Overcoming barriers in incorporating evaluation of quality of life (QL) and symptoms by using the ePRO version of the LCSS (eLCSS-QL) in a large-scale multinational NSCLC trial (AP-QL Trial).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8092-8092
Author(s):  
Sumitra Thongprasert ◽  
Richard J. Gralla ◽  
Patricia J Hollen ◽  
Hoon-Kyo Kim ◽  
Te-Chun Hsia ◽  
...  
Keyword(s):  
Large Scale ◽  
Prospective Trial ◽  
Primary Treatment ◽  
Computer Assisted ◽  
Asian Countries ◽  
Major Response ◽  
Symptom Evaluation ◽  
Symptom Awareness

8092 Background: Survival and QL improvements are primary treatment goals in advanced NSCLC. Few trials evaluate both of these major endpoints well: typically only a minority of patients (pts) have QL followed over time, preventing such data from assisting in key decisions concerning the effectiveness and value of treatment. To overcome barriers, we used a computer-assisted version of the validated LCSS measure and tested this prospectively in a large study. Prior trials indicated that the eLCSS-QL requires only 2 minutes to complete the pt version and is highly acceptable. Methods: 622 pts received initial docetaxel (D)-based chemo, at 65 sites in 9 Asian countries. 70% male; 65% adenocarcinoma; median: KPS = 90; ECOG = 1 (27% ECOG 0). Stages: IV (72%), IIIB (28%). 84% had > two major symptoms. 80% had combination chemo with cisplatin (52%) or carboplatin (28%). Computer skills were low in 73%. eLCSS-QL was completed every 3 weeks at the clinic. We also surveyed 98 physicians (MD) and nurses (RN) treating these pts regarding communication, usefulness and acceptability of the eLCSS-QL. Results: 97% of pts completed the eLCSS-QL at baseline; 90% completed follow-up evaluations. Over 90% found the eLCSS-QL easy to use, acceptable to complete at each visit; >80% reported increased awareness of symptoms; making it easier to speak with MDs / RNs. 1% refused eLCSS-QL completion. Of MDs/RNs: >90% found the eLCSS-QL easy to use and increased symptom awareness; >80% reported improved communication, enhanced satisfaction with the pt visit, and recommend its use. Nearly 90% of MDs reported they could identify benefit from chemo earlier; 76% would order fewer imaging tests and 80% said the eLCSS-QL could save time. Major response rate 37%; median survivals: 13.9 months (D + cisplatin), 12.7 months (D + carboplatin). Conclusions: Patients, MDs, RNs all found the eLCSS-QL to be highly acceptable and easy to use with 90% of pts doing repeated QL measures. This large prospective trial demonstrates the potential for QL / symptom evaluation to aid in decision making and to guide appropriate use of chemotherapy and imaging while enhancing staff and pt satisfaction.

Three-year follow-up of prospective trial of focused ultrasound thalamotomy for essential tremor

Neurology ◽  
2019 ◽  
Vol 93 (24) ◽  
pp. e2284-e2293 ◽  
Author(s):  
Casey H. Halpern ◽  
Veronica Santini ◽  
Nir Lipsman ◽  
Andres M. Lozano ◽  
Michael L. Schwartz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Essential Tremor ◽  
Focused Ultrasound ◽  
Rating Scale ◽  
Prospective Trial ◽  
Postural Tremor ◽  
Hand Tremor

