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 ◽  
...  

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]

Author(s):  
Jean Carruthers ◽  
Gyasi Bourne ◽  
Michaela Bell ◽  
Alan Widgerow

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.


2019 ◽  
pp. 112070001986401
Author(s):  
Ajay C Lall ◽  
Garrett R Schwarzman ◽  
Muriel R Battaglia ◽  
Sarah L Chen ◽  
David R Maldonado ◽  
...  

Introduction: Mental health and patient expectation have been identified as key predictors of recovery following THA; however, there is limited literature examining the effects of social support and marital status on patient-reported outcomes (PROs). Methods: Data were prospectively collected and retrospectively reviewed for patients who underwent THA between July 2008 and January 2016. Patients were included if they underwent primary THA during this period and if they had documented preoperative marital status of married, divorced, or never married. Married patients were group matched to non-married patients (divorced or never married) with similar sex, age, body mass index (BMI), gender distribution, and frequency of surgical approach. Results: There were 414 married patients and 98 non-married patients who were eligible and had minimum 2-year follow-up. Mean PROs were significantly worse in the non-married group than the married group for the following measures: modified Harris Hip Score ( p = 0.002), Harris Hip Score ( p = 0.002), Forgotten Joint Score ( p = 0.04), and the physical portions of the Veterans RAND ( p = 0.025) and Short Form ( p = 0.02) surveys. Conclusions: Our study demonstrated inferior absolute PRO scores at latest follow-up for patients who were non-married compared to married following THA. These results show that while total hip replacement may still yield clinical benefit in all patients, non-married patients may ultimately achieve an inferior functional status, and expectations should be adjusted accordingly. Physicians should assess levels of psychosocial support in their patients prior to undergoing hip arthroplasty in order to optimise results.


2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Sissel Ravn ◽  
Henriette Vind Thaysen ◽  
Victor Jilbert Verwaal ◽  
Mette Møller Soerensen ◽  
Jonas Funder ◽  
...  

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.


Circulation ◽  
2013 ◽  
Vol 127 (suppl_12) ◽  
Author(s):  
Sheila M McNallan ◽  
Yariv Gerber ◽  
Susan A Weston ◽  
Jill Killian ◽  
Shannon M Dunlay ◽  
...  

Background: Contemporary data on survival after incident acute coronary syndrome (ACS), including both myocardial infarction (MI) and unstable angina (UA), are limited. Objective: To describe survival after incident ACS, to determine if it differs by ACS type (MI or UA) and to determine whether it has improved over time. Methods: Olmsted County, MN residents hospitalized between 1/1/2005-12/31/2010 were screened for incident ACS. ACS was defined as either MI validated by standard epidemiological criteria or UA validated by the Braunwald classification. Patients were followed for death from any cause. Cox proportional hazards regression was used to determine whether survival differed by ACS type, while adjusting for year of diagnosis, age, sex and comorbidities. Results: Among 1,160 incident ACS cases (mean±SD age 66.9±14.8, 60% male), 35% were UA and 65% were MI. After a mean (SD) follow up of 3.7 (2.1) years, 274 deaths occurred. The 3-year Kaplan-Meier survival estimate for MI was 79.6% (95% CI: 76.7%-82.6%) and for UA was 84.9% (95% CI: 81.3%-88.6%) (log-rank p=0.011). The association of ACS type with survival differed by age (p=0.056). After adjustment for year of diagnosis, sex and comorbidities, no difference in survival was observed between ACS types among those aged <60 (HR for MI vs. UA: 0.64, 95% 0.29-1.42). By contrast, among patients aged 60-79, those with an MI had 2 times the risk of death compared to those with UA (HR: 2.04, 95% CI: 1.24-3.37). Patients aged 80 or older who had an MI had a 40% increased risk of death compared to patients of the same age who had UA (HR: 1.42, 95% CI: 1.02-1.98). There was no difference in survival over time (HR for 2010 vs. 2005: 0.91, 95% CI: 0.61-1.36). Conclusions: Survival did not differ between UA and MI patients younger than 60, however among patients 60 or older, survival was worse among those with an MI. Survival after ACS did not change over the study period.


