Long-Term HSC Donor Follow-up: Malignancy Incidences after Donation Are Identical Compared to a Matched Control Sample of Registered Donors, but Different to Expected General Population Rates

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 269-269
Author(s):  
Thilo Mengling ◽  
Camila J. Hernandez Frederick ◽  
Daniel Fandel ◽  
Jürgen Sauter ◽  
Johannes Schetelig ◽  
...  
Keyword(s):  
Stem Cell ◽  
General Population ◽  
Hematological Malignancies ◽  
Control Sample ◽  
Epidemiological Data ◽  
Control Group ◽  
Health Questionnaire ◽  
Health Related

Abstract Introduction: HSC donation is an established procedure with few, manageable short term side effects. As donation is, especially for unrelated volunteer donors, an entirely altruistic act with no direct health benefits, careful and systematic long-term follow-up is crucial. However, interpretation of follow-up data requires a suitable control group. Here, we report first results from a matched pair donor follow-up study. Since 2009, DKMS has extended the routine questionnaire-based donor follow-up to a control group of registered potential stem cell donors who had not actually donated at that time. Donors in the control group (CG) were matched for age, sex and, if possible, HLA to stem cell donors. Eligibility for controls was evaluated using the standard health questionnaire from confirmatory typing stage. After study recruitment, controls were sent identical follow-up questionnaires in the same intervals as real donors. As of July 1st, 2015, our data set for analysis extended to 170,484 questionnaires (58,306 from 21,633 unrelated donors (URD), and 112,178 from 65,543 controls (CG)). Of the URD, 17,472 have donated peripheral blood stem cells (PBSC), 3,735 bone marrow and 145 are donors of both, marrow and PBSC. For statistical reasons, 281 donors requested for donation but deferred at medical pre-examination are included in the donor group. Results: A total of 157 malignancies (excluding ICD-10 C44 neoplasms of skin other than malignant melanoma) have been reported (URD 63, CG 94). In multivariate analysis, significantly more malignancies were observed in females (p <0.001; OR 2.07, 95% CI 1.55 - 2.78), and with increasing age. No difference in the overall malignancy incidence was seen between the URD and control group. In both groups, incidences were significantly lower than the expected rates based on the standard incidences in the German population (standard incidence ratio (SIR) 0.64, 95% CI 0.54 - 0.74). SIR analysis for single ICD malignancy groups revealed significant or close to significant scarcity of reported neoplasms of the lung, oral cavity and colon, all known to correlate with certain health-related behavior (smoking, misuse of alcohol, diet). Due to the administration of GCSF to healthy volunteers for PBSC donation, any hematological malignancies in this group are of particular interest. In the URD group, 1 single case of leukemia (AML) and 2 cases of lymphoma (2 Hodgkin's lymphoma, 1 cutaneous T-cell lymphoma) have been reported from PBSC donors. Because eligibility for the control group was assessed by a confirmatory typing (CT) stage health questionnaire without physical examination, we have included potential donors who where originally cleared at CT stage but deferred during work-up process for medical reasons as part of the URD group for enhanced comparability ('intention to donate'). One case of multiple myeloma was seen in this subgroup (reason for deferral: monoclonal gammopathy). No cases were reported from donors who had donated via bone marrow extraction. In the control group, a total of 8 hematological malignancies were reported (2 Hodgkin's lymphoma, 4 NHL, 1 multiple myeloma, 1 Langerhans cell histiocytosis). No increased incidences of hematological malignancies were observed in either the URD or control group. Discussion: For evaluation of long-term HSC donor follow-up, the applicability of general population data for comparison must be discussed critically. Our data suggest that registered donors as a group are distinct from the general population regarding health-related behavior and attitude or disease susceptibility. Malignancy incidences lower than expected from epidemiological data can most likely be explained by selection effects. People willing to donate stem cells likely represent a healthy sample of the general population. While incomplete reporting cannot be ruled out, it should have affected both URD and CG in the same way. Thus, our approach to include registered potential donors as a control sample is a viable and thorough approach to identify (late) health hazards, further increasing safety and confidence for volunteer stem cell donors. Even more, our study will allow to evaluate donor follow-up data where epidemiological data is insufficient or not applicable, e.g. for autoimmune diseases or general well-being. Disclosures No relevant conflicts of interest to declare.

