scholarly journals Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial

2019 ◽  
Vol 40 (9) ◽  
pp. 1000-1008 ◽  
Author(s):  
Benjamin Ascher ◽  
Berthold Rzany ◽  
Philippe Kestemont ◽  
Said Hilton ◽  
Marc Heckmann ◽  
...  

Abstract Background The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid formulation) was the first to our knowledge to assess satisfaction with FACE-Q after glabellar line (GL) injection. Objectives The authors sought to evaluate patient satisfaction with ASI for GL treatment employing 3 FACE-Q scales: facial appearance, psychological well-being, and aging appearance. Methods This was a Phase 3, randomized, double-blind, placebo-controlled trial (NCT02353871) of ASI 50 units in adults with moderate-to-severe GL with 6-month follow-up. Results Significantly greater least squares mean changes from baseline were associated with ASI treatment (N = 125) vs placebo (N = 59) for satisfaction with facial appearance at all visits until day 148 (5 months; P < 0.0001-0.0037), psychological well-being at all visits (P < 0.0001-0.0279), and aging appearance at all visits except day 148 (P < 0.0001-0.0409). Significant differences (ASI vs placebo) were observed at all visits for individual items: “how rested your face looks” (P < 0.0001-0.0415), “I feel okay about myself” (P = 0.0011-0.0399), and “I feel attractive” (P < 0.0001-0.0102). Maximal least squares mean (standard error) changes in aging appearance score were −1.4 (0.3; ASI) and −0.3 (0.4; placebo). Investigators’ live assessment of GL at maximum frown significantly correlated with improvements in FACE-Q facial appearance and psychological scales (all patients: r = −0.41 and r = −0.36 [both P < 0.0001], respectively). Conclusions Significant improvements in patient satisfaction with aging, facial appearance, and, importantly, psychological well-being were demonstrated with ASI employing FACE-Q scales up to 5 to 6 months post-injection. Results support a long duration of efficacy with ASI and use of FACE-Q in future trials and clinical practice. Level of Evidence: 1

Author(s):  
Ileen Domela Nieuwenhuis ◽  
Kim Phi Luong ◽  
Lieke C M Vissers ◽  
Stefan Hummelink ◽  
Harm P Slijper ◽  
...  

Abstract Background To determine the success of an upper blepharoplasty, a popular cosmetic procedure, it is essential to measure outcomes from the patient perspective, these often outweigh objective outcomes. Objectives This study aimed to assess patient-reported satisfaction with facial appearance, psychological well-being, and aging appraisal after upper blepharoplasty with validated questionnaires. Methods This prospective cohort study included upper blepharoplasty patients from eight outpatient clinics. Patient-reported satisfaction was assessed using the FACE-Q at intake, six and twelve months postoperative. Results 2134 patients were included. High satisfaction with outcome and decision to undergo treatment were measured six months postoperative. Large improvements in FACE-Q scores (range, 0 - 100) between intake and six months postoperative were seen for satisfaction with appearance (mean, effect size; eyes +48, 2.6; upper eyelids +48, 3.1; facial appearance overall +26, 1.4), psychological well-being (+11, 0.56) and aging appraisal (+22, 1.0). Patients reported to appear 3.3 years younger (SD, ±5.2) postblepharoplasty. No clinically relevant changes were seen between six and twelve months. Additionally, improvements in appearance were not dependent on their intake scores, whereas improvements in psychological well-being and aging appraisal were smaller in patients with higher intake scores. Satisfaction with treatment outcome was strongly correlated with appearance satisfaction but not with aging appraisal. Conclusions Significant improvements in patient satisfaction regarding appearance, psychological well-being, and aging appraisal can be seen 6 months after blepharoplasty, and outcomes remain stable up to 12 months postoperative. These data may be used to inform patients and clinicians and improve the overall quality of care.


2021 ◽  
pp. 107110072110025
Author(s):  
Thomas L. Lewis ◽  
Thomas A. J. Goff ◽  
Robbie Ray ◽  
C. Ruth Varrall ◽  
Peter W. Robinson ◽  
...  

Background: There are many options for incision closure in forefoot surgery. The aim of this study was to compare topical skin adhesive (2-octyl-cyanoacrylate) to simple interrupted nylon sutures. Methods: A prospective randomized controlled trial comparing topical skin adhesive (TSA) and nylon sutures (NSs) for elective open forefoot surgery. Primary outcome was Hollander Wound Evaluation Scale (HWES) assessed 2 weeks following surgery. Secondary objectives included time taken for wound closure, wound assessment, patient satisfaction with wound cosmesis, incision pain, and infection rate. Results: Between January and December 2018, 84 feet (70 patients) underwent hallux valgus scarf/Akin osteotomy or first metatarsophalangeal arthrodesis and were randomized to receive either intervention (topical skin adhesive) or control (3/0 nylon sutures). We found worse HWES scores when using TSA compared to NSs (1.07 vs 0.60). Incision closure time was slower for TSA (mean, 272 vs 229 seconds). At 2 weeks postoperatively, wound care was faster for TSA (mean 71 secs) vs NSs (mean 120), and patient-reported pain was less with TSA (visual analog scale: TSA 1.2 vs NSs 2.1). A high degree of overall patient satisfaction was reported in both groups, without significant difference. Conclusion: Closure of elective forefoot surgery incisions with topical skin adhesive or interrupted nylon sutures offers high satisfaction rates, low pain scores, and low complications. However, topical skin adhesive was associated with more inflammation and areas of wound separation compared to nylon sutures. We recommend the use of sutures for wound closure in forefoot surgery. Level of Evidence: Level I, randomized controlled trial.