Arthritis ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Vandana Ayyar ◽  
Richard Burnett ◽  
Fiona J. Coutts ◽  
Marietta L. van der Linden ◽  
Thomas H. Mercer

This study retrospectively analysed the effects of obesity as described by Body Mass Index (BMI) on patient reported outcomes following total knee replacement. Participants (105 females and 66 males) who had undergone surgery under the care of a single surgeon were included in the review and were grouped according to their preoperative BMI into nonobese ( kg/m2), () obese ( kg/m2) (). Oxford Knee Score (OKS) and Short Form 12 scores (SF12) were taken preoperatively and 6 and 12 months after surgery to analyse differences between groups in the absolute scores as well as changes from before to after surgery. Preoperatively, the obese group had a significantly poorer OKS compared to non obese (44.7 versus 41.2, ). There were no statistically significant group effects on follow-up or change scores of the OKS and SF12. Correlations coefficients between BMI and follow-up and change scores were low (). There were no significant differences in the number of complications and revisions (local wound infection, 6.7% non obese, 11% obese, postoperative systemic complication, 8% non obese, 12% obese, revision, 4% nonobese, 3% obese). In conclusion, our findings indicate similar degrees of benefits from the surgery irrespective of patient BMI.


2021 ◽  
Vol 2 (7) ◽  
pp. 540-544
Author(s):  
Mads Moss Jensen ◽  
Stefan Milosevic ◽  
Gustav Østerheden Andersen ◽  
Leah Carreon ◽  
Ane Simony ◽  
...  

Aims The aim of this study was to identify factors associated with poor outcome following coccygectomy on patients with chronic coccydynia and instability of the coccyx. Methods From the Danish National Spine Registry, DaneSpine, 134 consecutive patients were identified from a single centre who had coccygectomy from 2011 to 2019. Patient demographic data and patient-reported outcomes, including pain measured on a visual analogue scale (VAS), Oswestry Disability Index (ODI), EuroQol five-dimension five-level questionnaire, and 36-Item Short-Form Health Survey questionnaire (SF-36) were obtained at baseline and at one-year follow-up. Patient satisfaction was obtained at follow-up. Regression analysis, including age, sex, smoking status, BMI, duration of symptoms, work status, welfare payment, preoperative VAS, ODI, and SF-36 was performed to identify factors associated with dissatisfaction with results at one-year follow-up. Results A minimum of one year follow-up was available in 112 patients (84%). Mean age was 41.9 years (15 to 78) and 97 of the patients were female (87%). Regression showed no statistically significant association between the investigated prognostic factors and a poor outcome following coccygectomy. The satisfied group showed a statistically significant improvement in patient-reported outcomes at one-year follow-up from baseline, whereas the dissatisfied group did not show a significant improvement. Conclusion We did not identify factors associated with poor outcome following coccygectomy. This suggests that neither of the included parameters should be considered contraindications for coccygectomy in patients with chronic coccydynia and instability of the coccyx. Cite this article: Bone Jt Open 2021;2(7):540–544.


2018 ◽  
Vol 12 (1) ◽  
pp. 126-131 ◽  
Author(s):  
Tae Sik Goh ◽  
Jong Ki Shin ◽  
Myung Soo Youn ◽  
Jung Sub Lee

