Clinical outcomes of first-line antiretroviral therapy in Latin America: analysis from the LATINA retrospective cohort study.

Science.gov (United States)

Angriman, Federico; Belloso, Waldo H; Sierra-Madero, Juan; Sánchez, Jorge; Moreira, Ronaldo Ismerio; Kovalevski, Leandro O; Orellana, Liliana C; Cardoso, Sandra Wagner; Crabtree-Ramirez, Brenda; La Rosa, Alberto; Losso, Marcelo H

2016-02-01

Nearly 2 million people are infected with human immunodeficiency virus (HIV) in Latin America. However, information regarding population-scale outcomes from a regional perspective is scarce. We aimed to describe the baseline characteristics and therapeutic outcomes of newly-treated individuals with HIV infection in Latin America. A Retrospective cohort study was undertaken. The primary explanatory variable was combination antiretroviral therapy based on either a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI). The main outcome was defined as the composite of all-cause mortality and the occurrence of an AIDS-defining clinical event or a serious non-AIDS-defining event during the first year of therapy. The secondary outcomes included the time to a change in treatment strategy. All analyses were performed according to the intention to treat principle. A total of 937 treatment-naive patients from four participating countries were included (228 patients with PI therapy and 709 with NNRTI-based treatment). At the time of treatment initiation, the patients had a mean age of 37 (SD: 10) years and a median CD4 + T-cell count of 133 cells/mm(3) (interquartile range: 47.5-216.0). Patients receiving PI-based regimens had a significantly lower CD4 + count, a higher AIDS prevalence at baseline and a shorter time from HIV diagnosis until the initiation of treatment. There was no difference in the hazard ratio for the primary outcome between groups. The only covariates associated with the latter were CD4 + cell count at baseline, study site and age. The estimated hazard ratio for the time to a change in treatment (NNRTI vs PI) was 0.61 (95% CI 0.47-0.80, p America present with similar clinical outcomes regardless of the choice of initial therapy. Patients treated with PIs are more likely to require a treatment change during the first year of follow up. © The Author(s) 2015.

Predictability of the individual clinical outcome of extracorporeal shock wave therapy for cellulite.

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Schlaudraff, Kai-Uwe; Kiessling, Maren C; Császár, Nikolaus Bm; Schmitz, Christoph

2014-01-01

Extracorporeal shock wave therapy has been successfully introduced for the treatment of cellulite in recent years. However, it is still unknown whether the individual clinical outcome of cellulite treatment with extracorporeal shock wave therapy can be predicted by the patient's individual cellulite grade at baseline, individual patient age, body mass index (BMI), weight, and/or height. Fourteen Caucasian females with cellulite were enrolled in a prospective, single-center, randomized, open-label Phase II study. The mean (± standard error of the mean) cellulite grade at baseline was 2.5±0.09 and mean BMI was 22.8±1.17. All patients were treated with radial extracorporeal shock waves using the Swiss DolorClast(®) device (Electro Medical Systems, S.A., Nyon, Switzerland). Patients were treated unilaterally with 2 weekly treatments for 4 weeks on a randomly selected side (left or right), totaling eight treatments on the selected side. Treatment was performed at 3.5-4.0 bar, with 15,000 impulses per session applied at 15 Hz. Impulses were homogeneously distributed over the posterior thigh and buttock area (resulting in 7,500 impulses per area). Treatment success was evaluated after the last treatment and 4 weeks later by clinical examination, photographic documentation, contact thermography, and patient satisfaction questionnaires. The mean cellulite grade improved from 2.5±0.09 at baseline to 1.57±0.18 after the last treatment (ie, mean δ-1 was 0.93 cellulite grades) and 1.68±0.16 at follow-up (ie, mean δ-2 was 0.82 cellulite grades). Compared with baseline, no patient's condition worsened, the treatment was well tolerated, and no unwanted side effects were observed. No statistically significant (ie, Pcellulite grade at baseline, BMI, weight, height, or age. Radial shock wave therapy is a safe and effective treatment option for cellulite. The individual clinical outcome cannot be predicted by the patient's individual cellulite grade at baseline, BMI, weight

Timing of renal replacement therapy and clinical outcomes in critically ill patients with severe acute kidney injury

NARCIS (Netherlands)

Bagshaw, Sean M.; Uchino, Shigehiko; Bellomo, Rinaldo; Morimatsu, Hiroshi; Morgera, Stanislao; Schetz, Miet; Tan, Ian; Bouman, Catherine; Macedo, Ettiene; Gibney, Noel; Tolwani, Ashita; Oudemans-van Straaten, Heleen M.; Ronco, Claudio; Kellum, John A.; French, Craig; Mulder, John; Pinder, Mary; Roberts, Brigit; Botha, John; Mudholkar, Pradeen; Holt, Andrew; Hunt, Tamara; Honoré, Patrick Maurice; Clerbaux, Gaetan; Schetz, Miet Maria; Wilmer, Alexander; Yu, Luis; Macedo, Ettiene V.; Laranja, Sandra Maria; Rodrigues, Cassio José; Suassuna, José Hermógenes Rocco; Ruzany, Frederico; Campos, Bruno; Leblanc, Martine; Senécal, Lynne; Gibney, R. T. Noel; Johnston, Curtis; Brindley, Peter; Tan, Ian K. S.; Chen, Hui De; Wan, Li; Rokyta, Richard; Krouzecky, Ales; Neumayer, Hans-Helmut; Detlef, Kindgen-Milles; Mueller, Eckhard; Tsiora, Vicky; Sombolos, Kostas; Mustafa, Iqbal; Suranadi, Iwayan; Bar-Lavie, Yaron; Nakhoul, Farid; Ceriani, Roberto; Bortone, Franco; Zamperetti, Nereo; Pappalardo, Federico; Marino, Giovanni; Calabrese, Prospero; Monaco, Francesco; Liverani, Chiara; Clementi, Stefano; Coltrinari, Rosanna; Marini, Benedetto; Fuke, Nobuo; Miyazawa, Masaaki; Katayama, Hiroshi; Kurasako, Toshiaki; Hirasaw, Hiroyuki; Oda, Shigeto; Tanigawa, Koichi; Tanaka, Keiichi; Oudemans-van Straaten, Helena Maria; de Pont, Anne-Cornelie J. M.; Bugge, Jan Frederik; Riddervold, Fridtjov; Nilsen, Paul Age; Julsrud, Joar; Teixeira e Costa, Fernando; Marcelino, Paulo; Serra, Isabel Maria; Yaroustovsky, Mike; Grigoriyanc, Rachik; Lee, Kang Hoe; Loo, Shi; Singh, Kulgit; Barrachina, Ferran; Llorens, Julio; Sanchez-Izquierdo-Riera, Jose Angel; Toral-Vazquez, Darío; Wizelius, Ivar; Hermansson, Dan; Gaspert, Tomislav; Maggiorini, Marco; Davenport, Andrew; Lombardi, Raúl; Llopart, Teresita; Venkataraman, Ramesh; Kellum, John; Murray, Patrick; Trevino, Sharon; Benjamin, Ernest; Hufanda, Jerry; Paganini, Emil; Warnock, David; Guirguis, Nabil

2009-01-01

The aim of this study is to evaluate the relationship between timing of renal replacement therapy (RRT) in severe acute kidney injury and clinical outcomes. This was a prospective multicenter observational study conducted at 54 intensive care units (ICUs) in 23 countries enrolling 1238 patients.

Hippocampal volume in relation to clinical and cognitive outcome after electroconvulsive therapy in depression.

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Nordanskog, P; Larsson, M R; Larsson, E-M; Johanson, A

2014-04-01

In a previous magnetic resonance imaging (MRI) study, we found a significant increase in hippocampal volume immediately after electroconvulsive therapy (ECT) in patients with depression. The aim of this study was to evaluate hippocampal volume up to 1 year after ECT and investigate its possible relation to clinical and cognitive outcome. Clinical and cognitive outcome in 12 in-patients with depression receiving antidepressive pharmacological treatment referred for ECT were investigated with the Montgomery-Asberg Depression Rating Scale (MADRS) and a broad neuropsychological test battery within 1 week before and after ECT. The assessments were repeated 6 and 12 months after baseline in 10 and seven of these patients, respectively. Hippocampal volumes were measured on all four occasions with 3 Tesla MRI. Hippocampal volume returned to baseline during the follow-up period of 6 months. Neither the significant antidepressant effect nor the significant transient decrease in executive and verbal episodic memory tests after ECT could be related to changes in hippocampal volume. No persistent cognitive side effects were observed 1 year after ECT. The immediate increase in hippocampal volume after ECT is reversible and is not related to clinical or cognitive outcome. © 2013 The Authors. Acta Psychiatrica Scandinavica published by John Wiley & Sons Ltd.

Effects of extracorporal shock wave therapy on symptomatic heel spurs: a correlation between clinical outcome and radiologic changes.

Science.gov (United States)

Yalcin, E; Keskin Akca, A; Selcuk, B; Kurtaran, A; Akyuz, M

2012-02-01

Plantar heel pain, a chronic and disabling foot alignment, occurs in the adult population. Extracorporal shock wave therapy (ESWT) offers a nonsurgical option in addition to stretching exercises, heel cups, NSAI, and corticosteroid injections. This study aimed to investigate the effects of ESWT on calcaneal bone spurs and the correlation between clinical outcomes and radiologic changes. The study involved 108 patients with heel pain and radiologically diagnosed heel spurs. All patients underwent ESWT once a week for 5 weeks at the clinic. Each patient received 2,000 impulses of shock waves, starting with 0.05 mJ/mm2 (1.8 bar) and increasing to 0.4 mJ/mm2 (4.0 bar). Standard radiographies of the affected heels were obtained before and after the therapy. Clinical results demonstrated excellent (no pain) in 66.7% of the cases, good (50% of pain reduced) in 15.7% of the cases, and unsatisfactory (no reduction in pain) in 17.6%. After five ESWT treatments, no patients who received shock wave applications had significant spur reductions, but 19 patients (17.6%) had a decrease in the angle of the spur, 23 patients (21.3%) had a decrease in the dimensions of the spur, and one patient had a broken spur. Therefore, results showed no correlation between clinical outcome and radiologic changes. The present study supports the finding that even with no radiologic change after ESWT therapy, the therapy produces significant effects in reducing patients' complaints about heel spurs.

Review of the Interaction Between Body Composition and Clinical Outcomes in Metastatic Renal Cell Cancer Treated With Targeted Therapies

Directory of Open Access Journals (Sweden)

Steven M Yip

2016-03-01

Full Text Available Treatment of metastatic renal cell cancer (mRCC currently focuses on inhibition of the vascular endothelial growth factor pathway and the mammalian target of rapamycin (mTOR pathway. Obesity confers a higher risk of RCC. However, the influence of obesity on clinical outcomes in mRCC in the era of targeted therapy is less clear. This review focuses on the impact of body composition on targeted therapy outcomes in mRCC. The International Metastatic Renal Cell Carcinoma Database Consortium database has the largest series of patients evaluating the impact of body mass index (BMI on outcomes in mRCC patients treated with targeted therapy. Overall survival was significantly improved in overweight patients (BMI ≥ 25 kg/m2, and this observation was externally validated in patients who participated in Pfizer trials. In contrast, sarcopenia is consistently associated with increased toxicity to inhibitors of angiogenesis and mTOR. Strengthening patients with mRCC and sarcopenia, through a structured exercise program and dietary intervention, may improve outcomes in mRCC treated with targeted therapies. At the same time, the paradox of obesity being a risk factor for RCC while offering a better overall survival in response to targeted therapy needs to be further evaluated.

Clinical outcomes and cost-effectiveness of brief guided parent-delivered cognitive behavioural therapy and solution-focused brief therapy for treatment of childhood anxiety disorders: a randomised controlled trial.

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Creswell, Cathy; Violato, Mara; Fairbanks, Hannah; White, Elizabeth; Parkinson, Monika; Abitabile, Gemma; Leidi, Alessandro; Cooper, Peter J

2017-07-01

Half of all lifetime anxiety disorders emerge before age 12 years; however, access to evidence-based psychological therapies for affected children is poor. We aimed to compare the clinical outcomes and cost-effectiveness of two brief psychological treatments for children with anxiety referred to routine child mental health settings. We hypothesised that brief guided parent-delivered cognitive behavioural therapy (CBT) would be associated with better clinical outcomes than solution-focused brief therapy and would be cost-effective. We did this randomised controlled trial at four National Health Service primary child and mental health services in Oxfordshire, UK. Children aged 5-12 years referred for anxiety difficulties were randomly allocated (1:1), via a secure online minimisation tool, to receive brief guided parent-delivered CBT or solution-focused brief therapy, with minimisation for age, sex, anxiety severity, and level of parental anxiety. The allocation sequence was not accessible to the researcher enrolling participants or to study assessors. Research staff who obtained outcome measurements were masked to group allocation and clinical staff who delivered the intervention did not measure outcomes. The primary outcome was recovery, on the basis of Clinical Global Impressions of Improvement (CGI-I). Parents recorded patient-level resource use. Quality-adjusted life-years (QALYs) for use in cost-utility analysis were derived from the Child Health Utility 9D. Assessments were done at baseline (before randomisation), after treatment (primary endpoint), and 6 months after treatment completion. We did analysis by intention to treat. This trial is registered with the ISCRTN registry, number ISRCTN07627865. Between March 23, 2012, and March 31, 2014, we randomly assigned 136 patients to receive brief guided parent-delivered CBT (n=68) or solution-focused brief therapy (n=68). At the primary endpoint assessment (June, 2012, to September, 2014), 40 (59%) children in

Clinical outcomes of implant therapy in ectodermal dysplasia patients: a systematic review.

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Wang, Y; He, J; Decker, A M; Hu, J C; Zou, D

2016-08-01

The purpose of this review was to determine the outcome of oral function reconstruction in ectodermal dysplasia (ED) patients who have received dental implant therapy. A search was made of the PubMed and Web of Science databases; key words used were "(ectodermal dysplasia) AND (implant OR implants)", with supplementary retrieval key words "dental implant", "zygomatic implant", "anodontia", and "edentulous". Patient age, use of bone graft, implant site, type of implant, and survival rate of the implants were included in the subsequent data analysis. Forty-five articles published between 1988 and October 2015 were included in this analysis. The cases of a total of 96 patients were retrieved (22 children and 74 adults); these patients received a total of 701 implants. Fourteen implants were removed during a median follow-up time of 24 months. The 24-month implant survival rate was 97.9% in adult subjects and 98.6% in children. Sixty-eight percent of adult patients underwent bone augmentation prior to implant placement. Based on this review, dental implants are commonly used in the oral reconstruction of ED patients. However, long-term data on bone augmentation and implant success are needed, as well as additional clinical evidence on bone resorption, the esthetic outcomes of implant therapy, and physiological considerations in ED patients. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Factors influencing the use of outcome measures in physical therapy practice.

Science.gov (United States)

Wedge, Frances M; Braswell-Christy, Jennifer; Brown, Cynthia J; Foley, Kathleen T; Graham, Cecilia; Shaw, Sharon

2012-02-01

Use of outcome measures in physical therapy practice is central to evaluating the effectiveness of treatment interventions, providing accountability and addressing quality of physical therapy programs. There is limited discussion on barriers and facilitators to using outcome measures in physical therapy practice. The purpose of this study was to identify factors that influence a physical therapist when deciding to use outcome measures in clinical practice. Participants were 21 physical therapists, seven each from skilled nursing facilities, outpatient clinics, and inpatient rehabilitation facilities. A grounded theory approach was used for interview and data collection. Common themes were determined from the data and a theory developed to explain the rationale behind physical therapists' decisions to use or not use outcome measures in clinical practice. Three overlapping themes related to (1) concepts of time, (2) knowledge, and (3) facility culture were indentified as factors influencing the use of outcome measures. A fourth encompassing theme, professionalism, identified the value placed on the use of outcome measures in practice. Data revealed that therapists require more information on the outcome measures available, and this information needs to be easily accessible within the workplace. Therapists value information generated by using outcome measures in the clinical setting, but need information on what measures are available and psychometric properties. Information must be easily accessible and measures easy to use. Newer graduates and recent learners have a foundation in the use of outcome measures, but more needs to be done in the clinic and through continuing education to promote increased use and understanding.

Psychosocial and Clinical Outcomes of a Cognitive Behavioral Therapy for Asians and Pacific Islanders with Type 2 Diabetes: A Randomized Clinical Trial.

Science.gov (United States)

Inouye, Jillian; Li, Dongmei; Davis, James; Arakaki, Richard

2015-11-01

Asian Americans and Pacific Islanders are twice as likely to be diagnosed with type 2 diabetes compared to Caucasians. The objective was to determine the effect of cognitive behavioral therapy on quality of life, general health perceptions, depressive symptoms, and glycemia in Asians and Pacific Islanders with type 2 diabetes. The design was a randomized controlled clinical trial comparing cognitive behavioral therapy to diabetes education and support for six weekly sessions. Participants were recruited from two endocrinology practices; 207 were enrolled. The cognitive behavioral therapy group was provided self-management tools which included biofeedback, breathing exercises, and stress relievers, while the diabetes education and support group included diabetes education and group discussions. Assessments of psychosocial and clinical outcomes were obtained before and after sessions and 12 months PostSession. Differences between the two groups were examined using linear mixed-effects models with linear contrasts. The cognitive behavioral therapy group had improved depressive symptom scores from PreSession to EndSession compared to the diabetes education and support group (P < .03), but the improvement did not extend to 12 months PostSession. Similar results were observed with misguided support scores in the Multidimensional Diabetes Questionnaire (P < .03) and susceptibility in health beliefs (P < .01), but no significant differences in HbA1c improvement were found between the two groups. Both interventions improved outcomes from baseline but were not sustained for 1 year.

Clinical outcomes in clinical trials of anti-HIV treatment

DEFF Research Database (Denmark)

Reekie, J; Mocroft, A; J, Neaton

2007-01-01

Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

Can Trainees Effectively Deliver Dialectical Behavior Therapy for Individuals With Borderline Personality Disorder? Outcomes From a Training Clinic.

Science.gov (United States)

Rizvi, Shireen L; Hughes, Christopher D; Hittman, Alexandra D; Vieira Oliveira, Pedro

2017-12-01

The aim of the current study was to evaluate the effectiveness of a 6-month course of comprehensive dialectical behavior therapy (DBT) provided in a training clinic with doctoral students as therapists and assessors. Clinical outcomes for 50 individuals with borderline personality disorder (80% female, M age = 29.52 [SD = 9.64]) are reported. Reliable change indices and clinical significance were calculated for measures. Finally, our results were benchmarked against a "gold standard" randomized clinical trial (RCT; McMain et al., 2009). Analyses with both the full sample and the treatment completers indicate significant reductions in mental health symptomatology that were reliable, clinically and statistically significant, and comparable in effect size to the benchmarked RCT. This DBT training clinic produced good outcomes, comparable to that of a large RCT. Results have implications for who can provide DBT treatment, as well as improving access to DBT in community settings where training clinics may be located. © 2017 Wiley Periodicals, Inc.

Benchmarking Outpatient Rehabilitation Clinics Using Functional Status Outcomes.

Science.gov (United States)

Gozalo, Pedro L; Resnik, Linda J; Silver, Benjamin

2016-04-01

To utilize functional status (FS) outcomes to benchmark outpatient therapy clinics. Outpatient therapy data from clinics using Focus on Therapeutic Outcomes (FOTO) assessments. Retrospective analysis of 538 clinics, involving 2,040 therapists and 90,392 patients admitted July 2006-June 2008. FS at discharge was modeled using hierarchical regression methods with patients nested within therapists within clinics. Separate models were estimated for all patients, for those with lumbar, and for those with shoulder impairments. All models risk-adjusted for intake FS, age, gender, onset, surgery count, functional comorbidity index, fear-avoidance level, and payer type. Inverse probability weighting adjusted for censoring. Functional status was captured using computer adaptive testing at intake and at discharge. Clinic and therapist effects explained 11.6 percent of variation in FS. Clinics ranked in the lowest quartile had significantly different outcomes than those in the highest quartile (p < .01). Clinics ranked similarly in lumbar and shoulder impairments (correlation = 0.54), but some clinics ranked in the highest quintile for one condition and in the lowest for the other. Benchmarking models based on validated FS measures clearly separated high-quality from low-quality clinics, and they could be used to inform value-based-payment policies. © Health Research and Educational Trust.

Clinical Outcomes of Intensity-Modulated Pelvic Radiation Therapy for Carcinoma of the Cervix

International Nuclear Information System (INIS)

Hasselle, Michael D.; Rose, Brent S.; Kochanski, Joel D.; Nath, Sameer K.; Bafana, Rounak; Yashar, Catheryn M.; Hasan, Yasmin; Roeske, John C.; Mundt, Arno J.; Mell, Loren K.

2011-01-01

Purpose: To evaluate disease outcomes and toxicity in cervical cancer patients treated with pelvic intensity-modulated radiation therapy (IMRT). Methods and Materials: We included all patients with Stage I-IVA cervical carcinoma treated with IMRT at three different institutions from 2000-2007. Patients treated with extended field or conventional techniques were excluded. Intensity-modulated radiation therapy plans were designed to deliver 45 Gy in 1.8-Gy daily fractions to the planning target volume while minimizing dose to the bowel, bladder, and rectum. Toxicity was graded according to the Radiation Therapy Oncology Group system. Overall survival and disease-free survival were estimated by use of the Kaplan-Meier method. Pelvic failure, distant failure, and late toxicity were estimated by use of cumulative incidence functions. Results: The study included 111 patients. Of these, 22 were treated with postoperative IMRT, 8 with IMRT followed by intracavitary brachytherapy and adjuvant hysterectomy, and 81 with IMRT followed by planned intracavitary brachytherapy. Of the patients, 63 had Stage I-IIA disease and 48 had Stage IIB-IVA disease. The median follow-up time was 27 months. The 3-year overall survival rate and the disease-free survival rate were 78% (95% confidence interval [CI], 68-88%) and 69% (95% CI, 59-81%), respectively. The 3-year pelvic failure rate and the distant failure rate were 14% (95% CI, 6-22%) and 17% (95% CI, 8-25%), respectively. Estimates of acute and late Grade 3 toxicity or higher were 2% (95% CI, 0-7%) and 7% (95% CI, 2-13%), respectively. Conclusions: Intensity-modulated radiation therapy is associated with low toxicity and favorable outcomes, supporting its safety and efficacy for cervical cancer. Prospective clinical trials are needed to evaluate the comparative efficacy of IMRT vs. conventional techniques.

Temporal evolution of vasospasm and clinical outcome after intra-arterial vasodilator therapy in patients with aneurysmal subarachnoid hemorrhage.

Directory of Open Access Journals (Sweden)

Laleh Daftari Besheli

Full Text Available Intra-arterial (IA vasodilator therapy is one of the recommended treatments to minimize the impact of aneurysmal subarachnoid hemorrhage-induced cerebral vasospasm refractory to standard management. However, its usefulness and efficacy is not well established. We evaluated the effect IA vasodilator therapy on middle cerebral artery blood flow and on discharge outcome. We reviewed records for 115 adults admitted to Neurointensive Care Unit to test whether there was a difference in clinical outcome (discharge mRS in those who received IA infusions. In a subset of 19 patients (33 vessels treated using IA therapy, we tested whether therapy was effective in reversing the trends in blood flow. All measures of MCA blood flow increased from day -2 to -1 before infusion (maximum Peak Systolic Velocity (PSV 232.2±9.4 to 262.4±12.5 cm/s [p = 0.02]; average PSV 202.1±8.5 to 229.9±10.9 [p = 0.02]; highest Mean Flow Velocity (MFV 154.3±8.3 to 172.9±10.5 [p = 0.10]; average MFV 125.5±6.3 to 147.8±9.5 cm/s, [p = 0.02] but not post-infusion (maximum PSV 261.2±14.6 cm/s [p = .89]; average PSV 223.4±11.4 [p = 0.56]; highest MFV 182.9±12.4 cm/s [p = 0.38]; average MFV 153.0±10.2 cm/s [p = 0.54]. After IA therapy, flow velocities were consistently reduced (day X infusion interaction p<0.01 for all measures. However, discharge mRS was higher in IA infusion group, even after adjusting for sex, age, and admission grades. Thus, while IA vasodilator therapy was effective in reversing the vasospasm-mediated deterioration in blood flow, clinical outcomes in the treated group were worse than the untreated group. There is need for a prospective randomized controlled trial to avoid potential confounding effect of selection bias.

Reflections on Clinical Learning in Novice Speech-Language Therapy Students

Science.gov (United States)

Hill, Anne E.; Davidson, Bronwyn J.; Theodoros, Deborah G.

2012-01-01

Background: Reflective practice is reported to enhance clinical reasoning and therefore to maximize client outcomes. The inclusion of targeted reflective practice in academic programmes in speech-language therapy has not been consistent, although providing opportunities for speech-language therapy students to reflect during their clinical practice…

Manual therapy in addition to physiotherapy does not improve clinical or economic outcomes after ankle fracture.

Science.gov (United States)

Lin, Chung-Wei Christine; Moseley, Anne M; Haas, Marion; Refshauge, Kathryn M; Herbert, Robert D

2008-06-01

The primary aim of this study was to determine the effectiveness and cost-effectiveness of adding manual therapy to a physiotherapy programme for ankle fracture. Assessor-blinded randomized controlled trial. Ninety-four adults were recruited within one week of cast removal for isolated ankle fracture. Inclusion criteria were: they were able to weight-bear as tolerated or partial weight-bear, were referred for physiotherapy, and experienced pain. Ninety-one participants completed the study. Participants were randomly allocated to receive manual therapy (anterior-posterior joint mobilization over the talus) plus a standard physiotherapy programme (experimental), or the standard physiotherapy programme only (control). They were assessed by a blinded assessor at baseline, and at 4, 12 and 24 weeks. The main outcomes were activity limitation and quality of life. Information on costs and healthcare utilization was collected every 4 weeks up to 24 weeks. There were no clinically worthwhile differences in activity limitation or quality of life between groups at any time-point. There was also no between-group difference in quality-adjusted life-years, but the experimental group incurred higher out-of-pocket costs (mean between-group difference = AU$200, 95% confidence interval 26-432). When provided in addition to a physiotherapy programme, manual therapy did not enhance outcome in adults after ankle fracture.

The outcome of clinical parameters in adults with severe Type I Gaucher disease using very low dose enzyme replacement therapy.

Science.gov (United States)

Wilson, Callum; Spearing, Ruth; Teague, Lochie; Robertson, Patsy; Blacklock, Hilary

2007-01-01

Enzyme replacement therapy is now well established as the treatment of choice in Type I Gaucher disease. Historically higher dosage regimens have been used in preference to lower doses despite the little clinical evidence in the way of large controlled clinical trials to support this. Moreover, the extraordinary cost of therapy means that not all eligible patients are able to be treated at the higher dose. Twelve type I adult patients with relatively severe disease were commenced on a very low dose of 7.5U of alglucerase/imiglucerase per kg every two weeks (initially given thrice weekly and later weekly). Follow-up 5 year data reveal a good visceral and haematological response with outcomes consistent with recently published treatment guidelines. Satisfactory clinical and radiological skeletal improvement was also demonstrated in most patients. Three patients had an inadequate overall skeletal response to therapy. Biomarkers also steadily improved although perhaps not quite at the same rate as that seen in higher doses. Very low dose enzyme replacement therapy may be appropriate for adult type I Gaucher patients with mild-moderate skeletal disease.

Narrative therapy for adults with major depressive disorder: improved symptom and interpersonal outcomes.

Science.gov (United States)

Vromans, Lynette P; Schweitzer, Robert D

2011-01-01

This study investigated depressive symptom and interpersonal relatedness outcomes from eight sessions of manualized narrative therapy for 47 adults with major depressive disorder. Post-therapy, depressive symptom improvement (d=1.36) and proportions of clients achieving reliable improvement (74%), movement to the functional population (61%), and clinically significant improvement (53%) were comparable to benchmark research outcomes. Post-therapy interpersonal relatedness improvement (d=.62) was less substantial than for symptoms. Three-month follow-up found maintenance of symptom, but not interpersonal gains. Benchmarking and clinical significance analyses mitigated repeated measure design limitations, providing empirical evidence to support narrative therapy for adults with major depressive disorder.

Phenotypic changes of methicillin-resistant Staphylococcus aureus during vancomycin therapy for persistent bacteraemia and related clinical outcome.

Science.gov (United States)

Kim, T; Kim, E S; Park, S Y; Sung, H; Kim, M-N; Kim, S-H; Lee, S-O; Choi, S-H; Jeong, J-Y; Woo, J H; Chong, Y P; Kim, Y S

2017-08-01

Persistent bacteraemia (PB) due to methicillin-resistant Staphylococcus aureus (MRSA) that fails to respond to glycopeptide therapy is a well-documented clinical problem. There are limited data on changes in agr functionality, vancomycin susceptibility and heteroresistance during MRSA PB. Thus, the frequency of these changes and their clinical significance remain unclear. Only patients with MRSA PB (≥7 days) from a prospective cohort of S. aureus bacteraemia were included. We collected isogenic paired strains and compared vancomycin MIC, vancomycin heteroresistance, and agr functionality between initial and final blood isolates. We also assessed the clinical outcome. A total of 49 patients had MRSA PB over 22 months. Bacteraemia persisted for a median of 13 days and most patients (98%) received glycopeptide as initial therapy. Among 49 isogenic pairs, only one pair showed a vancomycin MIC increase ≥2-fold by broth microdilution method, and only seven (14%) by E-test. Significant portions of initial isolates had vancomycin heteroresistance (49%) and agr dysfunction (76%). Development of vancomycin heteroresistance during PB occurred in four (16%) among 25 initial vancomycin-susceptible isolates, and acquisition of agr dysfunction occurred in two (16%) among 12 initial agr-functional isolates. Changes in the opposite direction occasionally occurred. These phenotypic changes during PB were not associated with mortality, whereas agr dysfunction of the initial isolates was significantly associated with mortality. During MRSA PB, phenotypic changes of MRSA isolates occurred occasionally under prolonged vancomycin exposure but were not significantly associated with clinical outcome. In contrast, initial agr dysfunction could be a predictor for mortality in MRSA PB.

Clinical Outcomes With Dose-Escalated Adaptive Radiation Therapy for Urinary Bladder Cancer: A Prospective Study

Energy Technology Data Exchange (ETDEWEB)

Murthy, Vedang, E-mail: vmurthy@actrec.gov.in [Department of Radiation Oncology, Tata Memorial Centre, Parel, Mumbai (India); Masodkar, Renuka; Kalyani, Nikhil; Mahantshetty, Umesh [Department of Radiation Oncology, Tata Memorial Centre, Parel, Mumbai (India); Bakshi, Ganesh; Prakash, Gagan [Department of Surgical Oncology, Tata Memorial Centre, Parel, Mumbai (India); Joshi, Amit; Prabhash, Kumar [Department of Medical Oncology, Tata Memorial Centre, Parel, Mumbai (India); Ghonge, Sujata; Shrivastava, Shyamkishore [Department of Radiation Oncology, Tata Memorial Centre, Parel, Mumbai (India)

2016-01-01

Purpose: The purpose of this study was to assess feasibility, clinical outcomes, and toxicity in patients with bladder cancer treated with adaptive, image guided radiation therapy (IGRT) for bladder preservation as a part of trimodality treatment. The role of dose escalation was also studied. Methods and Materials: Forty-four patients with localized bladder cancer were enrolled in a prospective study. They underwent maximal safe resection of bladder tumor and concurrent platinum-based chemotherapy. Patients with large tumors were offered induction chemotherapy. Radiation therapy planning was done using either 3 (n=34) or 6 (n=10) concentrically grown planning target volumes (PTV). Patients received 64 Gy in 32 fractions to the whole bladder and 55 Gy to the pelvic nodes and, if appropriate, a simultaneous integrated boost to the tumor bed to 68 Gy (equivalent dose for 2-Gy fractions assuming α/β of 10 [EQD2]{sub 10} = 68.7 Gy). Daily megavoltage (MV) imaging helped to choose the most appropriate PTV encompassing bladder for the particular day (using plan-of-the-day approach). Results: Most patients (88%) had T2 disease. Sixteen patients (36%) received neoadjuvant chemotherapy. A majority of the patients (73%) received prophylactic nodal irradiation, whereas 55% of the patients received escalated dose to the tumor bed. With a median follow-up of 30 months, the 3-year locoregional control (LRC), disease-free survival, and overall survival (OS) were 78%, 66%, and 67%, respectively. The bladder preservation rate was 83%. LRC (87% vs 68%, respectively, P=.748) and OS (74% vs 60%, respectively, P=.36) rates were better in patients receiving dose escalation. Instances of acute and late Radiation Therapy Oncology Group (RTOG) grade 3 genitourinary toxicity was seen in 5 (11%) and 2 (4%) patients, respectively. There was no acute or late RTOG grade 3 or higher gastrointestinal toxicity. Conclusions: Adaptive IGRT using plan-of-the-day approach for bladder

Clinical Outcomes With Dose-Escalated Adaptive Radiation Therapy for Urinary Bladder Cancer: A Prospective Study

International Nuclear Information System (INIS)

Murthy, Vedang; Masodkar, Renuka; Kalyani, Nikhil; Mahantshetty, Umesh; Bakshi, Ganesh; Prakash, Gagan; Joshi, Amit; Prabhash, Kumar; Ghonge, Sujata; Shrivastava, Shyamkishore

2016-01-01

Purpose: The purpose of this study was to assess feasibility, clinical outcomes, and toxicity in patients with bladder cancer treated with adaptive, image guided radiation therapy (IGRT) for bladder preservation as a part of trimodality treatment. The role of dose escalation was also studied. Methods and Materials: Forty-four patients with localized bladder cancer were enrolled in a prospective study. They underwent maximal safe resection of bladder tumor and concurrent platinum-based chemotherapy. Patients with large tumors were offered induction chemotherapy. Radiation therapy planning was done using either 3 (n=34) or 6 (n=10) concentrically grown planning target volumes (PTV). Patients received 64 Gy in 32 fractions to the whole bladder and 55 Gy to the pelvic nodes and, if appropriate, a simultaneous integrated boost to the tumor bed to 68 Gy (equivalent dose for 2-Gy fractions assuming α/β of 10 [EQD2] 10  = 68.7 Gy). Daily megavoltage (MV) imaging helped to choose the most appropriate PTV encompassing bladder for the particular day (using plan-of-the-day approach). Results: Most patients (88%) had T2 disease. Sixteen patients (36%) received neoadjuvant chemotherapy. A majority of the patients (73%) received prophylactic nodal irradiation, whereas 55% of the patients received escalated dose to the tumor bed. With a median follow-up of 30 months, the 3-year locoregional control (LRC), disease-free survival, and overall survival (OS) were 78%, 66%, and 67%, respectively. The bladder preservation rate was 83%. LRC (87% vs 68%, respectively, P=.748) and OS (74% vs 60%, respectively, P=.36) rates were better in patients receiving dose escalation. Instances of acute and late Radiation Therapy Oncology Group (RTOG) grade 3 genitourinary toxicity was seen in 5 (11%) and 2 (4%) patients, respectively. There was no acute or late RTOG grade 3 or higher gastrointestinal toxicity. Conclusions: Adaptive IGRT using plan-of-the-day approach for bladder preservation

A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design

International Nuclear Information System (INIS)

Thorsen, Lene; Nilsen, Tormod S; Raastad, Truls; Courneya, Kerry S; Skovlund, Eva; Fosså, Sophie D

2012-01-01

Studies indicate that strength training has beneficial effects on clinical health outcomes in prostate cancer patients during androgen deprivation therapy. However, randomized controlled trials are needed to scientifically determine the effectiveness of strength training on the muscle cell level. Furthermore, close examination of the feasibility of a high-load strength training program is warranted. The Physical Exercise and Prostate Cancer (PEPC) trial is designed to determine the effectiveness of strength training on clinical and muscle cellular outcomes in non-metastatic prostate cancer patients after high-dose radiotherapy and during ongoing androgen deprivation therapy. Patients receiving androgen deprivation therapy for 9-36 months combined with external high-dose radiotherapy for locally advanced prostate cancer are randomized to an exercise intervention group that receives a 16 week high-load strength training program or a control group that is encouraged to maintain their habitual activity level. In both arms, androgen deprivation therapy is continued until the end of the intervention period. Clinical outcomes are body composition (lean body mass, bone mineral density and fat mass) measured by Dual-energy X-ray Absorptiometry, serological outcomes, physical functioning (muscle strength and cardio-respiratory fitness) assessed with physical tests and psycho-social functioning (mental health, fatigue and health-related quality of life) assessed by questionnaires. Muscle cellular outcomes are a) muscle fiber size b) regulators of muscle fiber size (number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors and proteins involved in muscle protein degradation and muscle hypertrophy) and c) regulators of muscle fiber function such as proteins involved in cellular stress and mitochondrial function. Muscle cellular outcomes are measured on muscle cross sections and

Therapy optimization in multiple sclerosis: a prospective observational study of therapy compliance and outcomes.

Science.gov (United States)

Coyle, Patricia K; Cohen, Bruce A; Leist, Thomas; Markowitz, Clyde; Oleen-Burkey, MerriKay; Schwartz, Marc; Tullman, Mark J; Zwibel, Howard

2014-03-13

Data sources for MS research are numerous but rarely provide an objective measure of drug therapy compliance coupled with patient-reported health outcomes. The objective of this paper is to describe the methods and baseline characteristics of the Therapy Optimization in MS (TOP MS) study designed to investigate the relationship between disease-modifying therapy compliance and health outcomes. TOP MS was designed as a prospective, observational, nationwide patient-focused study using an internet portal for data entry. The protocol was reviewed and approved by Sterling IRB. The study was registered with ClinicalTrials.gov. It captured structured survey data monthly from MS patients recruited by specialty pharmacies. Data collection included the clinical characteristics of MS such as MS relapses. Disability, quality of life and work productivity and activity impairment were assessed quarterly with well-validated scales. When events like severe fatigue or new or worsening depression were reported, feedback was provided to treating physicians. The therapy compliance measure was derived from pharmacy drug shipment records uploaded to the study database. The data presented in this paper use descriptive statistics. The TOP MS Study enrolled 2966 participants receiving their disease-modifying therapy (DMT) from specialty pharmacies. The mean age of the sample was 49 years, 80.4% were female, 89.9% were Caucasian and 55.7% were employed full or part time. Mean time since first symptoms was 11.5 years; mean duration since diagnosis was 9.5 years. Patient-reported EDSS was 3.5; 72.2% had a relapsing-remitting disease course. The most commonly reported symptoms at the time of enrollment were fatigue (74.7%), impaired coordination or balance (61.8%) and numbness and tingling (61.2%). Half of the sample was using glatiramer acetate and half was using beta-interferons. Demographic and clinical characteristics of the TOP MS sample at enrollment are consistent with other community

Clinical outcomes with daptomycin: a post-marketing, real-world evaluation.

Science.gov (United States)

Sakoulas, G

2009-12-01

The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients.

Impact of Penicillin Allergy on Time to First Dose of Antimicrobial Therapy and Clinical Outcomes.

Science.gov (United States)

Conway, Erin L; Lin, Ken; Sellick, John A; Kurtzhalts, Kari; Carbo, James; Ott, Michael C; Mergenhagen, Kari A

2017-11-01

The objective of this study was to evaluate the impact of a listed penicillin allergy on the time to first dose of antibiotic in a Veterans Affairs hospital. Additional clinical outcomes of patients with penicillin allergies were compared with those of patients without a penicillin allergy. A retrospective chart review of veterans admitted through the emergency department with a diagnosis of pneumonia, urinary tract infection, bacteremia, and sepsis from January 2006 to December 2015 was conducted. The primary outcome was time to first dose of antibiotic treatment, defined as the time from when the patient presented to the emergency department to the medication administration time. Secondary outcomes included total antibiotic therapy duration and treatment outcomes, including mortality, length of stay, and 30-day readmission rate. A total of 403 patients were included in the final analysis; 57 patients (14.1%) had a listed penicillin allergy. The average age of the population was 75 years and 99% of the population was male. The mean time to first dose of antibiotic treatment for patients with a penicillin allergy was prolonged compared with those without a penicillin allergy (236.1 vs 186.6 minutes; P = 0.03), resulting in an approximately 50-minute delay. Penicillin-allergic patients were more likely to receive a carbapenem or fluoroquinolone antibiotic (P penicillin allergy had a prolonged time to first dose of antibiotic therapy. No significant differences were found in total antibiotic duration, length of stay, or 30-day readmission rate. The small sample size, older population, and single-center nature of this study may limit the generalizability of the present findings to other populations. Published by Elsevier Inc.

Clinical Outcomes and Patterns of Disease Recurrence After Intensity Modulated Proton Therapy for Oropharyngeal Squamous Carcinoma

Energy Technology Data Exchange (ETDEWEB)

Gunn, G. Brandon [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Blanchard, Pierre [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Department of Radiation Oncology, Institut Gustave Roussy, Villejuif (France); Garden, Adam S. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Zhu, X. Ronald [Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Fuller, C. David [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Medical Physics Program, The University of Texas Graduate School of Biomedical Sciences, Houston, Texas (United States); Mohamed, Abdallah S. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Department of Clinical Oncology and Nuclear Medicine, University of Alexandria (Egypt); Morrison, William H.; Phan, Jack; Beadle, Beth M.; Skinner, Heath D. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Sturgis, Erich M. [Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Kies, Merrill S. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Hutcheson, Kate A. [Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Rosenthal, David I. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Mohan, Radhe; Gillin, Michael T. [Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); and others

2016-05-01

Purpose: A single-institution prospective study was conducted to assess disease control and toxicity of proton therapy for patients with head and neck cancer. Methods and Materials: Disease control, toxicity, functional outcomes, and patterns of failure for the initial cohort of patients with oropharyngeal squamous carcinoma (OPC) treated with intensity modulated proton therapy (IMPT) were prospectively collected in 2 registry studies at a single institution. Locoregional failures were analyzed by using deformable image registration. Results: Fifty patients with OPC treated from March 3, 2011, to July 2014 formed the cohort. Eighty-four percent were male, 50% had never smoked, 98% had stage III/IV disease, 64% received concurrent therapy, and 35% received induction chemotherapy. Forty-four of 45 tumors (98%) tested for p16 were positive. All patients received IMPT (multifield optimization to n=46; single-field optimization to n=4). No Common Terminology Criteria for Adverse Events grade 4 or 5 toxicities were observed. The most common grade 3 toxicities were acute mucositis in 58% of patients and late dysphagia in 12%. Eleven patients had a gastrostomy (feeding) tube placed during therapy, but none had a feeding tube at last follow-up. At a median follow-up time of 29 months, 5 patients had disease recurrence: local in 1, local and regional in 1, regional in 2, and distant in 1. The 2-year actuarial overall and progression-free survival rates were 94.5% and 88.6%. Conclusions: The oncologic, toxicity, and functional outcomes after IMPT for OPC are encouraging and provide the basis for ongoing and future clinical studies.

Outcomes of endodontic therapy in general practice

Science.gov (United States)

Bernstein, Susan D.; Horowitz, Allan J.; Man, Martin; Wu, Hongyu; Foran, Denise; Vena, Donald A.; Collie, Damon; Matthews, Abigail G.; Curro, Frederick A.; Thompson, Van P.; Craig, Ronald G.

2014-01-01

Background The authors undertook a study involving members of a dental practice-based research network to determine the outcome and factors associated with success and failure of endodontic therapy. Methods Members in participating practices (practitioner-investigators [P-Is]) invited the enrollment of all patients seeking treatment in the practice who had undergone primary endodontic therapy and restoration in a permanent tooth three to five years previously. If a patient had more than one tooth so treated, the P-I selected as the index tooth the tooth treated earliest during the three- to five-year period. The authors excluded from the study any teeth that served as abutments for removable partial dentures or overdentures, third molars and teeth undergoing active orthodontic endodontic therapy. The primary outcome was retention of the index tooth. Secondary outcomes, in addition to extraction, that defined failure included clinical or radiographic evidence (or both) of periapical pathosis, endodontic retreatment or pain on percussion. Results P-Is in 64 network practices enrolled 1,312 patients with a mean (standard deviation) time to follow-up of 3.9 (0.6) years. During that period, 3.3 percent of the index teeth were extracted, 2.2 percent underwent retreatment, 3.6 percent had pain on percussion and 10.6 percent had periapical radiolucencies for a combined failure rate of 19.1 percent. The presence of preoperative periapical radiolucency with a diagnosis of either irreversible pulpitis or necrotic pulp was associated with failure after multivariate analysis, as were multiple canals, male sex and Hispanic/Latino ethnicity. Conclusions These results suggest that failure rates for endodontic therapy are higher than previously reported in general practices, according to results of studies based on dental insurance claims data. Clinical Implications The results of this study can help guide the practitioner in deciding the most appropriate course of therapy for

A retrospective, descriptive study of shoulder outcomes in outpatient physical therapy.

Science.gov (United States)

Millar, A Lynn; Lasheway, Philip A; Eaton, Wendy; Christensen, Frances

2006-06-01

A retrospective, descriptive study of clients with shoulder dysfunction referred to physical therapy. To (1) describe the clinical and functional outcomes of clients with shoulder dysfunction following outpatient physical therapy, and (2) to compare the outcomes by type of shoulder dysfunction. Although individuals with shoulder dysfunction are commonly referred to physical therapy few large descriptive studies regarding outcomes following physical therapy are available. Data for 878 clients (468 female, 410 male) were retrieved and analyzed. This database was developed between 1997 and 2000 and included 4 outpatient facilities from 1 healthcare system in the southwest corner of Michigan. Clients were classified by type of shoulder dysfunction, and standardized tests were performed upon admittance and discharge to physical therapy. Descriptive and inferential statistics were calculated for all data. Of all clients, 55.1% had shoulder impingement, while 18.3% had postoperative repair, 8.9% had a frozen shoulder, 7.6% had a rotator cuff tear, 3.0% had shoulder instability, 2.1% were post fracture, and the remaining 4.9% had miscellaneous diagnoses. The average (+/-SD) age of the patients was 53.6 +/- 16.4 years, with an average (+/-SD) number of treatment sessions of 13.7 +/- 11.0. All groups showed significant changes following physical therapy intervention. Clients with diverse types of shoulder dysfunction demonstrated improvement in both clinical and functional measures at the conclusion of physical therapy, although it is not possible to determine whether these changes were due to the interventions or due to time. The type of shoulder dysfunction appears to affect the prognosis, thus expected outcomes should be based upon initial diagnosis and specific measures.

Magnetic resonance imaging and morphometric histologic analysis of prostate tissue composition in predicting the clinical outcome of terazosin therapy in benign prostatic hyperplasia

Energy Technology Data Exchange (ETDEWEB)

Isen, K. [Karaelmas Univ., Zonguldak (Turkey). School of Medicine; Sinik, Z.; Alkibay, T.; Sezer, C.; Soezen, S.; Atilla, S.; Ataoglu, O.; Isik, S.

2001-02-01

The purpose of this study was to determine whether magnetic resonance imaging (MRI) or quantitative color-imaged morphometric analysis (MA) of the prostate gland are related to the clinical response to terazosin. Thirty-six male patients with symptomatic benign prostatic hyperplasia (BPH) with a serum prostate-specific antigen level of 4-10 ng/mL underwent MRI with body coil, transrectal prostate unltrasonography and biopsy prior to terazosin therapy. For MRI-determined stromal and non-stromal BPH, the ratio of the signal intensity of the inner gland to the obturator internus muscle was evaluated. Histologic sections were stained with hematoxylin and eosin. The MA of the specimens was performed by Samba 2000. Results of the two techniques were interpreted according to the terazosin therapy results. The mean stromal percentage was 60.5{+-}18.0%. No statistically significant relationship was found between the clinical outcome of terazosin and the MRI findings. The MA results showed a significant relationship between the percentage of stroma and the percent change of the peak urinary flow rate, but not with the percent change of the international prostate symptom score after terazosin therapy (P<0.05). Magnetic resonance imaging alone is not sufficient in predicting the response to terazosin therapy. Morphometric analysis of BPH tissue composition can be used in predicting the clinical outcome of terazosin therapy but it is suitable only in patients for whom prostatic biopsy is necessary in order to rule out prostate cancer. (author)

Magnetic resonance imaging and morphometric histologic analysis of prostate tissue composition in predicting the clinical outcome of terazosin therapy in benign prostatic hyperplasia

International Nuclear Information System (INIS)

Isen, K.; Sinik, Z.; Alkibay, T.; Sezer, C.; Soezen, S.; Atilla, S.; Ataoglu, O.; Isik, S.

2001-01-01

The purpose of this study was to determine whether magnetic resonance imaging (MRI) or quantitative color-imaged morphometric analysis (MA) of the prostate gland are related to the clinical response to terazosin. Thirty-six male patients with symptomatic benign prostatic hyperplasia (BPH) with a serum prostate-specific antigen level of 4-10 ng/mL underwent MRI with body coil, transrectal prostate unltrasonography and biopsy prior to terazosin therapy. For MRI-determined stromal and non-stromal BPH, the ratio of the signal intensity of the inner gland to the obturator internus muscle was evaluated. Histologic sections were stained with hematoxylin and eosin. The MA of the specimens was performed by Samba 2000. Results of the two techniques were interpreted according to the terazosin therapy results. The mean stromal percentage was 60.5±18.0%. No statistically significant relationship was found between the clinical outcome of terazosin and the MRI findings. The MA results showed a significant relationship between the percentage of stroma and the percent change of the peak urinary flow rate, but not with the percent change of the international prostate symptom score after terazosin therapy (P<0.05). Magnetic resonance imaging alone is not sufficient in predicting the response to terazosin therapy. Morphometric analysis of BPH tissue composition can be used in predicting the clinical outcome of terazosin therapy but it is suitable only in patients for whom prostatic biopsy is necessary in order to rule out prostate cancer. (author)

A randomized clinical trial of manual therapy and physiotherapy for persistent back and neck complaints : Subgroup analysis and relationship between outcome measures

NARCIS (Netherlands)

Koes, B. W.; Bouter, L. M.; Van Mameren, H.; Essers, A. H M; Verstegen, G. J M G; Hofhuizen, D. M.; Houben, J. P.; Knipschild, P. G.

1993-01-01

Objective: To study the efficacy of manual therapy and physiotherapy in subgroups of patients with persistent back and neck complaints. The second objective was to determine the correlation between three important outcome measures used in this trial. Design: Randomized clinical trial (subgroup

Two-year clinical outcomes following non-surgical mechanical therapy of peri-implantitis with adjunctive diode laser application.

Science.gov (United States)

Mettraux, Gérald R; Sculean, Anton; Bürgin, Walter B; Salvi, Giovanni E

2016-07-01

Non-surgical mechanical therapy of peri-implantitis (PI) with/without adjunctive measures yields limited clinical improvements. To evaluate the clinical outcomes following non-surgical mechanical therapy of PI with adjunctive application of a diode laser after an observation period ≥2 years. At baseline (BL), 15 patients with 23 implants with a sandblasted and acid-etched (SLA) surface diagnosed with PI were enrolled and treated. PI was defined as presence of probing pocket depths (PPD) ≥5 mm with bleeding on probing (BoP) and/or suppuration and ≥2 threads with bone loss after delivery of the restoration. Implant sites were treated with carbon fiber and metal curettes followed by repeated application of a diode laser 3x for 30 s (settings: 810 nm, 2.5 W, 50 Hz, 10 ms). This procedure was performed at Day 0 (i.e., baseline), 7 and 14. Adjunctive antiseptics or adjunctive systemic antibiotics were not prescribed. All implants were in function after 2 years. The deepest PPD decreased from 7.5 ± 2.6 mm to 3.6 ± 0.7 mm at buccal (P surgical mechanical therapy of PI with adjunctive repeated application of a diode laser yielded significant clinical improvements after an observation period of at least 2 years. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Adjunctive Non-Surgical Therapy of Inflamed Periodontal Pockets During Maintenance Therapy Using Diode Laser: A Randomized Clinical Trial.

Science.gov (United States)

Nguyen, Naomi-Trang; Byarlay, Matthew R; Reinhardt, Richard A; Marx, David B; Meinberg, Trudy A; Kaldahl, Wayne B

2015-10-01

Numerous studies have documented the clinical outcomes of laser therapy for untreated periodontitis, but very few have reported on lasers treating inflamed pockets during maintenance therapy. The aim of this study is to compare the effectiveness of scaling and root planing (SRP) plus the adjunctive use of diode laser therapy to SRP alone on changes in the clinical parameters of disease and on the gingival crevicular fluid (GCF) inflammatory mediator interleukin-1β (IL-1β) in patients receiving regular periodontal maintenance therapy. This single-masked and randomized, controlled, prospective study includes 22 patients receiving regular periodontal maintenance therapy who had one or more periodontal sites with a probing depth (PD) ≥ 5 mm with bleeding on probing (BOP). Fifty-six sites were treated with SRP and adjunctive laser therapy (SRP + L). Fifty-eight sites were treated with SRP alone. Clinical parameters, including PD, clinical attachment level (CAL), and BOP, and GCF IL-1β levels were measured immediately before treatment (baseline) and 3 months after treatment. Sites treated with SRP + L and SRP alone resulted in statistically significant reductions in PD and BOP and gains in CAL. These changes were not significantly different between the two therapies. Similarly, differences in GCF IL-1β levels between SRP + L and SRP alone were not statistically significant. In periodontal maintenance patients, SRP + L did not enhance clinical outcomes compared to SRP alone in the treatment of inflamed sites with ≥ 5 mm PD.

Outcomes of Vogt-Koyanagi-Harada disease: a subanalysis from a randomized clinical trial of antimetabolite therapies

Science.gov (United States)

Shen, Elizabeth; Rathinam, Sivakumar R.; Babu, Manohar; Kanakath, Anuradha; Thundikandy, Radhika; Lee, Salena M.; Browne, Erica N.; Porco, Travis C.; Acharya, Nisha R.

2016-01-01

Purpose To report outcomes of Vogt-Koyanagi-Harada (VKH) disease from a clinical trial of antimetabolite therapies. Design Subanalysis from an observer-masked randomized clinical trial for non-infectious intermediate, posterior, and pan- uveitis. Methods Setting clinical practice at Aravind Eye Hospitals, India Patient Population Forty-three of 80 patients enrolled (54%) diagnosed with VKH. Intervention Patients were randomized to either 25mg oral methotrexate weekly or 1g mycophenolate mofetil twice daily, with a corticosteroid taper. Main outcome measures Primary outcome was corticosteroid-sparing control of inflammation at 5 and 6 months. Secondary outcomes included visual acuity, central subfield thickness, and adverse events. Patients were categorized as acute (diagnosis ≤3 months prior to enrollment) or chronic (diagnosis >3 months prior to enrollment). Results Twenty-seven patients were randomized to methotrexate and 16 to mycophenolate mofetil; 30 had acute VKH. The odds of achieving corticosteroid-sparing control of inflammation with methotrexate were 2.5 times (95% CI: 0.6, 9.8; P=0.20) the odds with mycophenolate mofetil, a difference which was not statistically significant. The average improvement in visual acuity was 12.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. On average, visual acuity for patients with acute VKH improved by 14 more ETDRS letters than those with chronic VKH (P<0.001), but there was no difference in corticosteroid-sparing control of inflammation (P=0.99). All 26 eyes with a serous retinal detachment at baseline resolved, and 88% achieved corticosteroid-sparing control of inflammation. Conclusions The majority of patients treated with antimetabolites and corticosteroids were able to achieve corticosteroid-sparing control of inflammation by 6 months. Although patients with acute VKH gained more visual improvement than those with chronic VKH, this did not correspond with a higher rate of controlled inflammation. PMID

Predicting outcomes following cognitive behaviour therapy in child anxiety disorders: the influence of genetic, demographic and clinical information

OpenAIRE

Hudson, Jennifer L; Lester, Kathryn J; Lewis, Cathryn M; Tropeano, Maria; Creswell, Cathy; Collier, David A; Cooper, Peter; Lyneham, Heidi J; Morris, Talia; Rapee, Ronald M; Roberts, Susanna; Donald, Jennifer A; Eley, Thalia C

2013-01-01

Background. Within a therapeutic gene by environment (GxE) framework, we recently demonstrated that variation in \\ud the Serotonin Transporter Promoter Polymorphism; 5HTTLPR and marker rs6330 in Nerve Growth Factor gene; NGF is \\ud associated with poorer outcomes following cognitive behaviour therapy (CBT) for child anxiety disorders. The aim of this \\ud study was to explore one potential means of extending the translational reach of G×E data in a way that may be clinically \\ud informative. W...

Discontinuing VEGF-targeted Therapy for Progression Versus Toxicity Affects Outcomes of Second-line Therapies in Metastatic Renal Cell Carcinoma

DEFF Research Database (Denmark)

De Velasco, Guillermo; Xie, Wanling; Donskov, Frede

2017-01-01

BACKGROUND: A significant subgroup of metastatic renal cell carcinoma (mRCC) patients discontinue vascular endothelial growth factor-targeted therapies (VEGF-TT) because of toxicity. Whether clinical outcomes differ in patients who receive second-line (2L) targeted therapy on the basis of reason ...

78 FR 24750 - Scientific Information Request Therapies for Clinically Localized Prostate Cancer

Science.gov (United States)

2013-04-26

...) approaches. b. External Beam Radiotherapy, including standard therapy and therapies designed to decrease..., learning curve)? Key Question 4 How do tumor characteristics (e.g., Gleason score, tumor volume, screen-detected vs. clinically detected tumors, and PSA levels) affect the outcomes of these therapies overall and...

Persistent systemic inflammation is associated with poor clinical outcomes in COPD

DEFF Research Database (Denmark)

Agustí, Alvar; Edwards, Lisa D; Rennard, Stephen I

2012-01-01

Because chronic obstructive pulmonary disease (COPD) is a heterogeneous condition, the identification of specific clinical phenotypes is key to developing more effective therapies. To explore if the persistence of systemic inflammation is associated with poor clinical outcomes in COPD we assessed...

Common Factor Mechanisms in Clinical Practice and Their Relationship with Outcome.

Science.gov (United States)

Gaitan-Sierra, Carolina; Hyland, Michael E

2015-01-01

This study investigates three common factor mechanisms that could affect outcome in clinical practice: response expectancy, the affective expectation model and motivational concordance. Clients attending a gestalt therapy clinic (30 clients), a sophrology (therapeutic technique) clinic (33 clients) and a homeopathy clinic (31 clients) completed measures of expectancy and the Positive Affect and Negative Affect Schedule (PANAS) before their first session. After 1 month, they completed PANAS and measures of intrinsic motivation, perceived effort and empowerment. Expectancy was not associated with better outcome and was no different between treatments. Although some of the 54 clients who endorsed highest expectations showed substantial improvement, others did not: 19 had no change or deteriorated in positive affect, and 18 had the same result for negative affect. Intrinsic motivation independently predicted changes in negative affect (β = -0.23). Intrinsic motivation (β = 0.24), effort (β = 0.23) and empowerment (β = 0.20) independently predicted positive affect change. Expectancy (β = -0.17) negatively affected changes in positive affect. Clients found gestalt and sophrology to be more intrinsically motivating, empowering and effortful compared with homeopathy. Greater improvement in mood was found for sophrology and gestalt than for homeopathy clients. These findings are inconsistent with response expectancy as a common factor mechanism in clinical practice. The results support motivational concordance (outcome influenced by the intrinsic enjoyment of the therapy) and the affective expectation model (high expectations can lead for some clients to worse outcome). When expectancy correlates with outcome in some other studies, this may be due to confound between expectancy and intrinsic enjoyment. Common factors play an important role in outcome. Intrinsic enjoyment of a therapeutic treatment is associated with better outcome. Active engagement with a

Rational emotive behavior therapy, cognitive therapy, and medication in the treatment of major depressive disorder: a randomized clinical trial, posttreatment outcomes, and six-month follow-up.

Science.gov (United States)

David, Daniel; Szentagotai, Aurora; Lupu, Viorel; Cosman, Doina

2008-06-01

A randomized clinical trial was undertaken to investigate the relative efficacy of rational-emotive behavior therapy (REBT), cognitive therapy (CT), and pharmacotherapy in the treatment of 170 outpatients with nonpsychotic major depressive disorder. The patients were randomly assigned to one of the following: 14 weeks of REBT, 14 weeks of CT, or 14 weeks of pharmacotherapy (fluoxetine). The outcome measures used were the Hamilton Rating Scale for Depression and the Beck Depression Inventory. No differences among treatment conditions at posttest were observed. A larger effect of REBT (significant) and CT (nonsignificant) over pharmacotherapy at 6 months follow-up was noted on the Hamilton Rating Scale for Depression only. (c) 2008 Wiley Periodicals, Inc.

Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

Science.gov (United States)

Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

2015-09-01

An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

The NordiNet® International Outcome Study and NovoNet® ANSWER Program®: rationale, design, and methodology of two international pharmacoepidemiological registry-based studies monitoring long-term clinical and safety outcomes of growth hormone therapy (Norditropin®).

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Höybye, Charlotte; Sävendahl, Lars; Christesen, Henrik Thybo; Lee, Peter; Pedersen, Birgitte Tønnes; Schlumpf, Michael; Germak, John; Ross, Judith

2013-01-01

Randomized controlled trials have shown that growth hormone (GH) therapy has effects on growth, metabolism, and body composition. GH therapy is prescribed for children with growth failure and adults with GH deficiency. Carefully conducted observational study of GH treatment affords the opportunity to assess long-term treatment outcomes and the clinical factors and variables affecting those outcomes, in patients receiving GH therapy in routine clinical practice. The NordiNet® International Outcome Study (IOS) and the American Norditropin® Web Enabled Research (ANSWER Program®) are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepidemiological data. The studies include pediatric and adult patients receiving Norditropin®, as prescribed by their physicians. The studies gather long-term data on the safety and effectiveness of reallife treatment with the recombinant human GH, Norditropin®. We describe the origins, aims, objectives, and design methodology of the studies, as well as their governance and validity, strengths, and limitations. The NordiNet® IOS and ANSWER Program® studies will provide valid insights into the effectiveness and safety of GH treatment across a diverse and large patient population treated in accordance with real-world clinical practice and following the Good Pharmacoepidemiological Practice and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines.

