Thymoglobulin Decreases the Need for Immunosuppression at 12 Months after Myeloablative and Nonmyeloablative Unrelated Donor Transplantation: CBMTG 0801, a Randomized, Controlled Trial

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 38-38 ◽  
Author(s):  
Irwin Walker ◽  
Kirk R. Schultz ◽  
Cynthia L. Toze ◽  
Holly Margaret Kerr ◽  
John Moore ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Peripheral Blood ◽  
Chronic Gvhd ◽  
Immunosuppressive Agents ◽  
Analysis Of Covariance ◽  
Unrelated Donor ◽  
Symptom Scale ◽  
Serious Infections ◽  
Multicenter Rct

Abstract Background: Randomized trials (RCT) have shown that anti-thymocyte globulin (ATG) decreases the incidence and severity of chronic graft-versus-host disease (cGVHD) following unrelated donor transplants, but it is not used universally. We conducted a multicenter RCT to test whether the addition of Thymoglobulin® (TG) to both myeloablative (MA) and nonmyeloablative (NMA) preparative regimens results in a decrease in use of immunosuppression for cGVHD, leading to improvements in quality of life but without an increase in mortality, disease relapse or serious infections. Methods: Multicentric (Canada and Australia, 12 centres), open label RCT, in patients having transplantation from unrelated donors for a hematologic malignancy. Inclusion criteria: age 16-70, MA or NMA preparative regimen, bone marrow or peripheral blood graft, fully major histocompatibility complex (MHC) matched (HLA-A, B, C and DRB1) or 1-antigen/allele mismatched donor. Subjects were allocated by minimization procedure to TG or No Thymoglobulin® (NoTG). The TG arm received 0.5, 2.0, 2.0 mg/kg of TG on days -2, -1 and +1 respectively. Analyses were on a modified intention-to-treat basis for patients actually transplanted. The primary end-point was freedom from cGVHD at 12 months from transplantation defined as withdrawal of all systemic immunosuppressive agents (IST) without resumption up to 12 months after transplantation. Secondary end-points included relapse, serious infections, acute and chronic GVHD, overall survival (OS), and quality of life (QoL). QoL measures included Life Happiness Rating, Affect Balance Scale, FACT-BMT, EuroQol 5D, Center for Epidemiologic Studies-Depression Scale, Chronic GVHD Symptom Scale, and the Illness Intrusiveness Ratings Scale, collected prior to randomization and at 12 months. Treatment group comparisons, adjusted for baseline values, were made using logistic regression, analysis of covariance or the Cox proportional hazards model; in the presence of competing risks the method of Fine and Gray was implemented. Results: Data were locked on July 7, 2014. Two hundred and three (203) subjects consented and were randomized; seven were non-evaluable (6 withdrew before transplant, 3 having relapsed; 1 withdrew consent day 139), leaving 196 subjects for analysis. One subject was later found ineligible but was analyzed. Study populations were balanced for clinical risk factors. Sixty-seven percent (67%) received myeloablative conditioning, and 88% peripheral blood. Eighty-three percent (83%) were 8/8 HLA matched. Overall, freedom from IST at 12 months was twice as high in the TG group 37.4% vs. 16.5%, p=0.0001, even after adjusting for clinical factors: odds ratio 4.25 (95% CI, 1.87 – 9.67); p=0.006 or separately analyzing the MA and NMA groups. Acute GVHD (I-IV) and moderate/severe NIH grades of cGVHD were higher in the NoTG group, while relapse, non-relapse mortality, serious infections and OS were not significantly different. CGVHD (mild/mod/severe) was borderline significant using Fine and Gray (p=0.12; HR=0.65 95% CI (0.38 – 1.11) but the Cox result was significant p=0.01 (HR=0.48 95% CI (0.27 -0.85). Life Happiness was higher and Chronic GVHD Symptoms lower in the TG group as compared to the NoTG group (p=0.014 and 0.017 respectively); no other measure differed significantly. Conclusions: Addition of TG to the conditioning regimen for unrelated donor transplantation results in twice the likelihood of being alive and off immunosuppression at 12 months after transplantation, and is associated with modest improvements in some aspects of QoL. This benefit is seen without an increase in relapse, serious infections or non-relapse mortality. Our data support the use of TG in both MA and NMA preparative regimens before unrelated donor transplantation.TableTG N=97NoTG N=99p-valuePRIMARY ENDPOINTFreedom from IST at 12 mos37.4%16.5%0.001Myeloablative Subanalysis37.9%19.7%0.02Nonmyeloablative Subanalysis36.4%9.7%0.01SECONDARY ENDPOINTSAcute GVHD I-IV58.6%73.2%0.012cGVHD (NIH criteria)22.4%33.4%0.01 (Cox) 0.12 (Fine and Gray)cGVHD (NIH) Mod/Severe4.4%31%0.0001Serious infections38.4%37.1%0.85Relapse10.1%13.4%0.27Non-relapse mortality (12 mo)19.2%24.1%0.45Survival (12 mo)74.7%64.5%0.16Life Happiness Rating (QoL)*7.405.970.014GVHD Symptom Scale (QoL)*14.9520.930.017* Other QoL measures not significant Disclosures Walker: Sanofi: Research Funding. Off Label Use: Thymoglobulin which is the intervention in this randomized trial. Kuruvilla:Sanofi Aventis: Honoraria. Popradi:Sanofi: Honoraria.