<sec><title>Study Design</title><p>A prospective study.</p></sec><sec><title>Purpose</title><p>To identify associations between psychiatric factors and patient-reported outcomes after corrective surgery in patients with lumbar degenerative kyphosis (LDK).</p></sec><sec><title>Overview of Literature</title><p>Thus far, to the best of our knowledge, patient factors that may help predict patient-reported outcomes after corrective surgery for LDK have not been studied.</p></sec><sec><title>Methods</title><p>We prospectively investigated 46 patients with LDK who underwent surgical correction with a minimum follow-up of 2 years. Demographic data were collected. Short form-36, mental component scores (MCS), physical component scores (PCS), Scoliosis Research Society-22 (SRS-22) scores, and Roland-Morris Disability Questionnaire (RMDQ) scores were determined before the surgery and after 2 years of follow-up. Psychiatric conditions were preoperatively evaluated using the Zung depression scale (ZDS) and Zung anxiety scale (ZAS). Patients were divided into two groups (with or without psychiatric issues), according to baseline ZDS and ZAS scores.</p></sec><sec><title>Results</title><p>Patients included 43 women and 3 men. Twelve patients were deemed to have psychiatric problems (P group) and 34 patients had no psychiatric problems (NP group). No significant intergroup differences were found in MCS, PCS, SRS-22, and RMDQ scores preoperatively. However, at the 2-year follow-up, a significant intergroup difference was observed between PCS and RMDQ scores. Multiple regression analysis revealed that only the presence of a preoperative psychiatric problem can predict PCS and RMDQ scores. Other factors, such as, gender, age, body mass index, bone mineral density, osteotomy site, number of fusion segments, and instrumented levels did not affect PCS or RMDQ scores.</p></sec><sec><title>Conclusions</title><p>The presence of a psychiatric factor may be an important risk factor underlying poor physical and pain scores after corrective surgery in patients with LDK. The findings presented here suggest that psychiatric factors should be evaluated prior to surgery for determining the risk of a poor outcome.</p></sec>


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5514-5514 ◽  
Author(s):  
Karim Fizazi ◽  
Neal D. Shore ◽  
Teuvo Tammela ◽  
Albertas Ulys ◽  
Egils Vjaters ◽  
...  

5514 Background: DARO is a structurally distinct androgen receptor inhibitor with a favorable safety profile, approved for treating men with nmCRPC after demonstrating significantly prolonged metastasis-free survival, compared with placebo (PBO), in the phase III ARAMIS trial: median 40.4 vs 18.4 months, respectively (HR 0.41; 95% CI 0.34–0.50; P<0.0001). We report final analyses of OS and prospectively collected, patient-relevant secondary endpoints, and updated safety results. Methods: 1509 patients (pts) with nmCRPC were randomized 2:1 to DARO 600 mg twice daily (n=955) or PBO (n=554) while continuing ADT. Secondary endpoints included OS, and times to pain progression, first cytotoxic chemotherapy, and first symptomatic skeletal event. The OS analysis was planned to occur after approximately 240 deaths. Secondary endpoints were evaluated in a hierarchical order. Results: Final analysis was conducted after 254 deaths were observed (15.5% of DARO and 19.1% of PBO patients). After unblinding at the primary analysis, 170 pts crossed over from PBO to DARO. DARO showed a statistically significant OS benefit corresponding to a 31% reduction in the risk of death compared with placebo. All other secondary endpoints were significantly prolonged by DARO (Table), regardless of the effect of crossover and subsequent therapies on survival benefit. Incidences of treatment-emergent adverse events (AEs) with ≥5% frequency were generally comparable between DARO and PBO, similar to the safety profile observed at the primary analysis. Incidences of AEs of interest (including falls, CNS effects, and hypertension) were not increased with DARO compared with PBO when adjusted for treatment exposure. AEs in the crossover group were consistent with those for the DARO treatment arm. Conclusions: DARO showed a statistically significant OS benefit for men with nmCRPC. In addition, DARO delayed onset of cancer-related symptoms and subsequent chemotherapy, compared with PBO. With extended follow-up, safety and tolerability were favorable and consistent with the primary ARAMIS analysis (Fizazi et al, N Engl J Med 2019;380:1235-46). Clinical trial information: NCT02200614 .[Table: see text]


2016 ◽  
Vol 10 (1) ◽  
pp. 109-121 ◽  
Author(s):  
Caroline P. Schaefer ◽  
Edgar H. Adams ◽  
Margarita Udall ◽  
Elizabeth T. Masters ◽  
Rachael M. Mann ◽  
...  