Higher Incidence and Risk of Developing Second Solid Cancers (SSC) after Haematopoetic Stem Cell Transplantation (HSCT) As Compared to General Population

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4610-4610
Author(s):  
Samar Kulkarni ◽  
John Murray ◽  
Charlotte Smith ◽  
Stephanie Cleaver ◽  
Michael Dennis ◽  
...  
Keyword(s):  
Risk Factors ◽  
Multivariate Analysis ◽  
Stem Cell ◽  
General Population ◽  
Board Of Directors ◽  
Primary Site ◽  
Single Centre ◽  
Advisory Committees

Abstract Introduction: As the number of long-term survivors following HSCT is increasing, the long-term risks and associated morbidity has become important component of survivorship program. The known risk factors for developing cancer include use of chemotherapy agents, radiation exposure, immune dysfunction, previous malignancy in addition to other factors and as HSCT process involves all these factors, this single centre retrospective analysis was undertaken to evaluate the risk of developing SSC in the patients receiving transplant. Methods: From February 1982 to February 2016, 2231 patients received 2495 transplants (median age: 46yr., range: 14-76 yr.; M: 1586, F: 909) for haematological malignancies (Leuk: 744, lymphoma:767, myeloma:848, solid tumours/other:136). Donor was allogeneic (n=744) or autologous (n=1751) and conditioning was with (n=614) or without TBI (n=1881). Donor was sibling (n=375), matched unrelated (n=355), haploidentical relative (n=3) or umbilical cord blood (n=11). Source of stem cell was marrow (n=367), PBSC (n=2086), both (n=31) or cord blood (n=11). GVH prophylaxis included Campath or ATG in 369 cases. Of all the patients 1985 received single transplant, 231 had two, 13 had 3 and 2 had 4 HSCT procedures. Data was analysed as of 15/04/2016 using competing risk model with death as the competing event. Comparison of incidence to general population was performed by computing standardized incidence rates (SIR). Patients with second haematological malignancy were not included in this analysis. Results: Median follow-up was 5.3 years (range: 0-32 years). Patient follow-up was more than 10 years in 467 cases (19%), between 5 to 10 years in 430 (17%), 2 to 5 years in 607 (24%) and less than 1 year in 997 cases (40%). 36% patients were followed-up for more than 5 years. Second solid cancers developed in 116 patients with the incidence of 1% at 5yr (95% CI: 0.5-2.6), 3% at 10 yr (95% CI: 1.6-5.3), 6% at 15yr (95%CI: 3.6-8.8) and 10% (95% CI: 5.9-15.5) at 20 years. Median time to develop SSC from date of HSCT was 11 yr (range: 0.4-28.1 yr). Primary site for SSC included skin (n=37), breast (n=22), GI (n=15), GU (n=16), H&N (n=10), lung (n=6), CNS (n=4), Endocrine (n=4) & HPB (n=2). There was no difference with type of transplant i.e. auto or allograft. Autograft and allograft groups were analysed separately. In univariate analysis, allograft group showed higher cumulative incidence of SSC with use of PBSC (p<0.0001), campath/ATG (p=0.0002), donor other than sibling (P=0.0004), RIC (p<0.0001), non-TBI conditioning (p=0.007), older age at transplant (0.008), development of agvhd or cgvhd (p=0.023) and transplant year after 2000 (p=0.01). In multivariate analysis age above 50 (RR: 1.8, 95%CI: 1.2-1.8, p=0.046) and RIC (RR: 4.4, 95% CI: 1.2-8.3, p=0.03) were independently associated with higher risk of SSC. In autograft group, there were no independent risk factors in univariate or multivariate analysis. As compared to general population incidence was higher for all cancers (SIR=7.4) and also cancers at every primary site. Risk was highest for breast (SIR=14.3), Head/neck (SIR=25.6), brain (SIR=17.4) and colon (SIR=6.2). Overall survival is significantly shorter in patients who develop SSC (median: 12 yr vs. not reached, p<0.0001). The median time to develop SSC from the date of HSCT has significantly shortened over last three decades (years 1982-1990: 21yr, 1991-2000: 11.1 yr, 2001-2010: 6.34 yr, 2011-2016: 2.2 yr; p=0.0001) Conclusion: This single centre analysis confirms that the risk of developing SSC increases with advancing age, use of RIC allograft, longer follow-up and leads to inferior survival. Since the year 2000, SSC are developing early after transplant and it needs to be evaluated if this is a trend seen at other centers and if so, is it related to increasing use of RIC, increasing number of elderly patients, severity of immune-suppression or higher incidence of GVHD. Disclosures Somervaille: Novartis: Consultancy, Honoraria; Imago Biosciences: Consultancy. Bloor:Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Honoraria, Speakers Bureau; GSK: Consultancy, Speakers Bureau; Gilead: Honoraria; Abbvie: Membership on an entity's Board of Directors or advisory committees.