Cell therapy for intervertebral disc repair: advancing cell therapy from bench to clinics

Directory of Open Access Journals (Sweden)

LM Benneker

2014-05-01

Full Text Available Intervertebral disc (IVD degeneration is a major cause of pain and disability; yet therapeutic options are limited and treatment often remains unsatisfactory. In recent years, research activities have intensified in tissue engineering and regenerative medicine, and pre-clinical studies have demonstrated encouraging results. Nonetheless, the translation of new biological therapies into clinical practice faces substantial barriers. During the symposium "Where Science meets Clinics", sponsored by the AO Foundation and held in Davos, Switzerland, from September 5-7, 2013, hurdles for translation were outlined, and ways to overcome them were discussed. With respect to cell therapy for IVD repair, it is obvious that regenerative treatment is indicated at early stages of disc degeneration, before structural changes have occurred. It is envisaged that in the near future, screening techniques and non-invasive imaging methods will be available to detect early degenerative changes. The promises of cell therapy include a sustained effect on matrix synthesis, inflammation control, and prevention of angio- and neuro-genesis. Discogenic pain, originating from "black discs" or annular injury, prevention of adjacent segment disease, and prevention of post-discectomy syndrome were identified as prospective indications for cell therapy. Before such therapy can safely and effectively be introduced into clinics, the identification of the patient population and proper standardisation of diagnostic parameters and outcome measurements are indispensable. Furthermore, open questions regarding the optimal cell type and delivery method need to be resolved in order to overcome the safety concerns implied with certain procedures. Finally, appropriate large animal models and well-designed clinical studies will be required, particularly addressing safety aspects.

Long-term outcome of patients with chronic pancreatitis treated with micronutrient antioxidant therapy.

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Rupasinghe, Sukitha Namal; Siriwardena, Ajith K

2017-04-01

Micronutrient antioxidant therapy did not relieve pain in a European randomized trial of patients with chronic pancreatitis without malnutrition. However, intervention was undertaken only for 6 months leaving unanswered the question of whether long-term antioxidant therapy may modulate chronic pancreatitis. The aim of this study is to assess the outcome of long-term use of micronutrient antioxidant therapy in patients with chronic pancreatitis. This is a single center clinical cohort report of patients with chronic pancreatitis prescribed micronutrient antioxidant therapy and followed for up to 10 years. Data were collected on demographic detail, clinic pain assessment, insulin requirements, interventions and outcome. A group of 30 patients with a diagnosis of chronic pancreatitis constitute the study population. Median age at time of diagnosis was 40 years (range 14-66); 19 (63%) were male and the median duration of symptoms was 2 years (range 0-18). Alcohol was the dominant cause in 22 (73%) patients and 16 (53%) patients were Cambridge stage 1. Twenty-four (80%) patients had pain at presentation. During antioxidant treatment of 4 years (range 1-10), pain decreased but the proportion with abdominal pain compared to those who were pain-free remained constant (P=0.16; two-way ANOVA with Bonferroni correction). There was a significant increase in requirement for insulin (P=0.028) with time together with use of both endoscopic and surgical interventions. This is the first study to report long-term disease-specific outcome in patients with chronic pancreatitis prescribed micronutrient antioxidant therapy. There appears to be no effect of intervention on outcome.

Dialectical behavior therapy compared with general psychiatric management for borderline personality disorder: clinical outcomes and functioning over a 2-year follow-up.

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McMain, Shelley F; Guimond, Tim; Streiner, David L; Cardish, Robert J; Links, Paul S

2012-06-01

The authors conducted a 2-year prospective naturalistic follow-up study to evaluate posttreatment clinical outcomes in outpatients who were randomly selected to receive 1 year of either dialectical behavior therapy or general psychiatric management for borderline personality disorder. Patients were assessed by blind raters 6, 12, 18, and 24 months after treatment. The clinical effectiveness of treatment was assessed on measures of suicidal and nonsuicidal self-injurious behaviors, health care utilization, general symptom distress, depression, anger, quality of life, social adjustment, borderline psychopathology, and diagnostic status. The authors conducted between-group comparisons using generalized estimating equation, mixed-effects models, or chi-square statistics, depending on the distribution and nature of the data. Both treatment groups showed similar and statistically significant improvements on the majority of outcomes 2 years after discharge. The original effects of treatment did not diminish for any outcome domain, including suicidal and nonsuicidal self-injurious behaviors. Further improvements were seen on measures of depression, interpersonal functioning, and anger. However, even though two-thirds of the participants achieved diagnostic remission and significant increases in quality of life, 53% were neither employed nor in school, and 39% were receiving psychiatric disability support after 36 months. One year of either dialectical behavior therapy or general psychiatric management was associated with long-lasting positive effects across a broad range of outcomes. Despite the benefits of these specific treatments, one important finding that replicates previous research is that participants continued to exhibit high levels of functional impairment. The effectiveness of adjunctive rehabilitation strategies to improve general functioning deserves additional study.

Physiotherapy and Occupational Therapy vs No Therapy in Mild to Moderate Parkinson Disease: A Randomized Clinical Trial.

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Clarke, Carl E; Patel, Smitaa; Ives, Natalie; Rick, Caroline E; Dowling, Francis; Woolley, Rebecca; Wheatley, Keith; Walker, Marion F; Sackley, Catherine M

2016-03-01

It is unclear whether physiotherapy and occupational therapy are clinically effective and cost-effective in Parkinson disease (PD). To perform a large pragmatic randomized clinical trial to evaluate the clinical effectiveness of individualized physiotherapy and occupational therapy in PD. The PD REHAB Trial was a multicenter, open-label, parallel group, controlled efficacy trial. A total of 762 patients with mild to moderate PD were recruited from 38 sites across the United Kingdom. Recruitment took place between October 2009 and June 2012, with 15 months of follow-up. Participants with limitations in activities of daily living (ADL) were randomized to physiotherapy and occupational therapy or no therapy. The primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) Scale score at 3 months after randomization. Secondary outcomes were health-related quality of life (assessed by Parkinson Disease Questionnaire-39 and EuroQol-5D); adverse events; and caregiver quality of life. Outcomes were assessed before trial entry and then 3, 9, and 15 months after randomization. Of the 762 patients included in the study (mean [SD] age, 70 [9.1] years), 381 received physiotherapy and occupational therapy and 381 received no therapy. At 3 months, there was no difference between groups in NEADL total score (difference, 0.5 points; 95% CI, -0.7 to 1.7; P = .41) or Parkinson Disease Questionnaire-39 summary index (0.007 points; 95% CI, -1.5 to 1.5; P = .99). The EuroQol-5D quotient was of borderline significance in favor of therapy (-0.03; 95% CI, -0.07 to -0.002; P = .04). The median therapist contact time was 4 visits of 58 minutes over 8 weeks. Repeated-measures analysis showed no difference in NEADL total score, but Parkinson Disease Questionnaire-39 summary index (diverging 1.6 points per annum; 95% CI, 0.47 to 2.62; P = .005) and EuroQol-5D score (0.02; 95% CI, 0.00007 to 0.03; P = .04) showed small differences in favor of therapy. There was no difference in

A Comparison of Learning Outcomes in Cognitive Behavioural Therapy and Existential Therapy

DEFF Research Database (Denmark)

Sørensen, Anders Dræby

of the outcome of psychotherapy through qualitative research. The precise aim is to draw attention to the special characteristics of this outcome in terms of learning outcome. This regards both existential therapy and cognitive behavioural therapy and to clarify the possible differences and similarities between...... the lived experience of the learning outcomes of these approaches. The study also clarifies the differences between existential psychotherapy as an art of learning directed at existential learning of authenticity and cognitive- behavioural therapy as a learning-based medical treatment technology directed...... at behavioural and cognitive learning of adaptive and functional responses that alleviates pathological symptoms....

Photodynamic therapy in the management of actinic keratosis: Retrospective evaluation of outcome.

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Jerjes, Waseem; Hamdoon, Zaid; Abdulkareem, Ali A; Hopper, Colin

2017-03-01

Photodynamic therapy (PDT) is a minimally invasive intervention used in the management of tissue disorders. In this retrospective study, a total of 62 patients with actinic keratosis (AKs) were treated with surface illumination PDT. Comparisons with the clinical features, rate of recurrence as well as malignant transformation and overall outcome were made. The medical records of 62 consecutive patients who presented with suspicious skin lesions and diagnosed with AKs were examined. These patients with 178 AKs lesions were treated with surface illumination methyl aminolevulinate-photodynamic therapy (MAL-PDT). The 16% strength cream (MAL) was applied topically 3h prior to tissue illumination. A single-channel 628nm diode laser was used for illumination and light was delivered at 100J/cm 2 per site. These patients were followed-up for a mean of 7.4 years. Eight recurrences were reported after the first round of MAL-PDT, and two recurrences after the second round. Malignant transformation to squamous cell carcinoma (SCC) was noted in 2 patients only. The 3-year outcome resulted in 60 patients with complete response (CR), and this was maintained at the final outcome (last clinic review). Assessment of lesional outcome vs. response showed that 175/178 treated lesions had complete response (CR) at 3-year follow-up, which increased to 176/178 lesions at the last clinic follow-up. MAL-PDT offers an effective treatment for AKs lesions with excellent cosmetic outcome. Copyright © 2016 Elsevier B.V. All rights reserved.

Perinatal Outcomes with Tamsulosin Therapy for Symptomatic Urolithiasis.

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Bailey, George; Vaughan, Lisa; Rose, Carl; Krambeck, Amy

2016-01-01

Medical expulsive therapy represents an effective adjunctive treatment for nonpregnant patients with symptomatic urolithiasis. Tamsulosin is classified by the FDA (Food and Drug Administration) as a category B medication. However, to our knowledge no published data exist for human pregnancy. We explored the safety and efficacy of tamsulosin therapy for symptomatic urolithiasis occurring during pregnancy. We retrospectively identified patients treated with tamsulosin for stone disease during pregnancy at the Mayo Clinic during 2000 to 2014. This medical expulsive therapy cohort was matched 2:1 to pregnant women with symptomatic urolithiasis during pregnancy who did not receive medical expulsive therapy. Groups were compared using linear mixed models for continuous variables and exact conditional logistic regression models for nominal variables to take into account correlation due to matching. A total of 27 patients receiving medical expulsive therapy comprised the study cohort. Median duration of antepartum tamsulosin exposure was 3 days (range 1 to 110), occurring during the first, second and third trimester in 3 (11%), 11 (40.7%) and 18 (67%) patients, respectively. Mean gestational age at delivery was 38.1 weeks (SD 2.4) and 6 (22%) infants were born preterm. All infant birthweights were considered appropriate for gestational age, and no cases of spontaneous abortion, intrauterine demise or neonatal congenital anomalies were encountered. Comparison between the medical expulsive therapy and control groups demonstrated no significant differences in maternal or infant outcomes for any of the examined variables. Tamsulosin medical expulsive therapy does not appear to be associated with adverse maternal or fetal outcomes and may be considered as adjunctive therapy for urolithiasis during pregnancy. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Assessments in outcome evaluation in aphasia therapy

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Isaksen, Jytte; Brouwer, Catherine E.

2015-01-01

Abstract Outcomes of aphasia therapy in Denmark are documented in evaluation sessions in which both the person with aphasia and the speech-language therapist take part. The participants negotiate agreements on the results of therapy. By means of conversation analysis, we study how such agreements...... on therapy outcome are reached interactionally. The sequential analysis of 34 video recordings focuses on a recurrent method for reaching agreements in these outcome evaluation sessions. In and through a special sequence of conversational assessment it is claimed that the person with aphasia has certain...

Long-Term Clinical Outcomes of Subcutaneous Versus Transvenous Implantable Defibrillator Therapy

NARCIS (Netherlands)

Brouwer, Tom F.; Yilmaz, Dilek; Lindeboom, Robert; Buiten, Maurits S.; Olde Nordkamp, Louise R. A.; Schalij, Martin J.; Wilde, Arthur A.; van Erven, Lieselot; Knops, Reinoud E.

2016-01-01

Transvenous implantable cardioverter-defibrillators (TV-ICDs) improve survival in patients at risk for sudden cardiac death, but complications remain an important drawback. The subcutaneous ICD (S-ICD) was developed to overcome lead-related complications. Comparison of clinical outcomes of both

Endoscopic therapy for chronic pancreatitis: technical success, clinical outcomes, and complications.

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Kowalczyk, Lukasz M; Draganov, Peter V

2009-04-01

Chronic pancreatitis (CP) can cause failure of both the exocrine and endocrine portions of the gland. Pain is the most recalcitrant clinical complaint in CP. Generally, conservative measures are first attempted to manage pain. These include cessation of alcohol use and smoking, enzyme replacement therapy, and finally, opioid analgesia. Endoscopy can be employed to treat the pain and complications due to CP. The results of the only two prospective randomized controlled trials suggest that surgery has a more durable effect than endoscopic therapy in controlling pain. Both trials suffer from severe limitations, however, and endoscopy remains the preferred approach for many patients because of its minimally invasive nature. Endoscopic ultrasound celiac plexus block has limited value in helping to control pain. More randomized trials are needed, along with further technologic innovation to improve the current treatment modalities. When considering interventional therapy for a patient with CP, a tailored and multidisciplinary therapeutic approach should be taken.

Clinical Features and Outcome of Mucormycosis

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Carlos Rodrigo Camara-Lemarroy

2014-01-01

Full Text Available Mucormycosis (MCM is a life-threatening infection that carries high mortality rates despite recent advances in its diagnosis and treatment. The objective was to report 14 cases of mucormycosis infection and review the relevant literature. We retrospectively analyzed the demographic and clinical data of 14 consecutive patients that presented with MCM in a tertiary-care teaching hospital in northern Mexico. The mean age of the patients was 39.9 (range 5–65. Nine of the patients were male. Ten patients had diabetes mellitus as the underlying disease, and 6 patients had a hematological malignancy (acute leukemia. Of the diabetic patients, 3 had chronic renal failure and 4 presented with diabetic ketoacidosis. All patients had rhinocerebral involvement. In-hospital mortality was 50%. All patients received medical therapy with polyene antifungals and 11 patients underwent surgical therapy. Survivors were significantly younger and less likely to have diabetes than nonsurvivors, and had higher levels of serum albumin on admission. The clinical outcome of patients with MCM is poor. Uncontrolled diabetes and age are negative prognostic factors.

Clinical Features and Outcomes of 666 Cases with Therapy-Related Myelodysplastic Syndrome (t-MDS).

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El-Fattah, Mohamed Abd

2018-01-01

Therapy-related myelodysplastic syndrome (t-MDS) is a serious complication of chemoradiotherapy for primary diseases. This cohort was aimed to determine the clinical features and outcomes of t-MDS in comparison with de novo MDS. I retrieved data of 666 cases with t-MDS, and 29,703 cases with de novo MDS diagnosed between 2001 and 2012 from the database of U.S. National Cancer Institute. Survival curves were estimated, and Cox proportional hazards model was constructed. Compared with patients with de novo MDS, patients with t-MDS tended to be young (median age; 65 vs. 76 years, p  MDS than de novo MDS (17.2 months and 22% vs. 31 months and 32%, respectively, p  MDS cases, with a median follow-up of 16 months (range 1-143 months), 521 cases (78.2%) had died. Of which, 78 (15%) cases had died from acute myeloid leukemia, and 66 (12.7%) cases had died from solid cancers. Of the total 66 cases died from solid cancers; 19 cases (28.8%) died from cancer of lung/bronchus, 11 cases (16.7%) breast cancers, and 10 cases (15.2%) ovarian cancer. In a multivariate analysis adjusted for clinical features, calendar period and radiotherapy, the hazard of mortality was significantly low in de novo MDS compared with t-MDS (hazard ratio 0.59; p  MDS is a distinct entity of MDS in terms of clinical characteristics and prognosis.

Spot Scanning Proton Therapy for Malignancies of the Base of Skull: Treatment Planning, Acute Toxicities, and Preliminary Clinical Outcomes

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Grosshans, David R., E-mail: dgrossha@mdanderson.org [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Zhu, X. Ronald; Melancon, Adam [Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Allen, Pamela K. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Poenisch, Falk; Palmer, Matthew [Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); McAleer, Mary Frances; McGovern, Susan L. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Gillin, Michael [Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); DeMonte, Franco [Department of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Chang, Eric L. [Department of Radiation Oncology, University of Southern California Keck School of Medicine, Los Angeles, California (United States); Brown, Paul D.; Mahajan, Anita [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

2014-11-01

Purpose: To describe treatment planning techniques and early clinical outcomes in patients treated with spot scanning proton therapy for chordoma or chondrosarcoma of the skull base. Methods and Materials: From June 2010 through August 2011, 15 patients were treated with spot scanning proton therapy for chordoma (n=10) or chondrosarcoma (n=5) at a single institution. Toxicity was prospectively evaluated and scored weekly and at all follow-up visits according to Common Terminology Criteria for Adverse Events, version 3.0. Treatment planning techniques and dosimetric data were recorded and compared with those of passive scattering plans created with clinically applicable dose constraints. Results: Ten patients were treated with single-field-optimized scanning beam plans and 5 with multifield-optimized intensity modulated proton therapy. All but 2 patients received a simultaneous integrated boost as well. The mean prescribed radiation doses were 69.8 Gy (relative biological effectiveness [RBE]; range, 68-70 Gy [RBE]) for chordoma and 68.4 Gy (RBE) (range, 66-70) for chondrosarcoma. In comparison with passive scattering plans, spot scanning plans demonstrated improved high-dose conformality and sparing of temporal lobes and brainstem. Clinically, the most common acute toxicities included fatigue (grade 2 for 2 patients, grade 1 for 8 patients) and nausea (grade 2 for 2 patients, grade 1 for 6 patients). No toxicities of grades 3 to 5 were recorded. At a median follow-up time of 27 months (range, 13-42 months), 1 patient had experienced local recurrence and a second developed distant metastatic disease. Two patients had magnetic resonance imaging-documented temporal lobe changes, and a third patient developed facial numbness. No other subacute or late effects were recorded. Conclusions: In comparison to passive scattering, treatment plans for spot scanning proton therapy displayed improved high-dose conformality. Clinically, the treatment was well tolerated, and

A simple point of care test can indicate the need for periodontal therapy to reduce the risk for adverse pregnancy outcomes in mothers attending antenatal clinics.

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Turton, Mervyn Sydney; Henkel, Ralf Reinhold; Africa, Charlene Wilma Joyce

2017-12-01

Although the association between periodontal disease (PD) and adverse pregnancy outcomes has gained recognition amongst antenatal healthcare workers, not much has changed in practice to address it. This prospective study tested the hypothesis that BANA (N-benzoyl-DL-arginine-2-naphthylamide), a diagnostic test for PD, may inform obstetricians and other antenatal healthcare practitioners, of the risk of adverse pregnancy outcomes in mothers attending antenatal clinics. At first visit, the presence of suspected periodontopathogens was assessed by BANA testing of dental plaque from 443 mothers attending antenatal clinics in KwaZulu-Natal, South Africa and an association later sought with pregnancy outcomes. The accuracy of BANA to predict adverse pregnancy outcomes was evaluated by the calculation of likelihood ratios. The study complied with the Declaration of Helsinki. Significant differences were found between pregnancy outcomes of BANA-negative and BANA-positive mothers (p periodontal therapy to reduce the risk of adverse pregnancy outcomes and could form part of the routine antenatal examination.

TIAM1 variants improve clinical outcome in neuroblastoma.

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Sanmartín, Elena; Yáñez, Yania; Fornés-Ferrer, Victoria; Zugaza, José L; Cañete, Adela; Castel, Victoria; Font de Mora, Jaime

2017-07-11

Identification of tumor driver mutations is crucial for improving clinical outcome using a personalized approach to the treatment of cancer. Neuroblastoma is a tumor of the peripheral sympathetic nervous system for which only a few driver alterations have been described including MYCN amplification and ALK mutations. We assessed 106 primary neuroblastoma tumors by next generation sequencing using a customized amplicon-based gene panel. Our results reveal that genetic variants in TIAM1 gene associate with better clinical outcome, suggesting a role for these TIAM1 variants in preventing progression of this disease. The detected variants are located within the different domains of TIAM1 that signal to the upstream regulator RAS and downstream effector molecules MYC and RAC, which are all implicated in neuroblastoma etiology and progression. Clinical outcome was improved in tumors where a TIAM1 variant was present concomitantly with either ALK mutation or MYCN amplification. Given the function of these signaling molecules in cell survival, proliferation, differentiation and neurite outgrowth, our data suggest that the TIAM1-mediated network is essential to neuroblastoma and thus, inhibiting TIAM1 reflects a rational strategy for improving therapy efficacy in neuroblastoma.

Clinical outcomes and nadir prostate-specific antigen (PSA) according to initial PSA levels in primary androgen deprivation therapy for metastatic prostate cancer.

Science.gov (United States)

Kitagawa, Yasuhide; Ueno, Satoru; Izumi, Kouji; Kadono, Yoshifumi; Mizokami, Atsushi; Hinotsu, Shiro; Akaza, Hideyuki; Namiki, Mikio

2016-03-01

To investigate the clinical outcomes of metastatic prostate cancer patients and the relationship between nadir prostate-specific antigen (PSA) levels and different types of primary androgen deprivation therapy (PADT). This study utilized data from the Japan Study Group of Prostate Cancer registry, which is a large, multicenter, population-based database. A total of 2982 patients treated with PADT were enrolled. Kaplan-Meier analysis was used to compare progression-free survival (PFS) and overall survival (OS) in patients treated using combined androgen blockade (CAB) and non-CAB therapies. The relationships between nadir PSA levels and PADT type according to initial serum PSA levels were also investigated. Among the 2982 enrolled patients, 2101 (70.5 %) were treated with CAB. Although CAB-treated patients had worse clinical characteristics, their probability of PFS and OS was higher compared with those treated with a non-CAB therapy. These results were due to a survival benefit with CAB in patients with an initial PSA level of 500-1000 ng/mL. Nadir PSA levels were significantly lower in CAB patients than in non-CAB patients with comparable initial serum PSA levels. A small survival benefit for CAB in metastatic prostate cancer was demonstrated in a Japanese large-scale prospective cohort study. The clinical significance of nadir PSA levels following PADT was evident, but the predictive impact of PSA nadir on OS was different between CAB and non-CAB therapy.

Bridge Therapy Outcomes in Patients With Mechanical Heart Valves.

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Delate, Thomas; Meisinger, Stephanie M; Witt, Daniel M; Jenkins, Daniel; Douketis, James D; Clark, Nathan P

2017-11-01

Bridge therapy is associated with an increased risk of major bleeding in patients with atrial fibrillation and venous thromboembolism (TE) without a corresponding reduction in TE. The benefits of bridge therapy in patients with mechanical heart valve (MHV) prostheses interrupting warfarin for invasive procedures are not well described. A retrospective cohort study was conducted at an integrated health-care delivery system. Anticoagulated patients with MHV interrupting warfarin for invasive diagnostic or surgical procedures between January 1, 2006, and March 31, 2012, were identified. Patients were categorized according to exposure to bridge therapy during the periprocedural period and TE risk (low, medium, and high). Outcomes validated via manual chart review included clinically relevant bleeding, TE, and all-cause mortality in the 30 days following the procedure. There were 547 procedures in 355 patients meeting inclusion criteria. Mean cohort age was 65.2 years, and 38% were female. Bridge therapy was utilized in 466 (85.2%) procedures (95.2%, 77.3%, and 65.8% of high, medium, and low TE risk category procedures, respectively). The 30-day rate of clinically relevant bleeding was numerically higher in bridged (5.8%; 95% confidence interval [CI], 3.9%-8.3%) versus not bridged procedures (1.2%; 95% CI, bridge therapy is common among patients with MHV and may be associated with increased bleeding risk. Further research is needed to determine whether bridge therapy reduces TE in patients with MHV interrupting warfarin for invasive procedures.

Associations between HIV-RNA-based indicators and virological and clinical outcomes

DEFF Research Database (Denmark)

Laut, Kamilla G; Shepherd, Leah C; Pedersen, Court

2016-01-01

OBJECTIVES: To evaluate and compare the performance of six HIV-RNA-based quality of care indicators for predicting short-term and long-term outcomes. DESIGN: Multinational cohort study. METHODS: We included EuroSIDA patients on antiretroviral therapy (ART) with at least three viral load measureme......OBJECTIVES: To evaluate and compare the performance of six HIV-RNA-based quality of care indicators for predicting short-term and long-term outcomes. DESIGN: Multinational cohort study. METHODS: We included EuroSIDA patients on antiretroviral therapy (ART) with at least three viral load...... measurements after baseline (the latest of 01/01/2001 or entry into EuroSIDA). Using multivariate Poisson regression, we modelled the association between short-term (resistance, triple-class failure) and long-term (all-cause mortality, any AIDS/non-AIDS clinical event) outcomes and the indicators: viraemia...

Clinical Studies of Biofield Therapies: Summary, Methodological Challenges, and Recommendations

Science.gov (United States)

Hammerschlag, Richard; Mills, Paul; Cohen, Lorenzo; Krieger, Richard; Vieten, Cassandra; Lutgendorf, Susan

2015-01-01

Biofield therapies are noninvasive therapies in which the practitioner explicitly works with a client's biofield (interacting fields of energy and information that surround living systems) to stimulate healing responses in patients. While the practice of biofield therapies has existed in Eastern and Western cultures for thousands of years, empirical research on the effectiveness of biofield therapies is still relatively nascent. In this article, we provide a summary of the state of the evidence for biofield therapies for a number of different clinical conditions. We note specific methodological issues for research in biofield therapies that need to be addressed (including practitioner-based, outcomes-based, and research design considerations), as well as provide a list of suggested next steps for biofield researchers to consider. PMID:26665043

Manual Therapy and Exercise to Improve Outcomes in Patients With Muscle Tension Dysphonia: A Case Series

Science.gov (United States)

Archer, Kristin R.

2015-01-01

Background and Purpose Muscle tension dysphonia (MTD), a common voice disorder that is not commonly referred for physical therapy intervention, is characterized by excessive muscle recruitment, resulting in incorrect vibratory patterns of vocal folds and an alteration in voice production. This case series was conducted to determine whether physical therapy including manual therapy, exercise, and stress management education would be beneficial to this population by reducing excess muscle tension. Case Description Nine patients with MTD completed a minimum of 9 sessions of the intervention. Patient-reported outcomes of pain, function, and quality of life were assessed at baseline and the conclusion of treatment. The outcome measures were the numeric rating scale (NRS), Patient-Specific Functional Scale (PSFS), and Voice Handicap Index (VHI). Cervical and jaw range of motion also were assessed at baseline and postintervention using standard goniometric measurements. Outcomes Eight of the patients had no pain after treatment. All 9 of the patients demonstrated an improvement in PSFS score, with 7 patients exceeding a clinically meaningful improvement at the conclusion of the intervention. Three of the patients also had a clinically meaningful change in VHI scores. All 9 of the patients demonstrated improvement in cervical flexion and lateral flexion and jaw opening, whereas 8 patients improved in cervical extension and rotation postintervention. Discussion The findings suggest that physical therapists can feasibly implement an intervention to improve outcomes in patients with MTD. However, a randomized clinical trial is needed to confirm the results of this case series and the efficacy of the intervention. A clinical implication is the expansion of physical therapy to include referrals from voice centers for the treatment of MTD. PMID:25256740

Magnetic resonance imaging of injuries to the ankle joint: can it predict clinical outcome?

Science.gov (United States)

Zanetti, M; De Simoni, C; Wetz, H H; Zollinger, H; Hodler, J

1997-02-01

To predict clinical outcome after ankle sprains on the basis of magnetic resonance (MR) findings. Twenty-nine consecutive patients (mean age 32.9 years, range 13-60 years) were examined clinically and with MR imaging both after trauma and following standardized conservative therapy. Various MR abnormalities were related to a clinical outcome score. There was a tendency for a better clinical outcome in partial, rather than complete, tears of the anterior talofibular ligament and when there was no fluid within the peroneal tendon sheath at the initial MR examination (P = 0.092 for either abnormality). A number of other MR features did not significantly influence clinical outcome, including the presence of a calcaneofibular ligament lesion and a bone bruise of the talar dome. Clinical outcome after ankle sprain cannot consistently be predicted by MR imaging, although MR imaging may be more accurate when the anterior talofibular ligament is only partially torn and there are no signs of injury to the peroneal tendon sheath.

Collateral flow as causative of good outcomes in endovascular stroke therapy.

Science.gov (United States)

Sheth, Sunil A; Sanossian, Nerses; Hao, Qing; Starkman, Sidney; Ali, Latisha K; Kim, Doojin; Gonzalez, Nestor R; Tateshima, Satoshi; Jahan, Reza; Duckwiler, Gary R; Saver, Jeffrey L; Vinuela, Fernando; Liebeskind, David S

2016-01-01

Endovascular reperfusion techniques are a promising intervention for acute ischemic stroke (AIS). Prior studies have identified markers of initial injury (arrival NIH stroke scale (NIHSS) or infarct volume) as predictive of outcome after these procedures. We sought to define the role of collateral flow at the time of presentation in determining the extent of initial ischemic injury and its influence on final outcome. Demographic, clinical, laboratory, and radiographic data were prospectively collected on a consecutive cohort of patients who received endovascular therapy for acute cerebral ischemia at a single tertiary referral center from September 2004 to August 2010. Higher collateral grade as assessed by the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) grading scheme on angiography at the time of presentation was associated with improved reperfusion rates after endovascular intervention, decreased post-procedural hemorrhage, smaller infarcts on presentation and discharge, as well as improved neurological function on arrival to the hospital, discharge, and 90 days later. Patients matched by vessel occlusion, age, and time of onset demonstrated smaller strokes on presentation and better functional and radiographic outcome if found to have superior collateral flow. In multivariate analysis, lower collateral grade independently predicted higher NIHSS on arrival. Improved collateral flow in patients with AIS undergoing endovascular therapy was associated with improved radiographic and clinical outcomes. Independent of age, vessel occlusion and time, in patients with comparable ischemic burdens, changes in collateral grade alone led to significant differences in initial stroke severity as well as ultimate clinical outcome. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Outpatient rehabilitation care process factors and clinical outcomes among patients discharged home following unilateral total knee arthroplasty.

Science.gov (United States)

Brennan, Gerard P; Fritz, Julie M; Houck, L T C Kevin M; Hunter, Stephen J

2015-05-01

Research examining care process variables and their relationship to clinical outcomes after total knee arthroplasty has focused primarily on inpatient variables. Care process factors related to outpatient rehabilitation have not been adequately examined. We conducted a retrospective review of 321 patients evaluating outpatient care process variables including use of continuous passive motion, home health physical therapy, number of days from inpatient discharge to beginning outpatient physical therapy, and aspects of outpatient physical therapy (number of visits, length of stay) as possible predictors of pain and disability outcomes of outpatient physical therapy. Only the number of days between inpatient discharge and outpatient physical therapy predicted better outcomes, suggesting that this may be a target for improving outcomes after total knee arthroplasty for patients discharged directly home. Copyright © 2014 Elsevier Inc. All rights reserved.

Outcomes of physical therapy, speech pathology, and occupational therapy for people with motor neuron disease: a systematic review.

Science.gov (United States)

Morris, Meg E; Perry, Alison; Bilney, Belinda; Curran, Andrea; Dodd, Karen; Wittwer, Joanne E; Dalton, Gregory W

2006-09-01

This article describes a systematic review and critical evaluation of the international literature on the effects of physical therapy, speech pathology, and occupational therapy for people with motor neuron disease (PwMND). The results were interpreted using the framework of the International Classification of Functioning, Disability and Health. This enabled us to summarize therapy outcomes at the level of body structure and function, activity limitations, participation restrictions, and quality of life. Databases searched included MEDLINE, PUBMED, CINAHL, PSYCInfo, Data base of Abstracts of Reviews of Effectiveness (DARE), The Physiotherapy Evidence data base (PEDro), Evidence Based Medicine Reviews (EMBASE), the Cochrane database of systematic reviews, and the Cochrane Controlled Trials Register. Evidence was graded according to the Harbour and Miller classification. Most of the evidence was found to be at the level of "clinical opinion" rather than of controlled clinical trials. Several nonrandomized small group and "observational studies" provided low-level evidence to support physical therapy for improving muscle strength and pulmonary function. There was also some evidence to support the effectiveness of speech pathology interventions for dysarthria. The search identified a small number of studies on occupational therapy for PwMND, which were small, noncontrolled pre-post-designs or clinical reports.

Randomized controlled trial of cognitive behavioral therapy and acceptance and commitment therapy for social phobia: outcomes and moderators.

Science.gov (United States)

Craske, Michelle G; Niles, Andrea N; Burklund, Lisa J; Wolitzky-Taylor, Kate B; Vilardaga, Jennifer C Plumb; Arch, Joanna J; Saxbe, Darby E; Lieberman, Matthew D

2014-12-01

Cognitive behavioral therapy (CBT) is an empirically supported treatment for social phobia. However, not all individuals respond to treatment and many who show improvement do not maintain their gains over the long-term. Thus, alternative treatments are needed. The current study (N = 87) was a 3-arm randomized clinical trial comparing CBT, acceptance and commitment therapy (ACT), and a wait-list control group (WL) in participants with a diagnosis of social phobia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994). Participants completed 12 sessions of CBT or ACT or a 12-week waiting period. All participants completed assessments at baseline and posttreatment, and participants assigned to CBT and ACT also completed assessments 6 and 12 months following baseline. Assessments consisted of self-report measures, a public-speaking task, and clinician ratings. Multilevel modeling was used to examine between-group differences on outcomes measures. Both treatment groups outperformed WL, with no differences observed between CBT and ACT on self-report, independent clinician, or public-speaking outcomes. Lower self-reported psychological flexibility at baseline was associated with greater improvement by the 12-month follow-up in CBT compared with ACT. Self-reported fear of negative evaluation significantly moderated outcomes as well, with trends for both extremes to be associated with superior outcomes from CBT and inferior outcomes from ACT. Across treatment groups, higher perceived control and extraversion were associated with greater improvement, whereas comorbid depression was associated with poorer outcomes. Implications for clinical practice and future research are discussed.

Randomized controlled trial of cognitive behavioral therapy and acceptance and commitment therapy for social phobia: outcomes and moderators

Science.gov (United States)

Craske, Michelle G; Niles, Andrea N.; Burklund, Lisa J.; Wolitzky-Taylor, Kate B.; Vilardaga, Jennifer C. Plumb; Arch, Joanna J.; Saxbe, Darby E.; Lieberman, Matthew D.

2014-01-01

Objective Cognitive behavioral therapy (CBT) is an empirically supported treatment for social phobia. However, not all individuals respond to treatment and many who show improvement do not maintain their gains over the long-term. Thus, alternative treatments are needed. Method The current study (N=87) was a 3-arm randomized clinical trial comparing CBT, Acceptance and Commitment therapy (ACT), and a waitlist control group (WL) in participants with a DSM-IV diagnosis of social phobia. Participants completed 12 sessions of CBT or ACT or a 12-week waiting period. All participants completed assessments at baseline and post-treatment, and participants assigned to CBT and ACT also completed assessments at 6 and 12 months following baseline. Assessments consisted of self-report measures, a public speaking task, and clinician ratings. Results Multilevel modeling was used to examine between-group differences on outcomes measures. Both treatment groups outperformed WL, with no differences observed between CBT and ACT on self-report, independent clinician, or public speaking outcomes. Lower self-reported psychological flexibility at baseline was associated with greater improvement by the 12-mo follow-up in CBT compared to ACT. Self-reported fear of negative evaluation significantly moderated outcomes as well, with trends for both extremes to be associated with superior outcomes from CBT and inferior outcomes from ACT. Across treatment groups, higher perceived control, and extraversion were associated with greater improvement, whereas comorbid depression was associated with poorer outcomes. Conclusions Implications for clinical practice and future research are discussed. PMID:24999670

‘Third wave’ cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial

Directory of Open Access Journals (Sweden)

Jakobsen Janus Christian

2012-12-01

Full Text Available Abstract Background Most interventions for depression have shown small or no effects. ‘Third wave‘ cognitive therapy and mentalization-based therapy have both gained some ground as treatments of psychological problems. No randomised trial has compared the effects of these two interventions for patients with major depression. Methods/ design We plan a randomised, parallel group, assessor-blinded superiority clinical trial. During two years we will include 84 consecutive adult participants diagnosed with major depressive disorder. The participants will be randomised to either ‘third wave‘ cognitive therapy versus mentalization-based therapy. The primary outcome will be the Hamilton Rating Scale for Depression at cessation of treatment at 18 weeks. Secondary outcomes will be the proportion of patients with remission, Symptom Checklist 90 Revised, Beck’s Depression Inventory, and The World Health Organisation-Five Well-being Index 1999. Discussion Interventions for depression have until now shown relatively small effects. Our trial results will provide knowledge about the effects of two modern psychotherapeutic interventions. Trial registration ClinicalTrials: NCT01070134

Biomarkers in the clinical development of asthma therapies.

Science.gov (United States)

Staton, Tracy L; Choy, David F; Arron, Joseph R

2016-01-01

Here we review how biomarkers have been used in the design, execution and interpretation of recent clinical studies of therapeutic candidates targeting cytokine-mediated inflammatory pathways in asthma. This review focuses on type 2 inflammation, as there are multiple therapeutics and/or clinical studies that can be compared within that specific pathway. Comparative analyses of data from these clinical studies illustrate the utility of biomarkers to quantify pharmacodynamic effects, clarify mechanism of action and stratify patients, which may facilitate the interpretation of outcomes in the development of molecularly targeted therapies. These case examples provide a basis for biomarker considerations in the design of future studies in the asthma setting.

Volume of the human hippocampus and clinical response following electroconvulsive therapy

DEFF Research Database (Denmark)

Oltedal, Leif; Narr, Katherine L.; Abbott, Christopher

2018-01-01

Background: Hippocampal enlargements are commonly reported following electroconvulsive therapy (ECT). To clarify mechanisms, we examined if ECT induced hippocampal volume change relates to dose (number of ECT sessions and electrode placement) and acts as a biomarker of clinical outcome. Methods...

The effect of age in breast conserving therapy : A retrospective analysis on pathology and clinical outcome data

NARCIS (Netherlands)

Chen, Wei; Sonke, Jan-Jakob; Stroom, Joep; Bartelink, Harry; Verheij, Marcel; Gilhuijs, Kenneth

Background and propose: Age is an important prognostic marker of patient outcome after breast conserving therapy; however, it is not clear how age affects the outcome. This study aimed to explore the relationship between age with the cell quantity and the radiosensitivity of microscopic disease

Outcome-centered antiepileptic therapy: Rate, rhythm and relief.: Implementing AAN Epilepsy Quality Measures in clinical practice.

Science.gov (United States)

D'Cruz, O'Neill

2015-12-01

Clinicians who manage patients with epilepsy are expected to assess the relevance of clinical trial results to their practice, integrate new treatments into the care algorithm, and implement epilepsy quality measures, with the overall goal of improving patient outcomes. A disease-based clinical framework that helps with choice and combinations of interventions facilitates provision of efficient, cost-effective, and high-quality care. This article addresses the current conceptual framework that informs clinical evaluation of epilepsy, explores gaps between development of treatment options, quality measures and clinical goals, and proposes an outcome-centered approach that bridges these gaps with the aim of improving patient and population-level clinical outcomes in epilepsy. Copyright © 2015 The Author. Published by Elsevier Inc. All rights reserved.

Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

Energy Technology Data Exchange (ETDEWEB)

Mendenhall, Nancy P., E-mail: menden@shands.ufl.edu [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Hoppe, Bradford S.; Nichols, Romaine C.; Mendenhall, William M.; Morris, Christopher G.; Li, Zuofeng; Su, Zhong [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Williams, Christopher R.; Costa, Joseph [Division of Urology, College of Medicine, University of Florida, Jacksonville, Florida (United States); Henderson, Randal H. [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States)

2014-03-01

Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes.

Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

International Nuclear Information System (INIS)

Mendenhall, Nancy P.; Hoppe, Bradford S.; Nichols, Romaine C.; Mendenhall, William M.; Morris, Christopher G.; Li, Zuofeng; Su, Zhong; Williams, Christopher R.; Costa, Joseph; Henderson, Randal H.

2014-01-01

Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes

Intracranial tuberculosis in children: CT appearance and clinical outcome

Energy Technology Data Exchange (ETDEWEB)

Wallace, R C; Burton, E M; Gerald, B E [Le Bonheur Children' s Medical Center, Memphis, TN (United States). Dept. of Radiology Tennessee Univ., Memphis (United States); Barrett, F F; Leggiadro, R J [Le Bonheur Children' s Medical Center, Memphis, TN (United States). Dept. of Pediatrics Tennessee Univ., Memphis (United States); Lasater, O E [Le Bonheur Children' s Medical Center, Memphis, TN (United States). Dept. of Pathology Tennessee Univ., Memphis (United States)

1991-05-01

We retrospectively evaluated the CT studies of 9 children who presented with intracranial tuberculosis during 1981-1987, and compared their radiographic appearance with the clinical outcome. The most common radiographic findings were: 1) Ventriculomegaly (7/9), 2) tuberculoma formation (6/9), and 3) infarction (4/9). Of 7 patients with ventriculomegaly, 3 required a ventricular shunt and 2 had spontaenous resolution of ventricular dilatation. Four children with ventriculomegaly were moderately or severely retarded, one had cognitive dysfunction, and one was neurologically normal. Four of six children with tuberculoma also had infarction and/or ventriculomegaly; of these four children, three were moderately or severely retarded. Two patients with tuberculoma as the only intracranial abnormality had complete resolution or the granuloma with normal neurologic outcome following antituberculous therapy. The four children with large vessel infarction also had ventriculomegaly; three had poor clinical outcome. The presence of tuberculoma alone is not necessarily predictive of poor neurologic outcome; age less than 20 months, infarct, and/or ventriculomegaly are usually associated with sequelae. (orig.).

Clinical outcomes and toxicity of proton beam therapy for advanced cholangiocarcinoma

International Nuclear Information System (INIS)

Makita, Chiyoko; Kikuchi, Yasuhiro; Hareyama, Masato; Murakami, Masao; Fuwa, Nobukazu; Hata, Masaharu; Inoue, Tomio; Nakamura, Tatsuya; Takada, Akinori; Takayama, Kanako; Suzuki, Motohisa; Ishikawa, Yojiro; Azami, Yusuke; Kato, Takahiro; Tsukiyama, Iwao

2014-01-01

We examined the efficacy and toxicity of proton beam therapy (PBT) for treating advanced cholangiocarcinoma. The clinical data and outcomes of 28 cholangiocarcinoma patients treated with PBT between January 2009 and August 2011 were retrospectively examined. The Kaplan–Meier method was used to estimate overall survival (OS), progression-free survival (PFS), and local control (LC) rates, and the log-rank test to analyze the effects of different clinical and treatment variables on survival. Acute and late toxicities were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. The median age of the 17 male and 11 female patients was 71 years (range, 41 to 84 years; intrahepatic/peripheral cholangiocarcinoma, n = 6; hilar cholangiocarcinoma/Klatskin tumor, n = 6; distal extrahepatic cholangiocarcinoma, n = 3; gallbladder cancer, n = 3; local or lymph node recurrence, n = 10; size, 20–175 mm; median 52 mm). The median radiation dose was 68.2 Gy (relative biological effectiveness [RBE]) (range, 50.6 to 80 Gy (RBE)), with delivery of fractions of 2.0 to 3.2 Gy (RBE) daily. The median follow-up duration was 12 months (range, 3 to 29 months). Fifteen patients underwent chemotherapy and 8 patients, palliative biliary stent placement prior to PBT. OS, PFS, and LC rates at 1 year were 49.0%, 29.5%, and 67.7%, respectively. LC was achieved in 6 patients, and was better in patients administered a biologically equivalent dose of 10 (BED10) > 70 Gy compared to those administered < 70 Gy (83.1% vs. 22.2%, respectively, at 1 year). The variables of tumor size and performance status were associated with survival. Late gastrointestinal toxicities grade 2 or greater were observed in 7 patients <12 months after PBT. Cholangitis was observed in 11 patients and 3 patients required stent replacement. Relatively high LC rates after PBT for advanced cholangiocarcinoma can be achieved by delivery of a BED10 > 70 Gy. Gastrointestinal

Complex contexts and relationships affect clinical decisions in group therapy.

Science.gov (United States)

Tasca, Giorgio A; Mcquaid, Nancy; Balfour, Louise

2016-09-01

Clinical errors tend to be underreported even though examining them can provide important training and professional development opportunities. The group therapy context may be prone to clinician errors because of the added complexity within which therapists work and patients receive treatment. We discuss clinical errors that occurred within a group therapy in which a patient for whom group was not appropriate was admitted to the treatment and then was not removed by the clinicians. This was countertherapeutic for both patient and group. Two clinicians were involved: a clinical supervisor who initially assessed and admitted the patient to the group, and a group therapist. To complicate matters, the group therapy occurred within the context of a clinical research trial. The errors, possible solutions, and recommendations are discussed within Reason's Organizational Accident Model (Reason, 2000). In particular, we discuss clinician errors in the context of countertransference and clinician heuristics, group therapy as a local work condition that complicates clinical decision-making, and the impact of the research context as a latent organizational factor. We also present clinical vignettes from the pregroup preparation, group therapy, and supervision. Group therapists are more likely to avoid errors in clinical decisions if they engage in reflective practice about their internal experiences and about the impact of the context in which they work. Therapists must keep in mind the various levels of group functioning, especially related to the group-as-a-whole (i.e., group composition, cohesion, group climate, and safety) when making complex clinical decisions in order to optimize patient outcomes. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Disability outcome measures in multiple sclerosis clinical trials

DEFF Research Database (Denmark)

Cohen, Jeffrey A; Reingold, Stephen C; Polman, Chris H

2012-01-01

Many of the available disability outcome measures used in clinical trials of multiple sclerosis are insensitive to change over time, inadequately validated, or insensitive to patient-perceived health status or quality of life. Increasing focus on therapies that slow or reverse disability...... recommend practical refinements. Conversely, although substantial data support the multiple sclerosis functional composite as an alternative measure, changes to its component tests and scoring method are needed. Novel approaches, including the use of composite endpoints, patient-reported outcomes...... progression makes it essential to refine existing measures or to develop new tools. Major changes to the expanded disability status scale should be avoided to prevent the loss of acceptance by regulators as a measure for primary outcomes in trials that provide substantial evidence of effectiveness. Rather, we...

EFFICACY AND LONG-TERM CLINICAL OUTCOME OF COMORBID POSTTRAUMATIC STRESS DISORDER AND MAJOR DEPRESSIVE DISORDER AFTER ELECTROCONVULSIVE THERAPY.

Science.gov (United States)

Ahmadi, Naser; Moss, Lori; Simon, Edwin; Nemeroff, Charles B; Atre-Vaidya, Nutan

2016-07-01

Many patients fulfill criteria for both posttraumatic stress disorder (PTSD) and major depressive disorder (MDD). Electroconvulsive therapy (ECT) is generally acknowledged to be the most-effective treatment for refractory MDD. This study investigated the efficacy of ECT on long-term clinical outcome of comorbid PTSD and MDD. This retrospective nested matched case-control study is inclusive of 22,164 subjects [3,485 with comorbid MDD and PTSD (92 with ECT and 3,393 without ECT) and 18,679 without MDD and PTSD]. Using the clinical global impression scale (CGI) to assess efficacy, more-robust improvement of PTSD and MDD symptoms was observed with ECT (90%), compared to antidepressant-treatment alone(50%) (P = 0.001). During the median of 8 years of follow-up, the death-rate was 8% in subjects without PTSD and MDD, 9.7% in PTSD and MDD treated with ECT and 18% in PTSD and MDD without ECT (P 0.05). The relative risk of suicidality, all-cause, and cardiovascular mortality was reduced 64, 65, and 46% in MDD and PTSD patients treated with ECT, compared to those without ECT (P < 0.05). ECT is associated with a significant reduction of symptoms of PTSD and MDD, as well as reduction in risk of suicidality, cardiovascular, and all-cause mortality in MDD and PTSD, an effect more robust than antidepressant-therapy alone. © 2015 Wiley Periodicals, Inc.

Clinical predictors of outcome in vitiligo

Directory of Open Access Journals (Sweden)

Dave Shriya

2002-11-01

Full Text Available The significant inter-patient variability in progression, and response to therapy makes it a great challenge for the physician to predict the outcome of vitiligo at the very outset. Subjective factors like stress, pregnancy, sunburn and illness have been identified as aggravating factors for vitiligo. However, a few studies have evaluated the statistical significance of objective clinical parameters in predicting the outcome of vitiligo. Our retrospective analysis of 199 consecutive patients with vitiligo who presented to our OPD was aimed at evaluation of these objective clinical parameters utilizing a standard proforma. Patients already on treatment, and those with duration of disease less than 6 months were excluded from the study. Progression was defined as an increase in size or number of lesions in the 3 months prior to presentation. In all 76. 9% patients had progression of vitiligo. The clinical parameters significantly associated with progression were a positive family history (p=0. 027, mucosal involvement (p=0. 032, Koebner′s phenomenon (p=0. 036 and nonsegmental vitiligo (p=0. 033. Thrichrome sign, leucotrichia, longer duration and higher age at onset did not correlate significantly with progression. The one significant observation that we found to have the poor prognostic implication in vitiligo is the presence of mucosal vitiligo. The clinical prediction of disease progression at the outset enables the physician to set realistic treatment goals and optimize the therapeutic regimen for the individual patient.

Examining effectiveness of tailorable computer-assisted therapy programmes for substance misuse: Programme usage and clinical outcomes data from Breaking Free Online.

Science.gov (United States)

Elison, Sarah; Jones, Andrew; Ward, Jonathan; Davies, Glyn; Dugdale, Stephanie

2017-11-01

When evaluating complex, tailorable digital behavioural interventions, additional approaches may be required alongside established methodologies such as randomised controlled trials (RCTs). Research evaluating a computer-assisted therapy (CAT) programme for substance misuse, Breaking Free Online (BFO), is informed by Medical Research Council (MRC) guidance recommending examination of 'mechanisms of action' of individual intervention strategies, which is relevant when evaluating digital interventions with content that may evolve over time. To report findings from examination of mechanisms of action of tailoring advice within the BFO programme and outcomes from specific intervention strategies. Analysis of covariance and linear regressions were used to assess intervention completion data, and psychometric and clinical outcomes, for 2311 service users accessing drug and alcohol treatment services across the UK. Tailoring advice provided to users appeared to prompt them to prioritise completion of intervention strategies associated with their areas of highest biopsychosocial impairment. Completion of specific intervention strategies within BFO were associated with specific clinical outcomes, with a dose response also being found. Mechanisms of action analyses revealed the primacy of cognitions, with cognitive restructuring strategies being associated with improvements in mental health, severity of substance dependence, quality of life and global biopsychosocial functioning. The MRC framework provides an evolved research paradigm within the field of digital behavioural change. By assessing baseline profiles of need, BFO can target the most appropriate clinical content for individual users. Mechanisms of action research can be used to inform modifications to BFO to continually update clinical content and the technology platform. Copyright © 2017 Elsevier Ltd. All rights reserved.

[Assessment of individual clinical outcomes: regarding an electroconvulsive therapy case].

Science.gov (United States)

Iraurgi, Ioseba; Gorbeña, Susana; Martínez-Cubillos, Miren-Itxaso; Escribano, Margarita; Gómez-de-Maintenant, Pablo

2015-01-01

Evaluation of therapeutic results and of the efficacy and effectiveness of treatments is an area of interest both for clinicians and researchers. In general, randomized controlled trial designs have been used as the methodology of choice in which intergroup comparisons are made having a minimum of participants in each arm of treatment. However, these procedures are seldom used in daily clinical practice. Despite this fact, the evaluation of treatment results for a specific patient is important for the clinician in order to address if therapeutic goals have been accomplished both in terms of statistical significance and clinical meaningfulness. The methodology based on the reliable change index (Jacobson y Truax)1 provides an estimate of these two criteria. The goal of this article is to propose a procedure to apply the methodology with a single case study of a woman diagnosed with major depression and treated with electroconvulsive therapy. Copyright © 2014 SEP y SEPB. Published by Elsevier España. All rights reserved.

The association between waiting for psychological therapy and therapy outcomes as measured by the CORE-OM.

Science.gov (United States)

Beck, Alison; Burdett, Mark; Lewis, Helen

2015-06-01

To investigate the impact of waiting for psychological therapy on client well-being as measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) global distress (GD) score. Global distress scores were retrieved for all clients referred for psychological therapy in a secondary care mental health service between November 2006 and May 2013 and who had completed a CORE-OM at assessment and first session. GD scores for a subgroup of 103 clients who had completed a CORE-OM during the last therapy session were also reviewed. The study sample experienced a median wait of 41.14 weeks between assessment and first session. The relationship between wait time from referral acceptance to assessment, and assessment GD score was not significant. During the period between assessment and first session no significant difference in GD score was observed. Nevertheless 29.1% of the sample experienced reliable change; 16.0% of clients reliably improved and 13.1% reliably deteriorated whilst waiting for therapy. Demographic factors were not found to have a significant effect on the change in GD score between assessment and first session. Waiting time was associated with post-therapy outcomes but not to a degree which was meaningful. The majority of individuals (54.4%), regardless of whether they improved or deteriorated whilst waiting for therapy, showed reliable improvement at end of therapy as measured by the CORE-OM. The majority of GD scores remained stable while waiting for therapy; however, 29.1% of secondary care clients experienced either reliable improvement or deterioration. Irrespective of whether they improved, deteriorated or remained unchanged whilst waiting for therapy, most individuals who had a complete end of therapy assessment showed reliable improvements following therapy. There was no significant difference in GD score between assessment and first session recordings. A proportion of clients (29.1%) showed reliable change, either improvement or

Predicting outcome following psychological therapy in IAPT (PROMPT): a naturalistic project protocol.

Science.gov (United States)

Grant, Nina; Hotopf, Matthew; Breen, Gerome; Cleare, Anthony; Grey, Nick; Hepgul, Nilay; King, Sinead; Moran, Paul; Pariante, Carmine M; Wingrove, Janet; Young, Allan H; Tylee, André

2014-06-09

-psycho-social factors which may be relevant for treatment outcome. This will enable future clinical decision making to be based on the individual needs of the patient in an evidence-based manner. Moreover, the identification of individuals who fail to improve following therapy delivered by IAPT services could be utilised for the development of novel interventions.

Outcome Measures in Myasthenia Gravis: Incorporation Into Clinical Practice.

Science.gov (United States)

Muppidi, Srikanth

2017-03-01

The development of validated assessment tools for evaluating disease status and response to interventions in patients with myasthenia gravis (MG) has been driven by clinical studies of emerging MG therapies. However, only a small proportion of MG-focused neurology practices have adopted these assessment tools for routine clinical use. This article reviews the suitability of 5 assessment instruments for incorporation into clinical practice, which should be driven by their ability to contribute to improved patient outcomes, and to be implemented within practice personnel and resource constraints. It is recommended that assessments based on both physician-evaluated and patient-reported outcomes be selected, to adequately evaluate both point-in-time symptom load and functional impact of MG symptoms over time. Provider resource allocation and reimbursement issues may be the most significant roadblocks to successful ongoing use of these tools; to that end, the addition of regular assessments to MG standards of care is recommended.

Impact of the right ventricular lead position on clinical outcome and on the incidence of ventricular tachyarrhythmias in patients with CRT-D

DEFF Research Database (Denmark)

Kutyifa, Valentina; Bloch Thomsen, Poul Erik; Huang, David T.

2013-01-01

Data on the impact of right ventricular (RV) lead location on clinical outcome and ventricular tachyarrhythmias in cardiac resynchronization therapy with defibrillator (CRT-D) patients are limited.......Data on the impact of right ventricular (RV) lead location on clinical outcome and ventricular tachyarrhythmias in cardiac resynchronization therapy with defibrillator (CRT-D) patients are limited....

Predictors of Good Outcome After Endovascular Therapy for Vertebrobasilar Occlusion Stroke.

Science.gov (United States)

Bouslama, Mehdi; Haussen, Diogo C; Aghaebrahim, Amin; Grossberg, Jonathan A; Walker, Gregory; Rangaraju, Srikant; Horev, Anat; Frankel, Michael R; Nogueira, Raul G; Jovin, Tudor G; Jadhav, Ashutosh P

2017-12-01

Endovascular therapy is increasingly used in acute ischemic stroke treatment and is now considered the gold standard approach for selected patient populations. Prior studies have demonstrated that eventual patient outcomes depend on both patient-specific factors and procedural considerations. However, these factors remain unclear for acute basilar artery occlusion stroke. We sought to determine prognostic factors of good outcome in acute posterior circulation large vessel occlusion strokes treated with endovascular therapy. We reviewed our prospectively collected endovascular databases at 2 US tertiary care academic institutions for patients with acute posterior circulation strokes from September 2005 to September 2015 who had 3-month modified Rankin Scale documented. Baseline characteristics, procedural data, and outcomes were evaluated. A good outcome was defined as a 90-day modified Rankin Scale score of 0 to 2. The association between clinical and procedural parameters and functional outcome was assessed. A total of 214 patients qualified for the study. Smoking status, creatinine levels, baseline National Institutes of Health Stroke Scale score, anesthesia modality (conscious sedation versus general anesthesia), procedural length, and reperfusion status were significantly associated with good outcomes in the univariate analysis. Multivariate logistic regression indicated that only smoking (odds ratio=2.61; 95% confidence interval, 1.23-5.56; P =0.013), low baseline National Institutes of Health Stroke Scale score (odds ratio=1.09; 95% confidence interval, 1.04-1.13; P <0.0001), and successful reperfusion status (odds ratio=10.80; 95% confidence interval, 1.36-85.96; P =0.025) were associated with good outcome. In our retrospective case series, only smoking, low baseline National Institutes of Health Stroke Scale score, and successful reperfusion status were associated with good outcome in patients with posterior circulation stroke treated with endovascular

Immediate outcomes of eptifibatide therapy during intracoronary stent implantation.

Science.gov (United States)

Shariati, Hooman; Sanei, Hamid; Pourmoghadas, Ali; Salehizadeh, Leila; Amirpour, Afshin

2016-01-01

The objective of the present study was to assess the major immediate outcomes of eptifibatide therapy during intracoronary stent implantation. In an interventional study, patients undergoing percutaneous coronary intervention (PCI) were randomized into either the eptifibatide ( n = 100) or the control ( n = 107) group. In each group, demographic and clinical characteristics such as cardiac death, stent thrombosis (ST), myocardial infarction (MI), rates of target lesion and vessel revascularization, cerebral vascular accident (CVA), and emergency coronary artery bypass grafting (CABG) were recorded. The overall rates of major adverse events such as mortality, Stent thrombosis (ST), Myocardial Infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), CVA, and emergency CABG within 24 h after stent implantation were low and comparable between the two groups; P > 0.05 considered significant for all comparisons. There were no statistical differences between the clinical outcomes of groups administered with single-dose intracoronary eptifibatide and control groups among patients undergoing PCI during stent implantation.

Clinical outcome of pediatric collagenous gastritis: case series and review of literature.

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Hijaz, Nadia Mazen; Septer, Seth Steven; Degaetano, James; Attard, Thomas Mario

2013-03-07

Collagenous gastritis (CG) is characterized by patchy subepithelial collagen bands. Effective treatment and the clinical and histological outcome of CG in children are poorly defined. The aim of this study is to summarize the published literature on the clinical outcome and response to therapy of pediatric CG including two new cases. We performed a search in Pubmed, OVID for related terms; articles including management and clinical and/or endo-histologic follow up information were included and abstracted. Reported findings were pooled in a dedicated database including the corresponding data extracted from chart review in our patients with CG. Twenty-four patients were included (17 females) with a mean age of 11.7 years. The clinical presentation included iron deficiency anemia and dyspepsia. The reported duration of follow up (in 18 patients) ranged between 0.2-14 years. Despite most subjects presenting with anemia including one requiring blood transfusion, oral iron therapy was only documented in 12 patients. Other treatment modalities were antisecretory measures in 13 patients; proton pump inhibitors (12), or histamine-2 blockers (3), sucralfate (5), prednisolone (6), oral budesonide in 3 patients where one received it in fish oil and triple therapy (3). Three (13%) patients showed no clinical improvement despite therapy; conversely 19 out of 22 were reported with improved symptoms including 8 with complete symptom resolution. Spontaneous clinical resolution without antisecretory, anti-inflammatory or gastroprotective agents was noted in 5 patients (4 received only supplemental iron). Follow up endo-histopathologic data (17 patients) included persistent collagen band and stable Mononuclear cell infiltrate in 12 patients with histopathologic improvement in 5 patients. Neither collagen band thickness nor mononuclear cell infiltrate correlated with clinical course. Intestinal metaplasia and endocrine cell hyperplasia were reported (1) raising the concern of long

Translation and adaptation procedures for music therapy outcome instruments

DEFF Research Database (Denmark)

Ridder, Hanne Mette Ochsner; McDermott, Orii; Orrell, Martin

2017-01-01

With increasing occurrence of international multicentre studies, there is a need for music therapy outcome measures to become more widely available across countries. For countries where English is not the first language, translation and cross-cultural adaptation of outcome measures may be necessa...... procedural steps for the translation and adaptation of music therapy outcome instruments. OBS: 50 free online copies to share: http://www.tandfonline.com/eprint/d8TPZbkVMjzgKg7DjcmT/full......With increasing occurrence of international multicentre studies, there is a need for music therapy outcome measures to become more widely available across countries. For countries where English is not the first language, translation and cross-cultural adaptation of outcome measures may be necessary....... A literature review identified a knowledge gap regarding translation procedures of outcome measures used in music therapy research. However, a large body of translation guidelines is available in other health professions. We used the guidelines from these related fields to identify guidelines and outline...

A pharmacogenetics study to predict outcome in patients receiving anti-VEGF therapy in age related macular degeneration

Science.gov (United States)

Kitchens, John W; Kassem, Nawal; Wood, William; Stone, Thomas W; Isernhagen, Rick; Wood, Edward; Hancock, Brad A; Radovich, Milan; Waymire, Josh; Li, Lang; Schneider, Bryan P

2013-01-01

Purpose To ascertain whether single nucleotide polymorphisms (SNPs) in the Vascular Endothelial Growth factor (VEGFA), Complement Factor H (CFH), and LOC387715 genes could predict outcome to anti-VEGF therapy for patients with age related macular degeneration (AMD). Methods Patients with “wet” AMD were identified by chart review. Baseline optical coherence tomography (OCT) and visual acuity (VA) data, and at least 6 months of clinical follow up after 3 initial monthly injections of bevacizumab or ranibizumab were required for inclusion. Based on OCT and VA, patients were categorized into two possible clinical outcomes: (a) responders and (b) non-responders. DNA was extracted from saliva and genotyped for candidate SNPs in the VEGFA, LOC387715, and CFH genes. Clinical outcomes were statistically compared to patient genotypes. Results 101 patients were recruited, and one eye from each patient was included in the analysis. 97% of samples were successfully genotyped for all SNPs. We found a statistically significant association between the LOC387715 A69S TT genotype and outcome based on OCT. Conclusion Genetic variation may be associated with outcome in patients receiving anti-VEGF therapy. PMID:24143065

Exploring Learning Outcomes in Cognitive Behaviour Therapy and Existential Therapy in Denmark

DEFF Research Database (Denmark)

Sørensen, Anders Dræby

This is a presentation of a research project, which explores lived experience of psychotherapy in terms of learning outcomes. This includes both Existential therapy (ET) and Cognitive-Behavioural Therapy (CBT) and their possible differences and similarities. I can describe learning as any...... experiential change that occurs in the participants understanding as result of the therapy in which they participate. Learning outcomes are concerned with the achievements of the learner rather than the intentions of the educator, as expressed in the objectives of an educational effort. This research points...

