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Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study.

ABSTRACT: BACKGROUND:The long-term safety and efficacy of fremanezumab were evaluated in a 52-week extension study (NCT02638103). Patient satisfaction with fremanezumab, dosing preferences, and patient-reported outcomes were assessed in a subpopulation who completed the extension study and consented to a follow-up questionnaire. METHODS:In the extension study (N?=?1842), adults with migraine were randomized to quarterly or monthly fremanezumab. After completing active treatment, patients answered a survey evaluating patient satisfaction, treatment and dosing preferences, and changes in patient-reported outcomes. RESULTS:Of the 557 patients who could have been contacted upon completing the extension study, 302 consented and 253 completed the survey. The mean (standard deviation) satisfaction rating for fremanezumab was 6.1 (1.4; 1?=?"extremely dissatisfied" to 7?=?"extremely satisfied"). Most patients (175 [69.2%]) preferred quarterly over monthly fremanezumab dosing. Among patients taking antiepileptics (most common class of prior preventive medication; n?=?130), 91.5% preferred fremanezumab. Patients reported improvements in anxiety (74 [67.9%]), sleep quality (143 [56.5%]), and quality of time spent with others (210 [83.0%]) with fremanezumab. CONCLUSION:In this study, treatment satisfaction with fremanezumab was high, most patients preferred quarterly fremanezumab dosing, and fremanezumab was generally preferred to prior preventive medications. TRIAL REGISTRATION:ClinicalTrials.gov NCT02638103 (HALO LTS), registered December 22, 2015.

SUBMITTER: Buse DC

PROVIDER: S-EPMC7487845 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study.

Buse Dawn C DC Gandhi Sanjay K SK Cohen Joshua M JM Ramirez-Campos Verena V Cloud Blaine B Yang Ronghua R Cowan Robert P RP

The journal of headache and pain 20200904 1

<h4>Background</h4>The long-term safety and efficacy of fremanezumab were evaluated in a 52-week extension study (NCT02638103). Patient satisfaction with fremanezumab, dosing preferences, and patient-reported outcomes were assessed in a subpopulation who completed the extension study and consented to a follow-up questionnaire.<h4>Methods</h4>In the extension study (N = 1842), adults with migraine were randomized to quarterly or monthly fremanezumab. After completing active treatment, patients an ...[more]

PMID: 32887548

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Project description:PurposeThe purposes of this study were to evaluate the clinical outcomes (with the minimum mean follow-up period of 2 years) of arthroscopic superior capsular reconstruction (ASCR) using different grafts for massive irreparable rotator cuff tears (MIRCTs) and to explore whether margin convergence in ASCR affects range of motion (ROM) outcomes.MethodsThis systematic review was registered in PROSPERO and was then conducted following PRISMA guidelines by searching the databases: MEDLINE, EMBASE, Web of Science, and Cochrane Library database before April 2021. These literature searches investigating the clinical outcomes of ASCR were included. The methodological quality of included studies was assessed using the MINORS criteria. The data, including margin convergence, patient-reported outcome scores, range of motion, and complications, were extracted and analyzed. The minimal clinically important differences (MCID) criteria was used to define clinical significance.Results15 studies met the inclusion criteria. All studies reported statistically significant improvements in visual analog scale scores (range: 2.07 to 7.1) and American Shoulder and Elbow Surgeons scores (range: 18.1 to 58). Significant improvements of Constant scores were noted in 4 of 5 reporting studies (mean improvement ranged from 14.64 to 50.79). Active forward flexion/elevation (11 studies), active abduction (4 studies), and active external rotation (8 studies) displayed improvements in all reporting studies, with mean changes ranging from 12 to 73.68, 19 to 89.21, and 1 to 24.74, respectively. The mean change of postoperative acromiohumeral distance ranged from -0.86 mm to 3.2 mm in 9 studies. The postoperative complication rate of ASCR ranged from 4.5% to 47.6%. The anterior margin convergence in SCR was associated with a relatively poor improvement in active external rotation.ConclusionsASCR contributes to significant improvements in patient-reported clinical outcomes and ROM at follow-up after a mean of more than two years, emerging as a viable option for patients with MIRCTs. The anterior margin convergence should be prudently chosen, especially in ASCR using fascia lata autograft, on account of the probable restriction on postoperative active external rotation.Level of evidenceLevel IV, systematic review of Level III and IV studies.