scholarly journals Long‐term follow‐up, quality of life, and survival of patients with Lambert‐Eaton myasthenic syndrome

Neurology ◽  
2019 ◽  
Vol 94 (5) ◽  
pp. e511-e520 ◽  
Author(s):  
Alexander F. Lipka ◽  
Marion I. Boldingh ◽  
Erik W. van Zwet ◽  
Marco W.J. Schreurs ◽  
Jan B.M. Kuks ◽  
...  
Keyword(s):  
Quality Of Life ◽  
General Population ◽  
Functional Impairments ◽  
Tumor Survival ◽  
Related Quality ◽  
Health Related ◽  
Myasthenic Syndrome

ObjectiveTo study survival and to characterize long-term functional impairments and health-related quality of life (HRQOL) of patients with Lambert-Eaton myasthenic syndrome (LEMS).MethodsIn this observational study, survival of patients with LEMS, separately for nontumor (NT) and small cell lung cancer (SCLC), was compared to that of the Dutch general population and patients with SCLC. Disease course in patients with LEMS was recorded retrospectively. Several scales for functional impairments and health-related quality of life were assessed.ResultsWe included 150 patients with LEMS. Survival was similar to that of the general population in 65 patients with NT-LEMS. Tumor survival was significantly longer in 81 patients with SCLC-LEMS compared to patients with non-LEMS SCLC (overall median survival 17 vs 7.0 months, p < 0.0001). At diagnosis, 39 (62%) of 63 patients with complete follow-up data were independent for activities of daily living, improving to 85% at the 1-year follow-up. The physical HRQOL composite score (55.9) was significantly lower than in the general population (76.3, p < 0.0001) and comparable to that of patients with myasthenia gravis (60.5). The mental HRQOL composite score was 71.8 in patients with LEMS, comparable to that of the general population (77.9, p = 0.19) and patients with myasthenia gravis (70.3).ConclusionsThis study shows that patients with NT-LEMS have normal survival. Patients with SCLC-LEMS have an improved tumor survival, even after correction for tumor stage. A majority of patients with LEMS report a stable disease course and remain or become independent for self-care after treatment.

Second Cancers after Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Relapsed/Refractory Aggressive Non-Hodgkin’s Lymphoma (NHL).

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1673-1673 ◽  
Author(s):  
Tara Seshadri ◽  
Melania Pintilie ◽  
Richard Tsang ◽  
John Kuruvilla ◽  
Sahar Zadeh ◽  
...  
Keyword(s):  
Stem Cell ◽  
General Population ◽  
Cell Lymphoma ◽  
Primary Therapy ◽  
Second Cancer ◽  
Second Line ◽  
Second Cancers ◽  
Line Chemotherapy