Cognitive deficits in marijuana users: effects on motivational enhancement therapy plus cognitive behavioral therapy treatment outcome

Science.gov (United States)

Aharonovich, Efrat; Brooks, Adam C; Nunes, Edward V; Hasin, Deborah S

2008-01-01

Clinical variables that affect treatment outcome for marijuana dependent individuals are not yet well understood, including the effects of cognitive functioning. To address this, level of cognitive functioning and treatment outcome were investigated. Twenty marijuana-dependent outpatients were administered a neuropsychological battery at treatment entry. All patients received 12 weekly individual sessions of combined motivational enhancement therapy and cognitive behavioral therapy. The Wilcoxon Exact Test was used to compare cognitive functioning test scores between completers and dropouts, and the Fisher Exact Test was used to compare proportion of negative urines between those with higher and lower scores on the cognitive tests. Marijuana abstinence was unrelated to cognitive functioning. However, dropouts scored significantly lower than completers on measures of abstract reasoning and processing accuracy, providing initial evidence that cognitive functioning plays a role in treatment retention of adult marijuana dependent patients. If supported by further studies, the findings may help inform the development of interventions tailored for cognitively impaired marijuana dependent patients. PMID:18329188

Clinical Effectiveness of Statin Therapy After Ischemic Stroke: Primary Results From the Statin Therapeutic Area of the Patient-Centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) Study.

Science.gov (United States)

O'Brien, Emily C; Greiner, Melissa A; Xian, Ying; Fonarow, Gregg C; Olson, DaiWai M; Schwamm, Lee H; Bhatt, Deepak L; Smith, Eric E; Maisch, Lesley; Hannah, Deidre; Lindholm, Brianna; Peterson, Eric D; Pencina, Michael J; Hernandez, Adrian F

2015-10-13

In patients with ischemic stroke, data on the real-world effectiveness of statin therapy for clinical and patient-centered outcomes are needed to better inform shared decision making. Patient-Centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) is a Patient-Centered Outcomes Research Institute-funded research program designed with stroke survivors to evaluate the effectiveness of poststroke therapies. We linked data on patients ≥65 years of age enrolled in the Get With The Guidelines-Stroke Registry to Medicare claims. Two-year to postdischarge outcomes of those discharged on a statin versus not on a statin were adjusted through inverse probability weighting. Our coprimary outcomes were major adverse cardiovascular events and home time (days alive and out of a hospital or skilled nursing facility). Secondary outcomes included all-cause mortality, all-cause readmission, cardiovascular readmission, and hemorrhagic stroke. From 2007 to 2011, 77 468 patients who were not taking statins at the time of admission were hospitalized with ischemic stroke; of these, 71% were discharged on statin therapy. After adjustment, statin therapy at discharge was associated with a lower hazard of major adverse cardiovascular events (hazard ratio, 0.91; 95% confidence interval, 0.87-0.94), 28 more home-time days after discharge (PStatin therapy at discharge was not associated with increased risk of hemorrhagic stroke (hazard ratio, 0.94; 95% confidence interval, 0.72-1.23). Among statin-treated patients, 31% received a high-intensity dose; after risk adjustment, these patients had outcomes similar to those of recipients of moderate-intensity statin. In older ischemic stroke patients who were not taking statins at the time of admission, discharge statin therapy was associated with lower risk of major adverse cardiovascular events and nearly 1 month more home time during the 2-year period after hospitalization. © 2015 American Heart Association

Management of cannabis-induced periodontitis via resective surgical therapy: A clinical report.

Science.gov (United States)

Momen-Heravi, Fatemeh; Kang, Philip

2017-03-01

There is a lack of clinical research on the potential effect of cannabis use on the periodontium as well as its effect on treatment outcomes. The aim of this case report is to illustrate the clinical presentation of periodontal disease in a young woman who was a chronic cannabis user, as well as successful treatment involving motivating the patient to quit cannabis use and undergo nonsurgical and surgical therapy. A 23-year-old woman sought care at the dental clinic for periodontal treatment. During a review of her medical history, the patient reported using cannabis frequently during a 3-year period, which coincided with the occurrence of gingival inflammation. She used cannabis in the form of cigarettes that were placed at the mandibular anterior region of her mouth for prolonged periods. Localized prominent papillary and marginal gingival enlargement of the anterior mandible were present. The mandibular anterior teeth showed localized severe chronic periodontitis. The clinicians informed the patient about the potentially detrimental consequences of continued cannabis use; she was encouraged to quit, which she did. The clinicians performed nonsurgical therapy (scaling and root planing) and osseous surgery. The treatment outcome was evaluated over 6 months; improved radiographic and clinical results were observed throughout the follow-up period. Substantial availability and usage of cannabis, specifically among young adults, requires dentists to be vigilant about clinical indications of cannabis use and to provide appropriate treatments. Behavioral modification, nonsurgical therapy, and surgical therapy offer the potential for successful management of cannabis-related periodontitis. Copyright © 2017 American Dental Association. Published by Elsevier Inc. All rights reserved.

Clinical concepts for regenerative therapy in intrabony defects.

Science.gov (United States)

Cortellini, Pierpaolo; Tonetti, Maurizio S

2015-06-01

Evidence indicates that periodontal regeneration is an efficacious and predictable procedure for the treatment of isolated and multiple intrabony defects. Meta-analyses from systematic reviews indicate an added benefit, in terms of clinical attachment level gain, when demineralized freeze-dried bone allograft, barrier membranes and active biologic products/compounds are applied in addition to open flap debridement. On the other hand, a consistent amount of variability of the outcomes is evident among different studies and within the experimental population of each study. This variability is explained, at least in part, by different patient and defect characteristics. Patient-related factors include smoking habit, compliance with home oral hygiene and residual inflammation after cause-related therapy. Defect-associated factors include defect depth and radiographic angle, the number of residual bony walls, pocket depth and the degree of hypermobility. In addition, surgical-related variables, such as surgical skill, clinical experience and knowledge, and application of the different regenerative materials, have a significant impact on clinical outcomes. This paper presents a strategy to optimize the clinical outcomes of periodontal regeneration. The surgical design of the flap, the use of different regenerative materials and the application of appropriate passive sutures are discussed in this review along with the scientific foundations. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Clinical outcome of HIV-infected patients with sustained virologic response to antiretroviral therapy: long-term follow-up of a multicenter cohort.

Directory of Open Access Journals (Sweden)

Félix Gutierrez

Full Text Available BACKGROUND: Limited information exists on long-term prognosis of patients with sustained virologic response to antiretroviral therapy. We aimed to assess predictors of unfavorable clinical outcome in patients who maintain viral suppression with HAART. METHODS: Using data collected from ten clinic-based cohorts in Spain, we selected all antiretroviral-naive adults who initiated HAART and maintained plasma HIV-1 RNA levels <500 copies/mL throughout follow-up. Factors associated with disease progression were determined by Cox proportional-hazards models. RESULTS: Of 2,613 patients who started HAART, 757 fulfilled the inclusion criteria. 61% of them initiated a protease inhibitor-based HAART regimen, 29.7% a nonnucleoside reverse-transcriptase inhibitor-based regimen, and 7.8% a triple-nucleoside regimen. During 2,556 person-years of follow-up, 22 (2.9% patients died (mortality rate 0.86 per 100 person-years, and 40 (5.3% died or developed a new AIDS-defining event. The most common causes of death were neoplasias and liver failure. Mortality was independently associated with a CD4-T cell response <50 cells/L after 12 months of HAART (adjusted hazard ratio [AHR], 4.26 [95% confidence interval {CI}, 1.68-10.83]; P = .002, and age at initiation of HAART (AHR, 1.06 per year; 95% CI, 1.02-1.09; P = .001. Initial antiretroviral regimen chosen was not associated with different risk of clinical progression. CONCLUSIONS: Patients with sustained virologic response on HAART have a low mortality rate over time. Long-term outcome of these patients is driven by immunologic response at the end of the first year of therapy and age at the time of HAART initiation, but not by the initial antiretroviral regimen selected.

Outcome of radioiodine therapy without, on or 3 days off carbimazole: a prospective interventional three-group comparison

International Nuclear Information System (INIS)

Walter, Martin A.; Christ-Crain, Mirjam; Mueller, Beat; Schindler, Christian; Mueller-Brand, Jan

2006-01-01

Carbimazole ameliorates hyperthyroidism but reduces radioiodine uptake and adversely affects the outcome of simultaneous radioiodine therapy. We explored whether withdrawal of carbimazole for 3 days can restore the outcome of radioiodine treatment without concurrent exacerbation of hyperthyroidism. By generating three groups with comparable radioiodine uptake, we also investigated whether the effect of carbimazole depends on the radioiodine uptake. Stratified by a radioiodine uptake >30%, 227 consecutive adult patients were prospectively assigned to radioiodine therapy (target dose 200 Gy) without, on or 3 days off carbimazole. Patients were clinically (Crooks-Wayne score) and biochemically (T 3 , fT 4 , TSH) followed up after 3, 6 and 12 months. Primary endpoint was outcome 12 months after radioiodine therapy. A total of 207 patients completed follow-up (toxic nodular goitre, n=117; Graves' disease, n=90). The overall success rate was 71.5%. Patients without and 3 days off carbimazole had similar biochemical (81.4% and 83.3%, respectively; p=0.82) and clinical outcomes [median (range) Crooks-Wayne score 0 (0-16) and 1 (0-10), respectively; p=0.73], which were both higher than in patients on carbimazole [42.6%, p 4 , T 3 and TSH. (orig.)

Hypofractionated intensity-modulated arc therapy for lymph node metastasized prostate cancer: Early late toxicity and 3-year clinical outcome

International Nuclear Information System (INIS)

Fonteyne, Valérie; Lumen, Nicolaas; Ost, Piet; Van Praet, Charles; Vandecasteele, Katrien; De Gersem Ir, Werner; Villeirs, Geert; De Neve, Wilfried; Decaestecker, Karel; De Meerleer, Gert

2013-01-01

Background and purpose: For patients with N1 prostate cancer (PCa) aggressive local therapies can be advocated. We evaluated clinical outcome, gastro-intestinal (GI) and genito-urinary (GU) toxicity after intensity modulated arc radiotherapy (IMAT) + androgen deprivation (AD) for N1 PCa. Material and methods: Eighty patients with T1-4N1M0 PCa were treated with IMAT and 2–3 years of AD. A median dose of 69.3 Gy (normalized isoeffective dose at 2 Gy per fraction: 80 Gy [α/β = 3]) was prescribed in 25 fractions to the prostate. The pelvic lymph nodes received a minimal dose of 45 Gy. A simultaneous integrated boost to 72 Gy and 65 Gy was delivered to the intraprostatic lesion and/or pathologically enlarged lymph nodes, respectively. GI and GU toxicity was scored using the RTOG/RILIT and RTOG-SOMA/LENT-CTC toxicity scoring system respectively. Three-year actuarial risk of grade 2 and 3/4 GI–GU toxicity and biochemical and clinical relapse free survival (bRFS and cRFS) were calculated with Kaplan–Meier statistics. Results: Median follow-up was 36 months. Three-year actuarial risk for late grade 3 and 2 GI toxicity is 8% and 20%, respectively. Three-year actuarial risk for late grade 3–4 and 2 GU toxicity was 6% and 34%, respectively. Actuarial 3-year bRFS and cRFS was 81% and 89%, respectively. Actuarial 3-year bRFS and cRFS was, respectively 26% and 32% lower for patients with cN1 disease when compared to patients with cN0 disease. Conclusion: IMAT for N1 PCa offers good clinical outcome with moderate toxicity. Patients with cN1 disease have poorer outcome

Treatment outcomes of HIV-positive patients on first-line antiretroviral therapy in private versus public HIV clinics in Johannesburg, South Africa

Directory of Open Access Journals (Sweden)

Moyo F

2016-03-01

Full Text Available Faith Moyo,1 Charles Chasela,2,3 Alana T Brennan,1,4 Osman Ebrahim,5 Ian M Sanne,1,6 Lawrence Long,1 Denise Evans1 1Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 2Epidemiology and Biostatistics Department, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 3Epidemiology and Strategic Information (ESI, HIV/AIDS/STIs and TB, Human Sciences Research Council, Pretoria, South Africa; 4Center for Global Health and Development, Boston University, Boston, MA, USA; 5Brenthurst Clinic, Parktown, South Africa; 6Right to Care, Helen Joseph Hospital, Westdene, Johannesburg, South Africa Background: Despite the widely documented success of antiretroviral therapy (ART, stakeholders continue to face the challenges of poor HIV treatment outcomes. While many studies have investigated patient-level causes of poor treatment outcomes, data on the effect of health systems on ART outcomes are scarce.Objective: We compare treatment outcomes among patients receiving HIV care and treatment at a public and private HIV clinic in Johannesburg, South Africa.Patients and methods: This was a retrospective cohort analysis of ART naïve adults (≥18.0 years, initiating ART at a public or private clinic in Johannesburg between July 01, 2007 and December 31, 2012. Cox proportional-hazards regression was used to identify baseline predictors of mortality and loss to follow-up (>3 months late for the last scheduled visit. Generalized estimating equations were used to determine predictors of failure to suppress viral load (≥400 copies/mL while the Wilcoxon rank-sum test was used to compare the median absolute change in CD4 count from baseline to 12 months post-ART initiation.Results: 12,865 patients initiated ART at the public clinic compared to 610 at the private

Alberta Stroke Program Early CT Score-Time Score Predicts Outcome after Endovascular Therapy in Patients with Acute Ischemic Stroke: A Retrospective Single-Center Study.

Science.gov (United States)

Todo, Kenichi; Sakai, Nobuyuki; Kono, Tomoyuki; Hoshi, Taku; Imamura, Hirotoshi; Adachi, Hidemitsu; Yamagami, Hiroshi; Kohara, Nobuo

2018-04-01

Clinical outcomes after successful endovascular therapy in patients with acute ischemic stroke are associated with several factors including onset-to-reperfusion time (ORT), the National Institute of Health Stroke Scale (NIHSS) score, and the Alberta Stroke Program Early CT Score (ASPECTS). The NIHSS-time score, calculated as follows: [NIHSS score] × [onset-to-treatment time (h)] or [NIHSS score] × [ORT (h)], has been reported to predict clinical outcomes after intravenous recombinant tissue plasminogen activator therapy and endovascular therapy for acute stroke. The objective of the current study was to assess whether the combination of the ASPECTS and the ORT can predict the outcomes after endovascular therapy. The charts of 117 consecutive ischemic stroke patients with successful reperfusion after endovascular therapy were retrospectively reviewed. We analyzed the association of ORT, ASPECTS, and ASPECTS-time score with clinical outcome. ASPECTS-time score was calculated as follows: [11 - ASPECTS] × [ORT (h)]. Rates of good outcome for patients with ASPECTS-time scores of tertile values, scores 5.67 or less, scores greater than 5.67 to 10.40 or less, and scores greater than 10.40, were 66.7%, 56.4%, and 33.3%, respectively (P < .05). Ordinal logistic regression analysis showed that the ASPECTS-time score (per category increase) was an independent predictor for better outcome (common odds ratio: .374; 95% confidence interval: .150-0.930; P < .05). A lower ASPECTS-time score may predict better clinical outcomes after endovascular treatment. Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Family therapy and clinical psychology

OpenAIRE

Carr, Alan

1995-01-01

The results of a survey of 111 clinical psychologists in the Republic of Ireland along with some comparable data from US and UK surveys were used to address a series of questions about the link between family therapy and clinical psychology. Family therapy was not a clearly identifiable sub-specialty within clinical psychology in Ireland. Family therapy theoretical models were used by more than a quarter of the Irish sample to conceptualize their work but by less than a tenth of US and UK res...

Effect of Payment Model on Patient Outcomes in Outpatient Physical Therapy.

Science.gov (United States)

Charles, Derek; Boyd, Sylvester; Heckert, Logan; Lake, Austin; Petersen, Kevin

2018-01-01

Although the literature has well recognized the effectiveness of physical therapy for treating musculoskeletal injuries, reimbursement is evolving towards value-based or alternative payment models and away from procedure orientated, fee-for-service in the outpatient setting. Alternative models include cased-based clinics, pay-for-performance, out-of-network services, accountable care organizations, and concierge practices. There is the possibility that alternative payment models could produce different and even superior patient outcomes. Physical therapists should be alert to this possibility, and research is warranted in this area to conclude if outcomes in patient care are related to method of reimbursement.

Population-based differences in treatment outcome following anticancer drug therapies.

Science.gov (United States)

Ma, Brigette By; Hui, Edwin P; Mok, Tony Sk

2010-01-01

Population-based differences in toxicity and clinical outcome following treatment with anticancer drugs have an important effect on oncology practice and drug development. These differences arise from complex interactions between biological and environmental factors, which include genetic diversity affecting drug metabolism and the expression of drug targets, variations in tumour biology and host physiology, socioeconomic disparities, and regional preferences in treatment standards. Some well-known examples include the high prevalence of activating epidermal growth factor receptor (EGFR) mutations in pulmonary adenocarcinoma among northeast (China, Japan, Korea) and parts of southeast Asia (excluding India) non-smokers, which predict sensitivity to EGFR kinase inhibitors, and the sharp contrast between Japan and the west in the management and survival outcome of gastric cancer. This review is a critical overview of population-based differences in the four most prevalent cancers in the world: lung, breast, colorectal, and stomach cancer. Particular attention is given to the clinical relevance of such knowledge in terms of the individualisation of drug therapy and in the design of clinical trials. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Chemoradiation Therapy for Potentially Resectable Gastric Cancer: Clinical Outcomes Among Patients Who Do Not Undergo Planned Surgery

International Nuclear Information System (INIS)

Kim, Michelle M.; Mansfield, Paul F.; Das, Prajnan; Janjan, Nora A.; Badgwell, Brian D.; Phan, Alexandria T.; Delclos, Marc E.; Maru, Dipen; Ajani, Jaffer A.; Crane, Christopher H.; Krishnan, Sunil

2008-01-01

Purpose: We retrospectively analyzed treatment outcomes among resectable gastric cancer patients treated preoperatively with chemoradiation therapy (CRT) but rendered ineligible for planned surgery because of clinical deterioration or development of overt metastatic disease. Methods and Materials: Between 1996 and 2004, 39 patients with potentially resectable gastric cancer received preoperative CRT but failed to undergo surgery. At baseline clinical staging, 33 (85%) patients had T3-T4 disease, and 27 (69%) patients had nodal involvement. Most patients received 45 Gy of radiotherapy with concurrent 5-fluorouracil-based chemotherapy. Twenty-one patients underwent induction chemotherapy before CRT. Actuarial times to local control (LC), distant control (DC), and overall survival (OS) were calculated by the Kaplan-Meier method. Results: The cause for surgical ineligibility was development of metastatic disease (28 patients, 72%; predominantly peritoneal, 18 patients), poor performance status (5 patients, 13%), patient/physician preference (4 patients, 10%), and treatment-related death (2 patients, 5%). With a median follow-up of 8 months (range, 1-95 months), actuarial 1-year LC, DC, and OS were 46%, 12%, and 36%, respectively. Median LC and OS were 11.0 and 10.1 months, respectively. Conclusions: Patients with potentially resectable gastric cancer treated with preoperative CRT are found to be ineligible for surgery principally because of peritoneal progression. Patients who are unable to undergo planned surgery have outcomes comparable to that of patients with advanced gastric cancer treated with chemotherapy alone. CRT provides durable LC for the majority of the remaining life of these patients

Incidence, clinical presentation, and outcome of HIV-1-associated cryptococcal meningitis during the highly active antiretroviral therapy era

DEFF Research Database (Denmark)

Touma, Madeleine; Rasmussen, Line D.; Martin-Iguacel, Raquel

2017-01-01

: A nationwide, population-based cohort of HIV-infected individuals was used to estimate incidence and mortality of CM including risk factors. A description of neurological symptoms of CM at presentation and follow-up in the study period 1995-2014 was included in this study. RESULTS: Among 6,351 HIV......BACKGROUND: Human immunodeficiency virus (HIV) infection with advanced immunosuppression predisposes to cryptococcal meningitis (CM). We describe the incidence, clinical presentation, and outcome of CM in HIV-infected individuals during the highly active antiretroviral therapy (HAART) era. METHODS...... was associated with increased risk of CM [IRR, 2.05 (95% CI, 1.00-4.20)]. The main signs and symptoms at presentation were headache, cognitive deficits, fever, neck stiffness, nausea, and vomiting. All individuals diagnosed with CM had a CD4(+) cell count

Incidence, clinical presentation, and outcome of HIV-1-associated cryptococcal meningitis during the highly active antiretroviral therapy era

DEFF Research Database (Denmark)

Touma, Madeleine; Rasmussen, Line D.; Martin-Iguacel, Raquel

2017-01-01

Background: Human immunodeficiency virus (HIV) infection with advanced immunosup-pression predisposes to cryptococcal meningitis (CM). We describe the incidence, clinical presentation, and outcome of CM in HIV-infected individuals during the highly active antiretroviral therapy (HAART) era. Methods......: A nationwide, population-based cohort of HIV-infected individuals was used to estimate incidence and mortality of CM including risk factors. A description of neurological symptoms of CM at presentation and follow-up in the study period 1995–2014 was included in this study. Results: Among 6,351 HIV...... was associated with increased risk of CM [IRR, 2.05 (95% CI, 1.00–4.20)]. The main signs and symptoms at presentation were headache, cognitive deficits, fever, neck stiffness, nausea, and vomiting. All individuals diagnosed with CM had a CD4 + cell count

Clinical results of boron neutron capture therapy (BNCT) for glioblastoma

International Nuclear Information System (INIS)

Kageji, T.; Mizobuchi, Y.; Nagahiro, S.; Nakagawa, Y.; Kumada, H.

2011-01-01

The purpose of this study was to evaluate the clinical outcome of BSH-based intra-operative BNCT (IO-BNCT) and BSH and BPA-based non-operative BNCT (NO-BNCT). We have treated 23 glioblastoma patients with BNCT without any additional chemotherapy since 1998. The median survival time (MST) of BNCT was 19.5 months, and 2-year, 3-year and 5-year survival rates were 26.1%, 17.4% and 5.8%, respectively. This clinical result of BNCT in patients with GBM is superior to that of single treatment of conventional radiotherapy compared with historical data of conventional treatment. - Highlights: ► In this study, we evaluate the clinical outcome of boron neutron capture therapy (BNCT) for malignant brain tumors. ► We have treated 23 glioblastoma (GBM) patients with BNCT without any additional chemotherapy. ► Clinical results of BNCT in patients with GBM are superior to that of single treatment of conventional radiotherapy compared with historical data of conventional treatment.

Clinical databases in physical therapy.

NARCIS (Netherlands)

Swinkels, I.C.S.; Ende, C.H.M. van den; Bakker, D. de; Wees, Ph.J van der; Hart, D.L.; Deutscher, D.; Bosch, W.J.H. van den; Dekker, J.

2007-01-01

Clinical databases in physical therapy provide increasing opportunities for research into physical therapy theory and practice. At present, information on the characteristics of existing databases is lacking. The purpose of this study was to identify clinical databases in which physical therapists

Neonatal Pulmonary MRI of Bronchopulmonary Dysplasia Predicts Short-term Clinical Outcomes.

Science.gov (United States)

Higano, Nara S; Spielberg, David R; Fleck, Robert J; Schapiro, Andrew H; Walkup, Laura L; Hahn, Andrew D; Tkach, Jean A; Kingma, Paul S; Merhar, Stephanie L; Fain, Sean B; Woods, Jason C

2018-05-23

Bronchopulmonary dysplasia (BPD) is a serious neonatal pulmonary condition associated with premature birth, but the underlying parenchymal disease and trajectory are poorly characterized. The current NICHD/NHLBI definition of BPD severity is based on degree of prematurity and extent of oxygen requirement. However, no clear link exists between initial diagnosis and clinical outcomes. We hypothesized that magnetic resonance imaging (MRI) of structural parenchymal abnormalities will correlate with NICHD-defined BPD disease severity and predict short-term respiratory outcomes. Forty-two neonates (20 severe BPD, 6 moderate, 7 mild, 9 non-BPD controls; 40±3 weeks post-menstrual age) underwent quiet-breathing structural pulmonary MRI (ultrashort echo-time and gradient echo) in a NICU-sited, neonatal-sized 1.5T scanner, without sedation or respiratory support unless already clinically prescribed. Disease severity was scored independently by two radiologists. Mean scores were compared to clinical severity and short-term respiratory outcomes. Outcomes were predicted using univariate and multivariable models including clinical data and scores. MRI scores significantly correlated with severities and predicted respiratory support at NICU discharge (P<0.0001). In multivariable models, MRI scores were by far the strongest predictor of respiratory support duration over clinical data, including birth weight and gestational age. Notably, NICHD severity level was not predictive of discharge support. Quiet-breathing neonatal pulmonary MRI can independently assess structural abnormalities of BPD, describe disease severity, and predict short-term outcomes more accurately than any individual standard clinical measure. Importantly, this non-ionizing technique can be implemented to phenotype disease and has potential to serially assess efficacy of individualized therapies.

Clinical outcomes of psychotherapy dropouts: does dropping out of psychotherapy necessarily mean failure?

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Rodrigo T. Lopes

2017-09-01

Full Text Available Objective: A large proportion of psychotherapy patients remain untreated, mostly because they drop out. This study compares the short- and long-term outcomes of patients who dropped out of psychotherapy to those of therapy completers. Methods: The sample included 63 patients (23 dropouts and 40 completers from a controlled clinical trial, which compared narrative therapy vs. cognitive-behavioral therapy for major depressive disorder. Patients were assessed at the eighth session, post-treatment, and at 31-month follow-up. Results: Dropouts improved less than completers by the last session attended, but continued to improve significantly more than completers during the follow-up period. Some dropout patients improved with a small dose of therapy (17% achieved a clinically significant change before abandoning treatment, while others only achieved clinically significant change after a longer period (62% at 31-month follow-up. Conclusion: These results emphasize the importance of dealing effectively with patients at risk of dropping out of therapy.Patients who dropped out also reported improvement of depressive symptoms without therapy, but took much longer to improve than did patients who completed therapy. This might be attributable to natural remission of depression. Further research should use a larger patient database, ideally gathered by meta-analysis.

Improving clinical outcomes in psychiatric care with touch-screen technology.

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Newnham, Elizabeth A; Doyle, Emma L; Sng, Adelln A H; Hooke, Geoffrey R; Page, Andrew C

2012-05-01

Patient-focused research, which uses clinical characteristics to predict outcomes, is a field in which information technology has been effectively integrated with practice. The present research used touch-screen technology to monitor the daily self-report measures of 1,308 consecutive inpatients and day patients participating in a 2-week cognitive-behavioral therapy group. Providing regular feedback was effective in reducing symptoms for patients at risk of poor outcomes (Newnham, Hooke, & Page, 2010b). The use of touch screens in psychiatric monitoring encourages a collaborative dialogue between patients and therapists and promotes engagement in the process of progress monitoring and treatment evaluation.

Correlation of clinical outcome to the estimated radiation dose from Boron Neutron Capture Therapy (BNCT)

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Chadha, M. [Beth Israel Medical Center, NY (United States). Dept. of Radiation Oncology; Coderre, J.A.; Chanana, A.D. [Brookhaven National Lab., Upton, NY (United States)] [and others

1996-12-31

A phase I/II trial delivering a single fraction of BNCT using p-Boronophenylalanine-Fructose and epithermal neutrons at the the Brookhaven Medical Research Reactor was initiated in September 1994. The primary endpiont of the study was to evaluate the feasibility and safety of a given BNCT dose. The clinical outcome of the disease was a secondary endpoint of the study. The objective of this paper is to evaluate the correlation of the clinical outcome of patients to the estimated radiation dose from BNCT.

Correlation of clinical outcome to the estimated radiation dose from Boron Neutron Capture Therapy (BNCT)

International Nuclear Information System (INIS)

Chadha, M.

1996-01-01

A phase I/II trial delivering a single fraction of BNCT using p-Boronophenylalanine-Fructose and epithermal neutrons at the the Brookhaven Medical Research Reactor was initiated in September 1994. The primary endpiont of the study was to evaluate the feasibility and safety of a given BNCT dose. The clinical outcome of the disease was a secondary endpoint of the study. The objective of this paper is to evaluate the correlation of the clinical outcome of patients to the estimated radiation dose from BNCT

Motor programme activating therapy influences adaptive brain functions in multiple sclerosis: clinical and MRI study.

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Rasova, Kamila; Prochazkova, Marie; Tintera, Jaroslav; Ibrahim, Ibrahim; Zimova, Denisa; Stetkarova, Ivana

2015-03-01

There is still little scientific evidence for the efficacy of neurofacilitation approaches and their possible influence on brain plasticity and adaptability. In this study, the outcome of a new kind of neurofacilitation approach, motor programme activating therapy (MPAT), was evaluated on the basis of a set of clinical functions and with MRI. Eighteen patients were examined four times with standardized clinical tests and diffusion tensor imaging to monitor changes without therapy, immediately after therapy and 1 month after therapy. Moreover, the strength of effective connectivity was analysed before and after therapy. Patients underwent a 1-h session of MPAT twice a week for 2 months. The data were analysed by nonparametric tests of association and were subsequently statistically evaluated. The therapy led to significant improvement in clinical functions, significant increment of fractional anisotropy and significant decrement of mean diffusivity, and decrement of effective connectivity at supplementary motor areas was observed immediately after the therapy. Changes in clinical functions and diffusion tensor images persisted 1 month after completing the programme. No statistically significant changes in clinical functions and no differences in MRI-diffusion tensor images were observed without physiotherapy. Positive immediate and long-term effects of MPAT on clinical and brain functions, as well as brain microstructure, were confirmed.

Clinical outcome of critically ill, not fully recompensated, patients undergoing MitraClip therapy

DEFF Research Database (Denmark)

Rudolph, Volker; Huntgeburth, Michael; von Bardeleben, Ralph Stephan

2014-01-01

AIMS: As periprocedural risk is low, MitraClip implantation is often performed in critically ill, not fully recompensated patients, who are in NYHA functional class IV at the time of the procedure, to accelerate convalescence. We herein sought to evaluate the procedural and 30-day outcome.......3%. CONCLUSION: MitraClip therapy is feasible and safe even in critically ill, not fully recompensated patients and leads to symptomatic improvement in over two-thirds of these patients; however, it is associated with an elevated 30-day mortality....

Boron neutron capture therapy using mixed epithermal and thermal neutron beams in patients with malignant glioma-correlation between radiation dose and radiation injury and clinical outcome

International Nuclear Information System (INIS)

Kageji, Teruyoshi; Nagahiro, Shinji; Matsuzaki, Kazuhito; Mizobuchi, Yoshifumi; Toi, Hiroyuki; Nakagawa, Yoshinobu; Kumada, Hiroaki

2006-01-01

Purpose: To clarify the correlation between the radiation dose and clinical outcome of sodium borocaptate-based intraoperative boron neutron capture therapy in patients with malignant glioma. Methods and Materials: The first protocol (P1998, n = 8) prescribed a maximal gross tumor volume (GTV) dose of 15 Gy. In 2001, a dose-escalated protocol was introduced (P2001, n 11), which prescribed a maximal vascular volume dose of 15 Gy or, alternatively, a clinical target volume (CTV) dose of 18 Gy. Results: The GTV and CTV doses in P2001 were 1.1-1.3 times greater than those in P1998. The maximal vascular volume dose of those with acute radiation injury was 15.8 Gy. The mean GTV and CTV dose in long-term survivors with glioblastoma was 26.4 and 16.5 Gy, respectively. A statistically significant correlation between the GTV dose and median survival time was found. In the 11 glioblastoma patients in P2001, the median survival time was 19.5 months and 1- and 2-year survival rate was 60.6% and 37.9%, respectively. Conclusion: Dose escalation contributed to the improvement in clinical outcome. To avoid radiation injury, the maximal vascular volume dose should be <12 Gy. For long-term survival in patients with glioblastoma after boron neutron capture therapy, the optimal mean dose of the GTV and CTV was 26 and 16 Gy, respectively

Clinical Trials of Immunogene Therapy for Spontaneous Tumors in Companion Animals

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Gerardo Claudio Glikin

2014-01-01

Full Text Available Despite the important progress obtained in the treatment of some pets’ malignancies, new treatments need to be developed. Being critical in cancer control and progression, the immune system’s appropriate modulation may provide effective therapeutic options. In this review we summarize the outcomes of published immunogene therapy veterinary clinical trials reported by many research centers. A variety of tumors such as canine melanoma, soft tissue sarcomas, osteosarcoma and lymphoma, feline fibrosarcoma, and equine melanoma were subjected to different treatment approaches. Both viral and mainly nonviral vectors were used to deliver gene products as cytokines, xenogeneic tumor associated antigens, specific ligands, and proapoptotic regulatory factors. In some cases autologous, allogenic, or xenogeneic transgenic cytokine producing cells were assayed. In general terms, minor or no adverse collateral effects appeared during this kind of therapies and treated patients usually displayed a better course of the disease (longer survival, delayed or suppressed recurrence or metastatic spread, and improvement of the quality of life. This suggests the utility of these methodologies as standard adjuvant treatments. The encouraging outcomes obtained in companion animals support their ready application in veterinary clinical oncology and serve as preclinical proof of concept and safety assay for future human gene therapy trials.

Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes.

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Gibson, E J; Begum, N; Koblbauer, I; Dranitsaris, G; Liew, D; McEwan, P; Tahami Monfared, A A; Yuan, Y; Juarez-Garcia, A; Tyas, D; Lees, M

2018-01-01

Economic models in oncology are commonly based on the three-state partitioned survival model (PSM) distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O) suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs). The PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%). Increased sophistication in the representation of disease dynamics in economic models is desirable when attempting to model treatment response in I-O. However, the assumptions underlying different model structures and the availability of data for health state mapping may be important limiting factors.

Clinical Outcomes of Image Guided Adaptive Hypofractionated Weekly Radiation Therapy for Bladder Cancer in Patients Unsuitable for Radical Treatment

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Hafeez, Shaista, E-mail: shaista.hafeez@icr.ac.uk [The Institute of Cancer Research, London (United Kingdom); The Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom); McDonald, Fiona; Lalondrelle, Susan [The Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom); McNair, Helen; Warren-Oseni, Karole; Jones, Kelly [The Institute of Cancer Research, London (United Kingdom); The Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom); Harris, Victoria [The Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom); Taylor, Helen; Khoo, Vincent [The Royal Marsden NHS Foundation Trust, London (United Kingdom); Thomas, Karen [The Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom); Hansen, Vibeke; Dearnaley, David; Horwich, Alan; Huddart, Robert [The Institute of Cancer Research, London (United Kingdom); The Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom)

2017-05-01

Purpose and Objectives: We report on the clinical outcomes of a phase 2 study assessing image guided hypofractionated weekly radiation therapy in bladder cancer patients unsuitable for radical treatment. Methods and Materials: Fifty-five patients with T2-T4aNx-2M0-1 bladder cancer not suitable for cystectomy or daily radiation therapy treatment were recruited. A “plan of the day” radiation therapy approach was used, treating the whole (empty) bladder to 36 Gy in 6 weekly fractions. Acute toxicity was assessed weekly during radiation therapy, at 6 and 12 weeks using the Common Terminology Criteria for Adverse Events version 3.0. Late toxicity was assessed at 6 months and 12 months using Radiation Therapy Oncology Group grading. Cystoscopy was used to assess local control at 3 months. Cumulative incidence function was used to determine local progression at 1 at 2 years. Death without local progression was treated as a competing risk. Overall survival was estimated using the Kaplan-Meier method. Results: Median age was 86 years (range, 68-97 years). Eighty-seven percent of patients completed their prescribed course of radiation therapy. Genitourinary and gastrointestinal grade 3 acute toxicity was seen in 18% (10/55) and 4% (2/55) of patients, respectively. No grade 4 genitourinary or gastrointestinal toxicity was seen. Grade ≥3 late toxicity (any) at 6 and 12 months was seen in 6.5% (2/31) and 4.3% (1/23) of patients, respectively. Local control after radiation therapy was 92% of assessed patients (60% total population). Cumulative incidence of local progression at 1 year and 2 years for all patients was 7% (95% confidence interval [CI] 2%-17%) and 17% (95% CI 8%-29%), respectively. Overall survival at 1 year was 63% (95% CI 48%-74%). Conclusion: Hypofractionated radiation therapy delivered weekly with a plan of the day approach offers good local control with acceptable toxicity in a patient population not suitable for radical bladder treatment.

Clinical Outcomes of Image Guided Adaptive Hypofractionated Weekly Radiation Therapy for Bladder Cancer in Patients Unsuitable for Radical Treatment

International Nuclear Information System (INIS)

Hafeez, Shaista; McDonald, Fiona; Lalondrelle, Susan; McNair, Helen; Warren-Oseni, Karole; Jones, Kelly; Harris, Victoria; Taylor, Helen; Khoo, Vincent; Thomas, Karen; Hansen, Vibeke; Dearnaley, David; Horwich, Alan; Huddart, Robert

2017-01-01

Purpose and Objectives: We report on the clinical outcomes of a phase 2 study assessing image guided hypofractionated weekly radiation therapy in bladder cancer patients unsuitable for radical treatment. Methods and Materials: Fifty-five patients with T2-T4aNx-2M0-1 bladder cancer not suitable for cystectomy or daily radiation therapy treatment were recruited. A “plan of the day” radiation therapy approach was used, treating the whole (empty) bladder to 36 Gy in 6 weekly fractions. Acute toxicity was assessed weekly during radiation therapy, at 6 and 12 weeks using the Common Terminology Criteria for Adverse Events version 3.0. Late toxicity was assessed at 6 months and 12 months using Radiation Therapy Oncology Group grading. Cystoscopy was used to assess local control at 3 months. Cumulative incidence function was used to determine local progression at 1 at 2 years. Death without local progression was treated as a competing risk. Overall survival was estimated using the Kaplan-Meier method. Results: Median age was 86 years (range, 68-97 years). Eighty-seven percent of patients completed their prescribed course of radiation therapy. Genitourinary and gastrointestinal grade 3 acute toxicity was seen in 18% (10/55) and 4% (2/55) of patients, respectively. No grade 4 genitourinary or gastrointestinal toxicity was seen. Grade ≥3 late toxicity (any) at 6 and 12 months was seen in 6.5% (2/31) and 4.3% (1/23) of patients, respectively. Local control after radiation therapy was 92% of assessed patients (60% total population). Cumulative incidence of local progression at 1 year and 2 years for all patients was 7% (95% confidence interval [CI] 2%-17%) and 17% (95% CI 8%-29%), respectively. Overall survival at 1 year was 63% (95% CI 48%-74%). Conclusion: Hypofractionated radiation therapy delivered weekly with a plan of the day approach offers good local control with acceptable toxicity in a patient population not suitable for radical bladder treatment.

Single case design studies in music therapy: resurrecting experimental evidence in small group and individual music therapy clinical settings.

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Geist, Kamile; Hitchcock, John H

2014-01-01

The profession would benefit from greater and routine generation of causal evidence pertaining to the impact of music therapy interventions on client outcomes. One way to meet this goal is to revisit the use of Single Case Designs (SCDs) in clinical practice and research endeavors in music therapy. Given the appropriate setting and goals, this design can be accomplished with small sample sizes and it is often appropriate for studying music therapy interventions. In this article, we promote and discuss implementation of SCD studies in music therapy settings, review the meaning of internal study validity and by extension the notion of causality, and describe two of the most commonly used SCDs to demonstrate how they can help generate causal evidence to inform the field. In closing, we describe the need for replication and future meta-analysis of SCD studies completed in music therapy settings. SCD studies are both feasible and appropriate for use in music therapy clinical practice settings, particularly for testing effectiveness of interventions for individuals or small groups. © the American Music Therapy Association 2014. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Do ictal EEG characteristics predict treatment outcomes in schizophrenic patients undergoing electroconvulsive therapy?

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Simsek, Gulnihal Gokce; Zincir, Selma; Gulec, Huseyin; Eksioglu, Sevgin; Semiz, Umit Basar; Kurtulmus, Yasemin Sipka

2015-08-01

The aim of this study is to investigate the relationship between features of electroencephalography (EEG), including seizure time, energy threshold level and post-ictal suppression time, and clinical variables, including treatment outcomes and side-effects, among schizophrenia inpatients undergoing electroconvulsive therapy (ECT). This is a naturalistic follow-up study on schizophrenia patients, diagnosed using DSM-IV-TR criteria, treated by a psychosis inpatient service. All participants completed the Brief Psychiatric Rating Scale (BPRS), the Global Assessment of Functioning (GAF) scale, the Frontal Assessment Battery (FAB) and a Data Collection Form. Assessments were made before treatment, during ECT and after treatment. Statistically significant improvements in both clinical and cognitive outcome were noted after ECT in all patients. Predictors of improvement were sought by evaluating electrophysiological variables measured at three time points (after the third, fifth and seventh ECT sessions). Logistic regression analysis showed that clinical outcome/improvement did not differ by seizure duration, threshold energy level or post-ictal suppression time. We found that ictal EEG parameters measured at several ECT sessions did not predict clinical recovery/outcomes. This may be because our centre defensively engages in "very specific patient selection" when ECT is contemplated. ECT does not cause short-term cognitive functional impairment and indeed improves cognition, because symptoms of the schizophrenic episode are alleviated.

Dysphagia management: an analysis of patient outcomes using VitalStim therapy compared to traditional swallow therapy.

Science.gov (United States)

Kiger, Mary; Brown, Catherine S; Watkins, Lynn

2006-10-01

This study compares the outcomes using VitalStim therapy to outcomes using traditional swallowing therapy for deglutition disorders. Twenty-two patients had an initial and a followup videofluoroscopic swallowing study or fiberoptic endoscopic evaluation of swallowing and were divided into an experimental group that received VitalStim treatments and a control group that received traditional swallowing therapy. Outcomes were analyzed for changes in oral and pharyngeal phase dysphagia severity, dietary consistency restrictions, and progression from nonoral to oral intake. Results of chi(2) analysis showed no statistically significant difference in outcomes between the experimental and control groups.

PHOTODYNAMIC THERAPY IN PATIENTS WITH DIFFERENT CLINICAL FORMS OF BASAL CELL CARCINOMA OF THE SKIN

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O. V. Matveeva

2014-01-01

Full Text Available Background: Photodynamic therapy is frequently applied for non-invasive destruction of basal cell carcinomas (BCC of the skin; though, there is lack of evidence for efficacy of the method. Aim: To assess objective response of BCCs to photodynamic therapy with intralesional administration of photosensitizer Radachlorin in patients with different clinical forms, stages, flow patterns and localization of BCC. Materials and methods: 45  stage I–II BCCs patients with primary and recurrent solitary (ulcerative, superficial, scleroderma-like and nodular forms and multiple lesions (predominantly Т₁– Т₂N₀M₀, with difficult to treat localization and high risk of recurrence were included during the period from March 2004 to March 2007. All patients received one cycle of photodynamic therapy with intralesional Radachlorin (0.5–1  ml/1  cm² tumor surface and irradiation dose 300  J/cm² (wavelength 662 nm. A primary outcome measure was grade of clinical and cytological lesion regression after three months. Secondary outcome measure was stable clinical and cytological reaction at the lesion site. In the long-term, lesion recurrence was assessed yearly during 5 years. Results: Complete regression of BCCs was found in 43  (95.5% patients and 47  (95.9% lesions. In 2 (4.5% patients with partial regression of 2 (4.1% lesions repeated cycles of photodynamic therapy resulted in complete response. In BCCs Т₁N₀M₀, early outcome was independent from the clinical form of the diseases; by contrast, in BCCs Т₂N₀M₀, treatment of scleroderma-like BCCs was non-significantly less effective (66.7% compared to nodular, surface (100% for both and ulcerative (92.8% forms. In the long-term, 1  tumor recurrence was observed after 29 months at the site of completely regressed ulcerative lesion. Conclusion: Photodynamic therapy with intralesional administration of photosensitizer Radachlorin is an effective treatment method for different

Early Clinical Outcomes and Toxicity of Intensity Modulated Versus Conventional Pelvic Radiation Therapy for Locally Advanced Cervix Carcinoma: A Prospective Randomized Study

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Gandhi, Ajeet Kumar, E-mail: ajeetgandhi23@gmail.com [Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi (India); Sharma, Daya Nand; Rath, Goura Kisor; Julka, Pramod Kumar; Subramani, Vellaiyan; Sharma, Seema; Manigandan, Durai; Laviraj, M.A. [Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi (India); Kumar, Sunesh [Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi (India); Thulkar, Sanjay [Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi (India)

2013-11-01

Purpose: To evaluate the toxicity and clinical outcome in patients with locally advanced cervical cancer (LACC) treated with whole pelvic conventional radiation therapy (WP-CRT) versus intensity modulated radiation therapy (WP-IMRT). Methods and Materials: Between January 2010 and January 2012, 44 patients with International Federation of Gynecology and Obstetrics (FIGO 2009) stage IIB-IIIB squamous cell carcinoma of the cervix were randomized to receive 50.4 Gy in 28 fractions delivered via either WP-CRT or WP-IMRT with concurrent weekly cisplatin 40 mg/m{sup 2}. Acute toxicity was graded according to the Common Terminology Criteria for Adverse Events, version 3.0, and late toxicity was graded according to the Radiation Therapy Oncology Group system. The primary and secondary endpoints were acute gastrointestinal toxicity and disease-free survival, respectively. Results: Of 44 patients, 22 patients received WP-CRT and 22 received WP-IMRT. In the WP-CRT arm, 13 patients had stage IIB disease and 9 had stage IIIB disease; in the IMRT arm, 12 patients had stage IIB disease and 10 had stage IIIB disease. The median follow-up time in the WP-CRT arm was 21.7 months (range, 10.7-37.4 months), and in the WP-IMRT arm it was 21.6 months (range, 7.7-34.4 months). At 27 months, disease-free survival was 79.4% in the WP-CRT group versus 60% in the WP-IMRT group (P=.651), and overall survival was 76% in the WP-CRT group versus 85.7% in the WP-IMRT group (P=.645). Patients in the WP-IMRT arm experienced significantly fewer grade ≥2 acute gastrointestinal toxicities (31.8% vs 63.6%, P=.034) and grade ≥3 gastrointestinal toxicities (4.5% vs 27.3%, P=.047) than did patients receiving WP-CRT and had less chronic gastrointestinal toxicity (13.6% vs 50%, P=.011). Conclusion: WP-IMRT is associated with significantly less toxicity compared with WP-CRT and has a comparable clinical outcome. Further studies with larger sample sizes and longer follow-up times are warranted to justify

Perlappendiceal inflammatory masses: CT-directed management and clinical outcome in 70 patients

International Nuclear Information System (INIS)

Jeffrey, R.B. Jr.; Tolentino, C.S.; Federle, M.P.

1987-01-01

The clinical outcome was reviewed in 70 patients with CT evidence of periappendiceal inflammatory masses. Thirty-two patients had either phlegmons or small abscesses (less than 3 cm). These patients were initially treated with antibiotic therapy alone, with resolution of the inflammatory process in 28 of the patients (88%). Twenty-eight patients underwent percutaneous abscess drainage of periappendiceal abscesses that was successful in 26 patients (93%). Although 13 patients (46%) had low-output fistulas communicating with the cecum, 12 of 13 closed with 2 weeks of drainage. Ten patients had early surgical drainage for extensive, poorly defined abscesses. Based on CT, a rational approach can be chosen to reduce morbidity and optimize clinical outcome

Clinical Severity as a Moderator of Outcome in Psychodynamic and Dialectical Behavior Therapies for Borderline Personality Disorder.

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Sahin, Zeynep; Vinnars, Bo; Gorman, Bernard S; Wilczek, Alexander; Åsberg, Marie; Barber, Jacques P

2017-12-14

The aim of the present study was to assess the effect of initial level of psychiatric severity on treatment outcome in psychodynamic therapy and dialectical behavior therapy (DBT) for borderline personality disorder (BPD). It was hypothesized that DBT would lead to better outcome for patients with high psychiatric severity, whereas dynamic treatment would lead to better outcome for patients with lower psychiatric severity. Data from the 5th-year follow-up of the Stockholm City Council's and the Karolinska Institute's Psychotherapy Project were used in the present study. A total of 106 female patients diagnosed with BPD with at least 2 past suicide attempts were randomized into object-relational psychotherapy (ORP; based on transference-focused psychotherapy), DBT, and treatment as usual. Patients' baseline global severity index was used as a moderator. Global Assessment of Functioning (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [American Psychiatric Association, 1994]) was used to examine outcome. There was a significant 3-way interaction of Time × Treatment × Severity. Post hoc analyses suggested that patients with lower levels of severity had significantly better outcomes in object-relational psychotherapy. For patients with higher severity, the 3 treatments resulted in similar outcomes in terms of level of functioning. Outcome of treatment for BPD might differ significantly for patients depending on their initial levels of overall psychiatric severity. If our findings are replicated for patients with low severity and supported for a high-severity sample, psychiatric severity can be used as a low-cost and effective tool to match patients with BPD to optimal treatments. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Outcomes of changing immunosuppressive therapy after treatment failure in patients with noninfectious uveitis.

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Joshi, Lavnish; Talat, Lazha; Yaganti, Satish; Sandhu, Sartaj; Taylor, Simon R J; Wakefield, Denis; McCluskey, Peter; Lightman, Susan

2014-05-01

To evaluate the outcomes of changing immunosuppressive therapy for noninfectious uveitis after failure. Retrospective cohort study. Patients with noninfectious uveitis managed at 2 tertiary uveitis clinics in the United Kingdom and Australia. Participants with a history of using immunosuppressive therapy were identified in clinics, and notes were reviewed by doctors trained in uveitis therapy. Each treatment episode/course (starting or changing a therapy) was identified, and demographic details, clinical characteristics, drug used (second-line immunosuppressive agent [ISA] or biologicals), and drug doses were obtained. For each treatment episode, the reasons for changing therapy, corticosteroid-sparing effects, and control of inflammation were determined. A total of 147 patients were identified who underwent 309 different treatment episodes. Fifty-five percent of patients eventually required a change in treatment after their first treatment episode/course. Forty-five episodes involved switching from one ISA to another, with 50% to 100% of these patients achieving "success" (prednisolone ≤10 mg and sustained control) with the new ISA. A combination of ISAs were used in 53 episodes, with "success" being achieved in 50% to 71% of these patients. Biological agents were used in 45 episodes, the most common one being infliximab, which achieved success in 80% of patients. Our data suggest that control of inflammation can be achieved after switching or combining ISAs. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Cognitive predictors and moderators of winter depression treatment outcomes in cognitive-behavioral therapy vs. light therapy.

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Sitnikov, Lilya; Rohan, Kelly J; Evans, Maggie; Mahon, Jennifer N; Nillni, Yael I

2013-12-01

There is no empirical basis for determining which seasonal affective disorder (SAD) patients are best suited for what type of treatment. Using data from a parent clinical trial comparing light therapy (LT), cognitive-behavioral therapy (CBT), and their combination (CBT + LT) for SAD, we constructed hierarchical linear regression models to explore baseline cognitive vulnerability constructs (i.e., dysfunctional attitudes, negative automatic thoughts, response styles) as prognostic and prescriptive factors of acute and next winter depression outcomes. Cognitive constructs did not predict or moderate acute treatment outcomes. Baseline dysfunctional attitudes and negative automatic thoughts were prescriptive of next winter treatment outcomes. Participants with higher baseline levels of dysfunctional attitudes and negative automatic thoughts had less severe depression the next winter if treated with CBT than if treated with LT. In addition, participants randomized to solo LT who scored at or above the sample mean on these cognitive measures at baseline had more severe depressive symptoms the next winter relative to those who scored below the mean. Baseline dysfunctional attitudes and negative automatic thoughts did not predict treatment outcomes in participants assigned to solo CBT or CBT + LT. Therefore, SAD patients with extremely rigid cognitions did not fare as well in the subsequent winter if treated initially with solo LT. Such patients may be better suited for initial treatment with CBT, which directly targets cognitive vulnerability processes. Copyright © 2013 Elsevier Ltd. All rights reserved.

Photodynamic therapy in clinical practice

Directory of Open Access Journals (Sweden)

E. V. Filonenko

2016-01-01

Full Text Available The review is on opportunities and possibilities of application of photodynamic therapy in clinical practice. The advantages of this method are the targeting of effect on tumor foci and high efficiency along with low systemic toxicity. The results of the set of recent Russian and foreign clinical trials are represented in the review. The method is successfully used in clinical practice with both radical (for early vulvar, cervical cancer and pre-cancer, central early lung cancer, esophageal and gastric cancer, bladder cancer and other types of malignant tumors, and palliative care (including tumor pleuritis, gastrointestinal tumors and others. Photodynamic therapy delivers results which are not available for other methods of cancer therapy. Thus, photodynamic therapy allows to avoid gross scars (that is very important, for example, in gynecology for treatment of patients of reproductive age with cervical and vulvar cancer, delivers good cosmetic effect for skin tumors, allows minimal trauma for intact tissue surrounding tumor. Photodynamic therapy is also used in other fields of medicine, such as otorhinolaryngology, dermatology, ophthalmology, orthopaedics, for treatment of papilloma virus infection and purulent wounds as antibacterial therapy.

Couple characteristics and outcome of therapy in vaginismus.

Science.gov (United States)

Munasinghe, Thiloma; Goonaratna, Colvin; de Silva, Padmal

2004-06-01

To describe couple characteristics and outcome of therapy in vaginismus. A prospective before-after intervention descriptive study. Department of Physiology, Faculty of Medicine, Colombo, Sri Lanka. Fifty six couples with vaginismus, mostly self referrals and referrals from gynaecologists and general practitioners, were treated with a standard cognitive behaviour therapy protocol with before-after assessments of the degree of vaginismus and individual partner self-ratings of the relationship and psychological status (GHQ-30). Success at the end of the therapy was equated to the absence of or only mild vaginismus and, improvement in the couple relationship and psychological status scores. Twenty seven (48%) of the 52 (93%) couples with non-consummation reported failure of coitus following previous non-surgical and surgical interventions. Love marriages (70%), frequent attempts at sex (75%, 3 or 4 times/week) and sexual arousal (women = 86%, men = 89%) characterised couples. Ten men developed sexual problems, mostly erectile failure and premature ejaculation secondarily. Couple therapy enabled penetrative sex in 45 (80.3%). The single prognostic indicator of outcome was the degree of vaginismus at first visit, those with mild and moderate vaginismus (77%) being significantly more likely to establish coitus (p0.01) but the psychological status remained unchanged. Dropouts and referrals for psychiatric and marital counselling failed to complete therapy. Couple sex therapy is effective in the management of vaginismus. Health professionals, especially gynaecologists and general practitioners, need to be aware of the problem and the satisfactory outcome of sex therapy.

Longterm clinical outcomes of omalizumab therapy in severe allergic asthma: Study of efficacy and safety.

Science.gov (United States)

Mansur, Adel H; Srivastava, Sapna; Mitchell, Verity; Sullivan, Julie; Kasujee, Ismail

2017-03-01

Omalizumab has been shown to be an effective add-on therapy for patients with uncontrolled severe persistent allergic asthma. There has been a steady accumulation of evidence on the long-term effectiveness of omalizumab; however, data on real-life outcomes beyond one year of treatment is limited. In this study, we report on long-term outcomes of omalizumab treatment. We collected data from our severe asthma registry on hospitalisations, exacerbations, corticosteroid sparing, asthma control, lung function, biomarkers and side effects, to determine if the benefit was sustained and treatment was safe on the long term. Forty-five patients [mean age 44.9 years (range 19-69), females 37/45 (82%), mean duration of omalizumab treatment = 60.7 ± 30.9 months (range 23-121) were included in the analysis. We observed a reduction in the annual acute asthma related hospital admissions for the total population from 207 at baseline to 40 on treatment (80.7% reduction), whilst the per patient annual hospitalisations were reduced from a mean of 4.8 to 0.89 post-omalizumab treatment (p omalizumab therapy. Copyright © 2017 Elsevier Ltd. All rights reserved.

Project Baiterek: A Patient Access Program to Improve Clinical Outcomes and Quality of Life in Children with Type 1 Diabetes in Kazakhstan.

Science.gov (United States)

Muratalina, Aigul; Smith-Palmer, Jayne; Nurbekova, Akmaral; Abduakhassova, Gulmira; Zhubandykova, Leila; Roze, Stéphane; Karamalis, Manolis; Shamshatova, Gulzhakhan; Demessinov, Adi; D'Agostino, Nicola Dunne; Lynch, Peter; Yedigarova, Larisa; Klots, Motty; Valentine, William; Welsh, John; Kaufman, Francine

2015-09-01

Diabetes is a key driver in the rise of noncommunicable diseases globally. It causes expensive and burdensome short- and long-term complications, with both an economic and social impact. In many countries, however, access to care and disease management in type 1 diabetes is suboptimal, increasing the risk for complications. In 2011, Project Baiterek was initiated as a collaborative effort between the Kazakhstan Ministry of Health, industry (Medtronic Plc), local physicians, and the Diabetes Association of the Republic of Kazakhstan to enhance patient access to continuous subcutaneous insulin infusion (CSII) therapy. It was the first countrywide project to provide equity and universal access to insulin pump therapy among children with type 1 diabetes, increasing pump use from zero to two-thirds of this population in less than 3 years. The project also involved instigating longitudinal data collection, and long-term clinical outcomes continue to be monitored. Here, we provide an overview of the clinical, quality-of-life, and economic outcomes to date associated with providing CSII therapy to children with type 1 diabetes in Kazakhstan. Initial clinical data show that CSII therapy improved clinical outcomes and quality of life for patients entered into the program and that CSII therapy was cost-effective relative to multiple daily injection therapy. The positive outcomes of Project Baiterek provide a template for similar patient access programs in other settings, and its framework could be adapted to initiatives to change health care infrastructures and standards of care for other noncommunicable diseases. Copyright © 2015. Published by Elsevier Inc.

Effect of periodontal therapy on pregnancy outcome in women affected by periodontitis.

Science.gov (United States)

Tarannum, Fouzia; Faizuddin, Mohamed

2007-11-01

There is convincing evidence to suggest that infections affecting the mother during pregnancy may produce alterations in the normal cytokine- and hormone-regulated gestation, which could result in preterm labor, premature rupture of membranes, and preterm birth (PTB). Studies in the late 1990s associated periodontitis with preterm low birth weight (PLBW) deliveries, and this may have similar pathogenic mechanisms as other maternal infections. This study determined the effect of non-surgical periodontal therapy on pregnancy outcome. A total of 200 pregnant women with periodontitis were randomly assigned to treatment and control groups. Detailed data about previous and current pregnancies were obtained. All women received a full-mouth periodontal examination, including oral hygiene index-simplified, bleeding index, and clinical attachment level. The women in the treatment group received non-surgical periodontal therapy during the gestational period, and those in the control group received periodontal treatment after delivery. Periodontal therapy included plaque control instructions and scaling and root planing performed under local anesthesia. The outcome measures assessed were gestational age and birth weight of the infant. PTB was recorded when delivery occurred at PTBs in the treatment group and 68 PTBs in the control group. Twenty-six LBW infants were recorded in the treatment group, and 48 LBW infants were noted in the control group. The mean gestational ages were 33.8+/-2.8 weeks and 32.7+/-2.8 weeks in the treatment and control groups, respectively. The difference was statistically significant at P<0.006. The mean birth weight was 2,565.3+/-331.2 g in the treatment group and 2,459.6+/-380.7 g in the control group, with the difference being statistically significant at P<0.044. A multiple regression model showed a significant effect of periodontal treatment on birth outcomes. Non-surgical periodontal therapy can reduce the risk for preterm births in mothers who

[Individual therapy goals: on outcome documentation of inpatient psychotherapy from the patient and therapist viewpoint].

Science.gov (United States)

Heuft, G; Senf, W; Wagener, R; Pintelon, C; Lorenzen, J

1996-01-01

The results of a study evaluation in practicability of two newly developed documentation forms are presented. Examined are 82 inpatient treatment episodes in an already published clinical concept with different treatment settings. Parallel versions of the forms were completed by patients and therapists. The 'Erge-Doku-A-Form' allows for the naming of up to five therapy goals determined at the beginning of therapy and evaluated in relation to their achieved quality at the end of therapy. The 'Erge-Doku-B-Form' describes a variety of problem areas as well as questions related to medication and changes induced by therapy. Surprising there were a high number of 230 Individual Therapy Goals (ITG) by patients and 262 ITG by therapists which could be arranged into 89 content categories and 5 main categories. Outcome measurement shows different results. There was a significant relationship between the 'well-being', the impression of 'satisfying treatment' at the end of the inpatient period and 'success in the main ITG'. The documentation forms presented here allow an outcome-measurement depending on differential indications.

Clinical efficacy, onset time and safety of bright light therapy in acute bipolar depression as an adjunctive therapy: A randomized controlled trial.

Science.gov (United States)

Zhou, Tian-Hang; Dang, Wei-Min; Ma, Yan-Tao; Hu, Chang-Qing; Wang, Ning; Zhang, Guo-Yi; Wang, Gang; Shi, Chuan; Zhang, Hua; Guo, Bin; Zhou, Shu-Zhe; Feng, Lei; Geng, Shu-Xia; Tong, Yu-Zhen; Tang, Guan-Wen; He, Zhong-Kai; Zhen, Long; Yu, Xin

2018-02-01

Bright light therapy (BLT) is an effective treatment for seasonal affective disorder and non- seasonal depression. The efficacy of BLT in treating patients with bipolar disorder is still unknown. The aim of this study is to examine the efficacy, onset time and clinical safety of BLT in treating patients with acute bipolar depression as an adjunctive therapy (trial registration at ClinicalTrials.gov: NCT02009371). This was a multi-center, single blind, randomized clinical trial. Seventy-four participants were randomized in one of two treatment conditions: BLT and control (dim red light therapy, dRLT). Sixty-three participants completed the study (33 BLT, 30 dRLT). Light therapy lasted for two weeks, one hour every morning. All participants were required to complete several scales assessments at baseline, and at the end of weeks 1 and 2. The primary outcome measures were the clinical efficacy of BLT which was assessed by the reduction rate of HAMD-17 scores, and the onset time of BLT which was assessed by the reduction rate of QIDS-SR16 scores. The secondary outcome measures were rates of switch into hypomania or mania and adverse events. 1) Clinical efficacy: BLT showed a greater ameliorative effect on bipolar depression than the control, with response rates of 78.19% vs. 43.33% respectively (p < 0.01). 2) Onset day: Median onset day was 4.33 days in BLT group. 3) BLT-emergent hypomania: No participants experienced symptoms of hypomania. 4) Side effects: No serious adverse events were reported. BLT can be considered as an effective and safe adjunctive treatment for patients with acute bipolar depression. Copyright © 2017 Elsevier B.V. All rights reserved.