ObjectiveTo test the hypothesis that transcranial magnetic resonance–guided focused ultrasound (tcMRgFUS) thalamotomy is effective, durable, and safe for patients with medication-refractory essential tremor (ET), we assessed clinical outcomes at 3-year follow-up of a controlled multicenter prospective trial.MethodsOutcomes were based on the Clinical Rating Scale for Tremor, including hand combined tremor–motor (scale of 0–32), functional disability (scale of 0–32), and postural tremor (scale of 0–4) scores, and total scores from the Quality of Life in Essential Tremor Questionnaire (scale of 0–100). Scores at 36 months were compared with baseline and at 6 months after treatment to assess for efficacy and durability. Adverse events were also reported.ResultsMeasured scores remained improved from baseline to 36 months (all p < 0.0001). Range of improvement from baseline was 38%–50% in hand tremor, 43%–56% in disability, 50%–75% in postural tremor, and 27%–42% in quality of life. When compared to scores at 6 months, median scores increased for hand tremor (95% confidence interval [CI] 0–2, p = 0.0098) and disability (95% CI 1–4, p = 0.0001). During the third follow-up year, all previously noted adverse events remained mild or moderate, none worsened, 2 resolved, and no new adverse events occurred.ConclusionsResults at 3 years after unilateral tcMRgFUS thalamotomy for ET show continued benefit, and no progressive or delayed complications. Patients may experience mild degradation in some treatment metrics by 3 years, though improvement from baseline remains significant.Clinicaltrials.gov identifierNCT01827904.Classification of evidenceThis study provides Class IV evidence that for patients with severe ET, unilateral tcMRgFUS thalamotomy provides durable benefit after 3 years.

scholarly journals Post-operative hypothalamic lesions and obesity in childhood craniopharyngioma: results of the multinational prospective trial KRANIOPHARYNGEOM 2000 after 3-year follow-up

2011 ◽  
Vol 165 (1) ◽  
pp. 17-24 ◽  
Author(s):  
Hermann L Müller ◽  
Ursel Gebhardt ◽  
Carmen Teske ◽  
Andreas Faldum ◽  
Isabella Zwiener ◽  
...  
Keyword(s):  
Negative Impact ◽  
Prospective Trial ◽  
Multivariable Analysis ◽  
Multidisciplinary Teams ◽  
Hypothalamic Obesity ◽  
Surgical Strategies ◽  
Hypothalamic Lesions ◽  
Patient Load

BackgroundHypothalamic obesity has major impact on prognosis and quality of life (QoL) in childhood craniopharyngioma.Patients and methodsFor this study, 120 patients were prospectively recruited during 2001 and 2007 and evaluated after 3 years of follow-up (KRANIOPHARYNGEOM 2000). Body mass index (BMI) and QoL at diagnosis and 36 months after diagnosis were analysed based on the reference assessment of tumour localisation and post-surgical hypothalamic lesions. Treatment was analysed based on the neurosurgical strategy of 50 participating neurosurgical centres, the centre size based on the patient load.ResultsBMI SDS at diagnosis was similar in patients with or without hypothalamic involvement. Surgical lesions of anterior and posterior hypothalamic areas were associated with higher increase in BMI SDS during 36 months post-diagnosis compared with patients without or only anterior lesion (+1.8 BMISD, P=0.033, +2.1 BMISD; P=0.011), negative impact on QoL in patients with posterior hypothalamic lesions. Surgical strategies varied among the 50 neurosurgical centres (three large-sized, 24 middle-sized and 23 small-sized centres). Patients treated in small-sized centres presented with a higher rate of hypothalamic involvement compared with those treated in the middle- and large-sized centres. Treatment in large-sized centres was less radical, and the rates of complete resection and hypothalamic surgical lesions were lower in large-sized centres than those of the middle- and small-sized centres. However, a multivariable analysis showed that pre-operative hypothalamic involvement was the only independent risk factor for severe obesity (P=0.002).ConclusionsRadical neurosurgical strategies leading to posterior hypothalamic lesions are not recommended due to the potential to exacerbate hypothalamic obesity and impaired QoL. Treatment should be confined to experienced multidisciplinary teams.

Combination of Prednisolone and Azathioprine for Steroid-Responsive Meningitis-Arteritis Treatment in Dogs

2020 ◽  
Vol 57 (1) ◽  
pp. 1-7
Author(s):  
Lucile Giraud ◽  
Maud Girod ◽  
Laurent Cauzinille
Keyword(s):  
Side Effects ◽  
Relapse Rate ◽  
Primary Treatment ◽  
Immunosuppressive Drug ◽  
Duration Of Treatment ◽  
Glucocorticoid Treatment ◽  
Immune Mediated