Abstract ASCT results in long-term disease free survival for approximately 40–50% of patients (pts) with relapsed−/− refractory aggressive NHL who respond to second-line chemotherapy. The incidence of second cancers (SC) in long-term survivors and risk factors in this pt population has not been well studied. We performed a retrospective analysis of 372 pts undergoing ASCT at our institution from May 1987 to Dec 2006 for relapsed−/− refractory aggressive NHL after primary therapy. Second-line chemotherapy was given to best response, followed by high dose therapy for pts with chemotherapy-sensitive disease. Intensive therapy was melphalan 180mg/m2 + etoposide 60mg/kg in 86%; regimens including total body irradiation (TBI) 12 Gy were received in 16%. Stem cell source: autologous bone marrow (27%), peripheral blood (63%) or both (10%); 7% received post-ASCT involved field RT to sites of bulky disease. Estimates of SC risk were determined adjusting for competing risks. The incidence of SC was compared to the general population in Ontario from 1987 to 2002. Of 372 pts, 59% had diffuse large B cell lymphoma, 24% transformed from prior indolent NHL, 16% T cell lymphoma, 1% undefined aggressive NHL. Median age at ASCT was 50 years (range 19–70); female 44%. The majority of patients (74%) received 2 chemotherapy regimens prior to ASCT (range 1–8); all pts with de novo DLCL received CHOP or equivalent regimen as primary therapy. For first salvage therapy cytarabine/platinum combinations were used in 205 (55%) pts, miniBEAM (melphalan, etoposide, cytarabine, BCNU) in 40 (11%), gemcitabine/dexamethasone/cisplatinum in 37 (10%); CHOP or equivalent was used in 42 pts (11%). Median follow up is 4.3 years and 27/185 (15%) have been followed more than 10 years. 184 pts (49%) have experienced disease relapse and 32 (9%) have developed a SC (17 MDS/AML, 13 solid tumors, 1 chronic lymphocytic leukemia and 1 acute lymphoblastic leukemia). During the follow up period 187 (50%) patients have died (126 from relapsed lymphoma, 30 from treatment-related toxicity, 14 from second cancer, 5 unrelated medical condition, 7 unknown). The probability of SC is 5% (95% CI: 3%-8%) 3 years post-ASCT and 14% at 10 years (95%CI: 10%-20%). Age at ASCT, sex, receipt of TBI, number of chemotherapy regimens, prior RT, graft source and lymphoma subtype were not associated with development of a second malignancy. Use of miniBEAM as part of salvage therapy was significantly associated with the development of a second cancer (p=0.001). The incidence of malignancy in survivors of ASCT is 32 per 1180 person years of follow-up. When compared to the general population (AML and solid tumors only) the relative risk (RR) for developing AML or a solid tumor is 13.5 (p&lt;0.0001, 95% CI 5.4–27.8) and 2.4 (p=0.0013, 95% CI 1.3–4.0) respectively. The risk of developing a SC in pts treated with ASCT for relapsed aggressive NHL is substantially higher compared to the general population. Second cancers appear to develop both in the early and late post ASCT period and contribute to late mortality. Our observation of an unexpected increased risk of SC in ASCT patients receiving prior miniBEAM salvage suggests that the contribution of other salvage regimens to late adverse effects after ASCT warrants further investigation.

Favorable Outcome and Quality of Life in Patients Surviving 5 or More Years After Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 3312-3312
Author(s):  
Robert Quan Le ◽  
Margaret Bevans ◽  
Bipin N. Savani ◽  
Sandra Mitchell ◽  
Kate Stringaris ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Hematological Malignancies ◽  
Performance Status ◽  
Excellent Performance ◽  
Hematopoietic Stem

