scholarly journals Improvement in Clinical Outcomes, Physical Function, and Bodily Pain Following a 12 Week Course of Intermittent Pneumatic Compression Therapy in Patients with Chronic Venous Ulcers: Results of an Observational Longitudinal Retrospective Study

Cureus ◽  
2014 ◽  
Author(s):  
Eric Lullove ◽  
Oscar M. Alvarez
Keyword(s):  
Retrospective Study ◽  
Physical Function ◽  
Clinical Outcomes ◽  
Bodily Pain ◽  
Compression Therapy ◽  
Intermittent Pneumatic Compression ◽  
Venous Ulcers

Treatment of Chronic Venous Ulcers Using Sequential Gradient Intermittent Pneumatic Compression

1996 ◽  
Vol 11 (3) ◽  
pp. 111-116 ◽  
Author(s):  
J. J. Schuler ◽  
T. Maibenco ◽  
J. Megerman ◽  
M. Ware ◽  
J. Montalvo
Keyword(s):  
Compression Therapy ◽  
Intermittent Pneumatic Compression ◽  
Complete Healing ◽  
Venous Stasis ◽  
Compression Stockings ◽  
Venous Ulcers ◽  
Qualified Personnel ◽  
Table Analysis ◽  
Area And Perimeter ◽  
At Home

Objective: To determine if a limited regimen of sequential gradient intermittent pneumatic compression (‘HomeRx’: HRx) is as effective in promoting the healing of chronic venous stasis ulcers as is the Unna's boot (UB), considered the ‘gold standard’ in compression therapy. Design: Fifty-three patients, aged 31–85 years, with ulcers ranging up to 31.8 cm2 (mean 9.9, SE 1.1) were Prospectively randomized to treatments with UB or HRx and followed weekly for 180 days or until healing was complete, whichever came first. The HRx group wore graduated compression stockings, which were removed only while intermittent pneumatic compression was applied bilaterally at home for 1 h each morning and 2 h each evening. The UB was re-applied at least weekly. The two groups were equivalent in their use of hydrocolloid dressings and periods of leg elevation. Setting: Therapy performed at home, with weekly visits to an outpatient clinic. Main outcome measures: Complete ulcer healing and the rate of healing, based on area and perimeter changes; amounts of wound exudate and pain. Results: Complete healing was achieved in 20 of 28 Patients (71%) in the HRx group, compared with 15 of 25 (60%) treated with UB. Three patients had an adverse reaction to UB, one had cellulitis and five were non-compliant. Correcting for these withdrawn patients by life table analysis, healing rates were 76% and 64%, respectively. Healing rates did not correlate with haemodynamic measurements made prior to treatment. Conclusions: Using HRx for just a few hours daily to supplement graduated elastic compression heals venous ulcers at least as well as does the UB, without its disadvantages (e.g. the need for frequent re-application by qualified personnel, difficulty bathing), affording patients greater convenience during treatment.

Healing venous ulcers with different modalities of leg compression

Phlebologie ◽  
2006 ◽  
Vol 35 (05) ◽  
pp. 349-355 ◽  
Author(s):  
E. O. Brizzio ◽  
G. Rossi ◽  
A. Chirinos ◽  
I. Cantero ◽  
G. Idiazabal ◽  
...  
Keyword(s):  
Wound Care ◽  
Univariate Analysis ◽  
Compression Therapy ◽  
Healing Time ◽  
Clinical Parameters ◽  
Compression Stockings ◽  
Local Pressure ◽  
Ulcer Size ◽  
Venous Ulcers ◽  
Unexpected Findings