Prospective Evaluation of the NIH Staging Criteria in Chronic GVHD and Correlation to Quality of Life - Results of a German Multicenter Validation Trial.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 42-42 ◽  
Author(s):  
Daniel Wolff ◽  
Philipp Y. Herzberg ◽  
Pia Heussner ◽  
Friederike Mumm ◽  
Stephanie von Harsdorf ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Functioning ◽  
Chronic Gvhd ◽  
Well Being ◽  
Maximum Activity ◽  
Daily Activities ◽  
Point Scale ◽  
Symptom Scale ◽  
Time Points

Abstract The NIH staging and response criteria offer for the first time the chance for uniform documentation and evaluation of physical functioning and quality of life aspects of chronic graft-versus-host disease (cGVHD) as well as its response to immunosuppressive treatment. Here we present the interim analysis of a prospective Germany multicenter study on the NIH staging criteria in cGVHD. Methods: Seventy-six patients (median age 46 years, range 19–64) after allogeneic hematopoetic stem cell transplantation (HSCT) for hematologic malignancies were evaluated according to the NIH criteria based cGVHD activity assessment, the Lee Chronic GVHD Symptom-Scale, FACT-BMT, human activity profile (HAP), SF 36, Berliner Social Support Scale (BSSS), 24 item Adjective Measure (24 - AM), Hospital Anxiety and Depression Scale (HADS) and the NCCN-Distress-Thermometer. Enrolment occurred between day 100 and 1 year after HSCT or in the presence of active cGVHD also at later time points. Follow-up surveys were conducted at 1, 2, 3, 5, 8, 12 and 18 months after baseline survey. At all time points disease status, comorbidities and medication were documented. Additionally the NIH-Symptom-Scale was applied for clinician rating of cGVHD symptoms. Results: Fifty-one patients had cGVHD (mild n=15, moderate n=32, severe n=4) while 25 patients did not have cGVHD. The cGVHD NIH consensus grading as well as the 10 point scale correlated with impairment of physical functioning (p<0.01, r=.48), the FACT-G total score (p=0.02, r=.33) and mental health (p<0.01, r=.41). The HAP maximum activity score correlated inversely with severity of cGVHD (p=0.028, r=.44), with the physical functioning (p<0.01, r=.53) and with role limitation due to physical problems (p<0.01, r=.43) evaluated by the SF36. In addition an impaired physical functioning correlated with role limitations due to emotional problems (p<0.01, r=.52) and with impaired mental health (p<0,01, r=.63). Moreover the HAP maximum activity score correlated with emotional well being as evaluated by the FACT (p<0.01, r=.39). Depression as measured by the HADS depression score correlated with pain (p<0,01, r=.35) and impaired physical functioning (p=0.03, r=.26) while the HADS anxiety score did not. The results demonstrate, that severity of cGVHD as assessed by the NIH consensus grading and the 10 point scale correlate with impairment of physical functioning as well as daily activities and quality of life. Moreover reduction of daily activities lead to impairment of emotional well being.

