scholarly journals Prospective, Randomized, Comparative Study of the Cutaneous Effects of a Topical Body Treatment Compared to a Bland Moisturizer

2021 ◽  
Author(s):  
Jean Carruthers ◽  
Gyasi Bourne ◽  
Michaela Bell ◽  
Alan Widgerow
Keyword(s):  
Patient Reported Outcomes ◽  
Skin Thickness ◽  
Skin Rejuvenation ◽  
Recoil Velocity ◽  
Thickness Skin ◽  
Patient Reported ◽  
Skin Retraction ◽  
Topical Treatments ◽  
Over Time

Abstract Background Over time human skin thins and loses elasticity, and topical treatments attempt to reverse this process. Objectives Assess the efficacy of TransFORM Body Treatment (TFB) in skin rejuvenation compared to a bland moisturizer on the extensor and volar forearms. Methods Blinded participants were given two products to apply on the designated forearms with follow-up at 4, 8 and 12 weeks. Measurements included skin thickness, photography, dermatopathology, cutaneous elasticity by two separate devices, and patient reported outcomes. All were compared to baseline. Results Change in roughness: extensor -0.09 mm for bland moisturizer and -0.26 mm for TFB (P = 0.174); volar 0.01mm for bland moisturizer and -0.23 mm for TFB (P = 0.004). Change in recoil velocity: volar -56 degree/s for bland moisturizer and -24 degree/s for TFB (p = 0.61); extensor -95 degree/s for bland moisturizer and -63 degree/s for TFB (p = 0.57). Change in retraction speed: volar -3.25 ms for bland moisturizer and -20.08 ms for TFB (p = 0.33); extensor -2.17 ms for bland moisturizer and -10.83 ms for TFB (p = 0.66). Histology: TFB showed an increase in mucopolysaccharide content, new collagen and increase in elastin fibers in the papillary dermis. Change in Rao-Goldman score: volar -0.17 for bland moisturizer and -0.33 for TFB (p = 0.25); extensor -0.08 for bland moisturizer and -0.17 for TFB (p = 0.36). Conclusions Histology showed production of new collagen and elastin. Quantification of changes using skin thickness, skin retraction speed and skin recoil velocity showed trends that agree with the visual data.

scholarly journals Cancer follow-up supported by patient-reported outcomes in patients undergoing intended curative complex surgery for advanced cancer

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Sissel Ravn ◽  
Henriette Vind Thaysen ◽  
Victor Jilbert Verwaal ◽  
Mette Møller Soerensen ◽  
Jonas Funder ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Fixed Effects ◽  
Patient Reported Outcomes ◽  
Patient Activation ◽  
University Hospital ◽  
Mixed Effect ◽  
Patient Reported ◽  
Complex Surgery ◽  
Over Time

Abstract Background and aim Patient activation (PA) and Patient Involvement (PI) are considered elements in good survivorship. We aimed to evaluate the effect of a follow-up supported by electronic patient-reported outcomes (ePRO) on PA and PI. Method From February 2017 to January 2019, we conducted an explorative interventional study. We included 187 patients followed after intended curative complex surgery for advanced cancer at two different Departments at a University Hospital. Prior to each follow-up consultation, patients used the ePRO to screen themselves for clinical important symptoms, function and needs. The ePRO was graphically presented to the clinician during the follow-up, aiming to facilitate patient activation and involvement in each follow-up. PA was measured by the Patient Activation Measurement (PAM), while PI was measured by five indicator questions. PAM and PI data compared between (− ePRO) and interventional (+ ePRO) consultations. PAM data were analysed using a linear mixed effect regression model with intervention (yes/no) and time along with the interaction between them as categorical fixed effects. The analyses were further adjusted for time (days) since surgery. Results According to our data, ePRO supported consultations did not improve PA. The average mean difference in PAM score between + ePRO and − ePRO consultations were − 0.2 (95% confidence interval − 2.6; 2.2, p = 0.9). There was no statistically significant improvement in PAM scores over time in neither + ePRO nor − ePRO group (p = 0.5). Based on the five PI-indicator questions, the majority of all consultations were evaluated as “some, much or very much” involved in consultation; providing a wider scope of dialogue, encouraged patients to ask questions and share their experiences and concerns. Nevertheless, another few patients reported not to be involved at all in the consultations. Conclusion We did not demonstrate evidence for ePRO supported consultations to improve patient activation, and patient activation did not improve over time. Our results generate the hypotheses that factors related to ePRO supported consultation had the potential to support PI by offering a wider scope of dialogue, and encourage patients to ask questions and share their experiences and concerns during follow-up.