Examining the relation between the therapeutic alliance, treatment adherence, and outcome of cognitive behavioral therapy for children with anxiety disorders

NARCIS (Netherlands)

Liber, Juliette M.; McLeod, Bryce D.; van Widenfelt, Brigit M.; Goedhart, Arnold W.; van der Leeden, Adelinde J. M.; Utens, Elisabeth M. W. J.; Treffers, Philip D. A.

2010-01-01

Little is known about the contribution of technical and relational factors to child outcomes in cognitive behavioral therapy (CBT) for children with anxiety disorders. This study investigated the association between treatment adherence, the child-therapist alliance, and child clinical outcomes in

Comparison of Long-Term Outcomes in Adolescents with Anorexia Nervosa Treated with Family Therapy

Science.gov (United States)

Lock, James; Couturier, Jennifer; Agras, W. Stewart

2006-01-01

Objective: To describe the relative effectiveness of a short versus long course of family-based therapy (FBT) for adolescent anorexia nervosa at long-term follow-up. Method: This study used clinical and structured interviews to assess psychological and psychosocial outcomes of adolescents (ages 12-18 years at baseline) who were previously treated…

Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes

Directory of Open Access Journals (Sweden)

Gibson EJ

2018-03-01

Full Text Available EJ Gibson,1 N Begum,1 I Koblbauer,1 G Dranitsaris,2 D Liew,3 P McEwan,4 AA Tahami Monfared,5,6 Y Yuan,7 A Juarez-Garcia,7 D Tyas,8 M Lees9 1Wickenstones Ltd, Didcot, UK; 2Augmentium Pharma Consulting Inc, Toronto, ON, Canada; 3Department of Epidemiology and Preventive Medicine, Alfred Hospital, Monash University, Melbourne, VIC, Australia; 4Health Economics and Outcomes Research Ltd, Cardiff, UK; 5Bristol-Myers Squibb Canada, Saint-Laurent, QC Canada; 6Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada; 7Bristol-Myers Squibb, Princeton, NJ, USA; 8Bristol-Myers Squibb, Uxbridge, UK; 9Bristol-Myers Squibb, Rueil-Malmaison, France Background: Economic models in oncology are commonly based on the three-state partitioned survival model (PSM distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. Materials and methods: This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs. Results: The PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%. Conclusion: Increased sophistication in the representation of disease dynamics in economic models

Computerised mirror therapy with Augmented Reflection Technology for early stroke rehabilitation: clinical feasibility and integration as an adjunct therapy.

Science.gov (United States)

Hoermann, Simon; Ferreira Dos Santos, Luara; Morkisch, Nadine; Jettkowski, Katrin; Sillis, Moran; Devan, Hemakumar; Kanagasabai, Parimala S; Schmidt, Henning; Krüger, Jörg; Dohle, Christian; Regenbrecht, Holger; Hale, Leigh; Cutfield, Nicholas J

2017-07-01

New rehabilitation strategies for post-stroke upper limb rehabilitation employing visual stimulation show promising results, however, cost-efficient and clinically feasible ways to provide these interventions are still lacking. An integral step is to translate recent technological advances, such as in virtual and augmented reality, into therapeutic practice to improve outcomes for patients. This requires research on the adaptation of the technology for clinical use as well as on the appropriate guidelines and protocols for sustainable integration into therapeutic routines. Here, we present and evaluate a novel and affordable augmented reality system (Augmented Reflection Technology, ART) in combination with a validated mirror therapy protocol for upper limb rehabilitation after stroke. We evaluated components of the therapeutic intervention, from the patients' and the therapists' points of view in a clinical feasibility study at a rehabilitation centre. We also assessed the integration of ART as an adjunct therapy for the clinical rehabilitation of subacute patients at two different hospitals. The results showed that the combination and application of the Berlin Protocol for Mirror Therapy together with ART was feasible for clinical use. This combination was integrated into the therapeutic plan of subacute stroke patients at the two clinical locations where the second part of this research was conducted. Our findings pave the way for using technology to provide mirror therapy in clinical settings and show potential for the more effective use of inpatient time and enhanced recoveries for patients. Implications for Rehabilitation Computerised Mirror Therapy is feasible for clinical use Augmented Reflection Technology can be integrated as an adjunctive therapeutic intervention for subacute stroke patients in an inpatient setting Virtual Rehabilitation devices such as Augmented Reflection Technology have considerable potential to enhance stroke rehabilitation.

Endosonographic and manometric evaluation of internal anal sphincter in patients with chronic anal fissure and its correlation with clinical outcome after topical glyceryl trinitrate therapy.

Science.gov (United States)

Pascual, Marta; Pera, Miguel; Courtier, Ricard; Gil, Mariá José; Parés, David; Puig, Sonia; Andreu, Montserrat; Grande, Luis

2007-08-01

Anorectal pressure studies have demonstrated internal anal sphincter (IAS) hypertonia in patients with chronic anal fissure. It is unknown however, if these changes in IAS function are associated with any abnormality in sphincter morphology. The first aim was to investigate the clinical characteristics and the manometric and endosonographic findings of the IAS in a cohort of patients with chronic anal fissure. The second aim was to investigate the association between these findings and the outcome with topical Glyceryl trinitrate (GTN) therapy. All patients who presented with chronic anal fissure from November 1999 to May 2004 were included after failure of conservative therapy. Anorectal manometry and anal endosonography were performed before treatment with 0.2% GTN ointment twice daily was initiated. Patients were evaluated after 8 weeks. One hundred and twenty-four patients (66 women, mean age, 45.2 +/- 14.8 years) were included. Hypertonia of the IAS was found in 84 (68%) patients. The mean maximum IAS thickness was 3.6 +/- 0.76 mm (1.6-5.5). An abnormally thick IAS, adjusted by age, was observed in 113 (91.1%) patients. We found no correlation between resting pressure and IAS thickness (r = 0.074; p = 0.41). At 8 weeks, 52 patients (42%) had healed with complete symptoms resolution. No statistically significant differences were observed when clinical features and manometric and endosonographic findings were compared between healing and no-healing fissures. The majority of patients with chronic anal fissure present an abnormally thick IAS. Clinical, manometric and endosonographic features had no association with outcome after GTN treatment.

Criteria for evaluating response and outcome in clinical trials for children with juvenile myelomonocytic leukemia.

LENUS (Irish Health Repository)

Niemeyer, Charlotte M

2015-01-01

Juvenile myelomonocytic leukemia is a rare myeloproliferative disease in young children. While hematopoietic stem cell transplantation remains the only curative therapeutic option for most patients, children with juvenile myelomonocytic leukemia increasingly receive novel agents in phase I-II clinical trials as pre-transplant therapy or therapy for relapse after transplantation. However, response criteria or definitions of outcome for standardized evaluation of treatment effect in patients with juvenile myelomonocytic leukemia are currently lacking. Here we propose criteria to evaluate the response to the non-transplant therapy and definitions of remission status after hematopoietic stem cell transplantation. For the evaluation of non-transplant therapy, we defined 6 clinical variables (white blood cell count, platelet count, hematopoietic precursors and blasts in peripheral blood, bone marrow blast percentage, spleen size and extramedullary disease) and 3 genetic variables (cytogenetic, molecular and chimerism response) which serve to describe the heterogeneous picture of response to therapy in each individual case. It is hoped that these criteria will facilitate the comparison of results between clinical trials in juvenile myelomonocytic leukemia.

Clinical research evidence of cupping therapy in China: a systematic literature review

Directory of Open Access Journals (Sweden)

Wang Qian

2010-11-01

Full Text Available Abstract Background Though cupping therapy has been used in China for thousands of years, there has been no systematic summary of clinical research on it. This review is to evaluate the therapeutic effect of cupping therapy using evidence-based approach based on all available clinical studies. Methods We included all clinical studies on cupping therapy for all kinds of diseases. We searched six electronic databases, all searches ended in December 2008. We extracted data on the type of cupping and type of diseases treated. Results 550 clinical studies were identified published between 1959 and 2008, including 73 randomized controlled trials (RCTs, 22 clinical controlled trials, 373 case series, and 82 case reports. Number of RCTs obviously increased during past decades, but the quality of the RCTs was generally poor according to the risk of bias of the Cochrane standard for important outcome within each trials. The diseases in which cupping was commonly employed included pain conditions, herpes zoster, cough or asthma, etc. Wet cupping was used in majority studies, followed by retained cupping, moving cupping, medicinal cupping, etc. 38 studies used combination of two types of cupping therapies. No serious adverse effects were reported in the studies. Conclusions According to the above results, quality and quantity of RCTs on cupping therapy appears to be improved during the past 50 years in China, and majority of studies show potential benefit on pain conditions, herpes zoster and other diseases. However, further rigorous designed trials in relevant conditions are warranted to support their use in practice.

Clinical research evidence of cupping therapy in China: a systematic literature review.

Science.gov (United States)

Cao, Huijuan; Han, Mei; Li, Xun; Dong, Shangjuan; Shang, Yongmei; Wang, Qian; Xu, Shu; Liu, Jianping

2010-11-16

Though cupping therapy has been used in China for thousands of years, there has been no systematic summary of clinical research on it.This review is to evaluate the therapeutic effect of cupping therapy using evidence-based approach based on all available clinical studies. We included all clinical studies on cupping therapy for all kinds of diseases. We searched six electronic databases, all searches ended in December 2008. We extracted data on the type of cupping and type of diseases treated. 550 clinical studies were identified published between 1959 and 2008, including 73 randomized controlled trials (RCTs), 22 clinical controlled trials, 373 case series, and 82 case reports. Number of RCTs obviously increased during past decades, but the quality of the RCTs was generally poor according to the risk of bias of the Cochrane standard for important outcome within each trials. The diseases in which cupping was commonly employed included pain conditions, herpes zoster, cough or asthma, etc. Wet cupping was used in majority studies, followed by retained cupping, moving cupping, medicinal cupping, etc. 38 studies used combination of two types of cupping therapies. No serious adverse effects were reported in the studies. According to the above results, quality and quantity of RCTs on cupping therapy appears to be improved during the past 50 years in China, and majority of studies show potential benefit on pain conditions, herpes zoster and other diseases. However, further rigorous designed trials in relevant conditions are warranted to support their use in practice.

Cognitive-Behavior Therapy (CBT) for Panic Disorder: Relationship of Anxiety and Depression Comorbidity with Treatment Outcome

OpenAIRE

Allen, Laura B.; White, Kamila S.; Barlow, David H.; Shear, M. Katherine; Gorman, Jack M.; Woods, Scott W.

2009-01-01

Research evaluating the relationship of comorbidity to treatment outcome for panic disorder has produced mixed results. The current study examined the relationship of comorbid depression and anxiety to treatment outcome in a large-scale, multi-site clinical trial for cognitive-behavior therapy (CBT) for panic disorder. Comorbidity was associated with more severe panic disorder symptoms, although comorbid diagnoses were not associated with treatment response. Comorbid generalized anxiety disor...

Pneumothorax following Endobronchial Valve Therapy and Its Impact on Clinical Outcomes in Severe Emphysema

NARCIS (Netherlands)

Gompelmann, Daniela; Herth, Felix J. F.; Slebos, Dirk Jan; Valipour, Arschang; Ernst, Armin; Criner, Gerard J.; Eberhardt, Ralf

2014-01-01

Background: Patients who achieve significant target lobe volume reduction (TLVR) following endobronchial valve (EBV) treatment may experience substantial improvements in clinical outcome measures. However, in cases of rapid TLVR, the risk of pneumothorax increases due to parenchymal rupture of the

Impact Exerted by Nutritional Risk Screening on Clinical Outcome of Patients with Esophageal Cancer

OpenAIRE

Rui Wang; Hongfei Cai; Yang Li; Caiwen Chen; Youbin Cui

2018-01-01

Objective. Preoperative nutritional status of patients is closely associated with their recovery after the surgery. This study aims to ascertain the impact exerted by the nutritional risk screening on clinical outcome of patients with esophageal cancer. Methods. 160 patients with esophageal cancer aged over 60, having got therapy at the First Hospital of Jilin University from Jun 2016 to Feb 2017 were evaluated by adopting the NRS2002. 80 cases of patients got active therapy of nutritional su...

Antiretroviral therapy during pregnancy and the risk of an adverse outcome.

Science.gov (United States)

Tuomala, Ruth E; Shapiro, David E; Mofenson, Lynne M; Bryson, Yvonne; Culnane, Mary; Hughes, Michael D; O'Sullivan, M J; Scott, Gwendolyn; Stek, Alice M; Wara, Diane; Bulterys, Marc

2002-06-13

Some studies suggest that combination antiretroviral therapy in pregnant women with human immunodeficiency virus type 1 (HIV-1) infection increases the risk of premature birth and other adverse outcomes of pregnancy. We studied pregnant women with HIV-1 infection who were enrolled in seven clinical studies and delivered their infants from 1990 through 1998. The cohort comprised 2123 women who received antiretroviral therapy during pregnancy (monotherapy in 1590, combination therapy without protease inhibitors in 396, and combination therapy with protease inhibitors in 137) and 1143 women who did not receive antiretroviral therapy. After standardization for the CD4+ cell count and use or nonuse of tobacco, alcohol, and illicit drugs, the rate of premature delivery (women who received antiretroviral therapy and those who did not (16 percent and 17 percent, respectively); the rate of low birth weight (women who received combination therapy with protease inhibitors (5 percent) had infants with very low birth weight, as compared with nine women who received combination therapy without protease inhibitors (2 percent) (adjusted odds ratio, 3.56; 95 percent confidence interval, 1.04 to 12.19). As compared with no antiretroviral therapy or monotherapy, combination therapy for HIV-1 infection in pregnant women is not associated with increased rates of premature delivery or with low birth weight, low Apgar scores, or stillbirth in their infants. The association between combination therapy with protease inhibitors and an increased risk of very low birth weight requires confirmation.

The relationship between interpersonal problems, therapeutic alliance, and outcomes following group and individual cognitive behaviour therapy.

Science.gov (United States)

McEvoy, Peter M; Burgess, Melissa M; Nathan, Paula

2014-03-01

Cognitive behavioural therapy (CBT) is efficacious, but there remains individual variability in outcomes. Patient's interpersonal problems may affect treatment outcomes, either directly or through a relationship mediated by helping alliance. Interpersonal problems may affect alliance and outcomes differentially in individual and group (CBGT) treatments. The main aim of this study was to investigate the relationship between interpersonal problems, alliance, dropout and outcomes for a clinical sample receiving either individual or group CBT for anxiety or depression in a community clinic. Patients receiving individual CBT (N=84) or CBGT (N=115) completed measures of interpersonal problems, alliance, and disorder specific symptoms at the commencement and completion of CBT. In CBGT higher pre-treatment interpersonal problems were associated with increased risk of dropout and poorer outcomes. This relationship was not mediated by alliance. In individual CBT those who reported higher alliance were more likely to complete treatment, although alliance was not associated with symptom change, and interpersonal problems were not related to attrition or outcome. Allocation to group and individual therapy was non-random, so selection bias may have influenced these results. Some analyses were only powered to detect large effects. Helping alliance ratings were high, so range restriction may have obscured the relationship between helping alliance, attrition and outcomes. Pre-treatment interpersonal problems increase risk of dropout and predict poorer outcomes in CBGT, but not in individual CBT, and this relationship is not mediated by helping alliance. Stronger alliance is associated with treatment completion in individual, but not group CBT. Copyright © 2014 Elsevier B.V. All rights reserved.

Tobacco Smoking During Radiation Therapy for Head-and-Neck Cancer Is Associated With Unfavorable Outcome

International Nuclear Information System (INIS)

Chen, Allen M.; Chen, Leon M.; Vaughan, Andrew; Sreeraman, Radhika; Farwell, D. Gregory; Luu, Quang; Lau, Derick H.; Stuart, Kerri; Purdy, James A.; Vijayakumar, Srinivasan

2011-01-01

Purpose: To evaluate the effect of continued cigarette smoking among patients undergoing radiation therapy for head-and-neck cancer by comparing the clinical outcomes among active smokers and quitters. Methods and Materials: A review of medical records identified 101 patients with newly diagnosed squamous cell carcinoma of the head and neck who continued to smoke during radiation therapy. Each active smoker was matched to a control patient who had quit smoking before initiation of radiation therapy. Matching was based on tobacco history (pack-years), primary site, age, sex, Karnofsky Performance Status, disease stage, radiation dose, chemotherapy use, year of treatment, and whether surgical resection was performed. Outcomes were compared by use of Kaplan-Meier analysis. Normal tissue effects were graded according to the Radiation Therapy Oncology Group/European Organization for the Treatment of Cancer toxicity criteria. Results: With a median follow-up of 49 months, active smokers had significantly inferior 5-year overall survival (23% vs. 55%), locoregional control (58% vs. 69%), and disease-free survival (42% vs. 65%) compared with the former smokers who had quit before radiation therapy (p < 0.05 for all). These differences remained statistically significant when patients treated by postoperative or definitive radiation therapy were analyzed separately. The incidence of Grade 3 or greater late complications was also significantly increased among active smokers compared with former smokers (49% vs. 31%, p = 0.01). Conclusions: Tobacco smoking during radiation therapy for head-and-neck cancer is associated with unfavorable outcomes. Further studies analyzing the biologic and molecular reasons underlying these differences are planned.

Radiosensitivity Differences Between Liver Metastases Based on Primary Histology Suggest Implications for Clinical Outcomes After Stereotactic Body Radiation Therapy

Energy Technology Data Exchange (ETDEWEB)

Ahmed, Kamran A.; Caudell, Jimmy J. [Department of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida (United States); El-Haddad, Ghassan [Department of Interventional Radiology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida (United States); Berglund, Anders E.; Welsh, Eric A. [Department of Bioinformatics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida (United States); Yue, Binglin [Department of Biostastistics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida (United States); Hoffe, Sarah E.; Naghavi, Arash O.; Abuodeh, Yazan A.; Frakes, Jessica M. [Department of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida (United States); Eschrich, Steven A. [Department of Bioinformatics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida (United States); Torres-Roca, Javier F., E-mail: Javier.torresroca@moffitt.org [Department of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida (United States)

2016-08-01

Purpose/Objectives: Evidence from the management of oligometastases with stereotactic body radiation therapy (SBRT) reveals differences in outcomes based on primary histology. We have previously identified a multigene expression index for tumor radiosensitivity (RSI) with validation in multiple independent cohorts. In this study, we assessed RSI in liver metastases and assessed our clinical outcomes after SBRT based on primary histology. Methods and Materials: Patients were identified from our prospective, observational protocol. The previously tested RSI 10 gene assay was run on samples and calculated using the published algorithm. An independent cohort of 33 patients with 38 liver metastases treated with SBRT was used for clinical correlation. Results: A total of 372 unique metastatic liver lesions were identified for inclusion from our prospective, institutional metadata pool. The most common primary histologies for liver metastases were colorectal adenocarcinoma (n=314, 84.4%), breast adenocarcinoma (n=12, 3.2%), and pancreas neuroendocrine (n=11, 3%). There were significant differences in RSI of liver metastases based on histology. The median RSIs for liver metastases in descending order of radioresistance were gastrointestinal stromal tumor (0.57), melanoma (0.53), colorectal neuroendocrine (0.46), pancreas neuroendocrine (0.44), colorectal adenocarcinoma (0.43), breast adenocarcinoma (0.35), lung adenocarcinoma (0.31), pancreas adenocarcinoma (0.27), anal squamous cell cancer (0.22), and small intestine neuroendocrine (0.21) (P<.0001). The 12-month and 24-month Kaplan-Meier rates of local control (LC) for colorectal lesions from the independent clinical cohort were 79% and 59%, compared with 100% for noncolorectal lesions (P=.019), respectively. Conclusions: In this analysis, we found significant differences based on primary histology. This study suggests that primary histology may be an important factor to consider in SBRT radiation dose selection.

Radiosensitivity Differences Between Liver Metastases Based on Primary Histology Suggest Implications for Clinical Outcomes After Stereotactic Body Radiation Therapy

International Nuclear Information System (INIS)

Ahmed, Kamran A.; Caudell, Jimmy J.; El-Haddad, Ghassan; Berglund, Anders E.; Welsh, Eric A.; Yue, Binglin; Hoffe, Sarah E.; Naghavi, Arash O.; Abuodeh, Yazan A.; Frakes, Jessica M.; Eschrich, Steven A.; Torres-Roca, Javier F.

2016-01-01

Purpose/Objectives: Evidence from the management of oligometastases with stereotactic body radiation therapy (SBRT) reveals differences in outcomes based on primary histology. We have previously identified a multigene expression index for tumor radiosensitivity (RSI) with validation in multiple independent cohorts. In this study, we assessed RSI in liver metastases and assessed our clinical outcomes after SBRT based on primary histology. Methods and Materials: Patients were identified from our prospective, observational protocol. The previously tested RSI 10 gene assay was run on samples and calculated using the published algorithm. An independent cohort of 33 patients with 38 liver metastases treated with SBRT was used for clinical correlation. Results: A total of 372 unique metastatic liver lesions were identified for inclusion from our prospective, institutional metadata pool. The most common primary histologies for liver metastases were colorectal adenocarcinoma (n=314, 84.4%), breast adenocarcinoma (n=12, 3.2%), and pancreas neuroendocrine (n=11, 3%). There were significant differences in RSI of liver metastases based on histology. The median RSIs for liver metastases in descending order of radioresistance were gastrointestinal stromal tumor (0.57), melanoma (0.53), colorectal neuroendocrine (0.46), pancreas neuroendocrine (0.44), colorectal adenocarcinoma (0.43), breast adenocarcinoma (0.35), lung adenocarcinoma (0.31), pancreas adenocarcinoma (0.27), anal squamous cell cancer (0.22), and small intestine neuroendocrine (0.21) (P<.0001). The 12-month and 24-month Kaplan-Meier rates of local control (LC) for colorectal lesions from the independent clinical cohort were 79% and 59%, compared with 100% for noncolorectal lesions (P=.019), respectively. Conclusions: In this analysis, we found significant differences based on primary histology. This study suggests that primary histology may be an important factor to consider in SBRT radiation dose selection.

Rational use of intensity-modulated radiation therapy: the importance of clinical outcome.

Science.gov (United States)

De Neve, Wilfried; De Gersem, Werner; Madani, Indira

2012-01-01

During the last 2 decades, intensity-modulated radiation therapy (IMRT) became a standard technique despite its drawbacks of volume delineation, planning, robustness of delivery, challenging quality assurance, and cost as compared with non-IMRT. The theoretic advantages of IMRT dose distributions are generally accepted, but the clinical advantages remain debatable because of the lack of clinical assessment of the effort that is required to overshadow the disadvantages. Rational IMRT use requires a positive advantage/drawback balance. Only 5 randomized clinical trials (RCTs), 3 in the breast and 2 in the head and neck, which compare IMRT with non-IMRT (2-dimensional technique in four fifths of the trials), have been published (as of March 2011), and all had toxicity as the primary endpoint. More than 50 clinical trials compared results of IMRT-treated patients with a non-IMRT group, mostly historical controls. RCTs systematically showed a lower toxicity in IMRT-treated patients, and the non-RCTs confirmed these findings. Toxicity reduction, counterbalancing the drawbacks of IMRT, was convincing for breast and head and neck IMRT. For other tumor sites, the arguments favoring IMRT are weaker because of the inability to control bias outside the randomized setting. For anticancer efficacy endpoints, like survival, disease-specific survival, or locoregional control, the balance between advantages and drawbacks is fraught with uncertainties because of the absence of robust clinical data. Copyright © 2012 Elsevier Inc. All rights reserved.

National Institutes of Health Stroke Scale-Time Score Predicts Outcome after Endovascular Therapy in Acute Ischemic Stroke: A Retrospective Single-Center Study.

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Todo, Kenichi; Sakai, Nobuyuki; Kono, Tomoyuki; Hoshi, Taku; Imamura, Hirotoshi; Adachi, Hidemitsu; Kohara, Nobuo

2016-05-01

Outcomes after successful endovascular therapy in acute ischemic stroke are associated with onset-to-reperfusion time (ORT) and the National Institutes of Health Stroke Scale (NIHSS) score. In intravenous recombinant tissue plasminogen activator therapy, the NIHSS-time score, calculated by multiplying onset-to-treatment time with the NIHSS score, has been shown to predict clinical outcomes. In this study, we assessed whether a similar combination of the ORT and the NIHSS score can be applied to predict the outcomes after endovascular therapy. We retrospectively reviewed the charts of 128 consecutive ischemic stroke patients with successful reperfusion after endovascular therapy. We analyzed the association of the ORT, the NIHSS score, and the NIHSS-time score with good outcome (modified Rankin Scale score ≤ 2 at 3 months). Good outcome rates for patients with NIHSS-time scores of 84.7 or lower, scores higher than 84.7 up to 127.5 or lower, and scores higher than 127.5 were 72.1%, 44.2%, and 14.3%, respectively (P < .01). Multivariate logistic regression analysis revealed that the NIHSS-time score was an independent predictor of good outcomes (odds ratio, .372; 95% confidence interval, .175-.789) after adjusting for age, sex, internal carotid artery occlusion, plasma glucose level, ORT, and NIHSS score. The NIHSS-time score can predict good clinical outcomes after endovascular treatment. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Clinical application of optical coherence tomography in combination with functional diagnostics: advantages and limitations for diagnosis and assessment of therapy outcome in central serous chorioretinopathy.

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Schliesser, Joshua A; Gallimore, Gary; Kunjukunju, Nancy; Sabates, Nelson R; Koulen, Peter; Sabates, Felix N

2014-01-01

While identifying functional and structural parameters of the retina in central serous chorioretinopathy (CSCR) patients, this study investigated how an optical coherence tomography (OCT)-based diagnosis can be significantly supplemented with functional diagnostic tools and to what degree the determination of disease severity and therapy outcome can benefit from diagnostics complementary to OCT. CSCR patients were evaluated prospectively with microperimetry (MP) and spectral domain optical coherence tomography (SD-OCT) to determine retinal sensitivity function and retinal thickness as outcome measures along with measures of visual acuity (VA). Patients received clinical care that involved focal laser photocoagulation or pharmacotherapy targeting inflammation and neovascularization. Correlation of clinical parameters with a focus on functional parameters, VA, and mean retinal sensitivity, as well as on the structural parameter mean retinal thickness, showed that functional measures were similar in diagnostic power. A moderate correlation was found between OCT data and the standard functional assessment of VA; however, a strong correlation between OCT and MP data showed that diagnostic measures cannot always be used interchangeably, but that complementary use is of higher clinical value. The study indicates that integrating SD-OCT with MP provides a more complete diagnosis with high clinical relevance for complex, difficult to quantify diseases such as CSCR.

Clinical and radiological outcome following pneumothorax after endoscopic lung volume reduction with valves.

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Gompelmann, D; Benjamin, N; Kontogianni, K; Herth, Fjf; Heussel, C P; Hoffmann, H; Eberhardt, R

2016-01-01

Valve implantation has evolved as a therapy for patients with advanced emphysema. Although it is a minimally invasive treatment, it is associated with complications, the most common being pneumothorax. Pneumothorax occurs due to the rapid target lobe volume reduction and may be a predictor of clinical benefit despite this complication. The objective of this study was to conduct an exploratory data analysis of patients who developed a pneumothorax following endoscopic valve therapy for emphysema. This study performed a retrospective evaluation of pneumothorax management and the impact of pneumothorax on clinical outcomes in 70 patients following valve therapy in 381 consecutive patients. Pneumothorax rate following valve therapy was 18%. Pneumothorax management consisted of chest tube insertion, valve removal, and surgical intervention in 87% (61/70), 44% (31/70), and 19% (13/70) of the patients, respectively. Despite pneumothorax, patients experienced modest but significant improvements in lung function parameters (forced expiratory volume in 1 second: 55±148 mL, residual volume: -390±964 mL, total lung capacity: -348±876; all P pneumothorax, which was associated with relevant clinical improvement, was observed in only 21% (15/70) of the patients. Pneumothorax is a frequent severe complication following valve therapy that requires further intervention. Nevertheless, the pneumothorax does not impair the clinical status in the majority of patients. Patients with lobar atelectasis benefit after recovering from pneumothorax in terms of lung function parameters.

Treatment outcome of radiation therapy and concurrent targeted molecular therapy in spinal metastasis from renal cell carcinoma

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Park, Sang Joon; Kim, Kyung Hwan; Rhee, Woo Joong; Lee, Jeong Shin; Cho, Yeo Na; Koom, Woong Sub [Dept. of Radiation Oncology, Yonsei University College of Medicine, Seoul (Korea, Republic of)

2016-06-15

To evaluate the clinical outcomes of patients who underwent radiation therapy with or without targeted molecular therapy for the treatment of spinal metastasis from renal cell carcinoma (RCC). A total of 28 spinal metastatic lesions from RCC patients treated with radiotherapy between June 2009 and June 2015 were retrospectively reviewed. Thirteen lesions were treated concurrently with targeted molecular therapy (concurrent group) and 15 lesions were not (nonconcurrent group). Local control was defined as lack of radiographically evident local progression and neurological deterioration. At a median follow-up of 11 months (range, 2 to 58 months), the 1-year local progression-free rate (LPFR) was 67.0%. The patients with concurrent targeted molecular therapy showed significantly higher LPFR than those without (p = 0.019). After multivariate analysis, use of concurrent targeted molecular therapy showed a tendency towards improved LPFR (hazard ratio, 0.13; 95% confidence interval, 0.01 to 1.16). There was no difference in the incidence of systemic progression between concurrent and nonconcurrent groups. No grade ≥2 toxicities were observed during or after radiotherapy. Our study suggests the possibility that concurrent use of targeted molecular therapy during radiotherapy may improve LPFR. Further study with a large population is required to confirm these results.

Treatment outcome of radiation therapy and concurrent targeted molecular therapy in spinal metastasis from renal cell carcinoma

International Nuclear Information System (INIS)

Park, Sang Joon; Kim, Kyung Hwan; Rhee, Woo Joong; Lee, Jeong Shin; Cho, Yeo Na; Koom, Woong Sub

2016-01-01

To evaluate the clinical outcomes of patients who underwent radiation therapy with or without targeted molecular therapy for the treatment of spinal metastasis from renal cell carcinoma (RCC). A total of 28 spinal metastatic lesions from RCC patients treated with radiotherapy between June 2009 and June 2015 were retrospectively reviewed. Thirteen lesions were treated concurrently with targeted molecular therapy (concurrent group) and 15 lesions were not (nonconcurrent group). Local control was defined as lack of radiographically evident local progression and neurological deterioration. At a median follow-up of 11 months (range, 2 to 58 months), the 1-year local progression-free rate (LPFR) was 67.0%. The patients with concurrent targeted molecular therapy showed significantly higher LPFR than those without (p = 0.019). After multivariate analysis, use of concurrent targeted molecular therapy showed a tendency towards improved LPFR (hazard ratio, 0.13; 95% confidence interval, 0.01 to 1.16). There was no difference in the incidence of systemic progression between concurrent and nonconcurrent groups. No grade ≥2 toxicities were observed during or after radiotherapy. Our study suggests the possibility that concurrent use of targeted molecular therapy during radiotherapy may improve LPFR. Further study with a large population is required to confirm these results

Clinical outcomes research in gynecologic oncology.

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Melamed, Alexander; Rauh-Hain, J Alejandro; Schorge, John O

2017-09-01

Clinical outcomes research seeks to understand the real-world manifestations of clinical care. In particular, outcomes research seeks to reveal the effects of pharmaceutical, procedural, and structural aspects of healthcare on patient outcomes, including mortality, disease control, toxicity, cost, and quality of life. Although outcomes research can utilize interventional study designs, insightful use of observational data is a defining feature of this field. Many questions in gynecologic oncology are not amenable to investigation in randomized clinical trials due to cost, feasibility, or ethical concerns. When a randomized trial is not practical or has not yet been conducted, well-designed observational studies have the potential to provide the best available evidence about the effects of clinical care. Such studies may use surveys, medical records, disease registries, and a variety of administrative data sources. Even when a randomized trial has been conducted, observational studies can be used to estimate the real-world effect of an intervention, which may differ from the results obtained in the controlled setting of a clinical trial. This article reviews the goals, methodologies, data sources, and limitations of clinical outcomes research, with a focus on gynecologic oncology. Copyright © 2017. Published by Elsevier Inc.

Clinical Spectrum, Management and Outcome of Neonatal Candidiasis

International Nuclear Information System (INIS)

Khan, E. A.; Choudhry, S.; Fatima, M.; Batool, Z.

2015-01-01

Objective: To identify clinical spectrum, management and outcome of neonatal candidiasis. Methods: The retrospective study was conducted at the Shifa International Hospital, Islamabad, Pakistan, and comprised microbiological records of all the babies admitted to the Neonatal Intensive Care Unit from January 2009 to January 2014 that were reviewed to identify those with positive candida cultures. Medical records were analysed for demographic and clinical spectrum features, management and outcome. SPSS 16 was used statistical analysis. Results: Of the total 1550 neonatal admissions, 560 (36 percent) had positive cultures, and, of them, candida was isolated in 49(8.8 percent) neonates. Among them, 13(26 percent) had candida albicans and the rest had candida species. Majority were males 34(70 percent), and preterm with 30(61 percent) being <37 weeks. The mean birth weight was 2000±873 grams. Mean age at admission was 6±7.6 days. Overall, 39(80 percent) had >2 risk factors. The commonest site of isolation was blood in 41(84 percent). Besides, 32 (65 percent) received fluconazole alone for treatment. Mean duration of anti-fungal therapy was 10±5 days (range: 1-21 days). Twelve (24 percent) neonates expired and the cause of death was candida sepsis in 10(20 percent) cases. Mortality was not significantly associated with gender, place of birth, gestation, risk factors, length of stay, prior antibiotic exposure or receipt of antifungal prophylaxis except those who were <1500 grams (p<0.05). Conclusion: Approximately one in ten at-risk neonates may develop candida sepsis with high mortality. Early institution of anti-fungal therapy may prove to be life-saving. (author)

Comparison of autogeneic and allogeneic natural killer cells immunotherapy on the clinical outcome of recurrent breast cancer

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Liang S

2017-08-01

Full Text Available Shuzhen Liang,1,2 Kecheng Xu,1,2 Lizhi Niu,1,2 Xiaohua Wang,1 Yingqing Liang,1 Mingjie Zhang,3 Jibing Chen,1,2 Mao Lin1,2 1Department of Central Laboratory, Fuda Cancer Hospital, Jinan University School of Medicine, Guangzhou, Guangdong, China; 2Fuda Cancer Institute, Guangzhou, Guangdong, China; 3Hank Bioengineering Co., Ltd, Shenzhen, China Abstract: In the present study, we aimed to compare the clinical outcome of autogeneic and allogeneic natural killer (NK cells immunotherapy for the treatment of recurrent breast cancer. Between July 2016 and February 2017, 36 patients who met the enrollment criteria were randomly assigned to two groups: autogeneic NK cells immunotherapy group (group I, n=18 and allogeneic NK cells immunotherapy group (group II, n=18. The clinical efficacy, quality of life, immune function, circulating tumor cell (CTC level, and other related indicators were evaluated. We found that allogeneic NK cells immunotherapy has better clinical efficacy than autogeneic therapy. Moreover, allogeneic NK cells therapy improves the quality of life, reduces the number of CTCs, reduces carcinoembryonic antigen and cancer antigen 15-3 (CA15-3 expression, and significantly enhances immune function. To our knowledge, this is the first clinical trial to compare the clinical outcome of autogeneic and allogeneic NK cells immunotherapy for recurrent breast cancer. Keywords: clinical outcome, autogeneic, allogeneic, natural killer cells, recurrent breast cancer

Utilization of Patient-Reported Outcomes to Guide Symptom Management during Stereotactic Body Radiation Therapy for Clinically Localized Prostate Cancer

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Malika Danner

2017-10-01

Full Text Available IntroductionUtilization of patient-reported outcomes (PROs to guide symptom management during radiation therapy is increasing. This study focuses on the use of the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP as a tool to assess urinary and bowel bother during stereotactic body radiation therapy (SBRT and its utility in guiding medical management.MethodsBetween September 2015 and January 2017, 107 patients with clinically localized prostate cancer were treated with 35–36.25 Gy via SBRT in five fractions. PROs were assessed using EPIC-CP 1 h prior to the first fraction and after each subsequent fraction. Symptom management medications were prescribed based on the physician clinical judgment or if patients reported a moderate to big problem. Clinical significance was assessed using a minimally important difference of 1/2 SD from baseline score.ResultsA median baseline EPIC-CP urinary symptom score of 1.5 significantly increased to 3.7 on the day of the final treatment (p < 0.0001. Prior to treatment, 9.3% of men felt that their overall urinary function was a moderate to big problem that increased to 28% by the end of the fifth treatment. A median baseline EPIC-CP bowel symptom score of 0.3 significantly increased to 1.4 on the day of the final treatment (p < 0.0001. Prior to treatment, 1.9% of men felt that their overall bowel function was a moderate to big problem that increased to 3.7% by the end of the fifth treatment. The percentage of patients requiring an increased dose of alpha-antagonist increased to 47% by the end of treatment, and an additional 28% of patients required a short steroid taper to manage moderate to big urinary problems. Similarly, the percentage of patients requiring antidiarrheals reached 12% by the fifth treatment.ConclusionDuring the course of SBRT, an increasing percentage of patients experienced clinically significant symptoms many of which required medical management

Social outcomes in children with autism spectrum disorder: a review of music therapy outcomes

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LaGasse AB

2017-02-01

Full Text Available A Blythe LaGasse School of Music, Theatre & Dance, Colorado State University, Fort Collins, CO, USA Abstract: Autism spectrum disorder (ASD affects approximately one in 68 children, substantially affecting the child’s ability to acquire social skills. The application of effective interventions to facilitate and develop social skills is essential due to the lifelong impact that social skills may have on independence and functioning. Research indicates that music therapy can improve social outcomes in children with ASD. Outcome measures are primarily assessed using standardized nonmusical scales of social functioning from the parent or clinician perspective. Certified music therapists may also assess musical engagement and outcomes as a part of the individual’s profile. These measures provide an assessment of the individual’s social functioning within the music therapy session and generalizability to nonmusical settings. Keywords: autism spectrum disorder, music therapy, social skills

The impact of HIV clinical pharmacists on HIV treatment outcomes: a systematic review

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Saberi P

2012-04-01

Full Text Available Parya Saberi1, Betty J Dong2, Mallory O Johnson1, Ruth M Greenblatt2, Jennifer M Cocohoba21Department of Medicine, 2Department of Clinical Pharmacy, University of California, San Francisco, CA, USAObjective: Due to the rapid proliferation of human immunodeficiency virus (HIV treatment options, there is a need for health care providers with knowledge of antiretroviral therapy intricacies. In a HIV multidisciplinary care team, the HIV pharmacist is well-equipped to provide this expertise. We conducted a systematic review to assess the impact of HIV pharmacists on HIV clinical outcomes.Methods: We searched six electronic databases from January 1, 1980 to June 1, 2011 and included all quantitative studies that examined pharmacist's roles in the clinical care of HIV-positive adults. Primary outcomes were antiretroviral adherence, viral load, and CD4+ cell count and secondary outcomes included health care utilization parameters, antiretroviral modifications, and other descriptive variables.Results: Thirty-two publications were included. Despite methodological limitation, the involvement of HIV pharmacists was associated with statistically significant adherence improvements and positive impact on viral suppression in the majority of studies.Conclusion: This systematic review provides evidence of the beneficial impact of HIV pharmacists on HIV treatment outcomes and offers suggestions for future research.Keywords: pharmacist, HIV/AIDS, clinical, adherence, impact

Clinical processes in behavioral couples therapy.

Science.gov (United States)

Fischer, Daniel J; Fink, Brandi C

2014-03-01

Behavioral couples therapy is a broad term for couples therapies that use behavioral techniques based on principles of operant conditioning, such as reinforcement. Behavioral shaping and rehearsal and acceptance are clinical processes found across contemporary behavioral couples therapies. These clinical processes are useful for assessment and case formulation, as well as teaching couples new methods of conflict resolution. Although these clinical processes assist therapists in achieving efficient and effective therapeutic change with distressed couples by rapidly stemming couples' corrosive affective exchanges, they also address the thoughts, emotions, and issues of trust and intimacy that are important aspects of the human experience in the context of a couple. Vignettes are provided to illustrate the clinical processes described. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

Neoadjuvant Chemoradiation Therapy Using Concurrent S-1 and Irinotecan in Rectal Cancer: Impact on Long-Term Clinical Outcomes and Prognostic Factors

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Nakamura, Takatoshi; Yamashita, Keishi; Sato, Takeo; Ema, Akira; Naito, Masanori; Watanabe, Masahiko, E-mail: midoris@med.kitasato-u.ac.jp

2014-07-01

Purpose: To assess the long-term outcomes of patients with rectal cancer who received neoadjuvant chemoradiation therapy (NCRT) with concurrent S-1 and irinotecan (S-1/irinotecan) therapy. Methods and Materials: The study group consisted of 115 patients with clinical stage T3 or T4 rectal cancer. Patients received pelvic radiation therapy (45 Gy) plus concurrent oral S-1/irinotecan. The median follow-up was 60 months. Results: Grade 3 adverse effects occurred in 7 patients (6%), and the completion rate of NCRT was 87%. All 115 patients (100%) were able to undergo R0 surgical resection. Twenty-eight patients (24%) had a pathological complete response (ypCR). At 60 months, the local recurrence-free survival was 93%, disease-free survival (DFS) was 79%, and overall survival (OS) was 80%. On multivariate analysis with a proportional hazards model, ypN2 was the only independent prognostic factor for DFS (P=.0019) and OS (P=.0064) in the study group as a whole. Multivariate analysis was additionally performed for the subgroup of 106 patients with ypN0/1 disease, who had a DFS rate of 85.3%. Both ypT (P=.0065) and tumor location (P=.003) were independent predictors of DFS. A combination of these factors was very strongly related to high risk of recurrence (P<.0001), which occurred most commonly in the lung. Conclusions: NCRT with concurrent S-1/irinotecan produced high response rates and excellent long-term survival, with acceptable adverse effects in patients with rectal cancer. ypN2 is a strong predictor of dismal outcomes, and a combination of ypT and tumor location can identify high-risk patients among those with ypN0/1 disease.

Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia.

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Chow, Philip I; Ingersoll, Karen S; Thorndike, Frances P; Lord, Holly R; Gonder-Frederick, Linda; Morin, Charles M; Ritterband, Lee M

2018-07-01

The aim of this study was to investigate in a randomized clinical trial the role of sleep-related cognitive variables in the long-term efficacy of an online, fully automated cognitive behavioral therapy intervention for insomnia (CBT-I) (Sleep Healthy Using the Internet [SHUTi]). Three hundred and three participants (M age  = 43.3 years; SD = 11.6) were randomly assigned to SHUTi or an online patient education condition and assessed at baseline, postintervention (nine weeks after baseline), and six and 12 months after the intervention period. Cognitive variables were self-reported internal and chance sleep locus of control, dysfunctional beliefs and attitudes about sleep (DBAS), sleep specific self-efficacy, and insomnia knowledge. Primary outcomes were self-reported online ratings of insomnia severity (Insomnia Severity Index), and sleep onset latency and wake after sleep onset from online sleep diaries, collected 12 months after the intervention period. Those who received SHUTi had, at postassessment, higher levels of insomnia knowledge (95% confidence interval [CI] = 0.10-0.16) and internal sleep locus of control (95% CI = 0.04-0.55) as well as lower DBAS (95% CI = 1.52-2.39) and sleep locus of control attributed to chance (95% CI = 0.15-0.71). Insomnia knowledge, chance sleep locus of control, and DBAS mediated the relationship between condition and at least one 12-month postassessment sleep outcome. Within the SHUTi condition, changes in each cognitive variable (with the exception of internal sleep locus of control) predicted improvement in at least one sleep outcome one year later. Online CBT-I may reduce the enormous public health burden of insomnia by changing underlying cognitive variables that lead to long-term changes in sleep outcomes. Published by Elsevier B.V.

Outcomes of a contemporary cohort of 536 consecutive patients with acute ischemic stroke treated with endovascular therapy.

Science.gov (United States)

Abilleira, Sònia; Cardona, Pere; Ribó, Marc; Millán, Mònica; Obach, Víctor; Roquer, Jaume; Cánovas, David; Martí-Fàbregas, Joan; Rubio, Francisco; Alvarez-Sabín, José; Dávalos, Antoni; Chamorro, Angel; de Miquel, Maria Angeles; Tomasello, Alejandro; Castaño, Carlos; Macho, Juan M; Ribera, Aida; Gallofré, Miquel

2014-04-01

We sought to assess outcomes after endovascular treatment/therapy of acute ischemic stroke, overall and by subgroups, and looked for predictors of outcome. We used data from a mandatory, population-based registry that includes external monitoring of completeness, which assesses reperfusion therapies for consecutive patients with acute ischemic stroke since 2011. We described outcomes overall and by subgroups (age ≤ or >80 years; onset-to-groin puncture ≤ or >6 hours; anterior or posterior strokes; previous IV recombinant tissue-type plasminogen activator or isolated endovascular treatment/therapy; revascularization or no revascularization), and determined independent predictors of good outcome (modified Rankin Scale score ≤2) and mortality at 3 months by multivariate modeling. We analyzed 536 patients, of whom 285 received previous IV recombinant tissue-type plasminogen activator. Overall, revascularization (modified Thrombolysis In Cerebral Infarction scores, 2b and 3) occurred in 73.9%, 5.6% developed symptomatic intracerebral hemorrhages, 43.3% achieved good functional outcome, and 22.2% were dead at 90 days. Adjusted comparisons by subgroups systematically favored revascularization (lower proportion of symptomatic intracerebral hemorrhages and death rates and higher proportion of good outcome). Multivariate analyses confirmed the independent protective effect of revascularization. Additionally, age >80 years, stroke severity, hypertension (deleterious), atrial fibrillation, and onset-to-groin puncture ≤6 hours (protective) also predicted good outcome, whereas lack of previous disability and anterior circulation strokes (protective) as well as and hypertension (deleterious) independently predicted mortality. This study reinforces the role of revascularization and time to treatment to achieve enhanced functional outcomes and identifies other clinical features that independently predict good/fatal outcome after endovascular treatment/therapy.

Examining the Relation between the Therapeutic Alliance, Treatment Adherence, and Outcome of Cognitive Behavioral Therapy for Children with Anxiety Disorders

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Liber, Juliette M.; McLeod, Bryce D.; Van Widenfelt, Brigit M.; Goedhart, Arnold W.; van der Leeden, Adelinde J. M.; Utens, Elisabeth M. W. J.; Treffers, Philip D. A.

2010-01-01

Little is known about the contribution of technical and relational factors to child outcomes in cognitive behavioral therapy (CBT) for children with anxiety disorders. This study investigated the association between treatment adherence, the child-therapist alliance, and child clinical outcomes in manual-guided individual- and group-based CBT for…

Hemodynamic and oxygen transport patterns for outcome prediction, therapeutic goals, and clinical algorithms to improve outcome. Feasibility of artificial intelligence to customize algorithms.

Science.gov (United States)

Shoemaker, W C; Patil, R; Appel, P L; Kram, H B

1992-11-01

A generalized decision tree or clinical algorithm for treatment of high-risk elective surgical patients was developed from a physiologic model based on empirical data. First, a large data bank was used to do the following: (1) describe temporal hemodynamic and oxygen transport patterns that interrelate cardiac, pulmonary, and tissue perfusion functions in survivors and nonsurvivors; (2) define optimal therapeutic goals based on the supranormal oxygen transport values of high-risk postoperative survivors; (3) compare the relative effectiveness of alternative therapies in a wide variety of clinical and physiologic conditions; and (4) to develop criteria for titration of therapy to the endpoints of the supranormal optimal goals using cardiac index (CI), oxygen delivery (DO2), and oxygen consumption (VO2) as proxy outcome measures. Second, a general purpose algorithm was generated from these data and tested in preoperatively randomized clinical trials of high-risk surgical patients. Improved outcome was demonstrated with this generalized algorithm. The concept that the supranormal values represent compensations that have survival value has been corroborated by several other groups. We now propose a unique approach to refine the generalized algorithm to develop customized algorithms and individualized decision analysis for each patient's unique problems. The present article describes a preliminary evaluation of the feasibility of artificial intelligence techniques to accomplish individualized algorithms that may further improve patient care and outcome.

Gender differences in clinical, immunological, and virological outcomes in highly active antiretroviral-treated HIV–HCV coinfected patients

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Joel Emery

2010-05-01

Full Text Available Joel Emery1, Neora Pick2, Edward J Mills3, Curtis L Cooper11The Ottawa Hospital Division of Infectious Diseases, University of Ottawa, Ottawa, Canada; 2Oak Tree Clinic, BC Women’s Hospital, Vancouver, Canada; 3Faculty of Health Sciences, University of Ottawa, Ottawa, CanadaObjective: The influence of biological sex on human immunodeficiency virus (HIV antiretroviral treatment outcome is not well described in HIV–hepatitis C (HCV coinfection.Methods: We assessed patients’ clinical outcomes of HIV–HCV coinfected patients initiating antiretroviral therapy attending the Ottawa Hospital Immunodeficiency Clinic from January 1996 to June 2008.Results: We assessed 144 males and 39 females. Although similar in most baseline characteristics, the CD4 count was higher in females (375 vs 290 cells/μL. Fewer females initiated ritonavir-boosted regimens. The median duration on therapy before interruption or change was longer in males (10 versus 4 months (odds ratio [OR] 1.40 95% confidence interval: 0.95–2.04; P = 0.09. HIV RNA suppression was frequent (74% and mean CD4 count achieved robust (over 400 cells/μL at 6 months, irrespective of sex. The primary reasons for therapy interruption in females and males included: gastrointestinal intolerance (25% vs 19%; P = 0.42; poor adherence (22% vs 15%; P = 0.31; neuropsychiatric symptoms (19% vs 5%; P = 0.003; and lost to follow-up (3% vs 13%; P = 0.08. Seven males (5% and no females discontinued therapy for liver-specific complications. Death rate was higher in females (23% vs 7%; P = 0.003.Conclusion: There are subtle differences in the characteristics of female and male HIV–HCV coinfected patients that influence HIV treatment decisions. The reasons for treatment interruption and change differ by biological sex. This knowledge should be considered when starting HIV therapy and in efforts to improve treatment outcomes.Keywords: AIDS, HIV, HCV, coinfection, HAART, viral load, women, gender differences

Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries

DEFF Research Database (Denmark)

Reaney, Matthew; Mathieu, Chantal; Ostenson, Claes-Göran

2013-01-01

who did not meet this endpoint) and Diabetes Health Profile-18 scores (versus the main cohorts). High levels of missing data were observed for all PRO measures in both cohorts compared with those for clinical outcomes. CONCLUSIONS: These data from a clinical practice study support those from clinical...... clinical practice are lacking. We examined PROs in patients initiating injectable treatment in the CHOICE (CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy) study. METHODS: CHOICE was a 24-month, prospective observational study conducted in six European......BACKGROUND: Improvements in the clinical condition of patients with type 2 diabetes are often accompanied by improvements in health-related quality of life and other patient-reported outcomes (PROs), but data assessing injectable treatment initiation from the patient's perspective in routine...

Physiological and behavioral indices of emotion dysregulation as predictors of outcome from cognitive behavioral therapy and acceptance and commitment therapy for anxiety.

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Davies, Carolyn D; Niles, Andrea N; Pittig, Andre; Arch, Joanna J; Craske, Michelle G

2015-03-01

Identifying for whom and under what conditions a treatment is most effective is an essential step toward personalized medicine. The current study examined pre-treatment physiological and behavioral variables as predictors and moderators of outcome in a randomized clinical trial comparing cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT) for anxiety disorders. Sixty individuals with a DSM-IV defined principal anxiety disorder completed 12 sessions of either CBT or ACT. Baseline physiological and behavioral variables were measured prior to entering treatment. Self-reported anxiety symptoms were assessed at pre-treatment, post-treatment, and 6- and 12-month follow-up from baseline. Higher pre-treatment heart rate variability was associated with worse outcome across ACT and CBT. ACT outperformed CBT for individuals with high behavioral avoidance. Subjective anxiety levels during laboratory tasks did not predict or moderate treatment outcome. Due to small sample sizes of each disorder, disorder-specific predictors were not tested. Future research should examine these predictors in larger samples and across other outcome variables. Lower heart rate variability was identified as a prognostic indicator of overall outcome, whereas high behavioral avoidance was identified as a prescriptive indicator of superior outcome from ACT versus CBT. Investigation of pre-treatment physiological and behavioral variables as predictors and moderators of outcome may help guide future treatment-matching efforts. Copyright © 2014 Elsevier Ltd. All rights reserved.

Anti-TNFα therapy for chronic inflammatory disease in kidney transplant recipients: Clinical outcomes.

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Garrouste, Cyril; Anglicheau, Dany; Kamar, Nassim; Bachelier, Claire; Rivalan, Joseph; Pereira, Bruno; Caillard, Sophie; Aniort, Julien; Gatault, Philippe; Soubrier, Martin; Sayegh, Johnny; Colosio, Charlotte; Buisson, Anthony; Thervet, Eric; Bouvier, Nicolas; Heng, Anne Elisabeth

2016-10-01

Anti-tumor necrosis factor-α (TNFα) therapy has improved the prognosis of many chronic inflammatory diseases. It appears to be well-tolerated by liver-transplant patients. However, their use and their safety in kidney-transplant patients have yet to be determined.In this retrospective study, we identified 16 adult kidney-transplant patients aged 46.5 years (34-51.8) who received anti-TNFα therapy from 7 kidney transplantation centers. The indications for this treatment included: chronic inflammatory bowel disease (n = 8), inflammatory arthritis (n = 5), AA amyloidosis (n = 1), psoriasis (n = 1), and microscopic polyangiitis (n = 1).Anti-TNFα therapies resulted in a clinical response in 13/16 patients (81%). Estimated glomerular filtration rates (MDRD-4) were similar on day 0 and at 24 months (M24) after anti-TNFα treatment had been initiated (41 [12-55] and 40 [21-53] mL/min/1.73 m, respectively). Two allograft losses were observed. The 1st case was due to antibody-mediated rejection (M18), while the 2nd was the result of AA amyloidosis recurrence (M20). There were several complications: 8 patients (50%) developed 23 serious infections (18 bacterial, 4 viral, and 1 fungal) and 4 developed cancer. Five patients died (infection n = 2, cardiac AA amyloidosis n = 1, intraalveolar hemorrhage following microscopic polyangiitis n = 1, and acute respiratory distress syndrome n = 1). On univariate analysis, recipient age associated with death (P = 0.009) and infection development (P = 0.06).Using anti-TNFα therapies, remission can be achieved in chronic inflammatory diseases in kidney-transplant patients. However, concommitant anti-TNFα and immunosuppresive therapies must be used with caution due to the high risk of infection, particularly after the age of 50.

Outcome of orthodontic palatal plate therapy for orofacial dysfunction in children with Down syndrome: A systematic review.

Science.gov (United States)

Javed, F; Akram, Z; Barillas, A P; Kellesarian, S V; Ahmed, H B; Khan, J; Almas, K

2018-02-01

To evaluate the effects of orthodontic palatal plate therapy (OPPT) in the treatment of orofacial dysfunction in children with Down syndrome (DS). Indexed databases were searched. Clinical trials in DS allocated to test (treatment with palatal plates) versus control group (without palatal plates/special physiotherapy for orofacial stimulation) with follow-up of any time duration and assessing mouth closure, tongue position, active and inactive muscle function as outcomes. Study designs, subject demographics, frequency and duration of palatal plate therapy, method for assessment, follow-up period and outcomes were reported according to the PRISMA guidelines. Eight clinical studies were included. The risk of bias was considered high in three studies and moderate in 5 studies. The number of children with DS ranged between 9 and 42. The mean age of children with DS at the start of the study ranged between 2 months and 12 years. The duration of palatal plate therapy ranged between 4 months and 48 months. The follow-up period in all studies ranged from 12 to 58 months. All studies reported OPPT to be effective in improving orofacial disorders in children with DS. Most of the included studies suggest that palatal plate therapy in combination with physiotherapy/orofacial regulation therapy according to Castillo Morales/speech and language intervention seems to be effective in improving orofacial disorders in children with DS. However, the risk of bias of the included studies was high to moderate. Longitudinal trials with standardized evaluation methods, age of children at treatment initiation, treatment duration and standard orofacial outcomes are recommended. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Integrative Care Therapies and Physiological and Pain-related Outcomes in Hospitalized Infants

OpenAIRE

Hathaway, Elizabeth E.; Luberto, Christina M.; Bogenschutz, Lois H.; Geiss, Sue; Wasson, Rachel S.; Cotton, Sian

2015-01-01

Background: Pain management is a frequent problem in the neonatal intensive care unit (NICU). Few studies examining effects of integrative care therapies on pain-related outcomes in neonates have included physiological outcomes or investigated the use of such therapies in a practice-based setting. Objective: The purpose of this practice-based retrospective study was to examine the associations between integrative care therapies, particularly massage and healing touch, and pain-related outcome...

Clinical performance of stem cell therapy in patients with acute-on-chronic liver failure: a systematic review and meta-analysis.

Science.gov (United States)

Xue, Ran; Meng, Qinghua; Dong, Jinling; Li, Juan; Yao, Qinwei; Zhu, Yueke; Yu, Hongwei

2018-05-10

Stem cell therapy has been applied in the treatment of acute-on-chronic liver failure (ACLF). However, its clinical efficiency is still debatable. The aim of this systematic review and meta-analysis is to evaluate the clinical efficiency of stem cell therapy in the treatment of ACLF. The Cochrane Library, OVID, EMBASE, and PUBMED were searched to December 2017. Both randomized and non-randomized studies, assessing stem cell therapy in patients with ACLF, were included. The outcome measures were total bilirubin (TBIL), alanine transaminase (ALT), international normalized ratio (INR), albumin (ALB), and the model for end-stage liver disease (MELD) score. The quality of evidence was assessed by GRADEpro. Four randomized controlled trials and six non-randomized controlled trials were included. The TBIL levels significantly decreased at 1-, 3-, 12-month after the stem cell therapy (p = 0.0008; p = 0.04; p = 0.007). The ALT levels decreased significantly compared with the control group in the short-term (p stem cell therapy and control groups (p = 0.008). Further subgroup analysis for 3-month clinical performance according to the stem cell types have also been performed. This study suggests that the clinical outcomes of stem cell therapy were satisfied in patients with ACLF in the short-term. MSCs may be better than BM-MNCs in the stem cells transplantation of ACLF. However, more attention should focus on clinical trials in large-volume centers.

[Endogenous Endophthalmitis: Epidemiology, Clinic, Therapy and Visual Outcome].

Science.gov (United States)

Mayer, Christian; Loos, Daria; Feucht, Nikolaus; Zapp, Daniel; Prahs, Philipp Maximilian; Tandogan, Tamer; Khoramnia, Ramin

2018-04-11

Endogenous endophthalmitis is a rare and severe inflammation of the eye in the context of a systemic infectious disease, which can lead to the loss of the affected eye in the worst case. In a 5-year period, 20 eyes were treated for endogenous endophthalmitis and evaluated retrospectively. Evaluation parameters were epidemiological data, causes, concomitant diseases, assessment of the pathogen spectrum, therapy and visual acuity. 13.2% (n = 20/152; 20 eyes of 17 patients) of all endophthalmitis cases were of endogenous origin. In 15% (n = 3/20) of the cases, bilateral endogenous endophthalmitis was present. The cause for the endophthalmitis was generalised sepsis in 9 of 17 cases, an infection of the urogenital tract in 2 of 17 cases and endocarditis and liver abscess in 1 of 17 cases, respectively. In 4 of 17 cases, no primary foci were detected. Eight of 17 patients suffered from diabetes mellitus, 6 of 17 from renal insufficiency and 2 of 17 from malignancies, pneumonia or rheumatism. Two of 17 patients had had an organ transplantation, 15 of 17 suffered from cardiovascular diseases, 3 of 17 were immunosuppressed and 2 of 17 reported drug abuse. Four of 17 infections were caused by streptococci, 3 of 17 by Candida, 2 of 17 by herpes viruses and 1 of 17 by Staphylococcus aureus and Bacillus cereus. No pathogen could be found in 5 cases. The time interval between the onset of symptoms and diagnosis and the beginning of the therapy was 4 days (min.: 1 day; max.: 39 days). This was significantly longer in comparison with other causes of endophthalmitis (p Endogenous endophthalmitis is often misdiagnosed due to a severe underlying non-ophthalmological disease. Delayed presentation with consequent late initiation of therapy is an unresolved problem, because colleagues from other fields are often unexperienced in diagnosing the ocular infection. This is also a cause of the already poor visual prognosis. Ophthalmologists can usually only influence the choice

Social outcomes in children with autism spectrum disorder: a review of music therapy outcomes

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LaGasse, A Blythe

2017-01-01

Autism spectrum disorder (ASD) affects approximately one in 68 children, substantially affecting the child’s ability to acquire social skills. The application of effective interventions to facilitate and develop social skills is essential due to the lifelong impact that social skills may have on independence and functioning. Research indicates that music therapy can improve social outcomes in children with ASD. Outcome measures are primarily assessed using standardized nonmusical scales of social functioning from the parent or clinician perspective. Certified music therapists may also assess musical engagement and outcomes as a part of the individual’s profile. These measures provide an assessment of the individual’s social functioning within the music therapy session and generalizability to nonmusical settings. PMID:28260959

Clinical review: Optimal dose of continuous renal replacement therapy in acute kidney injury.

Science.gov (United States)

Prowle, John R; Schneider, Antoine; Bellomo, Rinaldo

2011-01-01

Continuous renal replacement therapy (CRRT) is the preferred treatment for acute kidney injury in intensive care units (ICUs) throughout much of the world. Despite the widespread use of CRRT, controversy and center-specific practice variation in the clinical application of CRRT continue. In particular, whereas two single-center studies have suggested survival benefit from delivery of higher-intensity CRRT to patients with acute kidney injury in the ICU, other studies have been inconsistent in their results. Now, however, two large multi-center randomized controlled trials - the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network (ATN) study and the Randomized Evaluation of Normal versus Augmented Level (RENAL) Replacement Therapy Study - have provided level 1 evidence that effluent flow rates above 25 mL/kg per hour do not improve outcomes in patients in the ICU. In this review, we discuss the concept of dose of CRRT, its relationship with clinical outcomes, and what target optimal dose of CRRT should be pursued in light of the high-quality evidence now available.

Comparison of clinical outcomes and prognostic utility of risk stratification tools in patients with therapy-related vs de novo myelodysplastic syndromes: a report on behalf of the MDS Clinical Research Consortium.

