuses and changes in mental health outcomes over time as the pandemic unfolds. Longitudinal data from the Internet-based Understanding Coronavirus in America survey collected bi-weekly between April and December 2020 were used (n=4,068, 15 repeated measures). Adult respondents (aged ≥18) were asked about their food insecurity experiences and stress/anxiety/depressive symptoms. Linear mixed-effect models examined changes in mental health outcomes over time among groups with various food insecurity statuses. Overall prevalence of food insecurity was 8%. Food insecurity was consistently associated with higher levels of stress/anxiety/depressive symptoms (p&lt;0.001). Stress/anxiety/depressive symptoms declined over time among food-secured U.S adults. However, mental health trajectories of respondents with various food insecurity categories, including food insecurity status, persistent food insecurity, and food insecurity of higher severity and longer duration, remained stable or worsened over time. Moreover, the mental health gap between food-secured and food-unsecured participants widened over time. Food insecurity represents a pressing public health problem during the Covid-19 pandemic with substantial mental health implications. Persistent and severe food insecurity may contribute to mental health disparity in the long term. Food insecurity reduction interventions may alleviate the estimated alarming mental health burden as the pandemic unfolds.

Effects of methylphenidate (MP) on symptom couplets associated with cancer-related fatigue (CRF) in patients with advanced cancer.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 191-191
Author(s):  
Sriram Yennu ◽  
Janet L. Williams ◽  
Minjeong Park ◽  
Diane D Liu ◽  
Eduardo Bruera
Keyword(s):  
Clinical Trials ◽  
Advanced Cancer ◽  
Treatment Effect ◽  
Repeated Measures ◽  
Repeated Measure ◽  
Significant Treatment Effect ◽  
Significant Treatment ◽  
Repeated Measures Analysis ◽  
Baseline Group ◽  
Over Time

191 Background: Psychostimulant clinical trials on CRF in pts with advanced cancer suggest mixed effects on CRF. The aim of this study was to determine the effects of MP and placebo (PL) on the pts with clinically significant CRF and associated symptoms such as depression, sedation, or depression and sedation (couplets). Methods: Secondary analysis of pts who received MP as a part of 3 prospective controlled clinical trials on MP for CRF. Pts were categorized one of 4 groups, fatigue+depression (FD), fatigue+ drowsiness (FDR), fatigue+drowsiness+depression (FDDR) or fatigue only (F), and outcomes were change in FACIT-F subscale and ESAS -fatigue scores at Day 8 of treatment with MP and PL. Repeated measures analysis was applied to assess the effects of treatment over time (Day8 – Day0) among the 4 groups on FACIT-F subscale and ESAS fatigue. Results: Of the 322 evaluable pts (34 FD, 100 FDR, 78 FDDR, 107F), at Day 8 there was a significant improvement in the ESAS fatigue in MP compared to PL groups [median (IQR)-2 (-4, -1) vs 2 (-3.5,0),p = 0.03, but the difference in the change of FACIT-F between the groups was not significant [median(IQR) 8(2,17) VS7(0,12), p = 0.09). Repeated measures analysis on FACIT-F with pairwise interactions(Time X Baseline Group, Time X Treatment) shows that regardless of treatment, the increase of FACIT-F from Day0 to Day8 was significantly different between FD and F (p = 0.001) and between FDDR and F (p = 0.03).However the change over time was not significantly different between two treatment groups (p = 0.23). Furthermore, the repeated measure analysis including three term interactions(Time X Treatment X Baseline Group) indicates no significant the treatment effect on FACIT-F over time is not significantly different among the four groups (p = 0.89). Similarly, there is no significant treatment effect in ESAS fatigue score over time among the four groups. Conclusions: Although there was a general improvement in CRF (FACIT-F) scores over time, there was no significant treatment effect on this improvement over time among F or FD, or FDR, or FDDR groups defined by fatigue/depression/sedation in the whole study population. Further studies are needed.

scholarly journals Patient-reported outcomes among people living with HIV on single- versus multi-tablet regimens: Data from a real-life setting

PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0262533
Author(s):  
Sophie Degroote ◽  
Linos Vandekerckhove ◽  
Dirk Vogelaers ◽  
Charlotte Vanden Bulcke
Keyword(s):  
Depressive Symptoms ◽  
Mixed Models ◽  
Treatment Satisfaction ◽  
Real Life ◽  
Hiv Treatment ◽  
People Living With Hiv ◽  
Patient Reported ◽  
Hiv Symptoms ◽  
Living With Hiv ◽  
Over Time

Background The use of single-tablet regimens (STRs) in HIV treatment is ubiquitous. However, reintroducing the (generic) components as multi-tablet regimens (MTRs) could be an interesting cost-reducing strategy. It is essential to involve patient-reported outcome measures (PROs) to examine the effects of such an approach. Hence, this study compared PROs of people living with HIV taking an STR versus a MTR in a real world setting. Materials and methods This longitudinal study included 188 people living with HIV. 132 remained on a MTR and 56 switched to an STR. At baseline, months 1-3-6-12-18 and 24, participants filled in questionnaires on health-related quality of life (HRQoL), depressive symptoms, HIV symptoms, neurocognitive complaints (NCC), treatment satisfaction and adherence. Generalized linear mixed models and generalized estimation equations mixed models were built. Results Clinical parameters and PROs of the two groups were comparable at baseline. Neurocognitive complaints and treatment satisfaction did differ over time among the groups. In the STR-group, the odds of having NCC increased monthly by 4,1% as compared to the MTR-group (p = 0.035). Moreover, people taking an STR were more satisfied with their treatment after 6 months: the median change score was high: 24 (IQR 7,5–29). Further, treatment satisfaction showed a contrary evolution in the groups: the estimated state score of the STR-group increased by 3,3 while it decreased by 0,2 in the MTR-group (p = 0.003). No differences over time between the groups were observed with regard to HRQoL, HIV symptoms, depressive symptoms and adherence. Conclusions Neurocognitive complaints were more frequently reported among people on an STR versus MTR. This finding contrasts with the higher treatment satisfaction in the STR-group over time. The long-term effects of both PROs should guide the decision-making on STRs vs. (generic) MTRs.

Longitudinal toxicity analysis with novel summary metrics of lenalidomide maintenance in follicular lymphoma in ECOG-ACRIN 2408.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6511-6511
Author(s):  
Gita Thanarajasingam ◽  
Amylou C. Dueck ◽  
Paul J Novotny ◽  
Thomas Matthew Habermann ◽  
Ranjana H. Advani ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Repeated Measures ◽  
Area Under The Curve ◽  
Time Profile ◽  
Time Dependent ◽  
Time To Event ◽  
Patient Reported ◽  
Toxicity Analysis ◽  
Trends Over Time ◽  
Over Time