Challenges ◽  
2021 ◽  
Vol 12 (1) ◽  
pp. 12
Author(s):  
Tanja Sobko ◽  
Gavin T. L. Brown

Urbanized children today have fewer opportunities to interact with nature which may lead to a greater risk of mental health problems. The objective of this randomized controlled trial was to investigate which particular changes in connectedness to nature (CN) would improve psychological well-being (PW) in young children. Six hundred and thirty-nine preschoolers (52.0% boys, age 34.9 ± 9.5 months) participated in Play&Grow, an early environmental education intervention. Children’s CN and PW were evaluated by parents before and after the program with validated measures; the CNI-PPC (four factors) and the SDQ, Strength and Difficulties questionnaire (five factors), respectively. The effectiveness of the intervention on the primary outcomes (CN, PW) as well as the relationship between them was analyzed in a repeated measures path model with intervention status as a causal predictor. Specific CN factors consistently increased ProSocial behavior and reduced Hyperactivity and Emotional problems. In summary, this study showed that the previously reported impact shifted from the total CN score to the specific CN factors. The Play&Grow intervention positively increased children’s CN and improved some aspects of psychological well-being in children which is a preliminary evidence of developmental benefits of connecting young children with nature. Our results indicate promising direction of action for the improvement of families’ psychological health.


Author(s):  
Ilona Stolpner ◽  
Jörg Heil ◽  
Fabian Riedel ◽  
Markus Wallwiener ◽  
Benedikt Schäfgen ◽  
...  

Abstract Background Poor patient-reported satisfaction after breast-conserving therapy (BCT) has been associated with impaired health-related quality of life (HRQOL) and subsequent depression in retrospective analysis. This prospective cohort study aimed to assess the HRQOL of patients who have undergone BCT using the BREAST-Q, and to identify clinical risk factors for lower patient satisfaction. Methods Patients with primary breast cancer undergoing BCT were asked to complete the BREAST-Q preoperatively (T1) for baseline evaluation, then 3 to 4 weeks postoperatively (T2), and finally 1 year after surgery (T3). Clinicopathologic data were extracted from the patients’ charts. Repeated measures analysis of variance (ANOVA) was used to determine significant differences in mean satisfaction and well-being levels among the test intervals. Multiple linear regression was used to evaluate risk factors for lower satisfaction. Results The study enrolled 250 patients. The lowest baseline BREAST-Q score was reported for “satisfaction with breast” (mean, 61 ± 19), but this increased postoperatively (mean, 66 ± 18) and was maintained at the 1 year follow-up evaluation (mean, 67 ± 21). “Physical well-being” decreased from T1 (mean, 82 ± 17) to T2 (mean, 28 ± 13) and did not recover much by T3 (mean, 33 ± 13), being the lowest BREAST-Q score postoperatively and in the 1-year follow-up evaluation. In multiple regression, baseline psychosocial well-being, body mass index (BMI), and type of incision were risk factors for lower “satisfaction with breasts.” Conclusion Both the aesthetic/surgery-related and psychological aspects are equally important with regard to “satisfaction with breasts” after BCT. The data could serve as the benchmark for future studies.


2018 ◽  
Vol 77 (7) ◽  
pp. 1017-1024 ◽  
Author(s):  
Imke Redeker ◽  
Falk Hoffmann ◽  
Johanna Callhoff ◽  
Hildrun Haibel ◽  
Joachim Sieper ◽  
...  

ObjectivesThe aim of this study was to assess the psychological well-being and to analyse factors associated with depressive symptoms in axial spondyloarthritis (axSpA).MethodsA stratified random sample of subjects with a diagnosis of axSpA (International Classification of Diseases, Tenth Revision, German Modification M45) was drawn from health insurance data in Germany. These persons received a postal questionnaire on disease-related, psychological and lifestyle factors as well as socioeconomic status. Additional information to verify the axSpA diagnosis was also collected. The psychological well-being was assessed by means of the 5-item WHO Well-Being Index (WHO-5), which is considered a screening tool for depression. The following established cut-offs on the WHO-5 were applied: >50: good well-being, no depressive symptoms; 29–50: mild depressive symptoms; ≤28: moderate-to-severe depressive symptoms. Information on comorbidities, drug prescriptions and non-pharmacological treatment was retrieved from claims data and linked to the questionnaire data.ResultsA total of 1736 persons with a confirmed axSpA diagnosis were included. Using the cut-offs on the WHO-5, 533 persons (31%) were found to have moderate-to-severe depressive symptoms, 479 (28%) had mild depressive symptoms and 724 (42%) had a good well-being. Multivariable logistic regression revealed that higher disease activity, higher level of functional impairment, lower income, self-reported stress and lack of exercise, and younger age represent factors associated with moderate-to-severe depressive symptoms.ConclusionsThe prevalence of depressive symptoms in axSpA subjects is high and associated with disease-related parameters, socioeconomic status and lifestyle factors. These findings highlight the need for the careful evaluation of depressive symptoms as a part of the management strategy for axSpA.


2020 ◽  
Vol 34 (7) ◽  
pp. 938-947 ◽  
Author(s):  
Mehdi Zemestani ◽  
Sharmin Mozaffari

Objective: To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. Design: Randomized controlled trial. Setting: State welfare organization in Kamyaran, Kurdistan, Iran. Participants: Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. Interventions: Participants in the ACT group ( n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group ( n = 29) received psychoeducation regarding depression. Main measures: Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. Results: After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT –10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control –0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control –1.90 ± 1.04, P < 0.001). Conclusion: Compared with control group, ACT significantly reduced the participants’ depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.


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