5 Year Results of BMT CTN 0201: Unrelated Donor Bone Marrow Is Associated with Better Psychological Well-Being and Less Burdensome Chronic Gvhd Symptoms Than Peripheral Blood

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 270-270 ◽  
Author(s):  
Stephanie J. Lee ◽  
Brent Logan ◽  
Peter Westervelt ◽  
Corey S Cutler ◽  
Ann E Woolfrey ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Peripheral Blood ◽  
Chronic Gvhd ◽  
Well Being ◽  
Unrelated Donor ◽  
Symptom Scale ◽  
Psychological Well Being ◽  
Donor Bone Marrow ◽  
Patient Reported

Abstract BMT CTN 0201 was a randomized study of unrelated donor bone marrow (BM) vs. peripheral blood (PB) (N=551) in hematopoietic cell transplantation (HCT) for hematologic malignancies. The primary analysis after 2 years of follow up showed similar survival, disease-free survival and treatment-related mortality between the graft types. There was a higher rate of graft failure with bone marrow (9% vs. 3%, p=0.002) and a higher rate of chronic GVHD with peripheral blood (53% vs. 41%, p=0.01). (Anasetti et al, NEJM 2012) Patient reported outcomes (PROs) were collected from patients > 16 years old at enrollment and 0.5, 1, 2 and 5 years after transplantation with the Functional Assessment of Cancer Therapies - Bone Marrow Transplant (FACT-BMT), Mental Health Inventory (MHI), and Lee chronic graft-versus-host disease (cGVHD) symptom scale. At 5 years, 102 BM and 93 PB participants were alive and eligible for the quality of life (QOL) study. Clinically meaningful differences (changes in scores that are noticeable to patients) were considered 0.5 x standard deviation of the total population based on the distribution method. Results: Data as of 5/25/15 were analyzed. 70% completed the pre-randomization assessment, and 74-78% of adult survivors completed the 5 year assessment. Age < 30 at transplant and high risk disease were associated with missing 5 year data, but not graft source. Response rates at 0.5, 1 and 2 years were 28-43% of survivors. There are no differences in any of the primary QOL scores in the first two years after HCT using univariate comparisons, although missing data severely limit conclusions during this period. At 5 years, the FACT-Trial Outcome Index (TOI), the MHI Psychological Well-Being, and the cGVHD symptom scale scores are all significantly better for BM patients, although only the latter two are still significant after adjustment for multiple testing (p<0.0125 because of 4 primary QOL variables). Results were similar when tested in multivariate models adjusting for baseline patient-reported scores and also imputing missing values based on patient characteristics (Table). Of the 7 chronic GVHD subscales, symptoms in the eye, lung, and energy were significantly better with BM (p<0.01). A diagnosis of cGVHD was highly associated with patient-reported cGVHD symptoms but not with QOL or psychological status. Inclusion of extensive cGVHD in the multivariate models did not change the significance of PRO differences suggesting that differences in cGVHD incidence do not explain the PRO findings. With a median follow up of 73 months for survivors, no difference in survival between PB and BM is observed (p=0.84, Figure). Conclusion: At 5 years after transplant, recipients of unrelated donor BM have better psychological well-being and less burdensome chronic GVHD symptoms than recipients of PB. Survival rates are similar. Table. Comparisons of primary QOL variables at 5 years, adjusted for QOL values at baseline and missing data using inverse probability weighting using significant clinical characteristics. QOL scale Bone marrow (n=102) Peripheral blood (n=93) P value Clinically significant difference* Difference between BM and PB (95% CI) FACT-BMT TOI, mean +/- SE (higher scores better) 76.7 +/- 1.6 (n=79) 70.5 +/- 1.9 (n=69) 0.014 8.5 6.2 (1.3-11.1) MHI - Psychological well-being, mean +/- SE (higher scores better) 78.9 +/- 1.7 (n=80) 72.2 +/- 1.9 (n=72) 0.011 8.4 6.7 (1.6-11.8) MHI-Psychological Distress, mean +/- SE (lower scores better) 16.0 +/- 1.3 (n=80) 19.0 +/- 1.5 (n=71) 0.128 6.5 -3.0 (-6.8,0.9) Chronic GVHD symptoms, mean +/- SE (lower scores better) 13.1 +/- 1.5 (n=80) 19.3 +/- 1.6 (n=72) 0.004 7.1 -6.3 (-10.5, -2.0) SE, standard error *0.5 x STD Figure 1. Figure 1. Disclosures Lee: Bristol-Myers Squibb: Consultancy; Kadmon: Consultancy. Maziarz:Athersys: Consultancy, Patents & Royalties, Research Funding; Novartis: Consultancy.