Health-related quality of life (HRQoL) and patient-reported outcomes at final analysis of the TITAN study of apalutamide (APA) versus placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5068-5068
Author(s):  
Neeraj Agarwal ◽  
Simon Chowdhury ◽  
Anders Bjartell ◽  
Byung Ha Chung ◽  
Andrea Juliana Pereira de Santana Gomes ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Proportional Hazards ◽  
Short Form ◽  
Energy Levels ◽  
Final Analysis ◽  
Primary Analysis ◽  
Risk Of Death ◽  
Patient Reported ◽  
Over Time

5068 Background: The phase 3 TITAN study evaluated APA vs PBO in pts with mCSPC receiving ADT. At primary analysis with 22.7 mo median follow-up, APA significantly improved overall survival (OS) and radiographic progression-free survival vs PBO (Chi NEJM 2019) while preserving HRQoL (Agarwal Lancet Oncol 2019). The study was unblinded; pts on PBO were allowed to cross over to APA. At final analysis with 44 mo median follow-up, APA significantly improved OS vs PBO, reducing risk of death by 35% despite crossover (Chi ASCO GU 2021). We evaluated HRQoL and treatment bother at final analysis. Methods: mCSPC pts (N = 1052) were randomized 1:1 to APA (240 mg QD; n = 525) or PBO (n = 527). All pts received ADT. Patient-reported outcomes were assessed using Brief Pain Inventory-Short Form (BPI-SF) and Functional Assessment of Cancer Therapy-Prostate (FACT-P). BPI was completed for 7d consecutively (Days -6 to 1 of each 28-d cycle [C]) through end of treatment (EOT). FACT-P was completed at baseline (BL), C2-C7, then every other C through EOT. Mean scores were reported by treatment group and over time. Time to deterioration on BPI and FACT-P scores was calculated by Kaplan-Meier methods and compared between groups by fitting proportional hazards regression models. Results: Of eligible pts per C, > 62% completed BPI through C32 and > 50% completed FACT-P through C31. Pts were relatively asymptomatic with good BL HRQoL: on 0-10 worst pain severity scale (BPI), median scores were 1.1 (APA) and 1.0 (PBO); on 0-156 HRQoL scale (FACT-P total; higher score = better HRQoL), median scores were 113.0 (APA) and 113.3 (PBO). Low BL BPI scores remained stable over time in both groups. On average, favorable BL FACT-P scores did not notably worsen over time in APA or PBO groups. There were no significant differences between groups in median time to deterioration in any BPI or FACT-P scores (Table). At each C at least 86% (APA) and 85% (PBO) of pts were either “not at all” or “a little bit” bothered by side effects. At BL, 76% (APA) and 72% (PBO) had favorable energy levels (reporting lack of energy “not at all” or “a little bit”). Energy levels remained stable or improved at each C for > 78% (APA) and > 71% (PBO) of pts. Conclusions: In the final analysis of TITAN, survival benefit with addition of APA to ADT was achieved without significant patient-reported side effect burden or reduced HRQoL compared with PBO in pts with mCSPC. Clinical trial information: NCT02489318. [Table: see text]

scholarly journals Patient-Reported Benefits of Extracranial Venous Therapy: British Columbia CCSVI Registry

2017 ◽  
Vol 44 (3) ◽  
pp. 246-254 ◽  
Author(s):  
A. Dessa Sadovnick ◽  
Irene M. Yee ◽  
Kristen Attwell-Pope ◽  
Glenn Keyes ◽  
Lucas Kipp ◽  
...  
Keyword(s):  
British Columbia ◽  
Patient Reported Outcomes ◽  
Positive Impact ◽  
Health Conditions ◽  
Positive Effects ◽  
Patient Reported ◽  
Initial Perception ◽  
Post Therapy ◽  
Over Time