Science.gov (United States)

Zeidan, A M; Al Ali, N; Barnard, J; Padron, E; Lancet, J E; Sekeres, M A; Steensma, D P; DeZern, A; Roboz, G; Jabbour, E; Garcia-Manero, G; List, A; Komrokji, R

2017-06-01

While therapy-related (t)-myelodysplastic syndromes (MDS) have worse outcomes than de novo MDS (d-MDS), some t-MDS patients have an indolent course. Most MDS prognostic models excluded t-MDS patients during development. The performances of the International Prognostic Scoring System (IPSS), revised IPSS (IPSS-R), MD Anderson Global Prognostic System (MPSS), WHO Prognostic Scoring System (WPSS) and t-MDS Prognostic System (TPSS) were compared among patients with t-MDS. Akaike information criteria (AIC) assessed the relative goodness of fit of the models. We identified 370 t-MDS patients (19%) among 1950 MDS patients. Prior therapy included chemotherapy alone (48%), chemoradiation (31%), and radiation alone in 21%. Median survival for t-MDS patients was significantly shorter than for d-MDS (19 vs 46 months, PMDS (PMDS had a significantly higher hazard of death relative to d-MDS in every risk model, and had inferior survival compared to patients with d-MDS within all risk group categories. AIC Scores (lower is better) were 2316 (MPSS), 2343 (TPSS), 2343 (IPSS-R), 2361 (WPSS) and 2364 (IPSS). In conclusion, subsets of t-MDS patients with varying clinical outcomes can be identified using conventional risk stratification models. The MPSS, TPSS and IPSS-R provide the best predictive power.

Analysis of influence of dosimetric factors on the outcome of I-131 therapy in patients with hyperthyroidism

International Nuclear Information System (INIS)

Knapska-Kucharska, M.; Oszukowska, L.; Makarewicz, J.; Lewinski, A.

2012-01-01

The influence of dosimetric factors on the outcome of 131 I therapy has been examined in hyperthyroid patients submitted to 131 I treatment. The following factors - which could have influence on the effects of therapy with radioiodine - were analysed: the goitre volume, the thyroid radioiodine uptake after 24 h, and the effective half-life time of 131 I (EHL). Five hundred (500) randomly selected patients with hyperthyroidism, treated with 131 I, were studied. They were divided into three groups (based on clinical examination, hormonal and immunological tests, thyroid scintigraphy and ultrasound imaging). The study shows that the effectiveness of 131 I therapy depends on the thyroid volume and absorbed dose in all the groups of patients and on the thyroid radioiodine uptake and EHL in patients with a single autonomously functioning thyroid nodule. We have failed to determine the borderline D, distinguishing between effective and ineffective therapy. The treatment outcome can be predicted with approximately 70% accuracy, based on minimal absorbed dose

Analysis of influence of dosimetric factors on the outcome of I-131 therapy in patients with hyperthyroidism

Energy Technology Data Exchange (ETDEWEB)

Knapska-Kucharska, M.; Oszukowska, L.; Makarewicz, J. [Department of Nuclear Medecine and Oncological Endocrinology, Province Hospital, Zgierz (Poland); Lewinski, A. [Chair and Department of Endocrinology and Metabolic Diseases, Medical University, Lodz (Poland)

2012-07-01

The influence of dosimetric factors on the outcome of {sup 131}I therapy has been examined in hyperthyroid patients submitted to {sup 131}I treatment. The following factors - which could have influence on the effects of therapy with radioiodine - were analysed: the goitre volume, the thyroid radioiodine uptake after 24 h, and the effective half-life time of {sup 131}I (EHL). Five hundred (500) randomly selected patients with hyperthyroidism, treated with {sup 131}I, were studied. They were divided into three groups (based on clinical examination, hormonal and immunological tests, thyroid scintigraphy and ultrasound imaging). The study shows that the effectiveness of {sup 131}I therapy depends on the thyroid volume and absorbed dose in all the groups of patients and on the thyroid radioiodine uptake and EHL in patients with a single autonomously functioning thyroid nodule. We have failed to determine the borderline D, distinguishing between effective and ineffective therapy. The treatment outcome can be predicted with approximately 70% accuracy, based on minimal absorbed dose

Effects of music therapy on intravitreal injections: a randomized clinical trial.

Science.gov (United States)

Chen, Xuejing; Seth, Rajeev K; Rao, Veena S; Huang, John J; Adelman, Ron A

2012-08-01

To investigate the effects of music therapy on anxiety, perceived pain, and satisfaction in patients undergoing intravitreal injections in the outpatient setting. This is a randomized clinical trial. Seventy-three patients were recruited from the retina clinic at 1 institution and randomized into a music therapy (n=37) or control (n=36) group. Prior to injection, patients completed the state portion of the Spielberger State Trait Anxiety Inventory (STAI-S). The music therapy group listened to classical music through computer speakers while waiting for and during the injection. The control group underwent the injection in the same setting without music. Afterward, all patients completed another STAI-S and a satisfaction and pain questionnaire. The main outcome measures were objective anxiety derived from STAI-S scores and subjective pain and anxiety from the post procedure questionnaire. The music therapy group had a greater decrease in anxiety than the control group (P=0.0480). Overall, 73% of all patients requested music for future injections (P=0.0001). The music therapy group (84%) requested music in future injections more frequently than the control group (61%) (P=0.0377). Both groups reported similar levels of pain (P=0.5879). Classical music before and during intravitreal injections decreases anxiety in patients without decreasing pain. Most patients desire to have music during future injections. Music therapy is a low-cost, easy, safe intervention that reduces anxiety during intravitreal injections in the outpatient setting.

A clinical audit of thrombolytic therapy in patients with normotensive pulmonary embolism and intermediate risk.

Science.gov (United States)

Nobre, Carla; Mesquita, Dinis; Thomas, Boban; Ponte, Teresinha; Santos, Luis; Tavares, João

2014-06-01

There is considerable debate regarding the use of thrombolytic therapy in patients with pulmonary embolism, normal blood pressure and intermediate clinical risk, as defined by right ventricular dysfunction on transthoracic echocardiography or elevated serum markers of cardiac necrosis. A clinical audit of normotensive patients diagnosed with acute pulmonary embolism using multi- detector computerized tomography pulmonary angiography (MDCTPA) and intermediate risk, was conducted to determine clinical outcomes at 30 days. The specific role played by imaging findings and clinical severity, on the decision to thrombolyse, was assessed. The two cohorts who did (n = 15) and did not receive thrombolysis (n = 20) were compared for age, heart rate, blood pressure and oxyhemoglobin saturation at presentation, and the simplified PESI score was calculated in each patient. MDCTPA findings suggestive of adverse clinical outcome including central PE and an increased RV/LV diameter were determined for each patient. RV dysfunction on echocardiography was compared to clinical scoring, and findings on MDCTPA. The patients who received thrombolytic therapy were younger (48.6 ± 19.11 years versus 64.2 ± 13.83 years) (P audit revealed a predilection to use thrombolysis in younger patients with clinical severity and imaging findings on MDCTPA being the key drivers. A perception of a fragile hemodynamic status, as implied by a higher heart rate and shock index, despite a normal BP probably inclined us to thrombolyse.

Outcome of radioiodine therapy without, on or 3 days off carbimazole: a prospective interventional three-group comparison

Energy Technology Data Exchange (ETDEWEB)

Walter, Martin A. [University Hospital, Institute of Nuclear Medicine, Basel (Switzerland); University Hospital Basel, Division of Endocrinology, Diabetology and Clinical Nutrition, Basel (Switzerland); Christ-Crain, Mirjam; Mueller, Beat [University Hospital Basel, Division of Endocrinology, Diabetology and Clinical Nutrition, Basel (Switzerland); Schindler, Christian [University Hospital Basel, Institute of Social and Preventive Medicine, Basel (Switzerland); Mueller-Brand, Jan [University Hospital, Institute of Nuclear Medicine, Basel (Switzerland)

2006-06-15

Carbimazole ameliorates hyperthyroidism but reduces radioiodine uptake and adversely affects the outcome of simultaneous radioiodine therapy. We explored whether withdrawal of carbimazole for 3 days can restore the outcome of radioiodine treatment without concurrent exacerbation of hyperthyroidism. By generating three groups with comparable radioiodine uptake, we also investigated whether the effect of carbimazole depends on the radioiodine uptake. Stratified by a radioiodine uptake >30%, 227 consecutive adult patients were prospectively assigned to radioiodine therapy (target dose 200 Gy) without, on or 3 days off carbimazole. Patients were clinically (Crooks-Wayne score) and biochemically (T{sub 3}, fT{sub 4}, TSH) followed up after 3, 6 and 12 months. Primary endpoint was outcome 12 months after radioiodine therapy. A total of 207 patients completed follow-up (toxic nodular goitre, n=117; Graves' disease, n=90). The overall success rate was 71.5%. Patients without and 3 days off carbimazole had similar biochemical (81.4% and 83.3%, respectively; p=0.82) and clinical outcomes [median (range) Crooks-Wayne score 0 (0-16) and 1 (0-10), respectively; p=0.73], which were both higher than in patients on carbimazole [42.6%, p<0.001; Crooks-Wayne score 3 (0-30), p<0.03]. Time to achieve cure was delayed on carbimazole. No changes in thyroid hormone levels occurred after 3 days' discontinuation of carbimazole. Logistic regression revealed that all observed cure rates were independent of entity, sex, age, thyroid volume, radioiodine uptake, radioiodine half-life, fT{sub 4}, T{sub 3} and TSH. (orig.)

Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)

Science.gov (United States)

Huang, Hongyun; Young, Wise; Chen, Lin; Feng, Shiqing; Zoubi, Ziad M. Al; Sharma, Hari Shanker; Saberi, Hooshang; Moviglia, Gustavo A.; He, Xijing; Muresanu, Dafin F.; Sharma, Alok; Otom, Ali; Andrews, Russell J.; Al-Zoubi, Adeeb; Bryukhovetskiy, Andrey S.; Chernykh, Elena R.; Domańska-Janik, Krystyna; Jafar, Emad; Johnson, W. Eustace; Li, Ying; Li, Daqing; Luan, Zuo; Mao, Gengsheng; Shetty, Ashok K.; Siniscalco, Dario; Skaper, Stephen; Sun, Tiansheng; Wang, Yunliang; Wiklund, Lars; Xue, Qun; You, Si-Wei; Zheng, Zuncheng; Dimitrijevic, Milan R.; Masri, W. S. El; Sanberg, Paul R.; Xu, Qunyuan; Luan, Guoming; Chopp, Michael; Cho, Kyoung-Suok; Zhou, Xin-Fu; Wu, Ping; Liu, Kai; Mobasheri, Hamid; Ohtori, Seiji; Tanaka, Hiroyuki; Han, Fabin; Feng, Yaping; Zhang, Shaocheng; Lu, Yingjie; Zhang, Zhicheng; Rao, Yaojian; Tang, Zhouping; Xi, Haitao; Wu, Liang; Shen, Shunji; Xue, Mengzhou; Xiang, Guanghong; Guo, Xiaoling; Yang, Xiaofeng; Hao, Yujun; Hu, Yong; Li, Jinfeng; AO, Qiang; Wang, Bin; Zhang, Zhiwen; Lu, Ming; Li, Tong

2018-01-01

Cell therapy has been shown to be a key clinical therapeutic option for central nervous system diseases or damage. Standardization of clinical cell therapy procedures is an important task for professional associations devoted to cell therapy. The Chinese Branch of the International Association of Neurorestoratology (IANR) completed the first set of guidelines governing the clinical application of neurorestoration in 2011. The IANR and the Chinese Association of Neurorestoratology (CANR) collaborated to propose the current version “Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)”. The IANR council board members and CANR committee members approved this proposal on September 1, 2016, and recommend it to clinical practitioners of cellular therapy. These guidelines include items of cell type nomenclature, cell quality control, minimal suggested cell doses, patient-informed consent, indications for undergoing cell therapy, contraindications for undergoing cell therapy, documentation of procedure and therapy, safety evaluation, efficacy evaluation, policy of repeated treatments, do not charge patients for unproven therapies, basic principles of cell therapy, and publishing responsibility. PMID:29637817

The clinical case for proton beam therapy

International Nuclear Information System (INIS)

Foote, Robert L; Haddock, Michael G; Yan, Elizabeth; Laack, Nadia N; Arndt, Carola A S

2012-01-01

Over the past 20 years, several proton beam treatment programs have been implemented throughout the United States. Increasingly, the number of new programs under development is growing. Proton beam therapy has the potential for improving tumor control and survival through dose escalation. It also has potential for reducing harm to normal organs through dose reduction. However, proton beam therapy is more costly than conventional x-ray therapy. This increased cost may be offset by improved function, improved quality of life, and reduced costs related to treating the late effects of therapy. Clinical research opportunities are abundant to determine which patients will gain the most benefit from proton beam therapy. We review the clinical case for proton beam therapy. Proton beam therapy is a technically advanced and promising form of radiation therapy

Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes.

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Johnson, Nils P; Tóth, Gábor G; Lai, Dejian; Zhu, Hongjian; Açar, Göksel; Agostoni, Pierfrancesco; Appelman, Yolande; Arslan, Fatih; Barbato, Emanuele; Chen, Shao-Liang; Di Serafino, Luigi; Domínguez-Franco, Antonio J; Dupouy, Patrick; Esen, Ali M; Esen, Ozlem B; Hamilos, Michalis; Iwasaki, Kohichiro; Jensen, Lisette O; Jiménez-Navarro, Manuel F; Katritsis, Demosthenes G; Kocaman, Sinan A; Koo, Bon-Kwon; López-Palop, Ramón; Lorin, Jeffrey D; Miller, Louis H; Muller, Olivier; Nam, Chang-Wook; Oud, Niels; Puymirat, Etienne; Rieber, Johannes; Rioufol, Gilles; Rodés-Cabau, Josep; Sedlis, Steven P; Takeishi, Yasuchika; Tonino, Pim A L; Van Belle, Eric; Verna, Edoardo; Werner, Gerald S; Fearon, William F; Pijls, Nico H J; De Bruyne, Bernard; Gould, K Lance

2014-10-21

Fractional flow reserve (FFR) has become an established tool for guiding treatment, but its graded relationship to clinical outcomes as modulated by medical therapy versus revascularization remains unclear. The study hypothesized that FFR displays a continuous relationship between its numeric value and prognosis, such that lower FFR values confer a higher risk and therefore receive larger absolute benefits from revascularization. Meta-analysis of study- and patient-level data investigated prognosis after FFR measurement. An interaction term between FFR and revascularization status allowed for an outcomes-based threshold. A total of 9,173 (study-level) and 6,961 (patient-level) lesions were included with a median follow-up of 16 and 14 months, respectively. Clinical events increased as FFR decreased, and revascularization showed larger net benefit for lower baseline FFR values. Outcomes-derived FFR thresholds generally occurred around the range 0.75 to 0.80, although limited due to confounding by indication. FFR measured immediately after stenting also showed an inverse relationship with prognosis (hazard ratio: 0.86, 95% confidence interval: 0.80 to 0.93; p < 0.001). An FFR-assisted strategy led to revascularization roughly half as often as an anatomy-based strategy, but with 20% fewer adverse events and 10% better angina relief. FFR demonstrates a continuous and independent relationship with subsequent outcomes, modulated by medical therapy versus revascularization. Lesions with lower FFR values receive larger absolute benefits from revascularization. Measurement of FFR immediately after stenting also shows an inverse gradient of risk, likely from residual diffuse disease. An FFR-guided revascularization strategy significantly reduces events and increases freedom from angina with fewer procedures than an anatomy-based strategy. Copyright © 2014. Published by Elsevier Inc.

Clinical characteristics of patients assessed within an Improving Access to Psychological Therapies (IAPT) service: results from a naturalistic cohort study (Predicting Outcome Following Psychological Therapy; PROMPT).

Science.gov (United States)

Hepgul, Nilay; King, Sinead; Amarasinghe, Myanthi; Breen, Gerome; Grant, Nina; Grey, Nick; Hotopf, Matthew; Moran, Paul; Pariante, Carmine M; Tylee, André; Wingrove, Janet; Young, Allan H; Cleare, Anthony J

2016-02-27

A substantial number of patients do not benefit from first line psychological therapies for the treatment of depression and anxiety. Currently, there are no clear predictors of treatment outcomes for these patients. The PROMPT project aims to establish an infrastructure platform for the identification of factors that predict outcomes following psychological treatment for depression and anxiety. Here we report on the first year of recruitment and describe the characteristics of our sample to date. One hundred and forty-seven patients awaiting treatment within an Improving Access to Psychological Therapies (IAPT) service were recruited between February 2014 and February 2015 (representing 48 % of those eligible). Baseline assessments were conducted to collect information on a variety of clinical, psychological and social variables including a diagnostic interview using the Mini International Neuropsychiatric Interview (MINI). Our initial findings showed that over a third of our sample were not presenting to IAPT services for the first time, and 63 % had been allocated to receive higher intensity IAPT treatments. Approximately half (46 %) were taking prescribed psychotropic medication (most frequently antidepressants). Co-morbidity was common: 72 % of the sample met criteria for 2 or more current MINI diagnoses. Our initial data also indicated that 16 % met criteria for borderline personality disorder and 69 % were at high risk of personality disorder. Sixty-one percent scored above the screening threshold for bipolarity. Over half of participants (55 %) reported experiencing at least one stressful life event in the previous 12 months, whilst 67 % reported experiencing at least one form of childhood trauma. Our results to date highlight the complex nature of patients seen within an urban IAPT service, with high rates of psychiatric comorbidity, personality disorder, bipolarity and childhood trauma. Whilst there are significant challenges associated with researching

Effect of estrogen replacement therapy on bone and cardiovascular outcomes in women with turner syndrome: a systematic review and meta-analysis.

Science.gov (United States)

Cintron, Dahima; Rodriguez-Gutierrez, Rene; Serrano, Valentina; Latortue-Albino, Paula; Erwin, Patricia J; Murad, Mohammad Hassan

2017-02-01

Patients with Turner syndrome have adverse bone and cardiovascular outcomes from chronic estrogen deficiency. Hence, long-term estrogen replacement therapy is the cornerstone treatment. The estimates of its effect and optimal use, however, remain uncertain. We aimed to summarize the benefits and harms of estrogen replacement therapy on bone, cardiovascular, vasomotor and quality of life outcomes in patients with Turner syndrome. A comprehensive search of four databases was performed from inception through January 2016. Randomized clinical trials and observational cohort studies studying the effect of estrogen replacement therapy in patients with Turner syndrome under the age of 40 were included. Independently and in duplicate reviewers selected studies, extracted data and assessed risk of bias. Subgroup analyses were based on route of administration and type of estrogen formulation. Twenty-five studies at moderate to high risk of bias (12 randomized trials, 13 cohort studies) with 771 patients were included. Using random-effects models, estrogen replacement therapy showed an increase in bone mineral density [weighted mean change from baseline 0.09 g/cm2 (0.04-0.14)] that differed by type of estrogen but not route of administration. Oral estrogen replacement therapy showed a higher increase in high density lipoprotein cholesterol levels when compared to transdermal [weighted mean difference 9.33 mg/dl (4.82-13.85)] with no significant effect on other lipid fractions. The current evidence suggests possible benefit of estrogen replacement therapy on bone mineral density and high density lipoprotein cholesterol. Whether this improvement translates into changes in patient important outcomes (cardiovascular events or fractures) remains uncertain. Larger randomized clinical trials with direct comparisons on patient important outcomes are necessary.

Does targeting manual therapy and/or exercise improve patient outcomes in nonspecific low back pain? A systematic review

Directory of Open Access Journals (Sweden)

Mjøsund Hanne L

2010-04-01

Full Text Available Abstract Background A central element in the current debate about best practice management of non-specific low back pain (NSLBP is the efficacy of targeted versus generic (non-targeted treatment. Many clinicians and researchers believe that tailoring treatment to NSLBP subgroups positively impacts on patient outcomes. Despite this, there are no systematic reviews comparing the efficacy of targeted versus non-targeted manual therapy and/or exercise. This systematic review was undertaken in order to determine the efficacy of such targeted treatment in adults with NSLBP. Method MEDLINE, EMBASE, Current Contents, AMED and the Cochrane Central Register of Controlled Trials were electronically searched, reference lists were examined and citation tracking performed. Inclusion criteria were randomized controlled trials of targeted manual therapy and/or exercise for NSLPB that used trial designs capable of providing robust information on targeted treatment (treatment effect modification for the outcomes of activity limitation and pain. Included trials needed to be hypothesis-testing studies published in English, Danish or Norwegian. Method quality was assessed using the criteria recommended by the Cochrane Back Review Group. Results Four high-quality randomized controlled trials of targeted manual therapy and/or exercise for NSLBP met the inclusion criteria. One study showed statistically significant effects for short-term outcomes using McKenzie directional preference-based exercise. Research into subgroups requires much larger sample sizes than traditional two-group trials and other included studies showed effects that might be clinically important in size but were not statistically significant with their samples sizes. Conclusions The clinical implications of these results are that they provide very cautious evidence supporting the notion that treatment targeted to subgroups of patients with NSLBP may improve patient outcomes. The results of the

Long-term outcomes of patent foramen ovale closure or medical therapy after cryptogenic stroke: A meta-analysis of randomized trials.

Science.gov (United States)

Abdelaziz, Hesham K; Saad, Marwan; Abuomara, Hossamaldin Z; Nairooz, Ramez; Pothineni, Naga Venkata K; Madmani, Mohamed E; Roberts, David H; Mahmud, Ehtisham

2018-05-04

To examine long-term clinical outcomes with transcatheter patent foramen ovale (PFO) closure versus medical therapy alone in patients with cryptogenic stroke. A long-standing debate regarding the optimal approach for the management of patients with PFO after a cryptogenic stroke exists. An electronic search was performed for randomized clinical trials (RCTs) reporting clinical outcomes with PFO closure vs. medical therapy alone after stroke. Random effects DerSimonian-Laird risk ratios (RR) were calculated. The main outcome was recurrence of stroke. Other outcomes included transient ischemic attack (TIA), new-onset atrial fibrillation/flutter (AF/AFL), major bleeding, serious adverse events, and device-related complications. All-cause mortality was also examined. Five RCTs with a total of 3,440 patients were included. At a mean follow-up of 4.02 ± 1.57 years, PFO closure was associated with less recurrence of stroke (RR = 0.43; 95% CI 0.19-0.91; P = .027) compared with medical therapy alone. No difference was observed between both strategies for TIA (P = .21), major bleeding (P = .69), serious adverse events (P = .35), and all-cause death (P = .48). However, PFO closure, was associated with increased new-onset AF/AFL (P < .001), risk of pulmonary embolism (P = .04), and device-related complications (P < .001). On a subgroup analysis, stroke recurrence rate remained lower in PFO closure arm regardless of the type of closure device used (P interaction  = .50), or the presence of substantial shunt in the majority of study population (P interaction  = .13). Transcatheter PFO closure reduces the recurrence of stroke compared with medical therapy alone, with no significant safety concerns. Close follow-up of patients after PFO closure is recommended to detect new-onset atrial arrhythmias. © 2018 Wiley Periodicals, Inc.

Predicting Outcomes Following Cognitive Behaviour Therapy in Child Anxiety Disorders: The Influence of Genetic, Demographic and Clinical Information

Science.gov (United States)

Hudson, Jennifer L.; Lester, Kathryn J.; Lewis, Cathryn M.; Tropeano, Maria; Creswell, Cathy; Collier, David A.; Cooper, Peter; Lyneham, Heidi J.; Morris, Talia; Rapee, Ronald M.; Roberts, Susanna; Donald, Jennifer A.; Eley, Thalia C.

2013-01-01

Background: Within a therapeutic gene by environment (G × E) framework, we recently demonstrated that variation in the Serotonin Transporter Promoter Polymorphism; "5HTTLPR" and marker rs6330 in Nerve Growth Factor gene; "NGF" is associated with poorer outcomes following cognitive behaviour therapy (CBT) for child anxiety…

Aspergillus Osteomyelitis: Epidemiology, Clinical Manifestations, Management, and Outcome

Science.gov (United States)

Gamaletsou, Maria N.; Rammaert, Blandine; Bueno, Marimelle A.; Moriyama, Brad; Sipsas, Nikolaos V.; Kontoyiannis, Dimitrios P.; Roilides, Emmanuel; Zeller, Valerie; Prinapori, Roberta; Tajaldeen, Saad Jaber; Brause, Barry; Lortholary, Olivier; Walsh, Thomas J.

2014-01-01

Background The epidemiology, pathogenesis, diagnosis, and management of Aspergillus osteomyelitis are not well understood. Methods Protocol-defined cases of Aspergillus osteomyelitis published in the English literature were reviewed for comorbidities, microbiology, mechanisms of infection, clinical manifestations, radiological findings, inflammatory biomarkers, antifungal therapy, and outcome. Results Among 180 evaluable patients, 127 (71%) were males. Possible predisposing medical conditions in 103 (57%) included pharmacological immunosuppression, primary immunodeficiency, and neutropenia. Seventy-three others (41%) had prior open fracture, trauma or surgery. Eighty (44%) followed a hematogenous mechanism, 58 (32%) contiguous infections, and 42 (23%) direct inoculation. Aspergillus osteomyelitis was the first manifestation of aspergillosis in 77%. Pain and tenderness were present in 80%. The most frequently infected sites were vertebrae (46%), cranium (23%), ribs (16%), and long bones (13%). Patients with vertebral Aspergillus osteomyelitis had more previous orthopedic surgery (19% vs 0%; P=0.02), while those with cranial osteomyelitis had more diabetes mellitus (32% vs 8%; P=0.002) and prior head/neck surgery (12% vs 0%; P=0.02). Radiologic findings included osteolysis, soft-tissue extension, and uptake on T2-weighted images. Vertebral body Aspergillus osteomyelitis was complicated by spinal-cord compression in 47% and neurological deficits in 41%. Forty-four patients (24%) received only antifungal therapy, while 121(67%) were managed with surgery and antifungal therapy. Overall mortality was 25%. Median duration of therapy was 90 days (range, 10–772 days). There were fewer relapses in patients managed with surgery plus antifungal therapy in comparison to those managed with antifungal therapy alone (8% vs 30%; P=0.006). Conclusions Aspergillus osteomyelitis is a debilitating infection affecting both immunocompromised and immunocompetent patients. The most

The clinical case for proton beam therapy

Directory of Open Access Journals (Sweden)

Foote Robert L

2012-10-01

Full Text Available Abstract Over the past 20 years, several proton beam treatment programs have been implemented throughout the United States. Increasingly, the number of new programs under development is growing. Proton beam therapy has the potential for improving tumor control and survival through dose escalation. It also has potential for reducing harm to normal organs through dose reduction. However, proton beam therapy is more costly than conventional x-ray therapy. This increased cost may be offset by improved function, improved quality of life, and reduced costs related to treating the late effects of therapy. Clinical research opportunities are abundant to determine which patients will gain the most benefit from proton beam therapy. We review the clinical case for proton beam therapy. Summary sentence Proton beam therapy is a technically advanced and promising form of radiation therapy.

Preparations for the next generation of clinical trials with proton therapy

International Nuclear Information System (INIS)

Newhauser, W.D.; Smith, A.R.; Fitzek, M.; Ibbott, G.; Munzenrider, J.

2002-01-01

Full text: As proton radiation therapy centers become more widely available, we anticipate an increase in clinical proton therapy research, e.g. clinical trials to compare the efficacy of proton therapy with that of conformal photon therapy. In this presentation, we explore some of the quality assurance (QA) work that will be necessary to support multi-institution clinical trials to include facilities in Europe, Asia and the United States. Specifically, we shall concentrate on three areas pertaining to practical clinical proton dosimetry for which clear, concise, and coherent guidance is needed. First, the existing proton therapy dosimetry protocols (e.g. ICRU Report 59, IAEA TRS-398) provide general methods that are well suited for adoption in proton therapy. Many additional techniques are required in order to implement dosimetry in a contemporary proton clinic. For example, special situations arise for small fields including those for radiosurgery and ocular treatments, and for rotational therapy. Fortunately, this additional information is emerging from various proton therapy centers. For example, Vatnitsky et al. described the dosimetry of small beams, Newhauser et al. described absolute proton dosimetry techniques for radiosurgery and for ocular beams. Newhauser et al. also reported on a general formalism and practical methods for dosimetry measurements in a rotational proton gantry. Our aim is to discuss some specific needs for the standardization of these tasks, which will be essential in achieving adequate uniformity in multi-institution clinical trials. Second, we will discuss means to standardize of writing the physics QA portion of protocols for multi-institution clinical trials, through which a statistically significant number of patient outcomes may be obtained more rapidly. Surprisingly, only two multi-institution proton clinical trials have been undertaken (a skull base sarcoma trial and a prostate cancer trial, both shared between MGH and Loma Linda

Subjective and objective outcomes in randomized clinical trials

DEFF Research Database (Denmark)

Moustgaard, Helene; Bello, Segun; Miller, Franklin G

2014-01-01

explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial......OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...

Pyogenic sacroiliitis: diagnosis, management and clinical outcome

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Kucera, Tomas; Sponer, Pavel [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Orthopaedic Surgery, Hradec Kralove (Czech Republic); Brtkova, Jindra [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Diagnostic Radiology, Hradec Kralove (Czech Republic); Ryskova, Lenka [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Clinical Microbiology, Hradec Kralove (Czech Republic); Popper, Eduard [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Rehabilitation, Hradec Kralove (Czech Republic); Frank, Martin [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Surgery, Hradec Kralove (Czech Republic); Kucerova, Marie [Regional Hospital in Pardubice, Department of Neurosurgery, Hradec Kralove (Czech Republic)

2015-01-15

The purpose of the present study was to evaluate the role of diagnostic tools and management options for patients with pyogenic sacroiliitis, including potential complications. This retrospective study included 16 patients with pyogenic sacroiliitis who were admitted to a single orthopaedic centre between 2007 and 2012. The following data were collected: demographics, history, radiography, magnetic resonance images (MRI), biological data, type of pathogenic agent, abscess formation, type of management, and clinical outcome. Our study demonstrated that only one-fifth of the patients with lumbogluteal or hip pain had established diagnoses of suspected pyogenic sacroiliitis upon admission. MRIs confirmed this diagnosis in all cases. MRI examinations revealed joint fluid in the sacroiliac joint and significant oedema of the adjacent bone and soft tissues. In 12 of the 16 cases, erosions of the subchondral bone were encountered. Contrast-enhanced MRI revealed that 9 patients had abscesses. All patients received antibiotic therapy. Antibiotic treatment was only successful in 9 cases. The other 7 patients underwent computed tomography (CT)-guided abscess drainage. Drainage was sufficient for 4 patients, but 3 patients required open surgery. One patient required sacroiliac arthrodesis. The clinical outcomes included minimal disability (n = 10), moderate disability (n = 5), and full disability (n = 1) of the spine. Contrast-enhanced MRI is mandatory for a reliable diagnosis. Abscess formation was observed in approximately half of the MRI-diagnosed sacroiliitis cases and required minimally invasive drainage under CT guidance or frequently open surgery. (orig.)

Pyogenic sacroiliitis: diagnosis, management and clinical outcome

International Nuclear Information System (INIS)

Kucera, Tomas; Sponer, Pavel; Brtkova, Jindra; Ryskova, Lenka; Popper, Eduard; Frank, Martin; Kucerova, Marie

2015-01-01

The purpose of the present study was to evaluate the role of diagnostic tools and management options for patients with pyogenic sacroiliitis, including potential complications. This retrospective study included 16 patients with pyogenic sacroiliitis who were admitted to a single orthopaedic centre between 2007 and 2012. The following data were collected: demographics, history, radiography, magnetic resonance images (MRI), biological data, type of pathogenic agent, abscess formation, type of management, and clinical outcome. Our study demonstrated that only one-fifth of the patients with lumbogluteal or hip pain had established diagnoses of suspected pyogenic sacroiliitis upon admission. MRIs confirmed this diagnosis in all cases. MRI examinations revealed joint fluid in the sacroiliac joint and significant oedema of the adjacent bone and soft tissues. In 12 of the 16 cases, erosions of the subchondral bone were encountered. Contrast-enhanced MRI revealed that 9 patients had abscesses. All patients received antibiotic therapy. Antibiotic treatment was only successful in 9 cases. The other 7 patients underwent computed tomography (CT)-guided abscess drainage. Drainage was sufficient for 4 patients, but 3 patients required open surgery. One patient required sacroiliac arthrodesis. The clinical outcomes included minimal disability (n = 10), moderate disability (n = 5), and full disability (n = 1) of the spine. Contrast-enhanced MRI is mandatory for a reliable diagnosis. Abscess formation was observed in approximately half of the MRI-diagnosed sacroiliitis cases and required minimally invasive drainage under CT guidance or frequently open surgery. (orig.)

Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial

Directory of Open Access Journals (Sweden)

Hengwei Jin

2017-09-01

Full Text Available Introduction: Brain arteriovenous malformations (BAVMs are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. Methods: This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety, and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy. Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula, volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS. Discussion: The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs. Keywords: Brain arteriovenous malformation, Clinical trial, Endovascular therapy, Gamma knife, Safety, Efficacy

Clinical aspects of patients with sarcoglycanopathies under steroids therapy

Directory of Open Access Journals (Sweden)

Marco A. V. Albuquerque

2014-10-01

Full Text Available Patients with sarcoglycanopathies, which comprise four subtypes of autosomal recessive limb-girdle muscular dystrophies, usually present with progressive weakness leading to early loss of ambulation and premature death, and no effective treatment is currently available. Objective To present clinical aspects and outcomes of six children with sarcoglycanopathies treated with steroids for at least one year. Method Patient files were retrospectively analyzed for steroid use. Results Stabilization of muscle strength was noted in one patient, a slight improvement in two, and a slight worsening in three. In addition, variable responses of forced vital capacity and cardiac function were observed. Conclusions No overt clinical improvement was observed in patients with sarcoglycanopathies under steroid therapy. Prospective controlled studies including a larger number of patients are necessary to determine the effects of steroids for sarcoglycanopathies.

Clinical Outcomes Used in Clinical Pharmacy Intervention Studies in Secondary Care

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Lene Juel Kjeldsen

2017-05-01

Full Text Available The objective was to investigate type, frequency and result of clinical outcomes used in studies to assess the effect of clinical pharmacy interventions in inpatient care. The literature search using Pubmed.gov was performed for the period up to 2013 using the search phrases: “Intervention(s” and “pharmacist(s” and “controlled” and “outcome(s” or “effect(s”. Primary research studies in English of controlled, clinical pharmacy intervention studies, including outcome evaluation, were selected. Titles, abstracts and full-text papers were assessed individually by two reviewers, and inclusion was determined by consensus. In total, 37 publications were included in the review. The publications presented similar intervention elements but differed in study design. A large variety of outcome measures (135 had been used to evaluate the effect of the interventions; most frequently clinical measures/assessments by physician and health care service use. No apparent pattern was established among primary outcome measures with significant effect in favour of the intervention, but positive effect was most frequently related to studies that included power calculations and sufficient inclusion of patients (73% vs. 25%. This review emphasizes the importance of considering the relevance of outcomes selected to assess clinical pharmacy interventions and the importance of conducting a proper power calculation.

Lithium as adjuvant to radioiodine therapy in differentiated thyroid carcinoma: clinical and in vitro studies

NARCIS (Netherlands)

Liu, Y. Y.; van der Pluijm, G.; Karperien, M.; Stokkel, M. P. M.; Pereira, A. M.; Morreau, J.; Kievit, J.; Romijn, J. A.; Smit, J. W. A.

2006-01-01

Lithium has been reported to increase radioactive iodine (RaI) doses in benign thyroid disease and in differentiated thyroid carcinoma (DTC). It is not known whether lithium influences the outcome of RaI therapy in DTC. We therefore studied the clinical effects of RaI without and with lithium

Predicting HIV RNA virologic outcome at 52-weeks follow-up in antiretroviral clinical trials. The INCAS and AVANTI Study Groups.

Science.gov (United States)

Raboud, J M; Rae, S; Montaner, J S

2000-08-15

To determine the ability of intermediate plasma viral load (pVL) measurements to predict virologic outcome at 52 weeks of follow-up in clinical trials of antiretroviral therapy. Individual patient data from three clinical trials (INCAS, AVANTI-2 and AVANTI-3) were combined into a single database. Virologic success was defined to be plasma viral load (pVL) <500 copies/ml at week 52. The sensitivity and specificity of intermediate pVL measurements below the limit of detection, 100, 500, 1000, and 5000 copies/ml to predict virologic success were calculated. The sensitivity, specificity, and positive and negative predictive values of a pVL measurement <1000 copies/ml at week 16 to predict virologic outcome at week 52 were 74%, 74%, 48%, and 90%, respectively, for patients on double therapy. For patients on triple therapy, the sensitivity, specificity, and positive and negative predictive values of a pVL measurement <50 copies/ml at week 16 to predict virologic outcome were 68%, 68%, 80%, and 47%, respectively. For patients receiving double therapy, a poor virologic result at an intermediate week of follow-up is a strong indicator of virologic failure at 52 weeks whereas intermediate virologic success is no guarantee of success at 1 year. For patients on triple therapy, disappointing intermediate results do not preclude virologic success at 1 year and intermediate successes are more likely to be sustained.

Clinical and laboratory features, hospital course, and outcome of Rocky Mountain spotted fever in children.

Science.gov (United States)

Buckingham, Steven C; Marshall, Gary S; Schutze, Gordon E; Woods, Charles R; Jackson, Mary Anne; Patterson, Lori E R; Jacobs, Richard F

2007-02-01

To describe the clinical characteristics and course of children with laboratory-diagnosed Rocky Mountain spotted fever (RMSF) and to identify clinical findings independently associated with adverse outcomes of death or discharge with neurologic deficits. Retrospective chart review of 92 patients at six institutions in the southeastern and southcentral United States from 1990 to 2002. Statistical analyses used descriptive statistics and multiple logistic regression. Children with RMSF presented to study institutions after a median of 6 days of symptoms, which most commonly included fever (98%), rash (97%), nausea and/or vomiting (73%), and headache (61%); no other symptom or sign was present in >50% of children. Only 49% reported antecedent tick bites. Platelet counts were <150,000/mm3 in 59% of children, and serum sodium concentrations were <135 mEq/dL in 52%. Although 86% sought medical care before admission, only 4 patients received anti-rickettsial therapy during this time. Three patients died, and 13 survivors had neurologic deficits at discharge. Coma and need for inotropic support and intravenous fluid boluses were independently associated with adverse outcomes. Children with RMSF generally present with fever and rash. Delays in diagnosis and initiation of appropriate therapy are unacceptably common. Prognosis is guarded in those with hemodynamic instability or neurologic compromise at initiation of therapy.

Gene Expression Profiling to Predict Clinical Outcome of Breast Cancer: reproducing, analyzing and extending the Nature publication by vhVeer et al

NARCIS (Netherlands)

Li R.; Visser, H.M.

2010-01-01

Chemotherapy and hormonal therapy as adjuvant systemic therapies to inhibit breast cancer recurrence are not necessary for each patient. In Veer's paper "Gene expression profiling predicts clinical outcome of breast cancer" (Nature 2002, PMID: 11823860), they introduced a method based on DNA

Outcome and Toxicity of an Ifosfamide-Based Soft Tissue Sarcoma Treatment Protocol in Children. The Importance of Local Therapy

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S. Murray Yule

1998-01-01

Full Text Available Background. Although the survival of children with soft tissue sarcoma (STS has improved considerably, the outcome of patients with metastatic disease, and those with primary tumours of the extremities or parameningeal sites remains disappointing. We describe the clinical outcome of an ifosfamide-based regimen with local therapy directed only to children who failed to achieve a complete response to initial chemotherapy.

Does short-term virologic failure translate to clinical events in antiretroviral-naïve patients initiating antiretroviral therapy in clinical practice?

DEFF Research Database (Denmark)

NN, NN; Mugavero, Michael J; May, Margaret

2008-01-01

, nevirapine, lopinavir/ritonavir, nelfinavir, or abacavir as third drugs in combination with a zidovudine and lamivudine nucleoside reverse transcriptase inhibitor backbone. MAIN OUTCOME MEASURES: Short-term (24-week) virologic failure (>500 copies/ml) and clinical events within 2 years of ART initiation.......58-2.22), lopinavir/ritonavir (1.32, 95% CI = 1.12-1.57), nelfinavir (3.20, 95% CI = 2.74-3.74), and abacavir (2.13, 95% CI = 1.82-2.50). However, the rate of clinical events within 2 years of ART initiation appeared higher only with nevirapine (adjusted hazard ratio for composite outcome measure 1.27, 95% CI = 1......OBJECTIVE: To determine whether differences in short-term virologic failure among commonly used antiretroviral therapy (ART) regimens translate to differences in clinical events in antiretroviral-naïve patients initiating ART. DESIGN: Observational cohort study of patients initiating ART between...

Statin Therapy and Outcome After Ischemic Stroke: Systematic Review and Meta-Analysis of Observational Studies and Randomized Trials.

LENUS (Irish Health Repository)

2013-01-03

Background-Although experimental data suggest that statin therapy may improve neurological outcome after acute cerebral ischemia, the results from clinical studies are conflicting. We performed a systematic review and meta-analysis investigating the relationship between statin therapy and outcome after ischemic stroke. METHODS: The primary analysis investigated statin therapy at stroke onset (prestroke statin use) and good functional outcome (modified Rankin score 0 to 2) and death. Secondary analyses included the following: (1) acute poststroke statin therapy (≤72 hours after stroke), and (2) thrombolysis-treated patients. RESULTS: The primary analysis included 113 148 subjects (27 studies). Among observational studies, statin treatment at stroke onset was associated with good functional outcome at 90 days (pooled odds ratio [OR], 1.41; 95% confidence interval [CI], 1.29-1.56; P<0.001), but not 1 year (OR, 1.12; 95% CI, 0.9-1.4; P=0.31), and with reduced fatality at 90 days (pooled OR, 0.71; 95% CI, 0.62-0.82; P<0.001) and 1 year (OR, 0.80; 95% CI, 0.67-0.95; P=0.01). In the single randomized controlled trial reporting 90-day functional outcome, statin treatment was associated with good outcome (OR, 1.5; 95% CI, 1.0-2.24; P=0.05). No reduction in fatality was observed on meta-analysis of data from 3 randomized controlled trials (P=0.9). In studies of thrombolysis-treated patients, an association between statins and increased fatality at 90 days was observed (pooled OR, 1.25; 95% CI, 1.02-1.52; P=0.03, 3 studies, 4339 patients). However, this association was no longer present after adjusting for age and stroke severity in the largest study (adjusted OR, 1.14; 95% CI, 0.90-1.44; 4012 patients). CONCLUSIONS: In the largest meta-analysis to date, statin therapy at stroke onset was associated with improved outcome, a finding not observed in studies restricted to thrombolysis-treated patients. Randomized trials of statin therapy in acute ischemic stroke are needed.

Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials

DEFF Research Database (Denmark)

Bottomley, Andrew; Pe, Madeline; Sloan, Jeff

2016-01-01

Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are anal......Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures...... are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient......-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes...

Child and Adolescent Adherence With Cognitive Behavioral Therapy for Anxiety: Predictors and Associations With Outcomes.

Science.gov (United States)

Lee, Phyllis; Zehgeer, Asima; Ginsburg, Golda S; McCracken, James; Keeton, Courtney; Kendall, Philip C; Birmaher, Boris; Sakolsky, Dara; Walkup, John; Peris, Tara; Albano, Anne Marie; Compton, Scott

2017-04-27

Cognitive behavioral therapy (CBT) for anxiety disorders is effective, but nonadherence with treatment may reduce the benefits of CBT. This study examined (a) four baseline domains (i.e., demographic, youth clinical characteristics, therapy related, family/parent factors) as predictors of youth adherence with treatment and (b) the associations between youth adherence and treatment outcomes. Data were from 279 youth (7-17 years of age, 51.6% female; 79.6% White, 9% African American), with Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.) diagnoses of separation anxiety disorder, generalized anxiety disorder, and/or social phobia, who participated in CBT in the Child/Adolescent Anxiety Multimodal Study. Adherence was defined in three ways (session attendance, therapist-rated compliance, and homework completion). Multiple regressions revealed several significant predictors of youth adherence with CBT, but predictors varied according to the definition of adherence. The most robust predictors of greater adherence were living with both parents and fewer youth comorbid externalizing disorders. With respect to outcomes, therapist ratings of higher youth compliance with CBT predicted several indices of favorable outcome: lower anxiety severity, higher global functioning, and treatment responder status after 12 weeks of CBT. Number of sessions attended and homework completion did not predict treatment outcomes. Findings provide information about risks for youth nonadherence, which can inform treatment and highlight the importance of youth compliance with participating in therapy activities, rather than just attending sessions or completing homework assignments.

Experience and outcome of radioiodine therapy in hyperthyroidism

International Nuclear Information System (INIS)

Miah, S.H.; Paul, A.K.; Rahman, H.A.

2005-01-01

Full text: Radioiodine is being increasingly used in the treatment of hyperthyroidism. The primary reasons for choosing radioiodine therapy are its effectiveness, ease of administration, relatively low cost and paucity of side effects. Here we presented our experiences and outcome of radioiodine therapy in hyperthyroidism in a divisional referral centre.We retrospectively analyzed 203 patients receiving radioiodine therapy for hyperthyroidism in Centre for Nuclear Medicine and Ultrasound, Khulna during the period from July 1994 to June 2004. All the patients had clinical signs and symptoms of hyperthyroidism as well as elevated triiodothyronine (T 3 ), thyroxine (T 4 ) and suppressed thyroid stimulating hormone (TSH). T 3 , T 4 and TSH were done in all cases. Radionuclide scan and ultrasound of thyroid gland, radioactive iodine uptake (RAIU), thyroid microsomal antibody (TMAb) and fine needle aspiration cytology (FNAC) was done in selected cases. We assessed all patients prior to radioiodine therapy. Elderly patients and all those with cardiac complications and severe hyperthyroidism were pretreated with a short course of antithyroid drug in full dosages until they were clinically and biochemically euthyroid. Ninety five patients were on antithyroid medication (Neomercazole) prior to radioiodine therapy. Antithyroid medication were stopped 3 days before radioiodine therapy and restarted 3 days later and continued for 1 to 2 months depending on patient's symptoms. The rest of the patients received either no treatment or beta-blocker prior to radioiodine therapy. Menstrual history was taken in female patients and pregnancy was excluded by ultrasonography in doubtful cases before administering radioiodine. The likely consequences of the treatment were fully explained to the patients and attendants, the usual precautions for radiation protection of the public and the necessity of the follow-up were discussed and verbal consent was taken before administering radioiodine

Long-term oncological outcomes of a phase II trial of neoadjuvant chemohormonal therapy followed by radical prostatectomy for patients with clinically localised, high-risk prostate cancer.

Science.gov (United States)

Silberstein, Jonathan L; Poon, Stephen A; Sjoberg, Daniel D; Maschino, Alexandra C; Vickers, Andrew J; Bernie, Aaron; Konety, Badrinath R; Kelly, W Kevin; Eastham, James A

2015-07-01

To determine long-term oncological outcomes of radical prostatectomy (RP) after neoadjuvant chemohormonal therapy (CHT) for clinically localised, high-risk prostate cancer. In this phase II multicentre trial of patients with high-risk prostate cancer (PSA level >20 ng/mL, Gleason ≥8, or clinical stage ≥T3), androgen-deprivation therapy (goserelin acetate depot) and paclitaxel, carboplatin and estramustine were administered before RP. We report the long-term oncological outcomes of these patients and compared them to a contemporary cohort who met oncological inclusion criteria but received RP only. In all, 34 patients were enrolled and followed for a median of 13.1 years. Within 10 years most patients had biochemical recurrence (BCR-free probability 22%; 95% confidence interval [CI] 10-37%). However, the probability of disease-specific survival at 10 years was 84% (95% CI 66-93%) and overall survival was 78% (95% CI 60-89%). The CHT group had higher-risk features than the comparison group (123 patients), with an almost doubled risk of calculated preoperative 5-year BCR (69% vs 36%, P < 0.01). After adjusting for these imbalances the CHT group had trends toward improvement in BCR (hazard ratio [HR] 0.76, 95% CI 0.43-1.34; P = 0.3) and metastasis-free survival (HR 0.55, 95% CI 0.24-1.29; P = 0.2) although these were not statistically significant. Neoadjuvant CHT followed by RP was associated with lower rates of BCR and metastasis compared with the RP-only group; however, these results were not statistically significant. Because this treatment strategy has known harms and unproven benefit, this strategy should only be instituted in the setting of a clinical trial. © 2014 The Authors BJU International © 2014 BJU International Published by John Wiley & Sons Ltd.

Radioiodine therapy in Graves' disease based on tissue-absorbed dose calculations: effect of pre-treatment thyroid volume on clinical outcome

Energy Technology Data Exchange (ETDEWEB)

Reinhardt, Michael J; Joe, Alexius Y; Mallek, Dirk von; Ezziddin, Samer; Palmedo, Holger [Department of Nuclear Medicine, University Hospital of Bonn, Sigmund-Freud-Strasse 25, 53127 Bonn (Germany); Brink, Ingo [Department of Nuclear Medicine, University Hospital of Freiburg (Germany); Krause, Thomas M [Department of Nuclear Medicine, Inselspital Bern (Switzerland)

2002-09-01

This study was performed with three aims. The first was to analyse the effectiveness of radioiodine therapy in Graves' disease patients with and without goitres under conditions of mild iodine deficiency using several tissue-absorbed doses. The second aim was to detect further parameters which might be predictive for treatment outcome. Finally, we wished to determine the deviation of the therapeutically achieved dose from that intended. Activities of 185-2,220 MBq radioiodine were calculated by means of Marinelli's formula to deliver doses of 150, 200 or 300 Gy to the thyroids of 224 patients with Graves' disease and goitres up to 130 ml in volume. Control of hyperthyroidism, change in thyroid volume and thyrotropin-receptor antibodies were evaluated 15{+-}9 months after treatment for each dose. The results were further evaluated with respect to pre-treatment parameters which might be predictive for therapy outcome. Thyroidal radioiodine uptake was measured every day during therapy to determine the therapeutically achieved target dose and its coefficient of variation. There was a significant dose dependency in therapeutic outcome: frequency of hypothyroidism increased from 27.4% after 150 Gy to 67.7% after 300 Gy, while the frequency of persistent hyperthyroidism decreased from 27.4% after 150 Gy to 8.1% after 300 Gy. Patients who became hypothyroid had a maximum thyroid volume of 42 ml and received a target dose of 256{+-}80 Gy. The coefficient of variation for the achieved target dose ranged between 27.7% for 150 Gy and 17.8% for 300 Gy. When analysing further factors which might influence therapeutic outcome, only pre-treatment thyroid volume showed a significant relationship to the result of treatment. It is concluded that a target dose of 250 Gy is essential to achieve hypothyroidism within 1 year after radioiodine therapy in Graves' disease patients with goitres up to 40 ml in volume. Patients with larger goitres might need higher doses. (orig.)

Radioiodine therapy in Graves' disease based on tissue-absorbed dose calculations: effect of pre-treatment thyroid volume on clinical outcome

International Nuclear Information System (INIS)

Reinhardt, Michael J.; Joe, Alexius Y.; Mallek, Dirk von; Ezziddin, Samer; Palmedo, Holger; Brink, Ingo; Krause, Thomas M.

2002-01-01

This study was performed with three aims. The first was to analyse the effectiveness of radioiodine therapy in Graves' disease patients with and without goitres under conditions of mild iodine deficiency using several tissue-absorbed doses. The second aim was to detect further parameters which might be predictive for treatment outcome. Finally, we wished to determine the deviation of the therapeutically achieved dose from that intended. Activities of 185-2,220 MBq radioiodine were calculated by means of Marinelli's formula to deliver doses of 150, 200 or 300 Gy to the thyroids of 224 patients with Graves' disease and goitres up to 130 ml in volume. Control of hyperthyroidism, change in thyroid volume and thyrotropin-receptor antibodies were evaluated 15±9 months after treatment for each dose. The results were further evaluated with respect to pre-treatment parameters which might be predictive for therapy outcome. Thyroidal radioiodine uptake was measured every day during therapy to determine the therapeutically achieved target dose and its coefficient of variation. There was a significant dose dependency in therapeutic outcome: frequency of hypothyroidism increased from 27.4% after 150 Gy to 67.7% after 300 Gy, while the frequency of persistent hyperthyroidism decreased from 27.4% after 150 Gy to 8.1% after 300 Gy. Patients who became hypothyroid had a maximum thyroid volume of 42 ml and received a target dose of 256±80 Gy. The coefficient of variation for the achieved target dose ranged between 27.7% for 150 Gy and 17.8% for 300 Gy. When analysing further factors which might influence therapeutic outcome, only pre-treatment thyroid volume showed a significant relationship to the result of treatment. It is concluded that a target dose of 250 Gy is essential to achieve hypothyroidism within 1 year after radioiodine therapy in Graves' disease patients with goitres up to 40 ml in volume. Patients with larger goitres might need higher doses. (orig.)

The clinical utility of long-term humidification therapy in chronic airway disease.

Science.gov (United States)

Rea, Harold; McAuley, Sue; Jayaram, Lata; Garrett, Jeffrey; Hockey, Hans; Storey, Louanne; O'Donnell, Glenis; Haru, Lynne; Payton, Matthew; O'Donnell, Kevin

2010-04-01

Persistent airway inflammation with mucus retention in patients with chronic airway disorders such as COPD and bronchiectasis may lead to frequent exacerbations, reduced lung function and poor quality of life. This study investigates if long-term humidification therapy with high flow fully humidified air at 37 degrees C through nasal cannulae can improve these clinical outcomes in this group of patients. 108 patients diagnosed with COPD or bronchiectasis were randomised to daily humidification therapy or usual care for 12 months over which exacerbations were recorded. Lung function, quality of life, exercise capacity, and measures of airway inflammation were also recorded at baseline, 3 and 12 months. Patients on long-term humidification therapy had significantly fewer exacerbation days (18.2 versus 33.5 days; p = 0.045), increased time to first exacerbation (median 52 versus 27 days; p = 0.0495) and reduced exacerbation frequency (2.97/patient/year versus 3.63/patient/year; p = 0.067) compared with usual care. Quality of life scores and lung function improved significantly with humidification therapy compared with usual care at 3 and 12 months. Long-term humidification therapy significantly reduced exacerbation days, increased time to first exacerbation, improved lung function and quality of life in patients with COPD and bronchiectasis. Clinical trial registered with www.actr.org.au; Number ACTRN2605000623695. Copyright 2010 Elsevier Ltd. All rights reserved.

Active tuberculosis is associated with worse clinical outcomes in HIV-infected African patients on antiretroviral therapy.

Directory of Open Access Journals (Sweden)

Abraham M Siika

Full Text Available This cohort study utilized data from a large HIV treatment program in western Kenya to describe the impact of active tuberculosis (TB on clinical outcomes among African patients on antiretroviral therapy (ART.We included all patients initiating ART between March 2004 and November 2007. Clinical (signs and symptoms, radiological (chest radiographs and laboratory (mycobacterial smears, culture and tissue histology criteria were used to record the diagnosis of TB disease in the program's electronic medical record system.We assessed the impact of TB disease on mortality, loss to follow-up (LTFU and incident AIDS-defining events (ADEs through Cox models and CD4 cell and weight response to ART by non-linear mixed models.We studied 21,242 patients initiating ART-5,186 (24% with TB; 62% female; median age 37 years. There were proportionately more men in the active TB (46% than in the non-TB (35% group. Adjusting for baseline HIV-disease severity, TB patients were more likely to die (hazard ratio--HR = 1.32, 95% CI 1.18-1.47 or have incident ADEs (HR = 1.31, 95% CI: 1.19-1.45. They had lower median CD4 cell counts (77 versus 109, weight (52.5 versus 55.0 kg and higher ADE risk at baseline (CD4-adjusted odds ratio = 1.55, 95% CI: 1.31-1.85. ART adherence was similarly good in both groups. Adjusting for gender and baseline CD4 cell count, TB patients experienced virtually identical rise in CD4 counts after ART initiation as those without. However, the overall CD4 count at one year was lower among patients with TB (251 versus 269 cells/µl.Clinically detected TB disease is associated with greater mortality and morbidity despite salutary response to ART. Data suggest that identifying HIV patients co-infected with TB earlier in the HIV-disease trajectory may not fully address TB-related morbidity and mortality.

Impact of Site Selection and Study Conduct on Outcomes in Global Clinical Trials.

Science.gov (United States)

Sarwar, Chaudhry M S; Vaduganathan, Muthiah; Butler, Javed

2017-08-01

There are over 25 million patients living with heart failure globally. Overall, and especially post-discharge, clinical outcomes have remained poor in heart failure despite multiple trials, with both successes and failures over the last two decades. Matching therapies to the right patient population, identifying high-quality sites, and ensuring optimal trial design and execution represent important considerations in the development of novel therapeutics in this space. While clinical trials have undergone rapid globalization, this has come with regional variation in comorbidities, clinical parameters, and even clinical outcomes and treatment effects across international sites. These issues have now highlighted knowledge gaps about the conduct of trials, selection of study sites, and an unmet need to develop and identify "ideal" sites. There is a need for all stakeholders, including academia, investigators, healthcare organizations, patient advocacy groups, industry sponsors, research organizations, and regulatory authorities, to work as a multidisciplinary group to address these problems and develop practical solutions to improve trial conduct, efficiency, and execution. We review these trial-level issues using examples from contemporary studies to inform and optimize the design of future global clinical trials in heart failure.

Gender-related differences in clinical characteristics and outcomes in patients with diabetic ketoacidosis.

Science.gov (United States)

Barski, Leonid; Harman-Boehm, Ilana; Nevzorov, Roman; Rabaev, Elena; Zektser, Miri; Jotkowitz, Alan B; Zeller, Lior; Shleyfer, Elena; Almog, Yaniv

2011-12-01

Diabetic ketoacidosis (DKA) is 1 of the most common and serious complications of diabetes, and is a significant cause of morbidity and mortality. There is a paucity of data regarding gender-related differences in clinical characteristics and outcomes of patients hospitalized for DKA. The purpose of this study was to assess whether gender plays a role in clinical characteristics and outcome of DKA. We performed a retrospective cohort study of patients hospitalized with DKA between January 1, 2003 and January 1, 2010. The outcomes of male and female patients were compared. The primary outcome was in-hospital all-cause mortality. The secondary outcomes were 30-day all-cause mortality and rate of complications: sepsis, respiratory failure, multiple organ failure, stroke, and myocardial infarction. Eighty-nine men and 131 women with DKA were included in the study. Male patients had higher rates of chronic renal failure compared with women (16.9% vs 3.1%; P = 0.001), whereas more women than men received oral hypoglycemic therapy (19.8% vs 9.0%; P = 0.046); women also had higher glycosated hemoglobin levels before admission (11.9% [1.7%] vs 9.9% [2.2%]; P = 0.025). The in-hospital mortality rate was not significantly different for both genders (4.5% in the male group vs 3.8% in the female group; P = 1.0). We did not find significant differences between the 2 groups in the 30-day mortality rate (4.5% vs 6.1%; P = 0.7) or the rate of complications (5.6% vs 6.9%; P = 0.9). Advanced age, mechanical ventilation, and bedridden state were independent predictors of 30-day mortality. In our study we did not find statistically significant differences in the in-hospital mortality, 30-day all-cause mortality, or rate of complications between men and women hospitalized with DKA. However, women with poorly controlled type 2 diabetes mellitus receiving oral hypoglycemic therapy required particular attention and might benefit from earlier introduction and intensification of insulin

Working alliance and competence as predictors of outcome in cognitive behavioral therapy for social anxiety and panic disorder in adults.

Science.gov (United States)

Haug, Thomas; Nordgreen, Tine; Öst, Lars-Göran; Tangen, Tone; Kvale, Gerd; Hovland, Ole Johan; Heiervang, Einar R; Havik, Odd E

2016-02-01

The research on the association between the working alliance and therapist competence/adherence and outcome from cognitive behavioral therapy (CBT) is limited and characterized by inconclusive findings. This study investigates the working alliance and competence/adherence as predictors of outcome of CBT for social anxiety disorder (SAD) and panic disorder (PD). Eighty-two clinically referred patients (58.5% female; age: M = 33.6 years, SD = 10.3) with PD (n = 31) or SAD (n = 51) were treated with 12 sessions of manualized CBT by 22 clinicians with limited CBT experience in a randomized controlled effectiveness trial. Independent assessors rated the CBT competence/adherence of the therapists using a revised version of the Cognitive Therapy Adherence and Competence Scale, and the patients rated the quality of the working alliance using the Working Alliance Inventory-short form in therapy sessions 3 and 8. The outcome was assessed by independent assessors as well as by patients self-report. A total of 20.7% of the patients (27.5% SAD, 9.7% PD) dropped out during treatment. The association between the alliance, competence/adherence, outcome and dropout was investigated using multiple regression analyses. Higher therapist' competence/adherence early in the therapy was associated with a better outcome among PD patients, lower competence/adherence was associated with dropout among SAD patients. Higher rating of the alliance late in the therapy was associated with a better outcome, whereas lower alliance rating late in the therapy was associated with dropout. The findings indicate that the therapist competence/adherence and the working alliance have independent contributions to the outcome from CBT for anxiety disorders, but in different phases of the treatment. Copyright © 2015 Elsevier Ltd. All rights reserved.

Outcome in hyperglycemic stroke with ultrasound-augmented thrombolytic therapy.

Science.gov (United States)

Martini, S R; Hill, M D; Alexandrov, A V; Molina, C A; Kent, T A

2006-08-22

Hyperglycemia independently predicts poor outcome after acute ischemic stroke. CLOTBUST (Combined Lysis Of Thrombus in Brain ischemia using transcranial Ultrasound and Systemic tPA) demonstrated that ultrasound-augmented thrombolysis improves recanalization and 24-hour outcome in patients with acute ischemic stroke. We hypothesized that ultrasound would preferentially benefit hyperglycemic patients, and reviewed CLOTBUST with respect to admission glucose and good outcome. We found that ultrasound's benefit on 90-day outcome was primarily apparent at higher glucose levels, suggesting that ultrasound therapy may improve outcome following hyperglycemic stroke.

The implementation of computerized cognitive behavioural therapies in a service user-led, third sector self help clinic.