Long Term Follow up of Two Randomized Trials on Antithymocyte Globulin (ATG) for GVHD Prophylaxis in Unrelated Donor Transplants: Chronic GVHD, Bronchiolitis and Quality of Life.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 438-438
Author(s):  
Andrea Bacigalupo ◽  
Maurizio Vignola ◽  
Teresa Lamparelli ◽  
Paolo Bruzzi ◽  
Stefano Guidi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Antithymocyte Globulin ◽  
Randomized Trials ◽  
Chronic Gvhd ◽  
Prospective Trial ◽  
Conditioning Regimen ◽  
Unrelated Donor ◽  
One Year

Abstract Background . We have reported that rabbit antithymocyte globulin (ATG Sangstat-Genzyme) prevents acute and chronic graft versus host disease (GvHD) in patients undergoing an unrelated donor transplant (Blood2001; 98 (10): 2942–2947). Patients had entered two consecutive randomized trials: in trial-1, 54 patients were randomized to non-ATG (n=25) or 7.5mg/kg rabbit ATG (n=29). In trial-2, 28 patients were randomized in the non-ATG arm and 27 in the ATG 15mg/kg arm. Aim of the study: to assess the risk of extensive chronic GvHD, bronchiolitis obliterans , quality of life, survival and transplant related mortality (TRM) 4 years later. Patients. Seventy five patients survived 100 days after BMT, and were available for analysis : in trial-1 there were 20 patients per arm, in trial-2 there were respectively 18 and 17 patients. The median follow up was 7.4 years for trial-1 and 5.3 years for trial-2. Each patients was updated and assessed for survival, chronic GvHD, for bronchiolitis , relapse of the original disease and quality of life. Results. Results are given in percentage, in the order non-ATG vs ATG patients. At last follow up chronic GvHD (limited+extensive) was scored in 74% vs 33% respectively for non-ATG and ATG of patients in trial 1 (p=0.01) and in 61% vs 29% in trial-2 (p=0.06): when the two trials are combined cGvHD is scored in 68% vs 31% of non-ATG vs ATG patients (p=0.002). Extensive chronic GvHD was scored in both trials in 35% and 13% of patients (0.03). Bronchiolitis was present at last follow up in trial-1 in 50% vs 0% (p=0.01), and in 33% vs 8% in trial-2 (p=0.1). Combined data show bronchiolitis in 40% vs 4% of non-ATG vs ATG patients (p=0.002). Median timing of bronchiolitis was 1155 days. When patients developed bronchiolitis, the mortality was high (50%). Quality of life was assessed by looking at proportion of patients with Karnowski score of 100% at last follow up: the proportion was 37% vs 91% patients in trial-1 (p=0.02), it was 75% vs 100% patients in trial-2 (p=0.2) and overall in 56% vs 95% of all non-ATG vs ATG patiens (p=0.007). Relapse related deaths were 13% in the non-ATG and 11% in the ATG group. Survival: the actuarial survival at 5 years in trial-1 is 48% vs 53% (non-ATG vs ATG) and in trial-2 30% vs 41%. The actuarial TRM is 48% vs 40%, and in trial-2 it is 62% vs 47% (non-ATG vs ATG patients). Actuarial 5 year TRM in patients surviving one year (late TRM) is 28% vs 4% (p=0.02). Conclusions. This updated analysis of two randomized GITMO trials, confirms with longer follow up, that ATG pre-transplant produces (1) a significant reduction of chronic GvHD (from 68% to 31%) and (2) a significant reduction of extensive chronic GvHD (from 35% to 13%). As a consequence quality of life is significantly improved in ATG patients. This study also shows that ATG reduces the risk of chronic bronchiolitis (from 40% to 4%), and late TRM (beyond one year) (from 28% to 4%). These data give strong support for the inclusion of ATG in the conditioning regimen of unrelated transplants: dosing and timing should be considered (Blood2003; 102 (11); 242a) and could be tested in a prospective trial. This work was supported by Fondazione CARIGE, GENOVA