AbstractObjective Chronic cerebrospinal venous insufficiency (CCSVI) has been hypothesized to be a risk factor for multiple sclerosis (MS). Venoplasty has been proposed as a treatment for CCSVI. The aim of our study was to gain a better understanding of the “real-world” safety and longitudinal effectiveness of venoplasty Methods: British Columbia residents who self-reported having had venoplasty and consented to participate in the study were interviewed and followed for up to 24 months post-therapy using standardized structured questionnaires Results: Participants reported procedure-related complications (11.5%) and complications within the first month after the procedure (17.3%). Initially, more than 40% of participants perceived that the venoplasty had had positive effects on their health conditions, such as fatigue, numbness, balance, concentration/memory and mobility. However, this improvement was not maintained over time Conclusions: Follow-up patient-reported outcomes indicated that the initial perception of the positive impact of venoplasty on the health conditions of MS patients was not sustained over time. In addition, venoplasty was not without associated morbidity.

Individualized cancer follow-up supported by electronic Patient-Reported Outcomes: Development and evaluation (Preprint)

2020 ◽  
Author(s):  
Sissel Ravn ◽  
Henriette Vind Thaysen ◽  
Lene Seibaek ◽  
Victor Jilbert Verwaal ◽  
Lene Hjerrild Iversen
Keyword(s):  
Ct Scan ◽  
Advanced Cancer ◽  
Patient Reported Outcomes ◽  
Cost Benefit Analysis ◽  
Cost Benefit ◽  
Structured Interviews ◽  
European Organization ◽  
Individualized Care ◽  
Patient Reported

BACKGROUND Cancer survivors experience unmet needs during follow-up. Besides recurrence, a follow-up includes detection of late side effects, rehabilitation, palliation and individualized care. OBJECTIVE We aimed to describe the development and evaluate the feasibility of an intervention providing individualized cancer follow-up supported by electronic patient-reported outcomes (e-PRO). METHODS The study was carried out as an interventional study at a Surgical and a Gynecological Department offering complex cancer surgery and follow-up for advanced cancer. The e-PRO screened for a priori defined clinical important symptoms and needs providing individualized follow-up. We included following questionnaires in the e-PRO; the general European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC validated for colorectal and ovarian cancer patients. To support individualization, we included three prioritized issues of the patient’s preference in each e-PRO. The response-algorithm was aggregated based on the severity of the patient’s response. To ensure the sensitivity of the e-PRO, we performed semi-structured interviews with five patients. All clinicians (surgeons and gynecologists) performing the consultations reviewed the e-PRO. The evaluation was divided in two, 1)The feasibility was assessed by a)Patients’ response rate of the e-PRO, b)Number of follow-up visits documenting the use of e-PRO and c)Patients’ prioritized issues prior to the consultation(‘yes’ / ‘no’), and after the follow-up 2)Patients assessment of a)The need and purpose of the follow-up visit and b)the support provided during the follow-up visit. RESULTS In total, 187 patients were included in the study, of which 73%(n=136/187) patients responded to the e-PRO and were subjected to an individualized follow-up. The e-PRO was documented as applied in 79% of the follow-up visits. In total, 23% of the prioritized issues did not include a response. Stratified by time since surgery, significantly more patients did not fill out a prioritized issue had a follow-up >6 months since surgery. In total, 72 % follow-up visits were evaluated to be necessary in order to discuss the outcome of the CT scan, symptoms, and/or prioritized issues. Contrary, 19% of the follow-up visits were evaluated to be necessary only to discuss the result of the CT scan. A range from 19.3–56.3% of patients assessed the follow-up visit to provide support with respect to physical (42% of patients), mental (56%), sexual (19%) or dietary (27%) issues. Further, a range from 34–60% of the patients reported that they did not need support regarding physical (43% of patients), mental (34%), sexual (63%) or dietary (57%) issues. CONCLUSIONS An individualized follow-up based on e-PRO is feasible, and support most patients surgically treated for advanced cancer. However, results indicate that follow-up based on e-PRO may not be beneficial for all patients and circumstances. A thorough cost-benefit analysis may be warranted before implementation in routine clinic.