6511 Background: Conventional adverse event (AE) analysis (ToxC) focuses on incidence of grade (gr) 3+ toxicities, and fails to capture AE time profile. Novel metrics that reflect chronic low gr and overall AE burden are needed. We applied the Toxicity over Time (ToxT) approach to ECOG-ACRIN 2408 to depict time-dependent toxicity of lenalidomide (L) with rituximab maintenance (MR) in follicular lymphoma (FL), and we developed a novel summary metric of symptomatic AE burden, the maximum gr over time (MGOT). Methods: In E2408, high risk FL patients (pts) were randomized (1:2:2) to: A) bendamustine-rituxumab (BR) x 6 then MR x 2 years (yrs) vs B) BR-bortezomib x 6 then MR x 2 yrs vs C) BR x 6 then MR x 2 yrs + L x 1 yr (MRL). Analysis included 3 laboratory and 5 symptomatic AEs of highest incidence during maintenance on arms A and C. Treatment-related AEs of any gr were analyzed by ToxC and ToxT. Repeated measures, time-to-event (TTE) and area under the curve (AUC) analyses capture trends over time in ToxT. MGOT combines the 5 symptomatic AEs. Results: 104 randomized pts (30 MR, 74 MRL) were included. For the laboratory AEs, by ToxC, neutropenia incidence was significantly higher in MRL (84%) than MR (47%, p < .001). ToxT additionally shows neutropenia does not worsen over time (10/14/20% gr 1/2/3+ at c1, 6/21/12% gr 1/2/3+ at c12). For the symptomatic AEs, ToxC indicates 2% gr 3+ GI AEs. However, gr 1-2 GI AEs are more common on MRL (59%) than MR (26%, p < .001). ToxT AUC captures a higher burden of GI AEs over time on MRL(2.8) vs MR(1.4, p = .002). TTE depicts sooner GI AE onset in MRL (10% vs 0% gr 2+ GI by day 50, p = 0.03). Bar charts of incidence and grade by cycle illustrate this improves over time (34/7/4% gr 1/2/3+ at c1, 13/0/0% gr 1/2/3+ at c12). ToxT MGOT analyses demonstrate earlier time to gr 2+ symptomatic AE on MRL vs MR (63% vs 31% by day 50, p < .001) and suggest that overall AE burden over time is higher for patients on MRL(AUC 18.2) than MR(11.8, p < .001). Conclusions: ToxT depicts AE time profile and can guide AE interventions. Summary metrics suggest that symptomatic AEs occur earlier and their burden over time is higher on MRL. We are implementing ToxT in patient-reported AE data to better characterize pt tolerability.

Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of pulmonary embolism; results from the EINSTEIN PE trial

2015 ◽  
Vol 135 (2) ◽  
pp. 281-288 ◽  
Author(s):  
Martin H. Prins ◽  
Luke Bamber ◽  
Stefan J. Cano ◽  
Maria Y. Wang ◽  
Petra Erkens ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Treatment Satisfaction ◽  
Standard Therapy ◽  
Patient Reported

scholarly journals Retained Knowledge and Use of Evidence-Based Practice Concepts

2018 ◽  
Vol 13 (3) ◽  
pp. 239-247 ◽  
Author(s):  
Sarah A. Manspeaker ◽  
Dorice A. Hankemeier
Keyword(s):  
Clinical Practice ◽  
Repeated Measures ◽  
Evidence Based Practice ◽  
Athletic Trainers ◽  
Evidence Based ◽  
Perceived Knowledge ◽  
Convenience Sample ◽  
Patient Reported ◽  
Board Of Certification ◽  
Over Time

Context: To maintain certification, athletic trainers (ATs) are required to obtain continuing education units (CEUs) in the area of evidence-based practice (EBP). Longitudinal analysis of outcomes after attending a Board of Certification–approved Foundations of EBP course is lacking. Objective: To evaluate ATs' knowledge retention of and confidence in EBP concepts 12 months after a Foundations of EBP course. A secondary aim was to determine ATs' perceptions regarding barriers to, use of, and resources for EBP. Design: Repeated measures within-subjects survey. Setting: Online survey. Patients or Other Participants: Twenty-seven respondents (22% response rate) from a convenience sample of 123 ATs. Intervention(s): Board of Certification–approved Foundations of EBP category workshop. Main Outcome Measure(s): The survey instrument, Evidence-Based Concepts: Knowledge, Attitudes, and Use (EBCKAU), ascertained ATs' perceived EBP knowledge over a 12-month period. Descriptive statistics and correlations were calculated; repeated measures analysis of variance determined differences between scores. Responses to open-ended questions were catalogued according to themes and coded. Results: For the knowledge score, a statistically significant increase in perceived knowledge (F2.0,52.0 = 18.91, P &lt; .001) from preworkshop (6.40 ± 1.77) to immediately postworkshop (8.15 ± 1.51) and from before to 12 months after workshop (7.30 ± 1.64) was noted. Confidence in knowledge was statistically significantly different over time (z = −4.55, P &lt; .001). Both before and since the workshop, ATs reported low levels of incorporating patient-reported outcome measures (PROM) and were equally likely to use compilation research findings in their clinical practice. Barriers of time and available resources were identified, and patient care was reported as the primary area in which ATs envision future use of EBP. Conclusions: Athletic trainers improved immediate perceived knowledge and retained knowledge of EBP concepts over time; however, confidence in knowledge decreased over time. ATs did not implement the workshop concepts into their daily clinical practice.