Calculated NIH Response Correlates with Changes in Patient-Reported Symptoms but Not with Quality of Life: Results From the Chronic Gvhd Consortium

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1988-1988
Author(s):  
Yoshihiro Inamoto ◽  
Corey S. Cutler ◽  
Xiaoyu Chai ◽  
Mukta Arora ◽  
Paul J. Martin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Gvhd ◽  
Symptom Burden ◽  
Symptom Scale ◽  
Overall Response ◽  
Patient Reported ◽  
Organ Specific ◽  
Symptom Measures

Abstract Abstract 1988 Background: In 2005, the National Institutes of Health (NIH) Consensus Conference recommended measurement tools to capture clinician or patient-assessed chronic GVHD manifestations. The NIH Conference also proposed a set of provisional definitions to calculate response using these measures. The correlation of the calculated NIH responses with patient-reported quality of life (QOL) or symptoms has not been examined. Ideally, improvement according to NIH response criteria would be associated with better QOL and fewer symptoms compared to patients who have stable disease or progress. Patients and methods: We studied 274 patients with chronic GVHD requiring systemic treatment who were enrolled in a multi-center, prospective, longitudinal, observational cohort. Treatment of chronic GVHD was not uniform for this study. 256 patients had follow-up visits at 6 months after enrollment. The 6 month time point was chosen to be consistent with many earlier phase II studies. Responses were classified according to the calculated NIH response algorithm (BBMT 2006;12:491) as complete, partial, stable or progression, separately in skin, eye, mouth, lung, liver and gastrointestinal (GI) tract as well as overall by comparing organ manifestations reported at the follow-up visit to the enrollment visit. Complete or partial response was considered “response”, and stable disease or progression as “no response”. QOL measures included the SF-36, FACT-BMT and Human Activities Profile (HAP) score. Symptom measures included the Lee symptom scale and 10-point global rating of symptoms. Linear regression models were used to estimate the change in measures associated with response vs. no response, adjusting for case type (incident vs. prevalent), donor/patient gender and NIH global severity at enrollment. Results: Patients with a median age of 52 years were enrolled at a median of 13 months from transplant. Of 274 patients, 247 (90%) had mobilized blood cell transplant, 132 (48%) had HLA-matched related donors, 138 (50%) had unrelated donors, and 153 (56%) had myeloablative conditioning. At 6 months, overall response rates were 10 (4%) CR, 72 (28%) PR, 14(6%) SD, and 157(62%) PD, for a CR+PR rate of 32%. Organ-specific CR+PR response rates were 31% for skin, 16% for eye, 26% for mouth, 23% for GI, and 31% for liver. Compared with no response, overall response was associated with improved overall symptom burden measures, but not with changes in QOL measures. For example, the Lee overall score was estimated to be 4.6 points lower in responders than in non-responders (Table 1). Organ-specific analyses showed that organ response was associated with improved symptom burden in skin, eye, mouth and GI except for mouth dryness (Table 2). Conclusion: The calculated organ-specific and overall NIH responses by the provisional algorithm correlated with corresponding organ-specific and overall changes in patient-reported symptom burden, but calculated overall response did not correlate with changes in patient-reported QOL. Our results suggest that the calculated NIH response is a surrogate measure for patient symptom burden in clinical trials.Table 1.Estimated change in QOL and symptom measures associated with overall responseOutcomeClinically meaningful change1R vs. NR Estimated change (95% CI)PSF-36 PCS4.80.8 (−1.9–3.5).57SF-36 MCS5.20.1 (−2.7–2.9).93FACT-BMT102.7 (−1.8–7.1).24HAP MAS6.20.7 (−3.2–4.6).73HAP AAS8.41.6 (−2.6–5.8).45Lee symptom overall score6.2−4.6 (−7.3–−1.9).001Patient-rated overall symptoms2−0.9 (−1.6–−0.3).003R, response; NR, no response; PCS, physical component score; MCS, mental component score; MAS, maximum activity score; AAS, adjusted activity score.1Half-standard deviation of baseline score or 2-point change on a 10-point scale.Table 2.Estimated change in symptom measures for each organ associated with organ responseOrganClinically meaningful changeR vs. NR Estimated change (95% CI)PLee symptom scale    Skin10.4−7.3 (−14–−0.8).03    Eye14.8−16 (−27–−4.7).005    Mouth13.8−16 (−24–−7.6)<.001    GI (nutrition)6.2−7.1 (−13–−1.1).02Patient-rated symptoms    Skin itching2−1.0 (−1.8–−0.1).03    Eye problem2−1.3 (−2.4–−0.2).03    Mouth dryness2−0.1 (−1.1–0.8).81    Mouth pain2−1.1 (−1.9–−0.2).02    Mouth sensitivity2−1.0 (−1.9–−0.1).03R, response; NR, no response. Disclosures: No relevant conflicts of interest to declare.