Science.gov (United States)

Cavanagh, Kate; Seccombe, Nick; Lidbetter, Nicky

2011-07-01

The efficacy and effectiveness of a computerized cognitive behavioural therapy (CCBT) package, Beating the Blues, has been demonstrated in a large randomized controlled trial and several pragmatic studies in the National Health Service (NHS). The current study tests the generalizability of this finding to the implementation of CCBT in a service user-led, third sector Self Help Clinic. 510 referrals for the Beating the Blues program were received over a 16 month period in routine care. The Patient Health Questionnaire Depression (PHQ-9) and Anxiety (GAD-7) Scales were administered pre-treatment and during each treatment session. The 10-item Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), Work and Social Adjustment Scale and Patient Experience Questionnaire were also administered pre-treatment and immediately on completing treatment. More than two-thirds of referrals were suitable for treatment and completed a baseline assessment; 84% of these started the Beating the Blues program. Two-hundred and twenty-six people meeting caseness criteria at baseline completed at least two sessions of CCBT. Of these, 50% met recovery criteria at their final point of measurement. Completer and intention-to-treat analysis also demonstrated statistically and clinically significant improvements on key outcome measures. CCBT can be effectively implemented in a service user-led, third sector Self Help Clinic, increasing access to psychological therapies to meet local needs for tier two interventions for depression and anxiety.

The Interaction of Motivation and Therapist Adherence Predicts Outcome in Cognitive Behavioral Therapy for Panic Disorder: Preliminary Findings

Science.gov (United States)

Huppert, Jonathan D.; Barlow, David H.; Gorman, Jack M.; Shear, M. Katherine; Woods, Scott W.

2006-01-01

This report is a post-hoc, exploratory examination of the relationships among patient motivation, therapist protocol adherence, and panic disorder outcome in patients treated with cognitive behavioral therapy within the context of a randomized clinical trial for the treatment of panic disorder (Barlow, Gorman, Shear, & Woods, 2000). Results…

Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design?

Directory of Open Access Journals (Sweden)

Jennifer Ai-Lian Woo

2015-03-01

Full Text Available Purpose: Stereotactic body radiation therapy (SBRT is increasingly utilized as primary treatment for clinically localized prostate cancer. Consensus regarding the appropriate patient-reported outcome (PRO endpoints for clinical trials for early stage prostate cancer RT is lacking. To aid in trial design, this study presents PROs over 36 months following SBRT for clinically localized prostate cancer. Methods: 174 hormone-naïve patients were treated with 35-36.25 Gy SBRT in 5 fractions. Patients completed the EPIC-26 questionnaire at baseline and all follow-ups; the proportion of patients developing a clinically significant decline in each EPIC domain was determined. The minimally important difference (MID was defined as a change of one-half SD from the baseline. Per RTOG 0938, we examined the percentage of patients who reported decline in EPIC urinary summary score of >2 points and EPIC bowel summary score of >5 points from baseline to one year. Results: 174 patients received SBRT with minimum follow-up of 36 months. The proportion of patients reporting a clinically significant decline in EPIC urinary/bowel scores was 34%/30%, 40%/32.2%, and 32.8%/21.5% at 6, 12, and 36 months. The percentage of patients reporting decline in the EPIC urinary summary score of >2 points was 43.2%, 51.6% and 41.8% at 6, 12, and 36 months. The percentage of patients reporting decline in EPIC bowel domain summary score of >5 points was 29.6% 29% and 22.4% at 6, 12, and 36 months. Conclusion: Our treatment protocol meets the RTOG 0938 criteria for advancing to a Phase III trial compared to conventionally fractionated RT. Between 12-36 months, the proportion of patients reporting decrease in both EPIC urinary and bowel scores declined, suggesting late improvement in these domains. Further investigation is needed to elucidate 1 which domains bear the greatest influence on post-treatment QOL, and 2 at what time point PRO endpoint(s should be assessed.

Reirradiation of Head and Neck Cancers With Proton Therapy: Outcomes and Analyses

Energy Technology Data Exchange (ETDEWEB)

Phan, Jack [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Sio, Terence T. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Department of Radiation Oncology, Mayo Clinic, Scottsdale, Arizona (United States); Nguyen, Theresa P. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Takiar, Vinita [Department of Radiation Oncology, University of Cincinnati, Cincinnati, Ohio (United States); Gunn, G. Brandon; Garden, Adam S.; Rosenthal, David I.; Fuller, Clifton D.; Morrison, William H.; Beadle, Beth; Ma, Dominic [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Zafereo, Mark E. [Department of Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Hutcheson, Kate A. [Department of Speech Pathology University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Kupferman, Michael E. [Department of Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); William, William N. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Frank, Steven J., E-mail: sjfrank@mdanderson.org [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

2016-09-01

Purpose: Reirradiation of head and neck (H&N) cancer is a clinical challenge. Proton radiation therapy (PRT) offers dosimetric advantages for normal tissue sparing and may benefit previously irradiated patients. Here, we report our initial experience with the use of PRT for H&N reirradiation, with focus on clinical outcomes and toxicity. Methods and Materials: We retrospectively reviewed the records of patients who received H&N reirradiation with PRT from April 2011 through June 2015. Patients reirradiated with palliative intent or without prior documentation of H&N radiation therapy were excluded. Radiation-related toxicities were recorded according to the Common Terminology Criteria for Adverse Events Version 4.0. Results: The conditions of 60 patients were evaluated, with a median follow-up time of 13.6 months. Fifteen patients (25%) received passive scatter proton therapy (PSPT), and 45 (75%) received intensity modulated proton therapy (IMPT). Thirty-five patients (58%) received upfront surgery, and 44 (73%) received concurrent chemotherapy. The 1-year rates of locoregional failure–free survival, overall survival, progression-free survival, and distant metastasis–free survival were 68.4%, 83.8%, 60.1%, and 74.9%, respectively. Eighteen patients (30%) experienced acute grade 3 (G3) toxicity, and 13 (22%) required a feeding tube at the end of PRT. The 1-year rates of late G3 toxicity and feeding tube independence were 16.7% and 2.0%, respectively. Three patients may have died of reirradiation-related effects (1 acute and 2 late). Conclusions: Proton beam therapy can be a safe and effective curative reirradiation strategy, with acceptable rates of toxicity and durable disease control.

Reirradiation of Head and Neck Cancers With Proton Therapy: Outcomes and Analyses

International Nuclear Information System (INIS)

Phan, Jack; Sio, Terence T.; Nguyen, Theresa P.; Takiar, Vinita; Gunn, G. Brandon; Garden, Adam S.; Rosenthal, David I.; Fuller, Clifton D.; Morrison, William H.; Beadle, Beth; Ma, Dominic; Zafereo, Mark E.; Hutcheson, Kate A.; Kupferman, Michael E.; William, William N.; Frank, Steven J.

2016-01-01

Purpose: Reirradiation of head and neck (H&N) cancer is a clinical challenge. Proton radiation therapy (PRT) offers dosimetric advantages for normal tissue sparing and may benefit previously irradiated patients. Here, we report our initial experience with the use of PRT for H&N reirradiation, with focus on clinical outcomes and toxicity. Methods and Materials: We retrospectively reviewed the records of patients who received H&N reirradiation with PRT from April 2011 through June 2015. Patients reirradiated with palliative intent or without prior documentation of H&N radiation therapy were excluded. Radiation-related toxicities were recorded according to the Common Terminology Criteria for Adverse Events Version 4.0. Results: The conditions of 60 patients were evaluated, with a median follow-up time of 13.6 months. Fifteen patients (25%) received passive scatter proton therapy (PSPT), and 45 (75%) received intensity modulated proton therapy (IMPT). Thirty-five patients (58%) received upfront surgery, and 44 (73%) received concurrent chemotherapy. The 1-year rates of locoregional failure–free survival, overall survival, progression-free survival, and distant metastasis–free survival were 68.4%, 83.8%, 60.1%, and 74.9%, respectively. Eighteen patients (30%) experienced acute grade 3 (G3) toxicity, and 13 (22%) required a feeding tube at the end of PRT. The 1-year rates of late G3 toxicity and feeding tube independence were 16.7% and 2.0%, respectively. Three patients may have died of reirradiation-related effects (1 acute and 2 late). Conclusions: Proton beam therapy can be a safe and effective curative reirradiation strategy, with acceptable rates of toxicity and durable disease control.

Clinical importance of achieving biochemical control with medical therapy in adult patients with acromegaly

Science.gov (United States)

Christofides, Elena A

2016-01-01

In acromegaly, achieving biochemical control (growth hormone [GH] level acromegaly is challenging because it is rooted in observing subtle clinical manifestations, and it is typical for acromegaly to evolve for up to 10 years before it is recognized. This results in chronic exposure to elevated levels of GH and IGF-1 and delay in patients receiving appropriate treatment, which consequently increases mortality risk. In this review, the clinical impact of elevated GH and IGF-1 levels, the effectiveness of current therapies, and the potential role of novel treatments for acromegaly will be discussed. Clinical burden of acromegaly and benefits associated with management of GH and IGF-1 levels will be reviewed. Major treatment paradigms in acromegaly include surgery, medical therapy, and radiotherapy. With medical therapies, such as somatostatin analogs, dopamine agonists, and GH receptor antagonists, a substantial proportion of patients achieve reduced GH and normalized IGF-1 levels. In addition, signs and symptoms, quality of life, and comorbidities have also been reported to improve to varying degrees in patients who achieve biochemical control. Currently, there are several innovative therapies in development to improve patient outcomes, patient use, and access. Timely biochemical control of acromegaly ensures that the patient can ultimately improve morbidity and mortality from this disease and its extensive consequences. PMID:27471378

Factors influencing radiation therapy student clinical placement satisfaction

Science.gov (United States)

Bridge, Pete; Carmichael, Mary-Ann

2014-01-01

Introduction: Radiation therapy students at Queensland University of Technology (QUT) attend clinical placements at five different clinical departments with varying resources and support strategies. This study aimed to determine the relative availability and perceived importance of different factors affecting student support while on clinical placement. The purpose of the research was to inform development of future support mechanisms to enhance radiation therapy students’ experience on clinical placement. Methods: This study used anonymous Likert-style surveys to gather data from years 1 and 2 radiation therapy students from QUT and clinical educators from Queensland relating to availability and importance of support mechanisms during clinical placements in a semester. Results: The study findings demonstrated student satisfaction with clinical support and suggested that level of support on placement influenced student employment choices. Staff support was perceived as more important than physical resources; particularly access to a named mentor, a clinical educator and weekly formative feedback. Both students and educators highlighted the impact of time pressures. Conclusions: The support offered to radiation therapy students by clinical staff is more highly valued than physical resources or models of placement support. Protected time and acknowledgement of the importance of clinical education roles are both invaluable. Joint investment in mentor support by both universities and clinical departments is crucial for facilitation of effective clinical learning. PMID:26229635

Factors influencing radiation therapy student clinical placement satisfaction

Energy Technology Data Exchange (ETDEWEB)

Bridge, Pete; Carmichael, Mary-Ann [School of Clinical Sciences, Queensland University of Technology, Brisbane (Australia)

2014-02-15

Introduction: Radiation therapy students at Queensland University of Technology (QUT) attend clinical placements at five different clinical departments with varying resources and support strategies. This study aimed to determine the relative availability and perceived importance of different factors affecting student support while on clinical placement. The purpose of the research was to inform development of future support mechanisms to enhance radiation therapy students’ experience on clinical placement. Methods: This study used anonymous Likert-style surveys to gather data from years 1 and 2 radiation therapy students from QUT and clinical educators from Queensland relating to availability and importance of support mechanisms during clinical placements in a semester. Results: The study findings demonstrated student satisfaction with clinical support and suggested that level of support on placement influenced student employment choices. Staff support was perceived as more important than physical resources; particularly access to a named mentor, a clinical educator and weekly formative feedback. Both students and educators highlighted the impact of time pressures. Conclusions: The support offered to radiation therapy students by clinical staff is more highly valued than physical resources or models of placement support. Protected time and acknowledgement of the importance of clinical education roles are both invaluable. Joint investment in mentor support by both universities and clinical departments is crucial for facilitation of effective clinical learning.

Factors influencing radiation therapy student clinical placement satisfaction

International Nuclear Information System (INIS)

Bridge, Pete; Carmichael, Mary-Ann

2014-01-01

Introduction: Radiation therapy students at Queensland University of Technology (QUT) attend clinical placements at five different clinical departments with varying resources and support strategies. This study aimed to determine the relative availability and perceived importance of different factors affecting student support while on clinical placement. The purpose of the research was to inform development of future support mechanisms to enhance radiation therapy students’ experience on clinical placement. Methods: This study used anonymous Likert-style surveys to gather data from years 1 and 2 radiation therapy students from QUT and clinical educators from Queensland relating to availability and importance of support mechanisms during clinical placements in a semester. Results: The study findings demonstrated student satisfaction with clinical support and suggested that level of support on placement influenced student employment choices. Staff support was perceived as more important than physical resources; particularly access to a named mentor, a clinical educator and weekly formative feedback. Both students and educators highlighted the impact of time pressures. Conclusions: The support offered to radiation therapy students by clinical staff is more highly valued than physical resources or models of placement support. Protected time and acknowledgement of the importance of clinical education roles are both invaluable. Joint investment in mentor support by both universities and clinical departments is crucial for facilitation of effective clinical learning

The role of p53 in radiation therapy outcomes for favorable-to-intermediate-risk prostate cancer

International Nuclear Information System (INIS)

Ritter, Mark A.; Gilchrist, Kennedy W.; Voytovich, Marta; Chappell, Richard J.; Verhoven, Bret M.

2002-01-01

Purpose: Some prostate cancers may have molecular alterations that render them less responsive to radiation therapy; identification of these alterations before treatment might allow improved treatment optimization. This study investigated whether p53, a potential molecular determinant, could predict long-term radiation therapy outcome in a restricted group of relatively favorable-risk prostate cancer patients treated uniformly with irradiation alone. Methods and Materials: This study included 53 patients previously treated with radiotherapy for favorable-to-intermediate-risk prostate cancer. These patients were selected for relatively low pretreatment PSAs (≤21 ng/mL) and Gleason scores (≤7) to decrease the likelihood of nonlocalized disease, because disease localization was necessary to examine the efficacy of localized radiation therapy. The status of p53 was immunohistochemically assessed in paraffin-embedded pretreatment biopsy specimens, along with appropriate controls. This marker was selected based upon a usable mutation prevalence in early-stage prostate cancer and its potential linkage with radiation response via cell cycle, DNA repair, and cell death pathways. Correlation between p53 mutation and clinical outcome was analyzed in univariate and multivariate fashion and included conventional prognosticators, such as stage, grade, and PSA. Freedom from biochemical failure was determined using American Society for Therapeutic Radiology and Oncology criteria. Limitations of prior studies were potentially avoided by requiring adequate posttreatment follow-up (median follow-up in nonfailing patients of 5.1 years), as well as pretreatment PSA and Gleason scores that suggested localized disease, and uniformity of treatment. Results: The total group of 53 favorable-to-intermediate-risk patients demonstrated an actuarial biochemical failure rate of 35% at 5 years. Forty percent of all specimens had a greater than 10% labeling index for p53 mutation, and

Gender differences in the management and clinical outcome of stable angina

DEFF Research Database (Denmark)

Daly, Caroline; Clemens, Felicity; Sendon, Jose L. Lopez

2006-01-01

Background- We sought to examine the impact of gender on the investigation and subsequent management of stable angina and to assess gender differences in clinical outcome at 1 year. Methods and Results- The Euro Heart Survey of Stable Angina enrolled patients with a clinical diagnosis of stable...... angina on initial assessment by a cardiologist. Baseline clinical details and cardiac investigations planned or performed within a 4-week period of the assessment were recorded, and follow-up data were collected at 1 year. A total of 3779 patients were included in the survey; 42% were female. Women were......, 1.13 to 3.85), even after multivariable adjustment for age, abnormal ventricular function, severity of coronary disease, and diabetes. Conclusions- Significant gender bias has been identified in the use of investigations and evidence-based medical therapy in stable angina. Women were also less...

Physical Therapy Protocol After Hip Arthroscopy: Clinical Guidelines Supported by 2-Year Outcomes.

Science.gov (United States)

Domb, Benjamin G; Sgroi, Terrance A; VanDevender, Jeremy C

2016-07-01

Femoroacetabular impingement (FAI) was first described by Ganz in 2003 and is a significant cause of decreased function and mobility. Femoroacetabular impingement must be treated in an individualized, goal-oriented, stepwise fashion. This protocol was developed with biomechanical considerations of soft tissue and bony structures surrounding the hip joint. The PubMed database was searched for scientific and review articles from the years 2000 to 2015 utilizing the search terms: hip rehabilitation, femoroacetabular impingement, and arthroscopy. Clinical review. Level 5. Five hundred ninety-five of 738 patients were available for follow-up showing improvement from preoperative to 2-year follow-up of 61.29 to 82.02 for modified Harris Hip Score (mHHS), 62.79 to 83.04 for Hip Outcome Score-Activities of Daily Living (HOS-ADL), 40.96 to 70.07 for Hip Outcome Score-Sport-Specific Subscale (HOS-SSS), and 57.97 to 80.41 for Non-Arthritic Hip Score (NAHS); visual analog scale (VAS) scores decreased from 5.86 preoperatively to 2.94 postoperatively. Following a structured, criteria-based program, appropriate patients undergoing hip arthroscopy may achieve excellent outcomes and return to full independent activities of daily living as well as sport. © 2016 The Author(s).

Hyperbaric oxygen therapy in experimental and clinical stroke

Directory of Open Access Journals (Sweden)

Wei-wei Zhai

2016-01-01

Full Text Available Stroke, which is defined as a neurologic deficit caused by sudden impaired blood supply, has been considered as a common cause of death and disability for decades. The World Health Organization has declared that almost every 5 seconds a new stroke occurs, placing immense socioeconomic burdens. However, the effective and available treatment strategies are still limited. Additionally, the most effective therapy, such as thrombolysis and stenting for ischemic stroke, generally requires a narrow therapeutic time window after the event. A large majority of patients cannot be admitted to hospital and receive these effective treatments for reperfusion timely. Hyperbaric oxygen therapy (HBOT has been frequently applied and investigated in stroke since 1960s. Numerous basic and clinical studies have shown the beneficial efficacy for neurological outcome after stroke, and meanwhile many underlying mechanisms associated with neuroprotection have been illustrated, such as cerebral oxygenation promotion and metabolic improvement, blood-brain barrier protection, anti-inflammation and cerebral edema, intracranial pressure modulation, decreased oxidative-stress and apoptosis, increased vascular and neural regeneration. However, HBOT in human stroke is still not sufficiently evidence-based, due to the insufficient randomized double-blind controlled clinical studies. To date, there are no uniform criteria for the dose and session duration of HBOT in different strokes. Furthermore, the additional effect of HBOT combined with drugs and other treatment strategies are being investigated recently. Therefore, more experimental and clinical research is imperative to identify the mechanisms more clearly and to explore the best protocol of HBOT in stroke treatment.

Do clinical outcomes in chronic hemodialysis depend on the choice of a dialyzer?

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Ward, Richard A

2011-01-01

Nephrologists are presented with a range of choices when selecting a dialyzer for chronic hemodialysis. Dialyzers differ in the material, structure, permeability and surface area of their membrane, and how the dialyzer is sterilized. Opinions vary regarding the impact of dialyzer characteristics on patient outcomes and which, if any, of these properties to take into account when choosing a dialyzer can be confusing. In the general dialysis population, there is no compelling evidence that the choice of a membrane material from among those materials currently in clinical use has a significant impact on morbidity or mortality (although there are rare patients who will react adversely to a given dialysis membrane). Similarly, most dialyzers are capable of adequately removing small solutes, such as urea, provided they are used with an appropriate blood flow rate and treatment time to ensure delivery of a single-pool Kt/V(urea) of at least 1.25 for men and 1.65 for women. However, in some dialysis patient subpopulations, the results of randomized clinical trials suggest that use of dialyzer containing high-flux membranes confers an outcome advantage. The extent to which this advantage is realized might also depend on how the dialyzer is used, with application in convective therapies such as hemodiafiltration being superior to diffusive therapies such as hemodialysis. This possibility is currently the subject of several large clinical trials. © 2011 Wiley Periodicals, Inc.

The use of joint mobilization to improve clinical outcomes in hand therapy: a systematic review of the literature.

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Heiser, Rick; O'Brien, Virginia H; Schwartz, Deborah A

2013-01-01

Systematic review. Joint mobilizations are used as an intervention for improving range of motion, decreasing pain and ultimately improving function in patients with a wide variety of upper extremity diagnoses. However, there are only a limited number of studies describing this treatment for conditions affecting the elbow, wrist, and hand. Furthermore, it is unclear as to the most effective joint mobilization technique utilized and the most beneficial functional outcomes gained. Examine the current evidence describing joint mobilizations for treatment of conditions of the elbow, wrist and hand, and offer informative practical clinical guidance. Twenty-two studies dated between 1980 and 2011 were included in the systematic review for analysis. The current evidence provides moderate support for the inclusion of joint mobilizations in the treatment of lateral epicondylalgia (LE). In particular, mobilization with movement as described by Mulligan is supported with evidence from nine randomized clinical trials as an effective technique for the treatment of pain. Other described techniques include those known as Kaltenborn, Cyriax physical therapy, and Maitland, but the evidence for these techniques is limited. There is also limited evidence for the joint mobilizations in the treatment of wrist and hand conditions. The current literature offers limited support for joint mobilizations of the wrist and hand, and moderate support for joint mobilizations of the elbow for LE. There is moderate support for mobilization with movement. . Copyright © 2013 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Neurologic Functional and Quality of Life Outcomes after TBI: Clinic Attendees versus Non-Attendees.

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Patel, Mayur B; Wilson, Laura D; Bregman, Jana A; Leath, Taylor C; Humble, Stephen S; Davidson, Mario A; de Riesthal, Michael R; Guillamondegui, Oscar D

2015-07-01

This investigation describes the relationship between TBI patient demographics, quality of life outcome, and functional status outcome among clinic attendees and non-attendees. Of adult TBI survivors with intracranial hemorrhage, 63 attended our TBI clinic and 167 did not attend. All were telephone surveyed using the Extended-Glasgow Outcome Scale (GOSE), the Quality of Life after Brain Injury (QOLIBRI) scale, and a post-discharge therapy questionnaire. To determine risk factors for GOSE and QOLIBRI outcomes, we created multivariable regression models employing covariates of age, injury characteristics, clinic attendance, insurance status, post-discharge rehabilitation, and time from injury. Compared with those with severe TBI, higher GOSE scores were identified in individuals with both mild (odds ratio [OR]=2.0; 95% confidence interval [CI]: 1.1-3.6) and moderate (OR=4.7; 95% CI: 1.6-14.1) TBIs. In addition, survivors with private insurance had higher GOSE scores, compared with those with public insurance (OR=2.0; 95% CI: 1.1-3.6), workers' compensation (OR=8.4; 95% CI: 2.6-26.9), and no insurance (OR=3.1; 95% CI: 1.6-6.2). Compared with those with severe TBI, QOLIBRI scores were 11.7 points (95% CI: 3.7-19.7) higher in survivors with mild TBI and 17.3 points (95% CI: 3.2-31.5) higher in survivors with moderate TBI. In addition, survivors who received post-discharge rehabilitation had higher QOLIBRI scores by 11.4 points (95% CI: 3.7-19.1) than those who did not. Survivors with private insurance had QOLIBRI scores that were 25.5 points higher (95% CI: 11.3-39.7) than those with workers' compensation and 16.8 points higher (95% CI: 7.4-26.2) than those without insurance. Because neurologic injury severity, insurance status, and receipt of rehabilitation or therapy are independent risk factors for functional and quality of life outcomes, future directions will include improving earlier access to post-TBI rehabilitation, social work services, affordable insurance

Proton therapy of cancer: Potential clinical advantages and cost-effectiveness

International Nuclear Information System (INIS)

Lundkvist, Jonas; Ekman, Mattias; Rehn Ericsson, Suzanne; Glimelius, Bengt; Akademiska sjukhuset, Uppsala

2005-01-01

Proton therapy may offer potential clinical advantages compared with conventional radiation therapy for many cancer patients. Due to the large investment costs for building a proton therapy facility, however, the treatment cost with proton radiation is higher than with conventional radiation. It is therefore important to evaluate whether the medical benefits of proton therapy are large enough to motivate the higher costs. We assessed the cost-effectiveness of proton therapy in the treatment of four different cancers: left-sided breast cancer, prostate cancer, head and neck cancer, and childhood medulloblastoma. A Markov cohort simulation model was created for each cancer type and used to simulate the life of patients treated with radiation. Cost and quality adjusted life years (QALYs) were used as primary outcome measures. The results indicated that proton therapy was cost-effective if appropriate risk groups were chosen. The average cost per QALY gained for the four types of cancer assessed was about Euro 10,130. If the value of a QALY was set to Euro 55,000, the total yearly net benefit of treating 925 cancer patients with the four types of cancer was about Euro 20.8 million. Investment in a proton facility may thus be cost-effective. The results must be interpreted with caution, since there is a lack of data, and consequently large uncertainties in the assumptions used

Clinical characterisation of Becker muscular dystrophy patients predicts favourable outcome in exon-skipping therapy.

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van den Bergen, J C; Schade van Westrum, S M; Dekker, L; van der Kooi, A J; de Visser, M; Wokke, B H A; Straathof, C S; Hulsker, M A; Aartsma-Rus, A; Verschuuren, J J; Ginjaar, H B

2014-01-01

Duchenne and Becker muscular dystrophy (DMD/BMD) are both caused by mutations in the DMD gene. Out-of-frame mutations in DMD lead to absence of the dystrophin protein, while in-frame BMD mutations cause production of internally deleted dystrophin. Clinically, patients with DMD loose ambulance around the age of 12, need ventilatory support at their late teens and die in their third or fourth decade due to pulmonary or cardiac failure. BMD has a more variable disease course. The disease course of patients with BMD with specific mutations could be very informative to predict the outcome of the exon-skipping therapy, aiming to restore the reading-frame in patients with DMD. Patients with BMD with a mutation equalling a DMD mutation after successful exon skipping were selected from the Dutch Dystrophinopathy Database. Information about disease course was gathered through a standardised questionnaire. Cardiac data were collected from medical correspondence and a previous study on cardiac function in BMD. Forty-eight patients were included, representing 11 different mutations. Median age of patients was 43 years (range 6-67). Nine patients were wheelchair users (26-56 years). Dilated cardiomyopathy was present in 7/36 patients. Only one patient used ventilatory support. Three patients had died at the age of 45, 50 and 76 years, respectively. This study provides mutation specific data on the course of disease in patients with BMD. It shows that the disease course of patients with BMD, with a mutation equalling a 'skipped' DMD mutation is relatively mild. This finding strongly supports the potential benefit of exon skipping in patients with DMD.

Clinical Outcomes of Volume-Modulated Arc Therapy in 205 Patients with Nasopharyngeal Carcinoma: An Analysis of Survival and Treatment Toxicities.

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Rui Guo

Full Text Available To investigate the clinical efficacy and treatment toxicity of volume-modulated arc therapy (VMAT for nasopharyngeal carcinoma (NPC.205 VMAT-treated NPC patients from our cancer center were prospectively entrolled. All patients received 68-70 Gy irradiation based on the planning target volume of the primary gross tumor volume. Acute and late toxicities were graded according to the Common Terminology Criteria for Adverse Events v3.0 and Radiation Therapy Oncology Group Late Radiation Morbidity Scoring Criteria.The median follow-up period was 37.3 months (range, 6.3-45.1 months. The 3-year estimated local failure-free survival, regional failure-free survival, locoregional failure-free survival, distant metastasis-free survival, disease-free survival and overall survival were 95.5%, 97.0%, 94.0%, 92.1%, 86.8% and 97.0%, respectively. Cox regression analysis showed primary gross tumor volume, N stage and EBV-DNA to be independent predictors of VMAT outcomes (P < 0.05. The most common acute and late side effects were grade 2-3 mucositis (78% and xerostomia (83%, 61%, 34%, and 9% at 3, 6, 12 and 24 months after VMAT, respectively.VMAT for the primary treatment of NPC achieved very high locoregional control with a favorable toxicity profile. The time-saving benefit of VMAT will enable more patients to receive precision radiotherapy.

Predictors of switch to and early outcomes on third-line antiretroviral therapy at a large public-sector clinic in Johannesburg, South Africa.

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Evans, Denise; Hirasen, Kamban; Berhanu, Rebecca; Malete, Given; Ive, Prudence; Spencer, David; Badal-Faesen, Sharlaa; Sanne, Ian M; Fox, Matthew P

2018-04-10

While efficacy data exist, there are limited data on the outcomes of patients on third-line antiretroviral therapy (ART) in sub-Saharan Africa in actual practice. Being able to identify predictors of switch to third-line ART will be essential for planning for future need. We identify predictors of switch to third-line ART among patients with significant viraemia on a protease inhibitor (PI)-based second-line ART regimen. Additionally, we describe characteristics of all patients on third-line at a large public sector HIV clinic and present their early outcomes. Retrospective analysis of adults (≥ 18 years) on a PI-based second-line ART regimen at Themba Lethu Clinic, Johannesburg, South Africa as of 01 August 2012, when third-line treatment became available in South Africa, with significant viraemia on second-line ART (defined as at least one viral load ≥ 1000 copies/mL on second-line ART after 01 August 2012) to identify predictors of switch to third-line (determined by genotype resistance testing). Third-line ART was defined as a regimen containing etravirine, raltegravir or ritonavir boosted darunavir, between August 2012 and January 2016. To assess predictors of switch to third-line ART we used Cox proportional hazards regression among those with significant viraemia on second-line ART after 01 August 2012. Then among all patients on third-line ART we describe viral load suppression, defined as a viral load third-line ART. Among 719 patients in care and on second-line ART as of August 2012 (with at least one viral load ≥ 1000 copies/mL after 01 August 2012), 36 (5.0% over a median time of 54 months) switched to third-line. Time on second-line therapy (≥ 96 vs. third-line ART, 78.3% (47/60) and 83.3% (35/42) of those in care and with a viral load suppressed their viral load at 6 and 12 months, respectively. Our results show that the need for third-line is low (5%), but that patients' who switch to third-line ART have good early treatment

[Clinical effect of Saccharomyces boulardii powder combined with azithromycin sequential therapy in treatment of children with diarrhea secondary to Mycoplasma pneumoniae pneumonia].

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Chen, Qi-Fen; Zhang, Yi-Wei

2018-02-01

To investigate the clinical effect of Saccharomyces boulardii powder combined with azithromycin sequential therapy in the treatment of children with diarrhea secondary to Mycoplasma pneumoniae pneumonia. A total of 88 children with diarrhea secondary to Mycoplasma pneumoniae pneumonia between June 2015 and March 2017 were divided into control group and study group using a random number table, with 44 children in each group. The children in the control group were given routine treatment combined with azithromycin sequential therapy, and those in the study group were given oral Saccharomyces boulardii powder in addition to the treatment in the control group until the end of azithromycin sequential therapy. After the treatment ended, the two groups were compared in terms of time to improvement of clinical symptoms, length of hospital stay, clinical outcome, defecation frequency before and after treatment, condition of intestinal dysbacteriosis, and incidence of adverse events. Compared with the control group, the study group had significantly shorter time to improvement of clinical symptoms and length of hospital stay (P0.05). In the treatment of children with diarrhea secondary to Mycoplasma pneumoniae pneumonia, Saccharomyces boulardii powder combined with azithromycin sequential therapy can improve clinical symptoms, shorten the length of hospital stay, reduce defecation frequency and the incidence of intestinal dysbacteriosis, and improve clinical outcomes, and does not increase the risk of adverse events.

Impact of identifying factors which trigger bothersome tinnitus on the treatment outcome in tinnitus retraining therapy.

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Molini, Egisto; Faralli, Mario; Calzolaro, Lucia; Ricci, Giampietro

2014-01-01

The aim of this work was to ascertain any differences in the effectiveness of rehabilitation therapy in relation to the presence or absence of a known negative reinforcement responsible for the tinnitus-related pathology. Between 1 January 2001 and 31 December 2008, we recruited 294 subjects suffering from incapacitating tinnitus and/or hyperacusis. The patients underwent tinnitus retraining therapy (TRT) according to the methods described by Jastreboff and Hazell [Tinnitus Retraining Therapy: Implementing the Neurophysiological Model. Cambridge, Cambridge University Press, 2004, pp 121-133]. We clinically assessed the presence or absence of known phenomena of associative learning, regarding the presence of adverse events temporally correlated with tinnitus and the treatment outcome. The separate analysis of the 2 subgroups shows a statistically significant difference in the improvement rate between the group with a known triggering factor and the group without a triggering factor, with a preponderance of the former with a 91% improvement rate versus approximately 56% for the latter. In our study, the inability to identify factors triggering bothersome tinnitus negatively affected the treatment outcome in TRT. © 2014 S. Karger AG, Basel.

DRAGON score predicts functional outcomes in acute ischemic stroke patients receiving both intravenous tissue plasminogen activator and endovascular therapy.

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Wang, Arthur; Pednekar, Noorie; Lehrer, Rachel; Todo, Akira; Sahni, Ramandeep; Marks, Stephen; Stiefel, Michael F

2017-01-01

The DRAGON score, which includes clinical and computed tomographic (CT) scan parameters, predicts functional outcomes in ischemic stroke patients treated with intravenous tissue plasminogen activator (IV tPA). We assessed the utility of the DRAGON score in predicting functional outcome in stroke patients receiving both IV tPA and endovascular therapy. A retrospective chart review of patients treated at our institution from February 2009 to October 2015 was conducted. All patients with computed tomography angiography (CTA) proven large vessel occlusions (LVO) who underwent intravenous thrombolysis and endovascular therapy were included. Baseline DRAGON scores and modified Rankin Score (mRS) at the time of hospital discharge was calculated. Good outcome was defined as mRS ≤3. Fifty-eight patients with LVO of the anterior circulation were studied. The mean DRAGON score of patients on admission was 5.3 (range, 3-8). All patients received IV tPA and endovascular therapy. Multivariate analysis demonstrated that DRAGON scores ≥7 was associated with higher mRS ( P DRAGON scores ≤6. Patients with DRAGON scores of 7 and 8 on admission had a mortality rate of 3.8% and 40%, respectively. The DRAGON score can help predict better functional outcomes in ischemic stroke patients receiving both IV tPA and endovascular therapy. This data supports the use of the DRAGON score in selecting patients who could potentially benefit from more invasive therapies such as endovascular treatment. Larger prospective studies are warranted to further validate these results.

Patient's quality of life after high-dose radiation therapy for thoracic carcinomas. Changes over time and influence on clinical outcome

International Nuclear Information System (INIS)

Schroeder, Christina; Engenhart-Cabillic, Rita; Vorwerk, Hilke; Schmidt, Michael; Huhnt, Winfried; Blank, Eyck; Sidow, Dietrich; Buchali, Andre

2017-01-01

Quality of life (QoL) is an important factor in patient care. This analysis is focused on QoL before and after radio(chemo)therapy in patients with thoracic carcinomas, as well as on its influence on clinical follow-up and survival, and the correlation with treatment-related toxicities. The analysis included 81 patients with intrathoracic carcinoma receiving radio(chemo)therapy. For analysis of QoL, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the lung cancer-specific supplement (EORTC QLQ-LC13) were used. QoL data were collected before radiation treatment (RT), and 6 weeks, 12 weeks, 6 months, and 12 months after RT. Other factors were additionally analyzed, including clinical outcome, survival, and side effects. The functional scales showed maximum values or at least a recovery 12 weeks after RT. Symptoms with a high mean symptom score (> 40) at all appointments were fatigue, dyspnea, and coughing. Insomnia, peripheral neuropathy, appetite loss, dyspnea (from QLQ-LC13), and all pain parameters had an intermediate mean score (10-40). There were low mean scores of < 10 for nausea and vomiting, diarrhea, sore mouth, and hemoptysis. There was a significant correlation between clinical dysphagia and radiation pneumonitis with the associated symptom scales. None of the QoL scores had a significant influence on local and distant control or survival. 12 weeks after RT the QLQ-C30 functional scales show the highest scores or at least a temporary recovery. The symptom scales accurately reflect the common symptoms and treatment-related toxicities. QoL did not prove to be a significant predictor for local and distant control or survival. (orig.) [de

Progressive multifocal leukoencephalopathy. Epidemiology, clinical pictures, diagnosis and therapy

International Nuclear Information System (INIS)

Kishida, Shuji

2007-01-01

Progressive multifocal leukoencephalopathy (PML) is a demyelinating disease of the central nervous system caused by the reactivation of a ubiquitous polyomavirus JC (JCV). PML was for many years a rare disease occurring only in patients with underlying severe impaired immunity. Over the past three decades, the incidence of PML has significantly increased related to the AIDS (acquired immunodeficiency syndrome) pandemic and, more recently, to the growing use of immunosuppressive drugs. The clinical presentation of PML is variable with neurological symptoms corresponding to affected cerebral areas. Usually, the clinical outcome of patients with PML is poor with an inexorable progression to death within 6 months of symptom onset. Although PML usually requires a brain biopsy or autopsy for confirmation, radiological imaging and a demonstration of JCV-DNA in the CSF (cerebrospinal fluid) provide supportive evidence for the diagnosis. Although there is no proven effective therapy for PML, patients with HIV (human immunodeficeincy virus)-related PML may benefit significantly from HAART (highly active antiretroviral therapy). In this article the author reviews the epidemiology, especially in Japan, current challenges in the diagnosis and the treatment guidelines of patients with PML based on recent advances in the understanding of the JC virus biology. (author)

P53 overexpression and outcome of radiation therapy in head and neck cancers

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Kim, In Ah; Choi, Ihl Bhong; Kang, Ki Mun; Jang, Ji Young; Kim, Kyung Mi; Park, Kyung Shin; Kim, Young Shin; Kang, Chang Suk; Cho, Seung Ho; Kim, Hyung Tae

1999-01-01

Experimental studies have implicated the wild type p53 in cellular response to radiation. Whether altered p53 function can lead to changes in clinical radiocurability remains an area of ongoing study. This study was performed to investigate whether any correlation between change of p53 and outcome of curative radiation therapy in patients with head and neck cancers. Immunohistochemical analysis with a mouse monoclonal antibody (D0-7) specific for human p53 was used to detect to overexpression of protein in formalin fixed, paraffin-embedded tumor sample from 55 head and neck cancer patients treated with curative radiation therapy (median dose of 7020 cGy) from February 1988 to March 1996 at St. Mary's Hospital. Overexpression of p53 was correlated with locoregional control and survival using Kaplan-Meier method. A Cox regression multivariate analysis was performed that included all clinical variables and status of p53 expression. Thirty-seven (67.2%) patients showed overexpression of p53 by immunohistochemical staining in their tumor. One hundred percent of oral cavity, 76% of laryngeal, 66.7% of oropharyngeal, 66.7% of hypopharyngeal cancer showed p53 overexpression (p=0.05). The status of p53 had significant relationship with stage of disease (p=0.03) and history of smoking (p=0.001). The overexpression of p53 was not predictive of response rate to radiation therapy. The locoregional control was not significantly affected by p53 status. Overexpression of p53 didn't have any prognostic implication for disease free survival and overall survival. Primary site and stage of disease were significant prognostic factors for survival. The p53 overexpression as detected by immunohistochemical staining had significant correlation with stage, primary site of disease and smoking habit of patients. The p53 overexpression didn't have any predictive value for outcome of curative radiation therapy in a group of head and neck cancers

P53 overexpression and outcome of radiation therapy in head and neck cancers

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Kim, In Ah; Choi, Ihl Bhong; Kang, Ki Mun; Jang, Ji Young; Kim, Kyung Mi; Park, Kyung Shin; Kim, Young Shin; Kang, Chang Suk; Cho, Seung Ho; Kim, Hyung Tae [College of Medicine, The Catholic Univ., Seoul (Korea, Republic of)

1999-03-01

Experimental studies have implicated the wild type p53 in cellular response to radiation. Whether altered p53 function can lead to changes in clinical radiocurability remains an area of ongoing study. This study was performed to investigate whether any correlation between change of p53 and outcome of curative radiation therapy in patients with head and neck cancers. Immunohistochemical analysis with a mouse monoclonal antibody (D0-7) specific for human p53 was used to detect to overexpression of protein in formalin fixed, paraffin-embedded tumor sample from 55 head and neck cancer patients treated with curative radiation therapy (median dose of 7020 cGy) from February 1988 to March 1996 at St. Mary's Hospital. Overexpression of p53 was correlated with locoregional control and survival using Kaplan-Meier method. A Cox regression multivariate analysis was performed that included all clinical variables and status of p53 expression. Thirty-seven (67.2%) patients showed overexpression of p53 by immunohistochemical staining in their tumor. One hundred percent of oral cavity, 76% of laryngeal, 66.7% of oropharyngeal, 66.7% of hypopharyngeal cancer showed p53 overexpression (p=0.05). The status of p53 had significant relationship with stage of disease (p=0.03) and history of smoking (p=0.001). The overexpression of p53 was not predictive of response rate to radiation therapy. The locoregional control was not significantly affected by p53 status. Overexpression of p53 didn't have any prognostic implication for disease free survival and overall survival. Primary site and stage of disease were significant prognostic factors for survival. The p53 overexpression as detected by immunohistochemical staining had significant correlation with stage, primary site of disease and smoking habit of patients. The p53 overexpression didn't have any predictive value for outcome of curative radiation therapy in a group of head and neck cancers.

Low-molecular-weight cyclin E: the missing link between biology and clinical outcome

International Nuclear Information System (INIS)

Akli, Said; Keyomarsi, Khandan

2004-01-01

Cyclin E, a key mediator of transition during the G 1 /S cellular division phase, is deregulated in a wide variety of human cancers. Our group recently reported that overexpression and generation of low-molecular-weight (LMW) isoforms of cyclin E were associated with poor clinical outcome among breast cancer patients. However, the link between LMW cyclin E biology in mediating a tumorigenic phenotype and clinical outcome is unknown. To address this gap in knowledge, we assessed the role of LMW isoforms in breast cancer cells; we found that these forms of cyclin E induced genomic instability and resistance to p21, p27, and antiestrogens in breast cancer. These findings suggest that high levels of LMW isoforms of cyclin E not only can predict failure to endocrine therapy but also are true prognostic indicators because of their influence on cell proliferation and genetic instability

Clinical and radiological outcome following pneumothorax after endoscopic lung volume reduction with valves

Directory of Open Access Journals (Sweden)

Gompelmann D

2016-12-01

Full Text Available D Gompelmann,1,2 N Benjamin,1 K Kontogianni,1 FJF Herth,1,2 CP Heussel,2–4 H Hoffmann,2,5 R Eberhardt1,2 1Pneumology and Critical Care Medicine, Thoraxklinik at University of Heidelberg, 2German Center for Lung Research, 3Diagnostic and Interventional Radiology, Thoraxklinik at University of Heidelberg, 4Diagnostic and Interventional Radiology, University Hospital Heidelberg, 5Thoracic Surgery, Thoraxklinik at University of Heidelberg, Heidelberg, Germany Introduction: Valve implantation has evolved as a therapy for patients with advanced emphysema. Although it is a minimally invasive treatment, it is associated with complications, the most common being pneumothorax. Pneumothorax occurs due to the rapid target lobe volume reduction and may be a predictor of clinical benefit despite this complication. Objective: The objective of this study was to conduct an exploratory data analysis of patients who developed a pneumothorax following endoscopic valve therapy for emphysema. Materials and methods: This study performed a retrospective evaluation of pneumothorax management and the impact of pneumothorax on clinical outcomes in 70 patients following valve therapy in 381 consecutive patients. Results: Pneumothorax rate following valve therapy was 18%. Pneumothorax management consisted of chest tube insertion, valve removal, and surgical intervention in 87% (61/70, 44% (31/70, and 19% (13/70 of the patients, respectively. Despite pneumothorax, patients experienced modest but significant improvements in lung function parameters (forced expiratory volume in 1 second: 55±148 mL, residual volume: -390±964 mL, total lung capacity: -348±876; all P<0.05. Persistent lobar atelectasis 3 months after recovering from pneumothorax, which was associated with relevant clinical improvement, was observed in only 21% (15/70 of the patients. Conclusion: Pneumothorax is a frequent severe complication following valve therapy that requires further intervention

Clinical impact of PET/CT imaging after adjuvant therapy in patients with oral cavity squamous cell carcinoma

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Lin, Huan-Chun [Chang Gung Memorial Hospital and Chang Gung University, Department of Nuclear Medicine and Molecular Imaging Center, Taoyuan (China); Kang, Chung-Jan; Huang, Shiang-Fu; Liao, Chun-Ta [Chang Gung Memorial Hospital and Chang Gung University, Department of Otorhinolaryngology, Head and Neck Surgery, Taoyuan (China); Wang, Hung-Ming [Chang Gung Memorial Hospital and Chang Gung University, Department of Medical Oncology, Taoyuan (China); Lin, Chien-Yu [Chang Gung Memorial Hospital and Chang Gung University, Department of Radiation Oncology, Taoyuan (China); Lee, Li-Yu [Chang Gung Memorial Hospital and Chang Gung University, Department of Pathology, Taoyuan (China); Yen, Tzu-Chen [Chang Gung Memorial Hospital and Chang Gung University, Department of Nuclear Medicine and Molecular Imaging Center, Taoyuan (China); Chang Gung Memorial Hospital at Linkou, Department of Nuclear Medicine, Taoyuan (China)

2017-09-15

This single-center retrospective study of prospectively collected data was aimed at comparing the clinical outcomes of positron emission tomography/computed tomography (PET/CT) for patients with oral cavity squamous cell carcinoma (OSCC) with symptomatic recurrences identified by PET/CT imaging following adjuvant therapy (Group A) versus those of cases with asymptomatic recurrences diagnosed through periodic post-adjuvant therapy PET/CT surveillance (Group B). We also sought to establish the priority of salvage therapy in the two study groups. We identified 111 patients with advanced resected OSCC who developed recurrences following adjuvant therapy (51 in Group A and 60 in Group B). Histopathology served as the gold standard for recurrent lesions. The impact of post-adjuvant therapy PET/CT surveillance was examined with Kaplan-Meier curves and Cox proportional hazards regression models. The 2-year DSS and OS rates were marginally or significantly higher in Group B than in Group A (P = 0.073 and P = 0.025, respectively). Time-dependent ROC curve analysis demonstrated that the optimal cutoff values for time to positive PET/CT findings in relation to OS were 12 months for Group A and 9 months for Group B, respectively. Independent risk factors identified in multivariate analyses were used to devise two prognostic scoring systems for 2-year DSS and OS in each study group (all P < 0.001). Scheduled periodic PET/CT surveillance is a valuable tool for early detection of recurrent lesion(s) in asymptomatic OSCC patients who bear risk factors for disease recurrence. The presence of clinical symptoms and a short time to positive PET/CT findings were adverse prognostic factors for clinical outcome in patients with advanced OSCC. The priority of salvage therapy is discussed in each patient subgroup according to the devised prognostic scoring systems. (orig.)

Good treatment outcomes among foreigners receiving antiretroviral therapy in Johannesburg, South Africa.

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McCarthy, K; Chersich, M F; Vearey, J; Meyer-Rath, G; Jaffer, A; Simpwalo, S; Venter, W D F

2009-12-01

Foreigners, including displaced persons, often have limited health-care access, especially to HIV services. Outcomes of antiretroviral therapy (ART) in South Africans and foreigners were compared at a Johannesburg non-governmental clinic. Records were reviewed of 1297 adults enrolled between April 2004 and March 2007 (568 self-identified foreigners, 431 South Africans citizens and 298 with unknown origin). Compared with citizens, foreigners had fewer hospital admissions (39%, 90/303 versus 51%, 126/244; P fail ART than citizens (95% CI = 0.23-0.87). These findings support United Nations High Commissioner for Refugees recommendations that ART should not be withheld from displaced persons.

Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Randomized Clinical Trial.

Science.gov (United States)

Weersing, V Robin; Brent, David A; Rozenman, Michelle S; Gonzalez, Araceli; Jeffreys, Megan; Dickerson, John F; Lynch, Frances L; Porta, Giovanna; Iyengar, Satish

2017-06-01

Anxiety and depression affect 30% of youth but are markedly undertreated compared with other mental disorders, especially in Hispanic populations. To examine whether a pediatrics-based behavioral intervention targeting anxiety and depression improves clinical outcome compared with referral to outpatient community mental health care. This 2-center randomized clinical trial with masked outcome assessment conducted between brief behavioral therapy (BBT) and assisted referral to care (ARC) studied 185 youths (aged 8.0-16.9 years) from 9 pediatric clinics in San Diego, California, and Pittsburgh, Pennsylvania, recruited from October 6, 2010, through December 5, 2014. Youths who met DSM-IV criteria for full or probable diagnoses of separation anxiety disorder, generalized anxiety disorder, social phobia, major depression, dysthymic disorder, and/or minor depression; lived with a consenting legal guardian for at least 6 months; and spoke English were included in the study. Exclusions included receipt of alternate treatment for anxiety or depression, presence of a suicidal plan, bipolar disorder, psychosis, posttraumatic stress disorder, substance dependence, current abuse, intellectual disability, or unstable serious physical illness. The BBT consisted of 8 to 12 weekly 45-minute sessions of behavioral therapy delivered in pediatric clinics by master's-level clinicians. The ARC families received personalized referrals to mental health care and check-in calls to support accessing care from master's-level coordinators. The primary outcome was clinically significant improvement on the Clinical Global Impression-Improvement scale (score ≤2). Secondary outcomes included the Pediatric Anxiety Rating Scale, Children's Depression Rating Scale-Revised, and functioning. A total of 185 patients were enrolled in the study (mean [SD] age, 11.3 [2.6] years; 107 [57.8%] female; 144 [77.8%] white; and 38 [20.7%] Hispanic). Youths in the BBT group (n = 95), compared with those in

Outcomes of intense pulsed light therapy for treatment of evaporative dry eye disease.

Science.gov (United States)

Gupta, Preeya K; Vora, Gargi K; Matossian, Cynthia; Kim, Michelle; Stinnett, Sandra

2016-08-01

To determine the clinical outcomes of intense pulsed light (IPL) therapy for the treatment of evaporative dry eye disease (DED). Multicentre cohort study. Patients with a diagnosis of meibomian gland dysfunction (MGD) and dry eye presenting to the ophthalmology clinic at either the Duke Eye Center, Durham, NC, or Matossian Eye Associates' private practice in Pennington, NJ, and Doylestown, PA. Clinical data were reviewed from 100 patients with diagnosis of MGD and DED who underwent IPL therapy from September 2012 through December 2014 at 1 of 2 centres (Duke Eye Center or Matossian Eye Associates). Demographics, clinical history, examination findings (eyelid and facial vascularity, eyelid margin edema, meibomian gland oil flow, and quality score-all graded on a scale of 0 to 4), tear break up time (TBUT), and ocular surface disease index (OSDI) scoring data were collected from each visit. On average, patients underwent 4 IPL sessions. There was significant decrease in scoring of lid margin edema (mean = -0.3; range -1.5 to 0), facial telangiectasia (mean = -0.7; range -2.5 to 0), lid margin vascularity (mean = -1.2; range -2.5 to 0), meibum viscosity (mean = -1.1; range -3 to 0), and OSDI score (mean = -9.6), all with p treatment for patients with evaporative DED. Copyright © 2016 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

[Clinical Tests Testing New Therapies for Stargardt Disease].

Science.gov (United States)

Kousal, B; Ďuďáková, Ľ; Hlavatá, L; Lišková, P

2016-02-01

To provide information on currently ongoing clinical trials for Stargardt disease. We have searched the clinical trial register (www.clinicaltrials.gov) for the keyword "Stargardt" and list active ongoing studies. There are currently eight registered clinical trials enrolling patients with Stargardt disease; all in phase I or II aiming at four mechanisms of action: inhibition of the production of vitamin A toxic dimers, gene therapy restoring wild type transcription of the ABCA4 gene, neuroprotection preventing retinal cells from oxidative damage, and replacement of the damaged retinal pigment epithelium using stem cell therapy. The basic prerequisite for enrolment in the vast majority of clinical trials is confirmation of the clinical diagnosis by mutational analysis. The wide variety of therapies that are registered as clinical trials for Stargardt disease significantly raises the possibility that effective treatments will be available in the near future for this currently incurable condition and that molecular genetic testing should be increasingly considered. Stargardt disease, clinical trial, ABCA4, mutation.

Biomarkers in T cell therapy clinical trials

Directory of Open Access Journals (Sweden)

Kalos Michael

2011-08-01

Full Text Available Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.

Korean Clinic Based Outcome Measure Studies

OpenAIRE

Jongbae Park

2003-01-01

Background: Evidence based medicine has become main tools for medical practice. However, conducting a highly ranked in the evidence hierarchy pyramid is not easy or feasible at all times and places. There remains a room for descriptive clinical outcome measure studies with admitting the limit of the intepretation. Aims: Presents three Korean clinic based outcome measure studies with a view to encouraging Korean clinicians to conduct similar studies. Methods: Three studies are presented...

Radioiodine therapy in Graves' disease based on tissue-absorbed dose calculations: effect of pre-treatment thyroid volume on clinical outcome

Energy Technology Data Exchange (ETDEWEB)

Reinhardt, Michael J.; Joe, Alexius Y.; Mallek, Dirk von; Ezziddin, Samer; Palmedo, Holger [Department of Nuclear Medicine, University Hospital of Bonn, Sigmund-Freud-Strasse 25, 53127 Bonn (Germany); Brink, Ingo [Department of Nuclear Medicine, University Hospital of Freiburg (Germany); Krause, Thomas M. [Department of Nuclear Medicine, Inselspital Bern (Switzerland)

2002-09-01

This study was performed with three aims. The first was to analyse the effectiveness of radioiodine therapy in Graves' disease patients with and without goitres under conditions of mild iodine deficiency using several tissue-absorbed doses. The second aim was to detect further parameters which might be predictive for treatment outcome. Finally, we wished to determine the deviation of the therapeutically achieved dose from that intended. Activities of 185-2,220 MBq radioiodine were calculated by means of Marinelli's formula to deliver doses of 150, 200 or 300 Gy to the thyroids of 224 patients with Graves' disease and goitres up to 130 ml in volume. Control of hyperthyroidism, change in thyroid volume and thyrotropin-receptor antibodies were evaluated 15{+-}9 months after treatment for each dose. The results were further evaluated with respect to pre-treatment parameters which might be predictive for therapy outcome. Thyroidal radioiodine uptake was measured every day during therapy to determine the therapeutically achieved target dose and its coefficient of variation. There was a significant dose dependency in therapeutic outcome: frequency of hypothyroidism increased from 27.4% after 150 Gy to 67.7% after 300 Gy, while the frequency of persistent hyperthyroidism decreased from 27.4% after 150 Gy to 8.1% after 300 Gy. Patients who became hypothyroid had a maximum thyroid volume of 42 ml and received a target dose of 256{+-}80 Gy. The coefficient of variation for the achieved target dose ranged between 27.7% for 150 Gy and 17.8% for 300 Gy. When analysing further factors which might influence therapeutic outcome, only pre-treatment thyroid volume showed a significant relationship to the result of treatment. It is concluded that a target dose of 250 Gy is essential to achieve hypothyroidism within 1 year after radioiodine therapy in Graves' disease patients with goitres up to 40 ml in volume. Patients with larger goitres might need higher doses

Implementation and Clinical Outcomes of an Employer-Sponsored, Pharmacist-Provided Medication Therapy Management Program.

Science.gov (United States)

Theising, Katie M; Fritschle, Traci L; Scholfield, Angelina M; Hicks, Emily L; Schymik, Michelle L

2015-11-01

Our objective was to describe the implementation and clinical outcomes of an employer-sponsored, pharmacist-provided medication therapy management (MTM) program for health plan beneficiaries with diabetes mellitus and/or hypertension. We conducted a single-center retrospective medical record review. The setting was a Pharmacy MTM Clinic at a self-insured health system consisting of six hospitals and several ancillary facilities. A total of 161 health plan beneficiaries with diabetes identified during annual wellness screenings for the health plan in 2012 and 225 health plan beneficiaries with diabetes and/or hypertension identified during annual wellness screenings for the health plan in 2013 were referred to the MTM clinic based on specific criteria. In 2012 the health system expanded its existing wellness program by implementing a voluntary diabetes care program for health plan beneficiaries with uncontrolled diabetes (hemoglobin A(1c) [A1C] 7% or higher); a similar program was added for hypertension for the 2013 plan year. All participants' A1C and blood pressure results were tracked from the date of their wellness screening through the end of the plan year. The pharmacists involved had the capability to directly implement drug regimen changes according to hospital protocol or provide recommendations to the physician, as specified by the referring physician. For the 2012-2013 plan year, the mean difference in A1C from baseline to program completion was -0.38% (95% confidence interval [CI] -0.58 to -0.18%, p<0.05). For beneficiaries with a baseline A1C of 7% or higher, the mean difference was -0.69% (95% CI -0.99 to -0.39%, p<0.05). For the 2013-2014 plan year, the mean difference in A1C from baseline to program completion was -0.62% (95% CI -0.81 to -0.44%, p<0.05). In that year, the mean difference in A1C for beneficiaries with A1C 7% or higher was -0.97% (95% CI -1.23 to -0.72%, p<0.05). For those referred for hypertension, a mean difference of -13 mm Hg (95

Current Status of Immunomodulatory and Cellular Therapies in Preclinical and Clinical Islet Transplantation

Directory of Open Access Journals (Sweden)

Preeti Chhabra

2011-01-01

Full Text Available Clinical islet transplantation is a -cell replacement strategy that represents a possible definitive intervention for patients with type 1 diabetes, offering substantial benefits in terms of lowering daily insulin requirements and reducing incidences of debilitating hypoglycemic episodes and unawareness. Despite impressive advances in this field, a limiting supply of islets, inadequate means for preventing islet rejection, and the deleterious diabetogenic and nephrotoxic side effects associated with chronic immunosuppressive therapy preclude its wide-spread applicability. Islet transplantation however allows a window of opportunity for attempting various therapeutic manipulations of islets prior to transplantation aimed at achieving superior transplant outcomes. In this paper, we will focus on the current status of various immunosuppressive and cellular therapies that promote graft function and survival in preclinical and clinical islet transplantation with special emphasis on the tolerance-inducing capacity of regulatory T cells as well as the -cells regenerative capacity of stem cells.

Awareness and use of Meseron therapy among clinical ...

African Journals Online (AJOL)

Despite strong underlying philosophies and benefits of non western therapies such as Meseron therapy, it is apparent they meet with several challenges which limit their ready adoption and applicability in clinical practice. This paper examined the views of Nigerian clinical psychologists about non-western psychotherapies ...

Client interpersonal impacts as mediators of long-term outcome in cognitive-behavioral therapy integrated with motivational interviewing for generalized anxiety disorder.

Science.gov (United States)

Constantino, Michael J; Romano, Felicia M; Coyne, Alice E; Westra, Henny A; Antony, Martin M

2017-03-24

A recent trial of generalized anxiety disorder treatment (Westra, H. A., Constantino, M. J., & Antony, M. M. (2016). Integrating Motivational Interviewing With Cognitive-Behavioral Therapy for Severe Generalized Anxiety Disorder: An Allegiance-Controlled Randomized Clinical Trial. Journal of Consulting and Clinical Psychology, 84, 768-782. doi: 10.1037/ccp0000098 ) revealed that cognitive-behavioral therapy (CBT) integrated with motivational interviewing (MI) outperformed CBT alone across a 12-month follow up. The present study examined whether this treatment effect was mediated by MI-CBT clients engaging over time in during-session interpersonal behaviors reflecting more friendly dominance, or agentic actions, and less friendly submissiveness (FS), or trustingly compliant actions both theory-specific MI mechanisms. Clients received 15 sessions of MI-CBT (n = 42) or CBT alone (n = 43). Therapists rated client interpersonal behavior following five sessions, and clients rated their worry at baseline, each session, and 6- and 12-month follow up. Mediator and outcome variables were derived from multilevel models. Mediation was tested using a bootstrapping procedure. There was a significant indirect effect for FS. As expected, CBT clients evidenced greater increases in FS than MI-CBT clients, which in turn, though unexpectedly, related to lower 12-month worry. However, long-term CBT outcomes remained inferior to MI-CBT outcomes even with CBT clients'greater increase in FS. Results suggest that CBT outcomes are more positive when clients trustingly comply; however, MI-CBT remained superior, but for as yet unexplained reasons. Clinical or methodological significance of this article: The findings highlight the clinical importance of GAD clients becoming more friendly dominant in the therapy relationship irrespective of whether they received CBT or integrative MI-CBT. Moreover, it seems clinically indicated to incorporate MI spirit and techniques into CBT when

Third prize : A blinded randomized clinical trial of manual therapy and physiotherapy for chronic back and neck complaints: Physical outcome measures

NARCIS (Netherlands)

Koes, B. W.; Bouter, L. M.; Van Mameren, H.; Essers, A. H M; Verstegen, G. M J R; Hofhuizen, D. M.; Houben, J. P.; Knipschild, P. G.

1992-01-01

In a blinded randomized clinical trial, we compared the effectiveness of manual therapy, physiotherapy, (continued) treatment by the general practitioner (GP), and a placebo therapy (detuned ultrasound and detuned short wave diathermy) for patients (n = 256) with chronic nonspecific back and neck

Stereotactic Radiation Therapy for Benign Meningioma: Long-Term Outcome in 318 Patients

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Fokas, Emmanouil, E-mail: emmanouil.fokas@kgu.de [Department of Radiotherapy and Radiation Oncology, Philipps-University Marburg, Marburg (Germany); Department of Radiation Therapy and Oncology, Johann Wolfgang Goethe University, Frankfurt (Germany); Henzel, Martin [Department of Radiotherapy and Radiation Oncology, Philipps-University Marburg, Marburg (Germany); Surber, Gunar; Hamm, Klaus [Department for Stereotactic Neurosurgery and Radiosurgery, HELIOS Klinikum Erfurt, Erfurt (Germany); Engenhart-Cabillic, Rita [Department of Radiotherapy and Radiation Oncology, Philipps-University Marburg, Marburg (Germany)

2014-07-01

Purpose: To investigate the long-term outcome of stereotactic-based radiation therapy in a large cohort of patients with benign intracranial meningiomas. Methods and Materials: Between 1997 and 2010, 318 patients with histologically confirmed (44.7%; previous surgery) or imaging-defined (55.3%) benign meningiomas were treated with either fractionated stereotactic radiation therapy (79.6%), hypofractionated stereotactic radiation therapy (15.4%), or stereotactic radiosurgery (5.0%), depending on tumor size and location. Local control (LC), overall survival (OS), cause-specific survival (CSS), prognostic factors, and toxicity were analyzed. Results: The median follow-up was 50 months (range, 12-167 months). Local control, OS, and CSS at 5 years were 92.9%, 88.7%, and 97.2%, and at 10 years they were 87.5%, 74.1%, and 97.2%, respectively. In the multivariate analysis, tumor location (P=.029) and age >66 years (P=.031) were predictors of LC and OS, respectively. Worsening of pre-existing neurologic symptoms immediately after radiation therapy occurred in up to 2%. Clinically significant acute toxicity (grade 3°) occurred in 3%. Only grade 1-2 late toxicity was observed in 12%, whereas no new neurologic deficits or treatment-related mortality were encountered. Conclusions: Patients with benign meningiomas predominantly treated with standard fractionated stereotactic radiation therapy with narrow margins enjoy excellent LC and CSS, with minimal long-term morbidity.