ABSTRACT Treatment with high corticosteroid dosages for steroid-responsive meningitis-arteritis (SRMA) is correlated with severe adverse effects and worse quality of life. In order to improve immunosuppression and decrease dosage and duration of glucocorticoid treatment, a second immunosuppressive drug is commonly used in most of the immune-mediated diseases. The objective of this retrospective study was to evaluate the efficacy, tolerability, and occurrence of relapse for the combination of prednisolone and azathioprine. All dogs received azathioprine 2 mg/kg q 24 hr for 1 mo and then 2 mg/kg every other day for 2 mo; prednisolone was started at an immunosuppressive dosage and tapered off gradually during a mean of 3 mo. Twenty-six dogs met inclusion criteria. Twenty-one dogs (81%) were in clinical remission with no relapse observed within the 2 yr follow-up period. Treatment was well tolerated in all dogs and side effects were most of the time mild and self-limiting. The relapse rate (19%) was lower than most published rates. A prednisolone and azathioprine combination appeared to be effective for primary treatment of dogs with SRMA and allows a quicker tapering in prednisolone dosage, a decrease in long-term side effects of steroids, a shorter duration of treatment, and a low relapse rate.

Impact of adjuvant ocular interventions on the quality of life of patients with uveal melanoma after proton beam therapy

2021 ◽  
Author(s):  
Johannes Gollrad ◽  
Christopher Rabsahl ◽  
Antonia M Joussen ◽  
Andrea Stroux ◽  
Volker Budach ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Visual Acuity ◽  
Proton Beam ◽  
Uveal Melanoma ◽  
Proton Beam Therapy ◽  
Primary Treatment ◽  
Intravitreal Injections ◽  
Signed Rank

Introduction Proton beam therapy is an established primary treatment for patients with non-metastasized uveal melanoma. Adjuvant local interventions, like intravitreal injections or surgery, were shown to improve long-term eye preservation; however, their impact on the patient’s quality of life (QOL) remains unknown. Methods In a post-radiotherapeutic follow-up, we prospectively collected data on QOL, visual acuity, and interventional adjuvant procedures. QOL was measured with QOL-C30 and QLQ-OPT30 questionnaires at baseline, and at three and twelve months after proton therapy. Patients were grouped by the type of adjuvant treatment. Impact on QOL was analyzed by comparing changes in mean score values and visual acuity for different interventional subgroups, with generalized linear mixed models and Wilcoxon signed-rank tests. Results We received 108 (100%) and 95 (88.0%) questionnaires at three and twelve months post-therapy, respectively. Adjuvant interventions included: observation (n=61, 56.5%), intravitreal injections (n=17, 15.7%), and an intraocular surgical procedure (n=30, 27.8%). In the latter group, several QOL items significantly declined after the 3 month adjuvant interval, but they partially recovered at the 12-month follow-up. In all adjuvant-intervention groups, global QOL scores returned to baseline levels at 12 months. Conclusion Post-treatment adjuvant interventions had no long-lasting effects on QOL in patients with uveal melanoma.

scholarly journals Problem-solving training: assessing the feasibility and acceptability of delivering and evaluating a problem-solving training model for front-line prison staff and prisoners who self-harm

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e026095 ◽  
Author(s):  
Amanda Perry ◽  
Mitchell Glenn Waterman ◽  
Allan House ◽  
Alexandra Wright-Hughes ◽  
Joanne Greenhalgh ◽  
...  
Keyword(s):  
Problem Solving ◽  
Large Scale ◽  
Outcome Data ◽  
Front Line ◽  
Prison Staff ◽  
Intervention Delivery ◽  
Routinely Collected Data ◽  
Self Harm