Histamine metabolism disorder in pathogenesis of chronic pelvic pain in patients with external genital endometriosis

2017 ◽  
pp. 56-60
Author(s):  
М.Р. Оразов ◽  
В.Е. Радзинский ◽  
М.Б. Хамошина ◽  
Е.Н. Носенко ◽  
Э.С. Токаева ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pelvic Pain ◽  
Peripheral Blood ◽  
Chronic Pelvic Pain ◽  
Pain Syndrome ◽  
Histamine Level ◽  
Life Assessment ◽  
Assay Method ◽  
Histamine Metabolism

Цель исследования - изучение особенностей обмена гистамина при хронической тазовой боли у пациенток с наружным генитальным эндометриозом. Методика. В сыворотке крови 100 пациенток методом высокоточного (в нг/мл) иммуноферментного твердофазного анализа определяли концентрацию гистамина. Использованы реактивы «Histamine ЕLISA», аппарат BAE-1000 Гистамин (Labor Diagnostika Nord - LDN, Германия). Оценка выраженности болевого синдрома осуществлялась по шкале ВАШ, оценка качества жизни - на основании опросника для оценки качества жизни при эндометриозе (EHR-30), оценка тревожности - опросника Спилбергера-Ханина. Результаты. Показано статистически значимое повышение уровня гистамина у пациенток с высокой интенсивностью болевого синдрома. Женщины с наружным генитальным эндометриозом, сопровождающимся интенсивным болевым синдромом в 100% случаев обнаруживали высокие уровни ситуативной и личностной тревожности, тогда как, лишь у 40% женщин (n = 16) контрольной группы выявлен умеренный уровень тревожности. Депрессивные расстройства выявлены у 58,3% женщин с хронической тазовой болью (n = 35), из них основную часть (n = 20) составили женщины с выраженной степенью болевого синдрома по ВАШ. Заключение. Психоэмоциональное состояние женщин с тазовой болью, ассоциированной с наружным генитальным эндометриозом, характеризуется высокими уровнями депрессивных и тревожных расстройств, значительным снижением уровня качества жизни. Выявлена прямая связь между интенсивностью болевого синдрома и уровнем гистамина в периферической крови пациенток с наружным генитальным эндометриозом. Objective. To study features of histamine metabolism in patients with chronic pelvic pain associated with external genital endometriosis. Methods. For quantitative assessment of histamine level in peripheral blood was taken from 100 patients which than was centrifuged. In blood serum histamine concentration was determined by enzyme-linked immunosorbent assay method with reagents «Histamine ЕLISA» on the machine BAE-1000 Histamine (Labor Diagnostika Nord - LDN, Hermany). A pain syndrome was assessed by Visual Analog Scale (VAS), quality of life assessment - by Endometriosis Health Profile Questionnaire (EHR-30), level of anxiety was determined by Spielberger-Khanin questionnaire. The results. Showed statistically higher histamine level in patients with severe pain according to VAS. After assessment of results obtained from Spielberger-Khanin questionnaire 100% experimental group’s women with external genital endometriosis (n = 60) were noted to be have high level of state and trait anxiety, then 40% women of control group (n = 16) have moderate level of anxiety. The incidence of depression in women with chronic pelvic pain was 58.3% (n = 35) and the main part (n = 20) were women with severe stage of pelvic pain according to VAS. Conclusions. Psycho emotional condition of women with external genital endometriosis associated pelvic pain characterized by higher depression and anxiety levels, with significant decrease quality of life. Direct relationship also was found between pain syndrome intensity and histamine level in peripheral blood in patients with external genital endometriosis.

