scholarly journals Association between periodontal health status and patient‐reported outcomes in patients managed in a non‐specialist, general dental practice

2018 ◽  
Vol 45 (12) ◽  
pp. 1440-1447 ◽  
Author(s):  
Praveen Sharma ◽  
Zehra Yonel ◽  
Michael Busby ◽  
Iain L. Chapple ◽  
Thomas Dietrich
Keyword(s):  
Health Status ◽  
Patient Reported Outcomes ◽  
Dental Practice ◽  
Periodontal Health ◽  
General Dental Practice ◽  
Patient Reported

scholarly journals 2484. Patient Reported Outcomes After Switching to a 2-Drug Regimen of Dolutegravir + Rilpivirine: Week 148 Results from the Sword-1 and Sword-2 Studies

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S861-S861
Author(s):  
Alan Oglesby ◽  
Kostas Angelis ◽  
Yogesh Punekar ◽  
Vasiliki Chounta ◽  
Antonio Antela ◽  
...  
Keyword(s):  
Health Status ◽  
Treatment Satisfaction ◽  
Patient Reported Outcomes ◽  
Symptom Burden ◽  
Drug Regimen ◽  
Virologic Suppression ◽  
Symptom Bother ◽  
Alternative Treatment Option ◽  
Maximum Utility ◽  
Patient Reported

Abstract Background The SWORD-1 and SWORD-2 studies previously demonstrated that high rates of virologic suppression were maintained for 148 weeks after switching virologically suppressed HIV-1 infected adults from their current 3- or 4-drug antiretroviral regimen (CAR) to the 2-drug regimen (2DR) of dolutegravir + rilpivirine on Day 1 (Early Switch (ES) DTG+RPV group). This abstract reports the pooled SWORD-1/2 results of patient reported outcomes (PRO) measures through Week 148. Methods HIV Treatment Satisfaction Questionnaire (HIVTSQ) and Symptom Distress Module (SDM) were secondary PRO endpoints in the SWORD trials. For HIVTSQ, high scores represent greater treatment satisfaction (range 0 to 60). SDM was assessed using the Symptom Bother Score with low values indicating less symptom bother (range 0 to 80). The EQ-5D-5L measure of general health status was assessed as an exploratory endpoint with maximum utility score of 1 to indicate perfect health. Change from Baseline in these endpoints was calculated for the ES subjects (over 148 weeks). Subjects randomized to CAR switched to DTG+RPV at Week 52 (Late Switch (LS) DTG+RPV group) and change from LS Baseline (i.e., last pre-switch assessment) was calculated (over 96 weeks). Results Low Symptom Bother (9.6 and 10.3) and high TSQ scores (54.4 and 54.3) were reported pre-switch in the ES and LS groups, respectively. ES subjects reported modest improvements from Baseline in both symptom burden and overall treatment satisfaction in all visits through Week 148 (Figures 1 and 2). Among the LS group, there was little change in symptom burden but similar improvement in treatment satisfaction. Pre-switch health status was high in ES and LS groups (EQ-5D mean utility: 0.96 and 0.94, respectively) and remained stable in both groups at all time points. Conclusion High treatment satisfaction and low symptom burden that were observed in patients under CAR were maintained long term after switching to DTG+RPV. These results corroborate DTG+RPV as a well-tolerated 2DR alternative treatment option in patients currently suppressed on other 3/4-drug regimens without previous virologic failure. Disclosures All authors: No reported disclosures.

scholarly journals The HOPE Pilot Study: Harnessing Patient-Reported Outcomes and Biometric Data to Enhance Cancer Care

2018 ◽  
pp. 1-12 ◽  
Author(s):  
Alexi A. Wright ◽  
Nikita Raman ◽  
Patrick Staples ◽  
Stephanie Schonholz ◽  
Angel Cronin ◽  
...  
Keyword(s):  
Physical Activity ◽  
Health Status ◽  
Clinical Outcomes ◽  
Mobile Health ◽  
Symptom Management ◽  
Patient Reported Outcomes ◽  
Perceived Effectiveness ◽  
Activity Data ◽  
Patient Reported ◽  
Wearable Accelerometers