Effect of advanced chronic kidney disease in clinical and echocardiographic outcomes of patients treated with MitraClip system

DEFF Research Database (Denmark)

Estévez-Loureiro, Rodrigo; Settergren, Magnus; Pighi, Michele

2015-01-01

BACKGROUND: Data regarding the influence of different levels of renal dysfunction on clinical and echocardiographic results of MitraClip therapy are scarce. We aimed to evaluate the impact of baseline advance renal failure in the outcomes of a cohort of patients treated with MitraClip. METHODS AN...

Patient retention, clinical outcomes and attrition-associated factors of HIV-infected patients enrolled in Zimbabwe's National Antiretroviral Therapy Programme, 2007-2010.

Directory of Open Access Journals (Sweden)

Tsitsi Mutasa-Apollo

Full Text Available Since establishment of Zimbabwe's National Antiretroviral Therapy (ART Programme in 2004, ART provision has expanded from <5,000 to 369,431 adults by 2011. However, patient outcomes are unexplored.To determine improvement in health status, retention and factors associated with attrition among HIV-infected patients on ART.A retrospective review of abstracted patient records of adults ≥ 15 years who initiated ART from 2007 to 2009 was done. Frequencies and medians were calculated for rates of retention in care and changes in key health status outcomes at 6, 12, 24 and 36 months respectively. Cox proportional hazards models were used to determine factors associated with attrition.Of the 3,919 patients, 64% were female, 86% were either WHO clinical stage III or IV. Rates of patient retention at 6, 12, 24 and 36 months were 90.7%, 78.1%, 68.8% and 64.4%, respectively. After ART initiation, median weight gains at 6, 12, and 24 months were 3, 4.5, and 5.0 kgs whilst median CD4+ cell count gains at 6, 12 and 24 months were 122, 157 and 279 cells/µL respectively. Factors associated with an increased risk of attrition included male gender (AHR 1.2; 95% CI, 1.1-1.4, baseline WHO stage IV (AHR 1.7; 95% CI, 1.1-2.6, lower baseline body weight (AHR 2.0; 95% CI, 1.4-2. 8 and accessing care from higher level healthcare facilities (AHR 3.5; 95% 1.1-11.2.Our findings with regard to retention as well as clinical and immunological improvements following uptake of ART, are similar to what has been found in other settings. Factors influencing attrition also mirror those found in other parts of sub-Saharan Africa. These findings suggest the need to strengthen earlier diagnosis and treatment to further improve treatment outcomes. Whilst decentralisation improves ART coverage it should be coupled with strategies aimed at improving patient retention.

Intensity-Modulated Radiation Therapy in Oropharyngeal Carcinoma: Effect of Tumor Volume on Clinical Outcomes

International Nuclear Information System (INIS)

Lok, Benjamin H.; Setton, Jeremy; Caria, Nicola; Romanyshyn, Jonathan; Wolden, Suzanne L.; Zelefsky, Michael J.; Park, Jeffery; Rowan, Nicholas; Sherman, Eric J.; Fury, Matthew G.; Ho, Alan; Pfister, David G.; Wong, Richard J.; Shah, Jatin P.; Kraus, Dennis H.; Zhang, Zhigang; Schupak, Karen D.; Gelblum, Daphna Y.; Rao, Shyam D.; Lee, Nancy Y.

2012-01-01

Purpose: To analyze the effect of primary gross tumor volume (pGTV) and nodal gross tumor volume (nGTV) on treatment outcomes in patients treated with definitive intensity-modulated radiation therapy (IMRT) for oropharyngeal cancer (OPC). Methods and Materials: Between September 1998 and April 2009, a total of 442 patients with squamous cell carcinoma of the oropharynx were treated with IMRT with curative intent at our center. Thirty patients treated postoperatively and 2 additional patients who started treatment more than 6 months after diagnosis were excluded. A total of 340 patients with restorable treatment plans were included in this present study. The majority of the patients underwent concurrent platinum-based chemotherapy. The pGTV and nGTV were calculated using the original clinical treatment plans. Cox proportional hazards models and log-rank tests were used to evaluate the correlation between tumor volumes and overall survival (OS), and competing risks analysis tools were used to evaluate the correlation between local failure (LF), regional failure (RF), distant metastatic failure (DMF) vs. tumor volumes with death as a competing risk. Results: Median follow-up among surviving patients was 34 months (range, 5-67). The 2-year cumulative incidence of LF, RF and DF in this cohort of patients was 6.1%, 5.2%, and 12.2%, respectively. The 2-year OS rate was 88.6%. Univariate analysis determined pGTV and T-stage correlated with LF (p < 0.0001 and p = 0.004, respectively), whereas nGTV was not associated with RF. On multivariate analysis, pGTV and N-stage were independent risk factors for overall survival (p = 0.0003 and p = 0.0073, respectively) and distant control (p = 0.0008 and p = 0.002, respectively). Conclusions: In this cohort of patients with OPC treated with IMRT, pGTV was found to be associated with overall survival, local failure, and distant metastatic failure.

Indirect vs Direct Voice Therapy for Children With Vocal Nodules: A Randomized Clinical Trial.

Science.gov (United States)

Hartnick, Christopher; Ballif, Catherine; De Guzman, Vanessa; Sataloff, Robert; Campisi, Paolo; Kerschner, Joseph; Shembel, Adrianna; Reda, Domenic; Shi, Helen; Sheryka Zacny, Elinore; Bunting, Glenn

2018-02-01

Benign vocal fold nodules affect 12% to 22% of the pediatric population, and 95% of otolaryngologists recommend voice therapy as treatment. However, no randomized clinical trials that we are aware of have shown its benefits. To determine the impact of voice therapy in children with vocal fold nodules according to pretherapy and posttherapy scores on the Pediatric Voice-Related Quality of Life (PVRQOL) survey; secondary objectives included changes in phonatory parameters. For this multicenter randomized clinical trial, 114 children ages 6 to 10 years with vocal fold nodules, PVRQOL scores less than 87.5, and dysphonia for longer than 12 weeks were recruited from outpatient voice and speech clinics. This age range was identified because these patients have not experienced pubertal changes of the larynx, tolerate stroboscopy, and cooperate with voice therapy. Participants were blinded to treatment arm. Participants received either indirect or direct therapy for 8 to 12 weeks. Indirect therapy focused on education and discussion of voice principles, while direct treatment used the stimulus, response, antecedent paradigm. The primary outcome measure was PVRQOL score change before and after treatment. Secondary phonatory measures were also compared. Overall, 114 children were recruited for study (mean [SD] age, 8 [1.4] years; 83 males [73%]); with 57 randomized to receive either indirect or direct therapy. Both direct and indirect therapy approaches showed significant differences in PVRQOL scores pretherapy to posttherapy. The mean increase in PVRQOL score for direct therapy was 19.2, and 14.7 for indirect therapy (difference, 4.5; 95.3% CI, -10.8 to 19.8). Of 44 participants in the direct therapy group, 27 (61%) achieved a clinically meaningful PVRQOL improvement, compared with 26 of 49 (53%) for indirect therapy (difference, 8%; 95% CI, -12 to 28). Post hoc stratification showed robust effects in the direct therapy group for older children (Cohen d = 0.50) and the

Preclinical and clinical experience in vascular gene therapy: advantages over conservative/standard therapy.

Science.gov (United States)

Nikol, S; Huehns, T Y

2001-04-01

No systemic pharmacological treatment has been shown to convincingly reduce the incidence of restenosis after angioplasty or increase the formation of collaterals in ischemic tissue in patients. The lack of success of many pharmaceutical agents in reducing restenosis rates or in inducing angiogenesis post-angioplasty and following stent implantation has encouraged the development of new technological treatment approaches. Gene therapy is a novel strategy with the potential to prevent some of the sequelae after arterial injury, particularly cell proliferation, and to induce growth of new vessels or remodeling of pre-existing vessel branches, which may help patients with critical ischemia. Gene therapy strategies have the advantage of minimizing systemic side effects and may have a long-term effect as the encoded protein is released. Most clinical trials investigating gene therapy for vascular disease have been uncontrolled phase I and IIa trials. Gene therapy into vessels with the genes for growth factors has been demonstrated to be feasible and efficient. Local drug delivery devices have been used in combination with gene therapy in several trials to maximize safety and efficiency. Data from experimental animal work indicates that gene therapy may modify intimal hyperplasia after arterial injury, but there are few clinical trials on restenosis in patients. Preliminary clinical results show only limited success in altering restenosis rates. In vitro and experimental in vivo investigations into gene therapy for angiogenesis demonstrate increased formation of collaterals and functional improvement of limb ischemia. There is some evidence of increased collateral formation and clinical improvement in patients with critical limb ischemia. Results of placebo-controlled and double-blind trials of gene therapy for vascular disease are awaited.

Meta-analysis of clinical studies supports the pharmacokinetic variability hypothesis for acquired drug resistance and failure of antituberculosis therapy.

Science.gov (United States)

Pasipanodya, Jotam G; Srivastava, Shashikant; Gumbo, Tawanda

2012-07-01

Using hollow-fiber tuberculosis studies, we recently demonstrated that nonadherence is not a significant factor for ADR and that therapy failure only occurs after a large proportion of doses are missed. Computer-aided clinical trial simulations have suggested that isoniazid and rifampin pharmacokinetic variability best explained poor outcomes. We were interested in determining whether isoniazid pharmacokinetic variability was associated with either microbiological failure or ADR in the clinic. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Prospective, randomized, controlled clinical trials that reported isoniazid acetylation status and microbiological outcomes were selected. The main effects examined were microbiological sputum conversion, ADR, and relapse. Effect size was expressed as pooled risk ratios (RRs) comparing rapid with slow acetylators. Thirteen randomized studies with 1631 rapid acetylators and 1751 slow acetylators met inclusion and exclusion criteria. Rapid acetylators were more likely than slow acetylators to have microbiological failure (RR, 2.0; 95% confidence interval [CI], 1.5-2.7), ADR (RR, 2.0; CI, 1.1-3.4), and relapse (RR, 1.3; CI, .9-2.0). Higher failure rates were encountered even in drug regimens comprising >3 antibiotics. No publication bias or small-study effects were observed for the outcomes evaluated. Pharmacokinetic variability to a single drug in the regimen is significantly associated with failure of therapy and ADR in patients. This suggests that individualized dosing for tuberculosis may be more effective than standardized dosing, which is prescribed in directly observed therapy programs.

Is administered radioiodine activity appropriate? The effects of pre- treatment antithyroid drugs on the therapy outcome

International Nuclear Information System (INIS)

Nanayakkara, D.; Udugama, C.; Perera, K.; Herath, S.

2007-01-01

Full text: Although radioiodine (RAI) therapy has been used in the treatment of thyrotoxicosis, there are both wide variations in current practice and deficiencies in outcome. There is concern as to decide the optimum activity to achieve better therapeutic outcome and uncertainty over the effects of pretreatment antithyroid drugs (ATD) on the post therapy outcome. Use of ATD (carbimazole) to control the severity of the disease prior to RAI therapy is a common accepted practice. The Royal college of Physicians (RCP) guideline on radioiodine therapy for thyrotoxicosis has recommended activity of 400mBq for Graves' disease (GD) and 15mCi for toxic multi nodular disease (TMND) to achieve euthyroidism with an incidence of hypothyroidism around 15-20% at 2 years. However, in the clinical setting, many patients have become hypothyroid very early than the expected time period. This study was carried out to see the fixed dose RAI therapy outcome of both GD and TMND. Another objective is to assess the effects of pre therapy ATD on the RAI therapy for both GD and TMND at 1 year. Post RAI therapy outcome was analyzed in thyrotoxic patients who received RAI at our institute from 2001-2005. Diagnosis of thyrotoxicosis was made on the basis of biochemical thyroid function tests and thyroid uptake scans. Both GD and TMND patients were selected. Patients who were treated with ATD were advised to stop drugs for at least 4 weeks before administration of RAI therapeutic dose. GD patients received 400mBq and TMND received 550mBq of RAI irrespective of the size of the thyroid gland. Both GD and TMND were further categorized into two groups on the basis of whether they have given ATD prior to RAI therapy. Patients with solitary toxic nodular disease were excluded from the study. Post therapy thyroid functions (free thyroxine and thyroid stimulating hormone) were done at 1, 2, 3, 6 and 12 months intervals. Therapy outcome over time was defined on the basis of thyroid function and

Mid- and long-term clinical results of surgical therapy in unicameral bone cysts

Directory of Open Access Journals (Sweden)

Hagmann Sébastien

2011-12-01

Full Text Available Abstract Background Unicameral (or simple bone cysts (UBC are benign tumours most often located in long bones of children and adolescents. Pathological fractures are common, and due to high recurrence rates, these lesions remain a challenge to treat. Numerous surgical procedures have been proposed, but there is no general consensus of the ideal treatment. The aim of this investigation therefore was to study the long-term outcome after surgical treatment in UBC. Methods A retrospective analysis of 46 patients surgically treated for UBC was performed for short and mid-term outcome. Clinical and radiological outcome parameters were studied according to a modified Neer classification system. Long-term clinical information was retrieved via a questionnaire at a minimum follow-up of 10 years after surgery. Results Forty-six patients (17 female, 29 male with a mean age of 10.0 ± 4.8 years and with histopathologically confirmed diagnosis of UBC were included. Pathological fractures were observed in 21 cases (46%. All patients underwent surgery for UBC (35 patients underwent curettage and bone grafting as a primary therapy, 4 curettage alone, 3 received corticoid instillation and 4 decompression by cannulated screws. Overall recurrence rate after the first surgical treatment was 39% (18/46, second (17.4% of all patients and third recurrence (4.3% were frequently observed and were addressed by revision surgery. Recurrence was significantly higher in young and in male patients as well as in active cysts. After a mean of 52 months, 40 out of 46 cysts were considered healed. Prognosis was significantly better when recurrence was observed later than 30 months after therapy. After a mean follow-up of 15.5 ± 6.2 years, 40 patients acknowledged clinically excellent results, while five reported mild and casual pain. Only one patient reported a mild limitation of range of motion. Conclusions Our results suggest satisfactory overall long-term outcome for the

Mid- and long-term clinical results of surgical therapy in unicameral bone cysts.

Science.gov (United States)

Hagmann, Sébastien; Eichhorn, Florian; Moradi, Babak; Gotterbarm, Tobias; Dreher, Thomas; Lehner, Burkhard; Zeifang, Felix

2011-12-13

Unicameral (or simple) bone cysts (UBC) are benign tumours most often located in long bones of children and adolescents. Pathological fractures are common, and due to high recurrence rates, these lesions remain a challenge to treat. Numerous surgical procedures have been proposed, but there is no general consensus of the ideal treatment. The aim of this investigation therefore was to study the long-term outcome after surgical treatment in UBC. A retrospective analysis of 46 patients surgically treated for UBC was performed for short and mid-term outcome. Clinical and radiological outcome parameters were studied according to a modified Neer classification system. Long-term clinical information was retrieved via a questionnaire at a minimum follow-up of 10 years after surgery. Forty-six patients (17 female, 29 male) with a mean age of 10.0 ± 4.8 years and with histopathologically confirmed diagnosis of UBC were included. Pathological fractures were observed in 21 cases (46%). All patients underwent surgery for UBC (35 patients underwent curettage and bone grafting as a primary therapy, 4 curettage alone, 3 received corticoid instillation and 4 decompression by cannulated screws). Overall recurrence rate after the first surgical treatment was 39% (18/46), second (17.4% of all patients) and third recurrence (4.3%) were frequently observed and were addressed by revision surgery. Recurrence was significantly higher in young and in male patients as well as in active cysts. After a mean of 52 months, 40 out of 46 cysts were considered healed. Prognosis was significantly better when recurrence was observed later than 30 months after therapy. After a mean follow-up of 15.5 ± 6.2 years, 40 patients acknowledged clinically excellent results, while five reported mild and casual pain. Only one patient reported a mild limitation of range of motion. Our results suggest satisfactory overall long-term outcome for the surgical treatment of UBC, although short-and mid

Cellular Therapies Clinical Research Roadmap: lessons learned on how to move a cellular therapy into a clinical trial.

Science.gov (United States)

Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M

2015-04-01

A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, by means of an Investigational New Drug (IND) application, into early-phase clinical trials. The roadmap describes four key areas: basic and preclinical research, resource development, translational research and Good Manufacturing Practice (GMP) and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value with the use of a model of the relevant disease. During resource development, the appropriate specialists and the required expertise to bring this product into the clinic are identified (eg, researchers, regulatory specialists, GMP manufacturing staff, clinicians and clinical trials staff, etc). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase, the plan to translate the research product into a clinical-grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States, this is done by filing an IND application with the Food and Drug Administration. The National Heart, Lung and Blood Institute-funded Production Assistance for Cellular Therapies program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five Production Assistance for Cellular Therapies facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Animal-assisted therapy at an outpatient pain management clinic.

Science.gov (United States)

Marcus, Dawn A; Bernstein, Cheryl D; Constantin, Janet M; Kunkel, Frank A; Breuer, Paula; Hanlon, Raymond B

2012-01-01

The objective of this study was to evaluate the effects of brief therapy dog visits to an outpatient pain management facility compared with time spent in a waiting room. The design of this study is open-label. Setting.  This study was conducted in a university tertiary care adult chronic pain outpatient clinic. The subjects of this study include outpatients, adults accompanying outpatients to their appointments, and clinic staff. Intervention.  Participants were able to spend clinic waiting time with a certified therapy dog instead of waiting in the outpatient waiting area. When the therapy dog was not available, individuals remained in the waiting area. Self-reported pain, fatigue, and emotional distress were recorded using 11-point numeric rating scales before and after the therapy dog visit or waiting room time. Two hundred ninety-five therapy dog visits (235 with patients, 34 family/friends, and 26 staff) and 96 waiting room surveys (83 from patients, 6 family/friends, and 7 staff) were completed over a 2-month study period. Significant improvements were reported for pain, mood, and other measures of distress among patients after the therapy dog visit but not the waiting room control, with clinically meaningful pain relief (decrease ≥2 points) in 23% after the therapy dog visit and 4% in the waiting room control. Significant improvements were likewise seen after therapy dog visits for family/friends and staff. Therapy dog visits in an outpatient setting can provide significant reduction in pain and emotional distress for chronic pain patients. Therapy dog visits can also significantly improve emotional distress and feelings of well-being in family and friends accompanying patients to appointments and clinic staff. Wiley Periodicals, Inc.

Hormone Therapy in Clinical Equine Practice.

Science.gov (United States)

McCue, Patrick M

2016-12-01

A wide variety of hormone therapies are used in clinical practice in the reproductive management of horses. The goal of this article is to review therapeutic options for a variety of clinical indications. Copyright © 2016 Elsevier Inc. All rights reserved.

CAR T-cell therapy for glioblastoma: ready for the next round of clinical testing?

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Prinzing, Brooke L; Gottschalk, Stephen M; Krenciute, Giedre

2018-05-01

The outcome for patients with glioblastoma (GBM) remains poor, and there is an urgent need to develop novel therapeutic approaches. T cells genetically modified with chimeric antigen receptors (CARs) hold the promise to improve outcomes since they recognize and kill cells through different mechanisms than conventional therapeutics. Areas covered: This article reviews CAR design, tumor associated antigens expressed by GBMs that can be targeted with CAR T cells, preclinical and clinical studies conducted with CAR T cells, and genetic approaches to enhance their effector function. Expert commentary: While preclinical studies have highlighted the potent anti-GBM activity of CAR T cells, the initial foray of CAR T-cell therapies into the clinic resulted only in limited benefits for GBM patients. Additional genetic modification of CAR T cells has resulted in a significant increase in their anti-GBM activity in preclinical models. We are optimistic that clinical testing of these enhanced CAR T cells will be safe and result in improved anti-glioma activity in GBM patients.

Full-mouth disinfection as a therapeutic protocol for type-2 diabetic subjects with chronic periodontitis: twelve-month clinical outcomes: a randomized controlled clinical trial.

Science.gov (United States)

Santos, Vanessa R; Lima, Jadson A; Miranda, Tamires S; Gonçalves, Tiago E D; Figueiredo, Luciene C; Faveri, Marcelo; Duarte, Poliana M

2013-02-01

The aim of this randomized controlled clinical trial was to evaluate the clinical effects of chlorhexidine (CHX) application in a full-mouth disinfection (FMD) protocol in poorly controlled type-2 diabetic subjects with generalized chronic periodontitis. Thirty-eight subjects were randomly assigned into FMD group (n=19): full-mouth scaling and root planing (FMSRP) within 24 h + local application of CHX gel + CHX rinses for 60 days or Control group (n = 19): FMSRP within 24 h + local application of placebo gel + placebo rinses for 60 days. Clinical parameters, glycated haemoglobin and fasting plasma glucose were assessed at baseline, 3, 6 and 12 months post-therapies. All clinical parameters improved significantly at 3, 6 and 12 months post-therapies for both groups (p clinical parameters, and glycemic condition at any time-point (p > 0.05). The treatments did not differ with respect to clinical parameters, including the primary outcome variable (i.e. changes in clinical attachment level in deep pockets), for up to 12 months post-treatments. © 2012 John Wiley & Sons A/S.

The steroids for corneal ulcers trial (SCUT): secondary 12-month clinical outcomes of a randomized controlled trial.

Science.gov (United States)

Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; O'Brien, Kieran S; Glidden, David V; Ray, Kathryn J; Oldenburg, Catherine E; Zegans, Michael E; Whitcher, John P; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R

2014-02-01

To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes. Randomized, placebo-controlled, double-masked clinical trial. This multicenter trial compared 1.0% prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization. The primary endpoint was 3 months from enrollment, and 399 patients were evaluated at 12 months. The outcomes examined were best spectacle-corrected visual acuity (BSCVA) and scar size at 12 months. Based on previous results, regression models with adjustments for baseline status and/or causative organism were used for analysis. No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models (BSCVA: -0.04 logMAR, 95% CI, -0.12 to 0.05, P = .39; scar size: 0.03 mm, 95% CI, -0.12 to 0.18, P = .69). A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers (-0.10 logMAR, 95% CI, -0.19 to -0.02, P = .02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, -0.04 to 0.41, P = .16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47 mm, 95% CI, 0.06-0.88, P = .02) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers (-0.06 mm, 95% CI, -0.21 to 0.10, P = .46). Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species. Copyright © 2014 Elsevier Inc. All rights reserved.

Effect of Adding Interferential Current in an Exercise and Manual Therapy Program for Patients With Unilateral Shoulder Impingement Syndrome: A Randomized Clinical Trial.

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Gomes, Cid André Fidelis de Paula; Dibai-Filho, Almir Vieira; Moreira, William Arruda; Rivas, Shirley Quispe; Silva, Emanuela Dos Santos; Garrido, Ana Claudia Bogik

The purpose of this study was to measure the additional effect of adding interferential current (IFC) to an exercise and manual therapy program for patients with unilateral shoulder impingement syndrome. Forty-five participants were randomly assigned to group 1 (exercise and manual therapy), group 2 (exercise and manual therapy + IFC), or group 3 (exercise and manual therapy + placebo ultrasound). Individuals participated in 16 treatment sessions, twice a week for 8 weeks. The primary outcome of the study was total score of the Shoulder Pain and Disability Index (SPADI). The secondary outcomes were the pain and disability subscales of SPADI, Numeric Rating Scale, and Pain-Related Self-Statement Scale. Adjusted between-group mean differences (MDs) and 95% confidence intervals (CIs) were calculated using linear mixed models. After 16 treatment sessions, statistically significant but not clinically important differences were identified in favor of the exercise and manual therapy program alone in the SPADI-total (group 1 vs group 2, MD 11.12 points, 95% CI 5.90-16.35; group 1 vs group 3, MD 13.43 points, 95% CI 8.21-18.65). Similar results were identified for secondary outcomes. The addition of IFC does not generate greater clinical effects in an exercise and manual therapy program for individuals with unilateral shoulder impingement syndrome. Copyright © 2018. Published by Elsevier Inc.

Clinical outcomes of image guided radiation therapy (IGRT) with gold fiducial vaginal cuff markers for high-risk endometrial cancer

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Monroe, Alan T.; Peddada, Anuj V. [Dept. of Radiation Oncology, Penrose Cancer Center, Colorado Springs (United States); Pikaart, Dirk [Dept. of Gynecologic Oncology, Penrose Cancer Center, Colorado Springs (United States)

2013-06-15

Objective. To report two year clinical outcomes of image guided radiation therapy (IGRT) to the vaginal cuff and pelvic lymph nodes in a series of high-risk endometrial cancer patients. Methods . Twenty-six consecutive high-risk endometrial cancer patients requiring adjuvant radiation to the vaginal cuff and regional lymph nodes were treated with vaginal cuff fiducial-based IGRT. Seventeen (65%) received sequential chemotherapy, most commonly with a sandwich technique. Brachytherapy followed external radiation in 11 patients to a median dose of 18 Gy in 3 fractions. The median external beam dose delivered was 47.5 Gy in 25 fractions. Results. All 656 fractions were successfully imaged and treated. The median overall translational shift required for correction was 9.1 mm (standard deviation, 5.2 mm) relative to clinical set-up with skin tattoos. Shifts of 1 cm, 1.5 cm, and 2 cm or greater were performed in 43%, 14%, and 4% of patients, respectively. Acute grade 2 gastrointestinal (GI) toxicity occurred in eight patients (30%) and grade 3 toxicity occurred in one. At two years, there have been no local or regional failures and actuarial overall survival is 95%. Conclusion. Daily image guidance for high-risk endometrial cancer results in a low incidence of acute GI/genitourinary (GU) toxicity with uncompromised tumor control at two years. Vaginal cuff translations can be substantial and may possibly result in underdosing if not properly considered.

Clinical outcomes of image guided radiation therapy (IGRT) with gold fiducial vaginal cuff markers for high-risk endometrial cancer

International Nuclear Information System (INIS)

Monroe, Alan T.; Peddada, Anuj V.; Pikaart, Dirk

2013-01-01

Objective. To report two year clinical outcomes of image guided radiation therapy (IGRT) to the vaginal cuff and pelvic lymph nodes in a series of high-risk endometrial cancer patients. Methods . Twenty-six consecutive high-risk endometrial cancer patients requiring adjuvant radiation to the vaginal cuff and regional lymph nodes were treated with vaginal cuff fiducial-based IGRT. Seventeen (65%) received sequential chemotherapy, most commonly with a sandwich technique. Brachytherapy followed external radiation in 11 patients to a median dose of 18 Gy in 3 fractions. The median external beam dose delivered was 47.5 Gy in 25 fractions. Results. All 656 fractions were successfully imaged and treated. The median overall translational shift required for correction was 9.1 mm (standard deviation, 5.2 mm) relative to clinical set-up with skin tattoos. Shifts of 1 cm, 1.5 cm, and 2 cm or greater were performed in 43%, 14%, and 4% of patients, respectively. Acute grade 2 gastrointestinal (GI) toxicity occurred in eight patients (30%) and grade 3 toxicity occurred in one. At two years, there have been no local or regional failures and actuarial overall survival is 95%. Conclusion. Daily image guidance for high-risk endometrial cancer results in a low incidence of acute GI/genitourinary (GU) toxicity with uncompromised tumor control at two years. Vaginal cuff translations can be substantial and may possibly result in underdosing if not properly considered

Immersion and distancing during assimilation of problematic experiences in a good-outcome case of emotion-focused therapy.

Science.gov (United States)

Barbosa, Eunice; Couto, Ana Bela; Basto, Isabel; Stiles, William B; Pinto-Gouveia, José; Salgado, João

2018-03-01

Some studies have suggested that a decrease in immersion (egocentric perspective on personal experiences) and an increase in distancing (observer perspective on personal experiences) are associated with the resolution of clinical problems and positive outcome in psychotherapy for depression. To help clarify how this change in perspectives relates to clinical change, the present study compared changes in immersion and distancing across therapy with progress in one client's assimilation of her problematic experiences. We analyzed all passages referring to the central problematic experience in a good-outcome case of emotion-focused therapy for depression using the Measure of Immersion and Distancing Speech and the Assimilation of Problematic Experiences Scale. Results showed that immersion and distancing were associated with different stages of assimilation. Immersion was associated with stages of emerging awareness and clarification of the problem and in the application of new understandings to daily life. Distancing was associated with problem-solving and attaining insight. The decrease of immersion and increase of distancing associated with therapeutic improvement should not be taken as a recommendation to avoid immersion and encourage distancing. Immersion and distancing may work as coordinated aspects of the processes of psychotherapeutic change.

Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial.

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Jin, Hengwei; Huo, Xiaochuan; Jiang, Yuhua; Li, Xiaolong; Li, Youxiang

2017-09-01

Brain arteriovenous malformations (BAVMs) are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety), and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy). Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula), volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS). The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.

Long-Term Therapy Outcomes When Treating Chronic Kidney Disease Patients with Paricalcitol in German and Austrian Clinical Practice (TOP Study

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Nicholas Obermüller

2017-09-01

Full Text Available Paricalcitol is approved for prevention and therapy of secondary hyperparathyroidism (sHPT in patients with chronic kidney disease (CKD, with only short-term data in clinical routine settings. A 12-month observational study was conducted in Germany and Austria (90 centers, 761 patients from 2008 to 2013. Laboratory values, demographical, and clinical data were documented in 629 dialysis patients and 119 predialysis patients. In predialysis patients, median intact parathormone (iPTH was 180.0 pg/mL (n = 105 at the start of the study, 115.7 pg/mL (n = 105 at last documentation, and 151.8 pg/mL (n = 50 at month 12, with 32.4% of the last documented iPTH values in the KDOQI (Kidney Disease Outcomes Quality Initiative target range. In dialysis patients, median iPTH was 425.5 pg/mL (n = 569 at study start, 262.3 pg/mL (n = 569 at last documentation, and 266.1 pg/mL (n = 318 at month 12, with 36.5% of dialysis patients in the KDOQI target range. Intravenous paricalcitol showed more homogenous iPTH control than oral treatment. Combined analysis of all dialysis patients indicated comparable and stable mean serum calcium and phosphate levels throughout the study. Clinical symptoms, such as itching, bone pain, and fatigue, were improved compared with study entry. The spectrum and frequency of adverse events mirrored the known pattern for patients on dialysis. Paricalcitol is efficacious and has a consistent safety profile in sHPT over 12 months.

Two-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter randomized clinical trial.

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Asgary, Saeed; Eghbal, Mohammad Jafar; Ghoddusi, Jamileh

2014-01-01

Oral healthcare expenses are increasing rapidly as a result of the growth of high-cost health technologies worldwide. In many developing/developed countries, low-cost tooth extraction is the alternative treatment option for a high-cost root canal therapy (RCT) for management of human molars with irreversible pulpitis. Vital pulp therapy with calcium-enriched mixture cement (VPT/CEM) as a new alternative treatment option has demonstrated excellent treatment outcomes up to 1 year; if 2-year radiographic/clinical effectiveness as well as cost-effectiveness of the VPT/CEM is also non-inferior compared with RCT, it can serve as a viable treatment for mature molars with irreversible pulpitis. In this prospective, multicenter (n = 23), non-inferiority clinical trial, 407 patients were randomized to either one-visit RCT (n = 202) or VPT/CEM (n = 205) for 27 months. In this part of study, the primary outcome measure was the 2-year clinical and radiographic treatment outcomes. Cost-effectiveness was also analyzed. Mean follow-up times were 24.62 ± 0.72 and 24.61 ± 0.69 months in RCT (n = 166) and VPT/CEM (n = 166) arms, respectively. Clinical success rates in the two study arms were equal (98.19%); however, radiographic success rates were 79.5 and 86.7% in RCT and VPT/CEM arms, respectively, with no statistical difference (P = 0.053). The treatment time span mean was approximately three times greater in the RCT than in the VPT/CEM arm (94.07 vs. 31.09 min; P pulpitis. Vital pulp therapy with CEM is a cost-effective and reliable biological technique for endodontic treatment of permanent molar teeth with irreversible pulpitis and can be recommended for general clinical practice.

Difficult Myotomy Is Not Determined by Preoperative Therapy and Does Not Impact Outcome

OpenAIRE

Cowgill, Sarah M.; Villadolid, Desiree V.; Al-Saadi, Sam; Rosemurgy, Alexander S.

2007-01-01

Objectives: The impact of preoperative endoscopic therapy on the difficulty of laparoscopic Heller myotomy and the impact of the difficulty of the myotomy on long-term outcome has not been determined. This study was undertaken to determine whether preoperative therapy impacts the difficulty of laparoscopic Heller myotomy and whether preoperative therapy or difficulty of myotomy impacts long-term outcomes. Methods: Since 1992, 305 patients, 56% male, median age 49 years, underwent laparoscopic...

Spot-Scanning Proton Radiation Therapy for Pediatric Chordoma and Chondrosarcoma: Clinical Outcome of 26 Patients Treated at Paul Scherrer Institute

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Rombi, Barbara [Center for Proton Therapy, Paul Scherrer Institute, Villigen (Switzerland); ATreP (Provincial Agency for Proton Therapy), Trento (Italy); Ares, Carmen, E-mail: carmen.ares@psi.ch [Center for Proton Therapy, Paul Scherrer Institute, Villigen (Switzerland); Hug, Eugen B. [Center for Proton Therapy, Paul Scherrer Institute, Villigen (Switzerland); ProCure Proton Therapy Center, Somerset, New Jersey (United States); Schneider, Ralf; Goitein, Gudrun; Staab, Adrian; Albertini, Francesca; Bolsi, Alessandra; Lomax, Antony J. [Center for Proton Therapy, Paul Scherrer Institute, Villigen (Switzerland); Timmermann, Beate [Center for Proton Therapy, Paul Scherrer Institute, Villigen (Switzerland); WestGerman Proton Therapy Center Essen (Germany)

2013-07-01

Purpose: To evaluate the clinical results of fractionated spot-scanning proton radiation therapy (PT) in 26 pediatric patients treated at Paul Scherrer Institute for chordoma (CH) or chondrosarcoma (CS) of the skull base or axial skeleton. Methods and Materials: Between June 2000 and June 2010, 19 CH and 7 CS patients with tumors originating from the skull base (17) and the axial skeleton (9) were treated with PT. Mean age at the time of PT was 13.2 years. The mean prescribed dose was 74 Gy (relative biological effectiveness [RBE]) for CH and 66 Gy (RBE) for CS, at a dose of 1.8-2.0 Gy (RBE) per fraction. Results: Mean follow-up was 46 months. Actuarial 5-year local control (LC) rates were 81% for CH and 80% for CS. Actuarial 5-year overall survival (OS) was 89% for CH and 75% for CS. Two CH patients had local failures: one is alive with evidence of disease, while the other patient succumbed to local recurrence in the surgical pathway. One CS patient died of local progression of the disease. No high-grade late toxicities were observed. Conclusions: Spot-scanning PT for pediatric CH and CS patients resulted in excellent clinical outcomes with acceptable rates of late toxicity. Longer follow-up time and larger cohort are needed to fully assess tumor control and late effects of treatment.

Relationship between massage therapy usage and health outcomes in older adults.

Science.gov (United States)

Munk, Niki; Zanjani, Faika

2011-04-01

Physical and emotional decline in older adults is a serious issue affecting not only quality of life but also susceptibility to injury. Non-pharmacological interventions addressing the needs of older adults are important for reducing medication burden and possible drug interactions. This study (N=144) examines the potential of massage therapy as such an intervention for older adults by comparing self-reported health outcome scores among adults 60 and older who have and have not utilized massage therapy in the past year. When controlling for age and cumulative morbidities, older adults who reported massage therapy usage in the past year had significantly better health outcome scores in the following domains: 1) emotional well-being, 2) limitations due to physical issues, and 3) limitations due to emotional issues. Because previous massage therapy research has not included or focused on older adults, studies examining massage therapy and emotional health, specifically among this population, are warranted. Copyright © 2010 Elsevier Ltd. All rights reserved.

Adherence to antiretroviral therapy and clinical outcomes among young adults reporting high-risk sexual behavior, including men who have sex with men, in coastal Kenya.

Science.gov (United States)

Graham, Susan M; Mugo, Peter; Gichuru, Evanson; Thiong'o, Alexander; Macharia, Michael; Okuku, Haile S; van der Elst, Elise; Price, Matthew A; Muraguri, Nicholas; Sanders, Eduard J

2013-05-01

African men who have sex with men (MSM) face significant stigma and barriers to care. We investigated antiretroviral therapy (ART) adherence among high-risk adults, including MSM, participating in a clinic-based cohort. Survival analysis was used to compare attrition across patient groups. Differences in adherence, weight gain, and CD4 counts after ART initiation were assessed. Among 250 HIV-1-seropositive adults, including 108 MSM, 15 heterosexual men, and 127 women, patient group was not associated with attrition. Among 58 participants who were followed on ART, 40 % of MSM had less than 95 % adherence, versus 28.6 % of heterosexual men and 11.5 % of women. Although MSM gained less weight after ART initiation than women (adjusted difference -3.5 kg/year), CD4 counts did not differ. More data are needed on barriers to adherence and clinical outcomes among African MSM, to ensure that MSM can access care and derive treatment and prevention benefits from ART.

Does Adipose-derived Stromal Cell Adjuvant Therapy for Fragmented Medial Coronoid Process in Dogs Influence Outcome? A Pilot Project

Directory of Open Access Journals (Sweden)

Kristina M Kiefer

2016-11-01

Full Text Available Objective: The primary objective of this study was to identify adverse events associated with multiple intra-articular injections of adipose stromal cell (ASC therapy and secondarily to objectively assess the therapeutic effect of ASC therapy for treatment of fragmented medial coronoid process (FMCP in dogs when used as an adjuvant to standard of care (SOC treatment. Background: Preliminary trials assessing autologous ASC therapy to treat osteoarthritis indicate a positive impact on clinical signs, but assessment of donated, allogeneic ASC therapy is lacking.Evidentiary value: This prospective, randomised, controlled trial in dogs (n=30 provides objective evidence for clinical practitioners regarding ASC therapy in a naturally occurring osteoarthritic disease model.Methods: Dogs diagnosed with FMCP and osteoarthritis were enrolled. All dogs had arthroscopic fragment removal and proximal ulnar osteotomy (PUO and were assigned into three groups (n=10/group: 1 control group with no further treatment beyond the PUO and fragment removal (SOC, 2 PUO + autologous ASCs and 3 PUO+ allogeneic ASCs. Each dog had force platform gait analysis, Canine Brief Pain Inventory (CBPI questionnaires, and delayed gadolinium enhanced magnetic resonance imaging scores prior to and six months after therapeutic intervention.Results: No serious adverse events were reported in any participant. 3/10 dogs in the control group, 3/10 autologous ASC group and 7/10 allogeneic ASC group participants were assessed as successful outcomes.Conclusion: This study provides preliminary safety data for the use of intra-articular allogeneic ASC therapy to treat osteoarthritis, and justification for larger clinical studies.Application: Clinical practitioners considering ASC therapy within their practice are provided with additional evidence of autologous ASC therapy for osteoarthritis. Researchers committed to developing and generating effective ASC therapies are provided with safety

Biofeedback therapy combined with diet to treating ODS (Anismus: 2 years outcome

Directory of Open Access Journals (Sweden)

Fakhryalsadat Anaraki

2017-04-01

Full Text Available Object: The advantages of biofeedback therapy along with diet in patients with constipation are among the issues discussed nowadays. The aim of this study was to evaluate 2 years outcome of biofeedback therapy along with diet in patients with obstructed defecation syndrome (ODS (Anismus. Methodology: The focus of this prospective study is a group of 129 patients with ODS constipation, who were referred to two tertiary-care referral academic centers from 2013 to 2016. Patients received biofeedback therapy combined with appropriate diet in cases group and received diet in controls group. Good response was defined as a subject with at least 50 percent improvement from before to after biofeedback therapy on a Cleveland Clinic Florida Constipation Scoring System (CCF. Factors associated with better outcome were analyzed using SPSS 20 software. Results: Out of the 129 patients, 112 patients (86.8% were female. The mean age of patients was 42.44 ± 15.05 years. The mean CCF score of the patients before and after biofeedback therapy was 12.41 ± 4.39 and 6.00 ± 3.28 respectively in case group (p-value < 0.001. In addition, the mean CCF score of the patients before and after diet therapy was 12.82 ± 4.85 and 9.43 ± 3.79 respectively in control group (p-value < 0.001. While CCF score in both case and control groups reduced significantly after therapy, the rate of this reduction was higher in case group (p < 0.001. Conclusion: Our findings suggest that biofeedback therapy combined with diet will improve patients outcome in ODS constipation. Prospective clinical trials with larger sample sizes are recommend allowing for causal correlations. Resumo: Objetivo: As vantagens da terapia por biofeedback, juntamente com a dieta, em pacientes com constipação se situam entre os tópicos atualmente em discussão. O objetvo desse estudo foi avaliar os resultados, após 2 anos, da terapia por biofeedback associada à dieta em pacientes com s

Current Status of Immunomodulatory and Cellular Therapies in Preclinical and Clinical Islet Transplantation

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Chhabra, Preeti; Brayman, Kenneth L.

2011-01-01

Clinical islet transplantation is a β-cell replacement strategy that represents a possible definitive intervention for patients with type 1 diabetes, offering substantial benefits in terms of lowering daily insulin requirements and reducing incidences of debilitating hypoglycemic episodes and unawareness. Despite impressive advances in this field, a limiting supply of islets, inadequate means for preventing islet rejection, and the deleterious diabetogenic and nephrotoxic side effects associated with chronic immunosuppressive therapy preclude its wide-spread applicability. Islet transplantation however allows a window of opportunity for attempting various therapeutic manipulations of islets prior to transplantation aimed at achieving superior transplant outcomes. In this paper, we will focus on the current status of various immunosuppressive and cellular therapies that promote graft function and survival in preclinical and clinical islet transplantation with special emphasis on the tolerance-inducing capacity of regulatory T cells as well as the β-cells regenerative capacity of stem cells. PMID:22046502

The Associations Between Physical Therapy and Long-Term Outcomes for Individuals with Lumbar Spinal Stenosis in the SPORT study

Science.gov (United States)

Fritz, Julie M.; Lurie, Jon D.; Zhao, Wenyan; Whitman, Julie M.; Delitto, Anthony; Brennan, Gerard P.; Weinstein, James N.

2013-01-01

Background/Context A period of non-surgical management is advocated prior to surgical treatment for most patients with lumbar spinal stenosis. Currently, little evidence is available to define optimal non-surgical management. Physical therapy is often used, however its use and effectiveness relative to other non-surgical strategies has not been adequately explored. Purpose Describe the utilization of physical therapy and other non-surgical interventions by patients with lumbar spinal stenosis and examine the relationship between physical therapy and long-term prognosis. Study Design Secondary analysis of the Spine Patient Outcomes Research Trial (SPORT) combining data from randomized and observational studies. Setting 13 spine clinics in 11 states in the United States. Patient Sample Patients with lumbar spinal stenosis receiving non-surgical management including those who did or did not receive physical therapy within 6 weeks of enrollment. Outcome Measures Primary outcome measures included cross-over to surgery, the bodily pain and physical function scales changes from the Survey Short Form 36 (SF-36), and the modified Oswestry Disability Index. Secondary outcome measures were patient satisfaction and the Sciatica Bothersomeness Index. Methods Baseline characteristics and rates of cross-over to surgery were compared between patients who did or did not receive physical therapy. Baseline factors predictive of receiving physical therapy were examined with logistic regression. Mixed effects models were used to compare outcomes between groups at 3 and 6 months, and 1 year after enrollment adjusted for baseline severity and patient characteristics. Results Physical therapy was used in the first 6 weeks by 90 of 244 patients (37%) and was predicted by the absence of radiating pain and being single instead of married. Physical therapy was associated with a reduced likelihood of cross-over to surgery after 1 year (21% vs 33%, p=0.045), and greater reductions on the SF-36

Cognitive behavioral therapy for compulsive buying behavior: Predictors of treatment outcome.

Science.gov (United States)

Granero, R; Fernández-Aranda, F; Mestre-Bach, G; Steward, T; Baño, M; Agüera, Z; Mallorquí-Bagué, N; Aymamí, N; Gómez-Peña, M; Sancho, M; Sánchez, I; Menchón, J M; Martín-Romera, V; Jiménez-Murcia, S

2017-01-01

Compulsive buying behavior (CBB) is receiving increasing consideration in both consumer and psychiatric-epidemiological research, yet empirical evidence on treatment interventions is scarce and mostly from small homogeneous clinical samples. To estimate the short-term effectiveness of a standardized, individual cognitive behavioral therapy intervention (CBT) in a sample of n=97 treatment-seeking patients diagnosed with CBB, and to identify the most relevant predictors of therapy outcome. The intervention consisted of 12 individual CBT weekly sessions, lasting approximately 45minutes each. Data on patients' personality traits, psychopathology, sociodemographic factors, and compulsive buying behavior were used in our analysis. The risk (cumulative incidence) of poor adherence to the CBT program was 27.8%. The presence of relapses during the CBT program was 47.4% and the dropout rate was 46.4%. Significant predictors of poor therapy adherence were being male, high levels of depression and obsessive-compulsive symptoms, low anxiety levels, high persistence, high harm avoidance and low self-transcendence. Cognitive behavioral models show promise in treating CBB, however future interventions for CBB should be designed via a multidimensional approach in which patients' sex, comorbid symptom levels and the personality-trait profiles play a central role. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.

NARCIS (Netherlands)

Hoeksma, H.L.; Dekker, J.; Ronday, H.K.; Heering, A.; Lubbe, N. van der; Vel, C.; Breedveld, F.C.; Ende, C.H.M. van den

2004-01-01

OBJECTIVE: To determine the effectiveness of a manual therapy program compared with an exercise therapy program in patients with osteoarthritis (OA) of the hip. METHODS: A single-blind, randomized clinical trial of 109 hip OA patients was carried out in the outpatient clinic for physical therapy of

Clinical outcome and cosmetic results of conservative surgery plus radiation therapy in early stage breast cancer patients

International Nuclear Information System (INIS)

Jin Yening; Wang Yajie; Zhang Xiaoqing; Meng Yan; Li Rongqing; Shi Junyi

2005-01-01

Objective: To evaluate the clinical outcome and cosmetic results in early stage breast cancer patients treated with conservative surgery plus radiation therapy. Methods: From May 1995 to December 2002, 109 such patients were so treated. The post-operative radiotherapy consisted of whole-breast 6 MV linear accelerator irradiation with two tangential half-fields to a total dose of 45-52 Gy (mean 48.6 Gy), followed by a boost irradiation to the tumor bed. Among them, 79 patients received 10-12 Gy (DB) boost by interstitial implantation brachytherapy ( 192 Ir HDR, Nucletron), with single plane implantation for T1 and double plane implantation for T2 tumor. Thirty patients received 15 Gy boost by electron beam. Adjuvant/concurrent chemotherapy (CMF or CEF) and hormonotherapy were also used according to the patients' clinical characteristics. The cosmetic results were scored by both the doctor and the patients. Results: The overall actuarial 5-year survival was 93.8%, with local recurrence of 6.5%. No radiation-induced ulcer was observed in the breast except for acute inflammation at skin pinholes in 5 patients treated by interstitial implant brachytherapy. Among the 75 patients who had had breast examination, cosmetic result scored as good by patient and doctor were 81% and 87%, respectively. The good rate assessed by doctor in brachytherapy boost group and electron beam boost group were 81.2% (39/48) and 85.2% (23/27), There was no significant difference between these two boost techniques (P>0.05). Conclusions: Tumor bed boost irradiation by either brachytherapy or electron beam technique can provide satisfactory local control in early breast cancer treated with conservative surgery plus radiotherapy without increasing the side effects. There is no significant difference in cosmetic result between these two boost techniques. (authors)

Communicative-Pragmatic Assessment Is Sensitive and Time-Effective in Measuring the Outcome of Aphasia Therapy

Directory of Open Access Journals (Sweden)

Benjamin Stahl

2017-05-01

Full Text Available A range of methods in clinical research aim to assess treatment-induced progress in aphasia therapy. Here, we used a crossover randomized controlled design to compare the suitability of utterance-centered and dialogue-sensitive outcome measures in speech-language testing. Fourteen individuals with post-stroke chronic non-fluent aphasia each received two types of intensive training in counterbalanced order: conventional confrontation naming, and communicative-pragmatic speech-language therapy (Intensive Language-Action Therapy, an expanded version of Constraint-Induced Aphasia Therapy. Motivated by linguistic-pragmatic theory and neuroscience data, our dependent variables included a newly created diagnostic instrument, the Action Communication Test (ACT. This diagnostic instrument requires patients to produce target words in two conditions: (i utterance-centered object naming, and (ii communicative-pragmatic social interaction based on verbal requests. In addition, we administered a standardized aphasia test battery, the Aachen Aphasia Test (AAT. Composite scores on the ACT and the AAT revealed similar patterns of changes in language performance over time, irrespective of the treatment applied. Changes in language performance were relatively consistent with the AAT results also when considering both ACT subscales separately from each other. However, only the ACT subscale evaluating verbal requests proved to be successful in distinguishing between different types of training in our patient sample. Critically, testing duration was substantially shorter for the entire ACT (10–20 min than for the AAT (60–90 min. Taken together, the current findings suggest that communicative-pragmatic methods in speech-language testing provide a sensitive and time-effective measure to determine the outcome of aphasia therapy.

TU-G-BRB-00: Clinical Trials in Proton and Particle Therapy

International Nuclear Information System (INIS)

2015-01-01

Proton therapy, in particular, and ion therapy, just beginning, are becoming an increasing focus of attention in clinical radiation oncology and medical physics. Both modalities have been criticized of lacking convincing evidence from randomized trials proving their efficacy, justifying the higher costs involved in these therapies. This session will provide an overview of the current status of clinical trials in proton therapy, including recent developments in ion therapy. As alluded to in the introductory talk by Dr. Schulte, opinions are diverging widely as to the usefulness and need for clinical trials in particle therapy and the challenge of equipoise. The lectures will highlight some of the challenges that surround clinical trials in particle therapy. One, presented by Dr. Choy from UT Southwestern, is that new technology and even different types of particles such as helium and carbon ions are introduced into this environment, increasing the phase space of clinical variables. The other is the issue of medical physics quality assurance with physical phantoms, presented by Mrs. Taylor from IROC Houston, which is more challenging because 3D and 4D image guidance and active delivery techniques are in relatively early stages of development. The role of digital phantoms in developing clinical treatment planning protocols and as a QA tool will also be highlighted by Dr. Lee from NCI. The symposium will be rounded off by a panel discussion among the Symposium speakers, arguing pro or con the need and readiness for clinical trials in proton and ion therapy. Learning Objectives: To get an update on the current status of clinical trials allowing or mandating proton therapy. Learn about the status of planned clinical trials in the U.S. and worldwide involving ion therapy. Discuss the challenges in the design and QA of clinical trials in particle therapy. Learn about existing and future physical and computational anthropomorphic phantoms for charged particle clinical trial

Designing for Anxiety Therapy, Bridging Clinical and Non-Clinical

DEFF Research Database (Denmark)

Bertelsen, Olav Wedege; Kramp, Gunnar

2012-01-01

In this position paper we discuss, in terms of the concept of boundary objects, how a mobile application, the MIKAT.app, bridge between clinical intervention in anxiety therapy, and life and coping strategies outside the clinic and across phases of being a person suffering from, or having suffered...... from anxiety. Thereby, we hope to provide a counterpoint in the discussion on illness trajectories....

Clinical Outcomes of 174 Nasopharyngeal Carcinoma Patients With Radiation-Induced Temporal Lobe Necrosis

International Nuclear Information System (INIS)

Lam, Tai-Chung; Wong, Frank C.S.; Leung, To-Wai; Ng, S.H.; Tung, Stewart Y.

2012-01-01

Purpose: To retrospectively study the clinical outcomes of nasopharyngeal carcinoma patients with radiation-induced temporal lobe necrosis (TLN) treated with steroids, surgery, or observation only. Methods and Patients: We performed a retrospective analysis of 174 consecutive patients diagnosed with TLN between 1990 and 2008. Before 1998, symptomatic patients were treated with oral steroids, while asymptomatic patients were treated conservatively. After 1998, most symptomatic and asymptomatic patients with a large volume of necrosis were treated by intravenously pulsed-steroid therapy with a standardized protocol. We examined factors affecting grade 4 complication-free survival and overall survival. Outcomes of the three treatment groups, those receiving conservative treatment, those receiving oral steroid, and those receiving intravenous pulse steroid, were compared. Results: The mean follow-up time was 115 months. Rates of grade 4 complication-free survival at 2 years and at 5 years after diagnosis of TLN were 72.2% and 54.1%, respectively. The 2-year and 5-year overall survival rates were 57.5% and 35.4%, respectively. Multivariate analysis revealed that being symptomatic at diagnosis (relative risk [RR], 4.5; p = 0.0001), re-irradiation of the nasopharynx (NP) (RR, 1.56; p = 0.008), salvage brachytherapy to the NP (RR, 1.75; p = 0.012), and a short latency period before the diagnosis of TLN (RR, 0.96, p < 0.0001) were independent prognosticators of poor grade 4 complication-free survival. Patients with all four factors had a 100% risk of developing grade 4 complications within 5 years; whereas if no factor was present, the risk was 12.5%. Intravenous pulse steroid therapy was associated with a higher clinical response rate compared with conventional steroid therapy (p < 0.0001); however, it did not affect complication-free survival in multivariate analysis. Conclusions: TLN patients with good prognosticators could be observed without active treatment. Although

High plasma cyst(e)ine level may indicate poor clinical outcome in patients with acute stroke: possible involvement of hydrogen sulfide.

Science.gov (United States)

Wong, Peter T H; Qu, Kun; Chimon, Ghislain N; Seah, Alvin B H; Chang, Hui Meng; Wong, Meng Cheong; Ng, Yee Kong; Rumpel, Helmut; Halliwell, Barry; Chen, Christopher P L H

2006-02-01

Cysteine is known to cause neuronal cell death and has been reported to be elevated in brain ischemia, but it has not been studied in clinical stroke. In this study, we correlated plasma levels of cyst(e)ine with long-term clinical outcome at 3 months in acute stroke. Patients were classified into 3 groups at 3 months as follows: good outcome (Rankin 0-1, n = 11), poor outcome (Rankin 2-5, n = 20), and dead (n = 5). Their plasma cyst(e)ine levels within 24 hours of stroke onset were 61 +/- 12, 67 +/- 9, and 82 +/- 14 micromol/L (standard deviation), respectively. The correlation between early plasma cyst(e)ine levels and long-term clinical outcome assessed at 3 months is significant with p ine was also significantly elevated in patients who had early stroke deterioration (p ine in patients with stroke may reflect increased production of H2S in the brain and thus predispose to poor outcome in clinical stroke. Inhibition of H2S formation may therefore be a novel approach in acute stroke therapy.

Prevalence and impact of extended-spectrum β-lactamase production on clinical outcomes in cancer patients with Enterobacter species bacteremia.

Science.gov (United States)

Kim, Sun Jong; Park, Ki-Ho; Chung, Jin-Won; Sung, Heungsup; Choi, Seong-Ho; Choi, Sang-Ho

2014-09-01

We examined the prevalence of extended-spectrum β-lactamase (ESBL) production and the impact of ESBL on clinical outcomes in cancer patients with Enterobacter spp. bacteremia. Using prospective cohort data on Enterobacter bacteremia obtained between January 2005 and November 2008 from a tertiary care center, the prevalence and clinical impact of ESBL production were evaluated. Two-hundred and three episodes of Enterobacter spp. bacteremia were identified. Thirty-one blood isolates (15.3%, 31/203) scored positive by the double-disk synergy test. Among 17 isolates in which ESBL genes were detected by polymerase chain reaction and sequencing, CTX-M (n = 12), SHV-12 (n = 11), and TEM (n = 4) were the most prevalent ESBL types. Prior usage of antimicrobial agents (77.4% vs. 54.0%, p = 0.02) and inappropriate empirical antimicrobial therapy (22.6% vs. 3.0%, p Enterobacter bacteremia. Although inappropriate empirical therapy was more common in the ESBL-positive group, ESBL production was not associated with poorer outcomes.

Preliminary Clinical Evaluation of Acupuncture Therapy in Patients With Postpartum Sciatica.

Science.gov (United States)

He, Bing-Shu; Li, Yang; Gui, Tong

2018-03-01

This study evaluated clinical outcomes following acupuncture treatment of postpartum sciatica. One hundred eleven women with postpartum sciatica were enrolled in an acupuncture group (n = 86) or a control group (n = 25), according to their preference. Participants in the acupuncture group attended acupuncture therapy sessions 3 times a week for 4 weeks, while participants in the control group were assigned to bed rest. Outcome measures included the Roland Disability Questionnaire for sciatica, a visual analog scale for leg pain, and patient-reported perceived recovery. In addition, participants were surveyed after treatment to assess the acceptability of acupuncture therapy. The outcome scores for disability and leg pain were significantly lower in the acupuncture group compared with the control group (P acupuncture improved their well-being after treatment. At one month after treatment, 98% of participants in the treatment group reported recovery compared with 24% of the control group participants (P acupuncture group believed that acupuncture had no significant interference with breast milk production. No adverse effects of acupuncture were reported. All participants in the acupuncture group stated they would choose acupuncture in case of relapse. However, the recurrence rate of sciatica in the acupuncture group (32%) was comparable to that of the control group (35%) at the one-year follow-up interview. Compared with bed rest, acupuncture might be an effective and acceptable strategy to relieve symptoms of postpartum sciatica. © 2018 by the American College of Nurse-Midwives.

Physiotherapy and occupational therapy interventions for people with benign joint hypermobility syndrome: a systematic review of clinical trials.

Science.gov (United States)

Smith, Toby O; Bacon, Holly; Jerman, Emma; Easton, Vicky; Armon, Kate; Poland, Fiona; Macgregor, Alex J

2014-01-01

This study assessed the literature to determine the efficacy and effectiveness of physiotherapy and occupational therapy interventions in the treatment of people with benign joint hypermobility syndrome (BJHS). Published literature databases including: AMED, CINAHL, MEDLINE, EMBASE, PubMed and the Cochrane Library, in addition to unpublished databases and trial registries were searched to October 2012. All clinical trials comparing the clinical outcomes of Occupational Therapy and Physiotherapy interventions compared to non-treatment or control intervention for people with BJHS were included. Of the 126 search results, 3 clinical studies satisfied the eligibility criteria. The data provides limited support for the use of wrist/hand splints for school children. While there is some support for exercise-based intervention, there is insufficient research to determine the optimal mode, frequency, dosage or type of exercise which should be delivered. The current evidence-base surrounding Occupational Therapy and Physiotherapy in the management of BJHS is limited in size and quality. There is insufficient research exploring the clinical outcomes of a number of interventions including sensory integration, positioning and posture management and education. Longer term, rigorous multi-centre randomised controlled trials are warranted to begin to assess the clinical and cost-effectiveness of interventions for children and adults with BJHS. Implications for Rehabilitation There is an evidence-base to support clinician's use of proprioceptive-based exercises in adults, and either tailored or generalised physiotherapy regimes for children with BJHS. Clinicians should be cautious when considering the prescription of hand/wrist splints for school age children with BJHS, based on the current research. Until further multi-centre trials are conducted assessing the clinical and cost-effectiveness of interventions for children and adult with BJHS, clinical decision-making should be

Five-year results of vital pulp therapy in permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized clinical trial.

Science.gov (United States)

Asgary, Saeed; Eghbal, Mohammad Jafar; Fazlyab, Mahta; Baghban, Alireza Akbarzadeh; Ghoddusi, Jamileh

2015-03-01

Previous reported results of up to 12 months as well as 24-month follow-ups revealed superior and equivalent treatment outcomes for vital pulp therapy (VPT) using calcium-enriched mixture cement (CEM) in comparison with root canal therapy (RCT) for mature molars with established irreversible pulpitis, respectively. Present non-inferiority multicenter randomized clinical trial assesses the final long-term (5-year) results as well as the effects of patients' age/gender and the presence of preoperative periapical lesion on the treatment outcomes. A total number of 407 patients were blindly allocated into two treatment groups [group 1 (VPT/CEM, n = 205) and group 2 (RCT, n = 202)] treated in 23 health-care centers by calibrated dentists. The treatment outcomes were assessed after 60 months. The 5-year results revealed no significant differences in the successes of both study arms (P = 0.29); a total number of 271 patients were available (~33 % were lost to follow-up). The patients' age/gender did not affect the outcomes; the presence of preoperative periapical lesion also did not implement a significant effect in both groups (P > 0.05). As an alternative for RCT, VPT/CEM can be considered as a valid treatment for vital mature permanent molars clinically diagnosed with irreversible pulpitis. Considering the favorable outcomes of 6- to 60-month follow-ups, as an evidence-based/simple/affordable/effective/biologic approach in cases of irreversible pulpitis, VPT/CEM is highly recommended for universal clinical practice.

Assessing Adverse Events of Postprostatectomy Radiation Therapy for Prostate Cancer: Evaluation of Outcomes in the Regione Emilia-Romagna, Italy

International Nuclear Information System (INIS)

Showalter, Timothy N.; Hegarty, Sarah E.; Rabinowitz, Carol; Maio, Vittorio; Hyslop, Terry; Dicker, Adam P.; Louis, Daniel Z.