scholarly journals Self-reported symptoms of arm lymphedema and health-related quality of life among female breast cancer survivors

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Kayo Togawa ◽  
Huiyan Ma ◽  
Ashley Wilder Smith ◽  
Marian L. Neuhouser ◽  
Stephanie M. George ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Physical Health ◽  
Analysis Of Covariance ◽  
Health Related Quality ◽  
Burning Pain ◽  
Related Quality ◽  
Health Related ◽  
Arm Lymphedema

AbstractWe examined cross-sectional associations between arm lymphedema symptoms and health-related quality of life (HRQoL) in the Health, Eating, Activity and Lifestyle (HEAL) Study. 499 women diagnosed with localized or regional breast cancer at ages 35–64 years completed a survey, on average 40 months after diagnosis, querying presence of lymphedema, nine lymphedema-related symptoms, e.g., tension, burning pain, mobility loss, and warmth/redness, and HRQoL. Analysis of covariance models were used to assess HRQoL scores in relation to presence of lymphedema and lymphedema-related symptoms. Lymphedema was self-reported by 137 women, of whom 98 were experiencing lymphedema at the time of the assessment. The most common symptoms were heaviness (52%), numbness (47%), and tightness (45%). Perceived physical health was worse for women reporting past or current lymphedema than those reporting no lymphedema (P-value < 0.0001). No difference was observed for perceived mental health (P-value = 0.31). Perceived physical health, stress, and lymphedema-specific HRQoL scores worsened as number of symptoms increased (P-values ≤ 0.01). Women reporting tension in the arm had lower physical health (P-value = 0.01), and those experiencing burning pain, tension, heaviness, or warmth/redness in the arm had lower lymphedema-specific HRQoL (P-values < 0.05). Treatment targeting specific lymphedema-related symptoms in addition to size/volume reduction may improve some aspects of HRQoL among affected women.

Long-term effectiveness of telephone-based health coaching for heart failure patients: A post-only randomised controlled trial

2016 ◽  
Vol 23 (8) ◽  
pp. 716-724 ◽  
Author(s):  
Michel Tiede ◽  
Sarah Dwinger ◽  
Lutz Herbarth ◽  
Martin Härter ◽  
Jörg Dirmaier
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Locus Of Control ◽  
Controlled Trial ◽  
Health Coaching ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Heart Failure Patients ◽  
Health Related

Introduction The * Equal contributors. health-status of heart failure patients can be improved to some extent by disease self-management. One method of developing such skills is telephone-based health coaching. However, the effects of telephone-based health coaching remain inconclusive. The aim of this study was to evaluate the effects of telephone-based health coaching for people with heart failure. Methods A total sample of 7186 patients with various chronic diseases was randomly assigned to either the coaching or the control group. Then 184 patients with heart failure were selected by International Classification of Diseases (ICD)-10 code for subgroup analysis. Data were collected at 24 and 48 months after the beginning of the coaching. The primary outcome was change in quality of life. Secondary outcomes were changes in depression and anxiety, health-related control beliefs, control preference, health risk behaviour and health-related behaviours. Statistical analyses included a per-protocol evaluation, employing analysis of variance and analysis of covariance (ANCOVA) as well as Mann-Whitney U tests. Results Participants’ average age was 73 years (standard deviation (SD) = 9) and the majority were women (52.8%). In ANCOVA analyses there were no significant differences between groups for the change in quality of life (QoL). However, the coaching group reported a significantly higher level of physical activity ( p = 0.03), lower intake of non-prescribed drugs ( p = 0.04) and lower levels of stress ( p = 0.02) than the control group. Mann-Whitney U tests showed a different external locus of control ( p = 0.014), and higher reduction in unhealthy nutrition ( p = 0.019), physical inactivity ( p = 0.004) and stress ( p = 0.028). Discussion Our results suggest that telephone-based health coaching has no effect on QoL, anxiety and depression of heart failure patients, but helps in improving certain risk behaviours and changes the locus of control to be more externalised.