Project description:BACKGROUND:Due to demographic change and, more recently, coronavirus disease (COVID-19), the importance of modern intensive care units (ICU) is becoming apparent. One of the key components of an ICU is the continuous monitoring of patients' vital parameters. However, existing advances in informatics, signal processing, or engineering that could alleviate the burden on ICUs have not yet been applied. This could be due to the lack of user involvement in research and development. OBJECTIVE:This study focused on the satisfaction of ICU staff with current patient monitoring and their suggestions for future improvements. We aimed to identify aspects of monitoring that interrupt patient care, display devices for remote monitoring, use cases for artificial intelligence (AI), and whether ICU staff members are willing to improve their digital literacy or contribute to the improvement of patient monitoring. We further aimed to identify differences in the responses of different professional groups. METHODS:This survey study was performed with ICU staff from 4 ICUs of a German university hospital between November 2019 and January 2020. We developed a web-based 36-item survey questionnaire, by analyzing a preceding qualitative interview study with ICU staff, about the clinical requirements of future patient monitoring. Statistical analyses of questionnaire results included median values with their bootstrapped 95% confidence intervals, and chi-square tests to compare the distributions of item responses of the professional groups. RESULTS:In total, 86 of the 270 ICU physicians and nurses completed the survey questionnaire. The majority stated they felt confident using the patient monitoring equipment, but that high rates of false-positive alarms and the many sensor cables interrupted patient care. Regarding future improvements, respondents asked for wireless sensors, a reduction in the number of false-positive alarms, and hospital standard operating procedures for alarm management. Responses to the display devices proposed for remote patient monitoring were divided. Most respondents indicated it would be useful for earlier alerting or when they were responsible for multiple wards. AI for ICUs would be useful for early detection of complications and an increased risk of mortality; in addition, the AI could propose guidelines for therapy and diagnostics. Transparency, interoperability, usability, and staff training were essential to promote the use of AI. The majority wanted to learn more about new technologies for the ICU and required more time for learning. Physicians had fewer reservations than nurses about AI-based intelligent alarm management and using mobile phones for remote monitoring. CONCLUSIONS:This survey study of ICU staff revealed key improvements for patient monitoring in intensive care medicine. Hospital providers and medical device manufacturers should focus on reducing false alarms, implementing hospital alarm standard operating procedures, introducing wireless sensors, preparing for the use of AI, and enhancing the digital literacy of ICU staff. Our results may contribute to the user-centered transfer of digital technologies into practice to alleviate challenges in intensive care medicine. TRIAL REGISTRATION:ClinicalTrials.gov NCT03514173; https://clinicaltrials.gov/ct2/show/NCT03514173.

Project description:Apremilast, a specific inhibitor of phosphodiesterase 4, modulates pro-inflammatory and anti-inflammatory cytokine production.Apremilast's effect on patient-reported outcomes (PROs) in patients with moderate to severe psoriasis was evaluated in a phase IIb randomized, controlled trial (NCT00773734).In this 16-week, placebo-controlled study, 352 patients with moderate to severe plaque psoriasis received placebo or apremilast (10, 20, or 30 mg BID). PROs included Dermatology Life Quality Index (DLQI), pruritus visual analog scale (VAS), and Short-Form Health Survey (SF-36) to assess health-related quality of life (HRQOL). Changes from baseline and patients reporting improvements ?minimum clinically important differences (MCID) were analyzed. Correlations between changes across various PRO instruments were explored.Baseline DLQI (>10 points) and SF-36 MCS and domain scores indicated impairments in HRQOL. At 16 weeks, greater improvements from baseline in DLQI scores were reported with apremilast 20 (-5.9) and 30 mg BID (-4.4) compared with placebo (1.9; P?0.005 for both), and a greater proportion of patients reported improvements ?MCID (20 mg BID, 49.4%, 30 mg BID, 44.3%) versus placebo (25.0%; P<0.04). Greater improvements from baseline in pruritus VAS scores were reported with apremilast 20 (-35.5%) and 30 mg BID (-43.7%) versus placebo (-6.1%; P?0.005). Significant and clinically meaningful improvements in SF-36 mental component summary scores (P?0.008) and Bodily Pain, Mental Health, and Role-Emotional domains were reported with all apremilast doses (P<0.05), and Social Functioning with 20 and 30 mg BID (P<0.05) and Physical Functioning with 20 mg BID (P<0.03). Correlations between SF-36 scores and DLQI were moderate (r>0.30 and ?0.60) and low between SF-36 and pruritus VAS (r?0.30), indicating they measure different aspects of the disease.Apremilast treatment resulted in improved HRQOL, including DLQI and pruritus VAS over 16 weeks of treatment, in patients with moderate to severe psoriasis.

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Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study.

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Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study.

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