Abstract Abstract 3312 Poster Board III-200 Allogeneic hematopoietic stem cell transplantation (SCT) is a curative treatment for some hematological malignancies. The ultimate measure of success of allogeneic SCT for hematological malignancies is its ability to eradicate malignant disease and restore a good quality of life (QOL) in long-term survivors. As numbers of survivors continue to increase, studies systematically examining outcomes in this group of survivors are needed. We studied the clinical and QOL outcomes in a large cohort of patients with hematological malignancies surviving 5 or more years after allogeneic SCT from a single institution. In 2005 we initiated a long term follow up protocol to further study complications in survivors after allogeneic SCT. Patients were enrolled at the third annual visit after transplantation. Annual follow-up visit includes comprehensive clinical evaluation and detailed assessment of QOL, symptom distress, physical and mental health. Measures for QOL included the Functional Assessment of Cancer Therapy-General (FACT-G), the Physical and Mental Component Summary scales (PCS, MCS) of the Medical Outcomes Short-Form 36 (SF-36), and the Rotterdam Symptom Checklist (RSCL). Two hundred sixty two patients with hematological disorder received a SCT from an HLA identical sibling since 1993. One hundred and twenty one patients (46 %) survived 3 or more years and were eligible for participation in the long-term evaluation protocol. Ninety two (35%) survived beyond 5 years from SCT (median follow-up 9.4 years, range 5.1-15.3) and were included in this analysis. Median age at transplantation was 35 years (range 10 - 56). Twenty-two (24%) received a bone marrow transplant, and 70 (76%) received a peripheral blood SCT. We examined chronic graft-versus-host-disease (cGVHD), disease relapse, survival and QOL. Seventeen (18%) of 92 survivors had active cGVHD (limited 9, extensive 8) and were receiving prolonged immunosuppressive treatment 5 years following allogeneic SCT. Four relapsed with leukemia, at a median of 8.5 years (range 6.2 -14.0) post SCT. Four (4.3%) died between 7.4 -13.4 years post SCT (1 relapse, 1 lung cancer, 1 pneumonia, 1 brain hemorrhage). Sixty (65%) completed QOL measures. Most survivors beyond 5 years had an excellent performance status with no difference in the PCS (p =0.89) and MCS (p =0.15) scores and higher FACT-G scores compared with population norms (p =0.02). Although the overall distress for physical and psychological symptoms was low, higher levels of symptom distress were associated with impairments in QOL. In eleven survivors with cGVHD, there was no statistical difference across QOL outcomes although the difference was meaningfully lower (≥5 points). In conclusion, five or more years after SCT for hematological malignancy most individuals survive disease free with an excellent performance status, preserved physical and psychological health, and excellent QOL. However patients with leukemia appear to have a persistent but low chance of disease recurrence. Although cGVHD persists in about 20% of patients it did not appear to affect the excellent QOL that most of our patients experience. The association between cGVHD severity and specific cGVHD manifestations and QOL outcomes requires further study. Disclosures No relevant conflicts of interest to declare.

scholarly journals Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Joseph P. McEvoy ◽  
Peter J. Weiden ◽  
Paul H. Lysaker ◽  
Xiaowu Sun ◽  
Amy K. O’Sullivan
Keyword(s):  
General Population ◽  
Trial Registration ◽  
Post Hoc Analysis ◽  
Related Quality ◽  
Health Related ◽  
Study Population ◽  
Post Hoc ◽  
Registration Date

Abstract Background This post hoc analysis of clinical trial data evaluated long-term, self-reported mental and physical health-related quality of life (HRQoL) scores in schizophrenia patients receiving aripiprazole lauroxil (AL), an atypical long-acting injectable (LAI) antipsychotic approved for the treatment of schizophrenia in adults. Methods The study population included 291 stable schizophrenia outpatients enrolled in 2 consecutive long-term safety studies of AL given every 4 weeks for up to 124 weeks. HRQoL was measured using the SF-36v2® Health Survey (SF-36v2) over the course of the follow-up. The primary outcome was change in SF-36v2 mental component summary (MCS) and physical component summary (PCS) scores from baseline to 124 weeks. To contextualize these scores, descriptive analyses were conducted to compare the scores with available scores for the general population as well as for other populations with chronic medical (ie, hypertension and type 2 diabetes) or psychiatric (ie, depression) conditions. Results Results from this post hoc analysis indicated that the mean MCS score for patients continuing AL improved significantly from baseline over 124 weeks (P < .05, all timepoints), while mean PCS score showed little change over 124 weeks. At baseline, patients had lower (worse) MCS scores than the normed general population, but by week 124, patients had MCS scores comparable to those in the general population. This pattern of change was not observed with PCS scores. Comparison of study MCS scores with those associated with other diseases showed that this schizophrenia cohort had lower scores than those with chronic medical conditions but higher scores than those with depression. PCS scores were higher in the study population than published scores for all reference populations at baseline and week 124. Conclusions In this post hoc analysis, outpatients with schizophrenia who continued the LAI antipsychotic AL showed gradual and sustained improvement in self-reported mental HRQoL over several years of follow-up, whereas self-reported physical HRQoL did not change. By the end of follow-up, mental health scores of study patients with schizophrenia were comparable to those of the general population and better than those of patients with depression. Trial registration ClinicalTrials.gov (NCT01626456 [trial registration date: June 15, 2012] and NCT01895452 [trial registration date: July 5, 2013]).