Minimum 10-Year Outcomes of Primary Arthroscopic Transosseous-Equivalent Double-Row Rotator Cuff Repair

2021 ◽  
pp. 036354652110154
Author(s):  
Adam M. Johannsen ◽  
Justin W. Arner ◽  
Bryant P. Elrick ◽  
Philip-C. Nolte ◽  
Dylan R. Rakowski ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Revision Surgery ◽  
Rotator Cuff Repair ◽  
Patient Reported Outcomes ◽  
Long Term Results ◽  
Double Row ◽  
Kaplan Meier ◽  
Patient Reported ◽  
Cuff Repair

Background: Modern rotator cuff repair techniques demonstrate favorable early and midterm outcomes, but long-term results have yet to be reported. Purpose: To determine 10-year outcomes and survivorship after arthroscopic double-row transosseous-equivalent (TOE) rotator cuff repair. Study Design: Case series; Level of evidence 4. Methods: The primary TOE rotator cuff repair procedure was performed using either a knotted suture bridge or knotless tape bridge technique on a series of patients with 1 to 3 tendon full-thickness rotator cuff tears involving the supraspinatus. Only patients who were 10 years postsurgery were included. Patient-reported outcomes were collected pre- and postoperatively, including American Shoulder and Elbow Surgeons (ASES), 12-Item Short Form Health Survey (SF-12), Single Assessment Numeric Evaluation (SANE), shortened version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and satisfaction. Kaplan-Meier survivorship analysis was performed. Failure was defined as progression to revision surgery. Results: A total of 91 shoulders (56 men, 31 women) were included between October 2005 and December 2009. Mean follow-up was 11.5 years (range, 10.0-14.1 years). Of 91 shoulders, 5 (5.5%) failed and required revision surgery. Patient-reported outcomes for patients who survived were known for 80% (69/86). Outcomes scores at final follow-up were as follows: ASES, 93.1 ± 10.8; SANE, 87.5 ± 14.2; QuickDASH, 11.1 ± 13.5; and SF-12 physical component summary (PCS), 49.2 ± 10.1. There were statistically significant declines in ASES, SANE, and SF-12 PCS from the 5-year to 10-year follow-up, but none of these changes met the minimally clinically important difference threshold. Median satisfaction at final follow-up was 10 (range, 3-10). From this cohort, Kaplan-Meier survivorship demonstrated a 94.4% survival rate at a minimum of 10 years. Conclusion: Arthroscopic TOE rotator cuff repair demonstrates high patient satisfaction and low revision rates at a mean follow-up of 11.5 years. This information may be directly utilized in surgical decision making and preoperative patient counseling regarding the longevity of modern double-row rotator cuff repair.

scholarly journals Sex differences in outcomes after arthroscopic bankart repair

2020 ◽  
Vol 6 (1) ◽  
pp. e000965
Author(s):  
Natalie A Lowenstein ◽  
Peter J Ostergaard ◽  
Daniel B Haber ◽  
Kirsten D Garvey ◽  
Elizabeth G Matzkin
Keyword(s):  
Mental Health ◽  
Sex Differences ◽  
Patient Reported Outcomes ◽  
Strength Function ◽  
Bankart Repair ◽  
Level Of Evidence ◽  
Arthroscopic Bankart Repair ◽  
Patient Reported ◽  
Males And Females

ObjectivesRisk factors for anterior shoulder dislocation include young age, contact activities and male sex. The influence of sex on patient-reported outcomes of arthroscopic Bankart repair (ABR) is unclear, with few studies reporting potential differences. This study’s purpose was to compare patient-reported outcomes of males and females following ABR.MethodsProspectively collected data was analysed for 281 patients (males: 206, females: 75) after ABR with preoperative, 1-year and 2-year follow-up responses. The Wilcoxon signed-rank and χ2 tests, preoperative, 1 year and 2 year follow-up results were examined to determine differences of scores in males versus females.ResultsNo statistically significant sex differences were observed in Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons (ASES), Visual Analogue Scale (VAS) or Single Assessment Numerical Evaluation (SANE) Scores at 1-year or 2-year follow-up. Females had lower Veterans RAND 12-item health survey (VR-12) mental health subscores at 2-year follow-up (females: 52.3±9.0, males: 55.8±7.6, p=0.0016). Females were more likely to report that treatment had ‘exceeded expectations’ at 2-year follow-up regarding motion, strength, function and normal sports activities.ConclusionResults of study demonstrate that ABR has similar outcomes for both males and females. There were no statistically significant sex-related differences in SST, ASES, VAS or SANE scores following ABR. VR-12 mental health subscores showed a minimal difference at 2-year follow-up, with lower scores in females.Level of evidenceRetrospective cohort study; level II.

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