scholarly journals Using Cluster Analysis to Explore Engagement and e-Attainment as Emergent Behavior in Electronic Mental Health

10.2196/14728 ◽  
2019 ◽  
Vol 21 (11) ◽  
pp. e14728
Author(s):  
Samineh Sanatkar ◽  
Peter Andrew Baldwin ◽  
Kit Huckvale ◽  
Janine Clarke ◽  
Helen Christensen ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Outcomes ◽  
Repeated Measures ◽  
Program Effectiveness ◽  
Emergent Behavior ◽  
Mental Health Outcomes ◽  
Trial Protocol ◽  
Self Assessment ◽  
Usage Patterns ◽  
Over Time

Background In most e-mental health (eMH) research to date, adherence is defined according to a trial protocol. However, adherence to a study protocol may not completely capture a key aspect of why participants engage with eMH tools, namely, to achieve personal mental health goals. As a consequence, trial attrition reported as non-adherence or dropout may reflect e-attainment, the discontinuation of eMH engagement after personal goals have been met. Clarifying engagement patterns, such as e-attainment, and how these align with mental health trajectories, may help optimize eMH design and implementation science. Objective This study aimed to use clustering techniques to identify real-world engagement profiles in a community of eMH users and examine if such engagement profiles are associated with different mental health outcomes. The novelty of this approach was our attempt to identify actual user engagement behaviors, as opposed to employing engagement benchmarks derived from a trial protocol. The potential of this approach is to link naturalistic behaviors to beneficial mental health outcomes, which would be especially informative when designing eMH programs for the general public. Methods Between May 2013 and June 2018, Australian adults (N=43,631) signed up to myCompass, a self-guided eMH program designed to help alleviate mild to moderate symptoms of depression, anxiety, and stress. Recorded usage data included number of logins, frequency of mood tracking, number of started and completed learning activities, and number of tracking reminders set. A subset of users (n=168) completed optional self-assessment mental health questionnaires (Patient Health Questionnaire-9 item, PHQ-9; Generalized Anxiety Disorder Questionnaire-7 item, GAD-7) at registration and at 28 and 56 days after sign-up. Another subset of users (n=861) completed the PHQ-9 and GAD-7 at registration and at 28 days. Results Two-step cluster analyses revealed 3 distinct usage patterns across both subsamples: moderates, trackers, and super users, signifying differences both in the frequency of use as well as differences in preferences for program functionalities. For both subsamples, repeated measures analysis of variances showed significant decreases over time in PHQ-9 and GAD-7 scores. Time-by-cluster interactions, however, did not yield statistical significance in both subsamples, indicating that clusters did not predict symptom reduction over time. Interestingly, users who completed the self-assessment questionnaires twice had slightly but significantly lower depression and anxiety levels at sign-up compared with users who completed the questionnaires a third time at 56 days. Conclusions Findings suggested that although users engaged with myCompass in different but measurable ways, those different usage patterns evoked equivalent mental health benefits. Furthermore, the randomized controlled trial paradigm may unintentionally limit the scope of eMH engagement research by mislabeling early mental health goal achievers as dropouts. More detailed and naturalistic approaches to study engagement with eMH technologies may improve program design and, ultimately, program effectiveness.

scholarly journals Fatigue is associated with disease activity in some, but not all, patients living with rheumatoid arthritis: disentangling “between-person” and “within-person” associations

2022 ◽  
Vol 6 (1) ◽  
Author(s):  
Grada A. Versteeg ◽  
Peter M. ten Klooster ◽  
Mart A. F. J. van de Laar
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Repeated Measures ◽  
Rating Scale ◽  
Pragmatic Trial ◽  
Tender Joint Count ◽  
Markers Of Inflammation ◽  
Patient Reported ◽  
Fatigue Severity ◽  
Over Time