Background:Longitudinal research on outcomes of patients with fibromyalgia is limited.Objective:To assess clinician and patient-reported outcomes over time among fibromyalgia patients.Methods:At enrollment (Baseline) and follow-up (approximately 2 years later), consented patients were screened for chronic widespread pain (CWP), attended a physician site visit to determine fibromyalgia status, and completed an online questionnaire assessing pain, sleep, function, health status, productivity, medications, and healthcare resource use.Results:Seventy-six fibromyalgia patients participated at both time points (at Baseline: 86.8% white, 89.5% female, mean age 50.9 years, and mean duration of fibromyalgia 4.1 years). Mean number of tender points at each physician visit was 14.1 and 13.5, respectively; 11 patients no longer screened positive for CWP at follow-up. A majority reported medication use for pain (59.2% at Baseline, 62.0% at Follow-up). The most common medication classes were opioids (32.4%), SSRIs (16.9%), and tramadol (14.1%) at Follow-up. Significant mean changes over time were observed for fibromyalgia symptoms (modified American College of Rheumatology 2010 criteria: 18.4 to 16.9;P=0.004), pain interference with function (Brief Pain Inventory-Short Form: 5.9 to 5.3;P=0.013), and sleep (Medical Outcomes Study-Sleep Scale: 58.3 to 52.7;P=0.004). Patients achieving ≥2 point improvement in pain (14.5%) experienced greater changes in pain interference with function (6.8 to 3.4;P=0.001) and sleep (62.4 to 51.0;P=0.061).Conclusion:Fibromyalgia patients reported high levels of burden at both time points, with few significant changes observed over time. Outcomes were variable among patients over time and were better among those with greater pain improvement.


2020 ◽  
Vol 49 (1) ◽  
pp. 130-136
Author(s):  
Justin W. Arner ◽  
Bryant P. Elrick ◽  
Philip-C. Nolte ◽  
Daniel B. Haber ◽  
Marilee P. Horan ◽  
...  

Background: Few long-term outcome studies exist evaluating glenohumeral osteoarthritis (GHOA) treatment with arthroscopic management. Purpose: To determine outcomes, risk factors for failure, and survivorship for the comprehensive arthroscopic management (CAM) procedure for the treatment of GHOA at minimum 10-year follow-up. Study Design: Case series; Level of evidence, 3. Methods: The CAM procedure was performed on a consecutive series of patients with advanced GHOA who opted for joint preservation surgery and otherwise met criteria for total shoulder arthroplasty. At minimum 10-year follow-up, postoperative outcome measures included change in the American Shoulder and Elbow Surgeons, Single Assessment Numeric Evaluation, 12-Item Short Form Health Survey (SF-12) Physical Component Summary, and visual analog scale for pain, along with the QuickDASH (shortened version of Disabilities of the Arm, Shoulder and Hand) and satisfaction score. Kaplan-Meier survivorship analysis was performed, with failure defined as progression to arthroplasty. Results: In total, 38 CAM procedures were performed with 10-year minimum follow-up (range, 10-14 years) with a mean patient age of 53 years (range, 27-68 years) at the time of surgery. Survivorship was 75.3% at 5 years and 63.2% at minimum 10 years. Those who progressed to arthroplasty did so at a mean 4.7 years (range, 0.8-9.6 years). For those who did not undergo arthroplasty, American Shoulder and Elbow Surgeons scores significantly improved postoperatively at 5 years (63.3 to 89.6; P < .001) and 10 years (63.3 to 80.6; P = .007). CAM failure was associated with severe preoperative humeral head incongruity in 93.8% of failures as compared with 50.0% of patients who did not go on to arthroplasty ( P = .008). Median satisfaction was 7.5 out of 10. Conclusion: Significant improvements in patient-reported outcomes were sustained at minimum 10-year follow-up in young patients with GHOA who underwent a CAM procedure. The survivorship rate at minimum 10-year follow-up was 63.2%. Humeral head flattening and severe joint incongruity were risk factors for CAM failure. The CAM procedure is an effective joint-preserving treatment for GHOA in appropriately selected patients, with sustained positive outcomes at 10 years.


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