ObjectivesProblem-solving skills training is adaptable, inexpensive and simple to deliver. However, its application with prisoners who self-harm is unknown. The study assessed the feasibility and acceptability of a problem-solving training (PST) intervention for prison staff and prisoners who self-harm, to inform the design of a large-scale study.Design and settingA mixed-methods design used routinely collected data, individual outcome measures, an economic protocol and qualitative interviews at four prisons in Yorkshire and Humber, UK.Participants(i) Front-line prison staff, (ii) male and female prisoners with an episode of self-harm in the previous 2 weeks.InterventionThe intervention comprised a 1 hour staff training session and a 30 min prisoner session using adapted workbooks and case studies.OutcomesWe assessed the study processes—coverage of training; recruitment and retention rates and adequacy of intervention delivery—and available data (completeness of outcome data, integrity of routinely collected data and access to the National Health Service (NHS) resource information). Prisoner outcomes assessed incidence of self-harm, quality of life and depression at baseline and at follow-up. Qualitative findings are presented elsewhere.ResultsRecruitment was higher than anticipated for staff n=280, but lower for prisoners, n=48. Retention was good with 43/48 (89%) prisoners completing the intervention, at follow-up we collected individual outcome data for 34/48 (71%) of prisoners. Access to routinely collected data was inconsistent. Prisoners were frequent users of NHS healthcare. The additional cost of training and intervention delivery was deemed minimal in comparison to ‘treatment as usual’. Outcome measures of self-harm, quality of life and depression were found to be acceptable.ConclusionsThe intervention proved feasible to adapt. Staff training was delivered but on the whole it was not deemed feasible for staff to deliver the intervention. A large-scale study is warranted, but modifications to the implementation of the intervention are required.

scholarly journals Computer-Assisted TKA : Long-Term Outcomes at a Minimum Follow-Up of 10 Years of 129 E-Motion FP Mobile Bearing Prostheses.

10.29007/p7sn ◽  
2018 ◽  
Author(s):  
Dominique Saragaglia ◽  
Olivier Seurat ◽  
Régis Pailhé ◽  
Brice Rubens-Duval
Keyword(s):  
Mobile Bearing ◽  
The Other ◽  
Computer Assisted ◽  
Long Term Outcomes ◽  
Initial Hypothesis

The hypothesis was that long-term outcomes were satisfactory or superior to the other implants design reported outcomes. This study confirms our initial hypothesis, that the outcomes of the TKA e-Motion FP with ultra-congruent mobile-bearing were satisfactory at more than 10 years of follow-up. Navigation, whose accuracy is well established, probably contributed to the quality of the results.

scholarly journals PENINGKATAN KUALITAS PUBLIKASI ILMIAH DAN PENELITIAN BAGI GURU SLTA DENGAN PEMANFAATAN SOFTWARE REFERENSI

2018 ◽  
Vol 2 (2) ◽  
pp. 77-82
Author(s):  
Afdhil Hafid ◽  
Harun Mukhtar ◽  
Regiolina Hayami ◽  
Yulia Fatma ◽  
Mitra Unik ◽  
...  
Keyword(s):  
Formal Education ◽  
Research Work ◽  
Computer Assisted ◽  
Main Task ◽  
Scientific Publications ◽  
Professional Educators ◽  
Research Activities ◽  
Service Activity

Republic of Indonesia Law No. 14 of 2005 describes teachers as professional educators with the main task of educating, teaching, guiding, directing, training, evaluating, and evaluating students in the formal education listed. The teacher has an important role in planning and implementing the learning process, so as to obtain opportunities to improve competence. One of the activities that must be carried out by teachers in developing their competence as teachers is scientific publications, which are listed in Article 11 of the Minister of PAN & RB Regulation No.16 of 2009 concerning teacher functional positions. In designing scientific publications there are stages and methods that are different from other papers. The research work comes from the research activities carried out so that it can be a reference in the follow-up of educational activities. The existence of information technology devices makes it easy for teachers to carry out research activities to publish them. The more research carried out at this time is not necessarily comparable with the quality of research. The demand to fulfill good and correct reference criteria is a challenge for teachers in the stages of reviewing and following up on publications. This service activity provides other insights into better article writing and reference techniques using computer-assisted devices. Problems with the obstacles faced so far by the teacher in writing are expected to be solved so that joint efforts in creating an environment of professionalism in education can be realized.