Abstract Background Previous research has shown an unclear and inconsistent association between fatigue and disease activity in patients with rheumatoid arthritis (RA). The aim of this study was to explore differences in “between-person” and “within-person” associations between disease activity parameters and fatigue severity in patients with established RA. Methods Baseline and 3-monthly follow-up data up to one-year were used from 531 patients with established RA randomized to stopping (versus continuing) tumor necrosis factor inhibitor treatment enrolled in a large pragmatic trial. Between- and within-patient associations between different indicators of disease activity (C-reactive protein [CRP], erythrocyte sedimentation rate [ESR], swollen and tender joint count [ SJC and TJC], visual analog scale general health [VAS-GH]) and patient-reported fatigue severity (Bristol RA Fatigue Numerical Rating Scale) were disaggregated and estimated using person-mean centering in combination with repeated measures linear mixed modelling. Results Overall, different indices of disease activity were weakly to moderately associated with fatigue severity over time (β’s from 0.121 for SJC to 0.352 for VAS-GH, all p’s < 0.0001). Objective markers of inflammation (CRP, ESR and SJC) were associated weakly with fatigue within patients over time (β’s: 0.104–0.142, p’s < 0.0001), but not between patients. The subjective TJC and VAS-GH were significantly associated with fatigue both within and between patients, but with substantially stronger associations at the between-patient level (β’s: 0.217–0.515, p’s < 0.0001). Within-person associations varied widely for individual patients for all components of disease activity. Conclusion Associations between fatigue and disease activity vary largely for different patients and the pattern of between-person versus within-person associations appears different for objective versus subjective components of disease activity. The current findings explain the inconsistent results of previous research, illustrates the relevance of statistically distinguishing between different types of association in research on the relation between disease activity and fatigue and additionally suggest a need for a more personalized approach to fatigue in RA patients. Trial registration Netherlands trial register, Number NTR3112.

The Role of a Decision Rule in Symptomatic Pulmonary Embolism Patients with a Non-high Probability Ventilation-perfusion Scan

1997 ◽  
Vol 78 (02) ◽  
pp. 794-798 ◽  
Author(s):  
Bowine C Michel ◽  
Philomeen M M Kuijer ◽  
Joseph McDonnell ◽  
Edwin J R van Beek ◽  
Frans F H Rutten ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Decision Rule ◽  
Predictive Value ◽  
Patient Population ◽  
High Probability ◽  
Characteristic Curve ◽  
Stepwise Logistic Regression ◽  
Pulmonary Angiogram ◽  
Symptomatic Pulmonary Embolism ◽  
Perfusion Scan

Summary Background: In order to improve the use of information contained in the medical history and physical examination in patients with suspected pulmonary embolism and a non-high probability ventilation-perfusion scan, we assessed whether a simple, quantitative decision rule could be derived for the diagnosis or exclusion of pulmonary embolism. Methods: In 140 consecutive symptomatic patients with a non- high probability ventilation-perfusion scan and an interpretable pulmonary angiogram, various clinical and lung scan items were collected prospectively and analyzed by multivariate stepwise logistic regression analysis to identify the most informative combination of items. Results: The prevalence of proven pulmonary embolism in the patient population was 27.1%. A decision rule containing the presence of wheezing, previous deep venous thrombosis, recently developed or worsened cough, body temperature above 37° C and multiple defects on the perfusion scan was constructed. For the rule the area under the Receiver Operating Characteristic curve was larger than that of the prior probability of pulmonary embolism as assessed by the physician at presentation (0.76 versus 0.59; p = 0.0097). At the cut-off point with the maximal positive predictive value 2% of the patients scored positive, at the cut-off point with the maximal negative predictive value pulmonary embolism could be excluded in 16% of the patients. Conclusions: We derived a simple decision rule containing 5 easily interpretable variables for the patient population specified. The optimal use of the rule appears to be in the exclusion of pulmonary embolism. Prospective validation of this rule is indicated to confirm its clinical utility.

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