Long Term Follow-up and Matched Pair Analysis of Adjuvant Donor Lymphocyte Transfusions Following Allogeneic Stem Cell Transplantation after Reduced Intensity Conditioning for High-Risk AML.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2142-2142
Author(s):  
Michael Schleuning ◽  
Christoph Schmid ◽  
Christian Koenecke ◽  
Bernd Hertenstein ◽  
Herrad Baurmann ◽  
...  
Keyword(s):  
Stem Cell ◽  
High Risk ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Allogeneic Stem Cell Transplantation ◽  
Control Group ◽  
Reduced Intensity Conditioning ◽  
Reduced Intensity

Abstract Adjuvant transfusion of donor lymphocytes (aDLT) may reduce the risk of relapse after allogeneic stem cell transplantation. We report our data on aDLT in high-risk AML. Cells were given within a prospective protocol that contained a sequence of chemotherapy, reduced intensity conditioning for allogeneic transplantation, and aDLT. For aDLT, patients had to be in CR at least 120 days from transplantation, off immunosuppression and free of GvHD. 30% of patients (n=46) alive at day +120 fulfilled the criteria for aDLT. They had been transplanted for refractory (n=11) or relapsed leukemia (n=24) or in CR1 because of unfavourable cytogenetics (n=7) or other unfavourable criteria (n=2) or in CR2 with unfavourable cytogenetics (n=2). 24 patients had an unfavourable karyotype, 10 with complex aberrations. Thirty-one patients with similar disease characteristics and fulfilling similar selection criteria (being alive in CR at d +120, no cGVHD and no history of aGVHD&gt; II°) transplanted during the same time period served as control. Of these, 10 pts. were transplanted at a different center not using aDLT and 21 at the center in Wiesbaden during 2000 and 2002 prior to the introduction of the protocol at this center. The median time from transplant to first aDLT was 160 days (range 71–303). Median follow up of the surviving transfused patients is 3.6 years (range 1.8–7.8). Seven patients received 1, 15 patients received 2, and 24 patients received 3 transfusions in escalating doses, containing a median of 1x106, 5x106 and 1x107 CD3+ cells/kg at aDLT 1, 2 and 3, respectively. Reasons for giving less than 3 transfusions were GvHD, relapse or patient’s refusal. Induction of GvHD was the main complication; grade II/III acute GvHD developed in 4, and chronic GvHD in 8 patients. So far, 9 (19.6%) patients have relapsed despite aDLT, as compared to 52.9% in the control group (Fisher-exact: p=0.004). Of these, 8 pts. finally died despite adoptive immunotherapy and only one patient is now surviving more than 3 years after relapse was treated by a second transplantation. Non relapse mortality post DLT was low with patients dying from infection, severe cGvHD, and secondary solid tumour one each. At the time of analysis, 35/46 patients are alive and all are in CR at a median of 3.2 years post first DLT. The actuarial overall survival four years after transplant is 79% as compared to 34% in the control group and at six years 63% vs. 31%, respectively (p=0.000). In conclusion, aDLT is safe, when given in escalating doses and to a selected group of patients. Results are encouraging, and improved long term leukemia-free survival can be achieved.

scholarly journals Quality of life in urologic cancer patients: importance of and satisfaction with specific quality of life domains

2021 ◽  
Author(s):  
Katja Leuteritz ◽  
Diana Richter ◽  
Anja Mehnert-Theuerkauf ◽  
Jens-Uwe Stolzenburg ◽  
Andreas Hinz
Keyword(s):  
Quality Of Life ◽  
General Population ◽  
Cancer Patients ◽  
Patient Group ◽  
Control Group ◽  
Health Related Qol ◽  
Health Related ◽  
Importance Ratings ◽  
Subjective Importance

Abstract Purpose Quality of life (QoL) has been the subject of increasing interest in oncology. Most examinations of QoL have focused on health-related QoL, while other factors often remain unconsidered. Moreover, QoL questionnaires implicitly assume that the subjective importance of the various QoL domains is identical from one patient to the next. The aim of this study was to analyze QoL in a broader sense, considering the subjective importance of the QoL components. Methods A sample of 173 male urologic patients was surveyed twice: once while hospitalized (t1) and once again 3 months later (t2). Patients completed the Questions on Life Satisfaction questionnaire (FLZ-M), which includes satisfaction and importance ratings for eight dimensions of QoL. A control group was taken from the general population (n = 477). Results Health was the most important QoL dimension for both the patient and the general population groups. While satisfaction with health was low in the patient group, the satisfaction ratings of the other seven domains were higher in the patient group than in the general population. The satisfaction with the domain partnership/sexuality showed a significant decline from t1 to t2. Multiple regression analyses showed that the domains health and income contributed most strongly to the global QoL score at t2 in the patient group. Conclusion Health is not the only relevant category when assessing QoL in cancer patients; social relationships and finances are pertinent as well. Importance ratings contribute to a better understanding of the relevance of the QoL dimensions for the patients.