235 5-YEAR FOLLOW-UP OF A PROSPECTIVE CLINICAL TRIAL OF AN ENDOSCOPIC FULL-THICKNESS PLICATION DEVICE (GERDX™) FOR THE TREATMENT OF GERD

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Andreas Tschoner ◽  
Paul Punkenhofer ◽  
Georg Spaun ◽  
Oliver Koch ◽  
Reinhold Fuegger
Keyword(s):  
Quality Of Life ◽  
Laparoscopic Fundoplication ◽  
Prospective Trial ◽  
Full Thickness ◽  
Reflux Symptoms ◽  
Redo Fundoplication ◽  
Significant Difference ◽  
Gerd Symptoms

Abstract   The gold-standard in the operative treatment of gastroesophageal reflux disease (GERD) is the laparoscopic fundoplication. Alternatively, endoscopic devices to rebuild the gastroesophageal valve were invented. The aim of our study is to assess the improvement of GERD symptoms and quality of life in patients five years after the endoscopic full-thickness plication with the GERDx™ device. Methods Between 2013 and 2016 a prospective trial was implemented with forty patients and an endoscopic plication due to reflux symptoms with a pathologic workup for GERD. Limitation for the use of GERDx™ was a 2 cm hiatal hernia. Follow-up workup was done with high resolution manometry (HRM), 24 h-pH-impedance-catheter gastroscopy and questionaires for quality of life (GIQLI) and reflux-symptoms (SCL). Results Median follow-up time was 57 months (36–74 months). There was a significant improvement of the DeMeester score, GIQLI and SCL between pre- and postoperative values in short-term as well as long-term follow-up. At least 55% of patients were assessed as failure of the plication device due to redo operations with laparoscopic fundoplication in 25% and/or necessary PPI use for GERD symptoms (40%). There is no pre- and postoperative significant difference in quality of life or reflux scores between successful and failed endoplications, but patients with laparoscopic redo operations showed significant higher DeMeester scores before and after endoscopic treatment. Conclusion There is a higher failure rate to the endoscopic full-thickness plication than to the laparoscopic fundoplication. A small group of well selected patients is eligible for the endoscopic GERDx™ device. In case of therapeutic failure a classic laparoscopic redo fundoplication is possible under more challenging operative conditions.

DISSEMINATING A CLINICALLY EFFECTIVE PHYSICAL ACTIVITY PROGRAM TO PRESERVE MOBILITY IN A COMMUNITY SETTING FOR OLDER ADULTS

2016 ◽  
pp. 1-6
Author(s):  
J. LAUSSEN ◽  
C. KOWALESKI ◽  
K. MARTIN ◽  
C. HICKEY ◽  
R.A. FIELDING ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Older Adults ◽  
Large Scale ◽  
Well Being ◽  
Moderate Intensity ◽  
Community Based ◽  
Counseling Intervention

Background: As the population of older adults continues to increase, the dissemination of strategies to maintain independence of older persons is of critical public health importance. Recent large-scale clinical trial evidence has definitively shown intervention of moderate-intensity physical activity (PA) reduces major mobility disability in at-risk older adults. However, it remains unknown whether structured PA interventions, with demonstrated efficacy in controlled, clinical environments, can be successfully disseminated into community settings to benefit wider populations of older adults. Objective: To assess the dissemination of an evidence-based PA program for older adults by evaluating program participation and its impact on mobility, strength and quality of life. Setting: An urban senior center. Participants: Fifty older adults (71.2 ± 8 years aged; BMI: 30.1 ± 7 kg/m2). Intervention: Average of 8.0 ± 1.8 months of participation in the Fit-4-Life Program, a community-based PA and nutrition counseling intervention. Measurements: Mobility (Short Physical Performance Battery (SPPB)), self-reported physical activity (CHAMPS questionnaire), leg strength, grip strength, and quality of life (Quality of Well-Being Self-Administered (QWB-SA) scale) were assessed at baseline and follow-up. Results: Mean attendance was 55.8%. Fourteen participants were lost to follow-up. Those who dropped-out engaged in less PA at baseline (78 ± 108 mins/wk) compared to those who completed follow-up (203 ± 177 mins/wk, P=0.01). Participants exhibited sustained increases of PA (65 ± 153 mins/wk, P= 0.08), and there were meaningful improvements in SPPB (0.5 ± 0.2, P< 0.01), knee extensor strength (2.6 ± 4.4 kg, P< 0.01) and QWB-SA (0.04 ± 0.09, P= 0.05). Conclusion: The dissemination of a clinically efficacious PA intervention into a community-based setting can improve mobility, strength and quality of life for older adults. This knowledge may be helpful for the design and implementation of larger-scale PA intervention studies designed to preserve mobility in older adults within community-based settings.

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

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