Summary Background: Compression therapy (CT) is the stronghold of treatment of venous leg ulcers. We evaluated 5 modalities of CT in a prospective open pilot study using a unique trial design. Patients and methods: A group of experienced phlebologists assigned 31 consecutive patients with 35 venous ulcers (present for 2 to 24 months with no prior CT) to 5 different modalities of leg compression, 7 ulcers to each group. The challenge was to match the modality of CT with the features of the ulcer in order to achieve as many healings as possible. Wound care used standard techniques and specifically tailored foam pads to increase local pressure. CT modalities were either stockings Sigvaris® 15-20, 20-30, 30-40 mmHg, multi-layer bandages, or CircAid® bandaging. Compression was maintained day and night in all groups and changed at weekly visits. Study endpoints were time to healing and the clinical parameters predicting the outcome. Results: The cumulative healing rates were 71%, 77%, and 83% after 3, 6, and 9 months, respectively. Univariate analysis of variables associated with nonhealing were: previous surgery, presence of insufficient perforating and/or deep veins, older age, recurrence, amount of oedema, time of presence of CVI and the actual ulcer, and ulcer size (p <0.05-<0.001). The initial ulcer size was the best predictor of the healing-time (Pearson r=0.55, p=0.002). The modality of CT played an important role also, as 19 of 21 ulcers (90%) healed with stockings but only 8 of 14 with bandages (57%; p=0.021). Regression analysis allowed to calculate a model to predict the healing time. It compensated for the fact that patients treated with low or moderate compression stockings were at lower risk of non-healing. and revealed that healing with stockings was about twice as rapid as healing with bandages. Conclusion: Three fourths of venous ulcers can be brought to healing within 3 to 6 months. Healing time can be predicted using easy to assess clinical parameters. Irrespective of the initial presentation ulcer healing appeared more rapid with the application of stockings than with bandaging. These unexpected findings contradict current believes and require confirmation in randomised trials.

Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial

Vascular ◽  
2021 ◽  
pp. 170853812110100
Author(s):  
Mohamed Shukri Abdelgawad ◽  
Amr M El-Shafei ◽  
Hesham A Sharaf El-Din ◽  
Ehab M Saad ◽  
Tamer A Khafagy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Radiofrequency Ablation ◽  
Controlled Trial ◽  
Compression Therapy ◽  
Randomized Controlled ◽  
Venous Ulcers ◽  
Group A ◽  
Group B ◽  
To Receive

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p  = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

scholarly journals Risk factors and clinical outcomes of acute coronary syndrome in men: A retrospective study

2020 ◽  
Vol 72 ◽  
pp. S5
Author(s):  
Shahood Ajaz Kakroo ◽  
Kala Jeethender Kumar ◽  
O. Sai Satish ◽  
M. Jyotsna ◽  
B. Srinivas ◽  
...  
Keyword(s):  
Risk Factors ◽  
Acute Coronary Syndrome ◽  
Retrospective Study ◽  
Clinical Outcomes ◽  
Coronary Syndrome

223 Racial differences in outcomes for metastatic renal cell carcinoma (mRCC) patients managed on immune-checkpoint inhibitor (ICI) therapy

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A242-A242
Author(s):  
T Anders Olsen ◽  
Dylan Martini ◽  
Subir Goyal ◽  
Yuan Liu ◽  
Sean Evans ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
African American ◽  
Retrospective Study ◽  
Cell Carcinoma ◽  
Clinical Outcomes ◽  
Immune Checkpoint ◽  
Renal Cell ◽  
Clear Cell ◽  
Emory University ◽  
Caucasian Patients