Long-Term Follow-Up of Early Cochlear Implant Device Activation

2021 ◽  
pp. 1-11
Author(s):  
Stefanie Bruschke ◽  
Uwe Baumann ◽  
Timo Stöver
Keyword(s):  
Speech Recognition ◽  
Side Effects ◽  
Cochlear Implant ◽  
Surgical Techniques ◽  
Control Group ◽  
First Year ◽  
Safe Procedure ◽  
Sound Processor

Background: The cochlear implant (CI) is a standard procedure for the treatment of patients with severe to profound hearing loss. In the past, a standard healing period of 3–6 weeks occurred after CI surgery before the sound processor was initially activated. Advancements of surgical techniques and instruments allow an earlier initial activation of the processor within 14 days after surgery. Objective: Evaluation of the early CI device activation after CI surgery within 14 days, comparison to the first activation after 4–6 weeks, and assessment of the feasibility and safety of the early fitting over a 12 month observation period were the objectives of this study. Method: In a prospective study, 127 patients scheduled for CI surgery were divided into early fitting group (EF, n = 67) and control group (CG, n = 60). Individual questionnaires were used to evaluate medical and technical outcomes of the EF. Medical side effects, speech recognition, and follow-up effort were compared with the CG within the first year after CI surgery. Results: The early fitting was feasible in 97% of the EF patients. In the EF, the processor was activated 25 days earlier than in the CG. No major complications were observed in either group. At the follow-up appointments, side effects such as pain and balance problems occurred with comparable frequency in both groups. At initial fitting, the EF showed a significantly higher incidence of medical minor complications (p < 0.05). When developing speech recognition within the first year of CI use, no difference was observed. Furthermore, the follow-up effort within the first year after CI surgery was comparable in both groups. Conclusions: Early fitting of the sound processor is a feasible and safe procedure with comparable follow-up effort. Although more early minor complications were observed in the EF, there were no long-term wound healing problems caused by the early fitting. Regular inspection of the magnet strength is recommended as part of the CI follow-up since postoperative wound swelling must be expected. The early fitting procedure enabled a clear reduction in the waiting time between CI surgery and initial sound processor activation.

scholarly journals Lichtenstein inguinal hernia repairs with porcine small intestine submucosa: a 5- year follow-up. a prospective randomized controlled study

2021 ◽  
Author(s):  
Baoshan Li ◽  
Xin Zhang ◽  
Yi Man ◽  
Jiadong Xie ◽  
Wei Hu ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Inguinal Hernia ◽  
Hernia Repair ◽  
Term Effect ◽  
Control Group ◽  
Small Intestine Submucosa ◽  
Long Term Effect ◽  
Porcine Small Intestine Submucosa

Abstract Porcine small intestine submucosa (SIS) biologic patch has been used in inguinal hernia repair. However, there are little data available to assess the long-term effect after repair. This study aimed to explore the long-term effect of SIS patch in open inguinal hernia repair. Sevent-six patients with unilateral inguinal hernia were treated with Lichtenstein tension-free hernia repair using SIS patch (Beijing Datsing Bio-Tech Co., Ltd.) and Surgisis patch (COOK, USA) in Tianjin Union Medical Center and China-Japan Friendship Hospital. In the trial, the long-term efficacy of the treatment group and the control group were compared. A total of 66 patients in both groups received long-term follow-up (&gt; 5 years) after surgery, with a follow-up rate of 86.8%. During the follow-up period, there was one case of recurrence, one case of chronic pain in the control group. There was no statistically significant difference (P &gt; 0.05) in terms of recurrence, chronic pain, foreign body sensation and infection between the two groups of patients. After long-term observations, it has been found that the porcine small intestinal submucosa (SIS) biological patch is safe and effective for inguinal hernia Lichtenstein repair, and has a low recurrence rate and complication rate.

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