Purpose Integrating patient-reported outcomes (PROs) into clinical practice is an increasingly promising strategy for improving patients’ symptoms, communication, and clinical outcomes. The objective of the current study was to assess the feasibility, acceptability, and perceived effectiveness of a mobile health intervention that was designed to collect PROs and activity data as a measure of health status. Patients and Methods This work was a pilot intervention with 10 patients with gynecologic cancers who received palliative chemotherapy. The HOPE (Helping Our Patients Excel) study used wearable accelerometers to assess physical activity and the Beiwe research platform to collect PROs, stratify patient responses by risk, provide tailored symptom management, and notify patients and clinicians of high-risk symptoms. Feasibility and acceptability were assessed through enrollment and adherence rates, and perceived effectiveness was evaluated by patients and oncologists at study completion. Results The approach-to-consent rate was 100%, and participants were 90% and 70% adherent to the wearable accelerometers and smartphone surveys, respectively. Participants’ mean daily step count was 3,973 (standard deviation [SD], 2,305 steps) and increased from week 1 (mean, 3,520 steps; SD, 1,937 steps) to week 3 (mean, 4,136 steps; SD, 1,578 steps). Active monitoring of participants’ heart rates, daily steps, and PROs throughout the study identified anomalies in participants’ behavior patterns that suggested poor health for two patients (20%). Patients and clinicians indicated that the intervention improved physical activity, communication, and symptom management. Conclusion A mobile health intervention that collects PROs and activity data as a measure of health status is feasible, acceptable, and was perceived to be effective in improving symptom management in patients with advanced gynecologic cancers. A larger, multisite, randomized clinical trial to assess the efficacy of the HOPE intervention on patients’ symptoms, health-related quality of life, clinical outcomes, and health care use is warranted.

scholarly journals Preoperative mental health status may not be predictive of improvements in patient-reported outcomes following an anterior cervical discectomy and fusion

2017 ◽  
Vol 26 (2) ◽  
pp. 177-182 ◽  
Author(s):  
Benjamin C. Mayo ◽  
Dustin H. Massel ◽  
Daniel D. Bohl ◽  
Ankur S. Narain ◽  
Fady Y. Hijji ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Status ◽  
Patient Reported Outcomes ◽  
Patient Reported Outcome ◽  
Mental Health Status ◽  
Anterior Cervical Discectomy ◽  
Arm Pain ◽  
Vas Score ◽  
Patient Reported ◽  
Postoperative Time

OBJECTIVE Prior studies have correlated preoperative depression and poor mental health status with inferior patient-reported outcomes following lumbar spinal procedures. However, literature regarding the effect of mental health on outcomes following cervical spinal surgery is limited. As such, the purpose of this study is to test for the association of preoperative SF-12 Mental Component Summary (MCS) scores with improvements in Neck Disability Index (NDI), SF-12 Physical Component Summary (PCS), and neck and arm pain following anterior cervical discectomy and fusion (ACDF). METHODS A prospectively maintained surgical database of patients who underwent a primary 1- or 2-level ACDF during 2014–2015 was reviewed. Patients were excluded if they did not have complete patient-reported outcome data for the preoperative or 6-week, 12-week, or 6-month postoperative visits. At baseline, preoperative SF-12 MCS score was assessed for association with preoperative NDI, neck visual analog scale (VAS) score, arm VAS score, and SF-12 PCS score. The preoperative MCS score was then tested for association with changes in NDI, neck VAS, arm VAS, and SF-12 PCS scores from the preoperative visit to postoperative visits. These tests were conducted using multivariate regression controlling for baseline characteristics as well as for the preoperative score for the patient-reported outcome being assessed. RESULTS A total of 52 patients were included in the analysis. At baseline, a higher preoperative MCS score was negatively associated with a lower preoperative NDI (coefficient: −0.74, p < 0.001) and preoperative arm VAS score (−0.06, p = 0.026), but not preoperative neck VAS score (−0.03, p = 0.325) or SF-12 PCS score (0.04, p = 0.664). Additionally, there was no association between preoperative MCS score and improvement in NDI, neck VAS, arm VAS, or SF-12 PCS score at any of the postoperative time points (6 weeks, 12 weeks, and 6 months, p > 0.05 for each). The percentage of patients achieving a minimum clinically important difference at 6 months did not differ between the bottom and top MCS score halves (p > 0.05 for each). CONCLUSIONS The results of this study suggest that better preoperative mental health status is associated with lower perceived preoperative disability but is not associated with severity of preoperative neck or arm pain. In contrast to other studies, the present study was unable to demonstrate that preoperative mental health is predictive of improvement in patient-reported outcomes at any postoperative time point following an ACDF.