BackgroundImmune checkpoint inhibitors (ICIs) have increased in prevalence for the treatment of metastatic clear-cell renal cell carcinoma (mccRCC) in recent years given their efficacy and favorable toxicity profile. However, there has been insufficient investigation in the literature of how clinical outcomes differ on the basis of race. In this paper, we investigated differences in clinical outcomes between African American (AA) and Caucasian mRCC patients treated with ICI therapy.MethodsWe performed a retrospective study of 198 patients with mRCC who received ICI at the Emory Winship Cancer Institute from 2015–2020. Clinical outcomes were measured by overall survival (OS), progression-free survival (PFS), and clinical benefit (CB). OS and PFS were calculated from ICI-initiation to date of death and radiographic or clinical progression, respectively. CB was defined as a best radiographic response of complete response, partial response, or stable disease maintained for at least 6 months per response evaluation criteria in solid tumors version 1.1. The association of self-identified race with OS and PFS was generally modeled by Cox proportional hazards model. Univariable and multivariable logistic regression models were used for binary outcomes of CB. The univariate association of immune-related adverse events (irAEs) and non-clear-cell RCC (nccRCC) with race was assessed using Chi-square test.ResultsOur cohort was made up of 38 AA (19%) and 160 Caucasian (81%) patients. Most of the patients were diagnosed with ccRCC (78%) and more than half received PD-1 monotherapy (57%). Most patients were international mRCC database consortium (IMDC) intermediate (57%) or poor-risk (25%) groups. AA patients displayed significantly shorter PFS (HR=1.52, 95% CI: 1.01–2.3, p=0.045) and trended towards decreased CB (OR=0.51, 95% CI: 0.22–1.17, p=0.111) in MVA (table 1). There was no difference in OS (HR=1.09, 95% CI: 0.61–1.95, p=0.778) between the two racial groups in MVA (table 1). On Kaplan-Meier method, AA patients had shorter median OS (17 vs 25 months, p=0.3676) and median PFS (3.1 vs 4.4 months, p=0.0676) relative to Caucasian patients (figure 1). Additionally, AA patients more commonly had nccRCC compared to Caucasian patients (41.7% vs 17.5% nccRCC, p-0.002). AA patients also trended towards a lower incidence of irAEs compared to Caucasian patients in UVA (23.7% vs 35.8%, p=0.153).Abstract 223 Table 1*MVA controlled for age, race, gender, IMDC risk group, number of prior lines of therapy, PD-1 monotherapy, and ccRCC**statistical significance at alpha < 0.05Abstract 223 Figure 1African-American (black) and Caucasian (white) for OS (left panel) and PFS (right panel)ConclusionsIn this group of mRCC patients treated with ICI, African American patients had significantly shorter PFS compared to Caucasian patients. These findings suggest race could play a role in the management of late-stage mRCC. Larger, prospective studies are needed to validate these findings.AcknowledgementsResearch reported in this publication was supported in part by the Breen Foundation and the Biostatistics Shared Resource of Winship Cancer Institute of Emory University and NIH/NCI under award number P30CA138292. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.Trial RegistrationNot applicable.Ethics ApprovalThis retrospective study was approved by the Emory University Institutional Review Board.ConsentNot applicable.ReferencesNot applicable

scholarly journals FRI0048 NUMBER NEEDED TO TREAT TO ACHIEVE MINIMUM CLINICALLY SIGNIFICANT DIFFERENCES IN PATIENT-REPORTED OUTCOMES IN PATIENTS TREATED WITH BARICITINIB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 599.1-600
Author(s):  
V. Strand ◽  
L. Sun ◽  
J. Ross Terres ◽  
C. L. Kannowski
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Bodily Pain ◽  
Health Assessment ◽  
Number Needed To Treat ◽  
Chronic Illness Therapy ◽  
Sf 36 ◽  
Patient Reported ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Background:Baricitinib (BARI) provided rapid and sustained improvements in patient-reported outcomes (PROs) in randomized, controlled trials (RCTs) in patients (pts) with active rheumatoid arthritis (RA) and inadequate responses (IR) to methotrexate (MTX) (RA-BEAM;NCT01710358)1,2and biologic DMARDs (bDMARD-IR; RA-BEACON;NCT01721044)3,4.Objectives:To determine the number needed to treat (NNT) to report improvements ≥minimum clinically important differences (MCIDs) in multiple PROs at Week (Wk) 12 after treatment with BARI 4-mg in RA-BEAM and BARI 2-mg or BARI 4-mg in RA-BEACON. NNTs ≤10 vs placebo (PBO) are considered clinically meaningful.Methods:Evaluated PROs with respective MCID definitions included Patient Global Assessment of Disease Activity (PtGA, 0-100 mm visual analog scale [VAS], MCID ≥10 mm), pain (0-100 mm VAS, MCID ≥10 mm), physical function (Health Assessment Questionnaire-Disability Index, MCID ≥0.22 points), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F], MCID≥4.0), and health-related quality of life (SF-36 physical component summary [PCS: MCID ≥2.5] and domain scores: physical function [PF], role physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role emotional [RE], mental health [MH], MCID ≥5.0).5The percentages of pts reporting improvements ≥MCID were determined at Wk 12. NNTs were calculated as 1/difference in response rates between BARI 2-mg or 4-mg and PBO.Results:At Wk 12, percentages of pts reporting clinically meaningful improvements were greater and statistically different from PBO (p<0.01) with BARI 2-mg and 4-mg across most PROs in both RCTs. Most NNTs were ≤10. (Figure)Conclusion:Across different populations, MTX-IR and bDMARD-IR pts with active RA reported clinically meaningful improvements in PROs after BARI treatment. The NNTs in these analyses indicate that <10 pts need to be treated with BARI 2- or 4-mg to report a clinically meaningful benefit.References:[1]Taylor et al. NEJM, 2017;376: 652-62[2]Keystone et al. Ann Rheum Dis, 2017;76:1853-61[3]Genovese et al. NEJM, 2016; 374: 1243-52[4]Smolen et al. Ann Rheum Dis, 2017; 76: 694-700[5]Strand et al. J Rheumatol, 2011; 38: 1720-27Figure.Percentages of patients reporting improvements ≥MCID with baricitinib vs placebo and associated NNTs for baricitinib in RA-BEAM and RA-BEACON. *p<0.05; **p<0.01; ***p<0.001. Abbreviations: BP, bodily pain; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; GH, general health; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCID, minimum clinically important difference; MH, mental health; NA, not applicable (ie, difference between treatment and placebo is not statistically significant, confidence interval of NNT is not calculated); NNT, numbers needed to treat; Pain, Patient’s assessment of pain; PCS, physical component score; PF, physical function; PtGA, Patient’s Global Assessment of Disease Activity; RE, role emotional; RP, role physical; SF-36, Short Form-36; SF, social functioning; VT, vitalityDisclosure of Interests:Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Luna Sun Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jorge Ross Terres Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Carol L. Kannowski Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company