2015-01-01

Purpose: Although the likelihood of radiation-related adverse events influences treatment decisions regarding radiation therapy after prostatectomy for eligible patients, the data available to inform decisions are limited. This study was designed to evaluate the genitourinary, gastrointestinal, and sexual adverse events associated with postprostatectomy radiation therapy and to assess the influence of radiation timing on the risk of adverse events. Methods: The Regione Emilia-Romagna Italian Longitudinal Health Care Utilization Database was queried to identify a cohort of men who received radical prostatectomy for prostate cancer during 2003 to 2009, including patients who received postprostatectomy radiation therapy. Patients with prior radiation therapy were excluded. Outcome measures were genitourinary, gastrointestinal, and sexual adverse events after prostatectomy. Rates of adverse events were compared between the cohorts who did and did not receive postoperative radiation therapy. Multivariable Cox proportional hazards models were developed for each class of adverse events, including models with radiation therapy as a time-varying covariate. Results: A total of 9876 men were included in the analyses: 2176 (22%) who received radiation therapy and 7700 (78%) treated with prostatectomy alone. In multivariable Cox proportional hazards models, the additional exposure to radiation therapy after prostatectomy was associated with increased rates of gastrointestinal (rate ratio [RR] 1.81; 95% confidence interval [CI] 1.44-2.27; P<.001) and urinary nonincontinence events (RR 1.83; 95% CI 1.83-2.80; P<.001) but not urinary incontinence events or erectile dysfunction. The addition of the time from prostatectomy to radiation therapy interaction term was not significant for any of the adverse event outcomes (P>.1 for all outcomes). Conclusion: Radiation therapy after prostatectomy is associated with an increase in gastrointestinal and genitourinary adverse events. However

Assessing Adverse Events of Postprostatectomy Radiation Therapy for Prostate Cancer: Evaluation of Outcomes in the Regione Emilia-Romagna, Italy

Energy Technology Data Exchange (ETDEWEB)

Showalter, Timothy N., E-mail: tns3b@virginia.edu [Department of Radiation Oncology, University of Virginia, Charlottesville, Virginia (United States); Hegarty, Sarah E. [Center for Research in Medical Education and Health Care, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Rabinowitz, Carol [Center for Research in Medical Education and Health Care, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Maio, Vittorio [Jefferson School of Population Health, Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Hyslop, Terry [Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, North Carolina (United States); Dicker, Adam P. [Department of Radiation Oncology, Kimmel Cancer Center & Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Louis, Daniel Z. [Center for Research in Medical Education and Health Care, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States)

2015-03-15

Purpose: Although the likelihood of radiation-related adverse events influences treatment decisions regarding radiation therapy after prostatectomy for eligible patients, the data available to inform decisions are limited. This study was designed to evaluate the genitourinary, gastrointestinal, and sexual adverse events associated with postprostatectomy radiation therapy and to assess the influence of radiation timing on the risk of adverse events. Methods: The Regione Emilia-Romagna Italian Longitudinal Health Care Utilization Database was queried to identify a cohort of men who received radical prostatectomy for prostate cancer during 2003 to 2009, including patients who received postprostatectomy radiation therapy. Patients with prior radiation therapy were excluded. Outcome measures were genitourinary, gastrointestinal, and sexual adverse events after prostatectomy. Rates of adverse events were compared between the cohorts who did and did not receive postoperative radiation therapy. Multivariable Cox proportional hazards models were developed for each class of adverse events, including models with radiation therapy as a time-varying covariate. Results: A total of 9876 men were included in the analyses: 2176 (22%) who received radiation therapy and 7700 (78%) treated with prostatectomy alone. In multivariable Cox proportional hazards models, the additional exposure to radiation therapy after prostatectomy was associated with increased rates of gastrointestinal (rate ratio [RR] 1.81; 95% confidence interval [CI] 1.44-2.27; P<.001) and urinary nonincontinence events (RR 1.83; 95% CI 1.83-2.80; P<.001) but not urinary incontinence events or erectile dysfunction. The addition of the time from prostatectomy to radiation therapy interaction term was not significant for any of the adverse event outcomes (P>.1 for all outcomes). Conclusion: Radiation therapy after prostatectomy is associated with an increase in gastrointestinal and genitourinary adverse events. However

The relationship between interpersonal problems, negative cognitions, and outcomes from cognitive behavioral group therapy for depression.

Science.gov (United States)

McEvoy, Peter M; Burgess, Melissa M; Nathan, Paula

2013-09-05

Interpersonal functioning is a key determinant of psychological well-being, and interpersonal problems (IPs) are common among individuals with psychiatric disorders. However, IPs are rarely formally assessed in clinical practice or within cognitive behavior therapy research trials as predictors of treatment attrition and outcome. The main aim of this study was to investigate the relationship between IPs, depressogenic cognitions, and treatment outcome in a large clinical sample receiving cognitive behavioral group therapy (CBGT) for depression in a community clinic. Patients (N=144) referred for treatment completed measures of IPs, negative cognitions, depression symptoms, and quality of life (QoL) before and at the completion of a 12-week manualized CBGT protocol. Two IPs at pre-treatment, 'finding it hard to be supportive of others' and 'not being open about problems,' were associated with higher attrition. Pre-treatment IPs also predicted higher post-treatment depression symptoms (but not QoL) after controlling for pre-treatment symptoms, negative cognitions, demographics, and comorbidity. In particular, 'difficulty being assertive' and a 'tendency to subjugate one's needs' were associated with higher post-treatment depression symptoms. Changes in IPs did not predict post-treatment depression symptoms or QoL when controlling for changes in negative cognitions, pre-treatment symptoms, demographics, and comorbidity. In contrast, changes in negative cognitions predicted both post-treatment depression and QoL, even after controlling for changes in IPs and the other covariates. Correlational design, potential attrition bias, generalizability to other disorders and treatments needs to be evaluated. Pre-treatment IPs may increase risk of dropout and predict poorer outcomes, but changes in negative cognitions during treatment were most strongly associated with improvement in symptoms and QoL during CBGT. Copyright © 2013 Elsevier B.V. All rights reserved.

Clinical education and clinical evaluation of respiratory therapy students.

Science.gov (United States)

Cullen, Deborah L

2005-09-01

Different blends of knowledge, decision making, problem solving,professional behaviors, values, and technical skills are necessary in the changing health care environments in which respiratory therapists practice. Frequently, novice students are expected to perform quickly and efficiently,and it may be forgotten that students are still learning and mastering the foundation pieces of practice. Clinical educators take on the responsibility of student development in addition to overseeing patient care. Normally,these volunteer instructors are role models for respiratory therapy students. The characteristic of initiative when demonstrated by a beginning student is attractive to the clinical instructor, promotes sharing of experiences, and may evolve into a mentor-protege relationship. Some clinical instructors may be underprepared to teach and are uncomfortable with student evaluation. Respiratory therapy facilities in conjunction with academic institutions may consider sponsoring ongoing programs for clinical teachers. Teaching and learning in the clinical environment is more than demonstration of skills and knowledge. Furthermore, it can be debated whether the memorization of facts or of the steps of a skill is more valuable than competency in problem solving, clinical reasoning, or information retrieval. New knowledge is built within a context and is further integrated when grounded by experience. Development of "prediction in practice" or the anticipation of the next necessary actions may be worth integrating into the instructional toolbox. Intuition has been defined as an "understanding without a rationale". This definition separates intuition from rational decision making and presents intuition as a type of innate ability. Reflection when guided by clinical instructors can help deepen critical thinking, as will Socratic questioning on a regular basis. Most clinical staff can agree on the performance of an incompetent student, but discrimination of the levels of

Proton therapy for head and neck cancer: Rationale, potential indications, practical considerations, and current clinical evidence

International Nuclear Information System (INIS)

Mendenhall, Nancy P.; Malyapa, Robert S.; Su, Zhong; Yeung, Daniel; Mendenhall, William M.; Li, Zuofeng

2011-01-01

There is a strong rationale for potential benefits from proton therapy (PT) for selected cancers of the head and neck because of the opportunity to improve the therapeutic ratio by improving radiation dose distributions and because of the significant differences in radiation dose distribution achievable with x-ray-based radiation therapy (RT) and PT. Comparisons of dose distributions between x-ray-based and PT plans in selected cases show specific benefits in dose distribution likely to translate into improved clinical outcomes. However, the use of PT in head and neck cancers requires special considerations in the simulation and treatment planning process, and currently available PT technology may not permit realization of the maximum potential benefits of PT. To date, few clinical data are available, but early clinical experiences in sinonasal tumors in particular suggest significant improvements in both disease control and radiation-related toxicity

Proton therapy for head and neck cancer: Rationale, potential indications, practical considerations, and current clinical evidence

Energy Technology Data Exchange (ETDEWEB)

Mendenhall, Nancy P.; Malyapa, Robert S.; Su, Zhong; Yeung, Daniel; Mendenhall, William M.; Li, Zuofeng (Univ. of Florida Proton Therapy Inst., Jacksonville, Florida (United States)), e-mail: menden@shands.ufl.edu

2011-08-15

There is a strong rationale for potential benefits from proton therapy (PT) for selected cancers of the head and neck because of the opportunity to improve the therapeutic ratio by improving radiation dose distributions and because of the significant differences in radiation dose distribution achievable with x-ray-based radiation therapy (RT) and PT. Comparisons of dose distributions between x-ray-based and PT plans in selected cases show specific benefits in dose distribution likely to translate into improved clinical outcomes. However, the use of PT in head and neck cancers requires special considerations in the simulation and treatment planning process, and currently available PT technology may not permit realization of the maximum potential benefits of PT. To date, few clinical data are available, but early clinical experiences in sinonasal tumors in particular suggest significant improvements in both disease control and radiation-related toxicity

Enhancing CBT for Chronic Insomnia: A Randomised Clinical Trial of Additive Components of Mindfulness or Cognitive Therapy.

Science.gov (United States)

Wong, Mei Yin; Ree, Melissa J; Lee, Christopher W

2016-09-01

Although cognitive behavioural therapy (CBT) for insomnia has resulted in significant reductions in symptoms, most patients are not classified as good sleepers after treatment. The present study investigated whether additional sessions of cognitive therapy (CT) or mindfulness-based therapy (MBT) could enhance CBT in 64 participants with primary insomnia. All participants were given four sessions of standard CBT as previous research had identified this number of sessions as an optimal balance between therapist guidance and patient independence. Participants were then allocated to further active treatment (four sessions of CT or MBT) or a no further treatment control. The additional treatments resulted in significant improvements beyond CBT on self-report and objective measures of sleep and were well tolerated as evidenced by no dropouts from either treatment. The effect sizes for each of these additional treatments were large and clinically significant. The mean scores on the primary outcome measure, the Insomnia Severity Index, were 5.74 for CT and 6.69 for MBT, which are within the good-sleeper range. Treatment effects were maintained at follow-up. There were no significant differences between CT and MBT on any outcome measure. These results provide encouraging data on how to enhance CBT for treatment of insomnia. Copyright © 2015 John Wiley & Sons, Ltd. CBT treatments for insomnia can be enhanced using recent developments in cognitive therapy. CBT treatments for insomnia can be enhanced using mindfulness-based treatments. Both cognitive therapy and mindfulness produce additional clinically significant change. Copyright © 2015 John Wiley & Sons, Ltd.

Effectiveness and cost-effectiveness of embedded simulation in occupational therapy clinical practice education: study protocol for a randomised controlled trial.

Science.gov (United States)

Imms, Christine; Chu, Eli Mang Yee; Guinea, Stephen; Sheppard, Loretta; Froude, Elspeth; Carter, Rob; Darzins, Susan; Ashby, Samantha; Gilbert-Hunt, Susan; Gribble, Nigel; Nicola-Richmond, Kelli; Penman, Merrolee; Gospodarevskaya, Elena; Mathieu, Erin; Symmons, Mark

2017-07-21

Clinical placements are a critical component of the training for health professionals such as occupational therapists. However, with growing student enrolments in professional education courses and workload pressures on practitioners, it is increasingly difficult to find sufficient, suitable placements that satisfy program accreditation requirements. The professional accrediting body for occupational therapy in Australia allows up to 200 of the mandatory 1000 clinical placement hours to be completed via simulation activities, but evidence of effectiveness and efficiency for student learning outcomes is lacking. Increasingly placement providers charge a fee to host students, leading educators to consider whether providing an internal program might be a feasible alternative for a portion of placement hours. Economic analysis of the incremental costs and benefits of providing a traditional versus simulated placement is required to inform decision-making. This study is a pragmatic, non-inferiority, single-blind, multicentre, two-group randomised controlled trial (RCT) with an embedded economic analysis. The RCT will compare a block of 40 hours of simulated placement (intervention) with a 40-hour block of traditional placement (comparator), with a focus on student learning outcomes and delivery costs. Six universities will instigate the educational intervention within their respective occupational therapy courses, randomly assigning their cohort of students (1:1 allocation) to the simulated or traditional clinical placements. The primary outcome is achievement of professional behaviours (e.g. communication, clinical reasoning) as assessed by a post-placement written examination. Secondary outcomes include proportions passing the placement assessed using the Student Practice Evaluation Form-Revised, changes in student confidence pre-/post-placement, student and educator evaluation of the placement experience and cost-effectiveness of simulated versus traditional

Clinical manifestations and outcome of tuberculous sclerokeratitis.

Science.gov (United States)

Shoughy, Samir S; Jaroudi, Mahmoud O; Tabbara, Khalid F

2016-09-01

To study the clinical manifestations and outcome of patients with tuberculous sclerokeratitis treated with antituberculous therapy without concomitant use of systemic steroids. We reviewed retrospectively the medical records of eight consecutive patients with tuberculous sclerokeratitis. Patients were treated unsuccessfully with topical and/or systemic steroids. They underwent complete ophthalmic examination, systemic evaluation, laboratory investigations and imaging. Tuberculin skin test was done with purified protein derivative (PPD) on all patients. The diagnosis of tuberculous sclerokeratitis was made based on clinical findings of scleritis with adjacent peripheral corneal stromal keratitis, positive PPD test of 15 mm of induration or more, response to antituberculous treatment (ATT) within 4 weeks and exclusion of other causes of sclerokeratitis. Antituberculous drugs were given for a minimum of 6 months without concomitant use of corticosteroids. The outcome measure was resolution of the ocular surface inflammation of the sclera and cornea. Eight consecutive patients with a diagnosis of tuberculous sclerokeratitis were included. There were one male and seven female patients. The mean age was 29 years with an age range of 7-43 years. The involvement of the sclera was nodular in six patients and diffuse in two. The involvement of the cornea consisted of peripheral corneal stromal inflammation adjacent to the area of scleritis. Patients responded to antituberculous medications with complete resolution of the sclerokeratitis without topical or systemic anti-inflammatory agents. Antituberculous medications can lead to complete resolution of the sclerokeratitis without concomitant use of steroids, or other anti-inflammatory agents. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Impact of the level of metabolic control on the non-surgical periodontal therapy outcomes in diabetes mellitus type 2 patients: Clinical effects

Directory of Open Access Journals (Sweden)

Mirnić Jelena

2013-01-01

Full Text Available Introduction. Diabetes mellitus as a complex metabolic disease influences functioning of numerous organs. Chronic periodontitis is one of frequent diabetic complications. Objective. The aim of this study was to compare the clinical effects of non­surgical periodontal therapy between diabetes mellitus type 2 patients (DM type 2 and non­diabetic individuals (control group. Methods. Our study included 41 DM type 2 subjects and 21 non­diabetic individuals, all of them with chronic periodontitis. The diabetic group was divided into two subgroups based on the level of glycosylated hemoglobin (HbA1c as follows: D1 - 18 subjects with good metabolic control (HbA1c<7%, and D2 - 23 subjects with poor metabolic (HbA1c≥7%. State of oral hygiene and periodontal clinical parameters of subjects, such as: plaque index (PI, gingival index (GI, papilla bleeding index (PBI, probing pocket depth (PPD and clinical attachment level (CAL, were evaluated at the baseline and 3 months after scaling and root­planning. Results. ANOVA test showed that there was no statistically significant difference of treatment success between studied groups in relation to GI (p=0.52, PBI (p=0.36 and CAL (p=0.11. Reduction of PI and PPD in the control group (ΔPI=0.84; ΔPPD=0.35 mm was significantly higher (p<0.05 than the reduction of PI and PPD in patients with the diabetes (group D1 ΔPI=0.60, ΔPPD=0.11 mm; group D2 ΔPI=0.53, ΔPPD=0.11 mm. Conclusion. Although there were differences in treatment success between DM subjects and non­diabetic individuals, they were not significant for the most measured parameters. The results of this study did not absolutely support the assumption that the level of glycemic control significantly affected the periodontal therapy outcome in diabetics. [Projekat Ministarstva nauke Republike Srbije, br. 175075

Radiological characteristics, histological features and clinical outcomes of lung cancer patients with coexistent idiopathic pulmonary fibrosis.

Science.gov (United States)

Khan, K A; Kennedy, M P; Moore, E; Crush, L; Prendeville, S; Maher, M M; Burke, L; Henry, M T

2015-02-01

Despite advances in diagnosis and management, the outcomes for both lung cancer and idiopathic pulmonary fibrosis (IPF) are still unfavourable. The pathophysiology and outcomes for patients with concomitant lung cancer and IPF remains unclear. A retrospective analysis was performed of all patients presenting with concomitant IPF and lung cancer to our centre over a 3-year period. Patients with connective tissue disease, asbestos exposure, sarcoidosis, previous thoracic radiation, radiological evidence of fibrosis but no histological confirmation of lung cancer, or the use of medications known to cause pulmonary fibrosis were excluded. We describe clinical, radiological and pathological characteristics of this group. We also report the response to standardized lung cancer therapy in this cohort. Of 637 lung cancer patients, 34 were identified with concomitant IPF (5.3 %) and all were smokers. 85 % had non-small cell lung cancer, 41 % were squamous cell cancers. The majority of tumours were located in the lower lobes, peripheral and present in an area of honeycombing. Despite the fact that approximately 2/3rds of the patients had localised or locally advanced lung cancer, the outcome of therapy for lung cancer was extremely poor regardless of tumour stage or severity of IPF. At our centre, 1/20 patients with lung cancer have concomitant IPF. The majority of these tumours are small in size, peripheral in location and squamous cell carcinoma; in an area of honey combing. The outcome for concomitant lung cancer and IPF regardless of stage or therapy is poor.

Long-term outcome on renal replacement therapy in patients who previously received a keto acid-supplemented very-low-protein diet.

Science.gov (United States)

Chauveau, Philippe; Couzi, Lionel; Vendrely, Benoit; de Précigout, Valérie; Combe, Christian; Fouque, Denis; Aparicio, Michel

2009-10-01

The consequences of a supplemented very-low-protein diet remain a matter of debate with regard to patient outcome before or after the onset of renal replacement therapy. We evaluated the long-term clinical outcome during maintenance dialysis and/or transplantation in patients who previously received a supplemented very-low-protein diet. We assessed the outcome of 203 patients who received a supplemented very-low-protein diet for >3 mo (inclusion period: 1985-2000) and started dialysis after a mean diet duration of 33.1 mo (4-230 mo). The survival rate in the whole cohort was 79% and 63% at 5 and 10 y, respectively. One hundred two patients continued with chronic dialysis during the entire follow-up, and 101 patients were grafted at least once. Patient outcomes were similar to those of the French Dialysis Registry patients for the dialysis group and similar to the 865 patients who were transplanted in Bordeaux during the same period for the transplant group. There was no correlation between death rate and duration of diet. The lack of correlation between death rate and duration of diet and the moderate mortality rate observed during the first 10 y of renal replacement therapy confirm that a supplemented very-low-protein diet has no detrimental effect on the outcome of patients with chronic kidney disease who receive renal replacement therapy.

Spectral pulsed-wave tissue Doppler imaging lateral-to-septal delay fails to predict clinical or echocardiographic outcome after cardiac resynchronization therapy

NARCIS (Netherlands)

O.I.I. Soliman (Osama Ibrahim Ibrahim); D.A.M.J. Theuns (Dominic); M.L. Geleijnse (Marcel); A. Nemes (Attila); K. Caliskan (Kadir); W.B. Vletter (Wim); L.J.L.M. Jordaens (Luc); F.J. ten Cate (Folkert)

2007-01-01

textabstractAims: The current study sought to assess if pre-implantation lateral-to-septal delay (LSD) ≥60 ms assessed by spectral pulsed-wave myocardial tissue Doppler imaging (PW-TDI) could predict successful long-term outcome after cardiac resynchronization therapy (CRT). Methods and results

Adherence to inhaled therapies, health outcomes and costs in patients with asthma and COPD

DEFF Research Database (Denmark)

Mäkelä, Mika J; Backer, Vibeke; Hedegaard, Morten

2013-01-01

Suboptimal adherence to pharmacological treatment of asthma and chronic obstructive pulmonary disease (COPD) has adverse effects on disease control and treatment costs. The reasons behind non-adherence revolve around patient knowledge/education, inhaler device convenience and satisfaction, age...... and clinical efficacy is positive, with improved symptom control and lung function shown in most studies of adults, adolescents and children. Satisfaction with inhaler devices is also positively correlated with improved adherence and clinical outcomes, and reduced costs. Reductions in healthcare utilisation......, adverse effects and medication costs. Age is of particular concern given the increasing prevalence of asthma in the young and increased rates of non-adherence in adolescents compared with children and adults. The correlation between adherence to inhaled pharmacological therapies for asthma and COPD...

Outcomes of radiation therapy for maxillary sinus carcinoma

International Nuclear Information System (INIS)

Komiyama, Takafumi; Kato, Daiki; Hara, Ryusuke; Itami, Jun; Onishi, Hiroshi; Kuriyama, Kengo; Tanaka Shiho; Araki, Tsutomu

2004-01-01

We evaluated the outcome of radiation therapy for maxillary sinus carcinoma treated in our institution. From 1984 to 2001, 48 patients with maxillary sinus carcinoma were irradiated with or without chemotherapy and surgery. Patients ranged from 20-89 years of age (median, 68 years) and included 29 men and 19 women. The clinical T factors for these patients, according to the International Union Against Cancer (UICC) classification (1997), were T2 (n=2), T3 (n=13), and T4 (n=29). Lymph node involvement was observed in 13 patients. The follow-up period ranged from 2.5 to 150 months (median, 25 months). The total radiotherapy dose ranged from 40 Gy to 72.8 Gy. Forty-three patients underwent surgery. Intra-arterial chemotherapy was delivered in 39 patients, and systemic chemotherapy was delivered in 7 patients. Fourteen patients were classified as ''unresected'' (radiation therapy with or without antrostomy), and 34 patients as ''resected'' (partial, total, or extended total maxillectomy with pre-or postoperative irradiation). The 5-year overall survival rate (OS), cause-specific survival rate (CSS), and local control rate (LC) of all patients were 52%, 64%, and 75%, respectively. There was no significant difference between the ''unresected'' and ''resected'' groups in OS, CSS, or LC. Local recurrence was observed in 12 patients. In the ''resected'' group, for local control, it was important to reduce viable tumor before maxillectomy. Preoperative ≥60 Gy irradiation was considered to be effective to reduce tumor viability. There was no significant difference between the ''unresected'' and ''resected'' groups in OS, CSS, or LC. In the ''resected'' group, preoperative irradiation ≥60 Gy was considered to be effective for local control. In radical treatment of maxillary sinus carcinoma, maxillectomy is not always necessary. Concurrent chemoradiation therapy with or without antrostomy is a reasonable treatment strategy. (author)

Clinical Outcomes Using Accelerated Partial Breast Irradiation in Patients With Invasive Lobular Carcinoma

Energy Technology Data Exchange (ETDEWEB)

Shah, Chirag; Wilkinson, J. Ben; Shaitelman, Simona; Grills, Inga; Wallace, Michelle; Mitchell, Christina [Department of Radiation Oncology, Beaumont Cancer Institute, Oakland University William Beaumont School of Medicine, Royal Oak, MI (United States); Vicini, Frank, E-mail: fvicini@beaumont.edu [Department of Radiation Oncology, Beaumont Cancer Institute, Oakland University William Beaumont School of Medicine, Royal Oak, MI (United States)

2011-11-15

Purpose: We compared clinical outcomes of women diagnosed with either invasive lobular carcinoma (ILC) or invasive ductal carcinoma (IDC) treated with accelerated partial breast irradiation (APBI). Methods and Materials: A total of 16 patients with ILC received APBI as part of their breast-conservation therapy (BCT) and were compared with 410 patients with IDC that received APBI as part of their BCT. Clinical, pathologic, and treatment related variables were analyzed including age, tumor size, hormone receptor status, surgical margins, lymph node status, adjuvant hormonal therapy, adjuvant chemotherapy, and APBI modality. Clinical outcomes including local recurrence (LR), regional recurrence (RR), disease-free survival (DFS), cause-specific survival (CSS), and overall survival (OS) were analyzed. Results: Median follow-up was 3.8 years for the ILC patients and 6.0 years for the IDC patients. ILC patients were more likely to have positive margins (20.0% vs. 3.9%, p = 0.006), larger tumors (14.1 mm vs. 10.9 mm, p = 0.03) and less likely to be node positive (0% vs. 9.5%, p < 0.001) when compared with patients diagnosed with IDC. The 5-year rate of LR was 0% for the ILC cohort and 2.5% for the IDC cohort (p = 0.59). No differences were seen in the rates of RR (0% vs. 0.7%, p = 0.80), distant metastases (0% vs. 3.5%, p = 0.54), DFS (100% vs. 94%, p = 0.43), CSS (100% vs. 97%, p = 0.59), or OS (92% vs. 89%, p = 0.88) between the ILC and IDC patients, respectively. Additionally, when node-positive patients were excluded from the IDC cohort, no differences in the rates of LR (0% vs. 2.2%, p = 0.62), RR (0% vs. 0%), DFS (100% vs. 95%, p = 0.46), CSS (100% vs. 98%, p = 0.63), or OS (92% vs. 89%, p = 0.91) were noted between the ILC and IDC patients. Conclusion: Women with ILC had excellent clinical outcomes after APBI. No difference in local control was seen between patients with invasive lobular versus invasive ductal histology.

Clinical Outcomes Using Accelerated Partial Breast Irradiation in Patients With Invasive Lobular Carcinoma

International Nuclear Information System (INIS)

Shah, Chirag; Wilkinson, J. Ben; Shaitelman, Simona; Grills, Inga; Wallace, Michelle; Mitchell, Christina; Vicini, Frank

2011-01-01

Purpose: We compared clinical outcomes of women diagnosed with either invasive lobular carcinoma (ILC) or invasive ductal carcinoma (IDC) treated with accelerated partial breast irradiation (APBI). Methods and Materials: A total of 16 patients with ILC received APBI as part of their breast-conservation therapy (BCT) and were compared with 410 patients with IDC that received APBI as part of their BCT. Clinical, pathologic, and treatment related variables were analyzed including age, tumor size, hormone receptor status, surgical margins, lymph node status, adjuvant hormonal therapy, adjuvant chemotherapy, and APBI modality. Clinical outcomes including local recurrence (LR), regional recurrence (RR), disease-free survival (DFS), cause-specific survival (CSS), and overall survival (OS) were analyzed. Results: Median follow-up was 3.8 years for the ILC patients and 6.0 years for the IDC patients. ILC patients were more likely to have positive margins (20.0% vs. 3.9%, p = 0.006), larger tumors (14.1 mm vs. 10.9 mm, p = 0.03) and less likely to be node positive (0% vs. 9.5%, p < 0.001) when compared with patients diagnosed with IDC. The 5-year rate of LR was 0% for the ILC cohort and 2.5% for the IDC cohort (p = 0.59). No differences were seen in the rates of RR (0% vs. 0.7%, p = 0.80), distant metastases (0% vs. 3.5%, p = 0.54), DFS (100% vs. 94%, p = 0.43), CSS (100% vs. 97%, p = 0.59), or OS (92% vs. 89%, p = 0.88) between the ILC and IDC patients, respectively. Additionally, when node-positive patients were excluded from the IDC cohort, no differences in the rates of LR (0% vs. 2.2%, p = 0.62), RR (0% vs. 0%), DFS (100% vs. 95%, p = 0.46), CSS (100% vs. 98%, p = 0.63), or OS (92% vs. 89%, p = 0.91) were noted between the ILC and IDC patients. Conclusion: Women with ILC had excellent clinical outcomes after APBI. No difference in local control was seen between patients with invasive lobular versus invasive ductal histology.

Effect of Field Size and Length of Plantar Spur on Treatment Outcome in Radiation Therapy of Plantar Fasciitis: The Bigger the Better?

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Hermann, Robert Michael, E-mail: hermann@strahlentherapie-westerstede.com [Zentrum für Strahlentherapie und Radioonkologie, Bremen/Westerstede (Germany); Abteilung Strahlentherapie und Spezielle Onkologie, Medizinische Hochschule Hannover (Germany); Meyer, Andreas [Abteilung Strahlentherapie und Spezielle Onkologie, Medizinische Hochschule Hannover (Germany); Gemeinschaftspraxis für Strahlentherapie Hildesheim/Goslar (Germany); Becker, Alexandra [Zentrum für Strahlentherapie und Radioonkologie, Bremen/Westerstede (Germany); Schneider, Michael [Orthopaedic Centre for Musculoskeletal Research, University of Würzburg (Germany); Reible, Michael; Carl, Ulrich Martin [Zentrum für Strahlentherapie und Radioonkologie, Bremen/Westerstede (Germany); Christiansen, Hans [Abteilung Strahlentherapie und Spezielle Onkologie, Medizinische Hochschule Hannover (Germany); Nitsche, Mirko [Zentrum für Strahlentherapie und Radioonkologie, Bremen/Westerstede (Germany); Klinik für Strahlentherapie, Karl-Lennert-Krebscentrum, Universität Kiel (Germany)

2013-12-01

Purpose: Radiation therapy is well established in the treatment of painful plantar fasciitis or heel spur. A retrospective analysis was conducted to investigate the effect of field definition on treatment outcome and to determine the impact of factors potentially involved. Methods and Materials: A review of treatment data of 250 patients (285 heels) with a mean follow-up time of 11 months showed that complete symptom remission occurred in 38%, partial remission in 32%, and no change in 19% (11% were lost to follow-up). Variables such as radiologic evidence of plantar spurs, their length, radiation dose, field size, age, sex, and onset of pain before administration of radiation therapy were investigated in univariate and multivariate regression analyses. Results: Treatment response depended upon age >53 years, length of heel spur ≤6.5 mm (or no radiologic evidence of a heel spur), and onset of pain <12 months before radiation therapy. Patients with these clinical prerequisites stood a 93% chance of clinical response. Without these prerequisites, only 49% showed any impact. No influence of field size on treatment outcome became evident. Conclusion: Patients with short plantar heel spurs benefit from radiation therapy equally well as patients without any radiologic evidence. Moreover, smaller field sizes have the same positive effect as commonly used large field definitions covering the entire calcaneal bone. This leads to a recommendation of a considerable reduction of field size in future clinical practice.

Effect of Field Size and Length of Plantar Spur on Treatment Outcome in Radiation Therapy of Plantar Fasciitis: The Bigger the Better?

International Nuclear Information System (INIS)

Hermann, Robert Michael; Meyer, Andreas; Becker, Alexandra; Schneider, Michael; Reible, Michael; Carl, Ulrich Martin; Christiansen, Hans; Nitsche, Mirko

2013-01-01

Purpose: Radiation therapy is well established in the treatment of painful plantar fasciitis or heel spur. A retrospective analysis was conducted to investigate the effect of field definition on treatment outcome and to determine the impact of factors potentially involved. Methods and Materials: A review of treatment data of 250 patients (285 heels) with a mean follow-up time of 11 months showed that complete symptom remission occurred in 38%, partial remission in 32%, and no change in 19% (11% were lost to follow-up). Variables such as radiologic evidence of plantar spurs, their length, radiation dose, field size, age, sex, and onset of pain before administration of radiation therapy were investigated in univariate and multivariate regression analyses. Results: Treatment response depended upon age >53 years, length of heel spur ≤6.5 mm (or no radiologic evidence of a heel spur), and onset of pain <12 months before radiation therapy. Patients with these clinical prerequisites stood a 93% chance of clinical response. Without these prerequisites, only 49% showed any impact. No influence of field size on treatment outcome became evident. Conclusion: Patients with short plantar heel spurs benefit from radiation therapy equally well as patients without any radiologic evidence. Moreover, smaller field sizes have the same positive effect as commonly used large field definitions covering the entire calcaneal bone. This leads to a recommendation of a considerable reduction of field size in future clinical practice

Predictive factors and outcomes for ibrutinib therapy in relapsed/refractory mantle cell lymphoma-a "real world" study.

Science.gov (United States)

Epperla, Narendranath; Hamadani, Mehdi; Cashen, Amanda F; Ahn, Kwang W; Oak, Eunhye; Kanate, Abraham S; Calzada, Oscar; Cohen, Jonathon B; Farmer, Luke; Ghosh, Nilanjan; Tallarico, Michael; Nabhan, Chadi; Costa, Luciano J; Kenkre, Vaishalee P; Hari, Parameswaran N; Fenske, Timothy S

2017-12-01

Ibrutinib has demonstrated significant activity in relapsed/refractory mantle cell lymphoma (MCL) in clinical trials. However, the impact of hematopoietic cell transplantation on the outcomes of ibrutinib and the predictive factors for ibrutinib response has not been well studied. Hence, we conducted a multicenter retrospective study of MCL patients who received ibrutinib to (1) determine the overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) of ibrutinib in routine clinical practice, (2) examine characteristics predictive of response to ibrutinib therapy, and (3) describe the outcomes of patients failing ibrutinib. Ninety-seven patients met the eligibility criteria. Overall response rate and median DOR to ibrutinib were 65% and 17 months, respectively. Only lack of primary refractory disease was predictive of ibrutinib response on multivariate analysis. Twenty-nine patients received postibrutinib therapies, with an ORR of 48% and a median DOR of 3 months. The median OS and PFS for the entire group (n = 97) was 22 and 15 months, respectively. On multivariate analysis, ibrutinib response, low MCL international prognostic index, and absence of primary refractory disease were predictors of better PFS, while ibrutinib response and Eastern Cooperative Oncology Group performance status ≤1 were predictors of better OS. The median OS postibrutinib failure was 2.5 months. Our results confirm the high ORR and DOR of ibrutinib in MCL and that prior hematopoietic cell transplantation does not negatively influence ibrutinib outcomes. Survival following ibrutinib failure is poor with no specific subsequent therapy showing superior activity in this setting. As a result, for select (transplant eligible) patients, allogeneic transplant should be strongly considered soon after ibrutinib response is documented to provide durable responses. Copyright © 2017 John Wiley & Sons, Ltd.

Physical therapy activities in stroke, knee arthroplasty, and traumatic brain injury rehabilitation: their variation, similarities, and association with functional outcomes.

Science.gov (United States)

DeJong, Gerben; Hsieh, Ching-Hui; Putman, Koen; Smout, Randall J; Horn, Susan D; Tian, Wenqiang

2011-12-01

concurrently considering other therapies such as occupational therapy, speech-language pathology, nursing care, and case management or the potential interaction of these inputs. This analysis did not consider the interventions that physical therapists used when patients participated in discrete physical therapy activities. All 3 patient groups spent a considerable portion of their physical therapy time in gait training relative to other activities. Both gait training and community mobility are higher-level activities that were positively associated with outcomes, although all 3 groups spent little time in community mobility activities. Further research studies, such as randomized clinical trials and predictive validity studies, are needed to investigate whether higher-level or more-integrated therapy activities are associated with better patient outcomes.

Physical Therapy Activities in Stroke, Knee Arthroplasty, and Traumatic Brain Injury Rehabilitation: Their Variation, Similarities, and Association With Functional Outcomes

Science.gov (United States)

Hsieh, Ching-Hui; Putman, Koen; Smout, Randall J.; Horn, Susan D.; Tian, Wenqiang

2011-01-01

focused primarily on physical therapy without concurrently considering other therapies such as occupational therapy, speech-language pathology, nursing care, and case management or the potential interaction of these inputs. This analysis did not consider the interventions that physical therapists used when patients participated in discrete physical therapy activities. Conclusions All 3 patient groups spent a considerable portion of their physical therapy time in gait training relative to other activities. Both gait training and community mobility are higher-level activities that were positively associated with outcomes, although all 3 groups spent little time in community mobility activities. Further research studies, such as randomized clinical trials and predictive validity studies, are needed to investigate whether higher-level or more-integrated therapy activities are associated with better patient outcomes. PMID:22003165

cagA Status and Eradication Treatment Outcome of Anti-Helicobacter pylori Triple Therapies in Patients with Nonulcer Dyspepsia

Science.gov (United States)

Broutet, Nathalie; Marais, Armelle; Lamouliatte, Hervé; de Mascarel, Antoine; Samoyeau, Roland; Salamon, Roger; Mégraud, Francis

2001-01-01

The differences in eradication rates reported in clinical trials aiming to cure Helicobacter pylori infection cannot be entirely explained by the type of regimen, bacterial resistance, or lack of compliance. Using data from a clinical trial, a logistic regression model was constructed to determine whether cagA status, assessed by PCR, affects the outcome of eradication. Resistance to clarithromycin (10% of the strains) predicted failure perfectly. In the model (n = 156), a cagA-lacking strain (odds ratio [OR] = 2.2; 95% confidence interval [CI], (1.1 to 4.7), tobacco smoking OR = 3.1; 95% CI, 1.3 to 7.0), and a double dose of proton pump inhibitor in the treatment regimen (OR = 0.3; 95% CI, 0.2 to 0.7) were associated with the treatment outcome. The exact role of cagA in the outcome of H. pylori eradication therapy has not been explored. However, the type of histological lesions which it causes in the gastric mucosa may be implicated. Regardless of the mechanism involved, cagA status is a good predictive marker of eradication outcome. PMID:11283049

Breast-conserving therapy as a model for creating new knowledge in clinical oncology

International Nuclear Information System (INIS)

Harris, Jay R.

1995-01-01

New knowledge can be derived from various kinds of studies. Studies of innovative approaches are the basis for progress. Some advances in treatment are so obvious that they do not need formal testing; e.g., penicillin for pneumococcal infection. For comparing interventions with small differences in efficacy or in groups without predictable outcome, prospective randomized trials are the 'gold standard'. However, randomized trials are cumbersome, expensive, and potentially difficult for both patients and physicians. Retrospective studies are less valid scientifically because they are more likely to suffer from bias, misclassification, confounding variables, and the use of multiple comparisons. Retrospective studies can be made more valid by first specifying the study design and analysis, but are generally most useful to generate hypotheses to be tested more formally. Retrospective studies can be particularly useful in improving outcome by identifying 'problems' and their causes. An important issue for radiation oncologists in doing retrospective studies is the difficulty of assessing an effect on local tumor control in diseases in which there are competing risks of local and distant failure. Many of these points will be illustrated in studies from the Joint Center for Radiation Therapy. Studies of innovative approaches, retrospective reviews and prospective randomized clinical trials have all been useful in establishing breast-conserving therapy as a safe and effective treatment for patients with early-stage breast cancer. Several studies of innovative breast-conserving therapy beginning in the 1960's showed favorable results. Based on this experience, a series of randomized clinical trials were initiated, beginning in the early 1970's, formally comparing mastectomy and breast-conserving therapy. These trials firmly established that the two forms of local treatment provide equivalent survival. Additional retrospective studies have also been useful in establishing

Ultrasound-Guided Application of Percutaneous Electrolysis as an Adjunct to Exercise and Manual Therapy for Subacromial Pain Syndrome: a Randomized Clinical Trial.

Science.gov (United States)

de-Miguel-Valtierra, Lorena; Salom-Moreno, Jaime; Fernández-de-Las-Peñas, César; Cleland, Joshua A; Arias-Buría, José L

2018-05-16

This randomized clinical trial compared the effects of adding US-guided percutaneous electrolysis into a program consisting of manual therapy and exercise on pain, related-disability, function and pressure sensitivity in subacromial pain syndrome. Fifty patients with subacromial pain syndrome were randomized into manual therapy and exercise or percutaneous electrolysis group. All patients received the same manual therapy and exercise program, one session per week for 5 consecutive weeks. Patients assigned to the electrolysis group also received the application of percutaneous electrolysis at each session. The primary outcome was Disabilities of the Arm, Shoulder and Hand (DASH). Secondary outcomes included pain, function (Shoulder Pain and Disability Index-SPADI) pressure pain thresholds (PPTs) and Global Rating of Change (GROC). They were assessed at baseline, post-treatment, and 3, and 6 months after treatment. Both groups showed similar improvements in the primary outcome (DASH) at all follow-ups (P=0.051). Subjects receiving manual therapy, exercise, and percutaneous electrolysis showed significantly greater changes in shoulder pain (P0.91) for shoulder pain and function at 3 and 6 months in favour of the percutaneous electrolysis group. No between-groups differences in PPT were found. The current clinical trial found that the inclusion of US-guided percutaneous electrolysis in combination with manual therapy and exercise resulted in no significant differences for related-disability (DASH) than the application of manual therapy and exercise alone in patients with subacromial pain syndrome. Nevertheless, differences were reported for some secondary outcomes such as shoulder pain and function (SPADI). Whether or not these effects are reliable should be addressed in future studies Perspective This study found that the inclusion of US-guided percutaneous electrolysis into a manual therapy and exercise program resulted in no significant differences for disability

Clinical, patient-related, and economic outcomes of home-based high-dose hemodialysis versus conventional in-center hemodialysis

Directory of Open Access Journals (Sweden)

Mitsides N

2016-07-01

Full Text Available Nicos Mitsides,1,2 Sandip Mitra,1,2 Tom Cornelis3 1Department of Renal Medicine, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Center, Manchester, 2National Institute for Healthcare Research Devices for Dignity Healthcare Co-operative, Sheffield, UK; 3Department of Nephrology, Jessa Hospital, Hasselt, Belgium Abstract: Despite technological advances in renal replacement therapy, the preservation of health and quality of life for individuals on dialysis still remains a challenge. The high morbidity and mortality in dialysis warrant further research and insight into the clinical domains of the technique and practice of this therapy. In the last 20 years, the focus of development in the field of hemodialysis (HD has centered around adequate removal of urea and other associated toxins. High-dose HD offers an opportunity to improve mortality, morbidity, and quality of life of patients with end-stage kidney disease. However, the uptake of this modality is low, and the risk associated with the therapy is not fully understood. Recent studies have highlighted the evidence base and improved our understanding of this technique of dialysis. This article provides a review of high-dose and home HD, its clinical impact on patient outcome, and the controversies that exist. Keywords: hemodialysis, home dialysis, high dose, outcomes

Children's resilience and trauma-specific cognitive behavioral therapy: Comparing resilience as an outcome, a trait, and a process.

Science.gov (United States)

Happer, Kaitlin; Brown, Elissa J; Sharma-Patel, Komal

2017-11-01

Resilience, which is associated with relatively positive outcomes following negative life experiences, is an important research target in the field of child maltreatment (Luthar et al., 2000). The extant literature contains multiple conceptualizations of resilience, which hinders development in research and clinical utility. Three models emerge from the literature: resilience as an immediate outcome (i.e., behavioral or symptom response), resilience as a trait, and resilience as a dynamic process. The current study compared these models in youth undergoing trauma-specific cognitive behavioral therapy. Results provide the most support for resilience as a process, in which increase in resilience preceded associated decrease in posttraumatic stress and depressive symptoms. There was partial support for resilience conceptualized as an outcome, and minimal support for resilience as a trait. Results of the models are compared and discussed in the context of existing literature and in light of potential clinical implications for maltreated youth seeking treatment. Copyright © 2017 Elsevier Ltd. All rights reserved.

Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer.

Science.gov (United States)

Tibau, Ariadna; Anguera, Geòrgia; Andrés-Pretel, Fernando; Templeton, Arnoud J; Seruga, Bostjan; Barnadas, Agustí; Amir, Eitan; Ocana, Alberto

2018-03-13

Clinical research is conducted by academia, cooperative groups (CGs) or pharmaceutical industry. Here, we evaluate the role of CGs and funding sources in the development of guidelines for breast cancer therapies. We identified 94 studies. CGs were involved in 28 (30%) studies while industry either partially or fully sponsored 64 (68%) studies. The number of industry funded studies increased over time (from 0% in 1976 to 100% in 2014; p for trend = 0.048). Only 10 (11%) government or academic studies were identified. Studies conducted by GCs included a greater number of subjects (median 448 vs. 284; p = 0.015), were more common in the neo/adjuvant setting ( p funding was associated with higher likelihood of positive outcomes favoring the sponsored experimental arm ( p = 0.013) but this relationship was not seen for CG-sponsored trials ( p = 0.53). ASCO, ESMO, and NCCN guidelines were searched to identify systemic anti-cancer therapies for early-stage and metastatic breast cancer. Trial characteristics and outcomes were collected. We identified sponsors and/or the funding source(s) and determined whether CGs, industry, or government or academic institutions were involved. Chi-square tests were used for comparison between studies. Industry funding is present in the majority of studies providing the basis for which recommendations about treatment of breast cancer are made. Industry funding, but not CG-based funding, was associated with higher likelihood of positive outcomes in clinical studies supporting guidelines for systemic therapy.

Dance/movement therapy for improving psychological and physical outcomes in cancer patients.

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Bradt, Joke; Shim, Minjung; Goodill, Sherry W

2015-01-07

Current cancer care increasingly incorporates psychosocial interventions. Cancer patients use dance/movement therapy to learn to accept and reconnect with their bodies, build new self-confidence, enhance self-expression, address feelings of isolation, depression, anger and fear and to strengthen personal resources. To update the previously published review that examined the effects of dance/movement therapy and standard care versus standard care alone or standard care and other interventions on psychological and physical outcomes in patients with cancer. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 6), MEDLINE (OvidSP, 1950 to June week 4, 2014), EMBASE (OvidSP, 1980 to 2014 week 26), CINAHL (EBSCOhost, 1982 to July 15 2014), PsycINFO (EBSCOhost, 1806 to July 15 2014), LILACS (Virual Health Library, 1982 to July 15 2014), Science Citation Index (ISI, 1974 to July 15 2014), CancerLit (1983 to 2003), International Bibliography of Theatre and Dance (1989 to July 15 2014), the National Research Register (2000 to September 2007), Proquest Digital Dissertations, ClinicalTrials.gov, and Current Controlled Trials (all to July 15 2014). We handsearched dance/movement therapy and related topics journals, reviewed reference lists and contacted experts. There was no language restriction. We included all randomized and quasi-randomized controlled trials of dance/movement therapy interventions for improving psychological and physical outcomes in patients with cancer. We considered studies only if dance/movement therapy was provided by a formally trained dance/movement therapist or by trainees in a formal dance/movement therapy program. Two review authors independently extracted the data and assessed the methodological quality, seeking additional information from the trial researchers when necessary. Results were presented using standardized mean differences. We identified one new trial for inclusion in this update. In

State of the Art for Deep Brain Stimulation Therapy in Movement Disorders: A Clinical and Technological Perspective.

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Wagle Shukla, Aparna; Okun, Michael S

2016-01-01

Deep brain stimulation (DBS) therapy is a widely used brain surgery that can be applied for many neurological and psychiatric disorders. DBS is American Food and Drug Administration approved for medication refractory Parkinson's disease, essential tremor and dystonia. Although DBS has shown consistent success in many clinical trials, the therapy has limitations and there are well-recognized complications. Thus, only carefully selected patients are ideal candidates for this surgery. Over the last two decades, there have been significant advances in clinical knowledge on DBS. In addition, the surgical techniques and technology related to DBS has been rapidly evolving. The goal of this review is to describe the current status of DBS in the context of movement disorders, outline the mechanisms of action for DBS in brief, discuss the standard surgical and imaging techniques, discuss the patient selection and clinical outcomes in each of the movement disorders, and finally, introduce the recent advancements from a clinical and technological perspective.

Prior antiplatelet therapy and outcome following intracerebral hemorrhage: a systematic review

DEFF Research Database (Denmark)

Thompson, B B; Béjot, Y; Caso, V

2010-01-01

Antiplatelet therapy (APT) promotes bleeding; therefore, APT might worsen outcome in patients with intracerebral hemorrhage (ICH). We performed a systematic review and meta-analysis to address the hypothesis that pre-ICH APT use is associated with mortality and poor functional outcome following ICH....

Kinematic measures for upper limb robot-assisted therapy following stroke and correlations with clinical outcome measures: A review.

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Tran, Vi Do; Dario, Paolo; Mazzoleni, Stefano

2018-03-01

This review classifies the kinematic measures used to evaluate post-stroke motor impairment following upper limb robot-assisted rehabilitation and investigates their correlations with clinical outcome measures. An online literature search was carried out in PubMed, MEDLINE, Scopus and IEEE-Xplore databases. Kinematic parameters mentioned in the studies included were categorized into the International Classification of Functioning, Disability and Health (ICF) domains. The correlations between these parameters and the clinical scales were summarized. Forty-nine kinematic parameters were identified from 67 articles involving 1750 patients. The most frequently used parameters were: movement speed, movement accuracy, peak speed, number of speed peaks, and movement distance and duration. According to the ICF domains, 44 kinematic parameters were categorized into Body Functions and Structure, 5 into Activities and no parameters were categorized into Participation and Personal and Environmental Factors. Thirteen articles investigated the correlations between kinematic parameters and clinical outcome measures. Some kinematic measures showed a significant correlation coefficient with clinical scores, but most were weak or moderate. The proposed classification of kinematic measures into ICF domains and their correlations with clinical scales could contribute to identifying the most relevant ones for an integrated assessment of upper limb robot-assisted rehabilitation treatments following stroke. Increasing the assessment frequency by means of kinematic parameters could optimize clinical assessment procedures and enhance the effectiveness of rehabilitation treatments. Copyright © 2018 IPEM. Published by Elsevier Ltd. All rights reserved.

Predicting clinical outcome using brain activation associated with set-shifting and central coherence skills in Anorexia Nervosa.

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Garrett, Amy S; Lock, James; Datta, Nandini; Beenhaker, Judy; Kesler, Shelli R; Reiss, Allan L

2014-10-01

Patients with Anorexia Nervosa (AN) have neuropsychological deficits in Set-Shifting (SS) and central coherence (CC) consistent with an inflexible thinking style and overly detailed processing style, respectively. This study investigates brain activation during SS and CC tasks in patients with AN and tests whether this activation is a biomarker that predicts response to treatment. FMRI data were collected from 21 females with AN while performing an SS task (the Wisconsin Card Sort) and a CC task (embedded figures), and used to predict outcome following 16 weeks of treatment (either 16 weeks of cognitive behavioral therapy or 8 weeks cognitive remediation therapy followed by 8 weeks of cognitive behavioral therapy). Significant activation during the SS task included bilateral dorsolateral and ventrolateral prefrontal cortex and left anterior middle frontal gyrus. Higher scores on the neuropsychological test of SS (measured outside the scanner at baseline) were correlated with greater DLPFC and VLPFC/insula activation. Improvements in SS following treatment were significantly predicted by a combination of low VLPFC/insula and high anterior middle frontal activation (R squared = .68, p = .001). For the CC task, visual and parietal cortical areas were activated, but were not significantly correlated with neuropsychological measures of CC and did not predict outcome. Cognitive flexibility requires the support of several prefrontal cortex resources. As previous studies suggest that the VLPFC is important for selecting context-appropriate responses, patients who have difficulties with this skill may benefit the most from cognitive therapy with or without cognitive remediation therapy. The ability to sustain inhibition of an unwanted response, subserved by the anterior middle frontal gyrus, is a cognitive feature that predicts favorable outcome to cognitive treatment. CC deficits may not be an effective predictor of clinical outcome. Copyright © 2014 Elsevier Ltd. All

Childhood asthma clusters and response to therapy in clinical trials.

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Chang, Timothy S; Lemanske, Robert F; Mauger, David T; Fitzpatrick, Anne M; Sorkness, Christine A; Szefler, Stanley J; Gangnon, Ronald E; Page, C David; Jackson, Daniel J

2014-02-01

Childhood asthma clusters, or subclasses, have been developed by computational methods without evaluation of clinical utility. To replicate and determine whether childhood asthma clusters previously identified computationally in the Severe Asthma Research Program (SARP) are associated with treatment responses in Childhood Asthma Research and Education (CARE) Network clinical trials. A cluster assignment model was determined by using SARP participant data. A total of 611 participants 6 to 18 years old from 3 CARE trials were assigned to SARP pediatric clusters. Primary and secondary outcomes were analyzed by cluster in each trial. CARE participants were assigned to SARP clusters with high accuracy. Baseline characteristics were similar between SARP and CARE children of the same cluster. Treatment response in CARE trials was generally similar across clusters. However, with the caveat of a smaller sample size, children in the early-onset/severe-lung function cluster had best response with fluticasone/salmeterol (64% vs 23% 2.5× fluticasone and 13% fluticasone/montelukast in the Best ADd-on Therapy Giving Effective Responses trial; P = .011) and children in the early-onset/comorbidity cluster had the least clinical efficacy to treatments (eg, -0.076% change in FEV1 in the Characterizing Response to Leukotriene Receptor Antagonist and Inhaled Corticosteroid trial). In this study, we replicated SARP pediatric asthma clusters by using a separate, large clinical trials network. Early-onset/severe-lung function and early-onset/comorbidity clusters were associated with differential and limited response to therapy, respectively. Further prospective study of therapeutic response by cluster could provide new insights into childhood asthma treatment. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

A clinical treatment intervention for dysphoria: externalizing metaphors therapy.

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McGuinty, Everett; Armstrong, David; Carrière, Anne-Marie

2014-01-01

The purpose of this article is to explore a novel, short-term treatment intervention for internalizing behaviours. This intervention is primarily based upon an externalizing process, transforming of metaphoric imagery, and shifting of underlying maladaptive emotional schemas. This article addresses the clinical population of children and youth, specifically through outlining the protocol, externalizing metaphors therapy. A selective review of significant works regarding the efficacy of short-term therapy was conducted, including the process of change within narrative therapy. It is proposed that two specific processes account for the mental health change experienced by clients who receive this new treatment intervention: (1) externalization of problems and (2) purposeful client-generated metaphor manipulation, impacting upon underlying schemas. From these theoretical constructs, the present article outlines a three-session treatment protocol that manualizes these key clinical processes. A case study is presented to illustrate this intervention for anxiety and depression. Further clinical research is underway to address the testable hypotheses resulting from the current theoretical model. Clinical trials in brief psychotherapy are suggested to empirically evaluate the efficacy of this new treatment intervention for dysphoria. This article outlines a short-term treatment intervention for anxiety and depression (dysphoira) through a novel 3-session model, where the clinician-practitioner can obtain competency through a one-day workshop.Its relevance for the clinical researcher and the mental health community is in its versatility in addressing internalizing behavior for four clinical populations: (1) children and adolescents; (2) children and adolescents on the autism spectrum; (3) adults in general; and, (4) adults with a dual-diagnosis. The treatment protocol described within is based upon the externalizing and deconstructive properties of Narrative Therapy, and the

Antiviral therapy and outcomes of patients with pneumonia caused by influenza A pandemic (H1N1 virus.

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Shi-gui Yang

Full Text Available BACKGROUND: There is limited data on the clinical outcome of patients with pandemic H1N1 (pH1N1 pneumonia who received oseltamivir treatment, especially when the treatment was administered more than 48 hours after symptom onset. METHODS: During the pandemic in 2009, a cohort of pH1N1 influenza pneumonia was built in China, and their clinical information was collected systematically, and analyzed with Cox models. RESULTS: 920 adults and 541 children with pneumonia who didn't receive corticosteroids were analyzed. In-hospital mortality was higher in adults who did not receive antiviral therapy (18.2% than those with who received oseltamivir ≤ 2 days (2.9%, between 2-5 days (4.6% and >5 days after illness onset (4.9%, p5 days, respectively. For males patients, aged ≥ 14 years and baseline PaO(2/FiO(23.8 mg/kg/d did not improve clinical outcome (mortality, higher dose 2.5% vs standard dose 2.8%, p>0.05. CONCLUSIONS: Antiviral therapy might reduce mortality of patients with pH1N1 pneumonia, even when initiated more than 48 hours after onset of illness. Greater protective effects might be in males, patients aged 14-60 years, and patients with PaO(2/FiO(2<200.

Comparing Treatment Outcome of Guided Imagery and Music and Psychodynamic Imaginative Trauma Therapy for Women with Complex PTSD

DEFF Research Database (Denmark)

Maack, Carola

2013-01-01

To investigate whether the use of recorded music enhances therapy outcome in psychodynamic trauma therapy for women with Complex PTSD, outcome measures of three groups of patients were compared. One group received 50 hours of outpatient trauma therapy with the Bonny Method of Guided Imagery and M....... Participants treated with GIM showed significantly better outcome in all measurements than participants treated with PITT. This indicates that the use of music is beneficial for women with Complex PTSD treated with psychodynamic trauma therapy.......To investigate whether the use of recorded music enhances therapy outcome in psychodynamic trauma therapy for women with Complex PTSD, outcome measures of three groups of patients were compared. One group received 50 hours of outpatient trauma therapy with the Bonny Method of Guided Imagery...... and Music (GIM), another group received 50 hours of outpatient trauma therapy with Psychodynamic Imaginative Trauma Therapy (PITT). The third group was a waiting-list control group of women who had to wait at least nine months for therapy. The participants filled out questionnaires measuring symptoms...

Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

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Ma, Christopher; Panaccione, Remo; Fedorak, Richard N; Parker, Claire E; Khanna, Reena; Levesque, Barrett G; Sandborn, William J; Feagan, Brian G; Jairath, Vipul

2017-06-09

Crohn's disease (CD) and ulcerative colitis (UC), the main forms of inflammatory bowel disease (IBD), are chronic, progressive and disabling disorders of the gastrointestinal tract. Although data from randomised controlled trials (RCTs) provide the foundation of evidence that validates medical therapy for IBD, considerable heterogeneity exists in the measured outcomes used in these studies. Furthermore, in recent years, there has been a paradigm shift in IBD treatment targets, moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance, inflammatory biomarkers and histological and radiographic end points. The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development. Accordingly, there exists a need to harmonise measures used in clinical trials through the development of a core outcome set (COS). The development of an IBD-specific COS includes four steps. First, a systematic literature review is performed to identify outcomes previously used in IBD RCTs. Second, semistructured qualitative interviews are conducted with key stakeholders, including patients, clinicians, researchers, pharmaceutical industry representatives, healthcare payers and regulators to identify additional outcomes of importance. Using the outcomes generated from literature review and stakeholder interviews, an international two-round Delphi survey is conducted to prioritise outcomes for inclusion in the COS. Finally, a consensus meeting is held to ratify the COS and disseminate findings for application in future IBD trials. Given that over 30 novel therapeutic compounds are in development for IBD treatment, the design of robust clinical trials measuring relevant and standardised outcomes is crucial. Standardising outcomes through a COS will reduce heterogeneity in trial reporting, facilitate valid comparisons of new therapies and improve

Comparison of outcomes parameters for induction of remission in new onset pediatric Crohn's disease

DEFF Research Database (Denmark)

Levine, Arie; Turner, Dan; Pfeffer Gik, Tamar

2014-01-01

BACKGROUND: Robust evaluation of induction therapies using both clinical and inflammatory outcomes in pediatric Crohn's disease (CD) are sparse. We attempted to evaluate clinical, inflammatory, and composite outcomes of induction of remission therapies (normal C reactive protein [CRP] remission) ...

Direct endoscopic necrosectomy versus step-up approach for walled-off pancreatic necrosis: comparison of clinical outcome and health care utilization.

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Kumar, Nitin; Conwell, Darwin L; Thompson, Christopher C

2014-11-01

Infected walled-off pancreatic necrosis (WOPN) is a complication of acute pancreatitis requiring intervention. Surgery is associated with considerable morbidity. Percutaneous catheter drainage (PCD), initial therapy in the step-up approach, minimizes complications. Direct endoscopic necrosectomy (DEN) has demonstrated safety and efficacy. We compared outcome and health care utilization of DEN versus step-up approach. This was a matched cohort study using a prospective registry. Twelve consecutive DEN patients were matched with 12 step-up approach patients. Outcomes were clinical resolution after primary therapeutic modality, new organ failure, mortality, endocrine or exocrine insufficiency, length of stay, and health care utilization. Clinical resolution in 11 of 12 patients after DEN versus 3 of 12 step-up approach patients after PCD (P endocrine insufficiency, and shorter length of stay (P < 0.05). Health care utilization was lower after DEN by 5.2:1 (P < 0.01). Direct endoscopic necrosectomy may be superior to step-up approach for WOPN with suspected or established infection. Primary PCD generally delayed definitive therapy. Given the higher efficacy, shorter length of stay, and lower health care utilization, DEN could be the first-line therapy for WOPN, with primary PCD for inaccessible or immature collections.

Music therapy in the assessment and treatment of autistic spectrum disorder: clinical application and research evidence.

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Wigram, T; Gold, C

2006-09-01

Children and adolescents with autistic spectrum disorder (ASD) presenting with significant limitations in conventional forms of verbal and non-verbal communication are found to respond positively to music therapy intervention involving both active, improvizational methods and receptive music therapy approaches. Improvizational musical activity with therapeutic objectives and outcomes has been found to facilitate motivation, communication skills and social interaction, as well as sustaining and developing attention. The structure and predictability found in music assist in reciprocal interaction, from which tolerance, flexibility and social engagement to build relationships emerge, relying on a systematic approach to promote appropriate and meaningful interpersonal responses. Published reports of the value and effectiveness of music therapy as an intervention for children with ASD range from controlled studies to clinical case reports. Further documentation has emphasized the role music therapy plays in diagnostic and clinical assessment. Music therapy assessment can identify limitations and weaknesses in children, as well as strengths and potentials. Research evidence from a systematic review found two randomized controlled trials that examined short-term effects of structured music therapy intervention. Significant effects were found in these studies even with extremely small samples, and the findings are important because they demonstrate the potential of the medium of music for autistic children. Case series studies were identified that examined the effects of improvizational music therapy where communicative behaviour, language development, emotional responsiveness, attention span and behavioural control improved over the course of an intervention of improvizational music therapy.

Influence of smoking associated with stress on the outcome of radioiodine therapy in patients with Graves' disease

International Nuclear Information System (INIS)

Sekulic, V.; Rajic, M.; Vlajkovic, M.; Ilic, S.; Stevic, M.

2015-01-01

Full text of publication follows. Introduction: Graves' disease (GD) is characterized by activation of the immune system as a result of interactions between genetic predisposition and environmental factors such as iodine intake, stressful events or smoking. Currently, there are no sufficient data on influence of nicotine and other components of tobacco smoking on outcome of radioiodine therapy in GD. The aim of this study was to analyze a possible influence of cigarette smoking associated with stress on the outcome of radioiodine therapy (RIT) in the patients with Graves' disease. Patients and methods: the study included 29 patients (23 female) aged from 22 to 73 years, who were subjects of a follow-up within 12 months after RIT. The stressful events were presented in all patients prior to diagnosing the GD. Patients were divided into two groups: 1. smokers - 15 patients who smoked cigarettes before, at the moment and after RIT, and 2. non-smokers - 14 patients who were always non-smokers. Patients were treated using a sliding scale of fixed activity of radioiodine according to the goiter size. Antithyroid drugs were discontinued 7 days before radioiodine therapy. Therapy outcome was assessed by serum TSH and thyroid hormones levels, and clinical evaluation. A successful response (SR) to RIT was defined as euthyroidism and subclinical or clinical hypothyroidism, and unsuccessful response (UR) as persistent hyperthyroidism. Results: comparison of age (48.0±9.39 vs. 49.6±14.3 years, P=0.715), values of TRAb (2.25±0.91 vs. 2.75±1.32 U/l, P=0.560), administered activity of 131 I-NaI (365±75.8 vs. 360±44.4 MBq, P=0.832), and duration of ATDs therapy before RIT (3.34±3.41 vs. 5.06±5.81 years, P=0.397) between smokers and non-smokers showed no significant difference. There was no significant influence of smoking on UR at 3., 6., 9. and 12. month compared with UR in patients who did not smoke (P=0.597, P=0.837, P=0.876, P=0.812, χ 2 test). The cumulative