Identification of Cutpoints for Acceptable Health Status and Important Improvement in Patient-Reported Outcomes, in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

2009 ◽  
Vol 37 (1) ◽  
pp. 26-31 ◽  
Author(s):  
MARIA KNOPH KVAMME ◽  
IVAR SØNBØ KRISTIANSEN ◽  
ELISABETH LIE ◽  
TORE KRISTIAN KVIEN
Keyword(s):  
Rheumatoid Arthritis ◽  
Psoriatic Arthritis ◽  
Health Status ◽  
Ankylosing Spondylitis ◽  
Patient Reported Outcomes ◽  
Classification Systems ◽  
Operating Characteristics ◽  
Percentile Method ◽  
Important Improvement ◽  
Patient Reported

Objective.To identify cutpoints reflecting Patient Acceptable Symptom State (PASS) and Minimal Clinically Important Improvement (MCII) in patient-reported multi-attribute health status classification systems and health status measurements among patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA).Methods.We identified patients with RA, AS, and PsA from the Norwegian disease-modifying antirheumatic drug (DMARD) register (NOR-DMARD). The patients (n = 4225) had started with DMARD and responded to the PASS and MCII anchoring questions at the 3-month followup examination. Receiver operating characteristics (ROC) curves with 80% specificity and the 75th percentile approach were used to identify PASS and MCII cutpoints in the EuroQol-5 Dimensions (EQ-5D) and the Short-Form-6 Dimensions (SF-6D) indexes, but also in other patient-reported outcomes (joint pain and patient global visual analog scale and Modified Health Assessment Questionnaire).Results.The PASS cutpoints estimated with 80% specificity were around 0.70 in EQ-5D in all diseases and around 0.65 in SF-6D. The cutpoints were around 0.65 and 0.60, respectively, when the 75th percentile approach was used. The MCII cutpoints assessed by 80% specificity varied from 0.10 to 0.19 in EQ-5D and from 0.07 to 0.10 in SF-6D.Conclusion.The cutpoints for PASS in EQ-5D and SF-6D indicate that PASS corresponds to a health-related quality of life that is far from perfect health. Somewhat different cutpoints were identified for both PASS and MCII with 80% specificity versus the 75th percentile method.

scholarly journals Bring Your Own Device (BYOD): A practical framework to leverage in the electronic patient-reported outcomes(ePRO) data collection in clinical trials

2021 ◽  
Author(s):  
Aman Thukral ◽  
Kelsey Linsmeier ◽  
Brooks Fowler ◽  
Sanjay Bhardwaj
Keyword(s):  
Clinical Trials ◽  
Health Status ◽  
Data Collection ◽  
Patient Reported Outcomes ◽  
Bring Your Own Device ◽  
Regulatory Submission ◽  
Patient Reported ◽  
Personal Devices