Dry Eye Syndrome-Related Quality of Life in Glaucoma Patients

2009 ◽  
Vol 19 (4) ◽  
pp. 572-579 ◽  
Author(s):  
Gemma Caterina Maria Rossi ◽  
Carmine Tinelli ◽  
Gian Maria Pasinetti ◽  
Giovanni Milano ◽  
Paolo Emilio Bianchi
Keyword(s):  
Quality Of Life ◽  
Dry Eye ◽  
Ocular Surface ◽  
Cross Sectional Study ◽  
Dry Eye Syndrome ◽  
Control Group ◽  
Ocular Surface Disease Index ◽  
Symptom Scale ◽  
Cross Sectional

Purpose To verify the presence of dry eye syndrome (DES) in treated patients with glaucoma and to analyze DES's impact on the patients' quality of life (QOL) versus the control group. Methods In this observational cross-sectional study, 61 patients were enrolled at a clinical practice. Patients were divided into three groups by number of glaucoma drops instilled per day (G1=1 drop/day, G2=2 drops/day, G3=3 drops/day). A control group of 20 subjects was also selected (G0). All subjects were submitted to a complete ocular examination (including tear function and ocular surface status) and completed the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ), Glaucoma Symptom Scale (GSS) questionnaire, and Ocular Surface Disease Index (OSDI). DES was defined as presence of punctate keratitis and decreased break-up time. Statistical analysis was performed applying the Kruskal-Wallis analysis of variance and Mann-Whitney U tests (to compare median values between groups) as well as the χ2 and Fisher test (to verify significant differences). Results A total of 40% of G3 and 39% of G2 patients presented DES versus 11% of G1 and 5% of G0 (p=0.01). QOL was significantly influenced and altered (NEI-VFQ 25 total mean and GSS total mean and symptoms average: p=0.0085, p=0.006, and p=0.03, respectively). OSDI pointed out differences by group: 26% of G2 and 15% of G3 presented moderate OSDI and 15% of G3 and 8.7% of G2 severe OSDI (p>0.05). Conclusions Patients with topically treated glaucoma present DES more often than a similar control group (p=0.01). The presence of DES negatively influences the patient's QOL. The patients with glaucoma's ocular surface status should be evaluated regularly to ensure the timely detection and treatment of pathologic signs on the ocular surface.

scholarly journals Effectiveness of Acceptance Commitment Therapy (ACT) in Social Anxiety Disorder: Application of a Longitudinal Method for Evaluation of Mediation Role of Acceptance, Cognitive Fusion and Values

2021 ◽  
Author(s):  
Esmail Soltani ◽  
◽  
Seyed Abdolmajid Bahrainian ◽  
Ali Farhoudian ◽  
Abbas Masjedi Arani ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Anxiety Disorder ◽  
Social Anxiety ◽  
Social Anxiety Disorder ◽  
Negative Evaluation ◽  
Fear Of Negative Evaluation ◽  
Analysis Of Covariance ◽  
Cognitive Fusion

Objectives: The purpose of the current study was to examine the effectiveness of ACT on symptom severity, fear about negative evaluation, quality of life and mediation role of acceptance, cognitive fusion and value among patients with Social Anxiety Disorder (SAD). Methods: Thirty patients diagnosed with SAD were randomized in the intervention (n=15) or waiting list groups (n=15). The Social Phobia and Anxiety Inventory (SPAI), Brief Fear of Negative Evaluation Scale (BFNE), WHO Quality of Life (WHOQOL), Social Anxiety - Acceptance and Action Questionnaire (SA-AAQ), Cognitive Fusion Questionnaire (CFQ) and Valued Living Questionnaire (VLQ) were administered before, immediately after, and at one month follow up. Repeated measurement design was used in the intervention group to investigate the changes of mediation and outcomes variables in the pretest, during, and post- therapy. Twenty-four patients completed the study. One-way analysis of covariance, Multivariate analysis of covariance and repeated measures was used for analysis. Results: Results showed that there were differences between the intervention and waiting list groups on the severity of symptoms (p=0.001), fear of negative evaluation (p=0.002), and quality of life (p=0.03), as well as in terms of specific measures of SA-AAQ(p=0.001), cognitive fusion (p=0.001), and important section of VLQ(p=0.001). Repeated measurement result showed that acceptance and action of social anxiety and cognitive fusion had a mediating role in the severity of anxiety, fear about negative evaluation, and quality of life. Discussion: Results of the study indicate the effectiveness of ACT for SAD and highlighted mediator contribution acceptance and action and cognitive fusion in severity of social anxiety.

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