scholarly journals THU0460 PHYSICAL FITNESS AND QUALITY OF LIFE IN WOMEN WITH FIBROMYALGIA: LONGITUDINAL ANALYSES FROM THE AL-ÁNDALUS PROJECT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 466.1-467
Author(s):  
B. Gavilán Carrera ◽  
I. C. Alvarez-Gallardo ◽  
M. Borges Cosic ◽  
A. Soriano Maldonado ◽  
M. Delgado-Fernández ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Fitness ◽  
Physical Function ◽  
Physical Component Summary ◽  
General Health ◽  
Bodily Pain ◽  
Physical Role ◽  
Over Time

Background:Optimizing the highly deteriorated quality of life (QoL) of patients with fibromyalgia is one of the main goals in the management of the disease1. Physical fitness has been identified as a powerful marker of health that is positively related to QoL in this population2, although previous evidence is mainly based on cross-sectional data.Objectives:This study aimed to examine the longitudinal associations (2- and 5-year follow-up) between physical fitness and QoL in women with fibromyalgia.Methods:In this prospective cohort study, women diagnosed with fibromyalgia (age: 51.3±7.6 years) with completed data were included at baseline (n=441), at 2-year follow-up (n=220) and at 5-year follow-up (n=227). The Senior Fitness Tests battery was used to assess physical fitness components and a standardized global fitness index was calculated. The eight dimensions plus the two physical and mental component summaries of the Short-Form health survey-36 questionnaire were used to assess QoL. To examine whether changes in fitness predicted QoL at follow-up, multiple linear regression models were built. The bidirectionallity of the associations (whether changes in QoL predicted fitness at follow-up) was also tested. Outcome values at baseline and age, fat percentage, analgesic consumption, educational level, and occupational status at follow-up were entered as potential confounders in all analyses.Results:Changes in fitness were associated with physical function (β=0.160), physical role (β=0.275), bodily pain (β=0.271), general health (β=0.144), and physical component summary (β=0.276) at 2-year follow-up (all,P<0.05) and with changes in physical role (β=0.215) and physical component summary (β=0.135) at 5-year follow-up (all,P<0.05). Changes in physical function (β=0.165), physical role (β=0.230), bodily pain (β=0.230), general health (β=0.130) and physical summary component (β=0.251) were associated with fitness at 2-year follow-up (all,P<0.05). Changes in all dimensions of QoL (β rating from 0.113 to 0.198), as well as the physical (β=0.174) and mental (β=0.164) summary components were associated with fitness at 5-year follow-up (all,P<0.05).Conclusion:Increasing levels of physical fitness over time predicts future QoL in women with fibromyalgia, especially for physical domains at 2-year follow-up. In addition, increasing QoL across all domains over time predicts future global fitness at 2- and, specially, 5-year follow-up. Future research is warranted to determine the clinical relevance of the bidirectional association between physical fitness and QoL in fibromyalgia.References:[1]Macfarlane GJ, et al. Ann Rheum Dis, 2018; 76(2), 318-328.[2]Álvarez-Gallardo IC, et al. 2019;99:1481–1494.Acknowledgments:This study was supported by the Spanish Ministry of Economy and Competitiveness (I+D+i DEP2010-15639; I+D+I DEP2013-40908-R; BES-2014-067612) and the Spanish Ministry of Education (FPU14/FPU 15/00002)Disclosure of Interests: :None declared

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