Patient-reported outcomes (PROs) are used in pharmaceuticaltrials to obtain trends in health status. Companies commonly provision tabletand smartphone devices to collect PRO information. Alternatively, the BringYour Own Device (BYOD) model allows patients to leverage personal devices andis actively being explored as a solution.&nbsp; This article investigates thepotential benefits of BYOD and outlines a framework of considerations. Theframework addresses current challenges and proposes potential solutions toMeasurement Equivalence, Technical, and Operational concerns. BYOD has not yet beenimplemented on any studies for regulatory submission. Nonetheless, there isreason to believe the model will gain traction in the coming years. With theprovided framework, sponsors can assess whether the BYOD model is right for theconsidered study.

Health-related quality of life/patient-reported outcomes in relapsed ovarian cancer: Results from a randomized phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD alone

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5526-5526
Author(s):  
C. N. Krasner ◽  
A. Poveda ◽  
T. Herzog ◽  
J. Vermorken ◽  
B. Monk ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ovarian Cancer ◽  
Health Status ◽  
Patient Reported Outcomes ◽  
Phase Iii ◽  
Gi Symptoms ◽  
Patient Reported ◽  
Phase Iii Study ◽  
The Impact

5526 Background: In an open-label, multicenter, randomized phase III study comparing the combination of trabectedin and PLD to PLD alone in patients with relapsed ovarian cancer, the combination demonstrated significantly improved progression free survival and response rates, manageable non-cumulative toxicity, and fewer PLD-associated adverse events. We studied the impact of the combination of trabectedin with PLD on the quality of life (QoL)/patient-reported outcomes (PRO) evaluated as part of the trial. Methods: QoL/PRO questionnaires, EORTC-QLQ C30, OV28, and EQ-5D were completed by patients at screening and on Day 1 of every other treatment cycle starting with Cycle 1, and at the end-of-treatment visit. Global health status/QoL, fatigue, rain subscales from QLQ C30, and abdominal pain/GI symptoms scale from OV28 were chosen a priori for primary analyses. Other scales of the three questionnaires were analyzed on a supportive basis. Results: A total of 672 patients were randomized. 663 (98%) completed at least the baseline questionnaires. Median cycles of treatment was 6 (131 days) for the combination arm and 5 (143 days) for the monotherapy arm. Mixed effects models (using a covariance structure of AR[1]) predicting the score at baseline and follow-up scores as a function of treatment, days after baseline, and interaction between treatment and days after baseline showed no significant differences between the treatment arms for any of the prespecified scales. Similar analyses of other scales, including EQ-5D Health Index scores and Health State on the Visual Analog Scale, support the findings. Conclusions: The addition of trabectedin to PLD results in superior efficacy in patients with relapsed ovarian cancer, with no added decrement to overall health status as assessed by PRO. [Table: see text]

scholarly journals Using Patient-Reported Outcomes to Assess Healthcare Quality: Toward Better Measurement of Patient-Centered Care in Cardiovascular Disease

2021 ◽  
pp. e1-e9
Author(s):  
Raul Angel Garcia ◽  
John A Spertus
Keyword(s):  
Health Status ◽  
Patient Reported Outcomes ◽  
Health Management ◽  
Clinical Care ◽  
Healthcare Quality ◽  
Patient Centered Care ◽  
Patient Centered ◽  
Patient Reported ◽  
Centered Care

Patient-reported outcomes (PROs) are elicited directly from patients so they can describe their overall health status, including their symptoms, function, and quality of life. While commonly used as end points in clinical trials, PROs can play an important role in routine clinical care, population health management, and as a means for quantifying the quality of patient care. In this review, we propose that PROs be used to improve patient-centered care in the treatment of cardiovascular diseases given their importance to patients and society and their ability to improve doctor- provider communication. Furthermore, given the current variability in patients’ health status across different clinics and the fact that PROs can be improved by titrating therapy, we contend that PROs have a key opportunity to serve as measures of healthcare quality.

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